StemCell Therapy

CAMBRIDGE, Mass.,ROTTERDAM, Netherlands, SUZHOU,China and XINXIANG, China, Sept. 11, 2020 /PRNewswire/ -- Harbour BioMed (HBM), a global, clinical-stage, innovative biopharmaceutical company today announced a strategic partnership agreement with Hualan Genetic Engineering Co., Ltd (Hualan Genetic) to develop HBM's three proprietary innovative monoclonal and bispecific antibodies.

Under the terms of the agreement, Hualan Genetic will be responsible for preclinical and process development in exchange for exclusive rights for the development, manufacturing, and commercialization of these innovative antibody drugs in Greater China (Mainland China, Hong Kong, Taiwan and Macau). HBM will retain the rights for advancing the clinical development and commercialization in rest of the world. Both parties will collaborate on clinical developments and drug manufacturing. HBM will receive an upfront payment of USD 8.75M and royalties based on sales in Greater China.

Using its proprietary H2L2 and HCAb fully human transgenic mouse platforms, HBM has developed a series of novel antibody candidates against oncology and immunological diseases. Many of these candidates have already progressed to preclinical and clinical stages. HBM has developed an immune cell engager platform HBICE, and one productof this collaboration with Hualan Genetic is HBICE bispecific antibody.

Hualan Genetic has been dedicated to R&D and the production of monoclonal antibodies, recombinant human coagulation factors, recombinant hormone drugs. To date, the company has 19 recombinant protein products under development and 7 monoclonal antibody products that received approval for the clinical trial, among which several are under Phase III clinical study. Hualan Genetic is a novel biopharmaceutical company specializing in R & D, production and sales with product indications covering a dozen major diseases, including breast cancer, melanoma, lung cancer, colorectal cancer, and diabetes mellitus.

"We are pleased to join forces with Hualan to accelerate the development of novel therapeutics based on our HCAb platform that gives us the flexibility to design and develop innovative therapeutics. This collaboration brings together complementary capabilities to address patients' needs across the world." said Dr. Jingsong Wang, Founder, Chairman & Chief Executive Officer of HBM. "As a global biopharma, we have been collaborating with several industry and academic partners around the world to leverage complementary capabilities in both research and development to advance the next generation of therapeutics in oncology and immunology." he added.

Dr. Wenqi An, General Manager of Hualan Genetic, said, "Business of antibody drugs is one of the core strategic directions for the future development of Hualan Genetic. Previously, Hualan Genetic has successfully completed R&D of 7 monoclonal antibody drugs and established an antibody-drug production line with a scale of 10,000L. Hualan Genetic is on the development path transiting from the production of biosimilars to R&D of products concentrated on the latest antibody technologies (such as HBICE bispecific antibody). Hualan is very pleased to cooperate with HBM to accelerate our buildup ofinnovative product pipeline and accomplish the upgrade from biosimilars to bio-innovative drugs."

About Harbour BioMed

Harbour BioMed is a global, clinical stage biopharmaceutical company developing innovative therapeutics in the fields of immuno-oncology, immunologic diseases, and COVID-19. 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) for generating both fully human monoclonal antibodies, heavy chain only antibodies (HCAb) and HBICE immune cell engager technology for developing bispecific antibodies. Harbour BioMed also licenses the platforms to companies and academic institutions. The company has operations in Cambridge, Massachusetts; Rotterdam, the Netherlands; and Suzhou & Shanghai, China. For more information, please visit: http://www.harbourbiomed.com

About Hualan Genetic

Hualan Genetic has been dedicated to R&D and production of monoclonal antibodies since its foundation in 2013. From generics to biologics, Hualan Genetic has started its independent innovation development path transiting from production of biosimilars to R&D of products with the latest antibody technologies (such as innovative drugs of bispecific antibody and heavy-chain-only antibody). The company has advanced and complete R&D testing platform, pilot test workshop, scale production workshop and inspection testing platform, with four 2,500L and two 500L cell culture production lines of EU and WHO standard design, and various fully automatic filling lines, which can realize production, filling and packaging and lyophilization for various products of different scales at the same time. Hualan also provides CRO and CMO services of biomacromolecules including monoclonal cell strain screening, assessment, process R&D, drug analysis, preparations development, submission and approval for production, filling and packaging and labeling.

Media and Investor Contact:

Harbour BioMed Atul Deshpande PhD, MBA Chief Strategy Officer and Head, US Ops. Phone: +1-908-210-3347 E-mail: [emailprotected]

Hualan Genetic International Business Director Kevin Cai E-mail: [emailprotected]

SOURCE Harbour BioMed

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Harbour BioMed and Hualan Genetic Announced Collaboration to Develop Multiple Innovative Antibody Programs - PRNewswire

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