Recently, Sichuan Yuanda Shuyang Pharmaceutical Co., Ltd. (hereinafter referred to as "Yuanda Shuyang Pharmaceutical" or "the company"), a subsidiary of Grand Life Science Group, has obtained a Certificate of Pharmaceutical Product issued by NMPA for its human coagulation factor products. Yuanda Shuyang Pharmaceutical's human coagulation factor IX (Shuyang Yinjiu) is about to be launched for sale.

About Hemophilia B

Hemophilia B is an X-chromosome-linked recessive inherited bleeding disorder. Hemophilia A accounts for 80-85% of all hemophiliacs and Hemophilia B accounts for 15-20%. Hemophilia B is triggered by a deficiency of human coagulation factor | (abbreviated as FIX) in the patient's body, and the severity of the disease is related to the degree of deficiency of FIX in the patient's body. The level of FIX in patients with severe hemophilia B is less than 1% of that in normal patients. Patients suffer from frequent spontaneous bleeding, e.g. intra-articular hemorrhage, soft-tissue hematoma, abdominal hemorrhage, cerebral hemorrhage, etc., which ultimately leads to severe arthropathy, chronic pain, disability, and death, significantly affecting their lifespan and quality of life. Coagulation factor replacement therapy remains the most effective hemostatic measure for acute bleeding in hemophilia. The principles are early treatment, adequate dosage, and sufficient duration. The dosage and duration of replacement therapy should take into account the site and severity of bleeding. Domestic and international guidelines for hemophilia management recommend FIX for replacement therapy in hemophilia B.

About Shuyang Yinjiu®

Human coagulation factor IX is mainly synthesized by liver parenchymal cells, which is one of the components of plasma protein and a vitamin K-dependent factor, with a molecular weight of 56,000. FIX is a highly purified preparation of human coagulation factor IX from human plasma. Shuyang human coagulation factor IX (Shuyang Yinjiu®) takes healthy human plasma as the bulk, and after centrifugal removal of cryoprecipitation, through 4-step chromatography, viral inactivation by S/D method and 15nm nanofilm filtration, Shuyang Yinjiu® can effectively remove the virus possibly contained in the product while ensuring the activity of the product, and by strictly following the development principles of safety and effectiveness, it can protect the health of patients. 

About Grand Life Science Group Co., Ltd.

Grand Life Science Group Co., Ltd. (hereinafter referred to as "Grand Life Science") is a modernized and comprehensive pharmaceutical enterprise group with a domestic base and an international outlook. With the idea of building a pharmaceutical industrial system integrating R&D, production and sales, and the concept of independent, group and internationalized innovative R&D, Grand Life Science focuses on five major therapeutic areas, i.e. immunity and infection, perioperative and critical care, hematology, digestion and metabolism, and wound management, striving to provide patients around the world with comprehensive and industry-wide services ranging from health management, disease prevention to disease treatment. With a global vision to study the future trends of the industry, Grand Life Science aims at the unmet clinical needs both at home and abroad. Relying on the technology platforms of vaccines, micro-ecological drugs, ecombinant macromolecules, blood products, polymer materials, pharmaceuticals, collagenase, etc., Grand Life Science has set up R&D centers and production bases in more than ten cities, including Beijing, Chengdu, Hangzhou, Shenyang, Wuhan, Chongqing, Nanjing, Zhengzhou, Yantai, and Anshan, and is committed to the R&D and production of high-end blood products, new recombinant vaccines, new generation of live bacterial formulations, nano-targeted formulations, degradable medical devices and high-value APIs, etc.

About Yuanda Shuyang

Yuanda Shuyang is a wholly-owned subsidiary of Grand Life Science Group Co., Ltd. founded in 1985, it is one of the first batch of nationally designated blood product manufacturers, with more than ten single source plasma subsidiaries in Sichuan and Guangxi. Yuanda Shuyang has been awarded Top 20 of China's Top 100 Pharmaceutical Enterprises in 2018, 2019 and 2020. It has been awarded Top 50 Industrial Enterprises in Sichuan Province, Top 20 Industrial Enterprises in Chengdu City, and has been selected as one of the Key Advantage Enterprises in Sichuan Province.

Yuanda Shuyang's production base is located in Chengdu Hi-Tech Zone, and now has three major categories of albumin, immunoglobulin and coagulation factors, with a clear layout of the pipeline in R&D and abundant products. The company currently holds multiple domestic and international authorized patients, among which the independent innovation of "double viral inactivation process without protective agent" has been granted patents in China, the U.S. and Australia. The self-developed product "Human Hepatitis B Immunoglobulin for Intravenous Injection" is the first of its kind in Asia and is in the leading position in the industry, which has won the National Key New Product, the First Prize of Sichuan Provincial Scientific and Technological Advancement, and Chengdu Municipal Outstanding Scientific and Technological Contribution Award. The company's annual plasma volume ranks the first echelon of the domestic blood product monomer manufacturers. The company's products are widely distributed in the national market, and it is also a leading exporter of blood products in China.

Looking ahead to the future, Yuanda Shuyang will become one of the most competitive blood product companies in China. In order to realize the vision of "internationalized quality service provider of the whole product chain of blood products", the company will continue to contribute to the advancement of human health by taking R&D as the core and scientific and technological innovation as the means.