Sintilimab

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Dec. 08, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that following the contract renewal with the China National Healthcare Security Administration (“NHSA”), the updated National Reimbursement Drug List (“NRDL”) effective on January 1, 2026 will continue to include ELUNATE®, ORPATHYS® and SULANDA®. In addition, TAZVERIK® will be included in the first edition of the National Commercial Health Insurance Innovative Drug List (“Commercial Insurance Drug List”). ELUNATE® (fruquintinib) is included for the treatment of patients with advanced endometrial cancer with Mismatch Repair proficient (pMMR) tumors that have failed prior systemic therapy and are not candidates for curative surgery or radiation, in combination with TYVYT® (sintilimab injection). It is also renewed for the treatment of patients with metastatic colorectal cancer who have previously received fluoropyrimidine, oxaliplatin and irinotecan-based chemotherapy, and those who have previously received or are not suitable for receiving anti-VEGF therapy or anti-epidermal growth factor receptor (EGFR) therapy (RAS wild-type). ORPATHYS® (savolitinib) is included for treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with MET exon 14 skipping alteration. SULANDA® (surufatinib) is renewed for the treatment of patients with unresectable; locally advanced or metastatic; progressive non-functional, well-differentiated (G1 or G2) pancreatic and non-pancreatic neuroendocrine tumors. TAZVERIK® (tazemetostat) is included in the Commercial Insurance Drug List for the treatment of adult patients with relapsed or refractory follicular lymphoma with EZH2 mutation who have received at least two prior systemic therapies. In July 2025, the NHSA issued the 2025 Adjustment Work Plan for the NRDL and the Commercial Health Insurance Innovative Drug List, announcing the establishment of the new Commercial Insurance Drug List. This list, together with the NRDL, forms a key component of China’s multi-level medical insurance system. This new list focuses on medicines with high innovation and significant clinical value that fall beyond the scope of basic medical insurance, including certain high-cost oncology drugs, gene therapies, and rare disease therapies, enabling reimbursement through commercial health insurance products such as high-limit medical insurance, inclusive health plans (“Huiminbao”) and group health insurance. This multi-layered reimbursement framework enhances patient access to breakthrough treatments while supporting the sustainable development of China’s innovative pharmaceutical sector. About NRDL The government in China has placed great importance on improving the affordability of drug treatments for the public. As of end of 2024, 1.33 billion people in China had basic medical insurance coverage, representing around 95% of the entire population. The NRDL is updated every year, and inclusion on the list is subject to renewal every two years. The NHSA annually convenes a broad network of experts in medicine, pharmacology, pharmacoeconomics and actuarial valuation to identify innovative medicines to consider for NRDL inclusion. Reimbursement of Category B medicines, including novel oncology medicines, requires varying degrees of copayment from patients, depending on their provinces or types of NHSA insurance scheme enrollment. About Fruquintinib Fruquintinib is a selective oral inhibitor of all three vascular endothelial growth factor receptors (“VEGFR”) -1, -2 and -3. Fruquintinib is co-developed and co-commercialized in China by HUTCHMED and Eli Lilly and Company under the brand name ELUNATE®. Takeda holds the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside mainland China, Hong Kong and Macau, marketing it under the brand name FRUZAQLA®. About Savolitinib Savolitinib is an oral, potent and highly selective MET tyrosine kinase inhibitor that has demonstrated clinical activity in advanced solid tumors. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations), gene amplification or protein overexpression. Savolitinib is being jointly developed by AstraZeneca and HUTCHMED, and commercialized by AstraZeneca under the brand name ORPATHYS®. About Surufatinib Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with VEGFRs and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Surufatinib is marketed in China by HUTCHMED under the brand name SULANDA®. HUTCHMED currently retains all rights to surufatinib worldwide. About Tazemetostat Tazemetostat is a first-in-class methyltransferase inhibitor of EZH2 developed by Epizyme, an Ipsen company. HUTCHMED entered into a strategic collaboration with Epizyme to research, develop, manufacture and commercialize tazemetostat in Chinese Mainland, Hong Kong, Macau and Taiwan. About HUTCHMED HUTCHMED (Nasdaq/AIM:​HCM; HKEX:​13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: www.hutch-med.com or follow us