CMSC has released a research report expressing optimism for AKESO (09926), citing the first-mover advantage and overseas value realization potential of its drug candidate AK112 as a next-generation foundational IO therapy. The exceptional overall survival (OS) benefit demonstrated in the HARMONi-6 study is expected to be applicable globally and could lead to a breakthrough in the fiercely competitive field of lung cancer immunotherapy. The firm maintains its profit forecasts and a "Strong Buy" investment rating.
The key points from CMSC's analysis are as follows:
**AKESO (09926)**
The HARMONi-6 study achieved a strongly positive OS result with a hazard ratio (HR) of 0.66, establishing a new standard for first-line squamous non-small cell lung cancer (1L sqNSCLC) and positioning the therapy to challenge the global lung cancer market. On the evening of May 31st, data presented at the 2026 ASCO Plenary Session revealed that AKESO's HARMONi-6 study, the first Chinese research in lung cancer ever selected for an ASCO plenary session, was a highlight of the conference. The disclosed OS results were excellent, significantly exceeding market expectations.
AKESO's globally first-in-class PD-1/VEGF bispecific antibody, ivonescimab, combined with chemotherapy, was compared against tislelizumab combined with chemotherapy in the Phase III HARMONi-6/AK112-306 study for first-line treatment of advanced squamous NSCLC. The significantly positive OS results were prominently released in the Plenary Session.
The HARMONi-6 study enrolled 532 subjects, with central-type squamous carcinoma accounting for approximately 63%, PD-L1 TPS <1% accounting for 39.0%, and patients with multi-site metastases/liver metastases/brain metastases accounting for about 33.8%. The results showed that at an event maturity of approximately 63%, an interim analysis was conducted: median OS (mOS) was 27.9 vs. 23.7 months, with an overall OS HR of 0.66 (p=0.0017), achieving a statistically strong positive outcome. The 24-month OS rate for the ivonescimab group was 64.7% vs. 48.6% for the control, meaning the ivonescimab group's OS rate was about 16.1 percentage points higher at the 24-month mark.
Subgroup analysis showed: PD-L1<1% OS HR 0.64; PD-L1≥1% OS HR 0.68, with PD-L1 1-49% OS HR 0.67 and PD-L1≥50% OS HR 0.64. The subgroup with ≥3 metastatic sites had an OS HR of 0.47; the liver metastasis subgroup had an OS HR of 0.69.
Regarding safety: Adverse events were primarily related to VEGF blockade, were generally manageable, and showed no new signals compared to ESMO 2025 data. Grade ≥3 treatment-related adverse events (TRAE) were 69% vs. 59%; VEGF-related AEs were 60% vs. 26%; Grade ≥3 bleeding was 3% vs. 1%; Grade ≥3 proteinuria/renal injury was 7% vs. 0%.
Based on the currently disclosed data, the H6 trial has perfectly fulfilled its historical mission. The ivonescimab regimen has, on the gold standard of OS, head-to-head defeated the standard of care (SOC) from the IO 1.0 era, signifying major clinical and commercial value. Historically, PD-1 combined with VEGF therapy for NSCLC had never achieved OS success; ivonescimab has once again proven the superior mechanism of bispecific antibodies in lung squamous carcinoma and is poised to become the new SOC. With 55,000-68,000 new cases annually in the US, AK112 has the potential to capture the largest market share in this multi-billion dollar lung squamous carcinoma market.
The strongly positive H6 OS result has strong implications for the H3 study. Looking at historical data from the global benchmark Keytruda's KN-407 trial, the 5-year follow-up mOS was 17.1 vs. 11.6 months (HR=0.71), with 18/24-month OS rates of 48.0%/37.5%. In the H6 trial, even with the control arm upgraded from chemotherapy to PD-1 + chemotherapy, an extremely robust OS HR and highly advantageous 18/24-month OS rates (70.5%/64.7%) were achieved. Even considering potential attenuation overseas, the H3 OS result is still highly likely to be significant.
Beyond lung cancer, other important indications for AK112 are expected to report data in 2026, which is highly anticipated. These include the final PFS data for H3 in the second half of 2026, the final OS data for H2 in the second half of 2026, the OS data from the Chinese Phase III study for biliary tract cancer (BTC) in the second half of 2026, and the FDA PDUFA date (for 2L+ EGFRm NSCLC) on November 14, 2026.
Risk factors include clinical trials not meeting expectations, technological iteration, policy changes, and model parameters not holding.
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