Rademikibart

全球医疗行业每日重点资讯文 | 苏丁企业动态制药巨头默沙东公司(MSD)以约100亿美元的价格收购专注于呼吸系统疾病的Verona Pharma公司。通过此次收购，默沙东公司将获得Verona的慢性阻塞性肺疾病药物Ohtuvayre。美国食品药品监督管理局于2024年6月批准Ohtuvayre用于成人慢性阻塞性肺疾病的维持治疗。该交易已获两家公司董事会批准，预计将于第四季度完成。但仍需获得Verona股东的批准以及英格兰及威尔士高等法院的认可。7月8日，赫力昂中国正式对外宣布，赫力昂（Haleon）已于近日完成对其非处方药合资企业中美天津史克制药有限公司（TSKF）的收购。赫力昂以总计16.23亿元人民币（约合2亿英镑）的价格，收购了TSKF剩余的12%股权。至此，中美史克正式成为赫力昂的全资子公司。7月9日，瑞士索诺瓦集团，总部直设的子公司“索诺瓦听力技术（海南）有限公司，在海南博鳌乐城国际医疗旅游先行区迎正式运营。索诺瓦听力技术（海南）有限公司与乐城先行区内博鳌超级医院、树兰（博鳌）医院签署了战略合作协议，整合优势资源，共同探索和打造听力健康服务新模式。碧迪公司(BD)宣布，自7月2日起，Bilal Muhsin被任命为执行副总裁，并将出任BD医疗四大部门之一的“智能互联监护” (Connected Care) 部门总裁，该任命立即生效。BD表示，该部门将成为公司未来的主要增长动力。Mushin将领导战略制定工作，向BD董事长、首席执行官兼总裁Tom Polen汇报工作，并作为核心成员参与BD全球执行领导团队决策。西门子医疗和柏林夏里特医学院将在预防医学领域更紧密地合作。双方将整合各自的专业优势，通过合作伙伴关系，携手加强以患者为中心的预防医学的研究和临床应用。双方将最先探索现代疾病预防在心脏病领域的潜力，将制定筛查计划、风险评估和患者画像系统，以精准识别高危人群并制定个性化治疗方案，同时加速这些创新成果在临床实践中的应用。双方还将启动联合研究项目，探索如何借助人工智能支持的创新诊疗协议。北京同仁堂医养投资股份有限公司向港交所主板递交上市申请。据招股书，同仁堂医养是中国一家中医医疗集团，为个人客户提供全面中医医疗服务，为机构客户提供标准化管理服务，并提供各种医药产品及其他产品。同仁堂医养已建立分级医疗服务网络，包括12家自有线下医疗机构及一家互联网医院，以及10家线下管理医疗机构。浙江数问生物技术有限公司宣布完成近亿元C1轮融资并开启C2轮融资。本轮融资由金创投领投，老股东元生创投持续注资。融资资金将用于加速数问生物全球首创诊断产品的国内外市场推广，同时加大新产品研发投入，进一步丰富和完善公司的女性健康精准诊疗产品管线。恩凯赛药（上海恩凯细胞技术有限公司）宣布完成近亿元A+++轮融资，本轮融资由浦东创投、星博生辉参与。本轮募集的资金将用于推进核心产品的临床试验及新产品管线开发，加速NK细胞药物临床转化。蒲公英Ouryao与加拿大多伦多知名孵化器LaunchHub联合，在LaunchHub孵化器正式挂牌联合成立“蒲公英（北美）生物医药孵化中心”（Ouryao NA Biomedical Incubator ）。蒲公英与北美本地组织战略合作也在持续推进中。蒲公英已与加拿大SCPA（加拿大华人医药协会）和iBIO（华人生物医药产业学会）等达成了多项合作意向。产业动态比尔·盖茨在最新文章中披露，阿尔茨海默病防治正迎来历史性突破。今年6月，美国FDA批准首个针对55岁以上人群的血液检测，通过测定脑内淀粉样蛋白斑块比例，可在认知衰退前数十年发现病灶。这种简便检测将推动常规筛查普及，为早期干预奠定基础。此外，FDA已批准两种药物，虽仅能适度减缓病程，但盖茨强调，若与早期检测结合，在症状出现前15-20年用药，效果可能远超当前预期。针对无症状患者的III期临床试验正在推进，2026年有望揭晓更积极结果。礼来治疗阿尔茨海默症的药物Kisunla获FDA批准更新药品标签，新给药方案可使不良事件发生率降低达41%。礼来宣布，美国食品药品监督管理局（FDA）已批准其每月一次的β淀粉样蛋白靶向疗法Kisunla（donanemab-azbt，多奈单抗）更新药品标签，新增推荐滴定给药方案。维泰瑞隆宣布与诺华达成一项战略协议，授予诺华一项独家选择权，以收购其专有的“脑部递送模组（Brain Delivery Module, BDM）”平台。该平台是一种差异化的血脑屏障穿透技术，旨在提高多种形式药物的脑部递送效率。同时，维泰瑞隆保留使用该平台继续开发选定项目的权利。诺华将在选择权期限内对BDM平台进行评估。若行使选择权，诺华将获得该平台的全球独家权利。维泰瑞隆有资格获得总计高达1.75亿美元的预付款及近期付款。百奥赛图宣布与百济神州达成抗体分子的全球许可协议。百济神州此前已获得百奥赛图RenMice全人抗体平台的授权使用许可，本次双方在已建立的良好合作基础上进一步将合作拓展至抗体分子授权许可领域，标志着双方合作的持续深化。百济神州将向百奥赛图支付首付款。此外，百奥赛图还将有权获得开发和监管里程碑付款、商业化里程碑付款，以及基于净销售额的特许权使用费。康华生物近日与信然博创签署补充协议，终止肺结核mRNA疫苗研发项目，以及狂犬mRNA疫苗及带状疱疹mRNA疫苗项目的后续研发合作。先声药业与康乃德生物医药合作的创新药乐德奇拜单抗新药上市申请（NDA）获国家药品监督管理局（NMPA）受理，用于治疗特应性皮炎。乐德奇拜单抗是靶向IL-4Rα的全人源单抗。驯鹿生物宣布，韩国食品药品安全部（MFDS）授予其自主研发的靶向BCMA的CAR-T细胞治疗产品伊基奥仑赛注射液（Fucaso）孤儿药资格认定（ODD），用于治疗既往经过至少三线治疗后出现疾病进展（至少使用过一种蛋白酶体抑制剂及免疫调节剂）的复发或难治性多发性骨髓瘤（R/R MM）成人患者。伊基奥仑赛注射液获得ODD后有望加速在韩国的注册审批，使当地患者早日获益。联系美通社+86-10-5953 9500info@prnasia.com

SAN DIEGO, July 09, 2025 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (“Connect Biopharma”, “Connect”, or the “Company”), a clinical-stage biopharmaceutical company focused on transforming care for the treatment of inflammatory diseases, today announced that the Company’s collaborator and exclusive licensee in China, Simcere Pharmaceutical Co., Ltd. (“Simcere”), has submitted its New Drug Application for rademikibart to the National Medical Products Administration of China (“NMPA”) for the treatment of atopic dermatitis (“AD”) in adults and adolescents. “Simcere continues to make strong progress in advancing rademikibart in China, our potentially best in class next generation IL-4Rα antibody,” said Barry Quart, Pharm.D., CEO and Director of Connect Biopharma. “Atopic dermatitis remains a large and growing market in China, and rademikibart has the potential to significantly improve the condition for millions of patients. Together, we remain committed to advancing rademikibart for the treatment of a range of inflammatory diseases including AD, asthma, and chronic obstructive pulmonary disease.” In 2023, Connect and Simcere entered into an exclusive license and collaboration agreement for rademikibart in China. Under the agreement, Simcere was granted exclusive rights to develop, manufacture, and commercialize rademikibart for all indications in Greater China, including mainland China, Hong Kong, Macau, and Taiwan, while Connect retains rights in all other markets. As part of the agreement, Connect is eligible to receive milestone payments up to an aggregate remaining amount of approximately $110 million upon the achievement of certain development, regulatory and commercial milestones. Connect is also eligible to receive royalties at tiered percentage rates up to low double-digit percentages on net sales in Greater China. The AD market in China represents considerable opportunity, with an estimated 70 million patients with AD. About Rademikibart Rademikibart is a fully human monoclonal antibody targeting interleukin-4 receptor alpha (IL-4Rα), a common subunit of interleukin-4 receptor (IL-4) and interleukin-13 receptor (IL-13). By binding with IL-4Rα, rademikibart can block the functions of IL-4 and IL-13 effectively, thereby blocking the T helper 2 (Th2) inflammatory pathway, thus achieving the goal of treating Th2 related inflammatory diseases such as atopic dermatitis and asthma. About Simcere Simcere Pharmaceutical Co., Ltd. is an innovation and R&D-driven pharmaceutical company and focuses on the therapeutic areas including neuroscience, anti-oncology, autoimmune and anti-infection. The company develops innovative therapies in disease areas that may have significant clinical needs in the future, aiming to achieve the mission of “for patients, for life”. Driven by its in-house R&D efforts and synergistic innovation, Simcere has established strategic cooperation partnerships with many innovative companies and research institutes. About Connect Biopharma Connect Biopharma is a global, clinical-stage biopharmaceutical company dedicated to developing innovative therapies and transforming care for the treatment of inflammatory diseases. The Company’s lead product candidate, rademikibart (formerly known as CBP-201), is an antibody designed to target IL-4Rα and has demonstrated activity in both atopic dermatitis and asthma. The Company is currently conducting global studies of rademikibart for the treatment of acute exacerbations of asthma and COPD, areas with significant unmet need. 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, adequacy of existing cash and potential partnership funding to fund operations and capital expenditure requirements, anticipated patient populations or market opportunities for our prospective products, if approved, 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,” “look forward to,” “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 annual and periodic reports filed 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 any forward-looking statements, which speak only as of the date of such presentation(s) or such statements. 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 our product candidate, rademikibart, which is under clinical investigation and has not yet been approved for marketing by the U.S. Food and Drug Administration, the NMPA, or by any other regulatory agency. No representation is made as to the safety or effectiveness of rademikibart for the uses for which it is 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.com David.schull@russopartnersllc.com (858) 717-2310 or (646) 942-5604