Pembrolizumab

SUZHOU, China, June 11, 2026 /PRNewswire/ -- The clinical datasets presented at ASCO 2026 by CStone further validate the trispecific synergistic mechanism of CS2009 and support its potential to become a next-generation immuno-oncology (I/O) backbone therapy. I. Trispecific Design Rationale and Differentiated Advantages 1. Greater Potential for Long-Term Survival Benefit vs. PD-1+VEGF Combinations, with Low CTLA-4-Related Toxicity and Favorable Tolerability CS2009 was designed to restore T-cell effector function, remodel the tumor microenvironment (TME), and enhance T-cell priming via simultaneous targeting of PD-1, VEGF, and CTLA-4, aiming to generate deeper and more durable anti-tumor immune responses. Differentiated CTLA-4 Design: The CTLA-4 component is engineered to avoid excessive activation of peripheral CTLA-4 single-positive T cells, thereby reducing systemic immune toxicity. Combined with VEGF-mediated tumor enrichment, this design preserves the immune-stimulatory benefit of CTLA-4 blockade while substantially improving tolerability. Clinical data has demonstrated that CTLA-4-related toxicities with CS2009 are notably lower than that of conventional CTLA-4 antibody regimens, with immune-related adverse events (irAEs) approaching incidence typically seen with PD-1 monotherapy or PD-1-based bispecific antibodies. Advantage of Continuous Dosing: Unlike conventional CTLA-4 antibodies, which are often limited to two or three doses due to tolerability concerns, CS2009 can be administered continuously, therefore fully leveraging the CTLA-4 mechanism—not only initiating and enhancing existing anti-tumor T-cell responses but also continuously priming new T-cell clones against newly released tumor antigens throughout treatment. This ongoing expansion of the anti-tumor T-cell repertoire, combined with CS2009's favorable tolerability, is expected to drive more durable immune responses, prolong clinical benefit, and ultimately improve overall survival. Pharmacodynamic Validation: Dose-dependent upregulation in ICOS, a recognized pharmacodynamic marker of CTLA-4 pathway activation and T-cell activation, were observed. The ICOS elevation suggests that CS2009 continuously promotes T-cell priming and clonal expansion, validating the biological activity of its CTLA-4 module and providing biological basis for long-term anti-tumor activity. Industry challenge: Historically, most anti-VEGF plus PD-(L)1 regimens have primarily improved progression-free survival (PFS), while overall survival (OS) benefits remains highly uncertain. By incorporating a CTLA-4 mechanism, CS2009 aims to break through this limitation. 