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Last update 07 Aug 2025

Nipocalimab-aahu

Last update 07 Aug 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

anti-FcRn monoclonal antibody(Momenta Pharmaceuticals), Immunoglobulin g1, anti-(human neonatal fc receptor) (human monoclonal m281 .gamma.-1 chain), disulfide with human monoclonal m281 .lambda.-chain, dimer, Nipocalimab (USAN)

+ [5]

Target

FcRn

Action

antagonists, modulators

Mechanism

FcRn antagonists(IgG receptor FcRn large subunit p51 antagonists), Immunomodulators

Therapeutic Areas

NeoplasmsImmune System DiseasesNervous System Diseases+ [7]

Active Indication

Myasthenia GravisPolyradiculoneuropathy, Chronic Inflammatory DemyelinatingSjogren's Syndrome+ [10]

Inactive Indication-

Originator Organization

Janssen Biotech, Inc.

Active Organization

Janssen Research & Development LLC

Johnson & Johnson (China) Investment Ltd.Janssen-Cilag International NV

+ [1]

Inactive Organization

Momenta Pharmaceuticals, Inc.

License Organization

Momenta Pharmaceuticals, Inc.

Johnson & Johnson

Drug Highest PhaseApproved

First Approval Date

United States (29 Apr 2025),

Myasthenia Gravis

RegulationBreakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Rare Pediatric Disease (United States), Orphan Drug (European Union), Priority Review (China), Breakthrough Therapy (China), Orphan Drug (Japan), Priority Review (United States)

Structure/Sequence

Sequence Code 19395495L

Source: *****

Sequence Code 19395504H

Source: *****

Clinical Trials associated with Nipocalimab-aahu

NCT04883619

/ Not yet recruitingPhase 2

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Nipocalimab in Adult Participants With Active Lupus Nephritis

The purpose of this study is to evaluate the efficacy of nipocalimab versus placebo in participants with active Lupus Nephritis (LN).

Start Date15 Jan 2026

Sponsor / Collaborator

Janssen Research & Development LLC

ISRCTN14534389

/ RecruitingPhase 2

A randomized, placebo-controlled, double-blind, multicenter phase 3 protocol to assess the efficacy and safety of nipocalimab in adults with moderate to severe Sjogren's disease (SjD)

Start Date27 Mar 2025

Sponsor / Collaborator

Janssen Research & Development LLC

NCT06533098

/ RecruitingPhase 3

Multicenter, Open-Label, Randomized Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

The purpose of this study is to assess the efficacy and safety of nipocalimab in reducing the risk of severe fetal and neonatal alloimmune thrombocytopenia (FNAIT).

Start Date10 Feb 2025

Sponsor / Collaborator

Janssen Research & Development LLC

100 Clinical Results associated with Nipocalimab-aahu

100 Translational Medicine associated with Nipocalimab-aahu

100 Patents (Medical) associated with Nipocalimab-aahu

Literatures (Medical) associated with Nipocalimab-aahu

31 Dec 2025·Human Vaccines & Immunotherapeutics

A randomized, open-label study on the effect of nipocalimab on vaccine responses in healthy participants

Article

Author: Jackson, Amanda ; Scott, Brittney ; Beier, Ulf H. ; Myshkin, Eugene ; Dimitrova, Dessislava ; Weisel, Kathleen ; Lam, Edwin ; Liu, Grace ; Cossu, Marta ; Bobadilla Mendez, Carolina ; Gao, Sheng ; Leu, Jocelyn H.

Nipocalimab, a human immunoglobulin G (IgG) 1 monoclonal antibody, selectively binds the IgG-binding site on the neonatal Fc receptor (FcRn) and blocks IgG recycling, reducing IgG levels without impacting antigen presentation or T-/B-cell functions. In this phase 1, open-label study, we assessed the effect of nipocalimab on IgG response in healthy adults receiving T-cell-dependent/-independent vaccines (ie, tetanus toxoid [TT], diphtheria, and acellular pertussis vaccine [Tdap] and 23-polysaccharide pneumococcal vaccine [PPSV®23], respectively). Participants received either no drug (control) or intravenous nipocalimab (30 mg/kg at Week 0; 15 mg/kg at Weeks 2 and 4). All participants received Tdap and PPSV®23 vaccinations on Day 3 and were followed through Week 16. Twenty-nine participants completed the study (active, n=15; control, n=14). All participants mounted a response to Tdap vaccination, with 3 (20%) participants in the active arm and 7 (50%) participants in the control arm achieving a positive anti-TT response at Week 4 (primary endpoint; p=.089). Nipocalimab treatment was associated with numerically lower anti-TT and anti-pneumococcal (PCP)-specific IgG responses at Week 4 but comparable responses at Weeks 2 and 16. Overall, anti-TT IgG levels remained above the protective threshold (0.16 IU/mL) for all participants, and anti-PCP IgG levels remained above the 50 mg/L threshold and showed a 2-fold increase from baseline in both arms. Nipocalimab coadministration with Tdap and PPSV®23 was safe and well tolerated. Results suggest that nipocalimab does not impact the development of IgG responses to T-cell-dependent/-independent vaccines and participants treated with nipocalimab can follow recommended vaccination schedules.Trial registration number: NCT05827874.

31 Dec 2025·mAbs

Nipocalimab, an immunoselective FcRn blocker that lowers IgG and has unique molecular properties

Article

Author: Sukumaran, Siddharth ; Xu, Rui ; Abouzahr, Katie ; Ling, Leona E. ; Avery, William ; Roy, Sucharita ; Beavers, Traymon ; Choudhury, Amit ; Sihapong, Samuel ; Price, Karen ; Kumar, Sujatha ; Narayanaswami, Pushpa ; DuPrie, Matthew ; Markowitz, Lynn ; Bhattacharya, Sayak ; Brown, Julia ; Daly, Thomas ; Seth, Nilufer P. ; Tyler, Steven ; Rutitzky, Laura ; Cochran, Edward ; Meador, James ; Hubbard, Jonathan J. ; Pao, Yvonne ; Elwood, Fiona ; Duffner, Jay ; Parge, Viraj ; Wang, Yang ; Chen, Hsin

Nipocalimab is a human immunoglobulin G (IgG)1 monoclonal antibody that binds to the neonatal Fc receptor (FcRn) with high specificity and high affinity at both neutral (extracellular) and acidic (intracellular) pH, resulting in the reduction of circulating IgG levels, including those of pathogenic IgG antibodies. Here, we present the molecular, cellular, and nonclinical characteristics of nipocalimab that support the reported clinical pharmacology and potential clinical application in IgG-driven, autoantibody- and alloantibody-mediated diseases. The crystal structure of the nipocalimab antigen binding fragment (Fab)/FcRn complex reveals its binding to a unique epitope on the IgG binding site of FcRn that supports the observed pH-independent high-binding affinity to FcRn. Cell-based and in vivo studies demonstrate concentration/dose- and time-dependent FcRn occupancy and IgG reduction. Nipocalimab selectively reduces circulating IgG levels without detectable effects on other adaptive and innate immune functions. In vitro experiments and in vivo studies in mice and cynomolgus monkeys generated data that align with observations from clinical studies of nipocalimab in IgG autoantibody- and alloantibody-mediated diseases.

01 Aug 2025·Neurology and Therapy

Pharmacokinetics, Pharmacodynamics, and Safety of Nipocalimab in Healthy Chinese Volunteers: A Single-Dose, Phase I Study

Article

Author: Liu, Jingyao ; Dong, Zhongqi ; Zhang, Lili ; Zhao, Weilong ; Liu, Juanfang ; Li, Haiyan ; Niu, Xiaoye ; Wang, Xiaohong

INTRODUCTION:

Nipocalimab is a high-affinity, fully human, immunoglobulin G (IgG) 1 monoclonal antibody that inhibits the neonatal Fc receptor. Nipocalimab is under development for the treatment of various IgG autoantibody- and alloantibody-mediated diseases. This study assessed the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of a single dose of nipocalimab in healthy Chinese volunteers.

METHODS:

In this phase I, open-label study, healthy volunteers received single doses of intravenous (IV) nipocalimab at 15, 30, or 45 mg/kg. The primary objective was to assess the PK following a single administration of nipocalimab. Secondary objectives included the PD effects of nipocalimab on change from baseline in total serum IgG levels, safety, and tolerability.

RESULTS:

A total of 30 healthy Chinese volunteers (mean age 31.0 years, 93.3% men) received single doses of IV nipocalimab. Following a single infusion of nipocalimab, mean exposure increased as the dose of nipocalimab increased. Maximum serum nipocalimab concentrations increased proportionally with doses, whereas the area under the concentration-time curve increased by greater than a dose-proportional manner. Nipocalimab led to dose-dependent reductions in serum IgG levels from baseline; this decrease was sustained over a longer period of time with higher dose levels. Nipocalimab was generally well tolerated, with an acceptable safety profile, across all three doses; most of the treatment-emergent adverse events (TEAEs) were mild. Higher doses of nipocalimab were not associated with increased frequency of TEAEs.

CONCLUSION:

Our findings add to the evidence on the safety, tolerability, and PD of nipocalimab in the Chinese population, and support for the treatment of pathogenic IgG-mediated diseases in this population.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT05151692.

