新药周观点：2026年多个国产新药海外关键临床数据读出值得期待-20251228

Investment Rating - The report does not explicitly state an investment rating for the biopharmaceutical industry, but it suggests a positive outlook based on upcoming catalysts and potential drug approvals. Core Insights - The biopharmaceutical sector is expected to see significant developments in 2026, with multiple domestic drugs anticipated to report key clinical data. This includes drugs from companies like Betta Pharmaceuticals, Hutchison China MediTech, and CanSino Biologics, which are expected to read out critical clinical data in 2026 [3][21]. - The report emphasizes that the long-term theme for the innovative drug sector is international expansion, with several sub-themes to focus on, including overseas business development (BD) licensing, key clinical trials, and unexpected overseas sales growth [3][18]. Summary by Sections Weekly New Drug Market Review - From December 22 to December 28, 2025, the top five gainers in the new drug sector were Dongyao Pharmaceutical (+23.15%), Beihai Kangcheng (+19.27%), Junshengtai (+16.41%), Shiyao Group (+6.95%), and Ailis (+5.78%). The top five losers were Gakos (-16.11%), Jiahe Biotech (-10.29%), Laika Pharmaceuticals (-9.33%), Yunding Xinyao (-8.98%), and Yongtai Biotech (-6.94%) [1][14]. Weekly Focused Stocks - The report suggests focusing on several stocks with high overseas expansion potential, including: 1. Companies with MNC certification and high overseas volume certainty: Sanofi, United Pharmaceuticals, and Kelun-Biotech. 2. Companies with overseas data catalysts: Betta Pharmaceuticals, Hutchison China MediTech, and InnoCare Pharma. 3. Potential heavyweights for overseas MNC licensing: Junshi Biosciences, Shiyao Group, and Yifang Biotech. 4. New innovative drug technology breakthroughs: small nucleic acids, in vivo CAR-T, fat loss and muscle gain, autoimmune CAR-T/bispecific antibodies, and gene therapy [2][18]. Weekly New Drug Approval & Acceptance Status - This week, 23 new drug or new indication applications were approved in China, and 10 new drug or new indication applications were accepted [4][19]. Weekly New Drug Clinical Application Approval & Acceptance Status - This week, 99 new drug clinical applications were approved, and 64 new drug clinical applications were accepted [5][24]. Key Domestic Market Events - Notable events include: 1. Xiansheng Zhaoming announced a global exclusive licensing agreement with Ipsen for an ADC drug, potentially worth up to $1.06 billion. 2. He Yu Pharmaceuticals received approval for its CSF-1R selective small molecule inhibitor. 3. Tongyi Pharmaceuticals announced a licensing agreement for a peptide conjugate drug for prostate cancer, with potential payments totaling around $2 billion [10]. Key Overseas Market Events - Significant overseas events include: 1. Novo Nordisk received FDA approval for a 25mg oral semaglutide tablet for weight loss. 2. Sanofi announced a cash acquisition agreement for Dynavax Technologies Corporation, valued at approximately $2.2 billion. 3. Agios Pharmaceuticals announced FDA approval for an oral PK activator for treating α or β thalassemia in adult patients [11].