全球首个EGFR ADC附条件获批上市，由中国企业自主研发；拥有2万只实验猴的鼎泰药研递表港交所｜掘金创新药

Core Insights - The pharmaceutical and biotechnology sector is experiencing fluctuations, with the medical biotechnology index declining by 2.81% over the week, underperforming the Shanghai Composite Index by 2 percentage points, marking six consecutive weeks of underperformance [4] - Jiangsu Dingtai Pharmaceutical Research has submitted its IPO application to the Hong Kong Stock Exchange, aiming for a listing after previously considering A-share listings [5] - The approval of the first EGFR ADC in China by Lepu Biotech represents a significant milestone in the development of targeted cancer therapies [9][10] Market Performance - The medical biotechnology index fell by 2.81%, while the innovative drug index (BK1106) rose by 3.61%, marking two consecutive weeks of gains [4] - The Hang Seng Healthcare Index (HSCICH) decreased by 0.08%, although the decline was less severe than in previous weeks [4] - The Hong Kong innovative drug ETF (513120) saw an increase of 2.38% during the week [4] IPO Developments - Jiangsu Dingtai Pharmaceutical Research plans to list on the Hong Kong Stock Exchange, having previously been listed on the New Third Board and considering an A-share listing [5] - The company reported revenues exceeding 700 million yuan from 2022 to 2024, with a net profit of 65 million yuan in the first half of 2025 after two years of losses [5] Clinical Trials - A total of 64 clinical trial registration information was disclosed by the National Medical Products Administration, with 16 trials in Phase II or above, primarily in oncology, cardiovascular, and dermatology [6] - Notable trials include Sibeprenlimab for IgA nephropathy and various studies targeting different cancers [11][12] Drug Approvals - Lepu Biotech's injection of Vebecotamab has been conditionally approved for treating recurrent/metastatic nasopharyngeal carcinoma, marking a breakthrough in the EGFR ADC field [9] - The drug demonstrated a confirmed objective response rate (ORR) of 30.2% in clinical trials, significantly outperforming traditional chemotherapy [10] Industry Insights - The innovative drug sector is witnessing a shift with companies like Lepu Biotech and Dingtai Pharmaceutical leading advancements in targeted therapies and clinical research [9][5] - The approval of new therapies and ongoing clinical trials indicate a robust pipeline in the pharmaceutical industry, particularly in oncology and chronic diseases [6][11]