2. Low VEGF-Related Toxicity Supporting More Adequate Treatment Exposure and Sustained Clinical Benefit Pharmacodynamic data demonstrated: Circulating VEGF levels have declined continuously following dosing, and no clear rebound has been observed after up to 147 days of follow-up. This pattern differs from results reported with traditional anti-VEGF antibodies or PD-1/VEGF bispecifics, potentially due to CS2009's enrichment in the tumor microenvironment and CTLA-4-mediated internalization and clearance of VEGF-antibody complexes. This may reduce reflux of VEGF and its antibody-bound complexes into the peripheral circulation, thereby lowering VEGF-related systemic toxicities such as hypertension and proteinuria. Clinical data demonstrated: The incidence of Grade ≥3 VEGF-related treatment-related adverse events (TRAEs) is only 5.1%, notably lower than reported rates for certain VEGF-based bispecifics. Industry challenge: VEGF is both a critical efficacy driver and a major source of toxicity in combination therapies. Achieving an optimal balance between efficacy and tolerability, particularly in elderly and high-risk patients, remains a longstanding, unresolved challenge in the VEGF field. 3. Consistent Activity Observed Across Multiple " Cold " Tumors, Highlighting the Value of the CTLA-4 Module and the Trispecific Mechanism Promising anti-tumor activity has been observed in several traditionally immunotherapy-insensitive tumor types, including: Immunotherapy-resistant non-small cell lung cancer (NSCLC), pMMR/MSS metastatic colorectal cancer (mCRC), Soft tissue sarcoma (STS), Non-clear cell renal cell carcinoma (nccRCC). These findings suggest that the combined blockade of PD-1 and CTLA-4, together with VEGF modulation, may enhance T-cell priming, broaden T-cell clonal diversity, promote durable immune memory, and improve T-cell infiltration within the TME—extending immune responsiveness to tumors that were previously I/O-insensitive. The consistent efficacy signals across multiple cold tumors support the ability of CS2009's PD-1, CTLA-4 and VEGF synergism to reshape the immunosuppressive TME, expand the I/O-benefiting population, and demonstrate the potential to transcend the efficacy boundaries of traditional PD-1 inhibitors and PD-1/VEGF bispecifics. Industry challenge: Effective immunotherapy options remain limited for cold tumors. PD-1 plus CTLA-4 blockade is still one of the most widely recognized strategies for enhancing immunotherapy responsiveness. 4. Consistent Benefit Observed Across Squamous and Non-Squamous NSCLC Across multiple NSCLC treatment settings, comparable response rates were observed in both squamous and non-squamous patients. CS2009 is showing a trend of consistent benefit across histological subtypes, indicating that its mechanism may not depend on a particular pathologic type and may cover a broader population of NSCLC patients, enhancing the probability of success in future global registrational trials. Industry challenge: Notable differences in efficacy between squamous and non-squamous NSCLC often limit the label expansion and commercial potential of certain products. II. Favorable Safety Profile with Notably Lower VEGF-Related Toxicity Compared with Bispecifics Safety data from