Harbour BioMed and Hualan Gene Announce Strategic Collaboration to Co-Develop Multiple Innovative Antibody Therapeutics

SUZHOU and XINXIANG, China; CAMBRIDGE, Mass., and ROTTERDAM, Netherlands, Sept. 11, 2020 /PRNewswire/ -- Harbour BioMed today announced that it has entered into a strategic collaboration agreement with Hualan Genetic Engineering Co., Ltd. (Hualan Genetic). The two parties will collaborate strategically on three innovative monoclonal antibody and bispecific antibody therapeutics independently developed by Harbour BioMed for the treatment of various cancers.

Under the agreement, Harbour BioMed grants Hualan Genetic exclusive licenses for the development, manufacturing, and commercialization of these projects in the Greater China region (including mainland China, Hong Kong, Taiwan, and Macau). Harbour BioMed retains the rights for clinical development and commercialization of these projects in all other regions worldwide. Hualan Genetic will be responsible for completing preclinical research and manufacturing process development for the collaborative projects. In addition, Harbour BioMed will receive an upfront payment of RMB 60 million and sales royalties. Meanwhile, both parties will collaborate across multiple areas, including preclinical studies, clinical development, and drug manufacturing.

Harbour BioMed has independently developed a portfolio of novel antibody drug candidates targeting oncology and autoimmune diseases, leveraging its proprietary H2L2 and HCAb fully human transgenic mouse platforms. Several of these programs have advanced into preclinical and clinical stages. Building on its unique fully human heavy-chain antibody (HCAb) transgenic mouse platform, Harbour BioMed has developed the HBICE immune engager platform.^TM. The collaborative project with Hualan Genetic this time includes one HBICE^TMBispecific Antibody Project.

Hualan Genetic specializes in the research, development, and production of monoclonal antibodies, recombinant human coagulation factors, and recombinant hormones. To date, the company has 19 recombinant protein products in its pipeline, with seven monoclonal antibody products having received clinical trial approval and entered into clinical studies, several of which are currently undergoing Phase III clinical trials. The therapeutic indications of its products cover more than ten major disease areas, including breast cancer, melanoma, lung cancer, colorectal cancer, and diabetes. Hualan Genetic is a novel biopharmaceutical enterprise integrating R&D, manufacturing, and sales.

“We are delighted to establish a strategic partnership with Hualan Biological Engineering. Our proprietary fully human heavy-chain antibody platform, HCAb, offers diverse possibilities for the design of next-generation innovative antibodies and provides a solid foundation for their development. This collaboration will fully leverage the respective strengths of both parties in R&D, manufacturing, and commercialization resources, accelerating the development of collaborative innovative drug projects to better and more rapidly meet the needs of patients worldwide.” Dr. Wang Jinsong, Founder, Chairman, and CEO of Harbour BioMed, stated, “As a global innovative biopharmaceutical company, we have engaged in early-stage co-discovery, development, and clinical collaborations with numerous pharmaceutical companies both in China and internationally, targeting various disease targets and major diseases, thereby accelerating the R&D progress of next-generation therapies for oncology and immune-mediated diseases.”

Dr. An Wenqi, General Manager of Hualan Genetic, stated, “The antibody drug business is one of Hualan Genetic’s core strategic directions for the future. Previously, Hualan Genetic successfully completed the research and development of seven monoclonal antibody drugs and established an antibody drug production line with a capacity of 10,000 liters. The company’s R&D products are evolving from biosimilars toward the integration of next-generation antibody technologies, such as bispecific antibodies and heavy-chain antibody innovative drugs. Hualan is pleased to collaborate with Harbour BioMed to accelerate the layout of its innovative product pipeline and complete the transition from biosimilars to bio-innovative drugs.”