Benralizumab

– FDA aligned on plan to initiate parallel Phase 2 trials of rademikibart in patients with moderate-to-severe asthma or COPD experiencing an acute exacerbation – – Expect to initiate both trials in Q2 2025 – SAN DIEGO, April 01, 2025 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (Connect or Connect Biopharma), a clinical-stage biopharmaceutical company focused on transforming acute and chronic care of asthma and chronic obstructive pulmonary disease (COPD), today announced positive feedback from its Type C meeting with the U.S. Food and Drug Administration (FDA), Division of Pulmonology, Allergy, and Critical Care, in the Office of Immunology and Inflammation. “We are pleased to have the FDA’s alignment on our two parallel Phase 2 trials evaluating rademikibart in patients experiencing an acute exacerbation of asthma or COPD, an area where no biologic therapies have been approved or systematically studied,” said Barry Quart, Pharm.D., CEO and Director of Connect Biopharma. “During our Type C meeting, the FDA acknowledged the unmet need for reducing recurrent exacerbations during the vulnerable 28-day period following an acute exacerbation of asthma or COPD. In our previously completed Phase 2 study for the maintenance treatment of asthma, a 600 mg subcutaneous (SC) loading dose of rademikibart was well-tolerated and delivered robust improvement in pulmonary function in less than 24 hours. This promising data suggests that rademikibart could provide meaningful and rapid benefit to the millions of patients who experience exacerbations of asthma or COPD and are seen in emergency departments or are hospitalized each year.” Based on the advice from the FDA at the meeting, Connect plans to begin enrolling patients in these trials during the second quarter of this year. The two parallel Phase 2 randomized, double-blind, placebo-controlled trials are expected to each enroll approximately 160 patients and include patients with uncontrolled, moderate-to-severe asthma or COPD with eosinophils ≥300 cells/µL who are experiencing an acute exacerbation. The trials are designed to evaluate the benefits of a single 600 mg SC dose of rademikibart in patients over 28 days following an acute exacerbation. Based on the results of a recently published trial of a similar design, approximately 45% of patients receiving the current standard of care experienced treatment failure in the 28 days following an acute exacerbation, demonstrating the continued unmet need for better treatments for these patients1. Connect expects to report data from both rademikibart Phase 2 trials in the first half of 2026 with a cash runway into 2027. “Asthma and COPD patients face a heightened risk of further exacerbations within the first 28 days following an initial episode. While biologics have demonstrated significant success in maintenance therapy, none have been approved to address airway symptoms immediately after an acute exacerbation,” said Mario Castro, MD, MPH, Professor and Chief of Pulmonary, Critical Care and Sleep Medicine at the University of Kansas School of Medicine. “The pulmonology community is encouraged by the plan to evaluate the potential benefits of a single 600 mg SC dose of rademikibart following an acute exacerbation in these Phase 2 trials in patients with asthma and COPD.” About Connect Biopharma and Rademikibart Connect Biopharma is a clinical-stage biopharmaceutical company dedicated to transforming care for asthma and COPD. Headquartered in San Diego, California, the company is advancing rademikibart, a next-generation, potentially best-in-class anti-interleukin-4-receptor alpha (IL-4Rα) antibody. With an initial focus on acute exacerbations—an area with significant unmet need—rademikibart has the potential to also drive chronic utilization in asthma and COPD amongst the approximately 1 million asthma patients and 1.3 million COPD patients in the U.S. who experience acute exacerbations annually. In a Phase 2 trial for asthma, rademikibart demonstrated strong efficacy and safety data, with clinically meaningful reductions in exacerbations and rapid, statistically significant improvements in FEV1, observed within one week—and in most cases, within 24 hours via home spirometry. For more information visit www.connectbiopharm.com. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended (the “Act”). Forward-looking statements are statements that are not of historical fact and include, without limitation, statements regarding future events, our future financial condition, results of operations, business strategy and plans, prospective products (as well as their potential to achieve a differentiated, competitive, or favorable benefit or profile or trend, including on safety, tolerability, improvement, maintenance, clinical response, dosing, efficacy and/or convenience), planned or expected product approval applications or approvals, anticipated milestones, expected data readouts and enrollments, research and development plans and costs, potential future partnerships, expectations about existing partnerships, timing and likelihood of success, objectives of management for future operations, future results of anticipated product development efforts, and adequacy of existing cash and potential partnership funding to fund operations and capital expenditure requirements, as well as statements regarding industry trends. These statements are based on management’s current expectations of future events only as of the date of this press release and are inherently subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control, including, among other things: the ability of our clinical trials to demonstrate safety and efficacy of our product candidates and other positive results; whether we will need expanded or additional trials in order to obtain regulatory approval for our product candidates; our ability to obtain and maintain regulatory approval of our product candidates; existing regulations and regulatory developments in the U.S., the PRC, Europe and other jurisdictions; the ability of our current cash and investments position to support planned operations; our plans and ability to obtain, maintain, protect and enforce our intellectual property rights and our proprietary technologies, including extensions of existing patent terms where available; our continued reliance on third parties to conduct additional clinical trials of our product candidates, and for the manufacture of our product candidates for preclinical studies and clinical trials; and the degree of market acceptance of our product candidates, if approved, by physicians, patients, healthcare payors and others in the medical community. Words such as “aim,” “anticipate,” “believe,” “could,” “expect,” “feel,” “goal,” “intend,” “may,” “optimistic,” “plan,” “potential,” “promising,” “will,” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. The inclusion of forward-looking statements should not be regarded as a representation by Connect Biopharma that any of its expectations, projections or plans will be achieved. Actual results may differ materially due to the risks and uncertainties inherent in our business and other risks described in our filings with the U.S. Securities and Exchange Commission (the “SEC”). Further information regarding these and other risks is included under the heading “Risk Factors” in our periodic reports filed with the SEC, including in our annual report on Form 10-K for the year ended December 31, 2024, and any subsequent filings with the SEC. These forward-looking statements should not be taken as forecasts or promises nor should they be taken as implying any indication, assurance or guarantee that the assumptions on which such forward-looking statements have been made are correct or exhaustive or, in the case of the assumptions, fully stated in this presentation. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You are cautioned not to place undue reliance on the scientific data presented or these forward-looking statements, which speak only as of the date of this presentation. Except as required by law, Connect Biopharma undertakes no obligation to publicly update any forward-looking statements, whether because of new information, future events or otherwise. Connect Biopharma claims the protection of the safe harbor for forward-looking statements contained in the Act for all forward-looking statements. This press release discusses product candidates that are under clinical study, and which have not yet been approved for marketing by the U.S. Food and Drug Administration or by any other regulatory agency. No representation is made as to the safety or effectiveness of these product candidates for the use for which such product candidates are being studied. The trademarks included herein are the property of the owners thereof and are used for reference purposes only. Investor Relations Contact: Alex Lobo Precision AQ Alex.lobo@precisionaq.com(212) 698-8802 Media Contact: Ignacio Guerrero-Ros, Ph.D., or David SchullRusso Partners, LLCIgnacio.guerrero-ros@russopartnersllc.comDavid.schull@russopartnersllc.com(858) 717-2310 or (646) 942-5604 Ramakrishnan S, et.al. Treating eosinophilic exacerbations of asthma and COPD with benralizumab (ABRA): a double-blind, double-dummy, active placebo-controlled randomised trial. Lancet 2025; 13(1): 59-68.

