Sinolink Securities released a research report highlighting that on December 7, 2025, China’s National Healthcare Security Administration (NHSA) unveiled the *2025 Updated National Reimbursement Drug List (NRDL)* and the inaugural *Commercial Health Insurance Innovative Drug Catalog*. The updated NRDL will take effect on January 1, 2026.
Driven by the outstanding clinical value of innovative drugs, the success rate of negotiations for new drugs in 2025 has significantly improved compared to previous years, with these drugs expected to achieve favorable pricing outcomes. Inclusion in the NRDL is anticipated to accelerate market penetration and expand market share for these products. The emergence of novel mechanism drugs further underscores the pivotal role of NRDL inclusion in facilitating broad patient access.
**Key Takeaways from Sinolink Securities:** 1. **Higher Negotiation Success Rate for Innovative Drugs** - The 2025 NRDL added 114 new drugs (approaching the record highs of 121 in 2022 and 2023), including 50 Class 1 innovative drugs, with an overall success rate of 88%—up from 76% in 2024. - Post-adjustment, the NRDL now covers 3,253 drugs (1,857 Western medicines and 1,396 traditional Chinese medicines), significantly enhancing coverage for critical areas such as oncology, chronic diseases, mental health, rare diseases, and pediatric treatments. - Since 2018, the average price reduction during negotiations has stabilized around 60%. While the NHSA did not disclose this year’s overall price cuts, the firm expects favorable outcomes for high-value innovative drugs, given the NHSA’s increasing support for innovation.
2. **105 Exclusive Drugs Added, Including Traditional Chinese Medicines** - Among the 114 newly added drugs, 105 are exclusive (including exclusive formulations, accounting for 92.11%), comprising 98 Western medicines and 7 traditional Chinese medicines (TCMs). All newly added TCMs are exclusive, involving companies such as Huarun 999, Yiling Pharmaceutical, Fangsheng Pharmaceutical, Kanion Pharmaceutical, and Guangdong Siji Pharmaceutical.
3. **Rapid Market Expansion for Newly Listed Drugs** - The 2025 negotiations covered 107 Western drug categories (116 drugs in total, with multiple manufacturers for some categories). - **Hengrui Medicine** led with 11 new drugs added, followed by **AstraZeneca** (4 drugs), and **Zhengda Tianqing**, **Kelun-Biotech**, **Eli Lilly**, **Qilu Pharmaceutical**, and **Roche** (3 drugs each). - Novel mechanism drugs included: - **2 ADCs**: Kelun-Biotech’s Sacituzumab Govitecan (TROP2 ADC) and Hengrui’s Trastuzumab Deruxtecan (HER2 ADC). - **siRNA drug**: Novartis’ Inclisiran (PCSK9 inhibitor). - **Bispecific TCE**: Roche’s Glofitamab (CD3×CD20). - **Peptide drug**: Eli Lilly’s Tirzepatide (GIPR/GLP-1R agonist).
4. **Competitive Selection for the First Commercial Health Insurance Innovative Drug Catalog** - Out of 121 submitted drugs, only 24 entered negotiations, with 19 ultimately included (from 18 companies). The catalog covers rare diseases (e.g., neuroblastoma, Gaucher disease) and high-need conditions like Alzheimer’s, multiple myeloma, and short bowel syndrome. - The list balanced imported (10) and domestic (9) drugs, including **Tazemetostat** (Hutchison MediPharma), **Lurbinectedin** (Luye Pharma), **Naxitamab** (SciClone), and **Dinutuximab Beta** (BeiGene). - By technology: 5 CAR-T therapies (priced at ¥990,000–1.29 million per dose), 5 monoclonal antibodies, 4 chemical drugs, 3 bispecific antibodies, 1 peptide, and 1 enzyme. CAR-T therapies, historically excluded from the NRDL due to high costs, were all included in the commercial catalog.
5. **TCM: Policy Favors Innovation Over Classical Formulas** - Among 23 TCMs (25 products) initially reviewed in August 2025, only 7 were finalized (4 Class 1 and 3 Class 3 new drugs). Classical formulas dominated submissions but had low selection rates.
**Investment Recommendations:** - **Western Drugs**: Focus on companies with multiple/newly added NRDL drugs (e.g., **Hengrui Medicine**, **BeiGene**, **Akeso Biopharma**, **Kelun-Biotech**, **Innovent Biologics**) and those with key first-time inclusions like **Keymed Biosciences** (IL-4 mAb) and **Amoytop Biotech** (long-acting growth hormone). - **TCMs**: Monitor growth potential for newly listed products (e.g., Huarun 999’s Yiqi Qingfei Granules, Yiling’s Qifang Bitong Tablets, Fangsheng’s Yangxue Qufeng Zhitong Granules, Kanion’s Yunüjian/Tanwen Jiedu Granules).
**Risks**: Unexpected price cuts, competition from rival drugs entering the NRDL.
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