2025 年末亚洲制药圈重磅：新药获批、试验暂停与大额合作频发

Group 1: Drug Approvals and Clinical Trials - AstraZeneca and Daiichi Sankyo's drug combination Enhertu and Perjeta received FDA approval as a first-line treatment for HER2-positive metastatic breast cancer, marking the first new first-line therapy in over a decade, showing a 44% reduction in disease progression or death risk compared to traditional THP therapy [1] - Takeda's oral TYK2 inhibitor zasocitinib demonstrated strong performance in two Phase III trials for moderate to severe plaque psoriasis, with over 75% improvement in key metrics after 16 weeks, and plans to submit for FDA approval in 2026 [2] Group 2: Clinical Trial Setbacks - Daiichi Sankyo's ADC drug ifinatamab deruxtecan has paused patient recruitment in its global Phase III trial due to unexpected interstitial lung disease deaths, which affects its accelerated approval plans based on Phase II data [1] Group 3: Mergers and Acquisitions - Fosun Pharma plans to acquire a 53% stake in Green Valley Pharmaceutical for approximately $200 million to revive the controversial Alzheimer's drug GV-971, which did not receive regulatory renewal in China [4] - Harbour BioMed entered into a collaboration agreement with Bristol-Myers Squibb worth up to $1.1 billion, including an initial payment of $90 million, for a multispecific antibody [5] - Sanofi signed two biotechnology collaboration agreements, including a deal worth up to $1.04 billion for the Alzheimer's candidate ADEL-Y01, with an initial payment of $80 million [6] Group 4: Regulatory Changes - The U.S. Congress passed the revised Biosecure Act as part of the annual defense bill, which is expected to raise entry barriers for Chinese life sciences companies into the U.S. market [3]