the ongoing Phase I study in a mixed tumor population (N=118): Grade ≥3 TRAE incidence: 24.6%; Grade ≥3 irAE incidence: 12.7%; Grade ≥3 VEGF-related TRAE incidence: 5.1%. Focusing on the later-line NSCLC cohort (n=57): Grade ≥3 TRAE rate: 19.3%; Grade ≥3 irAE rate: 12.3%; VEGF-related Grade ≥3 TRAE rate: 5.3%; Consistent with the safety profile of the overall heavily pretreated mixed-tumor population. Overall: CTLA-4-related toxicity appears very well controlled. No new or unexpected safety signals have been identified. The overall safety profile is comparable to that of PD-1/VEGF bispecific antibodies, while VEGF-related toxicity appears substantially lower. This safety profile provides an important foundation for long-term dosing and future global registrational development. III. Efficacy in "Cold" Tumors Demonstrates Differentiated Clinical Value CS2009 has demonstrated meaningful clinical activity across multiple "cold" tumors, highlighting the differentiated mechanism. 1. Monotherapy in Later-Line pMMR/MSS mCRC All enrolled patients had heavily pretreated, refractory CRC, including cases with BRAF mutations and right-sided tumors. CS2009 monotherapy achieved an ORR of 25% and a DCR of 87.5%. Given that ORR in later-line colorectal cancer are typically in the single digits, these results demonstrate clinically meaningful anti-tumor activity. More importantly, efficacy signals emerging in a typical cold-tumor population further supports the differentiated value of the CTLA-4 module. 2. Combination with XELOX in First-Line pMMR/MSS mCRC The study did not select patients by tumor sidedness, molecular subtype, or liver metastasis; the enrolled population better reflects real-world clinical practice. To date, all six patients have experienced tumor shrinkage, and three patients achieved a partial response (PR) at their first efficacy assessment. ORR was 66.7%, and DCR was 100%. Although the sample size remains small, highly consistent early efficacy signals have already been observed, providing positive support for subsequent global registrational development. The Company plans to expand the cohort to approximately 40 patients to generate a more comprehensive proof-of-concept (POC) dataset for upcoming discussions with the global regulatory authorities including the U.S. Food and Drug Administration (FDA) and China's National Medical Products Administration (NMPA) on a Phase III global registrational clinical trial. 3. Other "Cold" Tumors Monotherapy in Later-line Soft Tissue Sarcoma (STS): ORR 33.3%, DCR 66.7%; Monotherapy in Later-line non-clear cell renal cell carcinoma (nccRCC): ORR 33.3%, DCR 100%;. Durable responses have also been observed. Notably, the first patient enrolled in Phase I (an Australian female) has experienced sustained tumor shrinkage of more than 40% over 12 months. IV. NSCLC: Multi-Dimensional Data Support Global Registrational Development Dimension 1: Later-Line NSCLC Monotherapy (Pretreated