Tanfanercept

全文共2790字 共0图 预计阅读时间：8分钟 北京时间2025年3月21日傍晚，一笔和铂医药与阿斯利康之间的合作消息刷爆朋友圈。 据和铂医药，其已与阿斯利康达成全球战略合作。双方将共同研发针对免疫性疾病、肿瘤及其他多种疾病的新一代多特异性抗体疗法。此次战略合作内容涵盖基于和铂医药专有的Harbour Mice®全人源抗体技术平台在多治疗领域的多项目授权许可协议，以及阿斯利康对和铂医药的1.05亿美元股权投资。协议总金额高达45.75亿美元。 这不是和铂医药与阿斯利康第一次联手。此前，双方曾就一款CLDN18.2xCD3双特异性抗体HBM7022达成全球对外授权协议。另外，就在去年5月，和铂医药全资子公司诺纳生物与阿斯利康达成合作协议，将一款临床前阶段肿瘤靶向治疗单抗新药授权给阿斯利康。三笔交易叠加在一起，双方的合作交易总金额已经超过55亿美元。 毋庸置疑的是，这笔最高近46亿美元的交易将把近年来找准路线，并已经展现出猛烈发展势头的和铂医药带入新高度。 同时，对于已在中国扎根多年的阿斯利康而言，这也将是其在经历去年的风波后，在中国的又一次重磅布局。且从阿斯利康官网来看，其2025年的中国宏图远不局限于跟和铂医药的这笔交易。 和铂医药：2025再起飞 和铂医药成立于2016年。公司成立同年，和铂医药就收购了荷兰生物科技企业Harbour Antibodies，获得其全人源抗体转基因小鼠平台（Harbour Mice®）。这也是和铂医药后来的核心技术基础。 2017年，公司从韩国制药公司HanALL Biopharma（以下简称“HanALL”）手里收购了两款临床后期产品——巴托利单抗（HBM9161）和特那西普（HBM9036）。公司管线在短时间内得以丰富。 基于以上这些在平台建设上做出的努力，2018年和铂医药完成了A+轮和B轮融资。并于2020年底登陆港股，最高峰时市值已经触及100亿港币。 但和很多其他Biotech公司一样，和铂医药在经历巅峰后，也未能幸免于时间对一家公司长期价值的严峻考验。2022年10月，因管线进展不顺，和铂医药将此前从HanALL收购来的两个后期临床管线，先后处理、发卖。并亏本出售了其生物大分子研发创新中心项目的生产厂房。 也是在这个时候，和铂医药的转型决心更加坚定。2022年11月，和铂医药成立全资子公司诺纳生物，利用早期建立的平台，对外提供从发现到临床研究审批的完整临床前药物开发服务，一头扎进“卖水人”阵营。并进一步加强了对外管线授权及平台合作业务。据不完全统计，自2022年起，和铂医药已与阿斯利康、辉瑞、科伦博泰、Moderna、百济神州、Cullinan Oncology等多家知名公司建立授权/合作关系。 值得注意的是，通过建立新的运营模式，和铂医药在一年时间里便顺利扭亏为盈。这家公司2023年财报信息显示，其全年总盈利2276万美元，收入构成主要包括产品授权、研究服务和技术授权。 2025年，中国创新药资产在国际上大火。和铂医药基于此前在管线授权方面的积累，在这种积极趋势中水涨船高，对外合作更进一步。2025年截至目前，除阿斯利康外，其已于包括Windward Bio、英矽智能、HBM Alpha Therapeutics达成合作交易。并在年初宣布股份回购计划后，股价一路高涨，翻了差不多近4倍。 就昨夜官宣的与阿斯利康的这笔交易而言，其中有两个重点信息需要注意： 一是从合作内容来看，区别于此前单纯的管线授权及平台技术合作，和铂医药与阿斯利康的这次合作涉及的管线数量更多，合作时间更长（有延长到十年的可能）且范围更广（入股+共建创新中心），是一次绑定程度更深的合作。 二是从合作金额来看，与阿斯利康的这次合作，协议总金额高达45.75亿美元，是和铂医药自2022年来最大的一笔合作。 另外，阿斯利康此次给出的认购价为每股1.38美元（相当于每股约10.74港元）。此认购价较股份认购协议日期于联交所所报每股7.83港元的收市价溢价约37.2%。 一个猜测是，在阿斯利康的加持以及2025年整体中国创新资产授权前景大好的前提下，或许和铂医药的2025可能会飞得更高的。 阿斯利康2025中国宏图：不止和铂 对于阿斯利康而言，其对中国市场和创新资产的期待，并不止与和铂医药的合作这一步。 几乎与上述交易同时，阿斯利康中国发布了其2025年在中国的一系列投资计划。具体而言，阿斯利康已与北京市人民政府和北京经济技术开发区管理委员会达成战略合作伙伴关系，将在国内进行一项长达5年，总价25亿美元的投资计划，并将在北京建立第六个全球战略研发中心。已官宣的合作伙伴，除了上文提到的和铂医药外，还有元思生肽、康泰生物。此外，今年2月官宣的1.6亿美元收购珐博进中国也是此计划中的一部分。 其中，元思生肽是一家成立于2018年的创新口服大环肽药物研发企业，与阿斯利康的这项合作主要共同开发针对慢性疾病的全球首创大环肽类药物。 康泰生物则是一家成立于1992年的公司，专注人用疫苗的研发、生产和销售。阿斯利康表示，其将与康泰生物成立一家新的合资企业，进行呼吸道疾病和其他传染性疾病创新疫苗的开发、生产和商业化，以惠及中国及全球患者。这将成为阿斯利康在华首个也是唯一的疫苗生产基地，坐落于北京国际医药创新公园。 另外，就计划中的北京全球战略研发中心，阿斯利康表示，这将是继上海全球战略研发中心建立后，其在中国建立的第二个全球战略研发中心，将以先进的人工智能和数据科学实验室为支撑，致力于推动药物早期研究和临床开发。新的研发中心将坐落于北京国际医药创新公园（BioPark），毗邻领先的生物科技企业、研究型医院以及国家药品监督管理局。 小结 据阿斯利康，通过上述这一系列部署，其预计在北京的员工人数将增至1700人，规模将进一步扩大。 同时，这项价值25亿的投资计划也说明一件事，即作为2007年就在中国成立中国创新中心的MNC，阿斯利康对于中国市场及中国创新资产的热情是不会被去年的冷风吹灭的。 参考资料来源： 1.公司官网 2.其他公开资料 封面图来源：AI 版权声明/免责声明 本文为原创文章。 本文仅作信息交流之目的，不提供任何商用、医用、投资用建议。 文中图片、视频、字体、音乐等素材或为药时代购买的授权正版作品，或来自微信公共图片库，或取自公司官网/网络，部分素材根据CC0协议使用，版权归拥有者，药时代尽力注明来源。 如有任何问题，请与我们联系。 衷心感谢! 药时代官方网站:www.drugtimes.cn 联系方式: 电话:13651980212 微信:27674131 邮箱:contact@drugtimes.cn 点击，查看更多精彩!

Batoclimab receives Orphan Drug Designation in Japan, advancing treatment for active Thyroid Eye Disease (TED). Batoclimab, subcutaneous formulation, offers the potential for at-home administration, improving patient convenience and accessibility. Phase 3 study to confirm the potential of batoclimab to address unmet needs of patients with TED in process, with top-line results expected in the 2H 2025. SEOUL, South Korea, March 6, 2025 /PRNewswire/ -- HanAll Biopharma Co., Ltd. (KRX: 009420.KS), a global biopharmaceutical company committed to discovering and developing innovative medicines for patients, announced that Batoclimab, an anti-FcRn treatment being developed for a range of autoimmune diseases, has received Orphan Drug Designation (ODD) from the Ministry of Health, Labor and Welfare (MHLW) in Japan for active Thyroid Eye Disease (TED). The Orphan Drug Designation (ODD), granted by the MHLW, is awarded to drugs and biologics intended to treat rare diseases affecting fewer than 50,000 people in Japan, with eligibility based on criteria such as patient population size, medical needs, and the feasibility of development, and possibility of development[1]. Currently, it is estimated that approximately 35,000 people in Japan are affected by TED.[2] "We are thrilled to have received Orphan Drug Designation for Batoclimab in Japan, marking an important milestone in our efforts to bring this promising treatment to patients in need," said Sean Jeong, MD, MBA, CEO of HanAll Biopharma. "This designation highlights the potential impact Batoclimab could have on the lives of patients with TED. We remain dedicated to advancing the development of this treatment and are focused on bringing it closer to the market." Batoclimab is a monoclonal antibody designed to target and inhibit FcRn, which plays a crucial role in recycling IgG antibodies. By selectively binding to FcRn, Batoclimab reduces the levels of harmful IgG antibodies, offering the potential to treat a variety of IgG-mediated autoimmune diseases. Being developed as a subcutaneous (SC) formulation, Batoclimab is expected to allow patients to administer the treatment at home, improving convenience and accessibility. Currently, Batoclimab is being investigated globally for conditions such as generalized myasthenia gravis (gMG), thyroid eye disease (TED), chronic inflammatory demyelinating polyneuropathy (CIDP), and Graves' disease. HanAll, with its licensee, is conducting a Phase 3 study of Batoclimab in active TED. The study, which includes patient enrollment in Japan, aims to confirm the efficacy and safety of Batoclimab as a potential new treatment for individuals affected by TED. Thyroid Eye Disease (TED), also known as Graves' orbitopathy, is a rare and debilitating autoimmune disorder primarily affecting individuals with hyperthyroidism or Graves' disease. TED is characterized by a range of severe symptoms, including eye bulging, pain, double vision, and, in some cases, vision loss. TED can severely limit daily activities such as reading, driving, and working. In addition, many individuals face significant social and psychological challenges, including concerns about their appearance, anxiety, low mood, and social withdrawal. Currently, treatment options for those with moderate to severe cases of TED remain limited, highlighting the urgent need for more effective therapies to improve patient outcomes and quality of life. About HanAll Biopharma HanAll Biopharma (KRX: 009420.KS) is a global biopharmaceutical company with presence in Korea, the USA, Japan, and Indonesia with the mission of making meaningful contributions to patients' lives by introducing innovative, impactful medicines to address severe unmet medical needs. HanAll has been operating a portfolio of pharmaceutical products in the therapeutic areas of endocrine, circulatory, and urologic diseases for over 50 years. HanAll has also expanded its focus to immunology, oncology, neurology, and ophthalmology to discover and develop innovative medicines for patients with diseases for which