Harbour BioMed Announces Dosing of First Patient in Phase I Clinical Study of its Next-Generation Anti-CTLA-4 Antibody in China

Harbour BioMed (HBM) today announced the dosing of the first patient in its open Phase I clinical study of HBM4003 for Chinese patients suffering from advanced melanoma and other solid tumors (study No. 4003.2). This study will evaluate the safety, tolerability, PK/PD, and anti-tumor activity of HBM4003 in combination with teriprizumab (PD-1 antibody) in the treatment of solid tumors. Prior to this, the China National Medical Products Administration (NMPA) has approved this combined study of HBM4003 and PD-1 antibody/chemotherapy for patients with NSCLC and other solid tumors.

Professor Jun Guo, Deputy Dean of Beijing Cancer Hospital, Deputy Director of Beijing Institute for Cancer Research and Director of Melanoma Department, said: "Due to the special subtype of melanoma in China, treatment for this disease is especially challenging, resulting from poor prognosis, low survival rate, and the limited efficacy of current PD-1 monotherapy of around 16 percent. Innovative solutions that can improve the treatment efficacy and patients' overall survival is urgently needed. As this study by Harbour BioMed unfolds, we look forward to providing more effective and safer treatment options to Chinese patients with melanoma and other solid tumors in a near future."

"HBM4003 is a new generation of anti-CTLA-4 antibody. Based on its unique mechanism, it has shown great safety and strong anti-tumor activity in pre-clinical studies." Dr. Wang Jingsong, Founder, Chairman and CEO of Harbour BioMed said. "Each year, there are about 4 million newly diagnosed cancer patients in China and there is an urgent need for innovative drugs and therapeutic solutions for cancer treatment. We will continue to accelerate the global development of HBM4003 for multiple cancers, so that we can help cancer patients around the world to live better and longer lives."

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 high CTLA-4 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.HK) is a global, clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel antibody therapeutics in the areas of immunology and oncology diseases. The company is building its proprietary pipeline through internal R&D programs, collaborations with co-discovery and co-development partners and select acquisitions.

The company's internal discovery programs are centered around its two patented transgenic mouse platforms, Harbour Mice®, which generates fully human monoclonal antibodies in the classical two heavy and two light chain (H2L2) format, as well as heavy chain only (HCAb) format. Building on the HCAb antibodies, the company has also established HBICE™ (HCAb based immune cell engagers) platform for developing bispecific antibodies. Harbour BioMed also licenses the platforms to companies and academic institutions.