Temozolomide

2024年11月15日 - 南京英派药业有限公司（以下简称“英派药业” ），一家专注于肿瘤合成致死作用机制的创新药研发公司，欣然宣布近日顺利完成2.5亿元人民币D++轮融资，本轮融资由全球知名产业投资机构和知名保险基金共同投资。舟渡资本担任本轮融资的独家财务顾问。 本轮融资将支持英派具备同类最优疗效的核心产品塞纳帕利（Senaparib）的商业化，及包含PARP1选择性抑制剂在内的多个化合物的全球临床开发，同时用于加速多个早期项目的研发。 英派药业首席执行官蔡遂雄博士表示:“我们很高兴宣布顺利完成了D++轮的融资，衷心感谢新投资者对英派药业的支持和信任，也感谢老股东对公司发展的一路支持。 英派历经十余年研发积淀，搭建了源头创新的合成致死研发平台，组建了一支执行力卓越的研发运营团队。我们期待借助商业化合作伙伴华东医药广泛的市场营销网络和专业的学术推广经验，塞纳帕利能够尽快惠及更多的卵巢癌患者，为卵巢癌一线维持治疗方案带来新的更优选择。” 关于塞纳帕利 塞纳帕利（IMP4297, Senaparib）是由英派药业自主研发的新型、高效的PARP（1/2）抑制剂, 其独特的分子结构确保了出色的靶向选择性和广泛的安全窗口。早期临床试验显示了塞纳帕利具有良好前景的抗肿瘤作用，包括在卵巢癌中的显著疗效。塞纳帕利在关键的III期注册研究（FLAMES）中达到了主要终点。2023年9月，英派药业宣布，国家药品监督管理局已受理塞纳帕利在中国的新药上市申请(NDA)。2022年8月， 塞纳帕利和替莫唑胺（temozolomide, TMZ）的固定剂量组合胶囊用于治疗患有小细胞肺癌（SCLC）的成年患者, 获得美国食品药品监督管理局 (FDA)颁发孤儿药资格认定。2023年12月，英派药业与华东医药股份有限公司（SZ.000963）全资子公司杭州中美华东制药有限公司就塞纳帕利（IMP4297，Senaparib），在中国大陆的商业化推广达成合作。华东医药获得塞纳帕利在中国大陆的独家市场推广权益。 关于英派药业 英派药业致力于研发具有自主知识产权的靶向抗癌创新药，专注于合成致死作用机制。公司以DNA损伤修复通路（DDR）自主研发产品为基础，构建了全球生物医药公司中覆盖面最广的DDR产品管线之一，并且正在逐步拓展到更多的全新的合成致死靶点。 公司管线包括PARP抑制剂（Senaparib/IMP4297）、Wee1抑制剂（IMP7068）、ATR抑制剂（IMP9064）、PARP1选择性抑制剂 (IMP1734，与美国Eikon Therapeutics合作开发)以及多个其他DDR靶点抑制剂。 其中最成熟的研发项目PARP抑制剂（Senaparib/ IMP4297）在全球范围包含中国已开展卵巢癌、小细胞肺癌等适应症的临床II/III期研究。Senaparib用于晚期卵巢癌全人群一线维持治疗的III期临床研究（FLAMES）已达到主要研究终点,显示了同类最佳的药效和安全性。 基于FLAMES研究成果，中国国家药监局（NMPA）已受理了Senaparib的新药上市申请。Wee1抑制剂IMP7068和ATR抑制剂IMP9064已在包括美国、中国在内的全球多个国家及地区开展I期临床研究，确定了临床二期推荐剂量（RP2D）。 PARP1选择性抑制剂IMP1734 已经获得 FDA和NMPA的临床试验许可，在2024年初完成第一例患者入组。 医药融资新闻免费发布，请添加小编微信沟通：Songwazi9591 推荐阅读 美元投中国创新药玩法变了 NewCo浪潮背后：美元投中国创新药还赚钱 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。

SHANGHAI, November 15th, 2024 - IMPACT Therapeutics ("IMPACT"), a biopharmaceutical company focusing on the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality, announced the successful completion of its Series D++ financing of RMB 250 million. This round of financing was co-invested by a renowned corporate venture capital and a well-known insurance fund. Ark Capital is the sole financial advisor of this financing round. The proceeds from this round will support the commercialization of the core product Senaparib, which has demonstrated best-in-class potential in clinical pivotal phase III study, and accelerate the global clinical development of multiple compounds, including our novel PARP1 selective inhibitors, and the development of multiple early pre-clinical projects. “We are pleased to announce the successful completion of our Series D++ financing and would like to express our sincere gratitude to our new investors for their support and trust in IMPACT, and to our existing shareholders for their support along the way in the development of our company!" said Dr. Sui Xiong Cai, Chief Executive Officer of IMPACT. “With more than ten years of dedicated R&D efforts, IMPACT has built an integrated synthetic lethal R&D platform. We believe that Senaparib, with its best-in-class potential, backed up by the strong marketing network and professional promotion experience of our commercialization partner, Huadong Medicine, will benefit more ovarian cancer patients soon. Senaparib will bring a new and better choice of first-line maintenance therapy for ovarian cancer patients.” About Senaparib Senaparib, discovered and developed by IMPACT, is a potent and novel PARP1/2 inhibitor. Its distinctive molecular structure ensures exceptional target selectivity and wide therapeutic window. The Phase III registrational study (FLAMES) evaluating Senaparib as a first-line maintenance therapy in advanced ovarian cancer patients (all-comers) has met its primary endpoint. In August 2022, the fixed dose combination capsules of Senaparib and temozolomide for the treatment of adult patients with small cell lung cancer was granted orphan-drug designation by the U.S. Food and Drug Administration (FDA). In August 2023, the National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for Senaparib in China. About IMPACT Therapeutics IMPACT Therapeutics is a biopharmaceutical company dedicated to the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality. IMPACT Therapeutics has assembled one of the most comprehensive DNA damage responses (DDR) global pipeline of novel drug candidates generated by in-house discovery efforts and is expanding to other novel synthetic lethality targets to broaden its pipeline. IMPACT’s pipeline products include PARP inhibitor Senaparib (IMP4297), WEE1 inhibitor (IMP7068), ATR inhibitor (IMP9064), and PARP1 selective inhibitor (IMP1734, in collaboration with Eikon Therapeutics), as well as other novel DDR pathway inhibitors. The most advanced development program, PARP inhibitor Senaparib (IMP4297), has been in clinical Phase II/III studies globally, including China, in ovarian cancer, small cell lung cancer and other indications. The Phase III clinical study of Senaparib for advanced ovarian cancer maintenance treatment following first-line therapy met primary endpoint, with best-in-class efficacy and safety profile, and its NDA has been accepted by the National Medical Products Administration (NMPA). The Wee1 inhibitor IMP7068 and the ATR inhibitor IMP9064 have been investigated in Phase I clinical studies in several countries and regions around the world, including U.S. and China, and the recommended Phase II dose (RP2D) has been established. PARP1 selective inhibitor IMP1734 has obtained IND clearance from FDA and NMPA, as well as completed FPI in early 2024. For additional information, please visit www.impacttherapeutics.com/en/. IMPACT Therapeutics Contact: +86 21 6841 1121 IR@impacttherapeutics.com