Core Insights - Huadong Medicine's subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., has successfully obtained the drug registration certificate for the innovative drug, Maleate Mevanertinib Tablets, marking its official market approval [1] - This approval represents the second innovative drug acquired by Zhongmei Huadong in a short period, following the approval of Remabipine Injection on October 17 [1] - The company has significantly increased its R&D investment, with a total of 1.484 billion yuan in the first half of the year, reflecting a year-on-year growth of 33.75% [1] Group 1 - The newly approved Maleate Mevanertinib Tablets are a novel, potent, and highly selective irreversible EGFR/HER2 small molecule inhibitor for first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) [1] - The direct R&D expenditure reached 1.174 billion yuan, showing a year-on-year increase of 54.21%, and accounted for 15.97% of the pharmaceutical industrial revenue [1] Group 2 - The Hangzhou Market Supervision Administration has played a crucial role in facilitating the development of innovative drugs by establishing a regular communication mechanism with Zhongmei Huadong from the early stages of drug development [2] - The administration has implemented a "three commitments" approach to optimize the drug registration process, significantly shortening the approval timeline for the new drug [2]

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]

Core Viewpoint - The company has received approval for the marketing license of Remabizine Injection, a drug that requires specific equipment for assessing kidney function [1] Company Summary - East China Pharmaceutical (000963.SZ) announced that its wholly-owned subsidiary, Hangzhou Sino-American East China Pharmaceutical Co., Ltd. (referred to as "Sino-American East China"), has received the drug registration certificate issued by the National Medical Products Administration (NMPA) [1] - The approved drug, Remabizine Injection, is an exogenous fluorescent tracer used in conjunction with MediBeacon Inc's transcutaneous glomerular filtration rate measurement device (TGFR) to evaluate patients' glomerular filtration rate (GFR) [1]