Canakinumab

2025年6月5日，美国旧金山和中国苏州——信达生物制药集团（香港联交所股票代码：01801），一家致力于研发、生产和销售肿瘤、自身免疫、代谢、眼科等重大疾病领域创新药物的生物制药公司，宣布其全球首创PD-1/IL-2α-bias双特异性抗体融合蛋白IBI363已被中国国家药品监督管理局（NMPA）药品审评中心（CDE）纳入突破性治疗药物（BTD）品种名单，拟定适应症为经含铂化疗及抗PD - 1/PD - L1免疫治疗失败的局部晚期或转移性鳞状非小细胞肺癌。截至目前，IBI363在鳞状非小细胞肺癌和黑色素瘤的两项适应症已经分别获得中国CDE的BTD认证和美国FDA快速通道资格（FTD）认定，此次BTD标志着IBI363在解决免疫耐药及冷肿瘤治疗难题中再前进一步。IBI363在既往接受过免疫治疗的鳞状非小细胞肺癌受试者的临床I期研究最新数据在2025年ASCO大会上以口头形式报告。在免疫治疗耐药的鳞状非小细胞肺癌和野生型肺腺癌中，都观察到了可控的安全性、令人鼓舞的疗效和长期生存获益，有望为免疫耐药患者提供新的治疗希望。在今年ASCO会议上，IBI363口头报告了在免疫耐药非小细胞肺癌、结直肠癌、黑色素瘤三项免疫耐药及冷肿瘤中的突破性临床研究结果，并获得广泛关注。信达生物制药集团高级副总裁周辉博士表示：“IBI363引领着下一代免疫治疗的进化方向——通过‘PD-1靶向+IL-2激活扩增肿瘤特异性T细胞’的免疫检查点阻断+细胞因子激动双重作用，提升T细胞功能的同时扩增T细胞数量，重塑肿瘤免疫微环境。IBI363在近期接连获得多项FTD和BTD，标志着监管机构认可其针对未满足需求的临床价值。我们正在加速推进IBI363的多瘤种的全球开发，其中头对头帕博利珠单抗的首个注册临床研究在粘膜及肢端型黑色素瘤已启动，公司还将与监管沟通IBI363在肺癌和结直肠癌的注册临床研究方案，以创新疗法开启肿瘤免疫治疗新篇章。”突破性治疗药物资格认定是为了加快开发针对严重疾病、且已在初步临床试验中显示疗效或安全性方面显著优于现有治疗手段的新药而设计的。获得突破性治疗药物认定能够使该药在研发过程中与CDE密切交流、获得指导，从而加快新药上市，更早解决中国病患未满足的临床需求。关于鳞状非小细胞肺癌- 滑动查看更多介绍 -肺癌是全球及中国发病率和死亡率最高的恶性肿瘤1，是危害公共健康的重大问题。尽管免疫治疗已经彻底改变了非小细胞肺癌的治疗格局，但对于免疫治疗失败且无驱动基因突变的非小细胞肺癌患者，目前仍缺乏有效的治疗手段。标准治疗方案多西他赛疗效有限，ORR不到20%，PFS不到4个月，OS不到12个月2-7。近年来，虽然免疫联合治疗、抗体偶联药物（Antibody-drug conjugates，ADCs）等新型治疗方案的探索带来了新的希望，但多项针对含铂化疗及免疫治疗失败的非小细胞肺癌人群的大型III期临床研究均未获得令人满意的结果，其中多数研究未达到主要终点2-6。TROPION-Lung01研究虽然在NSCLC中达到PFS主要终点（未达到OS主要终点），但在鳞状非小细胞肺癌中，试验组的PFS/OS/ORR均未见提升7。因此，在免疫治疗失败的鳞状非小细胞肺癌中，存在巨大且迫切的未满足的临床需求。关于IBI363（PD-1/IL-2α-bias双特异性融合蛋白）- 滑动查看更多介绍 -IBI363是由信达生物自主研发的全球首创PD-1/IL-2α-bias双特异性融合蛋白，同时具有阻断PD-1/PD-L1通路和激活IL-2通路两项功能。IBI363的IL-2臂经过了设计改造，保留了其对IL-2 Rα的亲和力，但削弱了对IL-2Rβ和IL-2Rγ的结合能力，以此降低毒性；而PD-1结合臂可以同时实现对PD-1的阻断和IL-2的选择性递送。由于新激活的肿瘤特异性T细胞同时表达PD-1和IL-2α，这一差异性策略可以更精确和有效地实现对该T细胞亚群的靶向和激活。IBI363不仅在多种荷瘤药理学模型中展现出了良好抗肿瘤活性，在PD-1耐药和转移模型中也表现出了突出的抑瘤效力。在今年ASCO会议上，IBI363口头报告了在免疫耐药非小细胞肺癌、结直肠癌、黑色素瘤三项免疫耐药及冷肿瘤中的突破性临床研究结果，并获得广泛关注。从临床迫切需求出发，信达生物正在中国、美国、澳大利亚开展临床研究探索IBI363在针对各种恶性肿瘤的有效性和安全性。IBI363已开出首个关键注册临床研究，用于治疗未经免疫治疗的粘膜型和肢端型黑色素瘤。IBI363已获美国FDA两项快速通道资格认定，分别用于治疗晚期鳞状非小细胞肺癌和黑色素瘤。IBI363也获得中国NMPA纳入两项突破性疗法认证，治疗晚期黑色素瘤和鳞状非小细胞肺癌。关于信达生物- 滑动查看更多介绍 -“始于信，达于行”，开发出老百姓用得起的高质量生物药，是信达生物的使命和目标。信达生物成立于2011年，致力于研发、生产和销售肿瘤、自身免疫、代谢、眼科等重大疾病领域的创新药物，让我们的工作惠及更多的生命。公司已有15个产品获得批准上市，它们分别是信迪利单抗注射液（达伯舒®），贝伐珠单抗注射液（达攸同®），阿达木单抗注射液（苏立信®），利妥昔单抗注射液（达伯华®），佩米替尼片（达伯坦®），奥雷巴替尼片（耐立克®）， 雷莫西尤单抗注射液（希冉择®），塞普替尼胶囊（睿妥®），伊基奥仑赛注射液（福可苏®），托莱西单抗注射液（信必乐®），氟泽雷塞片（达伯特®），匹妥布替尼片(捷帕力®)，己二酸他雷替尼胶囊（达伯乐®），利厄替尼片（奥壹新®）和替妥尤单抗N01注射液（信必敏®）。目前，同时还有3个品种在NMPA审评中，4个新药分子进入III期或关键性临床研究，另外还有15个新药品种已进入临床研究。公司已与礼来、罗氏、赛诺菲、Incyte和MD Anderson 癌症中心等国际合作方达成30多项战略合作。信达生物在不断自研创新药物、谋求自身发展的同时，秉承经济建设以人民为中心的发展思想。多年来，始终心怀科学善念，坚守“以患者为中心”，心系患者并关注患者家庭，积极履行社会责任。公司陆续发起、参与了多项药品公益援助项目，让越来越多的患者能够得益于生命科学的进步，买得到、用得起高质量的生物药。截至目前，信达生物患者援助项目已惠及20余万普通患者，药物捐赠总价值36亿元人民币。信达生物希望和大家一起努力，提高中国生物制药产业的发展水平，以满足百姓用药可及性和人民对生命健康美好愿望的追求。   详情请访问公司网站：www.innoventbio.com或公司领英账号：Innovent Biologics。声明：1.信达不推荐任何未获批的药品/适应症使用。2.雷莫西尤单抗注射液（希冉择®），塞普替尼胶囊（睿妥®）和匹妥布替尼片（捷帕力®）由礼来公司研发。前瞻性声明本新闻稿所发布的信息中可能会包含某些前瞻性表述。这些表述本质上具有相当风险和不确定性。在使用“预期”、“相信”、“预测”、“期望”、“打算”及其他类似词语进行表述时，凡与本公司有关的，均属于前瞻性表述。本公司并无义务不断地更新这些预测性陈述。这些前瞻性表述是基于本公司管理层在做出表述时对未来事务的现有看法、假设、期望、估计、预测和理解。这些表述并非对未来发展的保证，会受到风险、不确性及其他因素的影响，有些是超出本公司的控制范围，难以预计。因此，受我们的业务、竞争环境、政治、经济、法律和社会情况的未来变化及发展的影响，实际结果可能会与前瞻性表述所含资料有较大差别。本公司、本公司董事及雇员代理概不承担 (a) 更正或更新本网站所载前瞻性表述的任何义务;及 (b) 若因任何前瞻性表述不能实现或变成不正确而引致的任何责任。