Sintilimab

TABOSUN® (ipilimumab N01 injection) has been approved in combination with TYVYT® (sintilimab injection) for the neoadjuvant treatment of patients with stage IIB-III resectable microsatellite instability-high or mismatch repair deficient (MSI-H/dMMR) colon cancer. The TABOSUN® and TYVYT® combination therapy significantly improved pathological complete response (pCR) rates and enabled most patients to avoid the burden of postoperative adjuvant chemotherapy. This therapy is the first and only dual-IO regimen approved globally for neoadjuvant treatment of colon cancer[i], filling a critical gap in neoadjuvant treatment of colon cancer and benefiting more patients with MSI-H/dMMR colon cancer. SAN FRANCISCO and SUZHOU, China, Dec. 25, 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 the New Drug Application (NDA) for TABOSUN® (ipilimumab N01 injection; R&D Code: IBI310), the first domestic cytotoxic lymphocyte-associated antigen-4 (CTLA-4) monoclonal antibody (mAb), has been approved by China's National Medical Products Administration (NMPA), in combination with sintilimab as neoadjuvant treatment for stage IIB-III resectable microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colon cancer. TABOSUN® (ipilimumab N01 injection) is the world's first approved CTLA-4 mAb for neoadjuvant treatment of colon cancer. Short-term neoadjuvant treatment with the ipilimumab N01 and sintilimab combination demonstrated a substantial improvement in pathological complete response, offering the potential to benefit a broader population of patients with MSI-H/dMMR colon cancer. Resectable MSI-H/dMMR colon cancer urgently requires effective neoadjuvant therapies to improve prognosis MSI-H/dMMR colon cancer accounts for around 15% of all resectable colon cancer cases[ii]. Due to its unique biological characteristics, this class of tumor shows limited sensitivity to chemotherapy and generally responds poorly[iii]. In recent years, immune checkpoint inhibitors have demonstrated significant efficacy in advanced MSI-H/dMMR colon cancer, but a gap remains in the neoadjuvant setting. For locally advanced MSI-H/dMMR colon cancer, the current standard of care is direct surgery followed by adjuvant chemotherapy. Under this regimen, approximately 10%-30% of patients experience disease recurrence or metastasis after surgery, while chemotherapy-related toxicities may negatively affect quality of life[iv]. Thus in the neoadjuvant setting, there remains an urgent need for more effective therapies to improve outcomes for patients with locally advanced MSI-H/dMMR colon cancer. The world ' s first dual-IO neoadjuvant therapy: TABOSUN ® (ipilimumab N01 injection) combined with TYVYT ® (sintilimab injection) markedly enhances pathological complete response rates Immune checkpoint blockade (ICB) therapy targeting PD-1 and CTLA-4 has transformed cancer treatment. The combination of DABOSUN® (ipilimumab N01 injection) and TYVYT® (sintilimab injection) as neoadjuvant therapy can significantly improve pathological complete response(pCR) rates and allow the majority of patients to avoid adjuvant chemotherapy. Previously, results from a randomized, controlled Phase 1b trial evaluating ipilimumab N01 plus sintilimab as neoadjuvant treatment for MSI-H/dMMR colon cancer were published in the top-tier journal Cancer Cell[i]. As of June 17, 2025, 101 patients were enrolled and randomized to receive ipilimumab N01 plus sintilimab (n=52) or sintilimab alone (n=49). In the per-protocol population, the pCR rate in the ipilimumab N01-plus-sintilimab arm was significantly higher than in the sintilimab-alone arm (80.0% vs 47.7%, p=0.0007). With median follow-up of 21.4 months, no patient experienced disease recurrence. Approval is based on results from the randomized, controlled, multicenter, pivotal Phase 3 clinical trial (NeoShot, NCT05890742), which evaluated the safety and efficacy of ipilimumab N01 combined with sintilimab as neoadjuvant therapy compared with direct radical surgery for MSI-H/dMMR colon cancer. The primary endpoints are pCR rate and event-free survival (EFS). Interim analysis by the Independent Data Monitoring Committee (IDMC) confirmed that the NeoShot trial met its primary endpoint. As of November 28, 2024, among the first 50 patients in the treatment arm, 41 achieved pathological complete response after neoadjuvant treatment, yielding a pCR rate of 82%. Neoadjuvant treatment with ipilimumab N01 combined with sintilimab did not significantly increase safety risks compared with direct surgery. Detailed results will be presented at future academic conferences or published in academic journals. The Principal Investigator of the NeoShot study, Academician of the Chinese Academy of Engineering, Prof. Ruihua Xu from Sun Yat-sen University Cancer Center, stated: "Achieving R0 resection remains challenging for certain patients with locally advanced colon cancer, who also face substantial surgical trauma and poor prognosis. Results from the FOxTROT study indicated that neoadjuvant chemotherapy provides limited benefit in MSI-H/dMMR colon cancer, with a pCR rate of only around 5%[v]. The NeoShot trial is the first randomized, controlled Phase 3 clinical trial to show promising efficacy of dual checkpoint inhibition as neoadjuvant therapy in MSI-H/dMMR colon cancer. Interim analysis suggests that ipilimumab N01 with sintilimab as short-term neoadjuvant treatment can lead to pathological complete response in 82% of treated patients. In addition, NeoShot Ph1b and Ph3 interim results both show the R0 resection under this regimen could reach 100% and spare patients from adjuvant chemotherapy. In NeoShot-1b, the dual-immunotherapy neoadjuvant regimen combining ipilimumab N01 and sintilimab significantly improved the pCR rate, which serves as a surrogate endpoint for long-term prognosis. Based on the existing data, this regimen shows promising potential to reduce recurrence risk and improve long-term survival outcomes. We look forward to observing continued reductions in recurrence with longer-term follow-up. The approval of this dual-immunotherapy regimen is expected to change clinical practice, fill a critical gap in neoadjuvant treatment of colon cancer and benefit more patients with MSI-H/dMMR colon cancer." Dr. Hui Zhou, Chief R&D Officer (Oncology) of Innovent, stated: "There remains a substantial unmet clinical need for neoadjuvant therapies for stage IIB-III resectable MSI-H/dMMR colon cancer in China. Interim analysis has shown that the NeoShot trial met its primary