On March 15, 2024, Tissue Factor Pathway Inhibitor (TFPI) monoclonal antibody KN057 was granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of hemophilia A.

On September 20th, 2023, Sichuan Yuanda Shuyang Pharmaceutical Co., Ltd. entered into a collaboration on the project with Suzhou Alphamab Oncology Biotechnology Co., Ltd. Yuanda Shuyang will be exclusively responsible for the marketing and commercialization of KN057 in Greater China. "Orphan drugs" are medicinal products used for the prevention, treatment and diagnosis of rare diseases. In the U.S., rare diseases are defined as diseases that affect fewer than 200,000 people. Since 1983, the U.S. has encouraged the R&D of medicinal products for rare diseases through the implementation of the Orphan Drug Act, which gives enterprises relevant policy support. After a drug is granted Orphan Drug status by the FDA, it will enjoy certain policy support for its subsequent R&D and commercialization in the U.S., including enjoyment of clinical trial fee tax exemption from new drug application fees, access to R&D grants, etc. In particular, the drug will be entitled to 7 years of exclusivity in the U.S. market after approval of the marketing of the indication.

About KN057

KN057 injection is a monoclonal antibody independently developed by Suzhou Alphamab Oncology with independent intellectual property rights. It achieves bleeding prevention by specifically targeting tissue factor pathway inhibitor (TFPI), neutralizing the inhibitory effect of TFPI on FXa and TF/FVIa complexes, and maintaining thrombin levels. With its unique mechanism of action and molecular design, KN057 is expected to play a preventive therapeutic role in hemophilia A and hemophilia B patients with or without inhibitors. Its safety and efficacy have been preliminarily validated in preliminary clinical trials. Currently, KN057 is being prepared for two Phase III clinical studies in China. KN057 injection is a highly concentrated liquid formulation with long half-life and once-weekly subcutaneous injection, which is conducive to improving the compliance and effectiveness of long-term prophylactic treatment for hemophilia patients, thereby reducing the number of bleeds, decreasing joint injuries, and improving patients' quality of life.

About Grand Life Science Group

Grand Life Science Group 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 Class I New Drug Collagenase for Injection and the exclusive variety of Collagenase Ointment in China; the innovative R&D platform centered on Yuanda Weixin 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 Group 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.