there are no effective treatments. One of its lead pipeline assets, HL161 (INN: batoclimab), an anti-FcRn antibody, is being developed in Phase 3 and Phase 2 trials across the world for the treatment of autoimmune diseases including generalized myasthenia gravis (gMG), thyroid eye disease (TED), chronic inflammatory demyelinating polyneuropathy (CIDP). HL161ANS (IMVT-1402), another anti-FcRn antibody from HanAll, is being evaluated in Graves' Disease (GD) and Rheumatoid arthritis (RA). Another lead asset, HL036 (INN: tanfanercept), a TNF inhibitor protein, has commenced a Phase 3 VELOS-4 study in the US and is also being evaluated in China for the treatment of dry eye disease. Results from the Phase 1 study, HL192 (ATH-399A), a Nurr1 activator targeting Parkinson's Disease (PD), have been released, and the preparations to initiate a next study in patients with PD is progressing. For further information, visit our website and connect with us on LinkedIn. For any media inquiries, please contact HanAll PR/IR ([email protected], [email protected]). Disclaimer Statement The contents of this announcement include statements that are, or may be deemed to be, "forward-looking statements." These forward-looking statements can be identified by the use of forward-looking terminology, including the terms "believes," "estimates," "anticipates," "expects," "intends," "may," "will," or "should," and include statements HANALL (the company, we) makes concerning its 2025 business and financial outlook and related plans; the therapeutic potential of its product candidates; the intended results of its strategy and the company, and its collaboration partners', advancement of, and anticipated clinical development, data readouts and regulatory milestones and plans, including the timing of planned clinical trials and expected data readouts; the design of future clinical trials and the timing and outcome of regulatory filings and regulatory approvals. By their nature, forward-looking statements involve risks and uncertainties, and readers are cautioned that any such forward-looking statements are not guarantees of future performance. The company's actual results may differ materially from those predicted by the forward-looking statements. These may include various significant factors, such as our expectations regarding the inherent uncertainties associated with competitive developments, preclinical and clinical trial and product development activities, and regulatory approval requirements. In addition, performance may be affected by our reliance on collaborations with third parties, estimating the commercial potential of our product candidates, our ability to obtain and maintain protection of intellectual property of technologies and drugs, our limited operating history, and our ability to obtain additional funding for operations and to complete the development and commercialization of product candidates. A further list and description of these risks, uncertainties, and other risks can be found in Korea Stock Exchange (KRX) filings and reports, including in our most recent annual report as well as subsequent filings and reports filed by the company with the KRX. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. We undertake no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by Korean law and regulations. SOURCE HanAll Biopharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED