Mitsubishi Tanabe Pharma Corp.

刚刚，京新药业发布公告，公司与Gedeon RichterPlc.签署了《专利许可协议》。根据协议，Gedeon Richter将授予京新药业一项专利独占许可，京新药业可在许可区域（中国大陆）内使用该专利开发、制造和商业化盐酸卡利拉嗪制剂及原料药（API）。京新药业将自主生产盐酸卡利拉嗪，并以自有品牌进行商业化。 欢迎加入群聊 根据协议约定，在满足包括获得监管批准在内的设定条件后，京新药业将向GedeonRichter支付总额不超过53万欧元的里程碑款项。此外，未来在许可区域（中国大陆）内盐酸卡利拉嗪产品上市销售后，京新药业将根据协议约定，在不同适用条件下，按许可区域内产品净销售额向GedeonRichter支付相应的销售分成。 盐酸卡利拉嗪胶囊，商品名Vraylar/Reagila，原研为匈牙利吉瑞大药厂(GedeonRichter)，后与艾伯维、艾尔建、田边三菱等公司合作，在不同国家上市。盐酸卡利拉嗪为非典型抗精神病药物，属于多巴胺D2、D3受体部分激动剂。主要用于成人精神分裂症的治疗、成人双相Ⅰ型障碍相关躁狂或混合发作的急性期治疗、成人双相I型障碍（双相抑郁症）相关抑郁发作的治疗以及抗抑郁治疗（ADT）中的重度抑郁症（MDD）辅助治疗。 盐酸卡利拉嗪已获得美国FDA批准用于治疗成人精神分裂症、双相躁狂、双相抑郁以及作为抗抑郁治疗（ADT）中的重度抑郁症（MDD）辅助治疗；已获得欧洲药品管理局（EMA）批准用于治疗成人精神分裂症；其在全球多国已获得精神分裂症、双相情感障碍等疾病的相关诊疗指南推荐。 目前，京新药业的盐酸卡利拉嗪在今年4月已正式提交上市申请，仅此一家。京新药业表示，此次与Gedeon Richter的此次合作，将有助于加快公司盐酸卡利拉嗪在国内的上市和商业化。

CARLSBAD, CA, USA I August 04, 2025 I Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel allogeneic, or “off the shelf”, cell therapies for serious neurological and ophthalmic conditions, announced today that the first-ever chronic spinal cord injury patient has been treated in the Company’s DOSED (Delivery of Oligodendrocyte Progenitor Cells (OPCs) for Spinal Cord Injury: Evaluation of a Novel Device) clinical study at UC San Diego Health. The DOSED study is designed to evaluate the safety and utility of a new parenchymal spinal delivery system, a novel delivery device developed to deliver OPC1 directly to the site of injury in patients with spinal cord injury (SCI), and will enroll both subacute (between 21 to 42 days following injury) and chronic (between 1 to 5 years following injury) SCI patients. OPC1 is an investigational, allogeneic stem cell-derived cell transplant, comprised of oligodendrocyte progenitor cells. OPC1 is designed to replace or support cells in the injured spinal cord that are absent or dysfunctional due to traumatic injury and is intended to help restore or augment functional activity in persons suffering from an SCI. Improved functional activity can lead to greater mobility and enhanced quality of life for patients and significant cost-savings for caregivers. The first patient treated in DOSED was a neurologically complete SCI injury (American Spinal Injury Association Impairment Scale [AIS] grade A), with a single neurological level of injury (NLI) from T1 to T10, and the novel spinal delivery system successfully administered the intended one-time injection of 10 million OPC1 cells. “Differentiated cell transplantation is a promising therapeutic approach that is increasingly being validated in a wide range of diseases and conditions. For this reason, it is exciting to advance the OPC1 program into further clinical testing and expand the OPC1-treated population to include chronic SCI patients,” stated Brian M. Culley, Lineage’s CEO. “DOSED is the third clinical study of OPC1 and is evaluating a superior delivery system, designed to deliver our proprietary cells over several minutes and without the need for stopping patient ventilation during administration. The delivery system is also compatible with a forthcoming immediate-use thaw-and-inject formulation of OPC1 that we developed for this program, which will eliminate the lengthy dose preparation steps conducted in prior studies. This is the first time OPC1 has been administered to a patient with a chronic spinal cord injury, which is an important milestone because those patients represent an additional and larger potential treatable population for this experimental therapy. In addition to evaluating the safety and performance of the new delivery device, we also will be collecting functional assessments on all patients, which gives us the opportunity to investigate any signals of efficacy that may arise in these patients. We are pleased the first-ever use of this custom delivery solution had a successful outcome with no administration issues and look forward to opening this study to additional sites.” OPC1 has extensive long-term safety data from two