智通财经APP获悉，9月29日，诺和诺德(NVO.US)宣布已向FDA递交依柯胰岛素(icodec)和Mim8的上市 申请，前者用于治疗2型糖尿病，后者用于治疗A型血友病。目前，依柯胰岛素已在欧盟和中国获批用 于治疗2型糖尿病。 依柯胰岛素是诺和诺德在口服胰岛素OI338的基础上设计的一款超长效胰岛素制剂，人体内半衰期长达 196h。其核心设计在于：①将18C长链脂肪酸替换为20C长链脂肪酸，提高分子与人血清白蛋白的结合 亲和力;②将B链16位Tyr(酪氨酸)替换为His(组氨酸)，降低分子对人胰岛素受体的亲和力。 诺和诺德曾在2023年4月第一次向FDA提交依柯胰岛素的生物制品许可申请(BLA)，当时申请的适应症 为1型糖尿病和2型糖尿病。2024年5月，FDA内分泌和代谢药物咨询委员会召开会议讨论了依柯胰岛素 治疗1型糖尿病的获益与风险。最终，委员会认为现有数据不足以得出依柯胰岛素治疗1型糖尿病的获 益-风险情况呈积极的结论。此次重新递交BLA，诺和诺德将依柯胰岛素的适应症缩小至2型糖尿病，申 请依据包括5项III期ONWARDS研究。 血友病是一种罕见的遗传性出血性疾病，会损害人体形成血栓的能力，而血栓 ...

以下文章来源于启阳路4号 ，作者风暴眼 启阳路4号 . 聚焦财经热点事件，通过深度调查寻找财经真相。 《风暴眼》工作室出品 文｜ 吕银玲 南方某城一家三甲医院的 B 超室门口，项欢的左肘关节愈发刺痛难忍。他能清晰感觉到有一股热流从血管迸出，在看不见的肌理骨骼间肆意下冲、淤 积在狭窄的关节腔里。肘部已经肿胀僵硬，连屈伸都困难。他的左臂无力地垂在身体一侧，右手攥着一叠单据，疼痛折磨得他汗流浃背， T 恤已湿了 大半。 B 超结果显示"左肘关节积液，考虑出血可能"。他松了口气，这将是他开出凝血药物的唯一凭证。 项欢患有重型血友病，不久前的这次出血，刚好在晚上七八点左右，医院只能挂急诊了。 与往年不同，医生要求他先做 B 超检测，证明确实正在出血，才能开通开药权限。于是，排队、缴费、检查、取药、注射 …… 项欢机械地在医院各 科室间腾挪，三个多小时过去了，直到晚上十点多，他才终于用上了救命的凝血因子。 他已与血友病相处几十年，早已习惯了无来由的自发出血。同十多万血友病患者一样，他认过命，靠着生扛走过了整个青春，也因生扛落下残疾。他 得到过帮助，在医保覆盖下，燃起过也能像正常人一样生活的希望。但最近，开药变得越来越难了 ...

Summary of the Conference Call for Shuyou Shen Company Overview - Shuyou Shen focuses on infectious diseases, respiratory and critical care, autoimmune diseases, and neurological disorders [2][6] - The company has faced revenue pressure due to declining sales of its main products, Sutai Sheng and Shuyou Qing, but has a rich pipeline of innovative products that present growth potential [2][6] Key Products and Market Potential - **Bomeipide Enzyme Alpha**: A new therapy for hemophilia, showing superior hemostatic efficiency, safety, and onset speed compared to existing therapies. It is expected to become a best-in-class option [2][7][9] - Clinical data indicates a hemostatic rate and onset speed better than existing treatments [2][9] - Anticipated peak sales could exceed 2 billion RMB, with its market application already accepted [2][9] - **C5A Pathway Drugs (001 and 1,002)**: Targeting ANCA-associated vasculitis (AAV) and acute respiratory distress syndrome (ARDS) [2][5][10] - 1,002 is an upgraded version of 001, with promising clinical trial progress [2][5] - The ARDS market is significant, with approximately 3 million new patients annually and high mortality rates [4][16] - The global market for ARDS treatments is largely unmet, presenting a blue ocean opportunity [4][16] Financial Performance and R&D Progress - The company has seen a decline in revenue since 2022 due to decreased sales of existing products and increased R&D expenses [6] - Despite financial pressures, the extensive R&D pipeline, including Bomeipide Enzyme Alpha and C5A pathway drugs, is expected to drive future growth [6][17] Competitive Landscape - The global hemophilia treatment market is approximately 30 billion RMB, with major competitors including recombinant factor VII, PCC, and emicizumab [3][8] - Bomeipide Enzyme Alpha is positioned as a first-in-class product with a unique mechanism, potentially capturing a significant market share due to its advantages over existing therapies [3][9][12] Commercialization Strategies - Bomeipide Enzyme Alpha's commercialization strategy may involve high pricing to target reimbursable patients or competitive pricing to expand market share [4][12] - The overseas market for hemophilia treatments is estimated at nearly 3 billion USD, with potential for market share capture through licensing [12][14] Clinical Trial Insights - The clinical trial data for 1,002 in ARDS has shown excellent results, indicating a strong potential for market entry [5][15] - The company is also exploring multiple indications for its products, enhancing its R&D pipeline diversity [17] Investor Concerns - Investors are particularly interested in the development of 1,002 and its potential patient population size, with expectations that it will serve a broader range of patients than initially thought [18][19] Conclusion - Shuyou Shen is positioned in a promising market with innovative products that address significant unmet medical needs. The company's strategic focus on R&D and potential market capture strategies could lead to substantial growth in the coming years [2][4][6]