Harbour BioMed Announces IND Approval for Phase II Trial of Anti-FcRn Batoclimab in Chronic Inflammatory Demyelinating Polyneuropathy in China

CAMBRIDGE,Mass. andROTTERDAM,Netherlands andSUZHOU,China,Sept.1,2021 -- Harbour BioMed ("HBM",HKEX: 02142) today announced that the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application to initiate phase II trial of Anti-FcRn Batoclimab in patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).

HBM is developing batoclimab (HBM9161) as a pipeline in a product to treat multiple pathogenic-IgG mediated autoimmune diseases with significant unmet medical needs.

Based on batoclimab's novel mechanism and high unmet medical needs in China,HBM has initiatedclinical trials in multiple autoimmune diseases with positive trial results reported,including myasthenia gravis,grave's ophthalmopathy,adult immune thrombocytopenia(ITP) and neuromyelitis optica spectrum disorder (NMOSD).

CIDP is a chronic and progressive disease characterized by progressive weakness and impaired sensory function in the legs and arms and is closely related to Guillain-Barre syndrome. Corticosteroid pulses and intravenous immunoglobulin (IVIg) are commontherapies for patients with CIDP,but they can hardly meet patients' increasing medical needs for side effect and availability of medicine.

"Due to the side effects of steroids and limited access to IVIg,there is still high unmet medical needs to explore new,effective and convenient therapies for CIDP. We believe this novel mechanism will bring a safe and effective therapeutic to the CIDP patients. We are committed to further accelerate this exciting novel therapeutic development to help Chinese patients in need," said Dr. Jingsong Wang,Founder,Chairman and CEO of Harbour BioMed.

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 2 study in myasthenia gravis showed that batoclimab can quickly and significantly alleviate patients' symptoms and improve quality of life. Earlier studies demonstrated that batoclimab is well tolerated and can rapidly reduce total IgG in a wide array of pathogenic IgG-mediated autoimmune diseases. HBM licensed batoclimab (HBM9161) from HanAll Biopharma and has the right to develop,manufacture and commercialize in Greater China (including Hong Kong,Macau and Taiwan).

About Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

CIDP is a chronic and progressive disease characterized by progressive weakness and impaired sensory function in the legs and arms and is closely related to Guillain-Barre syndrome. Corticosteroid pulses following high dose prednisone maintenance or intravenous immunoglobulin (IVIg) are common therapies for patients with CIDP,with an estimated two-thirds of the patients require IVIg over many years. Due to the side effects of steroids and limited access to IVIg,effective and convenient therapies for CIDP.

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

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