先必新注射液

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先声药业(2096.HK):创新药驱动业绩增长 自研新药技术平台厚积薄发
Ge Long Hui· 2025-09-04 04:11
(TL1A/IL23p19)针对IBD 大市场,具备长效化的竞争力;③SIM0815(TfR-Aβ双抗/AOC)具备透脑 特性,靶向pGlu 修饰的Aβ斑块。 "三个5"的创新产品梯队推动公司迈入加速发展的新阶段: 5 款基石产品:恩度、艾得辛、先必新注射 液、恩维达、先诺欣,为公司提供稳定的现金流。5 款快速放量新产品:科赛拉、恩立妥、恩泽舒、先 必新舌下片、科唯可,是业绩增长的重要推力,其中科赛拉、恩立妥今年纳入医保后正快速准入,恩泽 舒、先必新舌下片、科唯可已纳入2025 年商保创新药初审目录,同时恩泽舒亦通过了2025 年国家基本 医保目录初审。近期上市产品:2 款已进入NDA 审评阶段:玛氘诺沙韦(用于成人及青少年流感,其 儿童颗粒制剂的Ⅲ期研究也在进行中)、乐德奇拜单抗(有望作为国内第二款推动IL-4Rα单抗国产替 代);3 个创新产品处于临床Ⅲ期,包括JAK1 抑制剂、三代ALK、口服SERD,覆盖自免疾病、非小细 胞肺癌和晚期乳腺癌等领域。公司已上市及后期临床阶段的产品中,有多款产品是具备差异化的潜在大 单品:①先必新舌下片:全球唯一获美国FDA"突破性疗法"认定的卒中创新药,可在舌下与唾液接 ...
创新药出海再下一城!先声药业(02096)与NextCure达成重磅合作
智通财经网· 2025-06-16 11:30
Core Insights - The article discusses a licensing agreement between Sihuan Pharmaceutical (先声药业) and NextCure, Inc. for the innovative antibody-drug conjugate SIM0505, marking the first international recognition of Sihuan's ADC technology platform [1][2] - The agreement allows NextCure to develop SIM0505 outside Greater China, while Sihuan retains rights for a new ADC product targeting CDH6 in Greater China, indicating a strategic expansion in oncology [1][2] - Sihuan is expected to receive up to $745 million in total payments, including upfront and milestone payments, along with tiered royalties based on net sales outside Greater China [1] Company Developments - Sihuan has established a global innovation research network with centers in Boston, Shanghai, Nanjing, and Beijing, collaborating with top research institutions like Harvard Medical School [2] - The company has made significant investments in R&D, exceeding 8 billion yuan over the past five years, focusing on core technology platforms such as ADC and AI drug discovery [3] - Sihuan's innovative drug for stroke, Xianbixin injection, has been launched in China, and its sublingual tablet is undergoing clinical research in the U.S. with breakthrough therapy designation from the FDA [3] Market Position - CDH6 is identified as a promising new target for anti-tumor drugs, with no existing drugs targeting it globally, highlighting the competitive advantage of Sihuan's ADC technology [2] - The recent licensing agreement with NextCure is the second overseas licensing deal for Sihuan in 2023, following a collaboration with AbbVie for another antibody targeting GPRC5D/BCMA/CD3, which has a potential transaction value of $1.055 billion [2]