Iparomlimab

Multiple presentations to showcase the efficacy and safety of BRUKINSA® across a range of B-cell malignancies Company to present three-year data from RATIONALE-306 study of TEVIMBRA® in advanced or metastatic esophageal squamous cell carcinoma (ESCC) BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced it will share research outcomes from its broad hematology and solid tumor portfolio at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, May 31 - June 4, 2024. “Our presentations at this year’s ASCO highlight the strength of our growing oncology portfolio and our commitment to developing treatments that address the unmet needs of patients with B-cell malignancies and solid tumors,” Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene. “The exciting data we will share during ASCO showcase BRUKINSA’s uniquely differentiated clinical pro add to the growing body of evidence supporting its role across the blood cancer treatment paradigm.” BeiGene will share new data for BRUKINSA (zanubrutinib), which add to the robust efficacy and safety evidence differentiating it within the BTK class. Key highlights include: A network meta-analysis comparing the efficacy of BRUKINSA vs acalabrutinib in patients with relapsed/refractory chronic lymphocytic leukemia (CLL); and A post-hoc analysis from the Phase 3 ALPINE study of BRUKINSA vs ibrutinib evaluating the risk of developing hypertension based on the initiation and adjustment of antihypertensive medications. Reflecting BeiGene’s growing solid tumor development program, TEVIMBRA (tislelizumab-jsgr) will be the subject of multiple presentations – as a monotherapy, in combination with chemotherapy agents, and as part of immunotherapy regimens across a range of tumor types. Key highlights include: New data from the Phase 3 RATIONALE-306 study evaluating TEVIMBRA plus chemotherapy in patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC); and Initial data from a first-in-human study evaluating HPK1 inhibitor BGB-15025 alone and in combination with TEVIMBRA. “Our data at ASCO are a testament to the potential versatility of TEVIMBRA across a range of tumor types, and we are excited by the momentum of this critical pillar of our solid tumor development program,” said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeiGene. “During the meeting, we look forward to sharing a new analysis from our RATIONALE-306 study, which will provide insights into the three-year efficacy and safety of TEVIMBRA as a first-line treatment for ESCC.” BeiGene Presentations During ASCO 2024 Abstract Title Abstract # Presentation Details Lead Author Hematology Comparative efficacy of Bruton tyrosine kinase inhibitors in the treatment of relapsed/refractory chronic lymphocytic leukemia: a network meta-analysis (NMA) 7048 Session Type and Title: Poster Session – Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia Session Date and Time: June 3 at 9:00 AM-12:00 PM CDT M. Shadman Real-world treatment patterns and outcomes of zanubrutinib in chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL) 11158 Session