Southwest: AKESO (09926) HARMONi-6 data excellent, compared to the control group, the absolute difference in mPFS reached 4.24 months.

Southwest Research Institute announced that AKESO (09926) has announced the combination of Yavexi (PD-1/VEGF dual antibody) with chemotherapy, compared to the combination of Torrelizumab with chemotherapy for the first-line treatment of advanced squamous non-small cell lung cancer (sq-NSCLC) in the registration phase III clinical trial (AK112-306/HARMONi-6) has reached the primary endpoint of PFS. The data was published in The Lancet & ESMO. With the gradual focus of the company's research and development and the gradual landing of the pipeline, the company's performance has sufficient long-term growth momentum. The bank predicts that the company's revenue in 2025-2027 will be 3.31 billion, 5.36 billion, and 7.79 billion respectively. The main points of Southwest are as follows: Yavexi combined with chemotherapy significantly prolongs progression-free survival compared to Torrelizumab combined with chemotherapy The HARMONi-6 study is a Phase III clinical trial of Yavexi in the first-line treatment of squamous NSCLC, which achieved positive results in the first-line treatment of PD-L1 positive NSCLC compared to Pabloyzumab. The results showed that Yavexi combined with chemotherapy significantly prolonged the progression-free survival of patients compared to Torrelizumab combined with chemotherapy. The mPFS of Yavexi combined with chemotherapy in the first-line treatment of sq-NSCLC reached 11.14 months, while the mPFS of the control group Torrelizumab combined with chemotherapy was 6.90 months (HR=0.60, P<0.0001), with an absolute difference in mPFS between the two groups of 4.24 months. In July 2025, based on the excellent results of the HARMONi-6 study, the new indication for Yavexi combined with chemotherapy in the first-line treatment of sq-NSCLC was accepted by the National Medical Products Administration (NMPA) for marketing approval and is currently under review. Yavexi has been listed and included in the National Medical Insurance Drug List, with 13 Phase III clinical studies in progress AK112 has laid out a combination treatment plan for 30 indications, conducting approximately 30 clinical trials, including 13 Phase III clinical trials, four of which have achieved positive results, covering lung cancer, cholangiocarcinoma, head and neck squamous cell carcinoma, and other cancers. Two indications for Yavexi have been approved in China, the first indication being locally advanced or metastatic non-squamous NSCLC with EGFR mutations progressing after treatment with EGFR-TKIs, which has been successfully included in medical insurance; the second indication for monotherapy for first-line treatment of PD-L1-positive locally advanced or metastatic NSCLC has obtained marketing approval in April 2025; the third indication, comparing combination chemotherapy with Torrelizumab combined with chemotherapy in the first-line treatment of advanced sq-NSCLC, submitted an NDA application in July 2025. Cardunilu has added a new indication for first-line cervical cancer, with approximately 10 Phase III/registration clinical trials in progress. Currently, Cardunilu has been approved for three indications in China. In May 2025, Cardunilu in combination with chemotherapy, either alone or in combination with Bevacizumab, for first-line treatment of persistent, recurrent, or metastatic cervical cancer, was approved by the NMPA, filling the gap in first-line immunotherapy for cervical cancer in China. Cardunilu has laid out a combination treatment plan for approximately 20 indications, with approximately 10 Phase III/registration clinical trials actively in progress.