Harbour BioMed Announces Biologics License Application Acceptance of Batoclimab for Treatment of Generalized Myasthenia Gravis by NMPA

CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SUZHOU, China, June 29, 2023 /PRNewswire/ -- Harbour BioMed (the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery, development, and commercialization of novel antibody therapeutics focusing on oncology and immunology, announces that the National Medical Products Administration (NMPA) of China has accepted the Biologics License Application (BLA) of batoclimab (HBM9161) for the treatment of generalized myasthenia gravis (gMG). This is the first BLA accepted by NMPA since Harbour BioMed's establishment.

"Anti-FcRn treatment is at the center of focus in gMG disease area. Batoclimab is the first anti-FcRn treatment completed clinical development with positive results and confirmed efficacious and safe in Chinese gMG population. We believe that this innovative therapy  will set a new benchmark  for  the treatment of gMG, significantly improve drug availability and benefit more patients," said the principal investigator Chongbo Zhao, MD, Professor of Neurology at Huashan Hospital of Fudan University in Shanghai.

"We are delighted that batoclimab has become our first BLA successfully accepted by the NMPA demonstrating our strong R&D capability. The clinical studies of batoclimab, spanning the pandemic, are the result of joint efforts of investigators and patients with Harbour BioMed, and its success sets a monumental milestone for the development of  innovative therapeutics in the treatment of gMG. We are excited  to bring this much-needed drug to patients, and will continue to advance our innovative pipeline of next-generation therapeutics to fulfill the unmet medical needs." said Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed.

Batoclimab received the "Breakthrough Therapy Certificate" from NMPA in 2021, and subsequently achieved the positive outcome of the proof-of-concept study for the treatment of Chinese gMG patients completed in July 2021. The positive results of its phase III clinical trial were announced in March 2023.

In October 2022, the Company entered into an agreement with NBP Pharma, a wholly owned subsidiary of the CSPC Group, to co-develop batoclimab in Great China. The Company was responsible for developing and operating the full clinical trial of batoclimab for gMG in China, and will receive tiered royalties based on annual net sales of batoclimab in Greater China according to the agreement.

About Generalized Myasthenia Gravis (gMG)

Myasthenia gravis (MG) is an acquired autoimmune disease mediated by antibodies such as anti-acetylcholine receptor (AChR) immunoglobulin G (IgG) and anti-muscle-specific tyrosine kinase (Anti-MuSK) IgG, which involves the postsynaptic membrane of the neuromuscular junction, causes impaired transmission at the neuromuscular junction, and presents with skeletal muscle contraction weakness. Patients often have ocular muscle manifestations such as eyelid ptosis and diplopia, and most patients will show symptoms other than ocular muscles and develop generalized myasthenia gravis (gMG) which significantly affects their working status and quality of life, and some patients even develop myasthenic crisis which will be life-threatening in severe cases.

Current main treatments for MG include cholinesterase inhibitors and glucocorticoids and other immunosuppressive drugs, but the efficacy and safety cannot meet the clinical needs of many patients. Targeting reduction of pathogenic IgG autoantibodies is one of the best solutions in MG treatment in terms of the pathophysiological mechanism, such as plasmapheresis and intravenous immunoglobulin, however, there still remains a significant unmet need for these treatment options, including the accessibility, safety and economic cost.

About Batoclimab (HBM9161)

Batoclimab (HBM9161), a fully human anti-FcRn mAb, blocks FcRn-IgG interactions, accelerating the degradation of autoantibodies and leads to the treatment of pathogenic IgG-mediated autoimmune diseases. Phase III study in myasthenia gravis received positive results showing that batoclimab can quickly, significantly, and safely alleviate patients' symptoms and improve quality of life.

About Harbour BioMed

Harbour BioMed (HKEX: 02142) is a global biopharmaceutical company committed to the discovery, development, and commercialization of novel antibody therapeutics focusing on immunology and oncology. The Company is building its robust portfolio and differentiated pipeline through internal R&D capability, collaborations with co-discovery and co-development partners, and select acquisitions.

The Company's proprietary antibody technology platforms Harbour Mice^® generates fully human monoclonal antibodies in two heavy and two light chains (H2L2) format, as well as heavy chain only (HCAb) format. Building upon the HCAb antibodies, the HCAb-based immune cell engagers (HBICE^®) bispecific antibody technology is capable of delivering tumor-killing effects unachievable by traditional combination therapies. Integrating Harbour Mice^®, and HBICE^® with a single B cell cloning platform, our antibody discovery engine is highly unique and efficient for the development of next-generation therapeutic antibodies. For further information, please refer to www.harbourbiomed.com.

SOURCE Harbour BioMed