Harbour BioMed Announces Resubmission of Biologics License Application for Batoclimab to NMPA for Treatment of Generalized Myasthenia Gravis

CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SUZHOU, China, June 26, 2024 /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 it has resubmitted the Biologics License Application (BLA) of batoclimab (HBM9161) to the National Medical Products Administration (NMPA) of China for the treatment of generalized myasthenia gravis (gMG).

Following the clinical trial protocol, the Company completed the extension period for the Phase III clinical trial to collect additional long-term safety data without enrolling new patients. As a result, the Company voluntarily included this additional safety data and resubmitted the BLA for batoclimab (HBM9161) as planned.

"We are delighted to resubmit the BLA to the NMPA as scheduled and will continuously communicate closely with the NMPA to advance the review process of this innovative therapy. Based on the results of the Phase III clinical trial, which demonstrated the efficacy of batoclimab in both primary and secondary endpoints, we believe this innovative therapy will further enhance the treatment of generalized myasthenia gravis and benefit more patients," said Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed.

Batoclimab received the "Breakthrough Therapy Certificate" from the NMPA in 2021 and achieved a positive outcome in the proof-of-concept study for treating Chinese gMG patients in July 2021. The positive topline 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 Greater China. Under this agreement, the Company is responsible for developing and conducting 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.

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 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