endpoint. Through Innovent's efficient and high-quality clinical development, ipilimumab N01 has become China's first domestically developed innovative CTLA-4 inhibitor approved by the NMPA, offering a new treatment option for patients in China with stage IIB-III resectable MSI-H/dMMR colon cancer." About Ipilimumab N01 Ipilimumab N01 (R&D code: IBI310) is a fully human monoclonal antibody injection independently developed by Innovent. Ipilimumab N01 specifically binds cytotoxic T lymphocyte-associated antigen 4 (CTLA-4), thereby blocking CTLA-4-mediated inhibition of T cell activity, promoting T cell activation and proliferation, improving tumor immune response, and achieving anti-tumor effects. [vi] The NDA for ipilimumab N01 in combination with sintilimab as neoadjuvant treatment for stage IIB-III resectable microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colon cancer has recently been approved by the NMPA. About Sintilimab Sintilimab, marketed as TYVYT® (sintilimab injection) in China, is a PD-1 immunoglobulin G4 monoclonal antibody co-developed by Innovent and Eli Lilly and Company. Sintilimab is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells.[vii] In China, sintilimab has been approved and included in the updated NRDL for eight indications. The updated NRDL reimbursement scope for TYVYT® (sintilimab injection) includes: For the treatment of relapsed or refractory classic Hodgkin's lymphoma after two lines or later of systemic chemotherapy; For the first-line treatment of unresectable locally advanced or metastatic non-squamous non-small cell lung cancer lacking EGFR or ALK driver gene mutations; For the treatment of patients with EGFR-mutated locally advanced or metastatic non-squamous non-small cell lung cancer who progressed after EGFR-TKI therapy; For the first-line treatment of unresectable locally advanced or metastatic squamous non-small cell lung cancer; For the first-line treatment of unresectable or metastatic hepatocellular carcinoma with no prior systematic treatment; For the first-line treatment of unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma; For the first-line treatment of unresectable locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma; and In combination with fruquintinib for the treatment of patients with advanced endometrial cancer with pMMR tumors that have failed prior systemic therapy and are not candidates for curative surgery or radiation. The NDA for sintilimab's ninth indication, in combination with ipilimumab N01 as neoadjuvant treatment for stage IIB-III resectable MSI-H/dMMR colon cancer is recently approved by the NMPA. The NDA for sintilimab's tenth indication, in combination with fruquintinib for the treatment of locally advanced or metastatic renal cell carcinoma who previously failed systematic treatment, has been accepted by the Center for Drug Evaluation (CDE) of NMPA. In addition, two clinical studies of sintilimab have met their primary endpoints: Phase 2 study of sintilimab monotherapy as second-line treatment of esophageal squamous cell carcinoma; and Phase 3 study of sintilimab monotherapy as second-line treatment for squamous non-small cell lung cancer with disease progression following platinum-based chemotherapy. 