On September 20, 2023, Sichuan Yuanda Shuyang Pharmaceutical Co., Ltd. (referred to as "Yuanda Shuyang"), a wholly-owned subsidiary of Grand Life Science Group Co., Ltd. (referred to as "Grand Life Science"), and Suzhou Alphamab Oncology Biotechnology Co., Ltd. (referred to as "Suzhou Alphamab Oncology"), jointly announced that both parties have entered into a collaboration agreement for the licensing of KN057, a Tissue Factor Pathway Inhibitor (TFPI) monoclonal antibody developed by Suzhou Alphamab Oncology, in the Greater China region.
Under the terms of the agreement, Yuanda Shuyang will be exclusively responsible for the marketing and commercial sales of KN057 in the Greater China region, and will pay Suzhou Alphamab Oncology an aggregate of up to RMB 500 million in equity payments (including down payments and milestone payments) and tiered sales commissions. Suzhou Alphamab Oncology will continue to be responsible for the subsequent clinical studies, marketing registration applications and product supply of KN057 for hemophilia A and hemophilia B. KN057 is a monoclonal antibody developed by Suzhou Alphamab Oncology with independent intellectual property rights. By specifically targeting TFPI and neutralizing the inhibitory effect of TFPI on FXa as well as TF/FVIa complex, it maintains the level of thrombin and achieves the prevention of bleeding, and is expected to exert efficacy on both hemophilia A and B patients with or without inhibitors. KN057 has a long half-life and can be injected subcutaneously, which is conducive to improving the compliance and effectiveness of long-term prophylactic treatment for hemophilia patients, thus improving their quality of life. Currently, the phase I clinical study of KN057 for hemophilia has been basically completed. Dr. Xu Ting, Founder and Chairman of Suzhou Alphamab Oncology, said, "We are very pleased to enter into this collaboration with Grand Life Science on KN057. KN057 has a unique mechanism of action and molecular design, and there is currently no drug with the same target on the market worldwide. KN057 is expected to overcome the limitations of traditional hemophilia drugs and provide patients with an effective and more convenient preventive treatment option. This commercialization collaboration has further strengthened our confidence in the market potential of KN057. Next, we will accelerate the registration of KN057 for clinical studies and strive to benefit our patients as soon as possible." Mr. Feng Zenghui, Chairman of Grand Life Science, said, "Hematological diseases are one of the therapeutic areas that Grand Life Science focuses on. The cooperation between Grand Life Science and Suzhou Alphamab Oncology will better meet the clinical needs through innovative R&D and jointly improve the treatment level of hemophilia in China to benefit the majority of patients. We look forward to the early approval of KN057 with a strong sense of social responsibility."
About Suzhou Alphamab Oncology
Founded in 2008, Suzhou Alphamab Oncology is dedicated to the research and industrialization of antibody and protein macromolecule drugs. The company has a complete R&D technology platform for macromolecular drug development, and has established a complete R&D functional chain from the early screening of macromolecular drugs (antibody screening platform and early drug efficacy evaluation platform), cell engineering (antibody mixture platform and bispecific antibody platform), cell line construction, pilot study, pilot scale-up, quality research (macromolecular process development platform), non-clinical and clinical studies to the application andregistration. Up to now, the company has obtained clinical research approvals for 8 Category 1 oftherapeuticbiologicalproducts and 5 biosimilars, of which 3 varieties have been selected for the National Special Project for the Creation and Manufacture of Major New Drugs. The company has also transferred more than 30 biotechnologies and products to many domestic pharmaceutical companies, which has greatly promoted the industrialization of biopharmaceuticals in Suzhou, Jiangsu and even the whole country.
"Honesty, innovation, growth, honor and cooperation" are the core concepts of Suzhou Alphamab Oncology. The company hopes to provide more efficient and affordable biopharmaceuticals to patients through continuous innovation.
About Grand Life Science Group
Grand Life Science is a comprehensive pharmaceutical enterprise group with a profound industrial layout and international vision. The company has R&D centers and production bases in more than ten cities including Beijing, Chengdu, Hangzhou, Shenyang, Wuhan, Chongqing, Nanjing, Zhengzhou, Yantai, and Anshan. Among them, Yuanda Shuyang is based on the field of high-end blood products and is rapidly expanding to the field of protein recombination and genetic engineering innovative products; Hangzhou Yuanda, Chongqing Yuanda and Qingdao Yihao jointly construct a probiotic health industry chain; Yuanda (Liaoning) has been deeply engaged in perioperative drugs for many years and owns the State Category I New Drug Collagenase for Injection and the exclusive variety of Collagenase Ointment in China; the innovative R&D platform centered on Grand Theravac focuses on the R&D of therapeutic vaccines, new and improved vaccines and new adjuvants; and Yuanda Medical Nutrition strategically lays out the broad market of medical nutrition. Relying on its rich industrial experience and product pipeline, Grand Life Science explores international and domestic unmet clinical needs, and endeavors to provide global patients with professional services ranging from health management, disease prevention to disease treatment.
About Yuanda Shuyang
Yuanda Shuyang, a wholly-owned subsidiary of Grand Life Science, is one of the first nationally designated blood product manufacturers. Yuanda Shuyang has joined hands with the top international design team to build an internationally leading Industry 4.0 blood product drug manufacturing base with the integration of informatization and industrialization, which has been put into use, and its annual plasma delivery volume ranks the first echelon of the domestic blood product single-unit production enterprises. Its products spread all over the national market, and it is also the leading exporter of blood products in China. The company adheres to the development path of "high quality standard, full product coverage, and international market", basing itself on the full range of blood products, e.g. albumin, immunoglobulin, coagulation factors, etc., and expanding into the field of recombinant proteins and other products. The company has comprehensively laid out six technical platforms, including protein separation and purification, sterile freeze-dried products, quality standard research, special immune plasma screening, viral inactivation process, and recombinant protein, and is committed to becoming an internationalized and high-quality service provider for the whole product chain of blood products.