Akeso Biopharma AK112 Clinical Trial Shows Significant Survival Benefit, Deutsche Bank Maintains Buy Rating

Overview

Deutsche Bank releases update report on Akeso Biopharma (9926.HK), focusing on latest data of its AK112 drug in HARMONi-6 Phase 3 clinical trial. Trial data shows AK112 demonstrates significant Overall Survival benefit in first-line treatment of squamous non-small cell lung cancer; Deutsche Bank maintains Buy rating with 162 HKD target price.

Core views

HARMONi-6/AK112-306 Phase 3 clinical trial data shows AK112 combined with chemotherapy significantly reduces mortality risk by 34% compared to control group (HR=0.66, P=0.0017), median Overall Survival extended from 23.69 months to 27.89 months. 12-month survival rate increased from 72.2% to 78.9%, 24-month survival rate significantly increased from 48.6% to 64.7%. Previously announced Progression-Free Survival data shows median PFS for AK112 group was 11.1 months, control group 6.9 months (HR=0.60, P<0.0001). Regarding safety, AK112 shows good safety profile, although ≥Grade 3 adverse event rate was higher (69.2% vs 58.9%), the proportion of discontinuation or death due to adverse events was comparable to control group. Akeso Biopharma submitted supplemental New Drug Application to NMPA on July 28, 2025, currently in final review stage, data announced at ASCO expected to drive it to become new standard of care. Deutsche Bank believes this represents practice change, but still waiting for multi-regional clinical trial data verification.

Analysis framework

Deutsche Bank adopts clinical trial data analysis framework, focusing on changes in key efficacy endpoint indicators such as Overall Survival (OS), Progression-Free Survival (PFS), Objective Response Rate (ORR). Analysts evaluate drug clinical value and commercialization potential by comparing data differences between trial group and control group. Meanwhile focusing on regulatory approval progress and follow-up clinical trial arrangements, constructing investment logic chain.

Methodology notes

• Pharmaceutical Industry Specific TerminologyClinical Trial Endpoints

  Overall Survival (OS) and Progression-Free Survival (PFS)

  OS refers to time from randomization to death from any cause, is the most reliable endpoint in oncology clinical trials; PFS refers to time from randomization to disease progression or death, often used as early efficacy assessment indicator

• Pharmaceutical Industry Specific TerminologyHazard Ratio (HR)

  Hazard Ratio (HR)

  HR<1 indicates lower risk in trial group, e.g., HR=0.66 means trial group mortality risk reduced by 34% (1-0.66=0.34), is important statistical indicator for evaluating treatment effect

Asset mapping & comparison

Structured mapping from thesis to named assets (strengths, weaknesses, peers, risks).

• Akeso Biopharma (9926.HK)

  Direct beneficiary of AK112 drug R&D success

  Strengths

  Clinical trial data significantly superior to control group, obvious survival benefit

  Weaknesses

  Still requires multi-regional clinical trial verification

  Risks

  Regulatory approval uncertainty, market competition intensification risk

Key data

• Overall Survival Hazard RatioHR=0.66Mortality risk reduced by 34%, P=0.0017, statistically significant
• Median Overall Survival27.89 months vs 23.69 monthsAK112 group extended by 4.2 months compared to control group
• 24-month Survival Rate64.7% vs 48.6%AK112 group significantly higher than control group by 16.1 percentage points
• Progression-Free Survival Hazard RatioHR=0.60PFS benefit, P<0.0001, median PFS 11.1 months vs 6.9 months
• Current Stock Price118.10 HKDAs of May 29, 2026
• Target Price162.00 HKDImplied upside approx. 37%

Impact & implications

Positive results of this clinical trial data enhance AK112 commercialization prospects in China market, Deutsche Bank believes this may become new standard of care for squamous non-small cell lung cancer treatment. Although HARMONi-6 trial was conducted only in China patient population, still requires multi-regional clinical trial verification, but current data has proven PFS benefit can translate to survival benefit, providing partial evidence support for ongoing global trials.

Risks

• Multi-regional clinical trial results may not be as significant as China trial results
• Regulatory approval progress below expectations
• Market competition intensifies, similar products impact market share

What to watch

• HARMONi-3 Phase 2 trial sqNSCLC cohort primary PFS data readout (2H 2026) and early OS analysis
• HARMONi-3 trial nsqNSCLC cohort primary PFS data (1H 2027)
• US FDA PDUFA approval date for EGFRm NSCLC indication (November 14, 2026)