The Zhitong Finance App learned that the reporter learned from the State Drug Administration that in order to speed up the domestic marketing of drugs that are urgently needed for clinical use and meet the urgent needs of patients for clinical use, the State Drug Administration has further optimized the review and approval of such drugs. The State Drug Administration stated that it adheres to clinical value as the guide, encourages applicants to carry out simultaneous global research and development and simultaneous application for listing in China; encourages clinical use of original research drugs and generic drugs that have already been marketed abroad to be declared domestically, and that those that meet the requirements can be included in the scope of priority review and approval.
According to the announcement, the State Drug Administration will optimize the review mechanism and speed up the review; at the same time, it will also improve the inspection system to reflect the characteristics of varieties.
In 2025, the number of innovative drugs approved for marketing in China reached 76, far exceeding the 48 in 2024, a record high. Furthermore, in 2025, the total amount of foreign authorized transactions for innovative drugs in China exceeded 130 billion US dollars, and the number of authorized transactions exceeded 150, which also reached a record high.
According to information, the State Drug Administration approved 76 innovative drugs for marketing in 2025, including 47 chemicals, 23 biological products, and 6 traditional Chinese medicines. Of the 47 chemical drugs, 38 were domestically produced innovative drugs, and 9 were imported innovative drugs, accounting for 80.85%; of the 23 biological products, 21 were domestically produced innovative drugs and 2 were imported innovative drugs, accounting for 91.30% of domestic innovative drugs.
Many key policies in the industry have been broken through and implemented. The first edition of the “Commercial Health Insurance Innovative Drug Catalogue” was officially released in December 2025. The “Basic Medical Insurance Basics, Commercial Insurance Innovation” multi-level payment system has opened up new market channels for high-value innovative drugs.
Looking ahead to 2026, industry insiders are generally optimistic. With industrial policy support for true innovation and high-level innovation, a large number of innovative BDs will be implemented intensively.
Driven by both commercial insurance implementation and procurement optimization, the boom in the innovative drug industry chain is expected to continue, and high-value innovative drugs are expected to usher in a second growth curve.
Companies in the innovative medicine sector of the Hong Kong stock market include:
Hengrui Pharmaceutical (01276), Collumbotai Biological-B (06990), Hehuang Pharmaceutical (00013), Kangfang Biotech (09926), Cinda Biotech (01801), Shiyao Group (01093), Rongchang Biotech (09995), Sansheng Pharmaceutical (01530), Gax-B (01167), Laikai Pharmaceutical-B (02105), Hanson Pharmaceuticals (03692), etc.
Leading companies related to the CXO sector:
Gloria Ying (06821), Kanglong Chemical (03759), Zhaoyan New Pharmaceutical (06127), Pharmaceutical Biotech (02269), Pharmaceutical Kangde (02359), etc.