Pembrolizumab

今天聚焦的医药产业核心事件包括：贝达药业聘任张杰博士任副总裁、强化全球临床开发；复宏汉霖与山德士至多10款生物类似药打包出海；北京发布CGT促进措施9项举措；湘雅二医院停采4家药企产品、医药代表管理办法首批院内处罚落地；英矽智能获纳入MSCI全球小盘股指数；石药创新上半年净利润12.61亿元同比扭亏为盈；寻明生科完成1亿美元B轮融资；凡恩世spevatamig获FDA快速通道资格、携手默沙东K药攻胆道癌一线；西比曼C-CAR039获FDA许可、双靶点CAR-T挺进美国临床；康希诺青少年及成人用百白破疫苗NDA获受理；博安生物BA1302完成Ia期临床、全球唯一临床阶段CD228 ADC；JW制药Efapemnurad全球III期痛风达终点等。 ◍市场速递政策 · 产业动态 8/17贝达药业聘任张杰博士任副总裁，20余年跨国药企肿瘤临床开发经验 8月17日，贝达药业聘任张杰博士为公司副总裁，负责医学策略制定及临床开发规划。张杰博士毕业于北京大学医学院，曾任职于美国MD安德森癌症中心及强生、阿斯利康、默沙东等全球领先药企，拥有20余年跨瘤种肿瘤新药研发和临床开发经验，深度参与20余款创新药物的全球开发与注册，曾领导埃万妥单抗皮下制剂关键注册研究并推动FDA优先审评。贝达董事长丁列明表示，其加盟将加快重点创新项目进程，支撑公司"五年再造"战略目标。 解读：顶级跨国药企医学领导者回流本土Biopharma，已是创新药人才流动的新常态。贝达引进的不只是一个人，而是埃万妥单抗这类全球重磅药从注册到上市的完整方法论。肿瘤药竞争进入"临床开发效率"阶段后，头部公司的比拼点从管线数量转向"能不能把III期做对、做快"，这类人才的稀缺性会持续凸显。 8/17复宏汉霖与山德士至多10款生物类似药打包出海，首批最高3.22亿美元 8月17日，复宏汉霖（02696.HK）宣布与全球仿制药巨头山德士（Sandoz）签订合作框架协议，双方将围绕至多10款单抗及ADC生物类似药建立战略合作。首批3款产品（西妥昔单抗HLX05-N、依洛尤单抗HLX16、贝利尤单抗生物类似药）已敲定条款，山德士将支付首付款、里程碑及选择权费共计最高3.22亿美元，2026年预计开票金额不超1.005亿美元。首批3款对应原药2025年全球销售额合计107.73亿美元。山德士称这是其"有史以来规模最大的生物类似药合作之一"。 解读：这不是单品授权，是"框架打包"——最多10款生物类似药一次性谈定，覆盖肿瘤、心血管、自免多领域。复宏汉霖用早期管线借船出海，山德士拿成熟商业化网络换管线储备，各取所需。生物类似药BD从"点状"走向"平台化"，说明中国生物药产能已具备批量输出能力。 8/16北京发布CGT促进措施9项举措，单项关键技术攻关择优支持不超500万 8月16日，北京市科委、中关村管委会发布《促进细胞与基因治疗领域高质量发展若干措施（征求意见稿）》，围绕创新、临床、平台、监管、产业五个维度推出9项举措。创新端对免疫细胞药物、干细胞药物、基因编辑等关键技术攻关按每项不超过500万元择优支持；临床端鼓励制剂制备与研究型病房建设。征求意见截至8月18日。这是继上海之后又一地方政府出台CGT专项支持政策。 解读：北京跟进上海出台CGT专项政策，500万单项支持金额不高，但信号意义大于资金意义——真正的价值在审批绿色通道、临床资源对接和产业生态集聚。CGT从"单点突破"走向"区域竞逐"，京沪双城争抢产业高地的格局正在形成。 8/15湘雅二医院停采4家药企产品，新版医药代表管理办法首批院内处罚落地 近日，中南大学湘雅二医院通报：艾力斯、康蒂尼、赛诺菲、安进四家药企的医药代表未经预约擅入诊疗区域，医院决定暂停采购伏美替尼、吡非尼酮、甘精胰岛素利司那肽、地舒单抗四款药品三个月，并将相关企业列入负面名单。这是新版《医药代表管理办法》发布后首批院内处罚落地案例。 解读：以前代表闯诊室顶多被保安赶走，现在直接连累公司被停采——从个人行为约束升级到企业经营后果，是这批处罚的信号意义。合规培训不再是走形式，一线代表的拜访行为管理必须落到实处。对药企而言，一款核心产品在某家三甲被停采三个月，不仅是收入损失，更是处方习惯断裂的隐性成本。 ◍资本信息行情 · 融资 · IPO 8/17英矽智能获纳入MSCI全球小盘股指数，8月31日收盘后生效 8月17日，英矽智能（03696.HK）发布港交所自愿公告，公司将获纳入MSCI全球小盘股指数，相关变更于8月31日收盘后生效。自2025年12月30日港交所主板上市以来，公司已获13家内外资头部机构覆盖（摩根士丹利、中金、瑞银、汇丰、摩根大通等），全部给予积极看好评级，目标价最高达100港元。此前公司已纳入中证港股通创新药、恒生综合、富时全球小盘股等系列指数；7月发布盈利预喜，预计上半年营收1.025至1.065亿美元。 解读：纳入MSCI指数的直接价值是打开被动资金通道——全球跟踪MSCI系列的机构资金将按指数权重被动买入，提升流动性与国际知名度。英矽智能上市半年已连入中证、恒生、富时、MSCI四大指数系列，配合盈利预喜的营收兑现，AI制药公司正在从"讲故事"切换到"被指数和机构用脚投票"的阶段。 8/17石药创新上半年净利润12.61亿元 8月17日，石药创新（300765.SZ）发布2026年半年度报告：实现营业收入32.4亿元，同比增长208.72%；归属于上市公司股东的净利润12.61亿元，同比扭亏为盈。分季度看，Q2净利润13.55亿元，Q1净利润-0.94亿元，据此计算Q2环比扭亏为盈。 解读：营收翻三倍叠加净利润扭亏为盈，石药创新（石药集团旗下A股创新药平台）半年报印证创新药管线商业化放量逻辑。Q1亏损0.94亿、Q2单季盈利13.55亿的剧烈落差，更多是收入确认与费用投放的季度节奏错配。对石药系而言，平台公司从"投入期"切换至"兑现期"，是比单款药物获批更重要的资本信号。 8/16寻明生科完成1亿美元B轮融资，AI驱动药物发现基础设施 8月16日，AI原生TechBio企业寻明生科宣布完成1亿美元B轮融资，由Granite Asia领投，弘晖基金跟投，启明创投、经纬创投、纽尔利资本等老股东追加。公司2023年成立于苏州，聚焦AI驱动的药物发现基础设施，累计融资规模接近2亿美元。本轮资金将投向新一代生物基座模型与"Lab-in-the-Loop"闭环实验体系。 解读：AI制药叙事降温的背景下，头部TechBio仍获大体量融资，反映资本向具备自有湿实验闭环与商业化营收的平台型企业集中。1亿美元B轮在当前融资环境中属稀缺量级，说明资本在AI制药赛道的筛选标准已从"故事+模型"升级为"闭环+营收"。 ◍医药动态国内获批 · 临床进展 8/17凡恩世spevatamig获FDA快速通道资格，携手默沙东K药攻胆道癌一线 8月17日，凡恩世生物宣布，美国FDA授予其spevatamig（PT886）治疗晚期及转移性胆道癌的快速通道资格，这是该药继2024年获CLDN18.2阳性胰腺癌快速通道后的第二个快速通道资格。