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Last update 27 May 2025

Batoclimab

Last update 27 May 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Batoclimab (USAN/INN), Immunoglobulin g1(238-alanine, 239-alanine), anti-(human fcrn receptor) (human monoclonal hl161bkn .gamma.1-chain), disulfide with human monoclonal hl161bkn .lambda.-chain, dimer, HBM-9161

+ [5]

Target

FcRn

Action

antagonists, modulators

Mechanism

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

Therapeutic Areas

NeoplasmsImmune System DiseasesNervous System Diseases+ [8]

Active Indication

Myasthenia GravisGraves OphthalmopathyPurpura, Thrombocytopenic, Idiopathic+ [6]

Inactive Indication

Warm autoimmune hemolytic anemia

Originator Organization

HANALL BIOPHARMA Co., Ltd.

Active Organization

Immunovant Sciences Ltd.

Nona Biosciences Suzhou Co. Ltd.

Harbour BioMed (Shanghai) Co., Ltd.

+ [8]

Inactive Organization-

License Organization

CSPC NBP Pharmaceutical Co., Ltd.

Harbour BioMed (Shanghai) Co., Ltd.

Immunovant, Inc.

+ [2]

Drug Highest PhaseNDA/BLA

First Approval Date-

RegulationBreakthrough Therapy (China), Orphan Drug (Japan)

Structure/Sequence

Sequence Code 524289076H

Source: *****

Sequence Code 524289077L

Source: *****

Clinical Trials associated with Batoclimab

NCT05907668

/ Active, not recruitingPhase 2

IMVT-1401-2501: A Proof-of-Concept, Open-label Study to Assess the Safety and Efficacy of Batoclimab in Participants With Graves' Disease (GD)

The purpose of this study is to assess the efficacy and safety of 24 weeks of treatment with batoclimab in adult participants with biochemically documented hyperthyroidism due to GD who have failed to achieve euthyroidism on antithyroid drugs (ATDs).

Start Date15 May 2023

Sponsor / Collaborator

Immunovant Sciences Ltd.

NCT05581199

/ Active, not recruitingPhase 2

A Phase 2b, Multi-center, Randomized, Quadruple-blind, Placebo-controlled Study of Batoclimab Treatment in Adult Participants With Active Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

This is a multi-center, randomized, quadruple-blind, placebo-controlled study to evaluate the efficacy and safety of batoclimab in adult participants with active CIDP. The study includes an up to 4-week Screening Period, an up to 12-week Washout Period, a 12-week Randomized Treatment Period (Period 1), an up to 24-week Randomized Withdrawal Period (Period 2), an up to 52-week Long-term Extension (LTE) Period (optional), and Safety Follow-up 4 weeks after the last dose of study treatment. The total study duration will be up to approximately 109 weeks. Eligible participants will be assigned to one of four cohorts based upon their baseline CIDP treatment (Cohorts A and D - immunoglobulin [Ig] or plasma exchange [PLEX]; Cohort B - corticosteroids; Cohort C - naive or untreated in previous 3-24 months) and whether they meet diagnosis according to the European Academy of Neurology/Peripheral Nerve Society (EAN/PNS) criteria (Cohorts A, B, and C) or clinical criteria only (Cohort D) at the time of screening.

Start Date15 Dec 2022

Sponsor / Collaborator

Immunovant Sciences Ltd.

NCT05517421

/ RecruitingPhase 3

A Phase 3, Multi-center, Randomized, Quadruple-masked, Placebo-controlled Study of Batoclimab for the Treatment of Participants With Active Thyroid Eye Disease (TED)

To evaluate the efficacy of batoclimab 680 milligrams (mg) subcutaneous (SC) once a week (QW) for 12 weeks followed by 340 mg SC QW for 12 weeks versus placebo on proptosis responder rate at Week 24.

Start Date23 Nov 2022

Sponsor / Collaborator

Immunovant Sciences Ltd.