Type and Title: Poster Session – Quality Care/Health Services Research Session Date and Time: June 3 at 9:00 AM-12:00 PM CDT M. Krackeler Risk of hypertension in patients with CLL/SLL who participated in ALPINE: a post hoc analysis N/A Online D. Ramirez Risk of new-onset hypertension in newly diagnosed chronic lymphocytic leukemia (CLL) patients (pts) treated with Bruton tyrosine kinase inhibitors (BTKi): A real-world data study using the Symphony Health Solution database N/A Online T. Kou Real-world treatment switching and sequencing to next line of therapy of zanubrutinib, acalabrutinib, and ibrutinib in CLL/SLL N/A Online J. Pinilla-Ibarz Real-world adherence and healthcare resource utilization of Bruton tyrosine kinase inhibitors (BTKi) in mantle cell lymphoma N/A Online B. Shah Comparison of zanubrutinib (zanu) and acalabrutinib (acala) in B-cell malignancies: an adverse event (AE)-based analysis N/A Online T. Munir Clinical and financial burden of mental health (MH) conditions in patients (pts) with low-grade non-Hodgkin lymphoma (LG-NHL) 7072 Session Type and Title: Poster Session – Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia Session Date and Time: June 3 at 9:00 AM-12:00 PM CDT K. Yang Real-world evaluation of treatment pattern, time to next treatment (TTNT), healthcare resource utilization (HCRU), and cost of care in follicular lymphoma (FL) N/A Online S. Gaballa Real-world Bruton tyrosine kinase inhibitor (BTKi) treatment patterns and outcomes among patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) in US community oncology practices N/A Online J. Hou BGB-11417-203, an ongoing, phase 2 study of sonrotoclax (BGB-11417), a next-generation BCL2 inhibitor, in patients with Waldenström macroglobulinemia TPS7090 Session Type and Title: Poster Session – Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia Session Date and Time: June 3 at 9:00 AM-12:00 PM CDT H. Lee CELESTIAL-TNCLL: An ongoing, open-label, multiregional, phase 3 study of sonrotoclax (BGB-11417) + zanubrutinib vs venetoclax + obinutuzumab for treatment-naïve (TN) CLL TPS7087 Session Type and Title: Poster Session – Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia Session Date and Time: June 3 at 9:00 AM-12:00 PM CDT M. Shadman Solid Tumor/IO Global, randomized, phase III study of tislelizumab plus chemotherapy versus placebo plus chemotherapy as first-line treatment for advanced/metastatic esophageal squamous cell carcinoma (RATIONALE-306 update): minimum 3-year survival follow-up 4032 Session Type and Title: Poster Session – Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary Session Date and Time: June 1 at 1:30-4:30 PM CDT H. Yoon BGB-A317-212: A multicenter, open-label, phase II study to evaluate the efficacy and safety of tislelizumab in combination with lenvatinib in patients with selected solid tumors 2610 Session Type and Title: Poster Session – Developmental Therapeutics—Immunotherapy Session Date and Time: June 1 at 9:00 AM-12:00 PM CDT L. Yufei Preoperative (neoadjuvant) therapy with tislelizumab for locally advanced colorectal cancer with