头对头试验胜过“肺癌药王” ？同源康医药临床结果引争议

Core Viewpoint - The announcement of positive clinical trial results for TY-9591 by Tongyuan Kang Pharmaceutical has the potential to disrupt the existing lung cancer targeted therapy market, particularly against the backdrop of increasing competition in the pharmaceutical industry [2][4]. Summary by Sections Clinical Trial Results - Tongyuan Kang Pharmaceutical reported that TY-9591 demonstrated statistically significant and clinically meaningful improvements in intracranial objective response rate (iORR) compared to the existing drug Osimertinib in a head-to-head trial for treating EGFR-mutant lung cancer patients with brain metastases [2][3]. - The trial included 244 participants, and the company plans to submit a new drug application to the National Medical Products Administration (NMPA) soon [3][5]. Market Context - Osimertinib, known as the "lung cancer king," is projected to achieve global sales of $6.58 billion in 2024, reflecting a 16% year-on-year growth [4]. - The EGFR mutation is prevalent in about one-third of non-small cell lung cancer patients, making it a common target for therapies [4]. Stock Market Reaction - Following the announcement, Tongyuan Kang's stock price surged by 50% at one point on the first trading day, ultimately closing up 16.18%. The trading volume reached 3.39 million shares, significantly higher than the usual volume of around 200,000 shares [4][5]. - However, the stock experienced a subsequent decline of 21.23% over the next three trading days, raising questions about the sustainability of the initial market reaction [5]. Competitive Landscape - The clinical trial results have raised concerns regarding the robustness of the data, as the chosen endpoint (iORR) is not considered the industry gold standard compared to overall survival (OS) and progression-free survival (PFS) [5]. - The market for EGFR-TKIs is highly competitive, with at least six products already on the market and several others in late-stage clinical trials, including a product from Chintai Pharmaceutical that has already been approved for lung cancer brain metastases [6]. Financial Health - Tongyuan Kang, established in 2017, reported net losses of 312 million yuan, 383 million yuan, and 108 million yuan for the years 2022, 2023, and the first quarter of 2024, respectively. As of March 2024, the company had a net debt of 934 million yuan and cash reserves of 77.21 million yuan [6].