AKESO(HK:09926) Zhong Guo Xin Wen Wang·2025-04-30 11:38Core Viewpoint - 康方生物's new indication for依沃西单抗 has been approved by the National Medical Products Administration (NMPA) for first-line treatment of PD-L1 positive non-small cell lung cancer (NSCLC), based on positive results from the HARMONi-2 clinical trial [1][2]. Group 1: Clinical Trial Results - In the HARMONi-2 trial, the median progression-free survival (PFS) for the依沃西 group was 11.14 months, compared to 5.82 months for the帕博利珠 group, with a hazard ratio (HR) of 0.51, indicating a 49% reduction in the risk of disease progression or death [2]. - The interim analysis for overall survival (OS) showed a HR of 0.777, reflecting a 22.3% reduction in the risk of death for the依沃西 group compared to the帕博利珠 group [2]. Group 2: Market Reaction - Despite the positive clinical data,康方生物's stock fell over 19% on April 28, closing at 87.20 HKD per share, while its partner Summit's stock dropped more than 36% [3]. - Market sentiment suggests that while依沃西 shows clinical benefits compared to帕博利珠, it did not achieve the statistical significance expected by investors, as帕博利珠 has shown greater risk reductions in OS in previous trials [3]. Group 3: Company Perspective - 康方生物's CEO,夏瑜, stated that the market's interpretation of the data is somewhat misaligned, emphasizing that OS was not the primary endpoint of the study and that the low maturity of the OS data (39%) was intended to show a trend of benefit [3][4]. - The company designed the HARMONi-2 trial to focus on PFS as the primary endpoint, with the aim of obtaining approval for the first-line NSCLC indication in China [4].