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医药产业研发创新
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康哲药业拟在新加坡二次上市丨健讯Daily
Group 1: Brain-Computer Interface Standards - The National Standard for Non-Invasive Medical Devices Using Brain-Computer Interface Technology is open for public consultation, aiming to establish performance indicators and testing methods for such devices [1] - The standardization is expected to enhance international cooperation and improve regulatory efficiency, addressing the rapid development in the non-invasive neural modulation sector [1] Group 2: Pharmaceutical Industry Innovation - The head of the National Medical Products Administration emphasized the importance of supporting drug and medical device R&D innovation to strengthen China's pharmaceutical industry [2] - Key strategies include early intervention, tailored guidance for enterprises, and promoting international multi-center clinical trials to synchronize the development and approval of innovative drugs and devices [2][3] Group 3: Clinical Trials and Approvals - Shenzhou Cell announced that its product SCTB39G received approval for clinical trials in advanced solid tumors [4] - Hanyu Pharmaceutical's subsidiary received approval for the listing of the raw material drug Acetate Degarelix, which is used for treating advanced prostate cancer [6] Group 4: Market Expansion and IPOs - Kangzhe Pharmaceutical plans a secondary listing in Singapore, reflecting a trend of pharmaceutical companies expanding into Southeast Asian markets [7] - Lianya Pharmaceutical's IPO application has been accepted, focusing on complex drug formulations and high-end generic drugs [9] Group 5: Strategic Collaborations - Bayer and Tsinghua University signed a strategic cooperation agreement to enhance research in various medical fields, aiming to accelerate drug innovation [11][12] Group 6: Clinical Trial Developments - Fuhong Hanlin announced the first patient enrollment in a bridging clinical trial for its drug H, which is approved for first-line treatment of small cell lung cancer in multiple countries [13] Group 7: Corporate Leadership Changes - Fosun Pharma held a shareholder meeting to elect new board members, appointing Chen Yuqing as chairman and Liu Yi as CEO [14]
李利在天津调研支持医药产业研发创新工作
news flash· 2025-06-25 10:30
Core Viewpoint - The National Medical Products Administration (NMPA) is focusing on enhancing the regulatory framework for pharmaceuticals and medical devices to promote innovation and streamline the approval process for new products [1] Group 1: Regulatory Reforms - The NMPA is implementing a strategy of "early intervention, tailored approaches for each company, comprehensive guidance, and collaborative review" to improve communication and service throughout the product development process [1] - There is an emphasis on replicating and promoting pilot experiences to shorten the review and approval timelines for innovative drugs and medical devices [1] Group 2: Encouragement of Clinical Trials - The NMPA is encouraging the conduct of international multi-center clinical trials to facilitate the simultaneous development, application, review, and market launch of global innovative drugs and medical devices in China [1]