 |
The first NMPA-approved anti-FcRn therapy to complete its full clinical development for gMG patients in China
CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SHANGHAI, Oct. 23, 2026 /PRNewswire/ — Harbour BioMed (the “Company”; HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology, oncology and other areas, today announced that the National Medical Products Administration (NMPA) of China has approved the Biologics License Application (BLA) for batoclimab injection (subcutaneous injection) (batoclimab SC), 170 mg (1 mL)/vial, for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.
The approval is supported by positive results from a pivotal Phase 3 clinical study conducted at 27 centers in China. The main study population was patients with generalized myasthenia gravis who were positive for acetylcholine receptor antibodies (AChR-Ab) or muscle-specific tyrosine kinase antibodies (MuSK-Ab). The primary endpoint of the study was the proportion of the population with sustained improvement in the Myasthenia Gravis Activities of Daily Living Scale (MG-ADL) score during the first cycle of treatment. Sustained improvement was defined as a reduction in MG-ADL score of ≥ 3 points from baseline that persisted for at least 4 weeks. 58.2% of patients treated with batoclimab SC achieved the primary endpoint, which was significantly higher compared with 31.3% in the placebo group (P=0.001). Treatment effect was observed as early as the second week of therapy.
Additionally, batoclimab SC group demonstrated significant improvements in secondary endpoints compared with placebo group, including sustained Quantitative Myasthenia Gravis (QMG) improvement (64.2% vs 40.6%; P=0.008), duration of 3-point or greater MG-ADL improvement (51.5% vs 36.1%; P=0.008); proportion of people with clinical expression of minimal symptoms (defined as having a MG-ADL score of 0 or 1) at any visit (25.4% vs 4.7%; P=0.004), and sustained MG-ADL improvement in the second treatment cycle (62.7% vs 36.4%; P=0.002).
Batoclimab SC was generally well tolerated. The most frequently reported adverse event in the treatment group is peripheral edema (38.8% vs 4.6% for placebo), all of which were mild to moderate in severity. Plasma albumin levels decreased during treatment but returned spontaneously upon treatment discontinuation.
“The approval of batoclimab SC is a proud moment for everyone at Harbour BioMed,” Dr. Jingsong Wang, Founder, Chairman and Chief Executive Officer of Harbour BioMed, commented. “We believe that, with its unique mechanism of action, batoclimab SC has the potential to provide a new treatment option for patients with gMG. We are deeply grateful to the patients, investigators, and our partner for their trust and collaboration throughout this journey, and we look forward to making this therapy available to patients as quickly as possible, so that more people in need can benefit from it.”
“Batoclimab SC is the first FcRn-targeted therapy to complete its entire clinical development in China,” Professor Chongbo Zhao, MD, Principal Investigator of the pivotal Phase 3 study and Professor of Neurology at Huashan Hospital of Fudan University, commented. “The trial results showed rapid onset of action, deep symptom improvement, and a favorable safety profile. This high-level evidence, based on data from Chinese patients, indicates that batoclimab SC provides a new treatment option for myasthenia gravis. This approval represents a monumental milestone in this field, and we believe it will bring a highly valuable new treatment option to physicians and patients in China.”
Pursuant to the license agreement entered into between Harbour BioMed and NBP Pharma on October, 2022, commercialization of batoclimab in the Greater China region (Mainland China, Hong Kong, Macau, and Taiwan) will be conducted by NBP Pharma, a subsidiary of CSPC Pharmaceutical Group. Harbour BioMed will receive tiered royalties based on annual net sales of batoclimab in Greater China.
About Generalized Myasthenia Gravis (gMG)
Generalized myasthenia gravis (gMG) is a rare, chronic, autoimmune neuromuscular disorder. It is one of the most common forms of myasthenia gravis (MG), a disease mediated by antibodies such as anti-acetylcholine receptor (AChR) immunoglobulin G (IgG) and anti-muscle-specific tyrosine kinase (Anti-MuSK) IgG. These antibodies target proteins at the postsynaptic membrane of the neuromuscular junction, causing impaired transmission and resulting in skeletal muscle weakness. gMG significantly affects patients’ working status and quality of life, and some patients even develop myasthenic crisis, which can be life-threatening in severe cases.
Currently, the main treatment options for gMG include cholinesterase inhibitors, glucocorticoids, and other immunosuppressive drugs. However, these therapies have a slow onset of action and are associated with significant side effects with long-term use. Plasmapheresis and intravenous immunoglobulin (IVIg) allow rapid clearance or neutralization of circulating pathogenic antibodies, but they are costly and unsustainable as hospital procedures. Overall, there remains a significant unmet need for these treatment options, including accessibility, safety, and economic cost.
About Batoclimab and Batoclimab SC
Batoclimab is a fully human monoclonal antibody targeting the neonatal Fc receptor (FcRn). By blocking FcRn-mediated recycling of IgG antibodies, batoclimab accelerates the degradation of pathogenic IgG autoantibodies, offering a targeted therapeutic approach for autoimmune conditions including gMG. Batoclimab was originally developed by HanAll Biopharma Co., Ltd. (“HanAll”) and licensed to Harbour BioMed in 2017 under a strategic collaboration and license agreement.
Batoclimab SC is a subcutaneous biologic. The recommended dosing regimen is 680 mg once weekly; after 6 consecutive administrations, patients are observed for 4 weeks, making each treatment cycle a total of 9 weeks. Subcutaneous administration is convenient and easy to perform, reducing the time patients spend traveling to healthcare facilities and receiving intravenous infusions, thereby helping to alleviate the treatment burden and improve medication adherence. The marketing authorization holder (MAH) of batoclimab SC is Dragon Merit Holdings Limited, a subsidiary of CSPC Pharmaceutical Group.
About Harbour Medical
Harbour Medical is Harbour BioMed’s core platform for clinical development and medical services, delivering integrated, end-to-end solutions for innovative therapies from early clinical validation through post-marketing studies.
Serving both Harbour BioMed’s internal pipeline and external partners, Harbour Medical brings together clinical development services, co-development, and strategic partnerships within a unified platform.
With the Scientific Committee as our academic engine and an execution-driven team, Harbour Medical connects scientific innovation with clinical excellence, accelerating the journey of breakthrough therapies from the laboratory to patients.
About Harbour BioMed
Harbour BioMed (HKEX: 02142) is a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology, oncology and other areas. The Company is building a robust portfolio and differentiated pipeline through internal R&D capability, strategic global collaborations in co-discovery and co-development, and selective acquisitions.
Our proprietary antibody technology platform, Harbour Mice®, generates fully human monoclonal antibodies in both the conventional two heavy and two light chain (H2L2) format and the heavy chain-only (HCAb) format. Building upon HCAb antibodies, the HCAb-based immune cell engagers (HBICE®) bispecific antibody technology enables tumor-killing effects that traditional combination therapies cannot achieve. The HCAb-based Antibody Plus technology (HCAb PLUSTM) provides comprehensive modality solutions for the development of innovative multi-specific medicines in different disease areas. Additionally, building upon the Harbour Mice® platform, Harbour BioMed launched its first fully human Generative AI HCAb Model powered by its Hu-mAtrIxTM AI platform, accelerating the development of innovative therapies.
By integrating Harbour Mice®, HBICE®, HCAb PLUSTM, a single B-cell cloning platform and AI technologies, Harbour BioMed has built a highly efficient and distinctive antibody discovery engine for developing next-generation therapeutic antibodies. For more information, please visit www.harbourbiomed.com.