100 Clinical Results associated with Batoclimab

100 Translational Medicine associated with Batoclimab

100 Patents (Medical) associated with Batoclimab

Literatures (Medical) associated with Batoclimab

01 Jun 2024·CNS DRUGS

FcRn Inhibitor Therapies in Neurologic Diseases

Review

Author: Matic, Alexandria ; Karmastaji, Salama ; Alfaidi, Nouf ; Bril, Vera

In the last decade, the landscape of treating autoimmune diseases has evolved with the emergence and approval of novel targeted therapies. Several new biological agents offer selective and target-specific immunotherapy and therefore fewer side effects, such as neonatal Fc receptor (FcRn)-targeting therapy. Neonatal Fc receptor-targeted therapies are engineered to selectively target FcRn through various methods, such as Fc fragments or monoclonal anti-FcRn antibodies. These approaches enhance the breakdown of autoantibodies by blocking the immunoglobulin G recycling pathway. This mechanism reduces overall plasma immunoglobulin levels, including the levels of pathogenic autoantibodies, without affecting the other immunoglobulin class immunoglobulin A, immunoglobulin E, immunoglobulin M, and immunoglobulin D levels. Drugs that inhibit FcRn include efgartigimod, rozanolixizumab, batoclimab, and nipocalimab. These medications can be administered either intravenously or subcutaneously. Numerous clinical trials are currently underway to investigate their effectiveness, safety, and tolerability in various neurological conditions, including myasthenia gravis and other neurological disorders such as chronic inflammatory demyelinating polyneuropathy, myositis, neuromyelitis optica, and myelin oligodendrocyte glycoprotein antibody disease. Positive results from clinical trials of efgartigimod and rozanolixizumab led to their approval for the treatment of generalized myasthenia gravis. Additional clinical trials are still ongoing. Neonatal Fc receptor inhibitor agents seem to be well tolerated. Reported adverse events include headache (most commonly observed with efgartigimod and rozanolixizumab), upper respiratory tract infection, urinary tract infection, diarrhea, pyrexia, and nausea. Additionally, some of these agents may cause transient hypoalbuminemia and hypercholesterolemia notably reported with batoclimab and nipocalimab. In this review, we discuss the available clinical data for FcRN inhibitor agents in treating different neurological autoimmune diseases.

01 May 2024·Journal of neurology

The efficacy and safety of FcRn inhibitors in patients with myasthenia gravis: a systematic review and meta-analysis

Review

Author: Li, Jiaxuan ; Chu, Tianchen ; Wu, Xin ; Chen, Zhouqing ; Wang, Shixin ; Tan, Xin ; Qu, Ruisi ; Wang, Zhong

BACKGROUND:

Myasthenia gravis (MG) is an autoimmune disease that causes local or generalized muscle weakness. Complement inhibitors and targeting of the neonatal Fc receptor (FcRn) to block IgG cycling are two novel and successful mechanisms.

METHODS:

PubMed, EMBASE, the Cochrane Library, and ClinicalTrials.gov were systematically searched to identify relevant studies published before May 18, 2023. Review Manager 5.3 software was used to assess the data.

RESULTS:

We pooled 532 participants from six randomized controlled trials (RCTs). Compared to the placebo, the FcRn inhibitors were more efficacy in Myasthenia Gravis Activities of Daily Living (MG-ADL) (MD = - 1.69 [- 2.35, - 1.03], P < 0.00001), MG-ADL responder (RR = 2.01 [1.62, 2.48], P < 0.00001), Quantitative Myasthenia Gravis (QMG) (MD = - 2.45 [- 4.35, - 0.55], P = 0.01), Myasthenia Gravis Composite (MGC) (MD = - 2.97 [- 4.27, - 1.67], P < 0.00001), 15-item revised version of the Myasthenia Gravis Quality of Life (MGQoL15r) (MD = - 2.52 [- 3.54, - 1.50], P < 0.00001), without increasing the risk of safety. The subgroup analysis showed that efgartigimod was more effective than placebo in MG-ADL responders. Rozanolixizumab was more effective than the placebo except in QMG, and batoclimab was more effective than the placebo except in MG-ADL responder. Nipocalizumab did not show satisfactory efficacy in all outcomes. With the exception of rozanolixizumab, all drugs showed non-inferior safety profiles to placebo.

CONCLUSION:

FcRn inhibitors have good efficacy and safety in patients with MG. Among them, efgartigimod and nipocalimab were effective without causing an increased safety risk. Rozanolixizumab, despite its superior efficacy, caused an increased incidence of adverse events. Current evidence does not suggest that nipocalimab is effective in patients with MG.

01 Apr 2024·JAMA neurology

Batoclimab vs Placebo for Generalized Myasthenia Gravis

Article

Author: Ke, Qing ; Zhao, Hongdong ; Tan, Ying ; Zheng, Hui ; Zou, Zhangyu ; Fu, Jia ; Dai, Tingjun ; Jin, Luya ; Duan, Ruisheng ; Dong, Jun ; Li, Haifeng ; Chen, Sheng ; Li, Zunbo ; Luo, Jing ; Huang, Wenjiao ; Zhao, Chongbo ; Li, Xiuyun ; Zhao, Mingming ; Tu, Jianglong ; Zeng, Wenshuang ; Hu, Xingyue ; Ding, Xiaojun ; Xi, Jianying ; Shi, Jiayu ; Chang, Xueli ; Ruan, Zhe ; Yang, Bing ; Zhou, Hongyu ; Hou, Shifang ; Chen, Yu ; Yang, Ruihan ; Zeng, Quantao ; Zhang, Hua ; Xiao, Fei ; Wang, Jianwen ; Deng, Hui ; Zhang, Yali ; Zheng, Rui ; Lee, Michael ; Li, Huanhuan ; Tan, Song ; Shi, Jianquan ; Zhang, Min ; Jiao, Lidong ; Yan, Chuanzhu ; Xiao, Haibing ; Xiao, Xingyi ; Zhang, Wei ; Zhao, Yuying ; Jiang, Haishan ; Xiong, Ting ; Tao, Xiaolu ; Meng, Qiang ; Chen, Jialin ; Zhou, Hao ; Zhang, Lei ; Guan, Yuzhou ; Lu, Hui ; Song, Min ; Li, Ping ; Li, Wei ; Chang, Ting ; Du, Qin ; Ji, Xiaopei ; Ma, Jiaojiao ; Bai, Xue ; Chen, Kai ; Guo, Junhong ; Zeng, Li ; Li, Wenyu ; Wang, Congcong ; Xue, Qun ; Yue, Yaoxian ; Zhao, Shuai ; Bu, Bitao ; Li, Xiaoli ; Sun, Hongbin ; Zhang, Meng ; Xie, Yan ; Yan, Chong ; Yang, Huan ; Zhang, Bin ; Zhao, Cuiping ; Yin, Jian ; Wang, Xu