spevatamig是靶向CLDN18.2/CD47的天然IgG结构双特异性抗体，属先天免疫增强剂（I2E）新机制。近期公司扩大与默沙东的临床合作，将评估spevatamig联合帕博利珠单抗在一线胆道癌中的疗效。 解读：同一靶点CLDN18.2，spevatamig选择"CD47双抗+PD-1联用"的差异化路径：CD47激活先天免疫、PD-1释放适应性免疫，主攻对免疫检查点抑制剂应答差的"冷肿瘤"。连拿两个FDA快速通道，叠加默沙东K药合作，说明中国双抗管线在"机制创新+国际大药企背书"两个维度都开始被认可。 8/17西比曼双靶点CAR-T C-CAR039获FDA IND许可，ORR 91.5%冲击美国临床 8月17日，西比曼生物宣布，其靶向CD20/CD19的双特异性CAR-T疗法C-CAR039（普龙基奥伦赛）用于治疗复发或难治性大B细胞淋巴瘤（LBCL）的IND申请已获美国FDA许可。2026年7月，公司重获该产品的全球开发、监管、生产、商业化及对外许可权益。中国早期临床数据显示：48例复发或难治性B细胞非霍奇金淋巴瘤患者ORR 91.5%、CR 85.1%，中位PFS达60.1个月。 解读：C-CAR039的看点不在"又一个CAR-T"，而在双靶点设计：同时靶向CD20/CD19，降低单靶点丢失导致的耐药复发。48例样本、中位PFS 60.1个月的数据质量，让西比曼在CAR-T赛道竞争白热化时仍拿到FDA入场券。重获全球权益后直接推进美国临床，说明公司想从license-out模式转向自主全球化开发。 8/16康希诺青少年及成人用Td5cp百白破疫苗NDA获受理，填补国内加强免疫空白 8月16日，康希诺生物（688185.SH/06185.HK）公告，其吸附无细胞百(五组分)白破联合疫苗（6岁及以上人群用，简称Td5cp）境内生产药品注册上市许可申请获国家药监局受理，受理号CXSS2600123，已纳入优先审评。该产品较已获批的婴幼儿用三组分疫苗额外增加FIM2、FIM3两种百日咳抗原，构成五组分。目前国内尚无获批的青少年及成人用百白破加强疫苗。 解读：国内百白破疫苗长期只有婴幼儿剂型，青少年及成人加强免疫是空白。主要发达国家已将成人百白破加强疫苗纳入常规接种计划。康希诺从婴幼儿DT3cP到青少年及成人Td5cp，构建全生命周期覆盖；若获批将打开一个全新的加强免疫增量市场。 8/14博安生物BA1302完成中国Ia期临床 8月14日，博安生物（06955.HK）公告，其自主研发的靶向CD228 ADC药物BA1302已完成中国I期临床单药剂量递增阶段（Ia期）。截至8月1日，7个剂量水平（0.2-3.6mg/kg）累计入组36例受试者，83.3%存在2处及以上器官转移。结果显示BA1302在三阴性乳腺癌、食管癌、黑色素瘤及宫颈癌中观察到部分缓解（PR），安全耐受性良好。BA1302是目前全球唯一处于临床阶段的靶向CD228 ADC，已获FDA准许在美开展临床并取得两项孤儿药资格认定。 解读：CD228在多种实体瘤中高表达、正常组织表达低，是理想ADC靶点。BA1302采用可裂解亲水性连接子偶联MMAE，在多线治疗失败的重度患者中仍展现单药活性。当然，后续临床价值能否得到验证，还需要更多数据来证明。 ◍海外药闻全球视野 · 跨境动态 8/17JW制药Efapemnurad全球III期痛风达终点，促尿酸排泄药50% vs 非布司他38.3% 8月17日，韩国JW Pharmaceutical公布其促尿酸排泄药Efapemnurad（选择性URAT1抑制剂）在全球III期痛风试验中达到主要终点：6mg组50.0%（76/152）患者血清尿酸降至6mg/dL以下，优于对照药非布司他40mg组的38.3%（59/154）。公司计划明年提交上市申请。 解读：现有痛风治疗以抑制尿酸生成为主（别嘌醇、非布司他），促尿酸排泄方向因历史肝毒性顾虑长期缺位。Efapemnurad以50%对38.3%的降尿酸达标率优于非布司他，若安全性经受验证，有望改变痛风用药格局——从"抑制生成"单一路径走向"抑制生成+促进排泄"双路径。

CHENGDU, China, Aug. 17, 2026 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (" Kelun-Biotech" or the " Company", Stock Code: 6990.HK) announces its unaudited consolidated results for the period ended 30 June 2026 (the " Reporting Period"). Key information is as follows: Continue Reading Revenue amounted to approximately RMB 978 million, with sales of pharmaceutical products reaching RMB 657 million, up by 112% compared to the same period last year, driven by two factors: expert recognition of high quality clinical data and shift in treatment paradigms, and comprehensive enhancement of drug accessibility. The Company has established a comprehensive operational system in China encompassing R&D, manufacturing, quality management, and commercialization, with integrated drug development capabilities. The Company is also pursuing global expansion through international collaborations, leveraging external partnerships to accumulate global clinical development and commercialization experience, while exploring diversified pathways to progressively achieve independent overseas market entry. Focusing on ADC and novel DC, the Company not only has two ADC products that have been approved for marketing, but has also built a product pipeline that is differentiated and complimentary to approved ADCs in indications, efficacy performance and safety profile. Through the free combination of conjugation drug components, as well as the pairing with a diverse range of targeting conjugates including antibodies, small molecules, and peptides that leverage TAA/IO/ anti-angiogenetic-based mechanisms, the Company has proactively positioned innovative DC assets, including single-payload DCs such as radioisotope-based/ immuno-agonist-based/degrader-based, and dual-payload DCs such as cytotoxin + cytotoxin or immuno-agonist or degrader combinations, among others. Doubling down on ADC + IO therapies, including the combination of ADCs with PD-(L)1 or PD-1/VEGF agents, as well as the development of drug candidates with synergetic MoAs within one ADC compound. Beyond oncology, the Company has also expanded into important therapeutic areas such as autoimmune and metabolic diseases, and is currently conducting multiple clinical studies for asthma, chronic obstructive pulmonary disease (COPD), and atopic dermatitis. Clinical development progresses efficiently, with a tiered expansion of the pipeline matrix Focusing on high-incidence tumors such as lung cancer and breast cancer, the Company has built a well-layered clinical pipeline with significant synergistic potential, covering drug modalities including ADCs, immunotherapies, and small-molecule targeted therapies, while further expanding into major therapeutic areas such as autoimmune and metabolic diseases. Approved ADC Products Sac-TMT (TROP2 ADC, sacituzumab tirumotecan) (also known as SKB264/MK-2870) ( 佳泰莱 ® ) The product has currently received marketing approval for four indications, namely 2L+ TNBC, 2L/3L EGFR-mutant NSCLC, and 2L+ HR+/HER2- BC. In addition, two new indication drug applications have been accepted for review, covering the combination with pembrolizumab for 1L PD-L1-positive NSCLC, and as a monotherapy for 1L TNBC. Clinical progress in the reporting period: Marketing approval for 2L+ HR+/HER2- BC New indication drug applications accepted for 1L TNBC and 1L PD-L1-positive NSCLC The OptiTROP-Lung06 registrational trial in China for 1L PD-L1-negative non-squamous NSCLC met primary endpoint The global Phase 3 TroFuse-005 trial for 2L+ EC met primary endpoints Two global Phase 3 trials for OC & UC initiated in H1 2026 Phase 2 study in combination with SKB118 for NSCLC initiated Granted BTD for 1L PD-L1-positive NSCLC from NMPA Drawing on all the aforementioned key advances, sac‑TMT has clearly embodied four core development strategies: advancing from monotherapy to combo-therapy, shifting from later-line to earlier-line treatment settings, expanding indications, and