万联证券：国内药企崭露头角 前沿平台与出海潜力成投资主脉

Core Insights - In 2025, the FDA approved 46 new drugs, indicating a decline in the number of approvals compared to 2024 and 2023, but the approved drugs are diverse and highly innovative [2][3] Group 1: Drug Approval Overview - The approved new drugs in 2025 are characterized by high innovation, with over half classified as "first-in-class" therapies [3] - The majority of the approved drugs are small molecule drugs, with others including monoclonal antibodies, ADCs, siRNA, ASOs, fusion proteins, and bispecific T-cell engagers [3] Group 2: Therapeutic Areas - Oncology is the predominant therapeutic area for the approved new drugs, covering various solid tumors and hematological malignancies [4] - Other therapeutic areas include respiratory, endocrine and metabolic, and cardiovascular diseases, with 34 of the new drugs undergoing special review processes [4] Group 3: Company Performance - Major multinational pharmaceutical companies such as Merck, Eli Lilly, Boehringer Ingelheim, and GlaxoSmithKline each had two new drugs approved [5] - Domestic companies also achieved approvals, with Zhongshan Kangfang Biopharmaceutical Co., Ltd.'s Paimupili monoclonal antibody and Dize (Jiangsu) Pharmaceutical Co., Ltd.'s Shuwotini receiving FDA approval [5] Group 4: Investment Recommendations - The report suggests focusing on companies with cutting-edge technology platforms, particularly those involved in ADC, siRNA, and cell gene therapy (CGT) [1] - It is recommended to invest in Chinese innovations with global competitiveness, especially those conducting or planning global multi-center clinical trials, and those utilizing a collaboration model where Chinese companies handle early-stage R&D while multinational companies manage later-stage clinical and commercialization efforts [1]