HARMONi-6 OS Breakthrough: Akeso May Welcome a New Standard of Care

Overview

This report focuses on the overall survival (OS) data from the HARMONi-6 study presented at ASCO 2026 by Akeso. The study confirmed that its independently developed bispecific antibody ivonescimab combined with chemotherapy significantly surpassed the approved PD-1 inhibitor plus chemotherapy regimen in first-line squamous non-small cell lung cancer (1L sqNSCLC). This historic breakthrough not only validates the strong efficacy of its core drug but also greatly enhances market expectations for its future pipeline, making it one of the most significant events in the biotech sector recently.

Core views

Akeso's HARMONi-6 study achieved a milestone outcome. Among 532 patients, the median overall survival for the ivonescimab plus chemotherapy group was 27.9 months, while the control group (tislelizumab plus chemotherapy) was 23.7 months, showing a highly statistically significant difference (OS HR=0.66, 95% CI: 0.50–0.87; one-sided P=0.0017), reducing the risk of death by 34%. This result not only exceeded many people’s expectations but also perfectly matched J.P. Morgan's previously set best-case scenario (HR<0.7). More importantly, this benefit was consistently observed across all predefined subgroups and different PD-L1 expression levels, especially among PD-L1 negative populations where the risk of death still decreased by 36%, demonstrating strong universality. In addition, these results formed a 'clean and powerful' transmission with the previously reported progression-free survival (PFS) improvements (median PFS 11.14 vs 6.90 months), proving that early efficacy advantages can effectively translate into long-term survival benefits. In terms of safety, overall control was maintained without any new safety signals. These data make this regimen very likely to become the standard of care (SoC) for first-line squamous cancer in China, bringing enormous commercial potential to the company.

Analysis framework

The institution adopts an analytical framework combining 'clinical evidence-driven' and 'valuation reverse-engineering'. First, it evaluates product value strictly through the latest published clinical data (especially key endpoints like overall survival). Second, based on this major breakthrough, it makes forward-looking predictions of the company's future cash flows and applies discounted cash flow (DCF) modeling for valuation. The core of this methodology lies in: taking a disruptive clinical success as the starting point for valuation, then combining the company's future commercialization path (such as indication expansion, insurance access) to build a revenue model, thereby deriving a reasonable target price.

Methodology notes

• Valuation MethodDCF Discounted Cash Flow

  A discount model based on future free cash flows to assess enterprise intrinsic value

  The institution believes that Akeso's stock price should reflect the present value of the free cash flows it will generate over the next several years. Therefore, they forecasted the cash flows for the next ten years and applied a 9.6% weighted average cost of capital (WACC) and a 3% perpetual growth rate for discounting, ultimately arriving at a target price of HKD 162.

• Industry/Market Analysis FrameworkSupply-demand framework

  Evaluating drug market competitiveness solely based on clinical data

  In the innovative drug field, a product's competitive position is determined by its clinical data rather than marketing promotion or sales capabilities. This report entirely judges its value based on the core indicator of whether it can prove superior to existing standard therapies, reflecting the typical 'evidence-based' supply-demand logic of the biopharmaceutical industry.

• Cycle and Prosperity FrameworkProsperity Inflection Point Analysis

  Significant clinical breakthroughs can trigger rapid revaluation of companies

  When an innovative drug achieves overwhelming success in a key clinical trial, it marks the transition of the company from the 'R&D uncertainty' phase to the 'commercial certainty' phase. Such a turning point quickly changes market valuation expectations, driving substantial stock price increases, representing a typical 'prosperity inflection point'.

Asset mapping & comparison

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

• Akeso (9926.HK)

  Core beneficiary due to historical breakthrough in key clinical trials of ivonescimab leading to revaluation

  Strengths

  Possesses a globally leading bispecific antibody platform; achieved the first significant improvement in overall survival in 1L sqNSCLC; has a robust R&D pipeline (such as AK104)

  Weaknesses

  Relies heavily on a single core product; if subsequent pipeline progress falls short of expectations, it may face growth bottlenecks; overseas commercialization capability remains untested

  Comparison

  Compared to other Chinese biotech companies, its clinical data is more convincing with greater valuation elasticity; however, compared to multinational giants, there are gaps in scale and channels

  Risks

  Pipeline development setbacks, such as failure of subsequent key trials; sales performance of core products AK104 or AK112 falling below expectations

Key data

• Median Overall Survival (Treatment Group) in the HARMONi-6 Trial27.9 monthsSignificantly superior to the control group's 23.7 months
• OS Hazard Ratio (HR)0.66Reduced the risk of death by 34%, below the preset statistical boundary (P<0.0049)
• Median Overall Survival for PD-L1 TPS <1% PopulationNE (Not Reached)Control group was 18.6 months, reduced the risk of death by 36%
• Median Progression-Free Survival (Treatment Group) in the HARMONi-6 Trial11.14 monthsFormed a consistent efficacy trajectory with overall survival improvement
• Target PriceHK$162.00Based on DCF model, current price is HK$118.10, expected upside space about 37%

Impact & implications

This clinical breakthrough implies that Akeso's flagship product ivonescimab (AK112) could gain a leading position in the Chinese market. This will not only directly boost its sales in the non-small cell lung cancer area, with peak revenue potentially reaching RMB 8 billion, but also pave the way for its commercialization in overseas markets (especially the U.S.). At the same time, this successful case enhances investors' confidence in the entire Chinese innovative pharmaceutical enterprises, possibly attracting more funds to flow into this sector. For Akeso, this is a qualitative change from a 'R&D-focused company' to a 'commercialization leader', with its market value likely to see another round of expansion.

Risks

• Pipeline development hindered, such as failure of subsequent key trials
• Sales performance of core products AK104 or AK112 lower than expected

What to watch

• Final progression-free survival (PFS) result of the HARMONi-3 trial (expected in the second half of 2026)
• Progress of ivonescimab in China's medical insurance negotiations and its pricing
• Registration filing status of the company in international markets (such as FDA in the U.S.)