Importance:

Myasthenia gravis (MG) is caused by autoantibodies that disrupt the neuromuscular junction. The neonatal fragment crystallizable receptor (FcRn) antagonists, efgartigimod and rozanolixizumab, reduce immunoglobulin G (IgG) level in the circulation and alleviate symptoms in patients with generalized MG.

Objective:

To examine the efficacy and safety profile of batoclimab, a monoclonal IgG1 antibody, in patients with generalized MG.

Design, Setting, and Participants:

This was a multicenter randomized clinical trial conducted from September 15, 2021, to June 29, 2022, at 27 centers in China. Adult patients 18 years or older with generalized MG were screened, and those who were antibody positive were enrolled.

Intervention:

Eligible patients received batoclimab or matching placebo in addition to standard of care. Each treatment cycle consisted of 6 weekly subcutaneous injections of batoclimab, 680 mg, or matching placebo followed by 4 weeks of observation. A second treatment cycle was conducted in patients who required continuing treatment.

Main Outcome and Measure:

The primary outcome was sustained improvement, as defined by a 3-point or greater reduction in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score from baseline for 4 or more consecutive weeks in the first cycle in individuals who were positive for acetylcholine receptor or muscle-specific kinase antibodies.

Results:

A total of 178 adult patients with generalized MG were screened, 132 were randomly assigned, 131 tested positive for antibodies, and 1 tested negative for antibodies. A total of 132 patients (mean [SE] age, 43.8 [13.6] years; 88 women [67.2%]) were enrolled. The rate of sustained MG-ADL improvement in the first cycle in antibody-positive patients was 31.3% (20 of 64) in the placebo group vs 58.2% (39 of 67) in the batoclimab group (odds ratio, 3.45; 95% CI, 1.62-7.35; P = .001). The MG-ADL score diverged between the 2 groups as early as week 2. The mean (SE) maximum difference in MG-ADL score reduction occurred 1 week after the last dose (day 43, 1.7 [0.3] in the placebo group vs 3.6 [0.3] in the batoclimab group; group difference, −1.9; 95% CI, −2.8 to −1.0; nominal P &lt; .001). The rates of treatment-related and severe treatment-emergent adverse events in patients were 36.9% (24 of 65) and 7.7% (5 of 65) in the placebo group vs 70.1% (47 of 67) and 3.0% (2 of 67) in the batoclimab group, respectively.

Conclusions and Relevance:

Batoclimab increased the rate of sustained MG-ADL improvement and was well tolerated in adult patients with generalized MG. Clinical effects and the extent of IgG reduction were similar to those previously reported for efgartigimod and rozanolixizumab. Future studies of large sample size are needed to further understand the safety profile of batoclimab.

Trial Registration:

ClinicalTrials.gov Identifier: NCT05039190

154

News (Medical) associated with Batoclimab

22 May 2025

·www.prnewswire.com

Johnson & Johnson's IMAAVY Gets FDA Approval, Taking on Top Players in Myasthenia Gravis Market | DelveInsight