prior clinical trials: a five-patient Phase 1 safety trial in acute thoracic SCI, where all active subjects have been followed for at least 13 years; and a 25-patient Phase 1/2a multicenter dose-escalation trial in subacute cervical SCI, where all active subjects have been evaluated for at least 7 years. Long-term safety monitoring is ongoing for both studies, with no unexpected serious adverse events attributable to the OPC1 transplant being reported to date. Results from both studies have been published in the Journal of Neurosurgery: Spine. The Phase 1/2a publication of OPC1 in subacute cervical SCI is available here and the publication from the Phase 1 clinical study of OPC1 in acute thoracic SCI is available here . The OPC1 program was one of the first cell therapy clinical trials to be supported by the California Institute for Regenerative Medicine (CIRM) under Proposition 71. A publication focused on outlining the Magnetic Resonance Imaging (MRI) evidence from the 25-patient Phase 1/2a multicenter dose-escalation trial of OPC1 in subacute cervical SCI is also forthcoming. Lineage founded the Annual Spinal Cord Injury Investor Symposium in 2023 and has co-sponsored the event in partnership with The Christopher & Dana Reeve Foundation in each year since then. The goals of this collaborative effort include increasing disease awareness, improving the probability of success in product development, and supporting clinical trial participation. The Reeve Foundation is dedicated to curing spinal cord injury by funding innovative research and improving the quality of life for individuals and families impacted by paralysis. Presenting companies have included AbbVie, Mitsubishi Tanabe, Neuralink, NervGen Pharma, Neuvotion, NovaGo Therapeutics, ONWARD, Paradromics and Synchron. About OPC1 OPC1 is an oligodendrocyte progenitor cell (OPC) transplant therapy designed to provide clinically meaningful recovery in, and improvements to, motor function in individuals with spinal cord injuries (SCIs). OPCs are naturally occurring precursors to the cells that provide electrical insulation for nerve axons in the form of a myelin sheath. SCI most often occurs when the spinal cord is subjected to a severe crush or contusion injury and typically results in severe functional impairment, including limb paralysis, aberrant pain signaling, and loss of bladder control and other body functions. In the U.S., there are approximately 18,000 new spinal cord injuries annually and over 300,000 patients in total living with spinal cord injuries. There currently are no FDA-approved drugs or interventions specifically for the treatment of SCI. The clinical development of OPC1 has been partially funded by a $14.3 million grant from CIRM. OPC1 has received Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug designation from the U.S. Food and Drug Administration (FDA). A selection of patient focused media related to the OPC1 program is available onthe Media page of the Lineage website. About the DOSED Study The Delivery of Oligodendrocyte Progenitor Cells for Spinal Cord Injury: Evaluation of a Novel Device (DOSED) clinical study is an open label, multi-center, device safety study, in 3-5 subacute and 3-5 stable chronic subjects with complete (ASIA Impairment Scale A) or incomplete (ASIA Impairment Scale B), traumatic, focal SCI affecting either cervical (C4-C7) or thoracic (T1-T10) vertebrae (ClinicalTrials.gov Identifier: NCT06841770). The primary objective of this study is to evaluate the safety of a novel Manual Inject Parenchymal Spinal Delivery System (MI PSD System) to administer OPC1 to the spinal parenchyma. The primary endpoint is frequency and severity of the MI PSD System- or injection procedure-related adverse events (AEs) through 30 days (1 month). Secondary endpoints are frequency and severity of AEs through 90 days (3 months) following injection of OPC1 and/or the concomitant immunosuppression administered, and incidence of