high microsatellite instability or deficient mismatch repair: an open-label, single-arm, multicenter phase II study 3599 Session Type and Title: Poster Session – Gastrointestinal Cancer—Colorectal and Anal Session Date and Time: June 1 at 1:30-4:30 PM CDT K. Ding Tislelizumab First-Line (1L) Gastric/Gastroesophageal Junction Cancer (G/GEJ) Treatment Efficacy on PRO-Based Symptom Endpoints Adjusting for Informative Missing Data Bias: Results from RATIONALE 305 2605 Session Type and Title: Poster Session – Developmental Therapeutics—Immunotherapy Session Date and Time: June 1 at 9:00 AM-12:00 PM CDT D. Serrano A first‑in‑human phase 1a dose‑escalation study of BGB‑15025 (HPK1 inhibitor) as monotherapy and in combination with tislelizumab (TIS; anti‑PD‑1 antibody) in patients (pts) with advanced solid tumors 2585 Session Type and Title: Poster Session – Developmental Therapeutics—Immunotherapy Session Date and Time: June 1 at 9:00 AM-12:00 PM CDT S. Deva Long-term pooled safety analysis of tislelizumab as monotherapy or in combination with chemotherapy in patients with advanced cancers. N/A Online C. Zhou About BRUKINSA® (zanubrutinib) BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared with other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues. Please see full U.S. Prescribing Information for BRUKINSA® (zanubrutinib), including U.S. Patient Information or visit . About TEVIMBRA® (tislelizumab-jsgr) 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. Please see full U.S. Prescribing Information for TEVIMBRA® (tislelizumab-jsgr), including Medication Guide. About Sonrotoclax (BGB11417) Sonrotoclax is an investigational small molecule B-cell lymphoma 2 (BCL2) inhibitor. It belongs to a class of BCL2 homology 3 (BH3) mimetics, and preclinical and IND-enabling studies have demonstrated potent activity and high selectivity of sonrotoclax against the antiapoptotic protein BCL2. Sonrotoclax is more potent and selective for BCL2 relative to BCLxL than venetoclax and shows the potential to overcome common BCL2 resistance mutations. 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, X (formerly known as Twitter), and Facebook. 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 the strength and future growth of BeiGene’s oncology portfolio; BeiGene’s ability to develop treatments that address the unmet needs of patients with B-cell malignancies and solid tumors; the versatility of tislelizumab across tumor types; 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 Contact: Liza Heapes +1 857-302-5663 ir@beigene.com Source: BeiGene, Ltd. View this news release online at:

生物类似药是一类兼具更低研发风险、更高技术门槛、更高利润空间的药物，由此也成为全球药品市场版图上一颗令人垂涎的明珠。纵观全球生物类似药玩家，既有Sandoz、Celltrion这种在生物仿制药阵地持续深耕的传统高手，也有Teva、Mylan（现为晖致一部分）这种从小分子转战而来的化药仿制药巨头；既有从CDMO业务切入到生物类似药开发的新势力三星生物（Samsung Bioepis），也有下场较晚但来势汹汹的新生代费森尤斯卡比（Fresenius Kabi）。甚至Amgen、Biogen这种带有鲜明前沿技术气质的贵族也不惜放下身段，在生物类似药领域做得风生水起。中国生物类似药行业的起步虽较欧美国家晚，但发展势头迅猛。据医药魔方NextPharma数据库、PharmaGO数据库，自2019年2月NMPA批准首款生物类似药利妥昔单抗（汉利康）以来，截至目前，中国共有14种按新的注册分类获批的生物类似药品种（按通用名计算，仅关注多肽、融合蛋白、抗体类药物，胰岛素类产品未纳入），并且已有多款中国企业开发的生物类似药成功在欧美市场获批。