In the beginning of the new year, China Gene Medicine Valley brought forth joyful news. TransReco, a settled biotech enterprise within the valley, successfully passed the audit and on-site inspection conducted by Zhejiang Medical Products Administration. Consequently, it obtained the Class C Drug Production License, becoming the first enterprise in Wenzhou to secure this license for biopharmaceutical production. This achievement signifies that Ouhai’s biopharmaceutical CDMO platform now has the legal authorization to undertake commissioned drug production, heralding Wenzhou’s entry into a new era of commercial production for macromolecular biopharmaceuticals.

It is said that TransReco, located in the second phase of the valley, is a subsidiary of Biometa. The TransReco Biomacromolecule CDMO Platform represents the first industrialized R&D and production base for macromolecular protein drugs within the valley. Initiated by Li Xiaokun, academician of the Chinese Academy of Engineering and president of Wenzhou Medical University, the platform is invested by Ouhai District as a key program of state-owned assets and operated by TransReco. It primarily offers pilot tests for prokaryotic and eukaryotic fermentation recombinant protein drugs, alongside large-scale commercial production and preparation production including those for specialized ophthalmology. Since its inception, the platform has undertaken the development and production of over 20 recombinant protein and specialized preparation macromolecular biopharmaceutical projects.

In July of last year, TransReco secured the Class A Drug Production License issued by the Zhejiang Medical Products Administration, winning significant qualifications for commercial production. Wang Shumin, general manager of TransReco, remarked that obtaining the Class C license signifies a further escalation of the enterprise’s technical prowess and production adaptability. TransReco will officially enter the drug production commissioning market, accepting orders from drug marketing license holders and providing comprehensive services for the production of specific varieties of drugs. This will assist drug marketing license holders in shortening product marketing cycles, refining production processes, and enhancing product quality.

The official in charge of Ouhai Life and Health Town emphasized that securing the Class C license holds immense significance. It not only shows TransReco’s capacity to produce high-quality drugs under commission but also demonstrates the continuously improving ecosystem of China Gene Medicine Valley within the biomedicine domain. From initial development, pilot testing, clinical research, to final production and marketing, all links are continually being optimized. Furthermore, this will undoubtedly make the valley more attractive for pertinent scientific research projects and enterprises to settle, fostering a biomedical industry cluster in Wenzhou and propelling the high-quality development of Ouhai Life and Health Industry.