CITIC Securities released a research report highlighting AKESO's (09926) robust R&D pipeline, with multiple investigational products and indications nearing approval. The company continues to expand its early-stage pipeline, ensuring long-term sustainable growth.
On the sales front, the approval of Edvance has contributed incremental revenue, while Cindilimab maintains stable growth, driving year-over-year increases in product sales. Given the outstanding efficacy of its innovative drugs and vast market potential, CITIC Securities assigns a "Buy" rating.
The report noted that AKESO presented the final OS results of HARMONi-A at the 2025 SITC conference. With a median follow-up of 32.5 months, the OSHR for the Evunzekibart treatment group versus the control was 0.74 (0.58–0.95) (P=0.019), marking the first global Phase III immunotherapy trial to demonstrate clinically meaningful and statistically significant benefits in both PFS and OS for EGFR TKI-treated NSCLC.
Key future milestones include: (1) Updates on the final OS results of HARMONi-2 for Evunzekibart in China, BLA submission in the U.S., and HARMONi-3 mPFS analysis for squamous cell carcinoma overseas in H2 2026; (2) Global clinical trials for AK104 in 1L gastric cancer, 2L IO-resistant HCC, and PD-L1-negative NSCLC; (3) Progress of AK132 (Claudin18.2/CD47) and AK137 (CD73/LAG3) into Phase II trials, along with IND submission for AK150 (ILT2/ILT4/CSF1R).