Cambridge, MA, Rotterdam, NL, Suzhou, CN— September 30, 2020. Harbour BioMed (HBM), a global, clinical-stage, bio-pharmaceutical company announced today the dosing of the first patient in two separate Phase II clinical trials of Batoclimab (HBM 9161), a fully human anti-FcRn monoclonal antibody (mAb), in mainland China. These studies are designed to evaluate the efficacy and safety of Batoclimab for the treatment of Myasthenia Gravis (MG) and adult Immune thrombocytopenia (ITP) patient.

Batoclimab, a fully human anti-FcRn mAb, blocks FcRn-IgG interactions, accelerating the degradation of autoantibodies and lead to the treatment of pathogenic IgG-mediated autoimmune diseases. Earlier studies show Batoclimab is well tolerated​ and can rapidly reduce total IgG. These findings make Batoclimab the first anti-FcRn to demonstrate a sustained IgG reduction in both ​Chinese and Caucasian populations when administered via subcutaneous (SC) injection. With multiple trials ongoing simultaneously in MG, ITP, Graves’ ophthalmology (GO) and neuromyelitis optica spectrum disorder（NMOSD）, Batoclimab is on its way to become a portfolio-in-a-product.

MG is a severely debilitating condition that manifests itself in the form of skeletal muscle contraction and weakness limiting movement and could even result in fatal respiratory failure. In China, an estimated 250,000 patients suffer from this condition. Current therapies are limited due to inadequate efficacy, safety issues or limited availability.

Adult ITP is an autoimmune bleeding disorder that drives abnormally low platelet levels leading to bruising, spontaneous bleeding, and an increased risk of potentially fatal internal organ bleeding events. Current treatment options including splenectomy, anti-CD-20 mAb and others are limited due to inadequate efficacy and significant side effects. Recognizing the unmet need for these patient, the Chinese NMPA approved a seamless ph. II/III clinical trial of Batoclimab in ITP, which will significantly accelerate the availability of this next-generation treatment for patient. 

“We are excited to make strides with the enrollment of the patient for both MG and ITP trials. Given our commitment to drive next generation of therapeutics, Batoclimab is expected to bring life changing solutions for large numbers of patient in China,” said Dr. Jingsong Wang, Founder, Chairman, and CEO of Harbour BioMed. “The dosing of the first patient in the Ph II trials is only a start, and we will continue to accelerate the development of Batoclimab to treat patient with MG and ITP."

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 oncology and immunology. 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