Akeso Achieves Complete NRDL Coverage for Five Innovative Drugs in China, Including First-in-Class Bispecifics
核心洞察
Akeso (搜索) successfully secured inclusion of all approved indications for its five self-developed innovative drugs in China's 2025 National Reimbursement Drug List, effective January 1, 2026.
Ivonescimab, a first-in-class PD-1 (搜索)/VEGF (搜索) bispecific antibody, demonstrated superior efficacy over pembrolizumab in Phase III trials, reducing disease progression or death risk by 49%.
The NRDL inclusion covers major cancer types including lung, gastric, cervical, and nasopharyngeal cancers, as well as autoimmune and metabolic disorders like psoriasis and hypercholesterolemia.
Akeso (搜索), Inc. (9926.HK) announced the successful inclusion of all five of its self-developed innovative drugs into China's updated National Reimbursement Drug List (NRDL) for 2025, released by the National Healthcare Security Administration (NHSA) and effective January 1, 2026. This comprehensive coverage represents a significant milestone for the Hong Kong-based biopharmaceutical company, encompassing both newly added indications and first-time participants in national reimbursement negotiations.
The inclusion covers treatments for major tumor diseases with the highest incidence rates in China, including lung cancer, gastric cancer, cervical cancer, and nasopharyngeal cancer, as well as metabolic and autoimmune disorders such as hypercholesterolemia and psoriasis. According to Dr. Yu Xia, Founder, Chairwoman, President, and CEO of Akeso (搜索), this achievement "enables Chinese patients to be among the first in the world to benefit from optimal treatment options" while reducing financial burden and providing superior alternatives for significant public health challenges.
Ivonescimab Demonstrates Superior Efficacy in NSCLC
Akeso (搜索)'s first-in-class PD-1 (搜索)/VEGF (搜索) bispecific antibody, ivonescimab, secured inclusion of its new first-line indication for PD-L1 (搜索)-positive non-small cell lung cancer (NSCLC) in the NRDL. In a Phase III head-to-head clinical trial, ivonescimab demonstrated compelling results, reducing the risk of disease progression or death by 49% compared to pembrolizumab.
Notably, ivonescimab represents the first drug globally to show significantly superior efficacy over pembrolizumab in a Phase III trial. This breakthrough clinical value has gained recognition from global academic and biopharma communities, as well as expert evaluators during the NRDL negotiation process. The drug's indication for treating EGFR-TKI resistant NSCLC was previously included in the NRDL in 2024.
Cadonilimab Expands Coverage Across Multiple Cancer Types
Cadonilimab, Akeso (搜索)'s first-in-class PD-1 (搜索)/CTLA-4 (搜索) bispecific antibody, successfully negotiated inclusion of its new first-line gastric cancer and first-line cervical cancer indications into the NRDL. The drug stands as the only immuno-oncology therapy globally to demonstrate significant clinical benefits in first-line gastric cancer and first-line cervical cancer across all patient populations, regardless of PD-L1 (搜索) expression status.
The NRDL now covers cadonilimab's treatment of recurrent or metastatic cervical cancer, which was included in 2024, alongside the newly added first-line indications for both gastric and cervical cancers.
Comprehensive Coverage for Specialized Therapies
Penpulimab, a differentiated PD-1 (搜索) monoclonal antibody, participated in national reimbursement negotiations for the first time in 2025. The drug successfully secured NRDL inclusion for all four approved indications: first-line treatment of squamous NSCLC, first-line treatment of nasopharyngeal carcinoma (NPC), third-line or later treatment of NPC, and third-line or later treatment of relapsed/refractory classical Hodgkin lymphoma. Two of penpulimab's indications for nasopharyngeal carcinoma treatment have already received U.S. FDA approval.
Ebdarokimab, China's first independently developed innovative drug targeting IL-12 (搜索)/IL-23 (搜索) and Akeso (搜索)'s first approved drug in autoimmune diseases, gained NRDL inclusion for treating moderate-to-severe psoriasis. Similarly, ebronucimab, targeting PCSK9, secured coverage for both approved indications: treatment of primary hypercholesterolemia and mixed dyslipidemia, and heterozygous familial hypercholesterolemia.
Strategic Impact on Market Access
Dr. Xia emphasized that these drugs had already gained extensive recognition from hospitals, physicians, and patients in real-world clinical practice prior to NRDL inclusion, thanks to their breakthrough clinical value. The successful entry into the NRDL is expected to enhance end-user awareness and trust in the company's innovative drugs, laying a foundation for accelerated clinical adoption and supporting Akeso (搜索)'s global expansion strategy.
Founded in 2012, Akeso (搜索) has developed an integrated R&D innovation system centered on its comprehensive drug development platform (ACE Platform) and bispecific antibody technology (Tetrabody). The company maintains a robust pipeline of over 50 innovative assets across cancer, autoimmune disease, inflammation, and metabolic disease areas, with 26 candidates in clinical trials and seven new drugs commercially available.