Core Viewpoint - The core product TY-9591 from Sameorigin Pharma made its debut at the ASCO annual meeting, gaining significant attention due to its promising clinical results against the leading lung cancer drug, Osimertinib [1] Group 1: Product Overview - TY-9591 is an oral, irreversible third-generation EGFR inhibitor specifically targeting non-small cell lung cancer (NSCLC) with brain metastases, aiming to challenge Osimertinib's market dominance [2] - It is the first and only drug to show significant improvement over Osimertinib in head-to-head clinical studies for this indication [2] - The drug's pharmacokinetic properties have been optimized by substituting hydrogen atoms in Osimertinib's molecule with deuterium, resulting in a threefold increase in brain tissue concentration compared to Osimertinib [2] Group 2: Clinical Trial Results - In a key Phase II clinical trial, TY-9591 achieved the primary endpoint of intracranial objective response rate (iORR), demonstrating statistically significant and clinically meaningful improvements over Osimertinib across various patient subgroups [3] - The drug is positioned as the fastest-developing candidate for treating NSCLC with brain metastases, potentially reshaping the treatment landscape in China [3] Group 3: Market Potential - The EGFR-TKI market in China has shown significant growth, increasing from 3.1 billion yuan in 2017 to 14.5 billion yuan in 2023, with a compound annual growth rate of 29.3% [4] - The market for third-generation EGFR-TKIs is expected to exceed 20.1 billion yuan by 2027 and 28.4 billion yuan by 2033 [4] - There is a pressing need for innovative treatments for NSCLC with brain metastases, as current standard therapies have limited efficacy, with objective response rates of only 23%-45% [5][6] Group 4: Commercialization Outlook - TY-9591 is set to submit its NDA for conditional approval in China, with the potential to capture significant market share given Osimertinib's current sales exceeding 8 billion yuan [6] - The successful commercialization of TY-9591 is crucial for Sameorigin Pharma's path to profitability [6]
核心品种获批进入倒计时，为同源康医药-B(02410)价值兑现打上一针“强心剂”