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 18 products in the market. It has 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 Lilly, 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. Disclaimer: Innovent does not recommend any off-label usage. 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. Innovent 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 Innovent 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 Innovent'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, Innovent's competitive environment and political, economic, legal and social conditions. Reference: SOURCE Innovent Biologics 21% more press release views with Request a Demo

2022年11月1日起，行政相对人可登录国家药品监督管理局政务服务门户的法人空间查看电子证照，按照相关提示自行打印。序号受理号药品名称申请人批准文号批准日期1CXSS2400079冻干人用狂犬病疫苗（Vero细胞）广州白云山生物制品股份有限公司国药准字S202500692025年12月22日2CXSS2400125派安普利单抗注射液正大天晴康方（上海）生物医药科技有限公司国药准字S202100332025年12月22日3CXSS2500031信迪利单抗注射液信达生物制药（苏州）有限公司国药准字S201800162025年12月22日4CXSS2500032伊匹木单抗N01注射液信达生物医药科技（杭州）有限公司国药准字S202500702025年12月22日5CYHB2502385茜草双酯片湖北凯安晨医药科技有限公司————2025年12月23日6CYHB2502461利巴韦林注射液安徽双鹤药业有限责任公司————2025年12月23日7CYHB2502463呋塞米注射液海南倍特药业有限公司————2025年12月23日8CYHB2502464呋塞米注射液海南倍特药业有限公司————2025年12月23日9CYHB2550054盐酸利多卡因注射液山东益健药业有限公司————2025年12月22日10CYHS2101924铝镁匹林片（Ⅱ）北京诚济制药股份有限公司国药准字H202563312025年12月22日11CYHS2300294氨溴特罗口服溶液华萃国际生物科技（广东）有限公司国药准字H202563322025年12月22日12CYHS2300295氨溴特罗口服溶液华萃国际生物科技（广东）有限公司国药准字H202563332025年12月22日13CYHS2300296氨溴特罗口服溶液华萃国际生物科技（广东）有限公司国药准字H202563342025年12月22日14CYHS2302332氨溴特罗口服溶液江苏开元药业有限公司国药准字H202563352025年12月22日15CYHS2302866铝镁匹林片(II)仁合益康集团有限公司国药准字H202563362025年12月22日16CYHS2303200盐酸艾司洛尔注射液江西亿友药业有限公司国药准字H202563532025年12月22日17CYHS2303214盐酸艾司洛尔注射液山东新时代药业有限公司国药准字H202563372025年12月22日18CYHS2400245乙酰半胱氨酸注射液四川上善六经医药科技有限公司国药准字H202563542025年12月22日19CYHS2400550他克莫司胶囊广东粤和泽药物研究有限公司国药准字H202563552025年12月22日20CYHS2400551他克莫司胶囊广东粤和泽药物研究有限公司国药准字H202563562025年12月22日21CYHS2400953米诺地尔搽剂嘉实（湖南）医药科技有限公司国药准字H202563842025年12月22日22CYHS2400973吸入用乙酰半胱氨酸溶液德全药品（江苏）股份有限公司国药准字H202563382025年12月22日23CYHS2401085盐酸普萘洛尔注射液北京六环药业有限公司国药准字H202563392025年12月22日24CYHS2401217复合磷酸氢钾注射液嘉亨（珠海横琴）医药科技有限公司国药准字H202563402025年12月22日25CYHS2401244法莫替丁注射液河北智恒医药科技股份有限公司国药准字H202563852025年12月22日26CYHS2401300盐酸甲氧氯普胺注射液仁合益康汇泽药业河北有限公司国药准字H202563412025年12月22日27CYHS2401334、CYHB2501658氯化钙注射液南京恒道医药科技股份有限公司国药准字H202563422025年12月22日28CYHS2401355乙磺酸尼达尼布软胶囊瑞阳制药股份有限公司国药准字H202563572025年12月22日29CYHS2401360西咪替丁注射液云南药科院生物医药股份有限公司国药准字H202563582025年12月22日30CYHS2401440氨氯地平阿托伐他汀钙片宁波大红鹰药业股份有限公司国药准字H202563592025年12月22日31CYHS2401613乳果糖口服溶液重庆和平制药有限公司国药准字H202563602025年12月22日32CYHS2401614乳果糖口服溶液重庆和平制药有限公司国药准字H202563612025年12月22日33CYHS2401659硫酸沙丁胺醇注射液湖北民康药业集团有限公司国药准字H202563932025年12月22日34CYHS2401742盐酸异丙嗪注射液扬州中宝药业股份有限公司国药准字H202563942025年12月22日35CYHS2401873法莫替丁注射液江苏神龙药业有限公司国药准字H202563432025年12月22日36CYHS2401887注射用哌拉西林钠东阳祥昇医药科技有限公司国药准字H202563622025年12月22日37CYHS2401888注射用哌拉西林钠东阳祥昇医药科技有限公司国药准字H202563632025年12月22日38CYHS2401889注射用哌拉西林钠东阳祥昇医药科技有限公司国药准字H202563642025年12月22日39CYHS2401941碳酸镧颗粒福建博悦医药科技有限公司国药准字H202563442025年12月22日40CYHS2401942碳酸镧颗粒福建博悦医药科技有限公司国药准字H202563452025年12月22日41CYHS2401984艾拉莫德片浙江高跖医药科技股份有限公司国药准字H202563652025年12月22日42CYHS2401987氢溴酸伏硫西汀片山西远扬医药科技有限公司国药准字H202563462025年12月22日43CYHS2402087重酒石酸去甲肾上腺素注射液湖南华纳大药厂股份有限公司国药准字H202563862025年12月22日44CYHS2402116铝碳酸镁咀嚼片国乐（山东）医药科技有限公司国药准字H202563872025年12月22日45CYHS2402195间苯三酚注射液山东新华制药股份有限公司国药准字H202563472025