143

News (Medical) associated with Nipocalimab-aahu

16 Jul 2025

·www.investor.jnj.com

Johnson & Johnson Reports Q2 2025 Results; Raises 2025 Outlook

2025 Second-Quarter reported sales growth of 5.8% to $23.7 Billion with operational growth of 4.6%* and adjusted operational growth of 3.0%* 2025 Second-Quarter reflects earnings per share (EPS) of $2.29 and adjusted EPS of $2.77 Significant new product pipeline progress including approval of IMAAVY for generalized myasthenia gravis, priority review for TAR-200, data for CARVYKTI overall survival and progression-free benefits in multiple myeloma, and continuation of the clinical trial for a general surgery robotic system, OTTAVA Strong operational performance and favorable foreign exchange results in Company increasing full year estimated reported sales5 guidance at the midpoint by $2 billion dollars to 5.4% and full year EPS guidance by $0.25 to $10.85. Adjusted operational EPS increased to $10.68 at the midpoint. NEW BRUNSWICK, N.J.--(BUSINESS WIRE)-- Johnson & Johnson (NYSE: JNJ) today announced results for second-quarter 2025. “Today’s strong results reflect the depth and strength of Johnson & Johnson’s uniquely diversified business operating across both MedTech and Innovative Medicine,” said Joaquin Duato, Chairman and Chief Executive Officer, Johnson & Johnson. “Our portfolio and pipeline position us for elevated growth in the second half of the year, with game-changing approvals and submissions anticipated in areas like lung and bladder cancer, major depressive disorder, psoriasis, surgery and cardiovascular, which will extend and improve lives in transformative ways.” Overall financial results Q2 ($ in Millions, except EPS) 2025 2024 % Change Reported Sales $23,743 $22,447 5.8% Net Earnings $5,537 $4,686 18.2% EPS (diluted) $2.29 $1.93 18.7% Q2 Non-GAAP* ($ in Millions, except EPS) 2025 2024 % Change Operational Sales1,2 4.6% Adjusted Operational Sales1,3 3.0% Adjusted Net Earnings1,4 $6,699 $6,840 -2.1% Adjusted EPS (diluted)1,4 $2.77 $2.82 -1.8% Free Cash Flow6,7 ~$6,200 $7,507 1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules 2 Excludes the impact of translational currency 3 Excludes the net impact of acquisitions and divestitures and translational currency 4 Excludes intangible amortization expense and special items 5 Excludes COVID-19 Vaccine 6 Non-GAAP measure; defined as cash flow from operating activities, less additions to property, plant and equipment. Cash flow from operations, the most directly comparable GAAP financial measure, will be included in subsequent SEC filings. 7 Second-quarter YTD 2025 is estimated as of July 16, 2025 Regional sales results Q2 % Change ($ in Millions) 2025 2024 Reported Operational1,2 Currency Adjusted Operational1,3 U.S. $13,544 $12,569 7.8% 7.8 - 5.0 International 10,199 9,878 3.2 0.6 2.6 0.4 Worldwide $23,743 $22,447 5.8% 4.6 1.2 3.0 1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules 2 Excludes the impact of translational currency 3 Excludes the net impact of acquisitions and divestitures and translational currency Segment sales results Q2 % Change ($ in Millions) 2025 2024 Reported Operational1,2 Currency Adjusted Operational1,3 Innovative Medicine $15,202 $14,490 4.9% 3.8 1.1 2.4 MedTech 8,541 7,957 7.3 6.1 1.2 4.1 Worldwide $23,743 $22,447 5.8% 4.6 1.2 3.0 1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules 2 Excludes the impact of translational currency 3 Excludes the net impact of acquisitions and divestitures and translational currency Second-Quarter 2025 segment commentary: Operational sales* reflected below excludes the impact of translational currency. Innovative Medicine Innovative Medicine worldwide operational sales grew 3.8%*, with net acquisitions and divestitures positively impacting growth by 1.4%. Growth was primarily driven by DARZALEX, CARVYKTI, ERLEADA and RYBREVANT/LAZCLUZE in Oncology, TREMFYA and SIMPONI/SIMPONI ARIA in Immunology, and SPRAVATO in Neuroscience. Growth was partially offset by an approximate (1,170) basis points impact from STELARA in Immunology, and an approximate (130) basis points impact from COVID-19 in Infectious Diseases. MedTech MedTech worldwide operational sales grew 6.1%*, with net acquisitions and divestitures positively impacting growth by 2.0%. Growth was primarily driven by electrophysiology products and Abiomed in Cardiovascular, as well as wound closure products in General Surgery. Full-year 2025 guidance: Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis because the company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses, and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson's results computed in accordance with GAAP. ($ in Billions, except EPS) July 2025 April 2025 Adjusted Operational Sales1,2,5 Change vs. Prior Year / Mid-point 3.2% – 3.7% / 3.5% 2.0% – 3.0% / 2.5% Operational Sales2,5 / Mid-point Change vs. Prior Year / Mid-point $92.7B – $93.1B / $92.9B 4.5% – 5.0% / 4.8% $91.6B – $92.4B / $92.0B 3.3% – 4.3% / 3.8% Estimated Reported Sales3,5/ Mid-point Change vs. Prior Year / Mid-point $93.2B – $93.6B / $93.4B 5.1% – 5.6% / 5.4% $91.0B – $91.8B / $91.4B 2.6% – 3.6% / 3.1% Adjusted Operational EPS (Diluted)2,4 / Mid-point Change vs. Prior Year / Mid-point $10.63 – $10.73 / $10.68 6.5% – 7.5% / 7.0% $10.50 – $10.70 / $10.60 5.2% – 7.2% / 6.2% Adjusted EPS (Diluted)3,4 / Mid-point Change vs. Prior Year / Mid-point $10.80 – $10.90 / $10.85 8.2% – 9.2% / 8.7% $10.50 – $10.70 / $10.60 5.2% – 7.2% / 6.2% 1 Non-GAAP financial measure; excludes the net impact of acquisitions and divestitures 2 Non-GAAP financial measure; excludes the impact of translational currency 3 Calculated using Euro Average Rate: July 2025 = $1.13 and April 2025 = $1.10 (Illustrative purposes only) 4 Non-GAAP financial measure; excludes intangible amortization expense and special items 5 Excludes COVID-19 Vaccine Other modeling considerations will be provided on the webcast Notable announcements in the quarter: The information contained in this section should be read together with Johnson & Johnson’s other disclosures filed with the Securities and Exchange Commission, including its Current Reports on Form 8-K, Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The reader is also encouraged to review all other news releases and information available in the Investor Relations section of the company’s website at News Releases, as well as Innovative Medicine News Center, MedTech News & Events, and www.factsabouttalc.com. Regulatory Supplemental new drug application submitted to U.S. FDA for CAPLYTA® (lumateperone) with data demonstrating significant schizophrenia relapse prevention compared to placebo1 Press Release DARZALEX® (daratumumab) receives the first positive CHMP opinion for patients with high-risk smouldering multiple myeloma Press Release IMBRUVICA® (ibrutinib) receives positive CHMP opinion for the treatment of patients with previously untreated mantle cell lymphoma (MCL) who would be eligible for autologous stem cell transplant Press Release U.S. FDA Oncologic Drugs Advisory Committee votes in favor of the benefit-risk profile of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for high-risk smoldering multiple myeloma Press Release Johnson & Johnson receives FDA approval for IMAAVY™ (nipocalimab-aahu), a new FcRn blocker offering long-lasting disease control in the broadest population of people living with generalized myasthenia gravis (gMG) Press Release Johnson & Johnson MedTech Announces Completion of First Cases with OTTAVA™ Robotic Surgical System Press Release Data Releases IMAAVY™ (nipocalimab-aahu) showed greater sustained disease control versus approved FcRn blockers for generalized myasthenia gravis (gMG) at multiple timepoints over 24 weeks in newly published indirect treatment comparison (ITC) Press Release Investigational combination of first-in-class bispecifics TALVEY® and TECVAYLI® shows deep and durable responses in heavily pretreated multiple myeloma patients with extramedullary disease Press Release Johnson & Johnson's dual-targeting CAR T-cell therapy shows encouraging first results in large B-cell lymphoma Press Release New results for Johnson & Johnson's bleximenib demonstrate promising antileukemic activity in combination with venetoclax and azacitidine for acute myeloid leukemia Press Release Significant efficacy benefit of IMBRUVICA® (ibrutinib) plus venetoclax versus acalabrutinib plus venetoclax in frontline treatment of patients with chronic lymphocytic leukaemia suggested by indirect treatment comparison Press Release New data show TREMFYA® (guselkumab) is the only IL-23 inhibitor proven to significantly inhibit progression of joint structural damage in active psoriatic arthritis Press Release DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based regimen shows 95 percent progression-free survival at four years in transplant-eligible, newly diagnosed patients with multiple myeloma who achieved sustained MRD negativity Press Release Early results from Johnson & Johnson's trispecific antibody show promising response in heavily pretreated multiple myeloma patients Press Release Single infusion of CARVYKTI® (ciltacabtagene autoleucel) delivered lasting treatment-free remissions for at least five years in patients with relapsed or refractory multiple myeloma Press Release Johnson & Johnson leads with first PARP inhibitor combo to improve efficacy in patients with HRR-altered mCSPC Press Release Johnson & Johnson unveils first-in-human results for pasritamig, showing early anti-tumor activity in prostate cancer Press Release Shockwave Medical Study Confirms Benefit of IVL-First Strategy in Real-World Female Patients with Complex Calcified Lesions in Late-Breaking Data Presentation at EuroPCR 2025 Press Release Icotrokinra results show significant skin clearance in patients with difficult-to-treat scalp and genital psoriasis Press Release TREMFYA® (guselkumab) delivers sustained clinical and endoscopic remission in ulcerative colitis through two years Press Release TREMFYA® (guselkumab) positioned to become the first and only IL-23 inhibitor to offer subcutaneous