The FDA has approved Johnson & Johnson's anti-FcRn antibody, nipocalimab, for the treatment of generalized myasthenia gravis. The drug will be sold under the brand name IMAAVY. This approval positions J&J to challenge leading competitors in the myasthenia gravis market, such as AstraZeneca, which markets the monoclonal antibodies SOLIRIS and ULTOMIRIS. J&J will also be competing with Argenx's VYVGART and UCB's RYSTIGGO and ZILBRYSQ. LAS VEGAS, May 22, 2025 /PRNewswire/ -- Myasthenia gravis is an autoimmune disorder in which antibodies disrupt the communication between nerves and muscles, resulting in skeletal muscle weakness. This weakness primarily affects voluntary muscles that control eye movement, facial expression, swallowing, and limb function. The condition is predominantly driven by autoantibodies targeting either the acetylcholine receptor (AChR-Ab) or a receptor-associated protein known as muscle-specific tyrosine kinase (MuSK-Ab). According to DelveInsight's analysis, there were approximately 300,000 diagnosed prevalent cases of myasthenia gravis across the 7MM in 2024. This number is expected to grow steadily over the forecast period (2025–2034), with a projected CAGR. The current myasthenia gravis therapeutics market mainly consists of symptomatic treatments such as acetylcholinesterase inhibitors like Mestinon. However, achieving full clinical remission with symptomatic therapy alone is challenging. As a result, immunosuppressive drugs are frequently introduced. First-line immunotherapy typically involves high-dose oral corticosteroids such as prednisone or prednisolone, which can induce a rapid response within 2 to 4 weeks. To reduce reliance on steroids and improve long-term disease control, nonsteroidal immunosuppressants (NSISTs) are often used. These include antimetabolites (e.g., azathioprine, mycophenolate mofetil, methotrexate, and cyclophosphamide) and calcineurin inhibitors (e.g., tacrolimus and cyclosporine). While NSISTs may be used as standalone treatments, they usually take 6 to 9 months to produce noticeable effects. Immunomodulatory therapies, including intravenous immunoglobulin (IVIg) and plasmapheresis (PLEX), are typically reserved for acute exacerbations or myasthenic crises. They are also employed as chronic treatments in patients who cannot tolerate or do not respond to standard immunosuppressants. Although traditional immunosuppressive strategies can help manage symptoms, achieving long-term, stable remission remains difficult. Additionally, about 15% of patients are considered treatment-refractory, meaning they either fail to respond to or cannot tolerate multiple immunosuppressive options. These patients often face the dual challenge of persistent symptoms and the adverse effects of long-term immunosuppression. Learn more about the myasthenia gravis disease market @ Myasthenia Gravis Treatment Medications The myasthenia gravis treatment market is well-established, with multiple approved drugs for myasthenia gravis, including SOLIRIS, ULTOMIRIS, RYSTIGGO, ZILBRYSQ, and VYVGART, among others. Alexion Pharmaceuticals' SOLIRIS is a monoclonal antibody that targets and inhibits complement protein C5, thereby blocking the formation of the terminal complement complex. This action helps reduce complement-driven hemolysis in PNH and thrombotic microangiopathy in aHUS. Although its exact mechanism in gMG and NMOSD is not fully known, it is believed to decrease complement complex accumulation. Between 2017 and 2023, SOLIRIS gained regulatory approvals in Japan, the US, and the EU for treating gMG, including pediatric indications in Japan. ULTOMIRIS (ravulizumab), also from Alexion Pharmaceuticals, is the first long-acting C5 inhibitor, offering rapid, complete, and sustained suppression of complement activity. It binds to C5, preventing its cleavage and subsequent formation of the membrane attack complex (C5b-9). ULTOMIRIS is effective in managing terminal complement-mediated hemolysis in PNH and thrombotic microangiopathy in aHUS. Although the precise mechanism in gMG and NMOSD remains unclear, it is thought to reduce complement deposition at the neuromuscular junction and block aquaporin-4 antibody-mediated complement activation. It received approvals from the US FDA, EMA, and Japan's PMDA in 2022. Get an in-depth assessment on generalized myasthenia gravis medication for adults @ ULTOMIRIS vs SOLIRIS for Myasthenia Gravis UCB Biopharma's RYSTIGGO is a subcutaneously administered, humanized monoclonal antibody that binds with high affinity to the human neonatal Fc receptor (FcRn). It received regulatory approval from the US FDA and Japan's PMDA in 2023, followed by the EC in January 2024. ZILBRYSQ, also developed by UCB Biopharma, is the first once-daily subcutaneous peptide-based inhibitor specifically targeting complement protein C5. It works by blocking C5 cleavage and the formation of the terminal complement complex C5b-9. Although its precise action in gMG remains uncertain, it is thought to limit C5b-9 accumulation at the neuromuscular junction. ZILBRYSQ gained approval from the US FDA, EMA, and PMDA in 2023. VYVGART, from Argenx, is a human IgG1 antibody fragment that targets FcRn, leading to a decrease in circulating IgG autoantibodies. It is the first FcRn blocker to receive regulatory approval. Argenx's VYVGART HYTRULO (also marketed as VYVDURA) combines efgartigimod alfa, an FcRn inhibitor, with hyaluronidase, an endoglycosidase, for treating adults with generalized myasthenia gravis. This formulation was approved by the US FDA and EMA in 2023 and by the PMDA in January 2024. Uncover the mechanism of FcRn inhibitor myasthenia gravis medication @ Myasthenia Gravis MoA On April 30, 2025, the FDA approved Johnson & Johnson's nipocalimab, branded as IMAAVY, as a new therapy for gMG. This approval puts IMAAVY among the list of approved drugs for myasthenia gravis treatment. The approval, which J&J says encompasses the widest eligible patient population with gMG, includes individuals aged 12 and above who test positive for AChR or anti-muscle-specific kinase (MuSK) antibodies. IMAAVY functions by inhibiting the FcRn protein, which plays a role in maintaining circulating IgG antibodies, key drivers in many autoimmune disorders. By blocking FcRn, IMAAVY significantly reduces harmful IgG autoantibodies while preserving the body's overall immune response, according to clinical data. J&J sees broader potential for IMAAVY beyond gMG, believing its mechanism