四川新荷花再闯关，上市马拉松能否圆梦；恒瑞医药ADC药物挑战HER2阳性乳腺癌经典方案｜掘金创新药

Market Performance - The pharmaceutical and biotechnology index declined by 3.71% from October 13 to October 17, underperforming the Shanghai Composite Index by 1.76 percentage points, marking four consecutive weeks of underperformance [4] - The innovative drug index also fell by 0.85% during the same period, continuing its downward trend for four weeks [4] - The Hong Kong healthcare index decreased by 3.57%, with some stocks returning to their prices from six months ago [4] - The Hong Kong innovative drug ETF experienced a significant drop of 5.92%, the largest weekly decline since June 20 [4] IPO Developments - Three biopharmaceutical companies submitted applications to the Hong Kong Stock Exchange, including Sichuan Xinhehua, which is attempting its fifth listing [5] - Sichuan Xinhehua has been in the traditional Chinese medicine sector for 24 years, with a product matrix of approximately 770 types [5] - The company’s revenue is projected to grow from 780 million yuan to 1.249 billion yuan from 2022 to 2024, but the growth rate is expected to decline sharply from over 46% in 2023 to just 9% in 2024 [6] Clinical Trials - From October 13 to October 17, the National Medical Products Administration (NMPA) disclosed 84 new clinical trial registrations, with 29 of these being innovative drugs in Phase II or higher, primarily in the oncology field [6] - Notable trials include those for treatments targeting rheumatoid arthritis, acute heart failure, and various cancers [7][8] ESMO Conference Highlights - The 2025 European Society for Medical Oncology (ESMO) conference showcased significant contributions from Chinese researchers, with 23 studies included in the "Late-Breaking Abstract" category, a record number [9] - Key presentations included a Phase III study on a dual-targeting drug for advanced non-small cell lung cancer and two Phase III studies on antibody-drug conjugates (ADCs) for new indications [10][11] - The conference highlighted the growing international collaboration and recognition of Chinese pharmaceutical innovations [11] Innovative Drug Developments - Heng Rui Medicine's ADC SHR-A1811 has entered a Phase III trial for HER2-positive breast cancer, aiming to recruit 650 participants [12] - The drug has shown promising results in previous studies, with a high objective response rate (ORR) in HER2-positive patients [13] - Heng Rui has multiple ADCs in clinical development, focusing on providing more treatment options across various solid tumors [14] Regulatory Environment - Beijing has implemented measures to streamline the clinical trial approval process, reducing the approval time from 60 to 30 working days [14] - The city has seen significant improvements in the efficiency of clinical trial approvals and has facilitated the import of commercial-scale batches of drugs [14]