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Harbour BioMed Announces NMPA Approval of IND for Combination Therapy of Next Gen Anti-CTLA-4 Antibody for Treatment of NSCLC and Solid Tumors

February 26, 2021

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Harbour BioMed Announces NMPA Approval of IND for Combination Therapy of Next Gen Anti-CTLA-4 Antibody for Treatment of NSCLC and Solid Tumors

February 26, 2021

Cambridge, MA, Rotterdam, NL, Suzhou, CN – February 26, 2021.


Harbour BioMed (HBM) (HKEX:02142) today announced that the China National Medical Products Administration (NMPA) has approved its Investigational New Drug (IND) application for HBM4003, the next generation anti-CTLA-4 antibody in combination with PD-1 antibody/chemotherapy for the treatment of patients with advanced NSCLC and solid tumors. This study will evaluate the safety, tolerability, PK/PD, and anti-tumor activity of HBM4003 in combination with PD-1 antibody, with or without chemotherapy in patients with advanced NSCLC and other solid tumors. Professor Shun Lu, Chairman of Chinese Society of Lung Cancer in China Anti-Cancer Association, Chief Key Program Expert of Ministry of Science and Technology of the People´s Republic of China, Director of Oncology Department at Shanghai Chest Hospital, will be the leading PI of this study. HBM4003 has already received US FDA and China NMPA IND approvals of the mono therapy, as well as another combination therapy in China, and has completed patient dosing in several patients in its ongoing phase I study in Australia.


“The NMPA’s IND approval of HBM4003 for clinical trial in lung cancer is a significant leap forward in our global development plans for HBM4003. It has already demonstrated encouraging safety and anti-tumor activity in patients in our ongoing trials.” said Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed. “Across the world, lung cancer remains the leading cause of cancer incidence and mortality, with over 2 million new cases in 2020. There are over 1 million patients in China alone and we look forward to bringing this novel combination therapeutic to these patients soon.” 



About HBM4003


HBM4003 is the fully human anti-CTLA-4 monoclonal heavy chain only antibody (HCAb) generated from Harbour Mice®. HBM4003 shows enhanced antibody-dependent cell cytotoxicity (ADCC) killing activity and is extremely specific to CTLA-4High Treg cells in tumor tissues. The potent anti-tumor efficacy and differentiated pharmacokinetics with durable pharmacodynamic effect presents a favorable product profile. This novel and differentiated mechanism of action has the potential to improve efficacy while significantly reducing the toxicity of the drug.



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.  


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