AKESO(09926) 新京报·2025-04-27 02:04Core Viewpoint - 康方生物's drug Ivosidenib has shown strong positive results in head-to-head clinical trials against other leading PD-1 inhibitors, raising expectations for the company's financial recovery and market position [1][2][3]. Group 1: Clinical Trial Results - Ivosidenib (PD-1/VEGF dual antibody) demonstrated significant improvement in progression-free survival (PFS) compared to Tislelizumab in a Phase III head-to-head trial for advanced squamous non-small cell lung cancer (sq-NSCLC) [1][2]. - The trial involved 532 participants from 66 clinical research centers, with Ivosidenib showing clinically meaningful PFS benefits in both PD-L1 positive and negative populations [2]. - Ivosidenib previously outperformed Pembrolizumab (Keytruda) in a separate Phase III trial, achieving an objective response rate (ORR) of 50% compared to 38.5% for Keytruda, and a disease control rate (DCR) of 89.9% versus 70.5% [3]. Group 2: Financial Performance - 康方生物 reported a revenue of 4.526 billion yuan in 2023, achieving its first annual profit, but faced a loss of 501 million yuan in 2024 despite generating 2.124 billion yuan in revenue [4]. - The company's financial performance is closely tied to Ivosidenib's sales, which generated 103 million yuan in revenue shortly after its market approval in May 2024 [4]. Group 3: Future Prospects - Ivosidenib is currently involved in 12 ongoing Phase III clinical trials, with one indication in the final review stage for supplemental new drug application [5]. - Goldman Sachs predicts that Ivosidenib could become a leader in the PD-1/L1×VEGF dual-specific antibody market, potentially reaching peak sales of 53 billion dollars by 2041 [5]. - 康方生物 also has other products in its pipeline, including a PD-1/CTLA-4 dual antibody and a recently FDA-approved drug for nasopharyngeal carcinoma [5].