丨2025年11月26日星期三丨 NO.1 司美格鲁肽治疗阿尔茨海默病的临床试验失败 11月24日，诺和诺德宣布，其针对司美格鲁肽治疗阿尔茨海默病的两项大型Ⅲ期试验均未达到主要目 标。数据显示，与安慰剂相比，用药患者病情进展未获显著延缓。受此消息影响，公司股价大跌。 点评：阿尔茨海默病的致病机理至今未明确，相关药物研发的失败率一直高居不下，诺和诺德此次宣布 的消息，是对该领域在研药物的又一次打击。不过，中国药企在该领域的研发热情逐年升温，或将给患 者带来新的希望。 点评：今年以来，港股市场再度成为生物医药企业的"融资港湾"，科望医药、明宇制药递表，也反映出 港股市场在该领域的吸引力正在不断提升。然而，投资者也需保持理性，关注企业研发进展及潜在风 险，避免盲目跟风。 NO.4 信达生物玛仕度肽高剂量9mg上市申请获受理 11月25日，信达生物发布公告，宣布玛仕度肽注射液高剂量9mg用于成人中重度肥胖患者长期体重控制 的上市申请，已获中国国家药品监督管理局（NMPA）药品审评中心（CDE）受理。 点评：对于国内中重度肥胖人群，玛仕度肽有望在减重手术之外，提供一个新治疗选择。但随着减肥药 市场竞争日益激烈，该产品的 ...

Core Insights - The Hong Kong stock market has become a significant financing hub for biopharmaceutical companies, with 13 mainland biotech firms successfully listing since 2025, surpassing the total from the previous year [1] - A surge in IPOs for biopharmaceutical companies occurred in September, highlighted by the successful listing of digital healthcare platform Health 160, which opened with a 154.84% increase [1] - Several innovative drug companies, including Hangzhou New Element Pharmaceuticals and Shanghai Aike Baifa, are accelerating their listing processes, focusing on innovative therapies in various disease areas [1][4] Financing Environment - Despite a recovery trend in the pharmaceutical market, the financing environment remains challenging for unprofitable innovative drug companies, which need to adopt diverse financing strategies to ensure ongoing R&D and long-term survival [2] - Pivotal's managing partner emphasized the importance of prioritizing business development collaborations for upfront payments and milestone funds, while being cautious with IPOs and refinancing [2] Market Dynamics - The biopharmaceutical industry is characterized by high investment, long cycles, and significant risks, with an average drug requiring 12.5 years and $2.3 billion for development, yet clinical success rates are below 10% [3] - The introduction of the 18A listing rule in 2018 has allowed unprofitable biotech companies to list on the Hong Kong Stock Exchange, creating a crucial financing channel [3] - The market is currently focused on R&D pipelines and technological capabilities, with companies that have breakthrough therapies or unique technologies more likely to attract investment [3] Company Profiles - Hangzhou New Element Pharmaceuticals, founded in 2012, focuses on metabolic, inflammatory, and cardiovascular disease therapies, with clinical-stage products currently in trials [4] - Shanghai Aike Baifa, established in 2013, specializes in respiratory and pediatric diseases, with its lead drug recognized as a breakthrough therapy [4] - Jinfang Pharmaceuticals, founded in 2017, is focused on oncology and autoimmune diseases, with its core product being the first KRAS G12C inhibitor in China [4] Financial Performance - Companies like New Element Pharmaceuticals and Aike Baifa have reported significant losses, with New Element's losses reaching approximately 97.42 million yuan in 2023 and 434 million yuan in 2024 [7] - Jinfang Pharmaceuticals has also not achieved profitability, with losses of 270 million yuan in 2023 and 197 million yuan in 2024 [7] Investment Trends - The current market environment has led to a selective approach towards high-quality biotech firms, with Jinfang Pharmaceuticals expected to raise approximately 1.444 billion HKD in its IPO, which will support future R&D investments [5] - The introduction of notable cornerstone investors has bolstered market confidence, indicating recognition of long-term value despite market volatility [5] Future Outlook - The ability of biotech companies to achieve sustainable growth will depend on the progress of clinical trials, regulatory approvals, and the execution capabilities of partners [9] - The Hong Kong market provides a global development platform for innovative drug companies, although uncertainties remain a critical consideration for investment decisions [9]