Carfilzomib

Studies evaluate Aponermin combined with proteasome inhibitors, immunomodulatory drugs, cytotoxic agents, XPO-1 inhibitors, and BCL-2 inhibitors WUHAN, China, September 2026 – Wuhan Hiteck Biological Pharma Co., Ltd. (300683.SZ) announced that five basic and clinical studies of Aponermin for Injection (SunHiTrail®), the world's first approved DR4/DR5 agonist, were accepted for poster presentation at the 23rd International Myeloma Society (IMS) Annual Meeting & Exposition, held September 23–26, 2026 at the Scottish Event Campus (SEC) in Glasgow, United Kingdom. The studies were presented by investigators from Beijing Chaoyang Hospital of Capital Medical University, The First Affiliated Hospital of Zhejiang University School of Medicine, and The First Affiliated Hospital of Sun Yat-sen University, and include exploratory analyses of efficacy biomarkers for Aponermin-based regimens, as well as efficacy and safety evaluations of Aponermin combined with proteasome inhibitors, immunomodulatory drugs, cytotoxic agents, XPO-1 inhibitors, and BCL-2 inhibitors. The studies involve frail patients with newly diagnosed multiple myeloma (NDMM) who are not candidates for intensive chemotherapy, and patients with relapsed/refractory multiple myeloma (RRMM) facing major treatment challenges, including relapse after immunotherapy, bulky extramedullary disease, and multi-drug exposure. Presentation Overview Abstract Title Presenting Author PA-164 Efficacy and Safety of Aponermin (rhTRAIL)-Kd-Based Regimens in Relapsed/Refractory Multiple Myeloma: A Single-Center Retrospective Analysis Huixing Zhou, PhD, Beijing Chaoyang Hospital, Capital Medical University PA-037 Aponermin + KT-DECP, a Good Bridging Regimen for Relapsed/Refractory Multiple Myeloma with Extramedullary Disease Aijun Liu, PhD, Beijing Chaoyang Hospital, Capital Medical University PA-524 Venetoclax Synergizes with Circularly Permuted TRAIL Through DR5 Upregulation and BID-Dependent Crosstalk in Multiple Myeloma Yiwen Jiang, PhD, Beijing Chaoyang Hospital, Capital Medical University PA-036 Aponermin Combined with Carfilzomib, Pomalidomide, and Dexamethasone in RRMM Patients Relapsing after CAR-T or BiTE Therapy: A Subgroup Analysis of a Prospective, Single-Arm, Multicenter Trial Zhen Cai, MD, PhD, The First Affiliated Hospital, Zhejiang University School of Medicine PA-093 Clinical Efficacy and Safety of Epronermin ( Aponermin) Plus Selinexor (CPT+S) in Newly Diagnosed Ultra-Frail Patients with Multiple Myeloma Jingxia Li, The First Affiliated Hospital, Sun Yat-sen University All five studies were presented in poster format. Study Highlights • Ultra-frail newly diagnosed patients (PA-093): This study evaluates the clinical efficacy and safety of Aponermin combined with selinexor (CPT+S) in ultra-frail patients with NDMM. • Relapse after immunotherapy (PA-036): This subgroup analysis of a prospective, single-arm, multicenter trial evaluates Aponermin combined with carfilzomib, pomalidomide, and dexamethasone in patients with RRMM relapsing after CAR-T or BiTE therapy. • Carfilzomib-based regimens (PA-164): A single-center retrospective analysis assesses the efficacy and safety of Aponermin combined with carfilzomib and dexamethasone (Kd)-based regimens in RRMM. • Extramedullary disease (PA-037): This study evaluates Aponermin plus KT-DECP as a bridging regimen for RRMM with extramedullary disease. • Combination with a BCL-2 inhibitor (PA-524): This basic research study examines the synergy between venetoclax and circularly permuted TRAIL in multiple myeloma through DR5 upregulation and BID-dependent crosstalk. Mechanism of Action Aponermin for Injection is a circularly permuted form of human tumor necrosis factor-related apoptosis-inducing ligand (TRAIL) and the world's first approved DR4/DR5 agonist. It binds to death receptor 4 (DR4) and/or death receptor 5 (DR5) on the tumor cell surface, activating the extrinsic apoptotic pathway and triggering a caspase cascade that induces p53-independent apoptosis. Multiple studies have also shown that DR4/DR5 agonists exert immunomodulatory effects, suppressing regulatory T cells, tumor-associated macrophages, myeloid-derived suppressor cells, and other immunosuppressive cells in the tumor microenvironment, thereby helping to improve the tumor immune microenvironment. Scientific Context The IMS Annual Meeting is one of the most authoritative scientific gatherings in the global myeloma field, covering basic research, translational medicine, and clinical practice in multiple myeloma and other plasma cell disorders. This year's meeting featured 635 research abstracts, including poster presentations, and 35 late-breaking abstracts, together with multiple