年12月22日46CYHS2402214盐酸纳洛酮注射液浙江华海药业股份有限公司国药准字H202563952025年12月22日47CYHS2402246盐酸异丙嗪注射液汇禹远和（海南）药业有限公司国药准字H202563482025年12月22日48CYHS2402247盐酸异丙嗪注射液汇禹远和（海南）药业有限公司国药准字H202563492025年12月22日49CYHS2402252钠钾镁钙注射用浓溶液江苏正大丰海制药有限公司国药准字H202563502025年12月22日50CYHS2402275非那雄胺片山东鲁抗医药集团赛特有限责任公司国药准字H202563662025年12月22日51CYHS2402276非那雄胺片山东鲁抗医药集团赛特有限责任公司国药准字H202563672025年12月22日52CYHS2402361聚乙烯醇滴眼液湖南状元制药有限公司国药准字H202563682025年12月22日53CYHS2402387盐酸丙卡特罗吸入溶液浙江金华康恩贝生物制药有限公司国药准字H202563962025年12月22日54CYHS2402388盐酸丙卡特罗吸入溶液浙江金华康恩贝生物制药有限公司国药准字H202563972025年12月22日55CYHS2402390沙格列汀片浙江杭康药业有限公司国药准字H202563692025年12月22日56CYHS2402391沙格列汀片浙江杭康药业有限公司国药准字H202563702025年12月22日57CYHS2402397布瑞哌唑片成都康弘药业集团股份有限公司国药准字H202563882025年12月22日58CYHS2402398布瑞哌唑片成都康弘药业集团股份有限公司国药准字H202563892025年12月22日59CYHS2402404盐酸溴己新口服溶液江苏广承药业有限公司国药准字H202563712025年12月22日60CYHS2402522、CYHB2402105苯磺酸左氨氯地平片海南赛立克药业有限公司国药准字H202563722025年12月22日61CYHS2402523、CYHB2402106苯磺酸左氨氯地平片海南赛立克药业有限公司国药准字H202563732025年12月22日62CYHS2402687甘油磷酸钠注射液石家庄四药有限公司国药准字H202563512025年12月22日63CYHS2402757盐酸达泊西汀片江苏福邦药业有限公司国药准字H202563742025年12月22日64CYHS2402758枸橼酸西地那非口崩片北京北陆药业股份有限公司国药准字H202563902025年12月22日65CYHS2402766美阿沙坦钾片新乡市常乐制药有限责任公司国药准字H202563752025年12月22日66CYHS2402767美阿沙坦钾片新乡市常乐制药有限责任公司国药准字H202563762025年12月22日67CYHS2402789盐酸溴己新注射液陕西博森生物制药股份集团有限公司国药准字H202563982025年12月22日68CYHS2402866低钙腹膜透析液（碳酸氢盐-G1.5%）上海长征富民金山制药有限公司国药准字H202563772025年12月22日69CYHS2402867低钙腹膜透析液（碳酸氢盐-G2.5%）上海长征富民金山制药有限公司国药准字H202563782025年12月22日70CYHS2402868腹膜透析液（碳酸氢盐-G2.5%）上海长征富民金山制药有限公司国药准字H202563792025年12月22日71CYHS2402869腹膜透析液（碳酸氢盐-G1.5%）上海长征富民金山制药有限公司国药准字H202563802025年12月22日72CYHS2402871缬沙坦胶囊山东新华制药股份有限公司国药准字H202563912025年12月22日73CYHS2402953维生素B₆注射液江西泰吉立生物医药科技有限公司国药准字H202563812025年12月22日74CYHS2403034硫酸特布他林吸入溶液山东达因金控儿童制药有限公司国药准字H202563922025年12月22日75CYHS2403105非布司他片河北万岁药业有限公司国药准字H202563992025年12月22日76CYHS2403106非布司他片河北万岁药业有限公司国药准字H202564002025年12月22日77CYHS2403143盐酸乙哌立松片江苏吴中医药集团有限公司苏州制药厂国药准字H202563822025年12月22日78CYHS2403331苯磺酸左氨氯地平片江苏万高药业股份有限公司国药准字H202563832025年12月22日79CYHS2500465富马酸喹硫平缓释片国药集团工业有限公司国药准字H202563522025年12月22日80JTH2500186精氨酸培哚普利片上海博志研新药物研究有限公司————2025年12月23日81JTH2500187利托那韦片上海迪赛诺医药集团股份有限公司————2025年12月23日82JXHS2300040维生素K₁滴剂广西铭磊维生制药有限公司国药准字HJ202501482025年12月22日83JXHS2400044二十碳五烯酸乙酯软胶囊（Ⅱ）丸红制药（苏州）有限公司国药准字HJ202501502025年12月22日84JXHS2400075依普隆特生钠注射液阿斯利康全球研发（中国）有限公司国药准字HJ202501512025年12月22日85JXHS2400076甲磺酸兰泽替尼片西安杨森制药有限公司国药准字HJ202500922025年12月22日86JXHS2400117肾上腺素鼻喷雾剂祐儿医药科技（上海）有限公司国药准字HJ202501522025年12月22日87JXHS2500009呫诺美林曲司氯铵胶囊（I）再鼎医药（上海）有限公司国药准字HJ202501532025年12月22日88JXHS2500010呫诺美林曲司氯铵胶囊（II）再鼎医药（上海）有限公司国药准字HJ202501542025年12月22日89JXHS2500011呫诺美林曲司氯铵胶囊（III）再鼎医药（上海）有限公司国药准字HJ202501552025年12月22日90JXSS2400073帕西生长激素注射液诺和诺德（中国）制药有限公司国药准字SJ202500302025年12月22日91JXSS2400074帕西生长激素注射液诺和诺德（中国）制药有限公司国药准字SJ202500312025年12月22日92JXSS2400075/JXSS2400077/JXSS2400084埃万妥单抗注射液（皮下注射）西安杨森制药有限公司国药准字SJ202500282025年12月22日93JXSS2400076/JXSS2400078/JXSS2400085埃万妥单抗注射液（皮下注射）西安杨森制药有限公司国药准字SJ202500292025年12月22日94JXSS2500039本瑞利珠单抗注射液阿斯利康投资（中国）有限公司国药准字SJ202500072025年12月22日95JXSS2500040本瑞利珠单抗注射液阿斯利康投资（中国）有限公司国药准字SJ202400402025年12月22日96JXSS2500041注射用德曲妥珠单抗第一三共（中国）投资有限公司国药准字SJ202300052025年12月22日97JYHS2400015泊沙康唑口服混悬液深圳市贝美药业有限公司国药准字HJ202501492025年12月22日98JYSB2400233比奇珠单抗注射液优时比贸易（上海）有限公司————2025年12月22日99JYSB2400234比奇珠单抗注射液优时比贸易（上海）有限公司————2025年12月22日100CYHB2550055盐酸利多卡因注射液山东益健药业有限公司————2025年12月22日