百利天恒全球首创新药上市申请获受理 近六年累投48.1亿研发年内股价翻倍

Core Viewpoint - The innovative drug Iza-bren developed by Baillie Tianheng has received formal acceptance for its market application, marking it as the world's first EGFR×HER3 dual-target ADC to enter the III clinical phase, which is expected to accelerate its market launch [2][4]. Group 1: Drug Development and Clinical Trials - Iza-bren is currently undergoing over 40 clinical trials in China and the United States for various tumor types, specifically targeting locally advanced or metastatic nasopharyngeal carcinoma [2][5]. - The drug has been included in the priority review list by the National Medical Products Administration (NMPA) based on interim analysis results from the BL-B01D1-303 study [4][5]. - Iza-bren has seven indications recognized as breakthrough therapy by the NMPA and one by the U.S. FDA [5]. Group 2: Research and Development Investment - Baillie Tianheng has significantly increased its R&D investment from CNY 196 million in 2020 to CNY 1.443 billion in 2024, with a total of CNY 4.811 billion invested over the past six years [3][9]. - In the first three quarters of 2025, the company’s R&D expenditure reached CNY 1.772 billion, surpassing the total for 2024, reflecting a year-on-year growth of 90.23% [9][10]. - The company employs 1,360 R&D personnel, accounting for 48.16% of its total workforce, with a notable increase in staff with master's degrees or higher [10]. Group 3: Financial Performance and Market Response - Baillie Tianheng's stock price has doubled since the beginning of 2025, with a significant increase from CNY 24.70 per share at the time of its IPO to approximately CNY 384.97 per share by November 2025, representing a cumulative increase of over 14 times [10]. - The company experienced a substantial revenue increase in 2024, reaching CNY 5.823 billion, a 936.31% year-on-year growth, primarily due to a collaboration agreement with Bristol-Myers Squibb [7][10].