Sintilimab

Oct. 26, 2026 -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, today announced that a New Indication Application for sintilimab in combination with Nolgileucel injection (GC101) has been accepted for review by the China National Medical Products Administration (NMPA). The application is proposed to be sintilimab in combination with Nolgileucel Injection (GC101) for the treatment of patients with unresectable or metastatic melanoma whose disease has progressed following at least two lines of prior systemic therapy, including PD-1 antibody therapy. This would be the 11th indication for sintilimab, further consolidating its position as a cornerstone therapy in immuno-oncology (IO). The new indication application is primarily based on the results of the pivotal Phase II clinical study MIZAR-003. MIZAR-003 (NCT04943913) is a pivotal Phase II, multicenter, randomized, open-label, parallel-controlled study designed to evaluate the efficacy and safety of GC101 TIL cell injection with sintilimab support in melanoma patients who have failed or are intolerant to anti-PD-1 antibody therapy. The study results were first presented as an oral Late-Breaking Abstract (LBA 9509) at the 2026 ASCO Annual Meeting in June 2026. As of the data cutoff date of May 12, 2026, the primary endpoint was met. In patients with advanced melanoma who had failed prior anti-PD-1 antibody therapy and had received a median of 2 prior lines of systemic therapy, the median progression-free survival (mPFS) in the experimental arm reached 4.3 months, significantly superior to 1.6 months in the chemotherapy control arm, with a 57% reduction in the risk of disease progression or death (HR=0.43, 95% CI: 0.26–0.68; P=0.0002). Meanwhile, adverse reactions in the experimental arm were manageable. Grade ≥3 adverse reactions were mainly preconditioning-induced hematologic toxicity, and the median AE duration was comparable and rapidly reversible in experimental arm (8 days vs 13 days); most patients recovered without additional intervention. "Treatment options are very limited for patients with advanced, treatment-resistant melanoma," said Professor Guo Jun, Vice President of Peking University Cancer Hospital, Director of the Department of Melanoma and Sarcoma Medical Oncology, and Director of the Department of Urologic Oncology. "For patients whose disease continues to progress after prior PD-1 antibody therapy and multiple lines of systemic treatment, subsequent treatment presents significant challenges, and there is an urgent clinical need for more effective treatment options. The MIZAR-003 study demonstrated positive antitumor activity and a favorable safety profile in this patient population, offering a new treatment option for patients with unresectable or metastatic melanoma who have experienced disease progression following at least two prior systemic therapies, including an anti-PD-1 antibody. We look forward to sintilimab and Nolgileucel bringing further benefits to patients." "We are pleased that the 11th indication application for sintilimab has been accepted for review by the NMPA, with the potential to offer a more effective treatment option for patients with advanced melanoma in China," said Dr. Hui Zhou, Chief R&D Officer of Oncology at Innovent. "This acceptance further consolidates the position of sintilimab as a cornerstone therapy in immuno-oncology. It also marks another milestone for us in advancing the full life-cycle management of this product and continuously maximizing its clinical value." Sintilimab, marketed as TYVYT® (sintilimab injection) in China, is an innovative PD-1 inhibitor co-developed and commercialized by Innovent Biologics and Eli Lilly and Company. Sintilimab is a human immunoglobulin G4 (IgG4) monoclonal antibody that specifically binds to PD-1 molecules on the surface of T cells. By blocking the PD-1/programmed death-ligand 1 (PD-L1) pathway, which contributes to tumor immune tolerance, sintilimab reactivates the antitumor activity of lymphocytes to treat cancer.[i] GC101 was developed using the DeepTIL™ cell enrichment and expansion platform independently developed by Juncell Therapeutics. It is Juncell's most advanced tumor-infiltrating lymphocyte (TIL) therapy program and the world's first TIL therapy that does not require high-intensity lymphodepletion chemotherapy or IL-2 administration. The pivotal Phase II study of GC101 in malignant melanoma has met its primary endpoint, and GC101 has been included in the CSCO Guidelines for the Diagnosis and Treatment of Melanoma (2026 Edition). The study of GC101 for advanced NSCLC is in Phase II, while its use as adjuvant therapy following surgery for glioma is expected to enter a Phase II clinical study. 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 20 products in the market. It has 1 asset under NDA review, 5 assets in phase 3 or pivotal clinical trials, and 20 more molecules in early clinical stage. Innovent has entered into more than 30 strategic partnerships with global players such as Eli Lilly, Roche, Takeda, Pfizer, Sanofi, Incyte, and MD Anderson Cancer Center, representing an aggregate value of over RMB 350 billion. These efforts have set a benchmark for the high-quality outbound internationalization of China's innovative drug industry. 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. Statement: 1) Innovent does not recommend the use of any unapproved drug (s)/indication (s). 2) Ramucirumab (Cyramza®) and selpercatinib (Retsevmo®), pirtobrutinib (Jaypirca®) and abemaciclib (Verzenios®) were developed by Eli Lilly and Company. The content above comes from the network. if any infringement, please contact us to modify.

（医药健闻 2026年10月27日讯）信达生物制药集团宣布，信迪利单抗治疗晚期黑色素瘤的新增适应症上市申请已获中国国家药品监督管理局（NMPA）受理，联合诺吉仑赛注射液（GC101）用于既往接受过至少两种系统治疗（含PD-1抗体）失败的不可切除或转移性黑色素瘤患者。如成功获批，这将是信迪利单抗的第十一项适应症。 本次上市申请主要基于关键性II期临床研究MIZAR-003（NCT04943913）的结果。截至2026年5月12日，试验组中位无进展生存期（mPFS）达4.3个月，显著优于化疗对照组的1.6个月，疾病进展或死亡风险降低57%（HR=0.43，95% CI：0.26~0.68；P=0.0002）。 诺吉仑赛注射液（GC101）依托君赛生物DeepTIL™细胞富集扩增平台开发，是全球首款无需高强度清淋化疗、无需IL-2给药的TIL疗法。在《CSCO黑色素瘤诊疗指南（2026版）》中，诺吉仑赛已被纳入皮肤型、黏膜型及肢端型晚期黑色素瘤二线治疗的III级推荐。