Workflow
人EGFR/ALK/ROS1/MET/KRAS基因突变检测试剂盒(多重荧光PCR法)
icon
Search documents
六部门开展非法救护车专项整治;石药集团一高管被罚500万元
Policy Developments - The National Health Commission and five other departments launched a one-year special campaign against illegal ambulances, targeting both registered "ambulance" vehicles and unregistered "black ambulances" [2] - The campaign includes comprehensive inspections, management principles, and encourages social participation in medical transport services [2][3] Drug and Medical Device Approvals - Aied Bio received a medical device registration certificate for its gene mutation detection kit, which is now approved in China, Japan, and Europe, aiding non-small cell lung cancer patients [4] - Hainan Haiyao's subsidiary obtained a drug registration certificate for Fumaric Acid Vonoprazan Tablets, the first P-CAB for reflux esophagitis in China [5] Capital Market Activities - China National Pharmaceutical Modern signed a drug listing license transfer contract for Lactulose Oral Solution, with a total transfer fee of 5.86 million yuan, projected to generate 2.069 billion yuan in sales in 2024 [6] - Jiangsu Hengrui Medicine and Neurocrine Biosciences entered a collaboration for developing NLRP3 inhibitors, with a potential total value of $881.5 million [7][8] Industry Events - The 2025 medical insurance negotiation concluded, with results expected to be announced in early December [9] - The only approved stem cell drug in China, Aimi Maito Sai Injection, is included in the "Beijing Universal Health Insurance" with a maximum reimbursement of 65% [10] Regulatory Issues - The executive director of CSPC Pharmaceutical Group was fined 5 million yuan for insider trading related to a merger announcement [11]
艾德生物(300685.SZ)取得一项医疗器械注册证
智通财经网· 2025-11-03 10:22
Core Viewpoint - The company, Adicon Biological, has recently received a medical device registration certificate from the National Medical Products Administration for its product, the human EGFR/ALK/ROS1/MET/KRAS gene mutation detection kit (multiplex fluorescent PCR method) [1] Company Summary - Adicon Biological has been granted a medical device registration certificate, indicating regulatory approval for its gene mutation detection kit [1]
艾德生物取得一项医疗器械注册证
Zhi Tong Cai Jing· 2025-11-03 09:13
Core Viewpoint - The company, Aide Biology (300685.SZ), has recently received a medical device registration certificate from the National Medical Products Administration for its product, the human EGFR/ALK/ROS1/MET/KRAS gene mutation detection kit (multiplex fluorescent PCR method) [1] Group 1 - The product is designed for detecting multiple gene mutations, which is significant for personalized medicine and targeted therapies [1] - The approval from the regulatory authority indicates the product meets necessary safety and efficacy standards, potentially enhancing the company's market position [1] - This development may open new revenue streams for the company, as gene mutation testing is increasingly important in oncology [1]