跨国药企在中国重点资讯文 | 苏丁企业动态西门子医疗西门子医疗与南京市投资促进局签署战略合作协议。双方将合作共建南京“西门子医疗开放式医工转化平台”，聚焦医工转化、临床技术应用（如光子计数CT、高端7T磁共振，先进复合手术室等）、数字医疗生态及国际人才合作。此外，双方将通过远程诊疗支持基层医联体，推动优质医疗资源下沉，探索元宇宙技术赋能医疗展示中心，呈现未来诊疗场景，为南京生物医药医疗产业集群注入创新动能，助力打造“健康中国”示范城市。阿斯利康阿斯利康与全球领袖共聚博鳌亚洲论坛2025年年会。阿斯利康全球首席执行官苏博科强调，科技在助力早诊断、早干预以推动共同健康方面，拥有变革性的力量，可使更多患者受益。苏博科表示，将坚定推动在绿色发展方面的政企合作。阿斯利康正携手全球及中国领军企业，共同推动医疗供应链脱碳。阿斯利康已携手合作伙伴发起一项可再生能源购买协议，目前共同采购了425吉瓦时的绿色电力，每年减少25万吨二氧化碳当量的排放。上周，阿斯利康宣布在北京新建全球战略研发中心，这是其在京投资25亿美元计划的一部分。美敦力3月24日，美敦力数字化医疗创新基地签约及揭幕活动在国际医药创新公园（BioPark）举行。这是美敦力在华设立的首个数字化医疗创新基地。该基地是美敦力在华设立的首个数字化医疗创新基地，致力于研发基于人工智能和大数据的疾病管理解决方案，将聚焦心血管、微创外科、神经科学等领域建设医疗培训中心；建立患者关爱中心，引入数字化技术，提升患者预防管理的服务水平；同时建设美敦力博物馆。该创新基地将于今年底正式投入运营。CSL全球生物治疗领域先驱CSL有限公司首席执行官兼董事总经理保罗·麦肯齐（Paul McKenzie）到访中国，参加中国发展高层论坛（CDF），并出席一系列重要的行业活动。CSL集团旗下子公司杰特贝林（CSL Behring）与国药控股于上海续签战略4PL合作协议。杰特贝林将与国药控股携手，依托其全国一体化的物流网络、多元化的渠道资源、完备的商业布局以及领先的数字化营销能力，通过创新服务模式，提升杰特贝林创新疗法和药品的可及性，惠及更多中国患者。诺和诺德业内消息称，诺和诺德全球高级副总裁兼大中国区总裁周霞萍向员工宣布了一项人事任命，自3月31日起，罕见病业务部负责人牛燕来（Nicole Niu）将担任新兴事业部（EBD）企业副总裁职务，领导诺和诺德中国EBD团队，推动诺和诺德中国GLP-1糖尿病产品线的可持续增长。丹纳赫2025年1月，胡翔宇正式担任丹纳赫中国生命科学平台总裁一职。他围绕丹纳赫中国生命科学平台的运行现状、本土化战略、行业发展趋势、全球市场竞争环境、平台重点关注领域以及创新生态构建等话题进行了深入交流。胡翔宇介绍：丹纳赫中国生命科学平台已成长为中国生命科学领域的中坚力量。2025年，平台将聚焦精准医疗、生物制药、合成生物学和数字生命科学等领域。围绕生命科学领域，将通过投资和收购、行业高质量合作以及深度本土化，三管齐下，持续巩固市场领先地位，推动业务发展。赛诺菲欧彼乐（Opella，赛诺菲消费者健康药业）联合京东健康在北京举办以“远离疲惫与脂肪肝”为主题的2025年度合作发布会，旨在通过医患教育、疾病科普等行动，整合彼此资源，共同提升公众对脂肪肝的认知。双方将整合各自优势，依托欧彼乐的专业资源和健康解决方案，以及京东健康的数字化服务平台，持续提升公众对脂肪肝的疾病认知，促进诊疗水平升级，增强人们的体重管理能力、提升整体健康水平。产业动态罗氏制药和默克共同宣布双方正式签订协议，就拓得康（通用名：特泊替尼）在中国大陆市场的商业化达成合作。双方将充分整合各自优势资源，推动特泊替尼惠及更多METex 14跳跃突变局部晚期或转移性非小细胞肺癌成人患者。通过这次合作，罗氏制药将进一步丰富在中国的肺癌产品管线，继续携手各方推动肺癌规范化诊疗水平提升。特泊替尼由德国默克公司研发，是全球首个获批上市的MET抑制剂。卫材制药（Eisai）宣布一项重大决策，已将其质子泵抑制剂Pariet（商品名：波利特，通用名：雷贝拉唑钠肠溶片）在中国的权利转让给康桥资本集团（CBC Group）控制的北京顶峰生物医药有限公司（Peak Pharma）。波利特是一款知名的处方药，主要成分雷贝拉唑在抑制胃酸分泌方面效果显著，广泛用于治疗胃溃疡、十二指肠溃疡、吻合口溃疡、反流性食管病以及卓一艾氏综合征等消化系统疾病。拜耳与苏州浦合医药科技有限公司宣布，双方已就浦合医药口服小分子PRMT5抑制剂达成全球许可协议。该抑制剂可选择性靶向MTAP缺失型肿瘤。根据该协议，拜耳获得开发、制造和商业化MTA协同PRMT5抑制剂的全球独家许可。拜耳已招募首例患者参与I期人体首次剂量爬坡临床试验。该试验以BAY 3713372为代号，研究MTA协同PRMT5抑制剂用于治疗MTAP缺失型实体瘤。联邦制药宣布其全资附属公司联邦生物科技（珠海横琴）有限公司与诺和诺德股份有限公司签订独家许可协议。该协议涉及一种名为UBT251的药物，主要用于治疗肥胖、2型糖尿病等疾病，现处于早期临床开发阶段。根据协议，诺和诺德将获得全球（不包括中国大陆、香港、澳门和台湾）开发、制造和商业化UBT251的权利，而联邦生物科技则保留在上述地区的权利。联邦生物科技有资格收取2亿美元的预付款和最高18亿美元的潜在里程碑付款。恒瑞医药与默沙东（MSD）达成协议，将恒瑞的脂蛋白（a）口服小分子项目（包括名为HRS-5346的先导化合物）有偿许可给MSD，MSD将获得HRS-5346在大中华地区以外的全球范围内开发、生产和商业化的独家权利。默沙东将向恒瑞支付2亿美元的首付款，并且恒瑞有资格获得最高可达17.7亿美元的里程碑付款。阿斯利康宣布重度嗜酸粒细胞性哮喘（SEA）创新靶向生物制剂凡舒卓（本瑞利珠单抗注射液）在中国正式商业上市，用于成人和12岁及以上青少年重度嗜酸粒细胞性哮喘的维持治疗。本瑞利珠单抗是精准靶向嗜酸性粒细胞（EOS）的抗IL-5R创新生物制剂。阿斯利康的康可期（英文商品名：Calquence，通用名：阿可替尼胶囊）获中国国家药品监督管理局（NMPA）正式批准，本品单药适用于成人慢性淋巴细胞白血病（CLL）/小淋巴细胞淋巴瘤（SLL）患者。这是阿可替尼在中国获批的第3项适应症，标志着其将同时适用于初治和经治的CLL/SLL患者。在ADRIATIC III期临床试验中的中国队列研究数据显示：与安慰剂相比，阿斯利康的英飞凡（通用名：度伐利尤单抗）治疗同步放化疗（cCRT）后疾病无进展的局限期小细胞肺癌（LS-SCLC），患者在两个主要研究终点总生存期（OS）和无进展生存期（PFS）的获益趋势与全球患者一致。在全球530例随机受试者中95例（17.9%）为中国人群。礼来中国宣布，其阿尔茨海默病创新药物记能达（多奈单抗注射液）正式纳入广州定制型商业健康保险“穗新保珠江药安心”的创新药械保障目录。泰康口腔与瑞典Nobel种植牙品质联盟联合发布会3月20日举办，标志着双方合作的深化。泰康口腔是诺保科在中国市场中长期的重要合作伙伴，双方在推动口腔医疗技术进步和提升患者体验方面共同发力取得了显著成果。联系美通社+86-10-5953 9500info@prnasia.com