special sessions on basic biology, immunotherapy, disease monitoring, and other topics. In addition, the International Myeloma Working Group (IMWG) released an important new work, Defining Cure in Multiple Myeloma , during the meeting. In recent years, basic research, real-world case analyses, and early and interim data from investigator-initiated trials (IITs) of Aponermin for Injection have been successively presented at top-tier international congresses, including the IMS Annual Meeting. Ranging from study design to in-depth analysis of the target mechanism of action, this body of work fully reflects the recognition of DR4/DR5 agonists for the treatment of hematologic malignancies within the international hematology community, as well as a continuously deepening understanding of their mechanism. Future Development Hiteck will accelerate its ongoing research on Aponermin, with the goal of bringing additional safe, effective, and innovative treatment options to patients as early as possible. Aponermin for Injection is approved in China for relapsed or refractory multiple myeloma. Its use in newly diagnosed multiple myeloma and the combination regimens described above are investigational, and their safety and efficacy have not been established. FAQ What is Aponermin? Aponermin for Injection (SunHiTrail®) is a Class 1 innovative biologic developed by Hiteck. It is a circularly permuted form of human TRAIL and the world's first approved DR4/DR5 agonist, approved in China in 2023 for relapsed or refractory multiple myeloma. What was presented at the 23rd IMS Annual Meeting? Five posters: four clinical studies of Aponermin-based combination regimens in newly diagnosed and relapsed/refractory multiple myeloma, and one basic research study on the mechanism of synergy between Aponermin and venetoclax. Which patients do these studies focus on? Frail patients with newly diagnosed multiple myeloma, and patients with RRMM facing major treatment challenges, including relapse after CAR-T or bispecific therapy, extramedullary disease, and extensive prior drug exposure. About Hiteck Wuhan Hiteck Biological Pharma Co., Ltd. was founded in 1992 at the Medical School of Wuhan University and is a publicly listed biopharmaceutical company on the Shenzhen Stock Exchange (stock code: 300683). Guided by its mission of "Innovating for Life," Hiteck focuses on oncology, neurology, and immunology, with a continued commitment to the development of innovative biologics and small molecule therapeutics. In oncology, Hiteck developed Aponermin, the world's first approved DR4 and DR5 agonist, which received regulatory approval in 2023 and was rapidly included in the national reimbursement program, introducing a novel therapeutic target for patients with relapsed or refractory multiple myeloma. Hiteck continues to build the clinical evidence for Aponermin-based combination regimens across newly diagnosed and difficult-to-treat relapsed myeloma populations. In neurology, the company translated Nobel Prize winning discoveries into clinical practice with Jinlujie, the world's first approved nerve growth factor (NGF) therapy, which has benefited millions of patients. Leveraging the HiSMART™ platform, Hiteck is advancing multiple innovative small molecule programs in parallel, supported by GMP compliant manufacturing facilities and integrated value chain capabilities, with the aim of delivering sustained innovation and meaningful benefits to patients worldwide. Media Contact Company: Wuhan Hiteck Biological Pharma Co., Ltd. Website: Hiteckpharma.com Email: bd@hiteck.com.cn Address: Hiteck Science and Technology Park, Wuhan Economic and Technological Development Zone, Wuhan, Hubei Province, 430056, China.

Analysis shows ~87% of patients treated with TECVAYLI ® plus DARZALEX FASPRO ® as early as second line were estimated to have comparable mortality risk to the general population A separate analysis shows the survival benefit was driven by a 90% reduction in the risk of multiple myeloma progression versus standard of care, with no significant difference in rates of non-relapse mortality Johnson & Johnson is advancing a differentiated multiple myeloma portfolio designed to deliver deeper, more durable disease control and improve long-term outcomes for patients RARITAN, N.J. , Sept. 23, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ), a worldwide leader in multiple myeloma therapies, today announced new data from the Phase 3 MajesTEC-3 study showing sustained disease control and survival with TECVAYLI ® (teclistamab-cqyv) plus DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj) in patients with relapsed or refractory multiple myeloma (RRMM) who had received 1-3 prior lines of therapy. 