with IO, Chemotherapy, ADCs, or Bispecifics) Overall ORR in the 30 mg/kg cohort: 24% (squamous 25%, non-squamous 23.1%, consistent benefit); DCR 60%; In second-line NSCLC (30 mg/kg, post IO + chemotherapy): ORR improved to 30.8%, DCR 84.6%. In such post-PD-(L)1 patient populations, standard-of-care ORRs are generally low, thus CS2009 has demonstrated competitive single-agent activity. Additional observations include: 6-month duration-of-response (DOR) rate exceeded 80% (i.e., more than 80% of responders remained in response at 6 months); Depth of response has continued to deepen over time; DOR data are still maturing. Dimension 2: Later-Line NSCLC in Combination with Docetaxel All six evaluable patients experienced tumor shrinkage, resulting in an ORR of 66.7% and a DCR of 100%. Although the sample size is currently small, these results are already very competitive within this class of studies. The company plans to expand the cohort to approximately 20 patients to inform subsequent registrational decisions. Dimension 3: First-Line NSCLC Monotherapy (PD-L1 TPS ≥ 50%) Among 16 patients, ORR was 81.3% and DCR was 100%; Squamous ORR 87.5%, non-squamous ORR 75%, consistent benefit; Earlier data (March 2026) showed 9 PRs out of 10 patients; among the 6 newly enrolled patients, 4 achieved a PR at their first tumor assessment, bringing the total number of PRs observed to 13; No responding patients have experienced rapid disease progression, and patients have shown deepening responses over time. While cross-trial comparisons have limitations, CS2009's single-agent ORR in first-line NSCLC (PD-L1 TPS ≥50%) has reached a best-in-class range among comparable studies globally, demonstrating highly competitive clinical potential. Note: Data in the PD-L1 1%–49% population continue to mature. Dimension 4: First-Line NSCLC in Combination with Chemotherapy (Squamous, PD-L1 Low or Negative) Among 8 squamous patients enrolled to date, 7 patients have PD-L1 ≤1% (low/negative), and 1 patient has PD-L1 ≤5% (low expression); median age is 70 years; ORR was 75% and DCR was 100%; among PD-L1-negative patients, ORR reached 100%; Particularly noteworthy: A 100% response rate was observed among PD-L1-negative patients; Encouraging efficacy was also observed in elderly patients. Although longer follow-up is required, positive and consistent early efficacy signals are evident. Note: Enrollment is ongoing in the first-line all-comer squamous NSCLC (Chemo Combo) and first-line non-squamous NSCLC (Chemo Combo) cohorts. Data will be disclosed subsequently. V. Global Registration Strategy CS2009 is advancing through a global multi-regional clinical development pathway. Rapid enrollment supports timely data package generation and regulatory engagement. Registrational studies will not be conducted in a single country; all key registrational studies will be global multi-regional clinical trials (MRCTs) using current international standard-of-care