2 1 Shi Ji Jing Ji Bao Dao·2025-09-19 00:10Policy Developments - The 2025 Pharmaceutical Digital Development Conference was held in Beijing on September 17-18, focusing on the modernization of drug regulation through information technology and digital collaboration [1] Drug and Device Approvals - Hengrui Medicine's SHR-1501 has been included in the list of proposed breakthrough therapy varieties by the National Medical Products Administration, aimed at treating non-muscle invasive bladder cancer [2] - Kehua Bio's ferritin assay kit received a medical device registration certificate, valid from September 17, 2025, to September 16, 2030, for the quantitative measurement of ferritin in human serum and plasma [3] - Shanghai Pharmaceuticals' Nicorandil tablets passed the consistency evaluation for generic drugs, with approximately 5.5352 million yuan invested in R&D [4] Capital Market - Roche announced a definitive agreement to acquire biopharmaceutical company 89bio for up to nearly $3.5 billion, focusing on innovative therapies for liver and heart metabolic diseases [5] Industry Events - The first national group standard for "Non-Clinical Safety Technical Guidelines for Oligonucleotide Drugs" was released during the 9th China (Tianjin) Nucleic Acid Drug Conference [6] Research and Development - Chinese researchers developed a new generation of brain-machine interface electrodes, marking a shift towards dynamic and intelligent detection in bioelectronic interfaces [7] - A new blood testing tool, "HPV-DeepSeek," can identify HPV-related head and neck cancers up to 10 years before symptoms appear, potentially improving patient outcomes [9] Corporate Governance - The independent director of Buchang Pharma, Cheng Hua, resigned due to personal reasons, leading to a temporary reduction in the number of independent directors on the board [10] Strategic Collaborations - Siemens Healthineers and Stryker announced a strategic partnership to develop a new robotic system for neurovascular interventions [8]