1,2 Using a relative survival mixture cure model (MCM) and actual progression-free survival (PFS) and overall survival (OS) data from the trial, statistical modeling estimated that ~87% of patients treated with TECVAYLI ® plus DARZALEX FASPRO ® (Tec-Dara) may experience a mortality risk and projected life expectancy similar to an age-matched general population. 1 Modeling further predicted that median overall survival with Tec-Dara would be nearly four-fold longer than with the standard of care (SOC) comparator in the study, dexamethasone with pomalidomide or bortezomib (DPd/DVd). These data help to illustrate to what extent treatment with TECVAYLI ® plus DARZALEX FASPRO ® as early as second line may reshape survival expectations in multiple myeloma. 1 In the MajesTEC-3 study, TECVAYLI ® plus DARZALEX FASPRO ® significantly improved overall survival versus standard of care (SOC), with an estimated 83% of patients alive at 3 years. 3 A post hoc analysis showed that Tec-Dara reduced the risk of cumulative incidence of disease progression by 90% versus SOC, with no significant difference in non-relapse mortality over time between the treatment arms. 2 These data (Abstract #OA-58 and Abstract #OA-49) will be presented in two oral sessions at the International Myeloma Society (IMS) Annual Meeting. Expert and company perspectives emphasize the potential for durable, long-term disease control "These findings underscore how consequential treatment choice at first relapse can be in shaping a patient's long-term trajectory," said Dr. Luciano J. Costa, Professor of Multiple Myeloma and Director of the Multiple Myeloma Research and Treatment Program at the University of Alabama at Birmingham.* "The sustained disease control observed with TECVAYLI plus DARZALEX FASPRO is changing expectations for what treatment can achieve in relapsed or refractory multiple myeloma, moving beyond just delaying the next relapse toward the possibility of durable long-term disease control." "The continued analyses of the unprecedented MajesTEC-3 trial challenge long-held expectations of what may be possible in multiple myeloma," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson Innovative Medicine. "Our ambition is to build on this progress by fundamentally changing the long-term trajectory of multiple myeloma and, ultimately, creating a future in which this disease is no longer defined as incurable." Model-based analysis projects potential long-term survival outcomes The MajesTEC-3 study evaluated TECVAYLI ® plus DARZALEX FASPRO ® versus investigator's choice of daratumumab SC plus DPd/DVd in patients with RRMM who had received one to three prior lines of therapy. 3 In this analysis, a relative survival mixture cure model was applied to patients treated with TECVAYLI ® plus DARZALEX FASPRO ® (n=291) and DPd/DVd (n=296) to assess whether long-term disease control could translate into outcomes approaching those of the general population. 1 Best-fit models estimated cure fractions of 86.6% (95% confidence interval [CI], 81–91) for OS with the combination, compared with 0% (95% CI, 0–53) with DPd/DVd, with substantially greater uncertainty in the DPd/DVd estimates. 1 Model projected remaining life expectancy was 18.5 years with the combination, nearly four times the 4.9 years projected with DPd/DVd and approaching 21.1 years for the matched general population. 1 Reduced disease progression drives survival benefit A separate post hoc analysis provided further insight into the survival benefit observed in MajesTEC-3. 2 At 36 months, the cumulative incidence of disease progression was 8.7% with TECVAYLI ® plus DARZALEX FASPRO ® , versus 62.1% with DPd/DVd, representing a 90% reduction in the risk of disease progression (subdistribution hazard ratio [sHR]=0.10; 95% CI, 0.07–0.16; P400 mg/dL. Neutropenia - TECVAYLI can cause neutropenia and febrile neutropenia. In patients who received TECVAYLI at the recommended dosage in the clinical trials (monotherapy and combination therapy trials; N=448), decreased neutrophils occurred in 88% of patients, with Grade 3 or 4 decreased neutrophils in 70%. Febrile neutropenia occurred in 6% of patients. Monitor complete blood cell counts at baseline and periodically during treatment and provide supportive care per local institutional guidelines. Monitor patients with neutropenia for signs of infection. Withhold TECVAYLI based on severity. Hypersensitivity and Other Administration Reactions - TECVAYLI can cause both systemic administration-related and local injection-site reactions. Systemic Reactions - In patients who received the recommended TECVAYLI dosage in the clinical trials (monotherapy and combination therapy trials; N=448), 