conducting clinical research from China to the global. Trastuzumab botidotin (HER2 ADC, also known as A166) ( 舒泰莱 ® ) One indication has received marketing approval for the treatment of 2L+ HER2+ BC. Its Phase 2 clinical study in HER2+ BC patients previously treated with topoisomerase inhibitor ADCs is ongoing. Other ADC and novel DC assets The Company has also built a pipeline of innovative assets that are differentiated from and complementary to approved ADCs in indications, efficacy and safety profile, including SKB315 (CLDN18.2 ADC), SKB410 (Nectin-4 ADC), SKB571 (novel bsADC), SKB107 (RDC), SKB103 (TAA-IO bsADC), and SKB565 (novel dual-payload ADC), among others. Non-DC Assets Clinical progress in the reporting period: SKB118/CR-001 (PD-1/VEGF bsAb): The IND application for the treatment of solid tumors has been approved by the NMPA, and a Phase 1/2 clinical trial is ongoing. SKB378/WIN378 (TSLP mAb): A Phase 1 clinical trial in healthy subjects has been completed in China, and its IND application for the treatment of COPD has also been approved by the NMPA. SKB575 (TSLP/undisclosed target bsAb): Phase 1 clinical trials for atopic dermatitis and asthma are ongoing in China. Major Key Research Findings Presented at International Academic Conferences & Journals The Phase 3 trial evaluating sac-TMT plus pembrolizumab versus pembrolizumab monotherapy for first-line treatment of PD-L1-positive advanced NSCLC was delivered as an oral presentation at ASCO 2026 and concurrently published in The Lancet. Compared with single-agent immunotherapy, this combination regimen yielded a significant prolongation in PFS (HR = 0.35), with consistent PFS benefits observed across all predefined subgroups; an OS benefit trend was also observed (HR = 0.55). The final OS analysis results from the pivotal study of sac-TMT for 3L EGFR-mutant NSCLC were selected as a LBA at ELCC 2026 and presented as a mini oral presentation. Lunbotinib Fumarate Capsules (RET inhibitor, also known as A400/EP0031) (宁泰莱®[1]): Key Phase 2 clinical results for advanced RET fusion-positive NSCLC were presented in an oral presentation at ASCO 2026. Multiple products gain market traction, with robust commercial growth momentum To date, the Company has received marketing authorization for sac-TMT (佳泰莱®), tagitanlimab (科泰莱®), Cetuximab N01 (达泰莱®) and trastuzumab botidotin (舒泰莱®), of which 3 products covering 5 indications have been included in the National Reimbursement Drug List (NRDL). The Company has also submitted an NDA for Lunbotinib Fumarate Capsules, and upon regulatory communication and marketing approval, commercialization is expected to commence in the first half of 2027. With this, the Company's initial commercial product portfolio, comprising 5 products, has taken shape. In the first half of 2026, the total revenue from sales of pharmaceutical products reaching RMB 657 million, up