参考文献：[1] Globocan 2022 (version 1.1) - 08.02.2024[2] Paz-Ares LG, Juan-Vidal O, Mountzios GS, et al. Sacituzumab Govitecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer: The Randomized, Open-Label Phase III EVOKE-01 Study. J Clin Oncol. Aug 20 2024;42(24):2860-2872. doi:10.1200/JCO.24.00733[3] Neal J, Pavlakis N, Kim SW, et al. CONTACT-01: A Randomized Phase III Trial of Atezolizumab + Cabozantinib Versus Docetaxel for Metastatic Non-Small Cell Lung Cancer After a Checkpoint Inhibitor and Chemotherapy. J Clin Oncol. Jul 10 2024;42(20):2393-2403. doi:10.1200/JCO.23.02166[4] SAFFRON-301: Tislelizumab plus sitravatinib in advanced/metastatic NSCLC progressing on/after chemotherapy and anti–PD-(L)1. WCLC 2024.[5] 65O - Phase 3 LEAP-008 study of lenvatinib plus pembrolizumab versus docetaxel for metastatic non-small cell lung cancer (NSCLC) that progressed on a PD-(L)1 inhibitor and platinum-containing chemotherapy. ESMO IO 2023.[6] Canakinumab in combination with docetaxel compared with docetaxel alone for the treatment of advanced non-small cell lung cancer following platinum-based doublet chemotherapy and immunotherapy (CANOPY-2): A multicenter, randomized, double-blind, phase 3 trial. Lung Cancer . 2024 Mar:189:107451. doi: 10.1016/j.lungcan.2023.107451. Epub 2024 Jan 16.[7] Ahn MJ, Tanaka K, Paz-Ares L, et al. Datopotamab Deruxtecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer: The Randomized, Open-Label Phase III TROPION-Lung01 Study. J Clin Oncol. Sep 9 2024:JCO2401544. doi:10.1200/JCO-24-01544

SAN FRANCISCO and SUZHOU, China, June 3, 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, autoimmune, cardiovascular and metabolic, ophthalmology and other major diseases, announced the third oral presentation of clinical data for IBI363 (first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein) in advanced non-small cell lung cancer at the 2025 American Society of Clinical Oncology (ASCO), following IBI363's other two oral presentations in colorectal cancer and melanoma. A manageable safety profile, encouraging efficacy, and trends in long-term survival benefits have been observed in both immunotherapy-resistant squamous non-small cell lung cancer (NSCLC) and wild-type lung adenocarcinoma. It is worth mentioning that Innovent's pipeline has a total of 8 oral presentations at this ASCO conference, representing approximately 2% of the conference's total oral presentations. Innovent Biologics is conducting clinical studies in China, the United States, and Australia to explore the efficacy and safety of IBI363 for multiple tumor indications, including immune resistance, cold tumors, and front-line treatments. At this year's ASCO meeting, three oral presentations of IBI363 reported encouraging Phase 1/2 clinical data in the first three indications explored—NSCLC, CRC, and melanoma—focusing on IO-resistant and cold tumors. The data comprehensively demonstrated the breakthrough clinical outcomes of IBI363 across these indications, from robust tumor response to long-term survival benefits. These findings provide strong support of the drug's novel mechanism of action translating effectively into clinical outcomes, and imply its potential for broader clinical development, offering new hope in areas of immunotherapy where treatment options remain limited. PD-1/IL-2α-bias bispecific antibody fusion protein IBI363 in patients with immunotherapy resistant advanced non-small cell lung cancer: results from a Phase 1 study Updated data on IBI363 monotherapy in patients with advanced NSCLC were reported (ClinicalTrials.gov, NCT05460767). As