AKESO (09926): The second indication listing application of Yidafang (Yivose, PD-1/VEGF) has been approved by NMPA for use in first-line treatment of PD-L1 positive NSCLC.

AKESO (09926) announced that the new drug application (sNDA) for the global first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with programmed death-ligand 1 (PD-L1) positive (TPS 1%), epidermal growth factor receptor (EGFR) gene mutation negative, and anaplastic lymphoma kinase (ALK) negative with the self-developed dual-specificity antibody drug Yifasi (Yiwaxi, PD-1/VEGF) has been approved for marketing by the National Medical Products Administration (NMPA) of China. This is the second indication for Yiwaxi to be approved for marketing, making it a reality for Chinese patients to "be the first to use the best global treatment options." The approval of the new indication for first-line treatment of PD-L1 positive NSCLC with Yiwaxi is based on the significantly positive results obtained from the randomized, double-blind, controlled Phase III clinical study (AK112-303/HARMONi-2, CTR20222137, NCT05499390) compared to the "head-to-head" treatment with pembrolizumab: In the intention-to-treat (ITT) population, the median progression-free survival (PFS) in the Yiwaxi group and the pembrolizumab group were 11.14 months and 5.82 months, respectively, with a PFS hazard ratio (HR) of 0.51 (P <0.0001), reducing the risk of disease progression/death by 49% in the Yiwaxi treatment group. In the ITT population, the interim analysis of overall survival (OS) at 39% maturity showed a significant clinical survival benefit of Yiwaxi compared to pembrolizumab monotherapy, with an HR of 0.777, reducing the risk of death by 22.3%. Yiwaxi is the first drug in the world to obtain significantly positive results in a Phase III clinical study compared to pembrolizumab. Yiwaxi provides a new, more efficient, and safer "chemotherapy-free" option for first-line NSCLC treatment. The company plans to hold a communication meeting on recent business highlights on the morning of April 28, 2025, with specific information to be announced on the company's official website and public account before the meeting on April 28, 2025. AK112-303/HARMONi-2 (CTR20222137, NCT05499390) is a Phase III randomized, double-blind clinical trial designed to evaluate the registration of Yiwaxi monotherapy compared to pembrolizumab monotherapy for first-line treatment of locally advanced or metastatic NSCLC with PD-L1 expression (TPS 1%), with a total of 398 enrolled subjects. Yifasi (Yiwaxi, PD-1/VEGF) is a self-developed and globally first dual-specific tumor immunotherapy drug by the company. Yifasi was approved for marketing by the NMPA on May 24, 2024, for the treatment of locally advanced or metastatic non-squamous NSCLC with EGFR mutations after progression on EGFR TKI treatment. Currently, Yiwaxi has been approved for two indications in China and has conducted 12 Phase III clinical trials, including 3 international multicenter Phase III trials conducted overseas, and 6 Phase III trials with PD-(L)1 antibodies as positive control drugs. Yiwaxi is currently being tested in 18 indications, including lung cancer, cholangiocarcinoma, head and neck squamous cell carcinoma, triple-negative breast cancer, colorectal cancer, pancreatic cancer, hepatocellular carcinoma, etc.