路径打通，井喷上市政策支持为中国生物类似药的研发上市打通了路径。2015 年2 月，国家药监局药审中心（CDE）发布了《生物类似药研发与评价技术指导原则（试行）》，此后，又针对这一领域出台了一系列政策和指导文件。这为生物类似药的开发扫清了障碍，也吸引了大量企业入局。中国已上市的生物类似药（非胰岛素类）品种注：1）在汉利康之前，国内也已经获批了多款生物药的仿制品，由于国内之前未正式提出生物类似药概念，因此行业普遍将汉利康视作为中国首款获批的生物类似药；2）汉利康之前获批的生物药仿制药品种未按新规申报，不算严格意义的生物类似药，考虑到同通用名产品竞争格局考量，也列入表格，并标灰；3）人生长激素、人干扰素、肝素、促卵泡素、（培）非格司亭、阿法依泊汀等多种生物仿制药上市时间较早且数目多，多按旧注册分类申报获批，此表未纳入统计；4）表格未纳入胰岛素类产品；从布局生物类似药的企业来看，既有恒瑞、正大天晴、齐鲁等传统Pharma企业，也有信达生物、博锐生物、君实生物、复宏汉霖、博安生物等顶着鲜明Biopharma标签的新兴力量。或许各家企业入局开发生物类似药的初始战略目标不尽相同，但不置可否的是，生物类似药在各家企业的发展中都有着十分重要的意义。首先，从零开始做创新生物药，难度显然更大一些，尤其对于从化药起家的传统Pharma来说无异于再次尝试从0-1的突破。因此很多企业选择从生物类似药这一赛道切入，不仅提高了药物研发的成功率和上市速度，也为后续创新生物药的开发奠定了一定的物质和经验基础；其次，先生物类似药后创新药的开发策略也为新成立的很多Biotech商业化变现增加了更多的确定性，尤其是在当下资本寒冬中，这一模式的优势凸显。对于正大天晴、恒瑞、齐鲁这些传统Pharma来说，相较于生物类似药带来的商业化收入，他们可能更需要的是这类药物帮助企业从化药转向生物药这一全新领域的“温和探索”和“安全过度”。如今回头看，众多传统Pharma借助于生物类似药这块跳板已经成功切换到了生物药赛道。齐鲁制药已经有包括贝伐珠单抗、地舒单抗在内的8款生物类似药获批，3款生物类似药申报上市，其生物创新药也即将进入收获期，PD-1单抗艾帕洛利单抗和CTLA-4单抗/PD-1单抗复方均 已在国内递交了上市申请，后续管线中还有多款在研双抗、ADC候选药物。代表性传统Pharma生物药管线布局来源：医药魔方NextPharma数据库正大天晴也有4款抗体类生物类似药获批上市，后续管线中还有利拉鲁肽、司美格鲁肽等多款生物类似药即将进入收获阶段；包括三生国健、信立泰、丽珠医药、贝达药业等传统Pharma也通过生物类似药顺利过渡到生物创新药的开发，预计近两年也将有创新生物药获批上市。Biotech虽然没有传统Pharma从化药向生物药升级需要适应新的业务体系的负担，也无需承受仿制药集采带来的业务收入下降的阵痛，但是他们面临的是更严峻的挑战——生存危机。当中国创新药产业里的资本热钱退去的时候，确定的商业化收入、稳定的现金流、盈利前景成为衡量Biotech实力的新标准，，而对于已通过生物类似药获得商业化收入的企业来说，自然多了一份从容。2023年，复宏汉霖全年总收入53.95亿元，产品收入高达44.6亿元，这其中，4款生物类似药曲妥珠单抗（汉曲优）、贝伐珠单抗（汉贝泰）、阿达木单抗（汉达远）、利妥昔单抗（汉利康）合计贡献了近75%的份额，也助力复宏汉霖首次实现了全年盈利，稳定的营业收入也为公司的健康发展提供了保障。百奥泰目前已有3款生物类似药阿达木单抗（格乐立）、贝伐珠单抗（普贝希）、托珠单抗（施瑞立）获批上市；这3款药物在2023年为其带来了7亿美元的收入。同时，托珠单抗和贝伐珠单抗已经成功在美国获批，预计未来将会为其带来更丰厚的收入回报。博锐生物也有4款生物类似药获批上市。其中，安健宁（阿达木单抗）在国内的销售额已经与原研产品修美乐（艾伯维）不相上下，2023年国内医院终端销售额达2.38亿元，距离原研产品仅有一步之遥。安佰特（英夫利西单抗）也有着不俗的销售表现，国内医院终端销售收入占比仅次于原研产品类克（强生），不过再加上双通道药店和其他院外药房等，安佰特的整体销售预计已经超过类克。总的来说，国产生物类似药井喷式获批上市，打破了原研产品垄断的局面，大幅降低了药品价格，能最终从中获益的一定是患者，与中国当下的国情高度契合。海外盘子更大，中国生物类似药现出海潮随着国内生物类似药获批数量的日益增多，市场竞争也越来越激烈。2021年底，国家医保局组织开展了胰岛素专项集采，首次将带量集采拓展到生物药领域。近几年业内也传出了关于血液制品、生长激素、单抗、肝素、干扰素等生物药集采相关的报道。也有省份已经率先落地了生物药集采，2022年，广东药品集采联盟提出集采报量，利妥昔单抗、重组人凝血因子VIII、重组人生长激素等多款生物药被纳入，利妥昔单抗最终由信达生物降价59%中标。安徽省紧随其后，于同年11月将利妥昔单抗纳入集采，最终复宏汉霖独家中选。显然，生物药进入国家大面积集采大军只是时间问题。这也促使国内企业开始未雨绸缪，将目光瞄向了海外市场。复宏汉霖曲妥珠单抗生物类似药于2020年7月率先获欧盟委员会批准上市，之后不断开疆扩土，目前已于40余个国家和地区获批上市，包括英国、德国、澳大利亚、新加坡、巴西等，是获批上市国家和地区最多的国产生物类似药，其于美国、加拿大的上市申请亦已获得受理，有望于2024年获批上市。2023年，该产品海外收入近1亿元，同比增长162.3%，未来随着全球市场的持续渗透，其销售额有望进一步增长。紧随复宏汉霖曲妥珠单抗成功登陆欧洲市场之后，百奥泰的托珠单抗和贝伐珠单抗单抗前后脚在美国获批上市，其中，托珠单抗为FDA批准的首款托珠单抗生物类似药；这也再次证实了中国速度和中国质量已经得到了主流药品监管机构的认可。此外，齐鲁制药雷珠单抗生物类似药也于今年初成功获欧盟批准。如了抗体药之外，国产胰岛素产品也正逐渐走向全球市场，甘李药业、通化东宝的胰岛素产品目前正在接受欧洲和美国药品监管机构的审查。国产生物类似药出海情况来源：医药魔方NextPharma数据库除了欧美等主流药品市场外，南美洲、东南亚，一带一路国家和地区未来市场潜力巨大，博锐生物、博安生物、迈威生物等企业也正在将公司的生物类似药产品推向这些国家。博锐生物的阿达木单抗生物类似药已在巴基斯坦获批，博安生物的贝伐珠单抗也已在巴西递交BLA申请。可以预见的是，未来中国企业生产的生物类似药必定会使全球患者可及。总结随着肿瘤、自免等疾病患病率增加以及老龄化加剧，叠加K药、O药等更多创新生物药专利悬崖的到来，全球生物类似药市场规模将进一步扩大。据Vision Research报告，2022年全球单抗类生物类似药市场规模为87.6亿美元，预计到2032年将达到654.2亿美元左右，2023年至2032年复合年增长率为22.27%。而中国的生物类似药也将在全球市场竞争中占据一席之地。推荐阅读星条旗下的宝藏：美国生物类似药市场2023概览Copyright © 2024 PHARMCUBE. All Rights Reserved.欢迎转发分享及合理引用，引用时请在显要位置标明文章来源；如需转载，请给微信公众号后台留言或发送消息，并注明公众号名称及ID。免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任。精彩预告线下沙龙↑ 长按扫码，报名活动 ↑