by 112% compared to the same period last year. Major growth drivers: Expert Recognition of High ‑ Quality Clinical Data and Shift in Treatment Paradigms: Data from a number of high‑quality clinical studies of international caliber have continued to be released, thereby continuously reinforcing the evidence-based clinical foundation of our products. Recognized through authoritative endorsement from clinical guideline experts, as reflected in guidelines (CSCO, etc.) and clinical expert consensus. 佳泰莱® is recognized as the "standard of care in 2L and the preferred regimen in 3L" in the LC, and is also the preferred brand among TROP2 ADC in TNBC. Through ongoing medical education and academic exchange activities, clinicians have gained a deeper understanding of the products. Treatment paradigms have also evolved gradually. Comprehensive Enhancement of Drug Accessibility Effective translation of the benefits of NRDL inclusion : 3 indications of 佳泰莱® and 达泰莱® have been included in the 2025 NRDL, which officially took effect on January 1, 2026. This marks 佳泰莱® the only TROP2 ADC and the only domestic ADC in TNBC/NSCLC under the NRDL Broader hospital access channels: Covers 30 provinces, over 300 prefectures and over 2,000 hospitals; Broaden reimbursement channels, including formal access, temporary procurement and dual-channel reimbursement; Continuous expansion of the commercialization team : Established a team of 800+; nearly doubling YoY; Achieved extensive grassroots coverage of top-tier hospitals in high-potential districts Sac-TMT ( 佳泰莱 ® ) achieved positive results in its first global Phase 3 trial, accelerating global collaboration progress Collaboration with Merck Sharp & Dohme (hereinafter referred to as the "MSD") (默沙东): MSD has initiated 17 ongoing Phase 3 global clinical studies of sac-TMT as a monotherapy or in combination with pembrolizumab or other agents for several types of cancer, with indications covering breast cancer (BC), lung cancer (LC), gynecologic cancers, gastrointestinal (GI) cancers, and genitourinary (GU) cancers. In May 2026, MSD announced that the pivotal Phase 3 Trofuse-005 trial met its primary endpoints of OS and PFS in certain patients with advanced or recurrent EC. TroFuse-005 is the first global Phase 3 trial to demonstrate statistically significant improvement in both OS and PFS compared to chemotherapy for these patients, and sac-TMT is the first and only ADC to do so for patients with EC in this setting. Beyond sac‑TMT, the Company has also entered into collaborations with MSD on certain ADC assets, continuously exploring the optimal ADC pipeline portfolio. Collaboration with Ellipses Pharma: Lunbotinib Fumarate Capsules (A400/EP0031) have received FDA approval to proceed into Phase 2 clinical development. A total of 42 clinical trial sites has been established in the United States, UK, Europe, and the United Arab Emirates for Lunbotinib Fumarate Capsules. Collaboration with Windward Bio: Windward Bio is evaluating SKB378/WIN378 in the POLARIS Phase 2/3 global trial in patients with asthma and has dosed the first patients in the SIRIUS Phase 2 global study in patients with COPD. Collaboration with Crescent Biopharma: Entered into a licensing collaboration with Crescent Biopharma for SKB105/CR-003. ESG capabilities continue to strengthen, delivering outstanding results in capital market performance. In terms of ESG, in May 2026, the Company was included in the "China ESG Impact List" by Fortune and was awarded bronze medal for "Most Committed to ESG (China)" under "Asia's Best Company" by FinanceAsia. In March 2026, the Company had received a rating of "AA" in the MSCI ESG Rating Assessment. In terms of capital markets, the Company was approved by the Hong Kong Stock Exchange to officially remove the "B" marker from its stock code on April 14, 2026. In addition, the Company completed the placing of H Shares in July 2026, with net proceeds from the Placing amounting to approximately HK$2,723.4 million. Prospect Kelun-Biotech will continue to drive innovation and strengthen its operational capabilities, steadily advancing towards becoming a world-class biopharmaceutical company. Specifically, the Company will implement the following development strategies: advancing differentiated pipelines targeting indications with significant medical needs; optimizing payload-linker strategies and novel DC designs and structures, while expanding applications in non-oncology diseases; enhancing its end-to-end drug development and commercialization capabilities; expanding its global footprint through strategic partnerships and improve our capabilities for the development, registration and commercialization of our products in ex-China market; and optimizing its operational systems with the aim of becoming a leading global biopharmaceutical company.－End－ About Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical, which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. Kelun-Biotech focuses on major disease areas such as solid tumors, autoimmune, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. Kelun-Biotech is committed to becoming a leading global enterprise in the field of innovative drugs. At present, Kelun-Biotech has more than 30 ongoing key innovative drug projects, of which 4 projects with 8 indications have been approved for marketing, 2 projects with 3 indications are in the NDA stage and more than 10 projects are in the clinical stage. Kelun-Biotech has established one of the world's leading proprietary ADC and novel DC platforms, OptiDC™, and has 2 ADC projects with 5 indications approved for marketing, and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit . SOURCE Kelun-biotech 21% more press release views with Request a Demo