Wanlian Securities: Domestic pharmaceutical companies are emerging, cutting-edge platforms and overseas potential are the main source of investment

The Zhitong Finance App learned that Wanlian Securities released a research report saying that in 2025, the FDA approved the innovative “quality” improvement of new drugs and diversification of technological platforms, and domestic pharmaceutical companies have emerged. It is recommended to focus on cutting-edge technology platforms, focusing on companies with cutting-edge technology platforms such as ADC, siRNA, and cell gene therapy (CGT); it is recommended to lay out Chinese innovation with the potential to “go overseas”, focus on companies with global competitiveness in R&D pipelines that are currently or are planning to conduct global multi-center clinical trials, and companies that adopt the “Chinese pharmaceutical companies are responsible for early R&D, and multinational pharmaceutical companies are responsible for late-stage clinical and commercialization” cooperation model.

The main views of Wanlian Securities are as follows:

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In 2025, the FDA Drug Evaluation and Research Center (CDER) approved a total of 46 new drugs. Although the number of approved drugs decreased compared to 2024 and 2023, the types of approved new drugs are rich and highly innovative.

The types of new drugs approved by the FDA in 2025 are rich and highly innovative

In 2025, the FDA approved a total of 46 new drugs. The approved new drugs are highly innovative, accounting for more than half of the “first-in-class” treatments; there are many types of approved new drugs, mainly small-molecule chemicals. Others include monoclonal antibodies, ADC, siRNA, ASO, fusion proteins, and bispecific T-cell conjugators.

The treatment field of new drugs approved by the FDA in 2025 is mainly cancer treatment

In terms of the treatment field for which new drugs have been approved, tumors account for the largest proportion of treatment, covering various solid tumors and hematomas; other treatment fields also involve the respiratory system, endocrine and metabolism, and cardiovascular fields. Among them, the review and approval of as many as 34 new drugs involved special reviews.

Major foreign MNC pharmaceutical companies have been approved for leading new drugs, and domestic pharmaceutical companies have also received approval for new drugs

Two of the original new drugs from foreign pharmaceutical companies MSD, Eli Lilly, Boehringer Ingelheim, and GlaxoSmithKline have all been approved. Domestic pharmaceutical company Zhongshan Kangfang Biopharmaceutical Co., Ltd.'s Paiamprimab and DiZhe (Jiangsu) Pharmaceutical Co., Ltd.'s suvoritinib were approved for marketing by the FDA.

Risk warning: industry policy risk, risk of R&D falling short of expectations, risk of falling short of expectations in approval, risk of failure in new drug development.