induction in ulcerative colitis as demonstrated in new data through 24 weeks Press Release Johnson & Johnson's TAR-200 monotherapy achieves high disease-free survival of more than 80 percent in BCG-unresponsive, high-risk papillary NMIBC Press Release Johnson & Johnson's TAR-200 monotherapy demonstrates highest complete response rate with sustained clinical benefits in patients with certain types of bladder cancer Press Release Johnson & Johnson MedTech Presents 3-Month Data from Omny-IRE Clinical Trial at 2025 Heart Rhythm Society Annual Meeting Press Release Product Launch Johnson & Johnson Launches First and Only Daily Disposable Multifocal Toric Contact Lens - ACUVUE OASYS MAX 1-Day MULTIFOCAL for ASTIGMATISM Press Release Johnson & Johnson Launches VOLT™ Wrist and Proximal Humerus Plating Systems in the U.S. Press Release Johnson & Johnson Launches New TECNIS Odyssey Next-Generation Intraocular Lens in Europe, the Middle East, and Canada Offering Cataract Patients Precise Vision at Every Distance in Any Lighting Press Release Johnson & Johnson Launches KINCISE™ 2 System, the Only Automated Surgical Impactor Approved for Knee and Hip Revision Procedures Press Release Johnson & Johnson MedTech Launches SOUNDSTAR CRYSTAL™ in the US, Redefining Image Clarity in 2D Intracardiac Imaging Press Release Other Johnson & Johnson Elects Daniel Pinto, President, JPMorganChase to its Board of Directors Press Release 1 Subsequent to the quarter Webcast information: Johnson & Johnson will conduct a conference call with investors to discuss this earnings release today at 8:30 a.m., Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Johnson & Johnson website. A replay and podcast will be available approximately two hours after the live webcast in the Investor Relations section of the company's website at events-and-presentations. About Johnson & Johnson: At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at www.jnj.com. Non-GAAP financial measures: * “Operational sales growth” excluding the impact of translational currency, “adjusted operational sales growth” excluding the net impact of acquisitions and divestitures and translational currency, as well as “adjusted net earnings”, “adjusted diluted earnings per share” and “adjusted operational diluted earnings per share” excluding after-tax intangible amortization expense and special items, are non-GAAP financial measures and should not be considered replacements for, and should be read together with, the most comparable GAAP financial measures. Except for guidance measures, reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures can be found in the accompanying financial schedules of the earnings release and the Investor Relations section of the company's website at quarterly results. Copies of the financial schedules accompanying this earnings release are available on the company’s website at quarterly results. These schedules include supplementary sales data, a condensed consolidated statement of earnings, reconciliations of non-GAAP financial measures, and sales of key products/franchises. Additional information on Johnson & Johnson, including adjusted income before tax by segment, an Innovative Medicine pipeline of selected compounds in late stage development and a copy of today’s earnings call presentation can also be found in the Investor Relations section of the company's website at quarterly results. Note to investors concerning forward-looking statements: This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things: future operating and financial performance, product development, and market position and business strategy. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: economic factors, such as interest rate and currency exchange rate fluctuations or changes to applicable laws and regulations; competition, including technological advances, new products and patents attained by competitors; challenges inherent in new product research and development, including uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success for new and existing products; challenges to patents; the impact of patent expirations; the ability of the Company to successfully execute strategic plans, including restructuring plans; the impact of business combinations and divestitures; manufacturing difficulties or delays, internally or within the supply chain; product efficacy or safety concerns resulting in product recalls or regulatory action; significant adverse litigation or government action, including related to product liability claims; changes to applicable laws and regulations, including tax laws and global health care reforms; trends toward health care cost containment; changes in behavior and spending patterns of purchasers of health care products and services; financial instability of international economies and legal systems and sovereign risk; and increased scrutiny of the health care industry by government agencies. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, investor.jnj.com, or on request from Johnson & Johnson. Any forward-looking statement made in this release speaks only as of the date of this release. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. Percent Change Percent Change 2025 2024 Total Operations Currency 2025 2024 Total Operations Currency $ 9,161 8,510 7.6 % 7.6 - $ 17,253 16,122 7.0 % 7.0 - 6,041 5,980 1.0 (1.6 ) 2.6 11,822 11,930 (0.9 ) (0.1 ) (0.8 ) 15,202 14,490 4.9 3.8 1.1 29,075 28,052 3.6 4.0 (0.4 ) 4,383 4,059 8.0 8.0 - 8,596 8,067 6.6 6.6 - 4,158 3,898 6.7 4.1 2.6 7,965 7,711 3.3 3.6 (0.3 ) 8,541 7,957 7.3 6.1 1.2 16,561 15,778 5.0 5.1 (0.1 ) 13,544 12,569 7.8 7.8 - 25,849 24,189 6.9 6.9 - 10,199 9,878 3.2 0.6 2.6 19,787 19,641 0.7 1.4 (0.7 ) $ 23,743 22,447 5.8 % 4.6 1.2 $ 45,636 43,830 4.1 % 4.4 (0.3 ) Percent Change Percent Change 2025 2024 Total Operations Currency 2025 2024 Total Operations Currency $ 13,544 12,569 7.8 % 7.8 - $ 25,849 24,189 6.9 % 6.9 - 5,387 5,214 3.3 (1.9 ) 5.2 10,497 10,377 1.1 0.2 0.9 1,206 1,212 (0.5 ) 6.2 (6.7 ) 2,373 2,406 (1.3 ) 7.7 (9.0 ) 3,606 3,452 4.4 2.4 2.0 6,917 6,858 0.9 0.9 0.0 10,199 9,878 3.2 0.6 2.6 19,787 19,641 0.7 1.4 (0.7 ) $ 23,743 22,447 5.8 % 4.6 1.2 $ 45,636 43,830 4.1 % 4.4 (0.3 ) 2025 2024 Percent Percent Percent Increase Amount to Sales Amount to Sales (Decrease) $ 23,743 100.0 $ 22,447 100.0 5.8 7,628 32.1 6,869 30.6 11.0 16,115 67.9 15,578 69.4 3.4 5,889 24.8 5,681 25.3 3.7 3,516 14.8 3,440 15.3 2.2 - - 194 0.9 48 0.2 (125 ) (0.6 ) 107 0.5 653 2.9 64 0.3 (13 ) 0.0 6,491 27.3 5,748 25.6 12.9 954 4.0 1,062 4.7 (10.2 ) $ 5,537 23.3 $ 4,686 20.9 18.2 $ 2.29 $ 1.93 18.7 2,419.1 2,422.0 14.7 % 18.5 % $ 8,188 34.5 $ 8,404 37.4 (2.6 ) $ 6,699 28.2 $ 6,840 30.5 (2.1 ) $ 2.77 $ 2.82 (1.8 ) 18.2 % 18.6 % 2025 2024 Percent Percent Percent Increase Amount to Sales Amount to Sales (Decrease) $ 45,636 100.0 $ 43,830 100.0 4.1 14,985 32.8 13,380 30.5 12.0 30,651 67.2 30,450 69.5 0.7 11,001 24.1 10,938 25.0 0.6 6,741 14.8 6,982 16.0 (3.5 ) - - 194 0.4 (80 ) (0.2 ) (334 ) (0.8 ) (7,214 ) (15.8 ) 3,057 7.0 81 0.2 151 0.3 20,122 44.1 9,462 21.6 112.7 3,586 7.9 1,521 3.5 135.8 $ 16,536 36.2 $ 7,941 18.1 108.2 $ 6.82 $ 3.27 108.6 2,423.3 2,428.5 17.8 % 16.1 % $ 16,199 35.5 $ 16,281 37.1 (0.5 ) $ 13,405 29.4 $ 13,420 30.6 (0.1 ) $ 5.53 $ 5.53 0.0 17.2 % 17.6 % 2025 2024 2025 2024 $5,537 $4,686 $16,536 $7,941 57 352 (6,909) 3,078 1,267 1,106 2,387 2,184 - 64 - 73 79 (11) 134 160 - 68 - 119 246 452 378 600 21 431 60 411 - 194 - 194 27 - 27 - (321) (437) 994 (1,293) (214) (65) (202) (47) $6,699 $6,840 $13,405 $13,420 2,419.1 2,422.0 2,423.3 2,428.5 $2.77 $2.82 $5.53 $5.53 $2.71 $5.52 1 2 4.9% 7.3% 5.8% 7.6% 8.0% 7.8% 1.0% 6.7% 3.2% 1.1 1.2 1.2 - - - 2.6 2.6 2.6 3.8% 6.1% 4.6% 7.6% 8.0% 7.8% (1.6)% 4.1% 0.6% (2.2) (0.8) (3.5) (1.1) (0.9) (0.3) (1.4) (0.9) (2.4) (1.7) 0.0 0.0 0.0 0.2 0.1 0.0 0.2 0.0 0.0 0.2 0.1 2.4% 4.1% 3.0% 5.2% 4.7% 5.0% (1.6)% 3.4% 0.4% Innovative Medicine MedTech Total 3.6% 5.0% 4.1% 7.0% 6.6% 6.9% (0.9)% 3.3% 0.7% (0.4) (0.1) (0.3) - - - (0.8) (0.3) (0.7) 4.0% 5.1% 4.4% 7.0% 6.6% 6.9% (0.1)% 3.6% 1.4% (2.7) (1.0) (4.3) (1.5) (1.1) (0.5) (0.8) (0.5) (1.3) (0.9) 0.0 0.0 0.1 0.3 0.2 0.0 0.5 0.2 0.2 0.2 0.2 3.3% 2.7% 3.1% 5.7% 2.8% 4.7% 0.1% 2.7% 1.1% REPORTED SALES vs. PRIOR PERIOD ($MM) REPORTED SALES vs. PRIOR PERIOD ($MM) SECOND QUARTER SIX MONTHS % Change % Change 2025 2024 Reported Operational (1) Currency 2025 2024 Reported Operational (1) Currency $ 3,385 2,636 28.4 % 28.4 % - $ 6,398 5,019 27.5 % 27.5 % - 2,928 2,455 19.3 % 15.7 % 3.6 % 5,592 4,885 14.5 % 15.1 % -0.6 % 6,312 5,090 24.0 % 22.3 % 1.7 % 11,990 9,904 21.1 % 21.3 % -0.2 % 358 167 * * - 676 307 * * - 81 20 * * * 132 36 * * * 439 186 * * * 808 343 * * * 2,017 1,641 23.0 % 23.0 % - 3,846 3,105 23.9 % 23.9 % - 1,521 1,237 23.0 % 19.6 % 3.4 % 2,930 2,465 18.9 % 19.7 % -0.8 % 3,539 2,878 23.0 % 21.5 % 1.5 % 6,776 5,570 21.7 % 22.0 % -0.3 % 378 318 18.6 % 18.6 % - 670 603 11.0 % 11.0 % - 530 418 27.0 % 22.8 % 4.2 % 1,009 822 22.9 % 23.0 % -0.1 % 908 736 23.4 % 21.0 % 2.4 % 1,679 1,425 17.8 % 17.9 % -0.1 % 239 246 -2.7 % -2.7 % - 474 511 -7.3 % -7.3 % - 496 525 -5.4 % -8.4 % 3.0 % 970 1,043 -6.9 % -6.3 % -0.6 % 735 770 -4.5 % -6.6 % 2.1 % 1,444 1,554 -7.0 % -6.6 % -0.4 % 139 52 * * - 252 88 * * - 41 17 * * * 69 28 * * * 179 69 * * * 320 116 * * * 82 59 38.0 % 38.0 % - 150 109 36.7 % 36.7 % - 24 9 * * * 42 17 * * * 106 69 55.0 % 54.3 % 0.7 % 192 127 52.0 % 52.4 % -0.4 % 114 104 8.2 % 8.2 % - 219 205 6.6 % 6.6 % - 52 30 74.8 % 72.0 % 2.8 % 98 63 56.0 % 58.4 % -2.4 % 166 135 23.1 % 22.4 % 0.7 % 317 268 18.2 % 18.7 % -0.5 % 6 11 -38.9 % -38.9 % - 13 20 -31.9 % -31.9 % - 139 154 -9.8 % -13.3 % 3.5 % 257 326 -21.1 % -21.3 % 0.2 % 145 165 -11.6 % -14.9 % 3.3 % 270 346 -21.7 % -21.9 % 0.2 % 50 37 36.9 % 36.9 % - 97 70 39.8 % 39.8 % - 42 45 -8.7 % -12.3 % 3.6 % 84 86 -2.5 % -1.8 % -0.7 % 93 83 11.7 % 9.7 % 2.0 % 182 156 16.4 % 16.8 % -0.4 % REPORTED SALES vs. PRIOR PERIOD ($MM) REPORTED SALES vs. PRIOR PERIOD ($MM) SECOND QUARTER SIX MONTHS % Change % Change 2025 2024 Reported Operational (1) Currency 2025 2024 Reported Operational (1) Currency $ 2,505 2,978 -15.9 % -15.9 % - $ 4,701 5,431 -13.4 % -13.4 % - 1,489 1,744 -14.6 % -16.2 % 1.6 % 2,999 3,538 -15.2 % -13.8 % -1.4 % 3,993 4,722 -15.4 % -16.0 % 0.6 % 7,700 8,969 -14.1 % -13.6 % -0.5 % 283 231 22.5 % 22.5 % - 597 497 20.1 % 20.1 % - 34 35 -2.6 % -2.6 % - 44 62 -28.7 % -28.7 % - 138 127 8.6 % 8.8 % -0.2 % 281 268 4.8 % 7.7 % -2.9 % 455 393 15.9 % 15.9 % 0.0 % 922 827 11.5 % 12.4 % -0.9 % 305 267 14.0 % 14.0 % - 597 521 14.4 % 14.4 % - 387 270 43.1 % 40.8 % 2.3 % 753 569 32.2 % 35.0 % -2.8 % 690 537 28.6 % 27.5 % 1.1 % 1,349 1,091 23.7 % 25.1 % -1.4 % 1,078 1,855 -41.9 % -41.9 % - 2,059 3,251 -36.7 % -36.7 % - 575 1,030 -44.2 % -45.6 % 1.4 % 1,219 2,085 -41.5 % -40.6 % -0.9 % 1,653 2,885 -42.7 % -43.2 % 0.5 % 3,278 5,336 -38.6 % -38.2 % -0.4 % 796 589 35.2 % 35.2 % - 1,395 1,098 27.1 % 27.1 % - 391 317 23.2 % 20.5 % 2.7 % 747 616 21.2 % 22.4 % -1.2 % 1,186 906 31.0 % 30.1 % 0.9 % 2,142 1,714 25.0 % 25.4 % -0.4 % 8 2 * * - 9 2 * * - 0 0 - - - 0 0 - - - 8 2 * * - 9 2 * * - 1,377 1,102 24.9 % 24.9 % - 2,345 2,156 8.7 % 8.7 % - 674 679 -0.8 % -2.6 % 1.8 % 1,353 1,428 -5.2 % -4.1 % -1.1 % 2,051 1,782 15.1 % 14.4 % 0.7 % 3,698 3,585 3.2 % 3.6 % -0.4 % 211 - * * - 211 - * * - - - - - - - - - - - 211 - * * - 211 - * * - 24 34 -27.7 % -27.7 % - 62 75 -16.6 % -16.6 % - 139 129 7.5 % 7.0 % 0.5 % 249 265 -6.0 % -4.4 % -1.6 % 164 163 0.2 % -0.2 % 0.4 % 312 340 -8.3 % -7.1 % -1.2 % 732 784 -6.7 % -6.7 % - 1,357 1,549 -12.4 % -12.4 % - 260 269 -3.5 % -5.1 % 1.6 % 537 561 -4.2 % -3.1 % -1.1 % 992 1,054 -5.9 % -6.3 % 0.4 % 1,895 2,110 -10.2 % -9.9 % -0.3 % 366 226 61.1 % 61.1 % - 642 417 53.7 % 53.7 % - 50 44 12.8 % 11.0 % 1.8 % 93 78 18.1 % 20.1 % -2.0 % 414 271 53.3 % 53.0 % 0.3 % 734 496 48.1 % 48.4 % -0.3 % 45 57 -23.5 % -23.5 % - 73 115 -37.0 % -37.0 % - 226 237 -4.7 % -7.6 % 2.9 % 474 524 -9.5 % -8.8 % -0.7 % 270 294 -8.4 % -10.7 % 2.3 % 547 639 -14.4 % -13.9 % -0.5 % REPORTED SALES vs. PRIOR PERIOD ($MM) REPORTED SALES vs. PRIOR PERIOD ($MM) SECOND QUARTER SIX MONTHS % Change % Change 2025 2024 Reported Operational (1) Currency 2025 2024 Reported Operational (1) Currency $ 799 743 7.6 % 7.6 % - $ 1,543 1,509 2.3 % 2.3 % - 314 296 5.8 % 2.8 % 3.0 % 595 579 2.6 % 3.0 % -0.4 % 1,113 1,039 7.1 % 6.2 % 0.9 % 2,138 2,088 2.4 % 2.5 % -0.1 % 403 376 6.9 % 6.9 % - 766 732 4.6 % 4.6 % - 180 171 5.4 % 2.1 % 3.3 % 339 340 -0.3 % -0.2 % -0.1 % 582 548 6.4 % 5.4 % 1.0 % 1,104 1,072 3.0 % 3.1 % -0.1 % 382 349 9.4 % 9.4 % - 747 741 0.8 % 0.8 % - 94 76 22.4 % 19.8 % 2.6 % 180 152 17.9 % 18.7 % -0.8 % 476 426 11.7 % 11.3 % 0.4 % 927 894 3.7 % 3.8 % -0.1 % 16 17 -12.4 % -12.4 % - 31 35 -12.6 % -12.6 % - 40 49 -18.5 % -21.3 % 2.8 % 77 88 -12.4 % -12.1 % -0.3 % 55 67 -16.9 % -19.0 % 2.1 % 107 123 -12.5 % -12.3 % -0.2 % 320 334 -4.3 % -4.3 % - 635 658 -3.6 % -3.6 % - 484 631 -23.4 % -26.8 % 3.4 % 971 1,128 -13.9 % -14.1 % 0.2 % 803 965 -16.8 % -19.0 % 2.2 % 1,605 1,786 -10.1 % -10.2 % 0.1 % 6 8 -25.4 % -25.4 % - 14 16 -13.6 % -13.6 % - 354 288 23.0 % 16.7 % 6.3 % 704 603 16.7 % 15.6 % 1.1 % 360 297 21.6 % 15.5 % 6.1 % 718 620 15.9 % 14.9 % 1.0 % 312 321 -3.0 % -3.0 % - 617 635 -2.9 % -2.9 % - 85 117 -27.0 % -29.4 % 2.4 % 183 221 -17.2 % -15.8 % -1.4 % 396 438 -9.4 % -10.0 % 0.6 % 799 856 -6.6 % -6.3 % -0.3 % 2 5 -51.8 % -51.8 % - 4 7 -37.4 % -37.4 % - 45 227 -80.5 % -80.6 % 0.1 % 84 304 -72.5 % -72.1 % -0.4 % 47 233 -79.8 % -79.9 % 0.1 % 88 311 -71.7 % -71.3 % -0.4 % 776 717 8.2 % 8.2 % - 1,631 1,348 21.0 % 21.0 % - 154 176 -12.3 % -13.2 % 0.9 % 312 373 -16.2 % -14.3 % -1.9 % 930 892 4.2 % 4.0 % 0.2 % 1,943 1,721 12.9 % 13.3 % -0.4 % 621 587 5.6 % 5.6 % - 1,311 1,105 18.6 % 18.6 % - - - - - - - - - - - 621 587 5.6 % 5.6 % - 1,311 1,105 18.6 % 18.6 % - 155 129 20.0 % 20.0 % - 320 243 31.6 % 31.6 % - 154 176 -12.3 % -13.2 % 0.9 % 312 373 -16.2 % -14.3 % -1.9 % 309 305 1.4 % 0.9 % 0.5 % 632 616 2.7 % 3.9 % -1.2 % 9,161 8,510 7.6 % 7.6 % - 17,253 16,122 7.0 % 7.0 % - 6,041 5,980 1.0 % -1.6 % 2.6 % 11,822 11,930 -0.9 % -0.1 % -0.8 % $ 15,202 14,490 4.9 % 3.8 % 1.1 % $ 29,075 28,052 3.6 % 4.0 % -0.4 % REPORTED SALES vs. PRIOR PERIOD ($MM) REPORTED SALES vs. PRIOR PERIOD ($MM) SECOND QUARTER SIX MONTHS % Change % Change 2025 2024 Reported Operational (1) Currency 2025 2024 Reported Operational (1) Currency $ 1,364 1,119 21.9 % 21.9 % - $ 2,625 2,144 22.4 % 22.4 % - 948 753 25.9 % 22.9 % 3.0 % 1,790 1,534 16.7 % 16.7 % 0.0 % 2,313 1,873 23.5 % 22.3 % 1.2 % 4,416 3,679 20.0 % 20.0 % 0.0 % 741 705 5.1 % 5.1 % - 1,425 1,397 2.0 % 2.0 % - 728 618 17.8 % 15.2 % 2.6 % 1,366 1,270 7.6 % 7.8 % -0.2 % 1,468 1,323 11.0 % 9.8 % 1.2 % 2,791 2,667 4.7 % 4.7 % 0.0 % 360 309 16.6 % 16.6 % - 699 612 14.2 % 14.2 % - 89 72 25.0 % 18.4 % 6.6 % 170 139 22.4 % 20.9 % 1.5 % 448 379 18.2 % 16.9 % 1.3 % 868 750 15.7 % 15.5 % 0.2 % 233 77 * * - 439 77 * * - 58 0 * * * 110 0 * * * 292 77 * * * 550 77 * * - 31 29 5.4 % 5.4 % - 63 59 6.3 % 6.3 % - 72 64 13.4 % 11.6 % 1.8 % 144 126 14.2 % 14.5 % -0.3 % 104 93 10.8 % 9.7 % 1.1 % 207 185 11.7 % 11.8 % -0.1 % 1,420 1,422 -0.2 % -0.2 % - 2,804 2,870 -2.3 % -2.3 % - 885 890 -0.5 % -4.0 % 3.5 % 1,742 1,782 -2.2 % -2.4 % 0.2 % 2,305 2,312 -0.3 % -1.6 % 1.3 % 4,546 4,652 -2.3 % -2.3 % 0.0 % 271 265 2.1 % 2.1 % - 534 535 -0.2 % -0.2 % - 150 152 -1.0 % -4.3 % 3.3 % 296 304 -2.5 % -2.6 % 0.1 % 421 417 1.0 % -0.2 % 1.2 % 830 839 -1.1 % -1.1 % 0.0 % 226 230 -1.9 % -1.9 % - 457 472 -3.1 % -3.1 % - 164 163 0.0 % -2.9 % 2.9 % 322 323 -0.5 % -0.4 % -0.1 % 389 394 -1.1 % -2.3 % 1.2 % 778 795 -2.0 % -2.0 % 0.0 % 501 498 0.7 % 0.7 % - 1,003 1,002 0.1 % 0.1 % - 267 260 2.2 % -1.5 % 3.7 % 537 521 2.9 % 2.8 % 0.1 % 768 759 1.2 % -0.1 % 1.3 % 1,540 1,524 1.1 % 1.0 % 0.1 % 422 430 -1.7 % -1.7 % - 810 862 -6.0 % -6.0 % - 305 314 -2.7 % -6.4 % 3.7 % 588 634 -7.2 % -7.7 % 0.5 % 727 743 -2.1 % -3.7 % 1.6 % 1,398 1,495 -6.5 % -6.7 % 0.2 % REPORTED SALES vs. PRIOR PERIOD ($MM) REPORTED SALES vs. PRIOR PERIOD ($MM) SECOND QUARTER SIX MONTHS % Change % Change 2025 2024 Reported Operational (1) Currency 2025 2024 Reported Operational (1) Currency $ 1,043 995 4.8 % 4.8 % - $ 2,045 1,982 3.2 % 3.2 % - 1,512 1,493 1.3 % -0.2 % 1.5 % 2,906 2,922 -0.5 % 0.3 % -0.8 % 2,555 2,488 2.7 % 1.8 % 0.9 % 4,951 4,904 1.0 % 1.5 % -0.5 % 477 466 2.2 % 2.2 % - 934 912 2.4 % 2.4 % - 687 675 1.9 % 0.2 % 1.7 % 1,303 1,316 -1.0 % -0.4 % -0.6 % 1,164 1,141 2.0 % 1.0 % 1.0 % 2,237 2,228 0.4 % 0.8 % -0.4 % 567 528 7.2 % 7.2 % - 1,111 1,070 3.8 % 3.8 % - 825 818 0.9 % -0.6 % 1.5 % 1,603 1,606 -0.1 % 0.8 % -0.9 % 1,391 1,346 3.3 % 2.5 % 0.8 % 2,714 2,676 1.4 % 2.0 % -0.6 % 557 523 6.5 % 6.5 % - 1,123 1,070 4.9 % 4.9 % - 813 763 6.5 % 3.4 % 3.1 % 1,526 1,473 3.6 % 3.7 % -0.1 % 1,369 1,285 6.5 % 4.6 % 1.9 % 2,648 2,543 4.1 % 4.2 % -0.1 % 429 409 4.8 % 4.8 % - 881 847 3.9 % 3.9 % - 536 509 5.4 % 1.4 % 4.0 % 1,003 981 2.3 % 1.9 % 0.4 % 965 918 5.1 % 2.9 % 2.2 % 1,884 1,828 3.1 % 2.8 % 0.3 % 128 113 12.6 % 12.6 % - 242 223 8.5 % 8.5 % - 277 254 8.8 % 7.3 % 1.5 % 523 492 6.2 % 7.2 % -1.0 % 403 367 9.9 % 8.9 % 1.0 % 764 715 6.9 % 7.6 % -0.7 % 4,383 4,059 8.0 % 8.0 % - 8,596 8,067 6.6 % 6.6 % - 4,158 3,898 6.7 % 4.1 % 2.6 % 7,965 7,711 3.3 % 3.6 % -0.3 % $ 8,541 7,957 7.3 % 6.1 % 1.2 % $ 16,561 15,778 5.0 % 5.1 % -0.1 % Second Quarter June 29, 2025 GAAP Intangible asset amortization Litigation related Restructuring related Acquisition, integration and divestiture related (Loss)/gain on securities Tax legislation and other tax related Other Second Quarter June 29, 2025 Non-GAAP $ 3,978 (785 ) (13 ) 3,180 2,789 2,789 2,869 2,869 14 69 (207 ) 8 (13 ) (129 ) 5,552 785 (69 ) - 220 (8 ) - 13 6,493 $ 3,638 (482 ) (15 ) 1 3,142 2,862 2,862 647 43 690 190 (83 ) (64 ) (53 ) (29 ) (14 ) (53 ) 1,204 482 83 79 9 29 - 14 1,900 $ 12 12 238 238 - - 15 (43 ) (17 ) (45 ) (265 ) - 43 - 17 - - - (205 ) $ 7,628 (1,267 ) (15 ) (12 ) 6,334 5,889 5,889 3,516 43 3,559 107 (57 ) (277 ) (21 ) (27 ) (275 ) - - 48 48 64 (64 ) - 6,491 1,267 57 79 246 21 - 27 8,188 954 222 9 13 72 5 214 - 1,489 5,537 1,045 48 66 174 16 (214 ) 27 6,699 $ 3,603 (694 ) (4 ) 2,905 2,665 2,665 2,722 (10 ) 2,712 41 (43 ) (194 ) 63 (1 ) (70 ) (50 ) (254 ) 5,459 694 43 194 (63 ) 1 70 - 64 - 6,462 $ 3,248 (412 ) (2 ) (50 ) (30 ) 2,754 2,671 (5 ) 2,666 718 (15 ) (33 ) 670 231 4 (50 ) (344 ) (22 ) (181 ) 1,089 412 (4 ) - 52 409 22 68 - - 2,048 $ 18 18 345 345 - - 437 (313 ) (42 ) (339 ) (257 ) (800 ) - 313 - - 42 339 - - - (106 ) $ 6,869 (1,106 ) (2 ) (50 ) (30 ) (4 ) 5,677 5,681 (5 ) 5,676 3,440 (15 ) (33 ) (10 ) 3,382 653 (352 ) (387 ) (431 ) (50 ) (567 ) 194 (194 ) - (125 ) (125 ) (13 ) 13 - 5,748 1,106 352 194 (11 ) 452 431 68 64 - 8,404 1,062 156 70 43 (6 ) 125 21 14 14 65 1,564 4,686 950 282 151 (5 ) 327 410 54 50 (65 ) 6,840 Johnson & Johnson and Subsidiaries GAAP to Non-GAAP Reconciliation $ in Millions $ 7,998 (1,434 ) (13 ) 6,551 5,050 5,050 5,417 5,417 (152 ) 69 (227 ) (10 ) (13 ) (333 ) 10,762 1,434 (69 ) - 240 10 - 13 12,390 $ 6,964 (953 ) (23 ) (51 ) 5,937 5,518 5,518 1,324 37 1,361 130 (83 ) (111 ) (107 ) (50 ) (14 ) (235 ) 2,625 953 83 134 121 50 - 14 3,980 $ 23 23 433 433 - - (7,191 ) 6,923 (17 ) (285 ) 6,735 - (6,923 ) - 17 - - - (171 ) $ 14,985 (2,387 ) (23 ) (64 ) 12,511 11,001 11,001 6,741 37 6,778 (7,214 ) 6,909 (30 ) (351 ) (60 ) (27 ) (773 ) - - (80 ) (80 ) 81 (81 ) - 20,122 2,387 (6,909 ) 134 378 60 - 27 16,199 3,586 410 (1,544 ) 24 102 14 202 2,794 16,536 1,977 (5,365 ) 110 276 46 (202 ) 27 13,405 $ 6,973 (1,392 ) (6 ) 5,575 5,103 5,103 5,618 (17 ) 5,601 (70 ) (43 ) (194 ) (81 ) (48 ) (15 ) (50 ) (501 ) 10,428 1,392 43 194 81 48 15 - 73 - 12,274 $ 6,368 (792 ) (9 ) (50 ) (50 ) 5,467 5,253 (9 ) 5,244 1,364 (33 ) (60 ) 1,271 184 4 (70 ) (387 ) (44 ) (313 ) 2,609 792 (4 ) - 79 470 44 119 - - 4,109 $ 39 39 582 582 - - 2,954 (3,039 ) (82 ) (352 ) (519 ) (3,575 ) - 3,039 - - 82 352 - - - (102 ) $ 13,380 (2,184 ) (9 ) (50 ) (50 ) (6 ) 11,081 10,938 (9 ) 10,929 6,982 (33 ) (60 ) (17 ) 6,872 3,057 (3,078 ) (517 ) (411 ) (50 ) (999 ) 194 (194 ) - (334 ) (334 ) 151 (151 ) - 9,462 2,184 3,078 194 160 600 411 119 73 - 16,281 1,521 304 697 43 33 163 14 23 16 47 2,861 7,941 1,880 2,381 151 127 437 397 96 57 (47 ) 13,420 Media contact: media-relations@its.jnj.com Investor contact: investor-relations@its.jnj.com

Clinical ResultDrug ApprovalFinancial Statement

03 Jul 2025

·synapse.patsnap.com

April 2025 Therapeutic Breakthroughs: From FcRn-Targeted mAbs to COL7 Gene Therapy in DEB

In April 2025, a series of innovative drugs targeting various disease areas received regulatory approval, ranging from rare diseases such as dystrophic epidermolysis bullosa (DEB) to more prevalent conditions like chronic urticaria, polyarticular juvenile idiopathic arthritis (pJIA), and hospital-acquired pneumonia (HAP). These therapies not only represent the forefront of scientific advancement but also reflect modern medicine’s ongoing pursuit of precision and personalized treatment. 1. Nipocalimab-aahuNipocalimab-aahu (brand name: IMAAVY), developed by Janssen Biotech, a subsidiary of Johnson & Johnson, is a humanized monoclonal antibody targeting the neonatal Fc receptor (FcRn) for the treatment of generalized myasthenia gravis (gMG). It received its first approval in the United States on April 29, 2025, for this indication. Nipocalimab is an IgG1 monoclonal antibody that selectively binds to and inhibits the interaction between FcRn and IgG, thereby accelerating the degradation of pathogenic IgG antibodies and reducing their concentration in the bloodstream. Under physiological conditions, FcRn binds to the Fc region of IgG, protecting it from lysosomal degradation and prolonging its half-life. However, in autoimmune diseases, this mechanism contributes to the persistence and accumulation of pathogenic IgG. By competitively binding to FcRn, nipocalimab prevents this interaction, leading to the lysosomal degradation of IgG. This targeted mechanism is especially well-suited for diseases driven by IgG-mediated pathogenesis, such as generalized myasthenia gravis and warm autoimmune hemolytic anemia. Compared to traditional immunosuppressants or intravenous immunoglobulin (IVIG), nipocalimab offers effective reduction of pathogenic antibody load without broad immunosuppression, thus providing better safety and tolerability. In pivotal clinical trials for gMG, nipocalimab demonstrated significant clinical improvement, particularly in muscle function scores and reduction in exacerbation frequency, outperforming placebo. The treatment showed a rapid onset and durable efficacy. Additionally, its subcutaneous route of administration enhances patient adherence. Even after its approval, Johnson & Johnson plans to continue long-term follow-up studies to assess real-world safety and effectiveness, as well as explore broader applications in other rare autoimmune conditions. Currently, there are several therapeutic options available for gMG and other IgG-mediated autoimmune diseases, including corticosteroids, immunosuppressants, IVIG, plasma exchange, and newer targeted biologics. For instance, Argenx’s efgartigimod, a recombinant FcRn-targeting fusion protein, has been approved in multiple countries for gMG. While it shares a similar mechanism with nipocalimab, it is not antibody-based. Nipocalimab, as a monoclonal antibody, may offer stronger binding affinity and longer half-life, potentially making it more suitable for long-term maintenance therapy. Other competitors include Soliris (eculizumab) from Alexion and Rituxan (rituximab), which work via complement inhibition and B cell depletion, respectively, but are costly and require frequent infusions. 2. Prademagene zamikeracelPrademagene zamikeracel (EB-101), developed by Abeona Therapeutics, is a gene therapy approved on April 29, 2025, in the United States for the treatment of dystrophic epidermolysis bullosa (DEB). Prademagene zamikeracel is designed to restore the expression of type VII collagen (COL7) by delivering a functional COL7A1 gene to the patient’s own keratinocytes. DEB is a genetic disorder caused by mutations in the COL7A1 gene, leading to insufficient COL7 production and resulting in extremely fragile skin prone to blistering and wounds. This gene therapy uses a retroviral vector to transfer the functional COL7A1 gene into autologous keratinocytes, enabling these cells to synthesize and secrete normal COL7, which is essential for anchoring fibrils that maintain dermal-epidermal cohesion. The therapy employs a modified retroviral vector that efficiently integrates the gene into the host genome, ensuring long-term and stable gene expression. Its specificity and safety are further enhanced by targeting only the affected skin cells, minimizing off-target effects on other tissues or organs. Clinical studies have shown that Prademagene zamikeracel significantly improves wound healing and reduces blister formation, thereby enhancing patients' quality of life, without evidence of serious adverse effects or drug interactions. Abeona Therapeutics has employed advanced gene-editing technologies and manufacturing processes to ensure drug stability and bioavailability. Pharmacokinetic studies suggest that its efficacy is comparable or even superior to other gene therapies in development. Post-approval, the company continues to monitor the therapy closely, collecting additional clinical data to optimize its formulation and usage guidelines. A Phase IV clinical trial is planned to explore new indications and long-term outcomes. Preliminary findings suggest potential applicability in other types of inherited skin disorders. Currently, most treatments for DEB focus on supportive care, such as wound management, infection control, and pain relief, which do not address the underlying genetic cause. In contrast, Prademagene zamikeracel offers a curative approach by directly correcting the disease-causing gene mutation. Competing therapies include beremagene geperpavec (B-VEC) by Krystal Biotech, a gene therapy based on a herpes simplex virus (HSV) vector platform. Although both therapies aim at gene correction, they differ in their vector systems and gene delivery mechanisms. 3. Penpulimab*Penpulimab, developed by Akeso Biopharma Co., Ltd. (Zhongshan, China), was approved by the U.S. FDA on April 23, 2025, under the brand name AK105. It is indicated for the treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC) in adult patients who have failed prior first-line therapy. As a fully humanized IgG1 PD-1 monoclonal antibody, Penpulimab features unique structural optimizations and potentially improved safety characteristics. Penpulimab is a fully human IgG1 subtype monoclonal antibody targeting programmed cell death protein 1 (PD-1). Its mechanism of action centers on modulating T-cell–mediated anti-tumor immune responses. PD-1 is an immune checkpoint molecule expressed on activated T cells; when bound to its ligands (PD-L1/PD-L2), it inhibits T-cell activity, allowing tumors to evade immune surveillance. Penpulimab binds with high affinity to PD-1, blocking its interaction with PD-L1/PD-L2 and restoring the immune system’s ability to recognize and destroy tumor cells. Unlike many other PD-1 antibodies that use the IgG4 subtype, Penpulimab adopts an IgG1 framework, which enables a stronger antibody-dependent cellular cytotoxicity (ADCC) effect, potentially enhancing immune clearance within the tumor microenvironment. Additionally, the Fc region of Penpulimab has been engineered to reduce undesired immune activation, aiming to improve efficacy while minimizing immune-related adverse events. Penpulimab’s development has focused on nasopharyngeal carcinoma, a malignancy with high prevalence in China and other parts of Asia. In pivotal Phase II clinical trials, Penpulimab demonstrated a notable objective response rate (ORR) and durable disease control in PD-L1–positive patients, with especially pronounced efficacy in Epstein-Barr virus–associated NPC. Data showed that more than 30% of patients achieved tumor reduction, with many experiencing long-lasting responses, and some even achieving complete remission. The FDA approval was granted under Priority Review, recognizing Penpulimab’s clear clinical value in treating this difficult-to-manage cancer. Akeso employed a precision medicine approach in its clinical development by focusing on PD-L1–positive and previously treated advanced NPC patients, thereby improving response rates and optimizing the risk-benefit profile—reflecting the current trend toward individualized cancer immunotherapy. Currently, several blockbuster PD-1/PD-L1 inhibitors—such as Keytruda (pembrolizumab, Merck), Opdivo (nivolumab, Bristol Myers Squibb), and Tecentriq (atezolizumab, Roche)—have been approved for various solid tumors, including melanoma, non-small cell lung cancer, and head and neck squamous cell carcinoma. Some studies have explored their use in NPC. However, Penpulimab is the first PD-1 inhibitor formally approved by the FDA specifically for nasopharyngeal carcinoma, filling a critical gap in treatment. While other PD-1 inhibitors may be used off-label in clinical practice for NPC, they have not yet received regulatory approval for this specific indication. 4. LinvoseltamabLinvoseltamab (brand name: Lynozyfic), developed by Regeneron Pharmaceuticals, is a bispecific T-cell engager approved on April 23, 2025, in the European Union, Iceland, Liechtenstein, and Norway for the treatment of relapsed or refractory multiple myeloma (RRMM). Linvoseltamab is a bispecific antibody targeting both B-cell maturation antigen (BCMA) on myeloma cells and CD3 on T cells. It works by simultaneously binding to BCMA-expressing tumor cells and CD3-positive T cells, effectively forming a bridge between them. This interaction leads to the formation of an immunological synapse, activating T cells to release cytotoxic molecules such as perforin and granzymes, which induce direct tumor cell lysis. Beyond cell killing, this bispecific engagement enhances T-cell activation, proliferation, and persistence—amplifying the overall anti-tumor immune response. Unlike conventional monoclonal antibodies, Linvoseltamab does not rely on endogenous antigen presentation to activate T cells. Its ability to directly stimulate T cells gives it a significant therapeutic advantage in targeting BCMA-positive myeloma cells. Preclinical and clinical data have shown that Linvoseltamab not only suppresses tumor growth but also reduces the risk of relapse, offering a novel and promising treatment strategy for patients with advanced myeloma. Clinical studies have demonstrated Linvoseltamab’s efficacy in alleviating symptoms, prolonging progression-free survival (PFS) and overall survival (OS), and significantly improving quality of life, with no major adverse events or drug interactions reported. Regeneron has applied advanced bispecific antibody design and manufacturing technologies to ensure drug stability, bioavailability, and consistent pharmacokinetic profiles. Post-marketing, the company is continuing real-world monitoring, collecting further clinical data to optimize formulation and usage, and plans to initiate Phase IV trials to investigate additional indications and long-term benefits. Preliminary research suggests potential activity against other BCMA-positive hematologic malignancies as well. In the current treatment landscape for RRMM, a variety of therapeutic modalities are available, including monoclonal antibodies, CAR-T cell therapies, and targeted small molecules. For example, Darzalex (daratumumab, Johnson & Johnson) and Blenrep (belantamab mafodotin, GSK) are widely used monoclonal antibodies that target CD38 and BCMA, respectively. While effective, these agents often require combination regimens to maximize their benefit. In contrast, Linvoseltamab as a bispecific T-cell engager offers a standalone, efficient, and simplified treatment approach by directly activating T cells without the need for additional immunomodulatory agents. Other competitors include Abecma (idecabtagene vicleucel) from bluebird bio, a CAR-T therapy targeting BCMA, which has been approved for relapsed or refractory multiple myeloma. Despite their efficacy, CAR-T therapies are complex and costly, making Linvoseltamab a potentially more accessible and scalable option in this therapeutic area. 5. EbdarokimabEbdarokimab (AK-101), developed by Akeso Biopharma Co., Ltd., is a monoclonal antibody approved in China on April 15, 2025, for the treatment of plaque psoriasis. Ebdarokimab is a monoclonal antibody specifically targeting the IL-17A/F heterodimer, functioning by binding to and inhibiting this heterodimer to suppress inflammatory responses and prevent tissue damage. IL-17A and IL-17F are pro-inflammatory cytokines that can act individually or as a heterodimer, activating multiple cell types such as keratinocytes, fibroblasts, and endothelial cells. This activation triggers a cascade of inflammatory responses contributing to the pathogenesis of psoriasis and other autoimmune diseases. By binding to the IL-17A/F heterodimer and blocking its interaction with receptors, Ebdarokimab disrupts downstream signaling pathways, reduces the release of inflammatory mediators, and inhibits cell proliferation—thereby alleviating inflammation at affected sites. This targeted mechanism against the heterodimer offers more comprehensive symptom control and potentially fewer side effects. Moreover, studies suggest that the IL-17A/F heterodimer plays a critical role in ulcerative colitis, providing a theoretical foundation for the potential use of Ebdarokimab in other immune-related diseases. Clinical data show that Ebdarokimab significantly improves skin lesion scores (e.g., PASI scores), and reduces symptoms such as erythema and scaling, markedly enhancing patient quality of life, with no serious adverse reactions or drug interactions observed. Akeso has employed advanced monoclonal antibody production technologies and process optimization to ensure product stability and bioavailability, and pharmacokinetic studies have demonstrated comparable or superior efficacy to similar agents. Even after approval, the company continues post-marketing surveillance and plans Phase IV clinical trials to explore additional indications and long-term outcomes. Some research suggests Ebdarokimab may also have therapeutic potential in ulcerative colitis. Currently, the therapeutic landscape for plaque psoriasis includes several important drug classes such as TNF-α inhibitors, IL-17A inhibitors, and other biologics. Cosentyx (secukinumab, Novartis) and Taltz (ixekizumab, Eli Lilly) are widely used IL-17A inhibitors that specifically bind to and neutralize IL-17A to relieve psoriasis symptoms. Although effective, they only target the IL-17A monomer and do not block the IL-17A/F heterodimer. In contrast, Ebdarokimab offers a more comprehensive therapeutic approach by targeting the heterodimer, potentially delivering stronger inflammation control and reducing relapse rates. Other competitors include Stelara (ustekinumab, Johnson & Johnson), an IL-12/23 inhibitor approved for moderate-to-severe plaque psoriasis. 6. Desvenlafaxine BenzoateDesvenlafaxine Benzoate (brand name Desvela, 데스베라서방정), developed by Nexpharm Korea, is a small-molecule antidepressant approved in South Korea on April 9, 2025, for the treatment of major depressive disorder (MDD). Desvenlafaxine Benzoate is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). It works by inhibiting the reuptake of serotonin (5-HT) and norepinephrine (NE) into presynaptic neurons, thereby increasing the concentrations of these neurotransmitters in the synaptic cleft, which helps regulate mood and relieve depressive symptoms. By binding to serotonin and norepinephrine transporters, Desvenlafaxine Benzoate prevents their reabsorption into neurons, allowing greater neurotransmitter availability to exert mood-enhancing effects. This dual mechanism of action helps restore neurotransmitter balance in the brain, improving emotional state and reducing symptoms of depression. It also has mild dopamine reuptake inhibition, which may further contribute to its antidepressant efficacy. Compared to other antidepressants, Desvenlafaxine Benzoate demonstrates a favorable dose-response and safety profile, enabling more effective symptom management with fewer side effects. Clinical studies have shown that Desvenlafaxine Benzoate significantly improves depressive symptoms and enhances patient quality of life, while reducing the frequency and severity of depressive episodes. Nexpharm Korea has applied advanced drug design and development technologies to ensure drug stability and bioavailability, and pharmacokinetic studies have confirmed comparable or superior efficacy to similar agents. Post-approval, the company continues to monitor the product, collect clinical data, and refine the formulation and usage guidelines. Plans are in place for Phase IV clinical trials to evaluate additional indications and long-term effectiveness. In the MDD treatment landscape, several major drug classes are used, including selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants (TCAs), and other SNRIs. Notable examples include Pristiq (desvenlafaxine, Pfizer) and Effexor XR (venlafaxine extended-release, Wyeth)—both widely used SNRIs that act through similar mechanisms. Pristiq is known for its good tolerability and relatively low incidence of side effects, while Effexor XR is valued for its broad spectrum of indications. In comparison, Desvenlafaxine Benzoate developed by Nexpharm Korea incorporates a benzoate salt structure, offering enhanced stability and bioavailability, improved efficacy, and reduced side effects. Other competitors include Cymbalta (duloxetine, Eli Lilly), a widely used SNRI for depression and chronic pain management. 7. BARYTHRAXBARYTHRAX (GC-1109), a recombinant anthrax vaccine developed by GC Biopharma, was first approved in South Korea on April 8, 2025, for the prevention of anthrax infection. This recombinant vector-based anthrax vaccine is developed through genetic engineering and is designed to express and deliver the protective antigen (PA) of Bacillus anthracis, stimulating a specific immune response. The vaccine employs recombinant technology to insert the gene encoding the anthrax protective antigen into a viral or bacterial vector. Upon administration, these vectors express and release the PA antigen in the human body, which is then recognized by the host immune system—triggering both humoral and cellular immune responses, generating specific antibodies and memory T cells against Bacillus anthracis. Once the individual is exposed to the pathogen, the primed immune system can rapidly activate, neutralize toxins, and eliminate the bacteria, thus preventing disease onset and progression. Compared to traditional inactivated or live-attenuated vaccines, this recombinant vaccine offers enhanced safety, as it contains no live pathogens and only expresses selected antigenic components, thereby minimizing the risk of adverse reactions. Clinical studies have shown that the vaccine induces high-titer antibody responses, significantly enhancing immunity in subjects without serious adverse events. GC Biopharma applied advanced vector design and manufacturing technologies to ensure the vaccine’s stability and immunogenicity and conducted detailed pharmacokinetic and immunological studies demonstrating that the product provides equal or superior performance compared to existing vaccines. The company continues post-marketing surveillance and plans Phase IV trials to further optimize the formulation, usage guidelines, and explore additional indications and long-term efficacy. Currently, several key vaccine types are available for anthrax prevention, including inactivated, live-attenuated, and recombinant protein vaccines. BioThrax (manufactured by Emergent BioSolutions) is one of the most widely used anthrax vaccines, made from a cell-free extract of Bacillus anthracis PA. Although approved in multiple countries and widely used, BioThrax requires multiple doses and may cause local injection site reactions and mild side effects. In contrast, BARYTHRAX, as a novel recombinant vector vaccine, offers a safer and more effective alternative, potentially requiring fewer doses to establish durable immunity. Competing products include NuThrax (also from Emergent BioSolutions), a next-generation vaccine combining BioThrax with the CpG 7909 adjuvant to enhance the speed and strength of immune responses. 8. Dalnacogene PonparvovecDalnacogene ponparvovec (also known as BBM-H901), developed by Belief BioMed, is an adeno-associated virus (AAV)-based gene therapy approved in China on April 8, 2025, for the treatment of Hemophilia B. Dalnacogene ponparvovec delivers a functional human coagulation factor IX (FIX) gene into liver cells to correct the coagulation deficiency caused by mutations in the FIX gene. Using an AAV vector carrying an optimized FIX gene sequence, the therapy targets hepatocytes after administration, enabling the integration and expression of the FIX gene within the patient’s cells. This leads to sustained production and secretion of functional FIX protein, restoring coagulation ability. The therapy incorporates advanced gene engineering and sequence optimization to produce FIX protein with enhanced activity and stability, significantly improving therapeutic outcomes. Unlike traditional FIX replacement therapies, which require regular infusions, Dalnacogene ponparvovec offers a one-time treatment with long-lasting effects, reducing treatment burden and improving quality of life. Clinical studies have demonstrated that Dalnacogene ponparvovec significantly increases FIX protein levels and reduces bleeding episodes, leading to marked improvements in patients' coagulation function and overall well-being. Belief BioMed has employed cutting-edge AAV vector design and manufacturing technology to ensure product stability and bioavailability, and pharmacokinetic studies confirm comparable or superior efficacy to other gene therapies. Post-approval, the company is maintaining ongoing safety monitoring, gathering additional real-world data, and planning Phase IV clinical trials to explore broader indications and long-term benefits. Preliminary studies suggest the therapy may have potential in treating other inherited disorders. In the treatment landscape for Hemophilia B, current options include recombinant FIX protein replacement therapies, non-replacement therapies, and other gene therapies. Alprolix (a recombinant FIX-Fc fusion protein by Bioverativ) and BeneFIX (recombinant FIX by Pfizer) are widely used replacements that supplement exogenous FIX to correct coagulation deficits but require frequent infusions, which can be inconvenient. By contrast, Dalnacogene ponparvovec, as a single-administration AAV-based gene therapy, offers a long-term solution with sustained FIX expression and reduced treatment frequency. Other competitors include Valoctocogene roxaparvovec (BioMarin), an AAV gene therapy for Hemophilia A. Although targeting a different clotting factor, its clinical development has provided valuable insights applicable to the advancement of Dalnacogene ponparvovec. 9. Sitagliptin Phosphate Hydrate / Empagliflozin L-ProlineSitagliptin Phosphate Hydrate / Empagliflozin L-Proline (brand name: Empamax, 엠파맥스에스정), developed by Chong Kun Dang Pharmaceutical Corp., is a small-molecule combination drug for the treatment of type 2 diabetes mellitus (T2DM). It was first approved in South Korea on April 7, 2025. Sitagliptin phosphate is a dipeptidyl peptidase-4 (DPP-4) inhibitor that works by blocking the enzymatic degradation of glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), thereby prolonging the action of these incretin hormones. GLP-1 and GIP enhance insulin secretion and suppress glucagon release, leading to improved glycemic control. Sitagliptin also helps preserve β-cell function and slows the progression of T2DM. Empagliflozin, on the other hand, is a sodium-glucose co-transporter 2 (SGLT2) inhibitor that lowers blood glucose levels by inhibiting glucose reabsorption in the kidneys and increasing urinary glucose excretion. The combination of a DPP-4 inhibitor and an SGLT2 inhibitor offers a dual mechanism of action that not only improves glycemic control but also provides additional cardiovascular and weight management benefits. Empagliflozin promotes weight loss through glucosuria, while sitagliptin preserves β-cell function—making this fixed-dose combination particularly effective for comprehensive T2DM management. Clinical results demonstrate that Sitagliptin Phosphate Hydrate / Empagliflozin L-Proline significantly reduces HbA1c, improves glycemic control, and lowers the incidence of hypoglycemia, while also supporting weight loss. Chong Kun Dang utilized advanced formulation and drug development technologies to ensure the drug’s stability and bioavailability, supported by detailed pharmacokinetic studies showing equal or superior efficacy compared to individual agents. The company continues post-marketing surveillance and plans Phase IV clinical trials to further optimize dosing, explore long-term outcomes, and evaluate additional indications—such as cardiovascular protection, which has been suggested by emerging data. Currently, the T2DM treatment landscape includes various key drug classes such as DPP-4 inhibitors, SGLT2 inhibitors, and other oral hypoglycemic agents. Januvia (Merck) and Jardiance (Boehringer Ingelheim) are two widely used monotherapies that lower blood glucose via different mechanisms. Januvia is known for its tolerability and low risk of hypoglycemia, while Jardiance is favored for its cardiovascular benefits. Compared with these monotherapies, Chong Kun Dang’s fixed-dose combination offers a more comprehensive therapeutic option, especially for patients requiring simultaneous glycemic control and weight management. Competing products include Farxiga (AstraZeneca, an SGLT2 inhibitor) and Trulicity (Eli Lilly, a GLP-1 receptor agonist), both of which use different mechanisms to support glycemic control. 10. AtrasentanAtrasentan, marketed under the brand name Vanrafia, is an innovative small-molecule drug developed by Novartis Pharmaceuticals for the treatment of various kidney diseases. It received its first approval in the United States on April 2, 2025, for the treatment of IgA nephropathy (IgAN). As a selective endothelin receptor antagonist, Atrasentan offers patients a more effective and targeted therapeutic option, with the potential for global adoption to further improve treatment outcomes and quality of life. Atrasentan is a selective endothelin A (ETA) receptor antagonist that functions primarily by blocking the binding of endothelin-1 (ET-1) to the ETA receptor, thereby reducing vasoconstriction and inflammatory responses. ET-1 is a potent vasoconstrictor involved in regulating blood pressure and fluid-electrolyte balance. Under pathological conditions such as kidney disease, ET-1 contributes to excessive vasoconstriction and tissue damage. By selectively antagonizing ETA receptors, Atrasentan significantly lowers intraglomerular hypertension, reduces proteinuria, and helps preserve renal function. Additionally, Atrasentan suppresses the release of inflammatory mediators and mitigates renal fibrosis, thereby slowing disease progression. This dual mechanism of action allows Atrasentan to effectively slow the decline in kidney function and improve long-term outcomes in patients with IgA nephropathy and other glomerular diseases. Clinical studies have demonstrated that Atrasentan excels in reducing proteinuria and preserving renal function, significantly lowering the risk of kidney function deterioration. Novartis applied advanced drug design and development technologies to ensure drug stability and bioavailability, and conducted detailed pharmacokinetic studies, confirming that Atrasentan offers comparable or superior efficacy relative to similar therapies. Even after market launch, the company continues post-marketing surveillance to collect real-world clinical data, with plans to initiate Phase IV clinical trials to explore additional indications and long-term benefits. Notably, current research suggests that Atrasentan may also be effective in treating other glomerular diseases, such as focal segmental glomerulosclerosis (FSGS) and Alport syndrome. Currently, several important drug classes are available for the treatment of IgA nephropathy and other kidney diseases, including but not limited to angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), glucocorticoids, and immunosuppressants. For example, ACE inhibitors and ARBs are widely used to control hypertension and reduce proteinuria, but their mechanisms primarily focus on modulating the renin-angiotensin system, without directly targeting ET-1-mediated pathways. In contrast, Atrasentan, as a selective ETA receptor antagonist, provides a novel therapeutic approach by more effectively addressing glomerular hypertension and inflammatory responses. Other competing therapies include immunosuppressants such as cyclophosphamide and mycophenolate mofetil, which are commonly used to treat severe glomerular diseases but are often associated with significant adverse effects. Conclusion The wave of new drug approvals in April 2025 not only reflects the current advancements in pharmaceutical science and technology but also serves as a critical indicator of the future direction of medical innovation. Increasingly, targeted therapies and biologics are being developed to treat complex and difficult-to-cure diseases. This trend marks the gradual mainstream adoption of personalized medicine, which aims to deliver more effective and less toxic treatments by precisely targeting the key mechanisms of disease pathogenesis. How to obtain the latest research advancements in the field of biopharmaceuticals? In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!

23 Jun 2025

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IMAAVY™ (nipocalimab-aahu) showed greater sustained disease control versus approved FcRn blockers for generalized myasthenia gravis (gMG) at multiple timepoints over 24 weeks in newly published indirect treatment comparison (ITC)

The ITC compared all published Phase 3 data of these treatments, leveraging longitudinal results, and findings reinforce the importance of consistent, sustained disease control in managing a chronic autoantibody disease like gMG IMAAVY, an FcRn blocker, received U.S. FDA approval earlier this year for the broadest population of individuals living with gMG, including anti-AChR and anti-MuSK antibody positive adults and pediatric gMG patients aged 12 and older SPRING HOUSE, Pa., June 23, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced new data from an indirect treatment comparison (ITC) that showed consistent and sustained disease control with IMAAVY™ (nipocalimab-aahu) versus other approved FcRn blockers in adults with generalized myasthenia gravis (gMG). These data, featured at the European Academy of Neurology (EAN) 2025 Congress in Helsinki, Finland, are among the 11 abstracts Johnson & Johnson is presenting. Based on the ITC, which included the pivotal Phase 3 Vivacity-MG3 study data, IMAAVY showed comparable onset of symptom relief at Week 1 and showed consistent and sustained disease control with greater or statistically significant improvement of MG-ADLa scores versus the published Phase 3 data of other marketed FcRn blockers at several timepoints up to 24 weeksb of treatment.1 Results were consistent across multiple ITC methodsc. Population-adjusted ITCs without a common control exhibited significantly greater mean improvements in MG-ADL scores favoring IMAAVY over other FcRn blockers, at Weeks 8-24d versus one comparator and at Weeks 10-14d versus another comparator.1 In placebo-adjusted ITCs, IMAAVY was associated with numerically greater efficacy versus one treatment comparator at Weeks 8e and 18-24e and versus another at Weeks 10-14e, with statistical significance at Weeks 10f and 12f.1 "These analyses provide useful population-adjusted comparative data and add to the body of evidence supporting the use of IMAAVY for the treatment of gMG for certain patients," said Saiju Jacob, M.D., Professor, Department of Immunology and Immunotherapy at University of Birmingham, UK f, "The significantly greater mean improvements on MG-ADL scores with IMAAVY reflect important new evidence of the ongoing need for sustained disease control in a chronic condition like gMG." Unlike cyclic therapies that require clinical evaluation and symptom relapse prior to initiating subsequent treatment cycles, IMAAVY has a biweekly dosing regimen that may allow for a schedule that patients and healthcare providers can plan around.2 These data provide insights about the predictability that IMAAVY may offer and potentially help clinical decision making when treating patients with gMG. "At Johnson & Johnson, we recognize that for people living with gMG, the goal isn't just temporary relief, but rather sustained disease control. This analysis provides additional insights into the profile of IMAAVY and highlights its potential as a reliable treatment option for appropriate patients aged 12 and older living with gMG," said Katie Abouzahr, M.D., Vice President, Autoantibody Portfolio and Maternal Fetal Immunology Disease Area Leader, Johnson & Johnson Innovative Medicine. "As we continue to research the potential impact of IMAAVY and work with regulators worldwide, we are committed to helping patients with chronic, debilitating autoantibody conditions, like gMG." ITCs are utilized by regulatory agencies, health technology assessment agencies and medical guideline committees to comparatively evaluate treatment options when there is no or limited availability of evidence from head-to-head clinical trials.3 ITCs, however, cannot replace and should not be considered the same as head-to-head clinical trials.3 Unanchored population-adjusted and placebo-anchored Bucher ITC methods were used in this analysis.3 Unanchored population-adjusted indirect comparisons allow for adjustment of population differences using individual patient-level data from IMAAVY and aggregate data from other approved FcRn blockers.3 Placebo-anchored Bucher ITCs evaluate a small number of treatments through a common comparator such as the trial placebo and use aggregate data from different trials.3 IMAAVY is approved in the U.S. for adult and pediatric patients (12 years of age and older) with anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive gMG. Johnson & Johnson also submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of nipocalimab in gMG in September 2024. Editor's notes: a. MG-ADL (Myasthenia Gravis-Activities of Daily Living) provides a rapid clinical assessment of the patient's recall of symptoms impacting activities of daily living, with a total score range of 0 to 24; a higher score indicates greater symptom severity.4 b. There are no head-to-head data available for any FcRn blockers, and no claim of superiority can be made about any FcRn blockers in the absence of such head-to-head trial data. c. The ITC did not evaluate safety among the FcRn blocker agents. d. In unanchored population-adjusted indirect comparison, IMAAVY versus one treatment at Week 8 had a mean difference of -2.36 [(95% confidence interval [CI]: -3.56, -1.16); P=0.001]; this trend continued up to Week 24 (P<0.05). For another comparator, at Week 10 IMAAVY had a mean difference of –2.38 at one comparator dose [(95% CI: -3.57, -1.18); P<0.001] and a mean difference of -3.14 with a different comparator dose [(95% CI: -4.15, -2.14); P<0.001]; this trend continued up to Week 14 (P<0.001). e. In placebo-anchored indirect comparison, MG-ADL change from baseline (CFB) was greater at Week 8 by -1.24 versus one treatment comparator (95% CI: -2.78, 0.30), at Week 18 by -1.13 (95% CI: -2.77, 0.50), at Week 20 by -1.44 (95% CI: -3.21, -0.33), at Week 22 by -1.79 (95% CI: -4.16, 0.59), and at Week 24 by -2.89 (95% CI: -5.67, -0.12). f. In placebo-anchored indirect comparison, treatment with IMAAVY demonstrated a greater MG-ADL CFB versus a comparator dose at Week 10 (mean CFB=-1.19, 95% CI: -2.75, 0.37), Week 12 (mean CFB= -1.41, 95% CI: -2.94, 0.12) and Week 14 (mean CFB= -1.01, 95% CI: -2.51, 0.49). • Similar trends were observed for IMAAVY versus a different comparator dose at Week 10 (mean CFB= -2.16, 95% CI: -3.58, -0.73), Week 12 (mean CFB= -1.99, 95% CI: -3.53, -0.45) and Week 14 (mean CFB= -1.12, 95% CI: -2.55, 0.31). g. Saiju Jacob, M.D., has provided consulting, advisory, and speaking services to Johnson & Johnson. He has not been paid for any media work. ABOUT GENERALIZED MYASTHENIA GRAVIS (gMG) Myasthenia gravis (MG) is an autoantibody disease in which the immune system mistakenly makes antibodies (e.g., anti-acetylcholine receptor [AChR], anti-muscle-specific tyrosine kinase [MuSK]), which target proteins at the neuromuscular junction and can block or disrupt normal signaling from nerves to muscles, thus impairing or preventing muscle contraction.5,6,7 The disease impacts an estimated 700,000 people worldwide.5 The disease affects both men and women and occurs across all ages, racial and ethnic groups, but most frequently starts in young women and older men.8 Roughly 50 percent of individuals diagnosed with MG are women, and about one in five of those women are of child-bearing potential.9,10,11 Approximately 10 to 15% of new cases of MG are diagnosed in pediatric patients 12-17 years of age.12,13,14 Among juvenile MG patients, girls are affected more often than boys with over 65% of pediatric MG cases in the U.S. diagnosed in girls.15,16,17 Initial disease manifestations are usually eye-related but approximately 85% of MG patients experience additional advancements to the disease manifestations, referred to as generalized myasthenia gravis (gMG). This is characterized by severe muscle weakness and difficulties in speech and swallowing.18,19,20,21,22 Approximately 100,000 individuals in the U.S. are living with gMG.23 Vulnerable gMG populations, such as pediatric patients, have more limited therapeutic options.24 ABOUT THE INDIRECT TREATMENT COMPARISON Indirect treatment comparisons (ITCs) were conducted to compare efficacy onset using 1-week timepoint, and for consistency and sustained disease control, comparisons were conducted for multiple timepoints up to 24 weeks for one treatment comparator (up to 3-cycle duration) and up to 14 weeks for another treatment comparator (final visit data reported).1 The data used in the analysis came from published registrational trials of IMAAVY and comparator FcRn blockers approved to treat gMG (efgartigimod and rozanolixizumab).1 The differences in clinical trial design across FcRn blockers coupled with differences in background standard of care (SOC) required multiple indirect treatment comparison methods to be utilized.1 Therefore, ITCs were conducted using unanchored population-adjusted indirect comparisons (with active treatment arm only and adjusting for cross-trial patient differences) and placebo-anchored (includes both active treatment and placebo arms) Bucher method. Differences <0 favored nipocalimab for all comparisons.1 This ITC adheres to all governing standards and requirements as demanded by global health technology assessment agencies, journal review committees and regulatory authorities. The ITC was funded by Janssen Research & Development, LLC.1 THE PHASE 3 VIVACITY-MG3 STUDY The Phase 3 Vivacity-MG3 study (NCT04951622) was specifically designed to measure sustained efficacy and safety with consistent dosing in this unpredictable chronic condition where unmet need remains high. Antibody positive or negative adult gMG patients with insufficient response (MG-ADL ≥6) to ongoing SOC therapy were identified and 199 patients, 153 of whom were antibody positive, enrolled in the 24-week double-blind placebo-controlled trial.25,26 Randomization was 1:1, nipocalimab plus current SOC (30 mg/kg IV loading dose followed by 15 mg/kg every two weeks) or placebo plus current SOC.25 Baseline demographics were balanced across arms (77 nipocalimab, 76 placebo).25 The primary efficacy endpoint was the comparison of the mean change from baseline to Weeks 22, 23, and 24 between treatment groups in the MG-ADL total score.25 A key secondary endpoint included change in Quantitative Myasthenia Gravis (QMG) score. Long-term safety and efficacy were further assessed in an ongoing open-label extension (OLE) phase.26 ABOUT IMAAVY™ (nipocalimab-aahu) IMAAVY is a monoclonal antibody, designed to bind with high affinity to block FcRn and reduce levels of circulating immunoglobulin G (IgG) antibodies that underlie generalized myasthenia gravis (gMG) without additional detectable effects on other adaptive and innate immune functions. IMAAVY is currently approved in the U.S. for the treatment of gMG in adults and pediatric patients 12 years of age and older who are AChR or MuSK antibody positive.2 Nipocalimab is continuing to be investigated across three key segments in the autoantibody space including Rare Autoantibody diseases, Maternal Fetal diseases mediated by maternal alloantibodies and Rheumatic diseases.28,29,30,31,32,32,33,34,35,36 The investigational monoclonal antibody is designed to bind with high affinity to block FcRn and reduce levels of circulating immunoglobulin G (IgG) auto and alloantibodies potentially without additional detectable effects on other adaptive and innate immune functions. The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have granted several key designations to nipocalimab including: U.S. FDA Fast Track designation in hemolytic disease of the fetus and newborn (HDFN) and warm autoimmune hemolytic anemia (wAIHA) in July 2019, gMG in December 2021, fetal and neonatal alloimmune thrombocytopenia) FNAIT in March 2024 and Sjögren's disease (SjD) in March 2025 U.S. FDA Orphan drug status for wAIHA in December 2019, HDFN in June 2020, gMG in February 2021, chronic inflammatory demyelinating polyneuropathy (CIDP) in October 2021 and FNAIT in December 2023 U.S. FDA Breakthrough Therapy designation for HDFN in February 2024 and for Sjögren's disease in November 2024 U.S. FDA granted Priority Review in gMG in Q4 2024 EU EMA Orphan medicinal product designation for HDFN in October 2019 and FNAIT in April 2025 WHAT IS IMAAVY™ (nipocalimab-aahu)? IMAAVY™ is a prescription medicine used to treat adults and children 12 years of age and older with a disease called generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. It is not known if IMAAVY™ is safe and effective in children under 12 years of age. IMPORTANT SAFETY INFORMATION What is the most important information I should know about IMAAVY™? IMAAVY™ is a prescription medicine that may cause serious side effects, including: Infections are a common side effect of IMAAVY™ that can be serious. Receiving IMAAVY™ may increase your risk of infection. Tell your healthcare provider right away if you have any of the following infection symptoms: o fever o chills o shivering o cough o sore throat o fever blisters o burning when you urinate Allergic (hypersensitivity) reactions may happen during or up to a few weeks after your IMAAVY™ infusion. Get emergency medical help right away if you get any of these symptoms during or after your IMAAVY™ infusion: o a swollen face, lips, mouth, tongue, or throat o difficulty swallowing or breathing o itchy rash (hives) o chest pain or tightness Infusion-related reactions are possible. Tell your healthcare provider right away if you get any of these symptoms during or a few days after your IMAAVY™ infusion: o headache o rash o nausea o fatigue o dizziness o chills o flu-like symptoms o redness of skin Do not receive IMAAVY™ if you have a severe allergic reaction to nipocalimab-aahu or any of the ingredients in IMAAVY™. Reactions have included angioedema and anaphylaxis. Before using IMAAVY™, tell your healthcare provider about all of your medical conditions, including if you: ever had an allergic reaction to IMAAVY™. have or had any recent infections or symptoms of infection. have recently received or are scheduled to receive an immunization (vaccine). People who take IMAAVY™ should not receive live vaccines. are pregnant, plan to become pregnant, or are breastfeeding. It is not known whether IMAAVY™ will harm your baby. Pregnancy Safety Study. There is a pregnancy safety study for IMAAVY™ if IMAAVY™ is given during pregnancy or you become pregnant while receiving IMAAVY™. Your healthcare provider should report IMAAVY™ exposure by contacting Janssen at 1-800-526-7736 or www.IMAAVY.com. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. What are the possible side effects of IMAAVY™? IMAAVY™ may cause serious side effects. See "What is the most important information I should know about IMAAVY™?" The most common side effects of IMAAVY™ include: respiratory tract infection, peripheral edema (swelling in your hands, ankles, or feet), and muscle spasms. These are not all the possible side effects of IMAAVY™. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Please see the full Prescribing Information and Medication Guide for IMAAVY™ and discuss any questions you have with your doctor. Dosage Form and Strengths: IMAAVY™ is supplied as a 300 mg/1.62 mL and a 1,200 mg/6.5 mL (185 mg/mL) single-dose vial per carton for intravenous injection. ABOUT JOHNSON & JOHNSON At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at https://www.jnj.com/ or at https://innovativemedicine.jnj.com/ Follow us at @JNJInnovMed. Janssen Research & Development, LLC and Janssen Biotech, Inc. are Johnson & Johnson companies. CAUTIONS CONCERNING FORWARD-LOOKING STATEMENTS This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of IMAAVY™. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. REFERENCES 1 Saiju Jacob, Mahmoud Hashim, Brian Hutton, Kavita Gandhi, Rafal Slowik, Chris Drudge, Antoine C El Khoury, Maria Ait-Tihyaty, Mi Jun Keng, Xiwu Lin, Sumeet Singh, Nils Erik Gilhus. Comparative efficacy of nipocalimab with other FcRN-blocker therapies in generalized myasthenia gravis. Presented at the 2025 European Academy of Neurology (EAN) Congress. Available at: https://www.eanvirtualcongress.org/ean/ean2025/en-GB/presentation/5308352 IMAAVY™ U.S. Prescribing Information3 Nils Erik Gilhus, Saiju Jacob, Mahmoud Hashim, Suzy Van Sanden, Christopher Drudge, Anna Nero, Sumeet Singh, Kavita Gandhi, and Brian Hutton Network connectivity, between-study heterogeneity and timepoint challenges in generalized myasthenia gravis: a feasibility assessment of indirect treatment comparisons. (2025) Journal of Comparative Effectiveness Research. DOI: 10.57264/cer-2025-00094 Wolfe GI Myasthenia gravis activities of daily living profile. Neurology. 1999;22;52(7):1487-9. doi: 10.1212/wnl.52.7.1487.5 Chen J, Tian D-C, Zhang C, et al. Incidence, mortality, and economic burden of myasthenia gravis in China: A nationwide population-based study. The Lancet Regional Health - Western Pacific. https://www-thelancet-com.libproxy1.nus.edu.sg/action/showPdf?pii=S2666-6065%2820%2930063-8 6 Bacci ED et al. Understanding side effects of therapy for myasthenia gravis and their impact on daily life. BMC Neurol. 2019;19(1):335.7 Wiendl, H., et al., Guideline for the management of myasthenic syndromes. Therapeutic advances in neurological disorders, 16, 17562864231213240. https://doi-org.libproxy1.nus.edu.sg/10.1177/17562864231213240. Last accessed: June 2025.8 Bubuioc A, et al. The epidemiology of myasthenia gravis. Journal of Medicine & Life (2021). Jan-Mar;14(1):7-16. doi: 10.25122/jml-2020-0145.9 Ye, Yun et al. Epidemiology of myasthenia gravis in the United States. Frontiers in neurology vol. 15 1339167. 16 Feb. 2024, doi:10.3389/fneur.2024.1339167.10 Dresser, Laura et al. Myasthenia Gravis: Epidemiology, Pathophysiology and Clinical Manifestations. Journal of clinical medicine vol. 10,11 2235. 21 May. 2021, doi:10.3390/jcm10112235.11 J&J. Data on file.12 Evoli A, Batocchi AP, Bartoccioni E, Lino MM, Minisci C, Tonali P. Juvenile myasthenia gravis with prepubertal onset. Neuromuscul Disord. 1998 Dec;8(8):561-7. doi: 10.1016/s0960-8966(98)00077-7.13 Evoli A. Acquired myasthenia gravis in childhood. Curr Opin Neurol. 2010 Oct;23(5):536-40. doi: 10.1097/WCO.0b013e32833c32af.14 Finnis MF, Jayawant S. Juvenile myasthenia gravis: a paediatric perspective. Autoimmune Dis. 2011;2011:404101. doi: 10.4061/2011/404101.15 Haliloglu G, Anlar B, Aysun S, Topcu M, Topaloglu H, Turanli G, Yalnizoglu D. Gender prevalence in childhood multiple sclerosis and myasthenia gravis. J Child Neurol. 2002 May;17(5):390-2. doi: 10.1177/088307380201700516.16 Parr JR, Andrew MJ, Finnis M, Beeson D, Vincent A, Jayawant S. How common is childhood myasthenia? The UK incidence and prevalence of autoimmune and congenital myasthenia. Arch Dis Child. 2014 Jun;99(6):539-42. doi: 10.1136/archdischild-2013-304788.17 Mansukhani SA, Bothun ED, Diehl NN, Mohney BG. Incidence and Ocular Features of Pediatric Myasthenias. Am J Ophthalmol. 2019 Apr;200:242-249. doi: 10.1016/j.ajo.2019.01.004.18 National Institute of Neurological Disorders and Stoke. Myasthenia Gravis. Available at: https://www-ninds-nih-gov.libproxy1.nus.edu.sg/health-information/disorders/myasthenia-gravis. Last accessed: June 2025.19 Bever, C.T., Jr, Aquino, A.V., Penn, A.S., Lovelace, R.E. and Rowland, L.P. (1983), Prognosis of ocular myasthenia. Ann Neurol., 14: 516-519. https://doi-org.libproxy1.nus.edu.sg/10.1002/ana.410140504.20 Kupersmith MJ, Latkany R, Homel P. Development of generalized disease at 2 years in patients with ocular myasthenia gravis. Arch Neurol. 2003 Feb;60(2):243-8. doi: 10.1001/archneur.60.2.243. PMID: 12580710.21 Myasthenia gravis fact sheet. Retrieved April 2024 from https://www-ninds-nih-gov.libproxy1.nus.edu.sg/sites/default/files/migrate-documents/myasthenia_gravis_e_march_2020_508c.pdf.22 Myasthenia Gravis: Treatment & Symptoms. (2021, April 7). Retrieved April 2024 from https://my.clevelandclinic.org/health/diseases/17252-myasthenia-gravis-mg.23 DRG EPI (2021) & Optum Claims Analysis Jan 2012-December 2020.24 O'Connell K, Ramdas S, Palace J. Management of Juvenile Myasthenia Gravis. Front Neurol. 2020 Jul 24;11:743. doi: 10.3389/fneur.2020.00743. PMID: 32793107; PMCID: PMC7393473.25 Antozzi, C et al., Efficacy and safety of nipocalimab in adults with generalised myasthenia gravis (Vivacity MG3): a randomised, double-blind, placebo-controlled phase 3 study. The Lancet Neurology. Feb 2025; 24: 105–16. https://www-thelancet-com.libproxy1.nus.edu.sg/journals/laneur/article/PIIS1474-4422(24)00498-8/fulltext.26 ClinicalTrials.gov Identifier: NCT04951622. Available at: https://clinicaltrials.gov/ct2/show/NCT04951622. Last accessed: June 2025.27 Seth, N. P., Xu, R., DuPrie, M., Choudhury, A., Sihapong, S., Tyler, S., … Ling, L. E. (2025). Nipocalimab, an immunoselective FcRn blocker that lowers IgG and has unique molecular properties. mAbs, 17(1). https://doi-org.libproxy1.nus.edu.sg/10.1080/19420862.2025.246119128 ClinicalTrials.gov. NCT03842189. Available at: https://clinicaltrials.gov/ct2/show/NCT03842189. Last accessed: June 2025.29 ClinicalTrials.gov Identifier: NCT05327114. Available at: https://www.clinicaltrials.gov/study/NCT05327114. Last accessed: June 2025.30 ClinicalTrials.gov Identifier: NCT04119050. Available at: https://clinicaltrials.gov/study/NCT04119050. Last accessed: June 2025.31 ClinicalTrials.gov Identifier: NCT05379634. Available at: https://clinicaltrials.gov/study/NCT05379634. Last accessed: June 2025.32 ClinicalTrials.gov Identifier: NCT05912517. Available at: https://www.clinicaltrials.gov/study/NCT05912517. Last accessed: June 2025.33 ClinicalTrials.gov Identifier: NCT04968912. Available at: https://clinicaltrials.gov/study/NCT04968912. Last accessed: June 2025.34 ClinicalTrials.gov Identifier: NCT04882878. Available at: https://clinicaltrials.gov/study/NCT04882878. Last accessed: June 2025.35 ClinicalTrials.gov Identifier: NCT06449651. Available at: https://clinicaltrials.gov/study/NCT06449651. Last accessed: June 2025.36 ClinicalTrials.gov Identifier: NCT06533098. Available at: https://clinicaltrials.gov/study/NCT06533098. Last accessed: June 2025. Media contact: Bridget Kimmel bkimmel@its.jnj.com Investor contact: Lauren Johnson investor-relations@its.jnj.com View original content to download multimedia:https://www.prnewswire.com/news-releases/imaavy-nipocalimab-aahu-showed-greater-sustained-disease-control-versus-approved-fcrn-blockers-for-generalized-myasthenia-gravis-gmg-at-multiple-timepoints-over-24-weeks-in-newly-published-indirect-treatment-comparison-itc-302487317.html SOURCE Johnson & Johnson

Clinical ResultPhase 3Breakthrough TherapyDrug ApprovalImmunotherapy

100 Deals associated with Nipocalimab-aahu

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Approved

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Indication	Country/Location	Organization	Date
Myasthenia Gravis	United States	Janssen Biotech, Inc.	29 Apr 2025

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating	NDA/BLA	Canada	Janssen Research & Development LLC	01 Jan 2025
Sjogren's Syndrome	Phase 3	United States	Janssen Research & Development LLC	04 Dec 2024
Sjogren's Syndrome	Phase 3	China	Janssen Research & Development LLC	04 Dec 2024
Sjogren's Syndrome	Phase 3	Japan	Janssen Research & Development LLC	04 Dec 2024
Sjogren's Syndrome	Phase 3	Argentina	Janssen Research & Development LLC	04 Dec 2024
Sjogren's Syndrome	Phase 3	Australia	Janssen Research & Development LLC	04 Dec 2024
Sjogren's Syndrome	Phase 3	Austria	Janssen Research & Development LLC	04 Dec 2024
Sjogren's Syndrome	Phase 3	Brazil	Janssen Research & Development LLC	04 Dec 2024
Sjogren's Syndrome	Phase 3	Bulgaria	Janssen Research & Development LLC	04 Dec 2024
Sjogren's Syndrome	Phase 3	Canada	Janssen Research & Development LLC	04 Dec 2024

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05827874 (Pubmed \| Hum Vaccin Immunother)	Phase 1	-	-	Nipocalimab	ptsixztzra(giovvpmdse) = cvcvacdlxi driffwuyyf (bdtbrrenti )	Positive	31 Dec 2025
				nipocalimab (Control (No drug))	ptsixztzra(giovvpmdse) = ajcckkgjnn driffwuyyf (bdtbrrenti )
NCT04951622 (VIVACITY \| Vivacity-MG3, CTgov)	Phase 3	Myasthenia Gravis	219	placebo+nipocalimab (Double Blind (DB) Phase: Placebo)	eezudoxhgu(cosdbwczzl) = pkecxhdmsp rzqcxgjcpi (rxyjpiwnnc, 0.335) View more	-	23 Jul 2025
				nipocalimab (DB Phase: Nipocalimab)	eezudoxhgu(cosdbwczzl) = yqzcehvfpr rzqcxgjcpi (rxyjpiwnnc, 0.329) View more
NCT04951622 (Vivacity-MG3, Company_Website \| EAN2025) Manual	Phase 3	Myasthenia Gravis	153	nipocalimab +SOC	-	Positive	23 Jun 2025
NCT04951622 (Vivacity-MG3, AAN 12025 \| AAN 22025) Manual	Phase 3	Myasthenia Gravis	137	Nipocalimab+standard-of-care therapy	giqqczrger(gbztallibc) = rnonnyqsbv uhlyzelxmq (ndmgqafztv, 0.401) View more	Positive	07 Apr 2025
NCT04951622 (Vivacity-MG3, AAN2025)	Phase 3	Myasthenia Gravis	-	Nipocalimab+Standard-of-Care	yrmheslszh(vaadehmely) = ryiaehtoru pdseosuztg (slfkfgrqsj ) View more	Positive	07 Apr 2025
				Placebo+Standard-of-Care	yrmheslszh(vaadehmely) = asakoeaacv pdseosuztg (slfkfgrqsj ) View more
NCT04951622 (Vivacity-MG3, Lancet \| FDA_CDER) Manual	Phase 3	Myasthenia Gravis	196	Nipocalimab	bdlgxsjbxw(fbsmurtwpq) = wnunvbykuj mcltgaxlmc (vzrgjvdbty, 0.33) Met View more	Positive	01 Feb 2025
				Placebo	bdlgxsjbxw(fbsmurtwpq) = ilpumcgxkc mcltgaxlmc (vzrgjvdbty, 0.34) Met View more
NCT04968912 (DAHLIAS, ACR2024) Manual	Phase 2	Sjogren's Syndrome	163	Placebo	bzczhcnxyn(wueqdywajm) = utohszlrsh abovslntpg (kazoqjjrua, -4.74 to -2.75) Met View more	Positive	18 Nov 2024
				nipocalimab 5 mg/kg	bzczhcnxyn(wueqdywajm) = plvylotxdh abovslntpg (kazoqjjrua, -5.10 to -3.07) Met View more
NCT04968912 (DAHLIAS, ACR2024) Manual	Phase 2	Sjogren's Syndrome	163	nipocalimab 5 mg/kg	mmowcvkfgn(butdrkwdto) = kxdlthrcyk ebncwufhuv (fhwdtoyood )	Positive	18 Nov 2024
				nipocalimab 15 mg/kg	mmowcvkfgn(butdrkwdto) = yxwylygyig ebncwufhuv (fhwdtoyood, -66， - 46)
NCT04968912 (DAHLIAS, ACR2024) Manual	Phase 2	Sjogren's Syndrome	163	Nipocalimab 5 mg/kg	rbnvemaxqp(sqxvnnfmen) = uhsdmfwywq ycgftygyfk (qkxywovigr ) View more	Positive	17 Nov 2024
				Nipocalimab 15 mg/kg	rbnvemaxqp(sqxvnnfmen) = afoydrxwfw ycgftygyfk (qkxywovigr ) View more
NCT05265273 (Vibrance-MG, Corporate Publications) Manual	Phase 2/3	Myasthenia Gravis	7	Nipocalimab plus standard of care (SOC)	avpaddgnkb(qmyovtuwft) = fwvmjppioo xmdumwijmo (ioidrkgfgg ) Met View more	Positive	15 Oct 2024

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