of action could apply across multiple autoimmune conditions due to IgG's involvement in various diseases. The FDA's decision followed results from the ongoing Phase III Vivacity-MG3 trial, which evaluates IMAAVY in combination with standard care versus placebo and standard care in 199 adult gMG patients, including 153 antibody-positive individuals. Additionally, J&J is conducting a Phase II/III pediatric trial called Vibrance, where IMAAVY, combined with standard care, achieved its primary goal by reducing total serum IgG levels by 69% over 24 weeks. J&J acquired IMAAVY through its USD 6.5 billion acquisition of Momenta Pharmaceuticals in 2020, with the FcRn inhibitor myasthenia gravis serving as the centerpiece of that deal. The company is aiming for blockbuster status, forecasting peak annual sales of over USD 5 billion for the myasthenia gravis medication. Dive deep into the myasthenia gravis treatment cost @ Generalized Myasthenia Gravis Drug with Copay Myasthenia gravis pipeline possesses some drugs in mid- and late-stage development to be approved in the near future. The expected launch of myasthenia gravis treatment medications, such as Batoclimab (Immunovant Sciences GmbH), Descartes-08 (Cartesian Therapeutics), and others, are expected to further create a positive impact on the myasthenia gravis disease market. Discover which therapies are expected to grab major myasthenia gravis therapeutics market share @ Market Analysis on Myasthenia Gravis Batoclimab is a fully humanized monoclonal antibody designed to inhibit neonatal Fc receptors by blocking the interaction between FcRn and IgG, thereby promoting the breakdown of autoantibodies. It has received Orphan Drug Designation (ODD) from both the US FDA and the EMA. In March 2025, Immunovant announced topline results from its Phase III trial evaluating batoclimab in patients with myasthenia gravis. Descartes-08 represents the first RNA-engineered CAR T-cell (rCAR-T) therapy developed for autoimmune conditions. This therapy uses cytotoxic T-cells programmed to target and eliminate pathogenic plasma cells that produce autoantibodies. Created from a patient's own blood, Descartes-08 has also received ODD from the US FDA for treating myasthenia gravis. In December 2024, Cartesian Therapeutics shared encouraging updated findings from its Phase IIb study of Descartes-08 in myasthenia gravis. Furthermore, in January 2025, the FDA agreed to the company's Phase III AURORA trial design under a Special Protocol Assessment, with trial initiation planned for the first half of 2025. Curious about what the new myasthenia gravis treatments are in development? Visit Myasthenia Gravis Clinical Trials The anticipated launch of these emerging myasthenia gravis treatments are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the myasthenia gravis market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the myasthenia gravis market size in the 7MM is expected to grow from USD 5.2 billion in 2024 at a significant CAGR by 2034. According to DelveInsight's analysis, the myasthenia gravis market growth is anticipated with the introduction of emerging therapies, leading to an expansion in the myasthenia gravis market size throughout the forecast period (2025–2034). This anticipated myasthenia gravis market growth is driven by advancements in treatment options, greater healthcare access, and a rising myasthenia gravis prevalence, which together foster higher demand for innovative and effective therapies. DelveInsight's latest published market report titled Myasthenia Gravis Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which myasthenia gravis treatment market leader is going to capture the largest market share. The report provides comprehensive insights into the country-specific myasthenia gravis treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The myasthenia gravis market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Diagnosed Prevalent Cases of Myasthenia Gravis Gender-specific Diagnosed Prevalent Cases of Myasthenia Gravis Age-specific Diagnosed Prevalent Cases of Myasthenia Gravis Diagnosed Prevalent Cases of Myasthenia Gravis by MGFA Classification Diagnosed Prevalent Cases of Generalized Myasthenia Gravis by Antibody Serology The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM myasthenia gravis market. Highlights include: 10-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this myasthenia gravis market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the myasthenia gravis market. Also, stay abreast of the mitigating factors to improve your market position in the myasthenia gravis therapeutic space. Related Reports Myasthenia Gravis Epidemiology Forecast Myasthenia Gravis Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted myasthenia gravis epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Myasthenia Gravis Pipeline Myasthenia Gravis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key myasthenia gravis companies, including Harbour BioMed (Guangzhou) Co. Ltd., Kyverna Therapeutics, Cabaletta Bio, Takeda, Hoffmann-La Roche, Immunovant Sciences GmbH, Regeneron Pharmaceuticals, Novartis Pharmaceuticals, Janssen Research & Development, LLC, Momenta Pharmaceuticals, Inc., Amgen, Dianthus Therapeutics, Cartesian Therapeutics, COUR Pharmaceutical Development Company, Inc., Alexion Pharmaceuticals, Inc., among others. Generalized Myasthenia Gravis Market Generalized Myasthenia Gravis Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key gMG companies including Alexion Pharmaceuticals, Argenx, UCB Biopharma, Argenx-Halozyme Therapeutics, Horizon Therapeutics, Hoffmann-La Roche, Janssen Research & Development, LLC, Immunovant Sciences GmbH, Bristol Myers Squibb, Biogen Inc., Pfizer Inc., Novartis AG, Sanofi S.A., Roche Holding AG, Johnson & Johnson, Takeda Pharmaceutical Company Limited, AbbVie Inc., Eli Lilly and Company, Merck & Co., Inc., GlaxoSmithKline plc, AstraZeneca plc, Amgen Inc., Boehringer Ingelheim International GmbH, Genentech, Inc., Gilead Sciences, Inc., Celgene Corporation, Vertex Pharmaceuticals Incorporated , among others. Generalized Myasthenia Gravis Pipeline Generalized Myasthenia Gravis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key gMG companies, including Biocon, Cartesian Therapeutics, UCB, Momenta Pharmaceuticals, HanAll Biopharma, Roche, Alexion, Novartis, Takeda, BioMarin, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyPhase 3Drug ApprovalOrphan DrugClinical Result