comparators (pembrolizumab / pembrolizumab + chemotherapy / bevacizumab + chemotherapy). The trial designs and timelines are independent of data readouts from other bispecific/trispecific competitors, giving CS2009 a self-determined development advantage. October 2026: Discuss the Phase III global registrational clinical trial protocol for first-line NSCLC + chemotherapy (vs. pembrolizumab + chemotherapy) . Q4 2026: Discuss the Phase III global registrational clinical trial protocol for first-line mCRC + chemotherapy (vs. bevacizumab + chemotherapy) . Early 2027: Discuss the Phase III global registrational clinical trial protocol for second-line NSCLC (CS2009 + docetaxel vs. docetaxel) and first-line NSCLC monotherapy (head-to-head vs. pembrolizumab) . 20–60 patients of POC data are expected per indication. The company has already established a clinical, CMC (Chemistry, Manufacturing and Controls) and operational system that supports global development, laying the groundwork for subsequent global multi-center Phase III MRCTs . VI. Key Catalysts in 2026 Late August 2026: Interim results update featuring more mature post-ASCO clinical data. Around October 2026: FDA discussion regarding the Phase III global registrational clinical trial protocol for first-line NSCLC + chemotherapy. Q4 2026: FDA discussion regarding Phase III global registrational clinical trial protocol for first-line CRC + chemotherapy. Q4 2026: ESMO Congress – clinical data updates for CRC, NSCLC, and other indications. End of 2026: Initiation of the first-wave global Phase III MRCTs. Importantly, all pivotal studies are benchmarked against current global standard-of-care comparators, without dependency on competitors' development progress. VII. Business Development Progress In-depth discussions are ongoing with multiple multinational pharmaceutical companies (MNCs). Key areas of partner interest include: trispecific antibody design rationale, safety profile, clinical data in NSCLC and CRC, global registration strategy. As data continue to mature and the global development advances, the differentiated value of CS2009 is gaining increasingly broad and strong recognition. VIII. Management Confidence and Capital Markets Initiatives 1. Share Purchases by Management and the Board: Management and the Board believe that the recent share price volatility has significantly deviated from the Company's fundamental progress. Management and Board members have expressed their confidence in the long-term value of CS2009 and the Company's growth prospects by increasing their shareholdings. 