of the data cutoff date, April 7, 2025, a total of 136 patients with NSCLC had received IBI363 monotherapy (2 μg/kg QW~4mg/kg Q3W), including 67 with squamous cell carcinoma and 58 with EGFR wild-type adenocarcinoma. IBI363 showed breakthrough therapeutic potential from tumor response to long-term survival benefit in immuno-resistant squamous NSCLC All 67 squamous NSCLC patients were EGFR wild type. Among them, 28 patients received IBI363 at 1 mg/kg Q2W or 1.5 mg/kg Q3W, and 31 patients received IBI363 at 3 mg/kg Q3W. In the two groups of patients, the proportion of ≥2 lines of previous systemic therapy was 64.3% (18/28) vs 67.7% (21/31), the proportion of previous anti-PD-1/PD-L1 therapy was 100% (28/28) vs 96.8% (30/31) and the proportion of PD-L1 TPS<1% was 35.7% (10/28) vs 41.9% (13/31). In the 1/1.5 mg/kg dose group, promising ORR/DCR/PFS/OS were observed. Median OS achieved 15.3 months, suggesting the potential long-term survival benefit of IBI363 as a PD-1/IL-2α-bias bispecific immunotherapy. Compared with the 1/1.5 mg/kg dose group, the 3 mg/kg Q3W dose group observed more prominent confirmed ORR (36.7%), DCR (90.0%), PFS (median PFS 9.3 months) and OS trends (median OS not reached, 12-month OS rate 70.9%) (see the table below). Among the patients with PD-L1 TPS<1%, IBI363 demonstrated outstanding efficacy signals: in the 1/1.5 mg/kg group (N=10), the confirmed ORR was 30.0% and the DCR was 90.0%, while that of the 3 mg/kg group (N=13) were 46.2% and 92.3%, suggesting the potential advantage of IBI363 in the population with low expression of PD-L1. IBI363 showed potential for long-term survival benefits in immuno-resistant wild-type lung adenocarcinoma, especially in patients with smoking history Among the 58 patients with EGFR wild-type lung adenocarcinoma, 30 patients received IBI363 at 0.6 mg/kg Q2W or 1 mg/kg Q2W or 1.5 mg/kg Q3W, 25 patients received IBI363 at 3 mg/kg Q3W. In the two groups of patients, the proportions of ≥2 lines of previous systemic therapy were 80.0% (24/30) vs 64.0% (16/25), the proportions of previous anti-PD-1/PD-L1 therapy were both 100%, the proportions of PD-L1 TPS<1% were 26.7% (8/30) vs 40.0% (10/25) and the proportions of smoking history were 56.7% (17/30) vs 60.0% (15/25). In the 1/1.5 mg/kg dose group, median OS achieved 17.5 months, suggesting the potential long-term survival benefit of IBI363 as a PD-1/IL-2α-bias bispecific immunotherapy. Compared with the 0.6/1/1.5 mg/kg dose group, the 3 mg/kg dose group observed higher confirmed ORR (24.0%), DCR (76.0%), PFS (median PFS 5.6 months) and OS trends (median OS not reached, 12-month OS rate 71.6%) (see the table below). Higher ORR and PFS were observed in lung adenocarcinoma patients with a history of smoking. Among them, the confirmed ORR in the 0.6/1/1.5 mg/kg group (N=17) was 23.5%, and the confirmed ORR in the 3 mg/kg group (N=15) was 33.3%. In all dose groups (N=32), the median PFS of smokers was longer than non-smokers: 5.3 (2.0, 7.0) vs 3.0 (1.6, 5.1) months. In terms of long-term survival benefits, after follow-ups of 12.0 and 13.7 months, the median OS for non-smokers was 13.6 months, whereas the median OS for smokers was not yet reached, with only 9 (28.1%) events occurring. IBI363 had a manageable safety profile in advanced NSCLC Among the 57 patients with NSCLC in the 3 mg/kg dose group, the most common treatment related adverse