Innovent Secures NRDL Inclusion for Seven Innovative Therapies, Expanding Access to Cancer and Rare Disease Treatments in China
核心洞察
Innovent Biologics (搜索) announced that seven innovative drugs, including a new indication for TYVYT and first-time inclusions of SYCUME (搜索) and five targeted therapies, have been added to China's 2025 National Reimbursement Drug List.
The included therapies address critical unmet needs across oncology, thyroid eye disease, and hematological malignancies, with coverage spanning lung, liver, gastric, esophageal, and gynecological cancers.
SYCUME (搜索) represents China's first approved IGF-1R (搜索) antibody drug for thyroid eye disease, offering a groundbreaking non-invasive therapy after 70 years of limited treatment options.
Innovent Biologics (搜索) has achieved a significant regulatory milestone with the inclusion of seven innovative therapies in China's updated 2025 National Reimbursement Drug List (NRDL), marking a major expansion in patient access to cutting-edge cancer and rare disease treatments. The announcement, made on December 6, 2025, includes a new indication for the PD-1 (搜索) inhibitor TYVYT and first-time inclusions of six other innovative drugs, with coverage taking effect January 1, 2026.
Comprehensive Oncology Portfolio Gains Coverage
The NRDL inclusion encompasses multiple targeted therapies addressing diverse cancer types and genetic mutations. TYVYT (sintilimab injection), a PD-1 (搜索) immunoglobulin G4 monoclonal antibody co-developed with Eli Lilly, received approval for its eighth indication in combination with fruquintinib for advanced endometrial cancer patients with Mismatch Repair proficient (pMMR) tumors who have failed prior systemic therapy and are not candidates for curative surgery or radiation.
The targeted therapy portfolio includes several precision medicine options for non-small cell lung cancer (NSCLC). Limertinib, a third-generation EGFR (搜索) TKI developed in collaboration with ASK Pharm (搜索), gained coverage for both EGFR T790M-mutated NSCLC patients who experienced disease progression after prior EGFR TKI treatment and as first-line therapy for patients with EGFR exon 19 deletions or exon 21 L858R mutations. The drug's unique naphthylamine group structure provides enhanced lipophilicity, enabling effective blood-brain barrier penetration and reducing disease progression risk in patients with brain metastases.
Dupert (fulzerasib), a novel KRAS G12C (搜索) inhibitor developed with GenFleet Therapeutics (搜索), received coverage for advanced NSCLC patients harboring KRAS G12C mutations who have received at least one systemic therapy. DOVBLERON (搜索) (taletrectinib), a next-generation ROS1 (搜索) TKI developed with Nuvation Bio, was included for locally advanced or metastatic ROS1-positive NSCLC patients.
Breakthrough Therapy for Thyroid Eye Disease
SYCUME (搜索) (teprotumumab N01 injection) represents a particularly significant addition as China's first approved IGF-1R (搜索) antibody drug for moderate-to-severe thyroid eye disease. The recombinant anti-insulin-like growth factor 1 receptor antibody blocks IGF-1R signaling pathway activation, improving clinical manifestations including proptosis, inflammation, and diplopia while enhancing patient quality of life. According to Innovent, this groundbreaking non-invasive therapy addresses unmet needs that have persisted for over 70 years in China.
Expanding Treatment Options for Rare Cancers
The NRDL inclusion also covers therapies for rare cancer types and specific genetic alterations. Retsevmo (selpercatinib), a selective RET (搜索) kinase inhibitor developed by Eli Lilly, gained coverage for multiple indications including NSCLC with RET gene fusion, medullary thyroid cancer with RET mutation, and thyroid cancer with RET gene fusion in patients 12 years and older who are radioactive iodine-refractory. As the first globally approved RET inhibitor, selpercatinib provides innovative treatment options for patients with RET alterations.
Jaypirca (pirtobrutinib), the world's first and only non-covalent BTK (搜索) inhibitor, received coverage for adult patients with relapsed or refractory mantle cell lymphoma after at least two types of systemic therapy, including a BTK inhibitor. This inclusion addresses critical needs for heavily-treated patients who previously received BTK inhibitor treatment.
Strategic Impact on Healthcare Access
Dr. Michael Yu, Founder, Chairman and CEO of Innovent, emphasized the significance of the NRDL inclusion: "These therapies cover key disease areas that pose substantial public health challenges in China—particularly oncology (including lung, liver, gastric, esophageal, gynecological cancers, and hematological malignancies) as well as cardiovascular and metabolic diseases. Their inclusion will help broaden patients' access to and enhance their affordability of these medications, ultimately benefiting more individuals and families across the country."
The company's mission of "empowering patients worldwide with affordable, high-quality biopharmaceuticals" aligns with the NRDL inclusion's potential to improve drug affordability and accessibility across China's healthcare system.
Company Portfolio and Partnerships
Innovent, founded in 2011, has established itself as a leading biopharmaceutical company with 17 products currently in the market, one new drug application under regulatory review, four assets in Phase 3 or pivotal clinical trials, and 15 molecules in early clinical development. The company maintains partnerships with over 30 global healthcare companies, including Eli Lilly, Roche, Takeda, Sanofi, Incyte, LG Chem, and MD Anderson Cancer Center.
The NRDL inclusion represents a significant validation of Innovent's drug development strategy and its focus on addressing unmet medical needs across oncology, cardiovascular and metabolic diseases, autoimmune conditions, and ophthalmology. With the updated reimbursement coverage taking effect in January 2026, Chinese patients will gain significantly improved access to these innovative therapeutic options.