2. Anticipated inclusion in the Hong Kong Stock Connect Scheme Management expressed a positive expectation that the Company will be included in the Stock Connect scheme at the September 2026 adjustment window. IX. Key Takeaway The ASCO 2026 data mark CS2009's transition from mechanism validation to the clinical proof-of-concept (POC) stage. Its differentiated trispecific design not only delivers an excellent safety profile, but also consistently generates clinically meaningful efficacy signals and durable responses across a range of traditional I/O-cold tumors and lung cancer populations. As the key CRC and NSCLC programs move toward global registrational development, CS2009 is steadily emerging as a next-generation I/O backbone agent with significant potential. About CStone CStone (HKEX: 2616), established in late 2015, is an innovation-driven biopharmaceutical company focused on the research and development of therapies for oncology, immunology, inflammation, and other key disease areas. Dedicated to addressing patients' unmet medical needs in China and globally, the Company has made significant strides since its inception. To date, the Company has successfully launched 4 innovative drugs and secured approvals for 21 new drug applications covering 9 indications. The company's pipeline is balanced by 16 promising candidates, featuring antibody-drug conjugates (ADCs), multispecific antibodies, immunotherapies and precision medicines. CStone also prides itself on a management team with comprehensive experiences and capabilities that span the entire drug development spectrum, from preclinical and translational research to clinical development, drug manufacturing, business development, and commercialization. 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康方生物(9926.HK)欣然宣布，公司独立自主研发的靶向IL-17的单克隆抗体奇佑康®(古莫奇单抗，AK111)，已获得国家药品监督管理局(NMPA)批准上市，用于中重度斑块状银屑病成人患者的治疗。 本次古莫奇单抗获批治疗中重度斑块状银屑病，基于1项关键Ⅲ期临床研究(AK111-301)和3项支持性研究。 古莫奇单抗快速强效、持久全清、安全便捷 12周快速强效：12周PASI75应答率为94.6%，皮损全清PASI100应答率为47.7%（相关同靶点药物为28.6%）； 52周持久全清：52周PASI75（长期疗效终点）应答率接近100%，皮损全清PASI100应答率为68.9%（相关同靶点药物为为39.2%）； 安全性良好：TEAE、SAE、感染及侵袭类疾病发生率在相关同靶点药物中最低； 使用便捷：每次一针，全年17支（相关同靶点药物为34支）。 古莫奇单抗关键注册性研究主要研究者、 复旦大学附属华山医院徐金华教授表示： 银屑病常伴患者终生，需要长期规范治疗。皮疹及伴随症状不仅严重降低生活质量，更给患者的工作、社交和心理带来沉重负担。深度清除、长期控制、依从性是真实世界临床中的三大难题，越来越多的患者渴望实现更彻底的皮损清除，对起效快、短期疗效显著、长期控制稳定且耐受性良好的药物需求十分迫切。 古莫奇单抗是一种靶向IL-17的IgG1单克隆抗体，能够精准靶向IL-17，强效阻断银屑病关键致病通路。充分的循证医学证据显示，古莫奇单抗能够更高程度地满足患者“皮损基本清除、长期稳定疗效、给药便捷”的核心治疗期待，且安全可耐受。作为临床医生，我们非常欣喜地见证古莫奇单抗的获批上市，为广大银屑病患者提供了更高效、更稳定、更安全便捷的创新治疗选择。 康方生物创始人、董事长、 总裁兼首席执行官夏瑜博士表示： 感谢所有推动古莫奇单抗临床研究的研究者、参与者以及参加临床研究的患者，在大家的共同付出和努力下，古莫奇单抗治疗中重度银屑病适应症获批上市，让670万患者迎来更为便捷、高效、安全的治疗新选择。 银屑病患者对提升综合治疗效果的期待尤为迫切。康方生物针对不同患者的临床需求，先后成功开发上市了依若奇单抗和古莫奇单抗，二者靶向不同致病通路，优势互补，针对银屑病差异化治疗需求形成的战略组合拳，更全面地满足临床差异化治疗需求。 自身免疫系统疾病领域是创新药领域规模最大、发展最快的领域之一，康方生物针对自免领域重点开发了一系列创新药物，其中依若奇单抗(IL-12/IL-23)和古莫奇单抗已先后获批上市，曼多奇单抗多项适应症处于临床开发后期阶段，全球首创的IL-4R/ST2双抗AK139等新靶点新机制药物针对多适应症的深度开发高效推进中，公司在自免领域产品疗法矩阵的产品协同效应和全球竞争力持续增强。这些创新药满足了广泛的临床需求，为更多元化的患者群体带来全新解决方案，为康方生物全球化发展增添强劲动能。 银屑病是一种遗传、环境协同作用的免疫介导的慢性复发性疾病，其中斑块状银屑病是最常见类型，约占80%。银屑病皮疹及伴随症状不仅显著降低生活质量，对工作、社交、心理的影响及治疗相关费用等也给患者造成了沉重疾病负担。尽早启动以生物制剂为代表的治疗，及早干预疾病进程，是目前银屑病患者的迫切需求。 除了针对中重度银屑病，古莫奇单抗治疗活动性强直性脊柱炎的新药上市申请(sNDA)，已获得国家药品监督管理局药品审评中心受理。 说明：本文作为康方生物的新闻发布，用于披露公司最新进展，并非产品推广广告，不构成康方生物的信息披露或投资建议。 关于奇佑康® （IL-17单抗，古莫奇单抗） 古莫奇单抗注射液是康方生物自主研发的新型人源化IL-17(白介素-17)自身免疫疾病治疗药物，主要用于治疗银屑病、强直性脊柱炎等自身免疫性疾病。 