events (TRAEs) of grade 3 or above were arthralgia and rash. 7.0% of patients experienced TRAEs leading to discontinuation. The overall safety profile was manageable. In view of the encouraging efficacy signals and manageable safety demonstrated by IBI363 monotherapy, Innovent plans to conduct a Phase 3 registration clinical study in locally advanced or metastatic squamous NSCLC that has failed platinum-based chemotherapy and anti-PD-1 /PD-L1 immunotherapy. As of now, IBI363 has received Breakthrough Therapy (BTD) certification from China CDE and Fast Track Designation (FTD) from the US FDA for squamous NSCLC. Professor Jianya Zhou, The First Affiliated Hospital, School of Medicine, Zhejiang University, stated: "Lung cancer is the malignant tumor with the highest incidence and mortality rate both globally and in China[1], and it is a major issue endangering public health. Although immunotherapy has completely transformed the treatment landscape of NSCLC, for patients with wild-type NSCLC who have failed immunotherapy, the current standard treatment regimen docetaxel has limited efficacy, with an ORR of less than 20%, a PFS of less than 4 months, and an OS of less than 12 months [2-7]. In recent years, although the exploration of new treatment regimens such as immune combination therapy and antibody drug conjugates (ADCs) has brought new hope, many large-scale Phase 3 clinical studies on NSCLC patients who have failed platinum-based chemotherapy and immunotherapy have not achieved satisfactory results, and most of these studies have not met the primary endpoints[2-6]. Although the TROPION-Lung01 study achieved the primary endpoint of PFS in NSCLC, it did not reach the primary endpoint of OS. Especially in squamous NSCLC, no improvement was observed in PFS/OS/ORR in the experimental group. Therefore, there was a huge and urgent unmet medical need in NSCLC that has failed immunotherapy. As a PD-1/IL-2α-bias bispecific molecule, IBI363 not only shows clinical benefits in both ORR and PFS in immune-resistant NSCLC, but also enables us to see the potential of the tailing effect of immunotherapy to bring long-term survival benefits to patients compared with chemotherapy. We are also more looking forward to the survival data of the long-term follow up in the high dose IBI363 group." Dr. Hui Zhou, Senior Vice President of Innovent, stated: "It is a great pleasure to orally present the latest progress of IBI363 in the field of lung cancer at the ASCO conference. IBI363 shows remarkable efficacy in immune-resistant wild-type nsclc and clinical data suggests better trends in ORR, DCR, PFS and OS at higher doses. We expect longer-term follow-up to bring more mature data and look forward to seeing its potential as an immunotherapy for the long-term survival benefits of patients. Meanwhile, regardless of the expression level of PD-L1, IBI363 has demonstrated a powerful anti-tumor effect in immune-resistant NSCLC (especially squamous NSCLC), suggesting that the effect of IBI363 does not depend on the expression of PD-L1. In the future, it may also bring breakthroughs in cold tumors with low or no expression of PD-L1. We will continue to advance the clinical exploration of IBI363 in NSCLC and other tumor types." About IBI363 (First-in-class PD-1/IL-2α-bias bispecific antibody fusion protein) IBI363 is a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein independently developed by Innovent Biologics. It functions by both blocking the PD-1/PD-L1 pathway and activating the IL-2 pathway. The IL-2 arm of IBI363 is designed to maintain its affinity for IL-2Rα while reducing binding to IL-2Rβ and IL-2Rγ, thereby minimizing toxicity. The PD-1 binding arm not only blocks PD-1 but also selectively delivers IL-2. This approach targets and activates tumor-specific T cells that express both PD-1 and IL-2α, leading to more precise and effective activation of this T cell subpopulation. IBI363 has demonstrated robust antitumor activity in various tumor-bearing pharmacological models, but also showed outstanding efficacy in PD-1 resistance and metastasis models. In response to urgent clinical needs, Innovent is conducting clinical studies in China, the United States and Australia to further explore the efficacy and safety of IBI363 in various tumor indications, including immune-resistant, cold tumors, and front-line treatments. The first pivotal trial of IBI363 was initiated in 2025 for unresectable locally advanced or metastatic mucosal or acral melanoma who have not received prior systemic therapy. IBI363 has received two fast track designations (FTD) from the U.S. FDA and two breakthrough designations (BTD) from the China NMPA, for the treatment of squamous non-small cell lung cancer and melanoma, respectively. 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 15 products in the market. It has 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, 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. 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. Innovent, the Directors and the employees of Innovent 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 materialize or turn out to be incorrect. References [1] Globocan 2022 (version 1.1) - 08.02.2024 [2] Paz-Ares LG, Juan-Vidal O, Mountzios GS, et al. Sacituzumab Govitecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer: The Randomized, Open-Label Phase III EVOKE-01 Study. J Clin Oncol. Aug 20 2024;42(24):2860-2872. doi:10.1200/JCO.24.00733 [3] Neal J, Pavlakis N, Kim SW, et al. CONTACT-01: A Randomized Phase III Trial of Atezolizumab + Cabozantinib Versus Docetaxel for Metastatic Non-Small Cell Lung Cancer After a Checkpoint Inhibitor and Chemotherapy. J Clin Oncol. Jul 10 2024;42(20):2393-2403. doi:10.1200/JCO.23.02166 [4] SAFFRON-301: Tislelizumab plus sitravatinib in advanced/metastatic NSCLC progressing on/after chemotherapy and anti–PD-(L)1. WCLC 2024. [5] 65O - Phase 3 LEAP-008 study of lenvatinib plus pembrolizumab versus docetaxel for metastatic non-small cell lung cancer (NSCLC) that progressed on a PD-(L)1 inhibitor and platinum-containing chemotherapy. ESMO IO 2023. [6] Canakinumab in combination with docetaxel compared with docetaxel alone for the treatment of advanced non-small cell lung cancer following platinum-based doublet chemotherapy and immunotherapy (CANOPY-2): A multicenter, randomized, double-blind, phase 3 trial. Lung Cancer . 2024 Mar:189:107451. doi: 10.1016/j.lungcan.2023.107451. Epub 2024 Jan 16. [7] Ahn MJ, Tanaka K, Paz-Ares L, et al. Datopotamab Deruxtecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer: The Randomized, Open-Label Phase III TROPION-Lung01 Study. J Clin Oncol. Sep 9 2024:JCO2401544. doi:10.1200/JCO-24-01544 SOURCE Innovent Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED