BGB-B167

2024年的AACR，让中国药企展现出更富影响力的声音，尤其是在ADC领域，中国药企的展示数量几乎占据半数。撰文|  Erin编辑| 润屿 芳晨如果说2023年的AACR展现了中国药企更高的参与度，到了2024年，这一数量再次刷新纪录，直接以新增200项摘要个数创下历史新高。华创证券统计，今年的AACR上，来自国内药企的摘要约有700项，几乎是2021年的两倍。（来源：华创证券研报）尤其是在ADC领域，这几乎是国内药企的“统治区”，来自中国的bigpharma、biopharma与biotech们都表现出了空前的参与热情和差异化优势。恒瑞再次展现“制药一哥”实力，携5款ADC项目亮相，有4个项目都是首次公开；“创新药二哥”信达三个FIC“潜力股”入选重磅研究，两个来自ADC，一个为双抗；前两天刚刚官宣成为第四家被海外公司并购的中国biotech后，普方生物也携两个新型靶点ADC药物出席。另有橙帆生物、百奥赛图、多禧生物、华辉安健、启德生物等超二十家中国Biotech在会议期间展示了技术最前沿、最具FIC/BIC潜质的ADC研发成果。此外，还有来自维立志博、博奥信、烁星生物、丹序生物、辐联医药等Biotech带来了双抗和核药产品的展示。在如今并购与BD盛行的中国创新药行业，今年的AACR会议或又将开启新一波“交易热”。“一哥”恒瑞首秀ADC新品实力今年的AACR，绝对是中国ADC的主场。第一大亮点就来自“制药一哥”恒瑞医药。经历多年厚积薄发，恒瑞重现“一哥”实力，携9项研究成果，其中包括5款ADC新品亮相AACR，是与会的国内大药企中ADC项目数量最多的公司。5款ADC产品中，帕妥珠单抗偶联艾日布林衍生物SHR-4602进展最快，已于2023年4月获批临床。SHR-4602设计目标就是用于DS-8201，以及恒瑞“前代”HER2 ADC产品SHR-A1811耐药的后线治疗。除此之外，恒瑞还展示了TF靶向HRA00184-C004、LIV-1 ADC药物SDP03923-000-9106、PSMA ADC药物HRA00242-C004、DLL3 ADC药物HRA00130-C004，这四款早期研发阶段产品都是恒瑞首次对外披露详细数据，并具有FIC/BIC潜质。这5项早期产品的披露更加证实了恒瑞多年在ADC领域的积累。据悉，在今年JPM大会期间，恒瑞曾透露，公司已经在ADC领域积累了10年的经验，并打造了模块化ADC平台HRMAP，可快速开发各种差异化的ADC产品。“创新药二哥”信达也不甘示弱，带来了两款具有FIC潜质的ADC产品，分别为B7-H3/EGFR双抗ADC IBI3001和靶向Claudin 18.2的ADC IBI343。虽然全球的EGFR领域竞争激烈，但信达是全球最早布局B7-H3/EGFR双抗ADC的公司之一，其经过优化的B7-H3臂不但加强了EGFR信号阻断的效果，同时也降低了EGFR靶点的毒性。而IBI343是目前全球进展最快的Claudin 18.2 ADC之一，即将进入针对Claudin 18.2阳性HER2阴性胃癌的临床III期。更加值得一提的是，信达的这两项ADC研究成果皆入选了AACR特有的“重磅研究（Late-Breaking Research）”环节。该环节主要展示全球范围在肿瘤基础研究中的最新发现和肿瘤治疗领域中最具有创新价值的疗法。除了信达之外，橙帆医药的EGFR/cMet双抗ADC、Trop2/Nectin4双抗ADC，以及华辉安健/普方生物的CD98 ADC等研究成果也入选了重磅研究。其中，橙帆医药是此次AACR上难以忽视的中国新锐ADC力量。本次登场的两款ADC的临床前数据都展示出来优于前人安全性和有效性的潜力。其中，EGFR/cMet双抗ADC VBC101，是目前除了阿斯利康的AZD9592外，全球进展最快的EGFR/c-MET双抗ADC，并具有比后者更强疗效的潜力。据悉，阿斯利康也在本次AACR上报告了AZD9592的临床I期数据，最低剂量2mpk治疗EGFRm非小细胞肺癌的缓解率为41%。华辉安健/普方生物的CD98 ADC HH018-sesutecan则是汇集了两个公司的优势，是由华辉安健抗CD98单抗HH018为基础，通过普方生物的sesutecan ADC技术平台开发的泛瘤种ADC，在结直肠癌、头颈鳞癌、黑色素瘤、卵巢癌、淋巴瘤等多个领域都有应用潜力，并且还是具有FIC潜力的产品。除了这些入选重磅研究的研究成果外，已经在国内递交上市申请的科伦博泰，也在AACR上展示了TROP2 ADC芦康沙妥珠单抗（SKB264/sac-TMT）的两项最新研究成果：一是既往接受过治疗的晚期非小细胞肺癌(NSCLC)患者的II期研究的最新疗效和安全性结果；二是治疗既往接受过治疗的晚期胃癌或胃食管交界部(GEJ)癌症患者的II期研究的初步疗效和安全性结果。此外，还有更多来自中国药企的新型ADC或是全新靶点ADC产品在AACR上登场，如映恩生物、多禧生物、星亢原、康源久远、英诺湖生物、礼新医药等。或许下一个被MNC青睐、或有望成为并购对象的企业，就在这些Biotech当中产生。 推荐阅读 * AACR爆了！恒瑞ADC挑战DS-8201，百济、和誉携多款FIC，多达500项数据摘要，有何看点？* 130亿全现金，股东纯赚400%！当中国首家ADC Biotech被收购，下一个又是谁？PD-(L)1组合“竞速”；双抗百花齐放每年的肿瘤领域学术会议，总有一部分注意力是留给PD-(L)1，今年的AACR仍不例外，与PD-(L)1相关的双抗、三抗、ADC产品可谓百花齐放。AACR会议期间，至少有7家中国Biotech公司带来了PD-(L)1相关的双抗、三抗成果展示，也再次凸显了PD-(L)1赛道，没有最卷，只有更卷的竞争态势。光是PD-1/CTLA-4/VEGF三抗，就有两家企业在AACR上做展示，例如嘉和生物的GB268和宏成药业的HC010。荣昌生物带来的PD-1/VEGF双抗RC148，虽然是其进军双抗赛道的首款产品，但RC148在2023年7月刚获批临床试验，而PD-1/VEGF双抗赛道在国内并不算稀少，早前康方生物与summit的50亿美元合作也是全球首款PD-1/VEGF双抗AK112，君实生物也申报了PD-1/VEGF双抗的研发。此外，还有烁星生物带来的PD-L1/EGFR/CD28三抗SM2275和康源久远带来的CD47/PD-L1双抗ADC JY207进行了展示。当然，如果将目光放到PD-(L)1之外的领域，国内药企的双抗研发成果其实百花齐放。百济神州披露了其FIC潜力的4-1BB（CD137）/CEACAM5双抗BGB-B167，该产品在结直肠癌、胃癌、肺癌、胰腺癌、肝癌、乳腺癌和甲状腺癌等多个领域都有应用前景。并且，BGB-B167还是百济神州首款内部自主研发、具备FIC潜力的双抗。国内药企还有两款双抗产品研究成果入选了重磅研究环节，包括信达生物的B7-H3/EGFR双抗IBI334和宜明昂科的CD38/CD47双抗IMM5605。IBI334是信达生物利用其独特的Innobody平台所开发的新型抗体依赖性细胞毒性（ADCC）增强的B7-H3/EGFR双特异性抗体，摘要显示，IBI334已经显示出比强生的c-met/EGFR双抗Amivantamab更强的疗效。并已在2023年9月获批临床，拟用于治疗不可切除、局部晚期或转移性实体瘤患者。宜明昂科的CD38/CD47双抗IMM5605目前还在临床前阶段，但已经显示出了针对CD38 抗体耐药的血液恶性肿瘤强大的疗效。当然，在小分子领域，国内药企也依旧展现出对于KRAS赛道的竞逐，包括恒瑞和翰森两家大药企在内，有8家国内药企在AACR上展示了KRAS产品的研发成果。其中，KRAS G12C抑制剂HS-10370作为翰森的重要产品之一，已经在2022年获批临床。此外，细胞疗法和核药也是国内药企在AACR舞台上展示的重磅内容。来自方德门达的ThisCART通用型CAR-T平台技术和莱芒生物和CD19 CAR-T还入选了重磅研究环节。前者的平台突破了自体CAR-T产业化领域的痛点，从根本上避免基因编辑的脱靶风险。根据莱芒生物官网披露，其代谢增强型CD19 CAR-T细胞IIT临床研究已经连续完成20例患者的入组治疗（商业化CAR-T剂量的1%~5%），均获得完全缓解（CR）。而辐联科技的RDC项目225Ac-FL-020则是本次AACR会议上为数不多的核药研究成果，该药物旨在治疗转移性去势抵抗性前列腺癌，目前正处于开发阶段，预计将于2024年上半年进入全球临床一期研究，具有BIC潜力。回复“CXO”，了解电子期刊详情精彩推荐CM10 | 集采 | 国谈 | 医保动态 | 药审 | 人才 | 薪资 | 榜单 | CAR-T | PD-1 | mRNA | 单抗 | 商业化 | 国际化 ｜ 猎药人系列专题 | 出海启思会 | 声音·责任 | 创百汇 | E药经理人理事会 | 微解药直播 | 大国新药 | 营销硬观点 | 投资人去哪儿 | 分析师看赛道 | 药事每周谈 | 医药界·E药经理人 | 中国医药手册创新100强榜单 | 恒瑞 | 中国生物制药 | 百济 | 石药 | 信达 | 君实 | 复宏汉霖 ｜翰森 | 康方生物 | 上海医药 | 和黄医药 | 东阳光药 |  荣昌 | 亚盛医药 | 齐鲁制药 | 康宁杰瑞 | 贝达药业 | 微芯生物 | 复星医药 ｜再鼎医药｜亚虹医药跨国药企50强榜单 | 辉瑞 | 艾伯维 | 诺华 | 强生 | 罗氏 | BMS | 默克 | 赛诺菲 | AZ | GSK | 武田 | 吉利德科学 | 礼来 | 安进 | 诺和诺德 | 拜耳 | 莫德纳 | BI | 晖致 | 再生元

Multiple trials underscore the potential of tislelizumab-containing immuno-oncology combinations in a variety of solid tumor settings Additional highlights include preclinical characterization data for an investigational BTK degrader, BGB-16673, currently in clinical development for B-cell malignancies, including mantle cell lymphoma BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced the presentation of emerging oncology pipeline data at the American Association for Cancer Research (AACR) Annual Meeting April 5-10 in San Diego. BeiGene has nine abstracts scheduled for poster presentations at AACR. “Our presentations at this year’s AACR showcase our ongoing development of tislelizumab combinations in solid tumors as we assess the clinical potential of multiple novel immuno-oncology candidates and make data-driven decisions for further development,” said Lai Wang, Ph.D., Global Head of Research & Development at BeiGene. “More broadly, they reflect our deep commitment to discovering innovative new medicines for cancer patients, including by pioneering novel mechanisms like targeted degradation.” BeiGene will present results from the AdvanTIG-204 Phase 2 study of tislelizumab (anti-PD1) plus ociperlimab (anti-TIGIT) in first-line limited-stage small cell lung cancer (SCLC) as well as results of a biomarker study of the same doublet in the setting of first-line non-small cell lung cancer (NSCLC). An ongoing, global Phase 3 trial of ociperlimab plus tislelizumab in stage IV, PD-L1 high NSCLC, AdvanTIG-302, will complete enrollment this month (NCT04746924). An additional clinical presentation includes the first data from a Phase 1a dose escalation study of BGB-10188, a phosphatidylinositol 3 kinase delta (PI3Kδ) inhibitor, plus tislelizumab in patients with solid tumors. BeiGene will also be presenting preclinical characterizations of several novel molecules from its internal discovery engine, including a CEA x 4-1BB bispecific antibody and a chimeric degradation activation compound (CDAC) targeting BTK, BGB-16673. Clinical data from an ongoing Phase 1 study of BGB-16673 in relapsed/refractory B-cell malignancies were presented at ASH 2023, demonstrating clinical responses and a tolerable safety pro heavily pre-treated patients with B-cell malignancies, including those with BTK inhibitor-resistant disease (NCT05006716).​ An additional preclinical presentation highlights the therapeutic potential of the triple-combination of tislelizumab with anti-LAG-3 (LBL-007) and anti-TIM-3 (surzebiclimab); this combination is being evaluated in an ongoing Phase 2 study in head and neck squamous cell carcinoma (NCT05909904). BeiGene Presentations During AACR 2024 Abstract Title Abstract # Presentation Time (PDT) Lead Author Preclinical Characterization of the correlation between BTK degradation and tumor growth inhibition of the BTK target protein degraders using PK/PD modeling 2110 Monday, April 8 9 a.m. – 12:30 p.m. Section 30 Board #1 Y. Wu BGB-B167, a first-in-class 4-1BB/CEACAM5 bispecific antibody, exhibits potent in vitro and in vivo anti-tumor activity and superior safety pro > in preclinical models 2371 Monday, April 8 9 a.m. – 12:30 p.m. Section 38 Board #17 Z. Li Translational assessment of triple combination with tislelizumab (anti-PD-1), LBL-007 (anti-LAG- 3) and surzebiclimab (anti-TIM-3) highlights its strong anti-tumor activity and clinical potential in solid tumors such as HNSCC 4041 Tuesday, April 9 9 a.m. – 12:30 p.m. Section 3 Board #17 H. Zhu Clinical Exploration of potential biomarkers correlated with efficacy of ociperlimab (anti-TIGIT) plus tislelizumab (anti-PD1) in 1L PD-L1+ non-small cell lung cancer (NSCLC) CT053 Monday, April 8 9 a.m. – 12:30 p.m. Section 48 Board #3 S. Kim A first in human, phase 1a, dose escalation study of BGB 10188, a phosphatidylinositol 3 kinase delta (PI3Kδ) inhibitor, + tislelizumab (anti-PD-1) in patients with solid tumors CT189 Tuesday, April 9 9 a.m. – 12:30 p.m. Section 48 Board #17 R. Cosman AdvanTIG-204: A phase 2, multicenter, randomized, 3-arm, open-label study investigating the preliminary efficacy and safety of ociperlimab (anti-TIGIT) + tislelizumab (anti-PD-1) + concurrent chemoradiotherapy (cCRT) in patients with untreated limited-stage small cell lung