09 Apr 2025

·www.pharmaceutical-technology.com

Merida launches with $121m to target autoimmune antibodies

The funding was co-led by Bain Capital Life Sciences, BVF Partners, and Third Rock Ventures. Credit: Dalin Ou via Getty Images. US biotech Merida Biosciences has launched with $121m in Series A financing to develop therapeutics targeting disease-causing antibodies in autoimmune diseases and allergies. The financing round was co-led by Bain Capital Life Sciences, BVF Partners, and Third Rock Ventures, with participation from GV and Perceptive Xontogeny Venture (PXV) Funds. The biotech is advancing a proprietary protein engineering platform to develop fragment crystallisable (Fc)-based biologics that selectively bind and eliminate pathogenic antibodies while sparing healthy components of the immune system. Merida’s therapeutics also aim to deplete the B cells responsible for producing the harmful antibodies. Merida’s lead programme will focus on Graves’ disease, an autoimmune condition that causes the thyroid to overproduce hormones, resulting in hyperthyroidism. The company is positioning its candidate as a more targeted alternative to antithyroid drugs (ATDs), which while being standard of care (SOC), often fail to provide adequate disease control. The company claims its approach could offer a more convenient dosing schedule and an easier route of administration compared to current and emerging treatments. Merida is not the only biotech setting its sights on the Graves’ disease market. Immunovant is developing batoclimab, a monoclonal antibody currently in a Phase IIa trial (NCT05907668) for Graves’ disease patients who remain uncontrolled on ATDs. Interim data released in September 2024 showed a 76% response rate at 12 weeks. If batoclimab makes it to market, GlobalData projects that it will generate $872m in global sales by 2030. GlobalData is the parent company of Pharmaceutical Technology. In addition to Merida and Immunovant, Biohaven is developing BHV-1300, a small molecule therapy that targets and degrades immunoglobulin G1 (IgG1) autoantibodies that cause Graves’ disease. BioHaven previously announced plans to launch a Phase II study of the drug in mid-2025. Following its lead Graves’ disease programme, Merida plans to pursue candidates for food allergies and primary membranous nephropathy, a rare autoimmune kidney disorder. Merida will be led by CEO Adam Townsend, former COO of Apellis Pharmaceuticals and ex-Biogen executive. He will work alongside chief scientific officer Dario Gutierrez, a former executive director at MSD and current consultant at Third Rock Ventures. “For the first time, we have the potential to precisely target the clear pathogenic drivers of an intractable set of diseases with absolute selectivity and a degree of completeness and durability that has not been achievable through any approach to date,” said Townsend in the 8 April announcement.

Phase 2

08 Apr 2025

·medcitynews.com

Immunology Startup Merida Bio Unveils $121M and a Lead Program for Graves’ Disease - MedCity News

