AKESO(09926) 第一财经·2025-04-26 09:04Core Insights - The approval of the bispecific antibody drug Ivosidenib for the treatment of PD-L1 positive locally advanced or metastatic non-small cell lung cancer (NSCLC) is a significant milestone for the biopharmaceutical industry [2] - Ivosidenib's approval is based on positive results from the HARMONi-2 clinical trial, which demonstrated significant improvements in median progression-free survival (PFS) and overall survival (OS) [2] - Goldman Sachs predicts that if Ivosidenib succeeds in multiple indications, it could reshape the $90 billion immuno-oncology market, potentially making it the "new king of drugs" [3] Company Developments - Kangfang Biopharma's stock price has surged over 50% in the past month following the approval of Ivosidenib [3] - Summit Therapeutics, the U.S. partner of Kangfang Biopharma, saw its stock price plummet by over 36% after the approval announcement, raising concerns about the market's reaction [3] - The market speculates that the decline in Summit's stock may be due to investors shifting their focus to Kangfang Biopharma, which holds rights to Ivosidenib in China, allowing it to generate revenue sooner [3] Clinical Data Insights - Despite the favorable PFS data, the OS data does not show statistical significance, leading to concerns among investors regarding the drug's approval prospects in the U.S. [4] - The FDA considers OS as a critical endpoint for cancer treatment approval, while PFS is often used to assess the drug's efficacy in controlling tumor progression [4] - Analysts suggest that the OS curve data may not be available until later this year at a medical conference, with further interim analysis not expected until late 2025 or early 2026 [4]