Core Insights - The National Medical Products Administration has approved the launch of the innovative drug Remabizine Injection by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd, which is used in conjunction with MediBeacon Inc's TGFR device to assess patients' glomerular filtration rate (GFR) [1][2] - This approval reflects Hangzhou's commitment to high-quality development in the biopharmaceutical industry, translating policy into practice through regulatory support and service empowerment [1][2] Group 1 - The Hangzhou Market Supervision Administration has implemented a "one-stop" service system to address the challenges of long, complex, and difficult drug development cycles, enhancing communication and support for key enterprises [1][2] - The city has established a collaborative "Hangzhou service model" that includes a three-level coordination mechanism to ensure timely communication of policies and responses to issues [1][2] Group 2 - The administration has adopted a full lifecycle service approach for the innovative drug project, optimizing drug registration and inspection processes to expedite approvals [2] - By coordinating with higher-level agencies and providing tailored support, the administration has significantly shortened the approval timeline for the drug, showcasing the acceleration of innovative services in Hangzhou [2] - The successful approval of Remabizine Injection exemplifies the synergy between market regulation and corporate innovation, with plans for continued reforms to further enhance the biopharmaceutical industry's development [2]
赋能创新提速 重磅创新药获批上市