China's 2025 National Drug List Adds 114 Medicines with Historic Commercial Insurance Breakthrough
核心洞察
China's 2025 National Reimbursement Drug List successfully added 114 drugs with an 88% success rate, including 50 Class I innovative drugs, marking significant support for genuine pharmaceutical innovation.
All five CAR-T (搜索) cell therapies achieved breakthrough inclusion in the inaugural commercial insurance innovative drug directory, alongside 19 total innovative drugs, creating new payment pathways for high-value treatments.
The dual-track "basic medical insurance + commercial health insurance" model addresses previous cost-effectiveness barriers for expensive therapies while maintaining focus on clinical value and unmet medical needs.
China's National Healthcare Security Administration (搜索) announced the results of its 2025 National Reimbursement Drug List (NRDL) negotiations at the High-Quality Development Conference for Innovative Drugs in Guangzhou, marking a watershed moment for pharmaceutical access with the introduction of a dual-track reimbursement system.
The negotiations achieved an 88% overall success rate, significantly higher than the 76% recorded in 2024, with 114 drugs entering the National Medical Insurance Drug Catalog. Of these, 50 are Class I innovative drugs, representing nearly half of all newly added medications and demonstrating unprecedented support for genuine pharmaceutical innovation.
Historic Commercial Insurance Breakthrough
The most significant development was the establishment of China's first Commercial Insurance Innovative Drug List, which included 19 innovative drugs that previously struggled to gain basic medical insurance coverage due to cost-effectiveness concerns. This dual-track approach addresses a critical gap in the healthcare system by providing alternative payment pathways for high-value therapies.
All five CAR-T (搜索) cell therapies that underwent negotiations successfully entered the commercial insurance directory, marking a breakthrough for these life-saving but expensive treatments. The included CAR-T products are Fosun Kite (搜索)'s Axicabtagene Ciloleucel Injection, JW Therapeutics (搜索)' Relmacabtagene Autoleucel Injection, Hoin Biotech (搜索)'s Naxicabtagene Autoleucel (搜索) Injection, IASO Bio (搜索)'s Idecabtagene Vicleucel Injection, and Carsgen Therapeutics (搜索)' Zevalin Cabtagene Autoleucel (搜索) Injection.
"The inclusion of our CAR-T (搜索) product in the commercial insurance directory marks a critical step forward in the payment system's support for high-value innovative therapies, signaling a clear and positive message," stated CARsgen Therapeutics (搜索), parent company of one of the successful CAR-T manufacturers. "This move not only fully recognizes the clinical value of cell and gene therapies but also indicates that explorations into diversified payment systems have entered a substantive phase."
Major Pharmaceutical Wins
Hengrui Pharma emerged as a significant winner with ten products gaining NRDL inclusion for the first time, covering oncology, metabolism, cardiovascular diseases, immune system disorders, and ophthalmology. The company's portfolio includes Trastuzumab Deruxtecan among the newly covered treatments.
Innovent Bio (搜索) successfully included seven innovative products, including new indications for established treatments like the PD-1 (搜索) inhibitor Tyvyt (Sintilimab Injection), alongside recently launched drugs targeting oncology and chronic disease areas.
International pharmaceutical companies also achieved notable successes in the commercial insurance directory. Pfizer, Johnson & Johnson, Eli Lilly, and Eisai secured inclusion for key products, with Eisai's Alzheimer's drug Leqembi (lecanemab) and Eli Lilly's donanemab both entering the commercial insurance innovative drug directory.
Addressing Unmet Medical Needs
The 2025 NRDL expansion specifically targets gaps in coverage for major diseases including triple-negative breast cancer (搜索), pancreatic cancer (搜索), and lung cancer (搜索), as well as rare diseases like Langerhans cell histiocytosis (搜索) and chelation-intolerant thalassemia (搜索). Chronic conditions such as diabetes (搜索), hypercholesterolemia (搜索), and autoimmune diseases also received enhanced coverage.
Connoymab (搜索) achieved inclusion of its domestically developed first-in-class IL-4Rα (搜索) monoclonal antibody Kangyueda (spesolimab) in the national medical insurance. "The inclusion of our company in the medical insurance demonstrates the country's full recognition and strong support for the clinical value and differentiated innovation of domestic innovative drugs," said Dr. Bo Chen, Chairman and CEO of Connoymab.
Policy Impact and Industry Response
Zhang Ke, Party Secretary and Director of the National Healthcare Security Administration (搜索), noted that over eight consecutive years of catalog adjustments, the administration has incorporated 949 new drugs cumulatively. During agreement periods, the medical insurance fund spent over 460 billion yuan on negotiated drugs, driving sales exceeding 600 billion yuan.
"The biggest change in this year's national negotiation is the establishment of a 'Commercial Insurance Innovative Drug List' based on basic medical insurance, with a significant proportion of newly included innovative drugs for major diseases being added to the new medical insurance directory," explained Jin Chunlin, Director of the Shanghai Health Development Research Center.
Industry representatives expressed optimism about the policy changes while acknowledging implementation challenges. "This year's national negotiation has sent a core message of 'tiered payment supporting innovation and value-oriented development,'" stated a representative from Zhenlong Pharmaceuticals. "By establishing the commercial insurance innovative drug directory for the first time, the diversification of the payment system provides broader market opportunities for high-value products."
Implementation Challenges and Future Outlook
Despite the positive developments, industry stakeholders highlighted concerns about practical implementation of the commercial insurance mechanism. Companies noted that while directory inclusion represents a crucial first step, the real challenge lies in hospital access and reimbursement chain establishment.
"Getting a product into the commercial insurance innovative drug directory can be considered a fresh start in its lifecycle and provides a significant boost to commercialization," noted a market medical director from an innovative pharmaceutical company. "However, after a new product enters medical insurance, extensive communication with hospital pharmacy committees is still required, which is a complex and ongoing process."
The updated National Medical Insurance Drug List will officially take effect on January 1, 2026, with provincial medical insurance departments completing new drug listings by the end of December 2025. The adjustments are estimated to reduce patients' financial burden by over RMB 50 billion in 2025.
After this adjustment, the total number of drugs in the National Medical Insurance Drug List has increased to 3,253, including 1,857 Western medicines and 1,396 traditional Chinese medicines, significantly improving coverage for cancer, chronic diseases, mental illnesses, rare diseases, and pediatric medications.