on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including its expectations for the commercialization of fruquintinib, savolitinib, surufatinib and tazemetostat in China, the potential benefits and further clinical development of fruquintinib, savolitinib, surufatinib and tazemetostat, its expectations as to whether further studies would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the commercial acceptance of fruquintinib, savolitinib, surufatinib and tazemetostat, the impact of the inclusion of fruquintinib, savolitinib and surufatinib on the NRDL and tazemetostat on the Commercial Health Insurance Innovative Drug List on sales of the drug and its pricing, clinical trial enrollment rates, timing and availability of subjects meeting a study’s inclusion and exclusion criteria, changes to clinical protocols or regulatory requirements, unexpected adverse events or safety issues, the ability of fruquintinib, savolitinib, surufatinib and tazemetostat to obtain regulatory approval for a targeted indication in different jurisdictions and the sufficiency of funding. In addition, as certain studies rely on the use of other drug products such as sintilimab as combination therapeutics, such risks and uncertainties include assumptions regarding their safety, efficacy, supply and continued regulatory approval. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. CONTACTS Investor Enquiries+852 2121 8200 / ir@hutch-med.com Media Enquiries FTI Consulting –+44 20 3727 1030 / HUTCHMED@fticonsulting.comBen Atwell / Tim Stamper+44 7771 913 902 (Mobile) / +44 7421 898 348 (Mobile)Brunswick – Zhou Yi+852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com Panmure LiberumNominated Advisor and Joint BrokerAtholl Tweedie / Emma Earl / Rupert Dearden+44 20 7886 2500 CavendishJoint BrokerGeoff Nash / Nigel Birks+44 20 7220 0500 Deutsche NumisJoint BrokerFreddie Barnfield / Jeffrey Wong / Duncan Monteith+44 20 7260 1000

SAN FRANCISCO and SUZHOU, China, Dec. 6, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces that seven of its innovative products have been included in the updated 2025 National Reimbursement Drug List (NRDL). This list features a new indication of TYVYT® (sintilimab injection), and first-time inclusions of SYCUME® (teprotumumab N01 injection, a recombinant anti-IGF-1R antibody), Limertinib (EGFR TKI), Dupert® (fulzerasib, KRAS G12C inhibitor), DOVBLERON® (taletrectinib, ROS1 inhibitor), Retsevmo® (selpercatinib, RET inhibitor), and Jaypirca® (pirtobrutinib, BTK inhibitor). The updated NRDL will be officially effective from January 1, 2026. Dr. Michael Yu, Founder, Chairman of the Board and CEO of Innovent, stated: "We are pleased with the NRDL inclusion of our seven innovative therapies this year. 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 (CVM) 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. As a company with the mission of 'empowering patients worldwide with affordable, high-quality biopharmaceuticals', Innovent continues to invest in pioneering treatments across oncology, CVM, autoimmune and ophthalmology—areas of significant societal need. We remain committed to our patient-centered approach, leveraging our innovation and product capabilities to further improve drug affordability and accessibility, so that high-quality medicines can reach and benefit more patients and their families as soon as possible. We are proud to contribute to better care for our patients." TYVYT® (sintilimab injection) TYVYT® (sintilimab injection) is a PD-1 immunoglobulin G4 monoclonal antibody co-developed by Innovent and Eli Lilly and Company. In China, sintilimab has been approved for eight indications and two more NDAs are under review by the NMPA, including squamous non-small cell lung cancer (NSCLC), non-squamous NSCLC, liver cancer, gastric cancer, esophageal cancer, endometrial cancer and Hodgkin's lymphoma[i]. In the updated NRDL, the eighth indication of TYVYT®(sintilimab injection) is newly included, in combination with fruquintinib for the treatment of patients with advanced endometrial cancer with Mismatch Repair proficient (pMMR) tumors that have failed prior systemic therapy and are not candidates for curative surgery or radiation. This new indication addresses a critical gap in treatments available for advanced endometrial cancer patients with limited responses to traditional therapies. SYCUME® (teprotumumab N01 injection) SYCUME® (teprotumumab N01 injection) is a recombinant anti-insulin-like growth factor 1 receptor (IGF-1R) antibody developed by Innovent. SYCUME® blocks the activation of IGF-1R signaling pathway, consequently improving clinical manifestations such as proptosis, inflammation and diplopia, thus enhancing quality of life in patients with thyroid eye disease (TED)[ii]. In the updated NRDL, SYCUME®(teprotumumab N01 injection) is newly listed for moderate-to-severe thyroid eye disease. SYCUME®(teprotumumab N01 injection) is China's first approved IGF-1R antibody drug, and this groundbreaking non-invasive therapy redefines the standard of care and serves the unmet needs for thyroid eye disease over past 70 years in China. The NRDL inclusion will bring this world-class novel treatment option to Chinese patients with thyroid eye disease and significantly enhance patient accessibility and affordability. Limertinib Limertinib is a third-generation EGFR TKI in collaboration with ASK Pharm, and Innovent holds exclusive commercialization rights in Mainland China.[iii] In the updated NRDL, limertinib is newly listed for: 1) the treatment of adult patients with locally advanced or metastatic EGFR T790M-mutated non-small cell lung cancer (NSCLC), who have previously experienced disease progression during or after treatment with EGFR TKI; and 2) the first-line treatment of adult patients with locally advanced or metastatic NSCLC carrying EGFR exon 19 deletions or exon 21 L858R mutations. Limertinib incorporates a unique naphthylamine group structure, which endows it with enhanced lipophilicity. This property ensures effective drug penetrate across the blood-brain barrier (BBB), thereby significantly reducing the risk of disease progression—specifically, the risk of disease progression in patients with brain metastases and the risk of intracranial disease progression. The NRDL inclusion of limertinib will provide a more effective treatment option for NSCLC patients with EGFR mutations. Dupert® (fulzerasib) Dupert® (fulzerasib) is a novel KRAS G12C inhibitor in collaboration with GenFleet Therapeutics, and Innovent holds exclusive development and commercialization rights in Greater China.[iv] In the updated NRDL, Dupert®(fulzerasib) is newly listed for the treatment of advanced NSCLC adult patients harboring KRAS G12C mutation who have received at least one systemic therapy. The NRDL inclusion of Dupert®(fulzerasib) will provide a novel targeted therapy benefiting NSCLC patients harboring KRAS G12C mutation. DOVBLERON® (taletrectinib) DOVBLERON® (taletrectinib) is a novel next-generation ROS1 TKI in collaboration with Nuvation Bio China, a Nuvation Bio (NYSE: NUVB) Company, and Innovent holds exclusive commercialization rights in Greater China.[v] In the updated NRDL, DOVBLERON® (taletrectinib) is newly listed for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC. The NRDL inclusion of DOVBLERON® (taletrectinib) will provide a potentially best-in-class therapy benefiting patients with locally advanced ROS1-positive NSCLC. Retsevmo® (selpercatinib) Retsevmo® (selpercatinib) is a selective and potent rearranged during transfection (RET) kinase inhibitor developed by Eli Lilly and Company and solely commercialized in Mainland China by Innovent.[vi] In the updated NRDL, Retsevmo® (selpercatinib) is newly listed for the treatment of: 1) adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a RET gene fusion, 2) adult and pediatric patients 12 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation who require systemic therapy, and 3) adult and pediatric patients 12 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion who require systemic therapy and who are radioactive iodine-refractory. Retsevmo® (selpercatinib) is the first RET inhibitor approved globally and its NRDL inclusion will bring an innovative therapy for NSCLC and thyroid cancer patients with a RET alteration. Jaypirca® (pirtobrutinib) Jaypirca® (pirtobrutinib) is a non-covalent (reversible) BTK inhibitor developed by Eli Lilly and Company and solely commercialized in Mainland China by Innovent. Jaypirca® (pirtobrutinib) is the first and only non-covalent (reversible) BTK inhibitor approved in the world.[vii] In the updated NRDL, Jaypirca® is newly listed for the treatment of adult patients with relapsed or refractory mantle cell lymphoma after at least two types of systemic therapy, including a BTK inhibitor. Its NRDL inclusion will benefit heavily-treated MCL patients that previously received the treatment of a BTK inhibitor, addressing their unmet needs and further enhancing Jaypirca's affordability for those patients. About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 17 products in the market. It has 1 new drug applications under regulatory review, 4 assets in Phase 3 or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Roche, Takeda, Sanofi, Incyte, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action" Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Statements: Innovent does not recommend the use of any unapproved drug (s)/indication (s). Ramucirumab（Cyramza）, Selpercatinib (Retsevmo) and Pirtobrutinib (Jaypirca) were developed by Eli Lilly and Company. Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment and political, economic, legal and social conditions. The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialise or turn out to be incorrect. SOURCE Innovent Biologics 21% more press release views with Request a Demo