On February 8, 2023, Sichuan Yuanda Shuyang Pharmaceutical Co., Ltd. (hereinafter referred to as "Yuanda Shuyang"), a wholly-owned subsidiary of Grand Life Science Group, entered into a collaboration with GenScript ProBio on the project of recombinant coagulation factor V for injection (project code: GLS-C3512). GenScript ProBio will provide clinical sample production, process characterization, process validation research, BLA application, and commercial production services for Yuanda Shuyang.

GLS-C3512 is a human recombinant B-zone deleted factor VIII, which is used for hemorrhage control and prophylaxis in patients with hemophilia A. Hemophilia A is a common inherited bleeding disorder. Low levels or complete absence of coagulation factor V in the blood is the cause of hemophilia A. The most common clinical treatment is coagulation factor V replacement therapy. Coagulation factor V can be obtained from human blood or produced by recombination in vitro. According to statistics and prediction from the National Bureau of Statistics and the World Federation of Hemophilia, the number of hemophiliacs in China has reached 140,000 people. As human coagulation factor V is in short supply and expensive, hemophiliacs in China are mostly treated on an as-needed basis, with only 2-3% of the total number of patients receiving prophylactic treatment. The further promotion of prophylactic treatment in China in the future will bring further expansion of the hemophilia drug market size. Given the tight and expensive global supply of coagulation factors, the hemophilia field is in dire need of high-yield and affordable Coagulation Factor VIII products.

GLS-C3512 is based on patented technology for macromolecular protein expression, which has the characteristics of high expression and stable process control. Its production is far higher than that of its peers in the world. The reduction in cost will substantially increase the accessibility of the medicinal product to patients and change the plight of hemophiliacs in China who have difficulty in accessing drugs for prevention and treatment. The commercialization of GLS-C3512 is an important step for Yuanda Shuyang to become a quality supplier of the entire blood product industry chain.

The person in charge of Yuanda Shuyang stated that GLS-C3512 is an important step taken by Sichuan Yuanda Shuyang Pharmaceutical from traditional blood product products to the layout of recombinant blood product pipelines, opening up a new track for the layout of hemophilia product pipelines. Yuanda Shuyang looks forward to accelerating the clinical application and listing of the project through the cooperation with GenScript ProBio's leading international platform and professional team, which will fundamentally change the treatment and prevention situation of hemophilia patients in China, thus greatly improving the quality of life of the patients.

Dr. Brian Min, Chief Executive Officer of GenScript ProBio, said, "We believe that this collaboration will further demonstrate the technological and platform advantages of both companies. We look forward to utilizing GenScript ProBio's complete quality management system, professional quality management and regulatory team, and working with Yuanda Shuyang to benefit hemophiliacs as soon as possible."

About GenScript ProBio

With a one-stop biologics R&D and manufacturing platform, GenScript ProBio is focused on providing end-to-end CDMO services from target development to commercialization for Cell and gene therapy CGT drugs, vaccine and biologics discovery, antibody-protein drugs, etc. GenScript ProBio's total cell and gene therapy solution covers non-registered clinical and process development, registered clinical, and commercialization full-stage plasmid viral production. In terms of biopharmaceutical CDMO services, GenScript ProBio provides customers with integrated CDMO services including cell line development, host cell commercialization licensing, upstream and downstream process development, analytical method development and clinical sample, commercial production, etc., as well as batch replenishment and perfusion processes to meet the growing demand for antibody-protein drugs. The GMP manufacturing plant meets FDA, EMA and NMPA regulatory requirements.

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 Sichuan Yuanda Shuyang Pharmaceutical Co., Ltd.

Founded in 1985, the predecessor of Sichuan Yuanda Shuyang Pharmaceutical Co., Ltd. (hereinafter referred as "Yuanda Shuyang") was a military enterprise, was forwarded to the government of Chengdu City in 1998, was completely purchased by China Grand Group Company in 2001. Yuanda Shuyang has an annual sales revenue of more than RMB 1.8 bi

llion and generates an annual tax revenue of more than RMB 100 million. The existing production base is located in Chengdu Hi-tech Zone, with more than ten plasmapheresis subsidiary companies in Sichuan and Guangxi, and blood products in 9 categories and 24 specifications have been listed. Yuanda Shuyang is one of the first enterprises in the domestic blood products industry to pass the GMP and ISO9001 quality system certification, and the first to propose and pass the "Quality, Environment and Occupational Health" three-position integration certification in China. It has successively obtained the GMP certification of Russia, Turkey and other countries, many products of which have obtained the registration certificates of Eurasian and South American countries. The company has 9 categories and 24 specifications of Human Albumin, Human Immunoglobulin for Intravenous Injection, Human Hepatitis B Immunoglobulin for Intravenous Injection, Human Hepatitis B Immunoglobulin, Human Tetanus Immunoglobulin, Human Rabies Immunoglobulin, Human Immunoglobulin, Human Histamine Immunoglobulin, and Human Fibrinogen. The independent innovation of double viral inactivation process without protective agent has been awarded patents in the U.S., Australia and China. The self-developed Human Hepatitis B Immunoglobulin for Intravenous Injection, which is in the leading position in the industry, has won the National Key New Product, the First Prize of Sichuan Provincial Scientific and Technological Progress, and Chengdu Municipal Outstanding Scientific and Technological Contribution Award.