MRI findings indicative of deterioration or safety-related changes at 90 days post-administration of OPC1. Exploratory endpoints include measurements of neurological impairment and function, as well as pain, evaluated by changes from baseline on the following endpoints: changes in neurological function as measured by sensory and motor scores and motor level on International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) examinations; changes in post-injection pain, defined as a worsening of pain or neuropathic pain of greater than 7 days duration from baseline levels, as assessed by the International Spinal Cord Injury Pain Basic Data Set or occurrence of allodynia; changes from baseline at 30, 90 and 365 days post-injection of OPC1 in: ISNCSCI, SCIM, International Spinal Cord Injury Pain Questionnaire; patient and clinical impressions of changes in quality of life as reported by changes from baseline at 30, 90, and 365 days post-injection of OPC1 as measured by: Patient Global Impression of Severity (PGI-S), Patient Global Impression of Change (PGI-C), Clinician Global Impression of Severity (CGI-S) and Clinician Global Impression of Change (CGI-C). Lineage also currently plans to seek approval from the FDA to introduce its new forthcoming immediate-use thaw-and-inject formulation of OPC1 into the DOSED study. About Lineage Cell Therapeutics, Inc. Lineage Cell Therapeutics is a clinical-stage biotechnology company developing allogeneic, or “off the shelf”, cell therapies for serious neurological and ophthalmic conditions. Lineage’s programs are based on its proprietary cell-based technology platform and associated development and manufacturing capabilities. From this platform, Lineage designs, develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or identical to cells found naturally in the human body. These cells are created by applying directed differentiation protocols to established, well-characterized, and self-renewing pluripotent cell lines. These protocols generate cells with characteristics associated with specific and desired developmental lineages. Cells derived from such lineages are transplanted into patients in an effort to replace or support cells that are absent or dysfunctional due to degenerative disease, aging, or traumatic injury, and to restore or augment the patient’s functional activity. Lineage’s neuroscience focused pipeline currently includes: (i) OpRegen ® cell therapy, a retinal pigment epithelial cell therapy in Phase 2a development under a worldwide collaboration with Roche and Genentech, a member of the Roche Group, for the treatment of geographic atrophy secondary to age-related macular degeneration; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ReSonance (ANP1), an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage; and (v) RND1, a novel hypoimmune induced pluripotent stem cell line being developed under a gene editing partnership. For more information, please visit www.lineagecell.com or follow the company on X/Twitter @LineageCell . SOURCE: Lineage Cell Therapeutics

全文共1067字，共0图预计阅读时间：3分钟2025年7月28日，BMS宣布与贝恩资本成立一家新的独立生物制药公司——NewCo。据悉，这家新成立的公司已成立便将拥有5个来自BMS的自免管线，以及由贝恩资本领投的3亿美元融资承诺。BMS详细信息显示，新公司将拥有丰富的研发管线，包括3款临床阶段候选药物和2款已做好I期临床试验准备的在研药物，所有药物均针对自身免疫疾病中极具前景的作用机制。目前管线中最先进的资产包括：Afimetoran：一种口服TLR7/8抑制剂，具有成为同类最佳（best-in-class）的潜力，目前正针对系统性红斑狼疮（SLE）开展II期临床试验；BMS-986322：一种口服TYK2抑制剂，已在斑块状银屑病的II期试验中成功完成概念验证，结果积极。其他授权引进的资产还包括：BMS-986326：一种创新型、潜在同类最佳的IL-2融合蛋白，目前正针对SLE和特应性皮炎（Atopic Dermatitis）进行I期临床试验；BMS-986481与BMS-986498：处于I期临床阶段，分别靶向IL-18和IL-10。此外，作为协议的一部分，BMS将保留NewCo近20%的股权，并有权获得与每项资产成功相关的特许权使用费和里程碑。BMS执行副总裁兼首席研究官Robert Plenge博士也将在NewCo公司董事会任职。小结据不完全统计，与BMS的这笔合作是贝恩资本2025年的又一笔在医药领域的重磅投资。此前，这家私募巨头还在2月时以34亿美元的总价收购了田边三菱制药公司，并于5月传出正在洽谈收购全球知名CDMO企业PCI Pharma Services。参考资料：1.各公司官网2.药时代此前文章3.其他公开资料图片来源：公司官网GCG直击肝脏靶点，双管齐下“燃烧”肝脏脂肪2025-07-286000万美元！ADC新锐获得Pre-A+轮融资2025-07-285亿美元首付款！恒瑞达成120亿美元出海交易2025-07-28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点击这里，查看更多精彩！