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Recently, Yuanda Shuyang human immunoglobulin (pre-filled syringe packaging) was officially approved by National Medical Products Administration, and the drug approval number was: GYZZ S20247006.
Recently, Yuanda Shuyang Pharmaceutical has obtained the GMP certificate issued by the Ministry of Industry and Trade of the Russian Federation. This is the second overseas GMP certificate obtained after the Turkish GMP certificate, indicating that the production and quality management system of Yuanda Shuyang Pharmaceutical's new production base for blood products has been certified by the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and the Eurasian Economic Union (EAEU). This achieve
The Quality Control Center Laboratory (hereinafter referred to as "QIC") of Sichuan Yuanda Shuyang Pharmaceutical Co., Ltd. has passed the rigorous evaluation by China National Accreditation Service for Conformity Assessment (hereinafter referred to as "CNAS") and has obtained the certificate of CNAS Laboratory Accreditation, becoming a nationally accredited laboratory. A total of 33 items in three major testing fields of chemistry, microbiology and animal testing of the QIC have been approved.
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.
Recently, the Bureau of Economy and Information Technology of Chengdu Municipality released the List of Municipal Intelligent Factories in 2023 and the List of Municipal Digitalized Workshops in 2023. The blood product manufacturing workshop of Sichuan Yuanda Shuyang Pharmaceutical has been awarded the title of "Excellent Intelligent Manufacturing Scene of MIIT in 2023" and "Digital Workshop of Chengdu City in 2023".
On the afternoon of December 21, 2023, The "High tech Craftsman" (Industrial Workers) Commendation Conference was held in Jingrong Hui, Gaoxin Zone, Chengdu. The conference focused on recognizing 236 "Hi-Tech Craftsmen" selected in 2022 and 2023. Wang Mingzhi and Zhou Yangqing from the Production Department of Yuanda Shuyang were awarded the title of "High-tech Craftsman" in 2023 and received the commendation.
Recently, the SIPO issued the Notice of the State Intellectual Property Office on Determining the New Batch of National Intellectual Property Demonstration Enterprises and Advantage Enterprises in 2023 and Passing Review. After the procedures of enterprise evaluation, local assessment, recommendation and confirmation, Sichuan Yuanda Shuyang Pharmaceutical Co., Ltd. has been recognized as one of the new batch of national intellectual property advantage enterprises in 2023 by virtue of its industr
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 Alph
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.
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.
On January 15, 2023, Sichuan Yuanda Shuyang Pharmaceutical held its 2022 annual summary and commendation conference with the theme of "Developing by War, Strengthening Shuyang". Pan Wenqing, General Manager of the Group's Operation and Management Headquarters, Feng Zenghui, Chairman of the Grand Life Sciences Group and Chairman of Yuanda Shuyang Pharmaceutical, Zhou Lujin, Vice President of the Grand Life Sciences Group and General Manager of Yuanda Shuyang Pharmaceutical, and a number of leader
Recently, Yuanda Shuyang’s new production base achieved the first export of Human Immunoglobulin for Intravenous Injection (hereinafter referred to as "IVIG") to South American countries. As a leading exporter of blood products in China, Yuanda Shuyang has been deeply cultivating the international market over 20 years, with its products being sold to more than 10 countries and regions in Asia, Eastern Europe, the Middle East, Latin America, etc.