注射用阿格司亭α(迈粒生)

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迈威生物-U(688062):两项BD落地 驱动公司现金流优化 BD战略能力获强印证
Xin Lang Cai Jing· 2025-06-28 08:30
Core Viewpoint - The company has made significant licensing agreements that enhance cash flow and pave the way for future commercialization of its products, including the injection of Agonist α and IL-11 targeted therapy drugs [1][2]. Group 1: Financial Impact - The total upfront payments from the two transactions amount to over 560 million RMB (3.8 billion + 250 million), which alleviates the company's financial pressure, with an estimated cash balance of approximately 1.23 billion RMB in 2024 [2]. - The agreements include a maximum total transaction amount of 500 million RMB and a tiered royalty percentage based on net sales, which will further support the company's financial health [1]. Group 2: Technological Validation - The two business development targets (8MW0511 and 9MW3811) are self-developed by the company, validating its long-acting fusion protein technology and LALA modification technology's competitive edge [3][4]. - 8MW0511 is the first approved long-acting G-CSF in China, utilizing albumin fusion technology to avoid the toxicity risks associated with PEG modification, demonstrating low immunogenicity and high production efficiency [3]. - 9MW3811 employs LALA modification technology to reduce potential toxicity risks and has shown a long half-life in clinical data, indicating significant market potential in diseases like pulmonary fibrosis [4]. Group 3: Core Assets and Future Potential - The company possesses a proprietary technology platform in the ADC field, with multiple targets and new payloads, showing promising clinical data in combination therapies [5]. - In the TCE field, the company is optimizing target selection and spatial design to reduce cytokine release syndrome (CRS) risks, with preclinical models demonstrating significant tumor suppression effects [5]. - Collaborations with AI companies are being utilized to accelerate target screening and evaluation, enhancing the company's research capabilities [5]. Group 4: Revenue Forecast - The company projects revenues of 851 million, 1.514 billion, and 2.08 billion RMB for 2025-2027, with year-on-year growth rates of 325.97%, 77.91%, and 37.38% respectively [6]. - The expected net profit for the same period is projected to be -591 million, -280 million, and 104 million RMB, with growth rates of 43.4%, 52.65%, and 137.14% respectively [6].
5月30日晚间重要公告一览
Xi Niu Cai Jing· 2025-05-30 10:21
华培动力:收到新能源车企项目定点意向书 5月30日晚,华培动力(603121)发布公告称,公司近日收到国内一家新能源车企的项目定点意向书, 定点产品为热管理系统PTC水加热器,项目生命周期为5年,预计2026年开始量产,生命周期内销售金 额约900万元。 资料显示,华培动力成立于2006年6月,主营业务是涡轮增压器、传感器等关键零部件的研发、生产及 销售。 所属行业:汽车–汽车零部件–底盘与发动机系统 安图生物:产品取得医疗器械注册证 5月30日晚,安图生物(603658)发布公告称,公司及全资子公司安图实验仪器(郑州)有限公司于近 日收到国家药品监督管理局、河南省药品监督管理局颁发的医疗器械注册证。包括"巨细胞病毒IgM抗 体检测试剂盒"等产品。 资料显示,安图生物成立于1999年9月,主营业务是体外诊断试剂及仪器的研发、制造、整合及服务。 所属行业:医药生物–医疗器械–体外诊断 映翰通:调整回购股份价格上限至65.04元/股 5月30日晚,映翰通(688575)发布公告称,公司拟将回购价格上限调整为65.04元/股。此次调整旨在 保障回购方案顺利实施,除价格调整外,回购方案其他内容不变。公司已累计回购股份 ...
迈威(上海)生物科技股份有限公司自愿披露关于迈粒生 获得国家药品监督管理局批准上市的公告
Shang Hai Zheng Quan Bao· 2025-05-29 21:15
登录新浪财经APP 搜索【信披】查看更多考评等级 ■ 证券代码:688062 证券简称:迈威生物 公告编号:2025-026 迈威(上海)生物科技股份有限公司 自愿披露关于迈粒生 获得国家药品监督管理局 批准上市的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏,并对其内容 的真实性、准确性和完整性依法承担法律责任。 重要内容提示: 近日,迈威(上海)生物科技股份有限公司(以下简称"公司")全资子公司江苏泰康生物医药有限公司 提交的注射用阿格司亭α(商品名:迈粒生,曾用名:注射用重组(酵母分泌型)人血清白蛋白-人粒细 胞集落刺激因子(I)融合蛋白,产品代号:8MW0511)上市申请获得国家药品监督管理局批准,适用 于成年非髓性恶性肿瘤患者在接受容易引起发热性中性粒细胞减少症的骨髓抑制性抗癌药物治疗时,使 用本品降低以发热性中性粒细胞减少症为表现的感染发生率。为公司首个创新药上市品种,亦是首个国 内上市的采用白蛋白长效融合技术开发的G-CSF药物。现将相关情况公告如下: 一、药品基本情况 药品名称:注射用阿格司亭α 剂型:注射剂 规格:20mg/瓶 受理号:CXSS23000 ...