Immunology continues to be one of the most active areas for drug research as the field aims to bring patients new ways to eliminate the antibodies driving autoimmune disease, but in a manner that does not also compromise the immune system. Merida Biosciences, a startup formed by venture capital firm Third Rock Ventures, emerged from stealth Tuesday, revealing $121 million in financing and a lead program for a common autoimmune condition that has not had a new approved therapy in decades. The lead disease target of Cambridge, Massachusetts-based Merida is Graves’ disease, which develops as antibodies produced by the immune system attack the thyroid gland, a butterfly-shaped gland located at the front of the neck. Thyroid hormone regulates functions such as metabolism and growth. In Graves’ disease, the attack on the gland results in excess thyroid hormone production that speeds up the heart rate and weakens bones among other problems. Standard Graves’ treatment includes radioactive iodine therapy to shrink the gland, anti-thyroid medications, or beta blockers that block the effect of thyroid hormone on the body. Each of these treatments introduces complication risks elsewhere in the body. Surgical removal of the thyroid gland is another treatment option, but patients need lifelong hormone replacement therapy afterward. presented by Sponsored Post What Are the Best Medical Coding Outsourcing Companies? Outsourcing your medical coding can help ensure a healthy revenue cycle. Discover the best medical coding outsourcing companies and find the right one for you. By Global Healthcare Resources Merida is developing drugs designed to selectively bind to Fc receptors, receptors on immune cells that regulate immune responses. The company says its protein engineering platform generates unique Fc therapeutics that selectively bind to their antibody targets. The drugs then lead to the elimination of these antibodies by leveraging built-in mechanisms for clearing antibody complexes, which are molecular structures formed when an antibody binds to its specific target antigen. The company says its drugs are designed to eliminate only pathogenic antibodies, sparing healthy components of the immune system. In Graves’ disease, this approach is intended to spare healthy thyroid signaling. The Merida drugs are biotherapeutics that the startup describes as “antibody-like” in the way they move through the body. For example, these drugs could provide longer-lasting effects that enable less frequent dosing compared to some other therapies. The Graves program is currently undergoing the preclinical research that could support an investigational new drug application. Other disclosed Merida programs are in preclinical development for primary membranous nephropathy, which is a chronic inflammatory kidney disease, and food allergies mediated by immunoglobulin E antibodies. “At the heart of Merida is understanding the mechanisms behind antibody-driven diseases like Graves’ at the molecular level, and leveraging these insights to develop precision therapeutics that have thus far evaded the field,” Merida co-founder and Chief Scientific Officer Dario Gutierrez said in a prepared statement. “Our highly differentiated approach has the potential to yield best-in-class treatments by going after the root causes of these devastating diseases.” Merida’s launch comes as other immunology-focused biotech companies, including startups, make headway with their own selective Fc-receptor targeting drugs. Roivant Sciences subsidiary Immunovant is pursuing various immunological indications with IMVT-1402 and batoclimab. Both drug candidates are monoclonal antibodies. The clinical program for IMVT-1402 includes a Phase 2/3 study underway in Graves’. Batoclimab is currently in Phase 2 testing in Graves’. Last September, Immunovant reported preliminary data showing batoclimab achieved a strong response and a lowering of levels of antibodies associated with the disease. The study is expected to post additional data this summer. Sponsored Post Changes in Nurse Staffing Answer Clinician Demands The ongoing nursing shortage facilitates high turnover rates since nurses know they won’t have difficulties finding new jobs. In order to retain and attract staff, it’s in a facility’s best interest to understand what nurses want. By Tomasz Rezik Zenas Biopharma is developing bifunctional antibodies for immunology and inflammation indications. Lead program obexelimab is designed to bind to CD19 and Fc gamma receptor IIb, both of them targets expressed on B cells. A Phase 3 test is underway in immunoglobulin G4-related disease, supported by a $225 million IPO last September. Meanwhile, startup Nuvig Therapeutics is developing proteins engineered to target Fc receptors. Late last year, the Nuvig raised $161 million to support mid-stage clinical development of its lead program, a potential treatment for the rare autoimmune condition chronic inflammatory demyelinating polyneuropathy. Merida received seed financing from Third Rock in 2022, when Gutierrez was an entrepreneur in residence at the firm. The Series A financing announced Tuesday was co-led by Bain Capital Life Sciences, BVF Partners, and Third Rock. The other investors in the new round are GV and Perceptive Xontogeny Venture Funds. The startup is led by CEO Adam Townsend, who was most recently chief operating officer at Apellis Pharmaceuticals, a company that develops drugs that address the complement system, a part of the immune system. Illustration: Sebastian Kaulitzki/Science Photo Library, via Getty Images

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D11983	-	-	DB16104

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Myasthenia Gravis	NDA/BLA	China	SAMSUNG BIOLOGICS Co., Ltd.	28 Jun 2023
Myasthenia Gravis	NDA/BLA	China	Nona Biosciences Suzhou Co. Ltd.	28 Jun 2023
Myasthenia Gravis	NDA/BLA	China	Dragon Merit Holdings Ltd.	28 Jun 2023
Purpura, Thrombocytopenic, Idiopathic	Phase 3	China	Harbour BioMed (Shanghai) Co., Ltd.	23 Jun 2022
Graves Ophthalmopathy	Phase 3	China	Hopp Pharmaceutical (Guangzhou) Co., Ltd.	22 Sep 2021
Thrombocytopenia	Phase 3	-	HANALL BIOPHARMA Co., Ltd.	-
Thrombocytopenia	Phase 3	-	Roivant Sciences Ltd.	-
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating	Phase 2	United States	Immunovant Sciences Ltd.	15 Dec 2022
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating	Phase 2	Argentina	Immunovant Sciences Ltd.	15 Dec 2022
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating	Phase 2	Belgium	Immunovant Sciences Ltd.	15 Dec 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05403541 (NEWS) Manual	Phase 3	Myasthenia Gravis acetylcholine receptor antibody positive (AChR+)	-	Batoclimab 340mg weekly	xpyxixkrdt(pnsqmaetyr) = fzikqsjbjx dmwehqykfj (reljfiuyuz ) Met View more	Positive	19 Mar 2025
				Batoclimab 680mg weekly	xpyxixkrdt(pnsqmaetyr) = tcconxeefm dmwehqykfj (reljfiuyuz ) Met View more
NCT05581199 (NEWS) Manual	Phase 2	Polyradiculoneuropathy, Chronic Inflammatory Demyelinating	73	Batoclimab 340 mg/680 mg	zgcyhuydrc(qmcvvwtfdu) = oymfmjyzhm eqvlddhfjs (lktzvqtfty ) View more	Positive	19 Mar 2025
NCT05907668 (GlobeNewswire) Manual	Phase 2	Graves Disease	-	12 weeks of high dose batoclimab, followed by 12 weeks of lower dose batoclimab	wlfpxgqdyk(ypkzfqonca) = xodjtmidkf xrwfqhqedj (pmelmvivvn ) View more	Positive	09 Sep 2024
				12 weeks of high dose batoclimab	wlfpxgqdyk(ypkzfqonca) = dcvzicvimt xrwfqhqedj (pmelmvivvn ) View more
NCT05039190 (Literature) Manual	Phase 3	Myasthenia Gravis	132	Batoclimab	dkoxzrdbne(dplvyhyivj) = ieosqbpekz vztodctvar (nkhdbjrpag ) View more	Positive	04 Mar 2024
				Placebo	dkoxzrdbne(dplvyhyivj) = gxdhbcoacm vztodctvar (nkhdbjrpag ) View more
NCT03922321 (Corporate Publications) Manual	Phase 2	Graves Ophthalmopathy	-	RVT-1401	yzocixxrhi(qqnbatamrj) = nxwhnzjyqu qollompfyj (uhpmwtlqxa ) View more	Positive	20 Dec 2023
NCT03863080 (Phase 2 Study of Subcutaneous IMVT-1401 \| ASCEND MG, CTgov)	Phase 2	Myasthenia Gravis	17	RVT-1401+DB (Double-blind Treatment Period: Placebo)	wzxunfpeox = kbuvjaplgc uzwhyawase (uraafqsuxr, ldishcnpix - xyqonjcvzk) View more	-	20 Dec 2023
				RVT-1401 (Double-blind Treatment Period: RVT-1401 340 mg/Week)	wzxunfpeox = gyqgxkcvzi uzwhyawase (uraafqsuxr, dhpsgdetxd - bcssljptrf) View more
NCT03938545 (RF35 \| PSAT269, ENDO2022)	Phase 2	Graves Ophthalmopathy	65	Batoclimab 680mg	cdpkzjhglr(aauhwhncmh) = mmovwsutrp lokajoeqqc (zusflqssco ) View more	Positive	01 Nov 2022
				Batoclimab 340mg	cdpkzjhglr(aauhwhncmh) = gibglblesp lokajoeqqc (zusflqssco ) View more
NCT03922321 (ODP509, ENDO2022)	Phase 2	Graves Ophthalmopathy anti-TSHR-Ab positive	7	Batoclimab 680 mg for two weeks followed by 340 mg for four weeks	nstcpxtscv(dmhavmabeu) = n=2 for each whdflebegy (huqvtijfzj ) View more	Positive	01 Nov 2022
NCT03938545 (RF35 \| PSAT269, CTgov)	Phase 2	Graves Ophthalmopathy	65	Placebo (Administered via subcutaneous injection)	bazzcwmhbg = ugbnrwyjsx qutcehodzr (ijdbhryqbx, ttrzukrgqs - mncfqqkdsu) View more	-	22 Sep 2022
NCT04253236 (ASCEND-WAIHA, CTgov)	Phase 2	Warm autoimmune hemolytic anemia	5	RVT-1401 (Cohort 1: RVT-1401 680 mg/Week)	vgaoiwprmg = epynnsarmp ofithmipdc (jafmgfaecz, vgpfzjzanp - mpbfctncpq) View more	-	28 Jul 2022
				RVT-1401 (Cohort 2: RVT-1401 340 mg/Week)	pqymenxouz(riurmbwegl) = spbffmauxr kplytxbjdb (azhshobjxn, lumnruuvkm - twmmyegqfr) View more

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