IL-17是一种主要由活化的Th17细胞(辅助性T细胞17)分泌的促炎性细胞因子，与细胞表面受体(IL-17R)结合后介导免疫炎症反应，在银屑病和强直性脊柱炎的发病机理中起着关键作用。古莫奇通过与IL-17 特异性结合以阻断IL-17与IL-17R介导的信号通路，抑制相关免疫炎症反应的发生与发展。 2026年6月，古莫奇单抗治疗中度至重度斑块状银屑病适应症获批上市，治疗活动性强直性脊柱炎的新药上市申请(sNDA)获得国家药品监督管理局药品审评中心受理中。 关于康方生物 康方生物(9926.HK)是一家集研究、开发、生产及商业化全球首创或同类最佳创新生物新药于一体的领先企业。自2012年成立以来，公司始终以患者为中心，以临床价值为导向，打造了独有的端对端康方全方位新药研究开发平台，建立了以Tetrabody双抗/多抗技术、Dual-Shield ADC、Dual-Lock TCE、Tissue-Smart siRNA、细胞治疗及Flex-Nano mRNA等技术为核心的研发创新体系，国际化标准的GMP生产体系和运作模式先进的商业化体系，成为了在全球范围内具有竞争力的生物医药创新公司。 公司已开发了50个以上用于治疗肿瘤、自身免疫、炎症、代谢疾病等重大疾病的创新候选药物，27个新药已进入临床(包括15个双抗/多抗/双抗ADC)，8个新药已在商业化销售，3个新药4个适应症的上市申请处于审评审批阶段。 康方生物是全球迄今唯一拥有2个肿瘤免疫双抗新药的制药公司： 2022年6月，公司全球首创的PD-1/CTLA-4双抗卡度尼利获批上市，是全球首个获批的肿瘤免疫治疗双抗新药，也是中国第一个双特异性抗体新药。目前卡度尼利一线治疗胃癌、一线治疗宫颈癌和治疗复发/转移性宫颈癌的适应症已获批，12个注册性/III期临床正在开展。 2024年5月，公司全球首创的PD-1/VEGF双抗新药依沃西获批上市，用于EGFR-TKI治疗进展的局部晚期或转移性nsq-NSCLC，成为全球首个获批的“肿瘤免疫+抗血管生成”机制双抗新药。同期，依沃西在与全球“药王”帕博利珠单抗的随机、双盲、对照一线治疗PD-L1阳性NSCLC的“头对头”III期临床研究中获得显著阳性结果，依沃西可降低患者疾病进展/死亡风险达49%，依沃西成为全球首个在头对头III期临床研究中证明疗效显著优于“药王”帕博利珠单抗的药物。基于该研究结果，依沃西该项适应症于2025年4月获批上市，成为一线肺癌治疗新的标准治疗方案，为患者提供全新更优的“去化疗”选择。目前依沃西有15项注册性/III期临床已开展/启动，包括5项国际多中心注册性III期临床研究。 2024年12月，卡度尼利和依沃西均通过医保谈判被纳入国家新版医保目录。2025年12月，除派安普利新获批的一线肝细胞癌适应症，康方生物5个自主商业化自研新药的其余全部获批适应症均已纳入国家医保目录。 此外，基于公司在肿瘤免疫双抗领域取得的全球领先优势，公司正全力推进IO2.0+ADC2.0全球战略，构建“跨代”式国际竞争优势。目前，公司自主研发的首个双抗ADC药物Trop2/Nectin4 ADC(AK146D1)、新一代Her3 ADC(AK138D1)联合卡度尼利和依沃西治疗实体瘤II期临床研究正在开展。此前，该组合疗法 I 期临床已获美国 FDA 和中国 NMPA 批准开展。后续一系列自研新一代ADC/双抗ADC也将相继进入临床开发阶段。这将助力公司产品组合在全球范围内建立“跨代”式的竞争战略优势。 国际市场开发是康方生物核心发展战略，继2015年开中国先河将自主研发的CTLA-4单抗权益许可给默沙东公司之后，2022年12月，公司再次创造中国纪录，以50亿美金+2位数百分比销售提成的方案，将依沃西部分海外权益许可给美国Summit公司，该合作创下了彼时中国新药对外许可的最高交易金额纪录。此外，派安普利单抗治疗鼻咽癌的两项适应症于2025年4月获得美国食品药品监督管理局(FDA)批准上市。 公司自身免疫相关疾病及中枢神经系统疾病治疗领域也已全面进入商业化发展阶段：伊努西单抗(PCSK9)治疗高胆固醇血症两项适应症获批销售；依若奇单抗(IL-12/IL-23)、古莫奇单抗(IL-17)治疗中重度斑块状银屑病成人患者适应症获批上市销售；此外，古莫奇单抗和曼多奇单抗(IL-4R)多项III期临床研究成功，正处于上市审评阶段。公司各领域产品协同效应和战略组合力进一步提升。 康方生物期望通过高效及突破性的研发创新，开发国际首创及同类药物最佳疗法的新药，为全球患者提供更优疾病解决方案，成为全球领先的生物制药企业。 往期推荐 数据发布 OS显著阳性，HR=0.66！依沃西联合化疗战胜PD-1联合化疗OS结果在ASCO盛大发布，一线治疗sq-NSCLC 产品动态 康方5个新药所有适应症全部谈判成功，纳入国家医保：2个首创双抗新增一线适应症及3个新药首次进医保 数据发布 HARMONi-A OS最终分析显示：依沃西达到OS临床终点，取得具有临床意义和统计学显著的OS获益 数据发布 HARMONi研究发布：PFS HR=0.52，OS HR=0.79，依沃西2L+ EGFRm NSCLC国际多中心III期 产品动态 卡度尼利获批第三项适应症：一线宫颈癌全人群 产品动态 依沃西一线治疗NSCLC获批上市(全球首个对比帕博利珠单抗获显著阳性结果的III期研究） 产品动态 派安普利2个适应症美国重磅上市！获FDA批准用于晚期鼻咽癌治疗 临床 进展 康方首个双抗ADC(Trop2/Nectin4 ADC)临床入组，“IO+ADC”2.0 迭代战略加速推进 临床 进展 康方非肿瘤领域首个双抗IL-4Rα/ST2(AK139)IND获受理，剑指呼吸系统及皮肤疾病领域 临床 进展 头对头度伐利尤单抗方案，依沃西方案一线治疗胆道肿瘤III期临床完成首例患者入组 临床 进展 全球首个CD47单抗实体瘤III期临床首例入组：依沃西联合莱法利一线治疗HNSCC（对比帕博利珠单抗） 数据发布 IGCS 2024 LBA & 《柳叶刀》主刊，卡度尼利1L宫颈癌III期研究PFS和OS双阳性结果重磅发布 产品动态 卡度尼利第二个适应症获批：一线胃癌全人群 数据发布 全球首个对比帕博利珠单抗取得显著阳性结果的随机对照大III期研究——依沃西HARMONi-2重磅研究成果在WCLC发表 临床 进展 卡度尼利联合方案治疗uHCC的III期临床研究完成首例患者入组 临床 进展 针对PD-1/L1治疗进展晚期胃癌，卡度尼利+普络西(VEGFR-2)联合疗法Ⅲ期临床完成首例入组 数据发布 ASCO Oral & JAMA主刊丨Ⅲ期HARMONi-A研究重磅公布，依沃西疗法有望改变EGFR-TKI进展肺癌全球治疗标准 临床 进展 国际多中心注册性III期研究HARMONi-3中国启动：依沃西单抗联合化疗对比帕博利珠单抗联合化疗1L治疗sq-NSCLC 产品动态 高达50亿美金！康方生物与Summit就PD-1/VEGF双抗依沃西达成合作和许可协议