2.5% of patients experienced systemic administration reactions, which included recurrent pyrexia and rash. Local Reactions - In patients who received TECVAYLI at the recommended dosage in the clinical trials (monotherapy and combination therapy trials; N=448), injection-site reactions occurred in 37% of patients, with Grade 1 injection-site reactions in 29% and Grade 2 in 9%. Withhold TECVAYLI or consider permanent discontinuation of TECVAYLI based on severity. Embryo-Fetal Toxicity - Based on its mechanism of action, TECVAYLI may cause fetal harm when administered to a pregnant patient. Advise pregnant patients of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with TECVAYLI and for 5 months after the last dose. ADVERSE REACTIONS The most common adverse reactions (≥20%) in patients who received TECVAYLI monotherapy were pyrexia, CRS, musculoskeletal pain, injection site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, and diarrhea. The most common adverse reactions (≥20%) in patients who received TECVAYLI in combination with daratumumab and hyaluronidase-fihj were hypogammaglobulinemia, upper respiratory tract infection, CRS, cough, diarrhea, musculoskeletal pain, COVID-19, pneumonia, injection site reaction, fatigue, pyrexia, headache, nausea, gastroenteritis, and weight decreased. The most common Grade 3 to 4 laboratory abnormalities (≥20%) with TECVAYLI (as monotherapy or in combination with daratumumab and hyaluronidase-fihj) were decreased lymphocytes, decreased neutrophils, decreased white blood cells, decreased hemoglobin, and decreased platelets. Please read full Prescribing Information , including Boxed WARNING, for TECVAYLI. DARZALEX FASPRO ® INDICATIONS AND IMPORTANT SAFETY INFORMATION INDICATIONS DARZALEX ® (daratumumab) is indicated for the treatment of adult patients with multiple myeloma: In combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy In combination with bortezomib, melphalan, and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant In combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant In combination with bortezomib and dexamethasone in patients who have received at least one prior therapy In combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy In combination with pomalidomide and dexamethasone in patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor (PI) As monotherapy in patients who have received at least three prior lines of therapy including a PI and an immunomodulatory agent or who are double refractory to a PI and an immunomodulatory agent DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj) is indicated for the treatment of adult patients with multiple myeloma: In combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation in newly diagnosed patients who are eligible for autologous stem cell transplant In combination with bortezomib, lenalidomide, and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant In combination with bortezomib, melphalan, and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant In combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy In combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant In combination with pomalidomide and dexamethasone in patients who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor (PI) In combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy In combination with bortezomib and dexamethasone in patients who have received at least one prior therapy As monotherapy in patients who have received at least three prior lines of therapy including a PI and an immunomodulatory agent or who are double refractory to a PI and an immunomodulatory agent IMPORTANT SAFETY INFORMATION DARZALEX ® ANDDARZALEX FASPRO ® : CONTRAINDICATIONS DARZALEX ® and DARZALEX FASPRO ® are contraindicated in patients with a history of severe hypersensitivity to daratumumab, hyaluronidase (for DARZALEX FASPRO ® ), or any of the components of the formulations. WARNINGS AND PRECAUTIONS DARZALEX ® : Infusion-Related Reactions DARZALEX ® can cause severe and/or serious infusion-related reactions including anaphylactic reactions. These reactions can be life-threatening, and fatal outcomes have been reported. In clinical trials (monotherapy and combination: N=2066), infusion-related reactions occurred in 37% of patients with the Week 1 (16 mg/kg) infusion, 2% with the Week 2 infusion, and cumulatively 6% with subsequent infusions. Less than 1% of patients had a Grade 3/4 infusion-related reaction at Week 2 or subsequent infusions. The median time to onset was 1.5 hours (range: 0 to 73 hours). Nearly all reactions occurred during infusion or within 4 hours of completing DARZALEX ® . Severe reactions have occurred, including bronchospasm, hypoxia, dyspnea, hypertension, tachycardia, headache, laryngeal edema, pulmonary edema, and ocular adverse reactions, including choroidal effusion, acute myopia, and acute angle closure glaucoma. Signs and symptoms may include respiratory symptoms, such as nasal congestion, cough, throat irritation, as well as chills, vomiting, and nausea. Less common signs and symptoms were wheezing, allergic rhinitis, pyrexia, chest discomfort, pruritus, hypotension, and blurred vision. When DARZALEX ® dosing was interrupted in the setting of autologous stem cell transplant (ASCT) (CASSIOPEIA) for a median of 3.75 months (range: 2.4 to 6.9 months), upon re-initiation of DARZALEX ® , the incidence of infusion-related reactions was 11% for the first infusion following ASCT. Infusion-related reactions occurring at re-initiation of DARZALEX ® following ASCT were consistent in terms of symptoms and severity (Grade 3 or 4: 1%) injection-site reactions were injection site erythema and injection site rash. In patients with high-risk smoldering multiple myeloma (N=193), injection-site reactions occurred in 28% of patients, including Grade 2 reactions in 3%. These local reactions occurred a median of 6 minutes (range: 0 minutes to 6.5 days) after starting administration of DARZALEX FASPRO ® . Monitor for local reactions and consider symptomatic management. DARZALEX ® and DARZALEX FASPRO ® : Infections DARZALEX ® and DARZALEX FASPRO ® can cause serious, life-threatening, or fatal infections. In patients who received DARZALEX ® in a pooled safety population (N=2066), serious infections, including opportunistic infections, occurred in 22.6% of patients, Grade 3 or 4 infections occurred in 24.3%, and fatal infections occurred in 1.2%. The most common (≥2%) types of serious infection reported were pneumonia (11%), upper respiratory tract infection (4%), sepsis (3%), and bronchitis (2%). In patients who received DARZALEX FASPRO ® in a pooled safety population including patients with smoldering multiple myeloma and light chain (AL) amyloidosis (N=1639), serious infections, including opportunistic infections, occurred in 24% of patients, Grade 3 or 4 infections occurred in 22%, and fatal infections occurred in 2.5%. The most common type of serious infection reported was pneumonia (8.5%). Monitor patients for signs and symptoms of infection prior to and during treatment with DARZALEX ® or DARZALEX FASPRO ® and treat appropriately. Administer prophylactic antimicrobials according to guidelines. DARZALEX ® and DARZALEX FASPRO ® : Neutropenia and Thrombocytopenia DARZALEX ® and DARZALEX FASPRO ® may increase neutropenia and thrombocytopenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer's prescribing information for background therapies. Monitor patients with neutropenia for signs of infection. Consider withholding DARZALEX ® or DARZALEX FASPRO ® until recovery of neutrophils or for recovery of platelets. In lower body weight patients receiving DARZALEX FASPRO ® , higher rates of Grade 3-4 neutropenia were observed. DARZALEX ® and DARZALEX FASPRO ® : Interference With Serological Testing Daratumumab binds to CD38 on red blood cells (RBCs) and results in a positive indirect antiglobulin test (indirect Coombs test). Daratumumab-mediated positive indirect antiglobulin test may persist for up to 6 months after the last daratumumab administration. Daratumumab bound to RBCs masks detection of antibodies to minor antigens in the patient's serum. The determination of a patient's ABO and Rh blood type are not impacted. Notify blood transfusion centers of this interference with serological testing and inform blood banks that a patient has received DARZALEX ® and DARZALEX FASPRO ® . Type and screen patients prior to starting DARZALEX ® and DARZALEX FASPRO ® . DARZALEX ® and DARZALEX FASPRO ® : Interference With Determination of Complete Response Daratumumab is a human immunoglobulin G (IgG) kappa monoclonal antibody that can be detected on both the serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of complete response and of disease progression in some patients with IgG kappa myeloma protein. DARZALEX ® and DARZALEX FASPRO ® : Embryo-Fetal Toxicity Based on the mechanism of action, DARZALEX ® and DARZALEX FASPRO ® can cause fetal harm when administered to a pregnant woman. DARZALEX ® and DARZALEX FASPRO ® may cause depletion of fetal immune cells and decreased bone density. Advise pregnant women of the potential risk to a fetus. Advise females with reproductive potential to use effective contraception during treatment with DARZALEX ® or DARZALEX FASPRO ® and for 3 months after the last dose. The combination of DARZALEX ® or DARZALEX FASPRO ® with lenalidomide, pomalidomide, or thalidomide is contraindicated in pregnant women because lenalidomide, pomalidomide, and thalidomide may cause birth defects and death of the unborn child. Refer to the lenalidomide, pomalidomide, or thalidomide prescribing information on use during pregnancy. DARZALEX ® : ADVERSE REACTIONS The most frequently reported adverse reactions (incidence ≥20%) with DARZALEX ® were upper respiratory infection, neutropenia, infusion-related reactions, thrombocytopenia, diarrhea, constipation, anemia, peripheral sensory neuropathy, fatigue, peripheral edema, nausea, cough, pyrexia, dyspnea, and asthenia. The most common hematologic laboratory abnormalities (≥40%) with DARZALEX ® are neutropenia, lymphopenia, thrombocytopenia, leukopenia, and anemia. DARZALEX FASPRO ® : ADVERSE REACTIONS In multiple myeloma, the most common adverse reaction (≥20%) with DARZALEX FASPRO ® monotherapy is upper respiratory tract infection. The most common adverse reactions with combination therapy (≥20% for any combination) include fatigue, nausea, diarrhea, dyspnea, sleep disorder, headache, rash, renal impairment, motor dysfunction, pyrexia, cough, muscle spasms, back pain, vomiting, hypertension, musculoskeletal pain, decreased appetite, urinary tract infection, abdominal pain, upper respiratory tract infection, peripheral neuropathy, peripheral sensory neuropathy, constipation, pneumonia, edema, dizziness, bruising, and COVID-19. The most common hematologic laboratory abnormalities (≥40%) with DARZALEX FASPRO ® are decreased leukocytes, decreased lymphocytes, decreased neutrophils, decreased platelets, and decreased hemoglobin. Please click here to read full Prescribing Information for DARZALEX ® . Please click here to read full Prescribing Information for DARZALEX FASPRO ® . 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  or at  . Follow us at  @JNJInnovMed . Caution Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 related to TECVAYLI ®  (teclistamab-cqyv) and DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj). 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  ,  ,  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. Footnote * Dr. Luciano J. Costa, Professor of Multiple Myeloma and Director of the Multiple Myeloma Research and Treatment Program at the University of Alabama at Birmingham, has provided consulting, advisory, and speaking services to Johnson & Johnson; he has not been paid for any media work. 1 Effelterre T, et al. Projecting Functional Cure in Patients (Pts) With Relapsed/Refractory Multiple Myeloma (RRMM) in the MajesTEC-3 Study of Teclistamab-Daratumumab (Tec-Dara) Using a Mixture Cure Model. Presented at: The 2026 International Myeloma Society (IMS) Annual Meeting; September 23, 2026; Glasgow, Sweden. 2 Costa L, et al. Overall Survival, Progression and Non-Relapse Mortality With Teclistamab Plus Daratumumab (Tec-Dara) vs Dara-Based Triplets in Relapsed/Refractory Multiple Myeloma (RRMM): MajesTEC-3 Post Hoc Analysis. Presented at: The 2026 International Myeloma Society (IMS) Annual Meeting; September 24, 2026; Glasgow, Sweden. 3 MajesTEC-3, NCT05083169. A Phase 3 Randomized Study Comparing Teclistamab + Subcutaneous Daratumumab (Tec-Dara) Versus Daratumumab SC + Pomalidomide + Dexamethasone (DPd) or Daratumumab SC + Bortezomib + Dexamethasone (DVd). Accessed September 2026 4 Rajkumar SV. Multiple myeloma: 2020 update on diagnosis, risk-stratification and management. Am J Hematol . 2020;95(5):548-567. 5 National Cancer Institute. Plasma cell neoplasms. Accessed September 2026.  6 City of Hope. Multiple myeloma: Causes, symptoms & treatments. 2022. Accessed September 2026.  7 International Agency for Research on Cancer (World Health Organization). Multiple myeloma fact sheet. 2024. Accessed September 2026.  8 SEER Explorer: An interactive website for SEER cancer statistics. Surveillance Research Program, National Cancer Institute. Accessed September 2026.  9 American Cancer Society. What is multiple myeloma? Accessed September 2026.  10 American Cancer Society. Multiple myeloma early detection, diagnosis, and staging. Accessed September 2026.  11 Kazandjian D. Multiple myeloma epidemiology and survival: a unique malignancy.  J Clin Oncol.  2018;36(15):1479-1487.  12 Johnson & Johnson. U.S. FDA approves TECVAYLI ®  (teclistamab-cqyv), the first bispecific T-cell engager antibody for the treatment of patients with relapsed or refractory multiple myeloma. Accessed September 2026.  13 DARZALEX FASPRO ®  U.S. Prescribing Information. 2025. Horsham, PA: Janssen Biotech, Inc. 14 DARZALEX ®  U.S. Prescribing Information. 2022. Horsham, PA: Janssen Biotech, Inc. View original content to download multimedia: SOURCE Johnson & Johnson