cancer (SCLC) CT255 Tuesday, April 9 1:30 p.m. – 5 p.m. Section 48 Board #14 Y. Gong BGB-A317-LBL-007-202 (NCT06010303): A phase 2, randomized, active-controlled, open- label study to evaluate the efficacy and safety of LBL 007 (anti-LAG-3) in combination with tislelizumab (TIS; anti-PD-1) plus chemotherapy (chemo) as first-line (1L) treatment in patients with unresectable locally advanced/metastatic esophageal squamous cell carcinoma (ESCC) CT274 Tuesday, April 9 1:30 p.m. – 5 p.m. Section 50 Board #4 S. Park Liberty-201 (NCT05609370): Maintenance fluoropyrimidine and bevacizumab with or without anti-lymphocyte activation gene-3 (LAG-3) antibody LBL-007 plus anti-programmed cell death protein-1 (PD-1) antibody tislelizumab (TIS) for patients (pts) with metastatic or unresectable microsatellite stable (MSS)/mismatch repair proficient (pMMR)colorectal cancer (CRC) CT276 Tuesday, April 9 1:30 p.m. – 5 p.m. Section 50 Board #6 H.-J. Lenz BGB-LC-201 (NCT05635708): A phase 2, open- label, multi-arm study of tislelizumab (TIS; anti- PD-1) in combination with investigational agents +/- chemotherapy as first-line treatment for patients with locally advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC) CT277 Tuesday, April 9 1:30 p.m. – 5 p.m. Section 50 Board #7 G. Blumenschein About Tislelizumab Tislelizumab is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD‑1) monoclonal antibody with high affinity and binding specificity against PD‑1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors. About BeiGene BeiGene is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeiGene, please visit and follow us on LinkedIn and X (formerly known as Twitter). Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding BeiGene’s ability to discover innovative new medicines for cancer patients and pioneer novel mechanisms; the future development, regulatory filing and approval, and commercialization of tislelizumab, BGB-16673, and other novel molecules; and BeiGene’s plans, commitments, aspirations, and goals under the heading “About BeiGene.” Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing, and progress of clinical trials and marketing approval; BeiGene's ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeiGene's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeiGene's reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeiGene’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products; BeiGene’s ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent annual report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law. View source version on businesswire.com: Contacts Investor: Liza Heapes +1 857-302-5663 ir@beigene.com Media: Kyle Blankenship +1 667-351-5176 media@beigene.com Source: BeiGene, Ltd. View this news release online at: