《医疗器械管理法》立法调研在京开展;翰森ADC药物卖给罗氏
2 1 Shi Ji Jing Ji Bao Dao·2025-10-20 00:06

Policy Developments - The State Administration for Market Regulation and the National Medical Products Administration conducted legislative research on the draft Medical Device Management Law, emphasizing the importance of scientific, democratic, and legal legislation to enhance the quality of laws and promote implementation [1] Drug and Device Approvals - East China Pharmaceutical's subsidiary received a drug registration certificate for Remabizine injection, which is used in conjunction with MediBeacon's device to assess patients' glomerular filtration rate [2] - Kelun Pharmaceutical's subsidiary obtained approval for its ADC product, Botuzumab, for treating HER2-positive breast cancer, showing significant improvement in progression-free survival compared to T-DM1 [3] Financial Reports - WoHua Pharmaceutical reported a net profit increase of 179.34% year-on-year for the first three quarters, with revenue of 625 million yuan [4] - Pianzihuang's third-quarter net profit decreased by 28.82%, with revenue down 26.28% year-on-year, attributed to reduced sales in the pharmaceutical manufacturing sector [5] Capital Market Activities - Weigao Blood Products is planning to acquire 100% of Shandong Weigao Puri Pharmaceutical Packaging Co., leading to a stock suspension for up to 10 trading days [7] - Hansoh Pharmaceutical entered a licensing agreement with Roche, potentially earning up to $1.45 billion in milestone payments for the development of HS-20110, a targeted ADC for colorectal cancer [8] Industry Developments - Sanofi announced the launch of its insulin raw material project in Beijing, with a total investment of 1 billion euros, expected to be completed by 2032 [12]