先为达生物递表港交所，近两年半累计亏损超10亿元；百利天恒ADC药物BL-M07D1胃癌新公示三期临床试验登记｜掘金创新药

Core Insights - The article discusses the recent trends and developments in the pharmaceutical industry, particularly focusing on the performance of innovative drug companies and their clinical trials [5][11][18]. Group 1: Market Performance - The pharmaceutical and biotechnology indices experienced a decline, with the pharmaceutical index dropping by 1.21%, underperforming the Shanghai Composite Index by 0.91 percentage points [5]. - The Hang Seng Healthcare Index fell by 1.55%, and the Hong Kong innovative drug ETF decreased by 1.52% during the same period [5]. Group 2: Company Developments - Xianweida Biotechnology submitted an A1 listing application to the Hong Kong Stock Exchange, with cumulative losses exceeding 1 billion yuan over the past two and a half years [6][7]. - Xianweida's core product, Ecnoglutide, is expected to submit applications for overweight/obesity and type 2 diabetes indications by the end of 2024, with anticipated approval in early 2026 [7][8]. - The company reported no revenue for 2023 and 2024, with losses of 620 million yuan and 486 million yuan, respectively [8]. Group 3: Clinical Trials - Bai Li Tianheng's ADC drug BL-M07D1 has entered a phase III clinical trial for HER2-positive gastric cancer, with a focus on overall survival and progression-free survival as primary endpoints [15][16]. - The SLIMMER study, a significant phase III trial for Ecnoglutide, showed that participants could lose up to 13.8 kg over 48 weeks, with minimal weight regain after stopping the treatment [7]. Group 4: Stock Market Dynamics - The stock of Yaojie Ankang-B experienced extreme volatility, with a price drop from 679.5 HKD to 192 HKD per share, reflecting the high-risk nature of the Hong Kong market for uncommercialized biotech firms [12][13]. - The market's reaction to Yaojie Ankang-B's inclusion in the Hong Kong Stock Connect innovative drug index raised concerns about the decision-making process for including emerging companies in such indices [13]. Group 5: Regulatory Recognition - Yunding Xinyao's core product, Budesonide enteric-coated capsules, has been included in the global kidney disease guidelines, marking it as the only recommended treatment for IgA nephropathy [18].