格隆汇10月17日丨科伦博泰生物-B(06990.HK)宣布，公司靶向人类表皮生长因子受体2(HER2)的抗体偶 联药物(ADC)博度曲妥珠单抗(亦称A166)(舒泰莱®)获国家药品监督管理局(NMPA)批准用于既往接受过 一种或一种以上抗HER2药物治疗的不可切除或转移性HER2阳性成人乳腺癌(BC)患者。 本次批准是基于一项多中心、随机、开放标签、对照3期KL166-III-06研究，旨在评估博度曲妥珠单抗对 比恩美曲妥珠单抗(T-DM1)用于治疗既往接受过曲妥珠单抗和紫杉类治疗的HER2阳性不可切除或转移 性BC患者中的疗效和安全性结果。在预设的期中分析中，与T-DM1相比，博度曲妥珠单抗单一疗法在 主要研究终点盲态独立中心评估(BICR)评估的无进展生存期(PFS)具有显着统计学意义和临床意义的改 善；亦观察到博度曲妥珠单抗总生存期(OS)的获益趋势。该研究结果将在于德国柏林举行的2025年欧洲 肿瘤内科学会(ESMO)大会上以口头报告的形式进行展示(报告编号：LBA24，优选论文专场1－转移性 乳腺癌)。 公司已启动博度曲妥珠单抗用于治疗既往接受过有效载荷为拓扑异构酶抑制剂ADC治疗的HER2+不可 ...

智通财经APP讯，中石化炼化工程(02386)发布公告，截至2025年9月30日止九个月期间，集团新签订合 同总值为人民币913.47亿元，较截至2024年9月30日止九个月期间的人民币734.57亿元增加24.4%;于2025 年9月30日，集团未完成合同量为人民币2154.70亿元，较2024年12月31日的人民币1726.77亿元增加 24.8%。 ...

Core Viewpoint - The recent postponement of the IPO for Haixi New Drug highlights ongoing challenges in the Hong Kong stock market, particularly regarding compliance and investor behavior in the context of the FINI system [1][4][5] Group 1: IPO Details - Haixi New Drug's IPO was initially scheduled for October 17, following a successful subscription period from October 9 to October 14, which saw a subscription amount of HKD 309.4 billion, oversubscribed by 3,113 times [4] - The company planned to issue 11.5 million shares, with approximately 10% allocated for public offering in Hong Kong and 90% for international placement, at a price range of HKD 69.88 to HKD 86.40 per share [4] - The announcement of the postponement came after a 25% increase in the dark market, raising concerns and speculation about potential issues with international placements [4][5] Group 2: Market Context - The Hong Kong IPO market has seen a significant increase in activity, with 66 new IPOs in the first three quarters of the year, a year-on-year increase of 46.7%, raising a total of HKD 182.4 billion, which is a 228.1% increase [7] - The healthcare sector has been particularly strong, with seven out of the top ten performing new stocks in the first nine months being in the medical field, showcasing the sector's robust performance amid a booming market for innovative drugs [7] Group 3: Company Profile - Haixi New Drug focuses on a hybrid model of generic and innovative drugs, with a strong emphasis on first-generic, difficult-to-generate, and high-generic drug development [9] - The company has a pipeline that includes one Phase II clinical project and three preclinical projects, targeting oncology, ophthalmology, and respiratory diseases [9] - Financially, Haixi New Drug reported revenues of approximately HKD 2.12 million, HKD 3.17 million, HKD 4.67 million, and HKD 2.49 million over the reporting period, with a compound annual growth rate of 48.4% [9] Group 4: Financial Metrics - The company's gross margin has consistently remained above 80%, indicating strong profitability and stable performance [9] - The estimated price-to-earnings (P/E) ratio for the IPO is around 41 times, which is lower than the average P/E of 58 times for similar A-share generic drug companies, suggesting potential for valuation appreciation [10]

智通财经APP讯，摩比发展(00947)发布公告，于2025年10月17日，该公司斥资1686港元回购1.1万股。 ...

摩比发展(00947)发布公告，于2025年10月17日，该公司斥资1686港元回购1.1万股。 ...

据悉，博度曲妥珠单抗是一款用于治疗晚期HER2+实体瘤的差异化HER2ADC。作为一款由本公司开发 的创新HER2ADC，其通过稳定的酶可裂解连接子将新型单甲基奥瑞他汀F(MMAF)衍生物(高细胞毒性 微管蛋白抑制剂Duo-5)与HER2单克隆抗体偶联，药物抗体比(DAR)为2。博度曲妥珠单抗特异性地结合 肿瘤细胞表面的HER2，并被肿瘤细胞内吞，在胞内释放毒素分子Duo-5。Duo-5诱导肿瘤细胞週期阻滞 在G2/M期，引起肿瘤细胞凋亡。博度曲妥珠单抗靶向结合HER2后也可抑制HER2介导的信号通路;其具 有抗体依赖细胞介导细胞毒作用(ADCC)活性。 本次批准是基于一项多中心、随机、开放标签、对照3期KL166-III-06研究，旨在评估博度曲妥珠单抗对 比恩美曲妥珠单抗(T-DM1)用于治疗既往接受过曲妥珠单抗和紫杉类治疗的HER2阳性不可切除或转移 性BC患者中的疗效和安全性结果。在预设的期中分析中，与T-DM1相比，博度曲妥珠单抗单一疗法在 主要研究终点盲态独立中心评估(BICR)评估的无进展生存期(PFS)具有显著统计学意义和临床意义的改 善;亦观察到博度曲妥珠单抗总生存期(OS)的获益趋势。该研 ...

中石化炼化工程(02386)发布公告，截至2025年9月30日止九个月期间，集团新签订合同总值为人民币 913.47亿元，较截至2024年9月30日止九个月期间的人民币734.57亿元增加24.4%;于2025年9月30日，集 团未完成合同量为人民币2154.70亿元，较2024年12月31日的人民币1726.77亿元增加24.8%。 ...

Core Viewpoint - Hang Seng Bank has announced the appointment of Ms. Lin Huihong as the Executive Director and Chief Executive Officer, effective from October 20, 2025, marking a significant leadership change within the bank [1] Group 1: Leadership Changes - Ms. Lin Huihong will take over as Executive Director and Chief Executive Officer of Hang Seng Bank, also serving as the Chairman of the Operations Committee and a member of the Nomination Committee [1] - Ms. Shi Yingyin will step down from her roles as Executive Director and Chief Executive Officer, as well as from the positions of Chairman of the Operations Committee and member of the Nomination Committee, transitioning to a role as Vice Chairman of HSBC Hong Kong [1]

（原标题：汇丰控股(00005)10月16日斥资2.14亿港元回购209.48万股） 智通财经APP讯，汇丰控股(00005)发布公告，于2025年10月16日斥资7639.78万英镑回购773.65股股份; 斥资2.14亿港元回购209.48万股股份。 ...

智通财经APP讯，佳辰控股(01937)发布公告，朱文已获委任为执行董事，自2025年10月17日起生效。 ...