Improved HARMONi OS data; Nomura maintains Buy rating on Akeso

Overview

This report is Nomura's quick commentary on the updated overall survival data from Akeso's HARMONi study. The company's overseas partner, Summit Therapeutics, disclosed that an additional analysis conducted in June 2026 showed an OS HR of 0.76 for both the overall ITT population and the Western patient subgroup in the HARMONi study. Nomura believes this result is an improvement over prior analyses and is broadly comparable to the 0.74 OS HR from Akeso's HARMONi-A study conducted in China, thereby increasing the likelihood of approval for the 2L+ EGFRm NSCLC indication.

Core views

The core view is that the continued improvement in HARMONi OS HR strengthens the regulatory approval signal, but the conclusion still depends on the disclosure of more complete follow-up data. In the April 2025 analysis, PFS met the primary endpoint while OS did not; after this additional OS analysis improved, Nomura maintained its positive view on Akeso. The report also maintains the Buy rating and HKD142.50 target price, and notes that the current share price implies 3.7x FY35F sales, with FY35F sales forecast at CNY22.4bn.

Analysis framework

The report uses a combination of clinical data event commentary and DCF valuation: it first compares changes in OS HR across different time points in the HARMONi study, then benchmarks them against results from China's HARMONi-A study, next assesses approval probability in conjunction with the PDUFA regulatory milestone, and finally derives the target price using a DCF model.

Methodology notes

• Clinical data analysisOS HR comparison

  Assess efficacy signal strength by comparing OS HR across the overall ITT population, the Western patient subgroup, and the HARMONi-A study.

  An HR below 1 usually indicates a lower risk in the treatment group relative to the control group; the 0.76 in this additional HARMONi analysis improved from prior data and is close to the 0.74 in HARMONi-A.

• Regulatory event analysisPDUFA milestone tracking

  Use the regulatory decision date as a key catalyst.

  Summit management mentioned that the PDUFA action day for this indication is November 14, 2026. Subsequent detailed data disclosure and the regulatory outcome are important bases for judging approval probability.

• Valuation methodsDCF model

  Discounted cash flow valuation

  Nomura derives its HKD142.50 target price using a DCF model with 10.8% WACC and a 4% terminal growth rate.

Asset mapping & comparison

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

• Akeso 9926.HK

  The company covered in the report, rated Buy.

  Strengths

  Improved additional OS analysis from HARMONi; HR for the Western patient subgroup fell to 0.76 after extended follow-up; results are broadly comparable to the 0.74 from the HARMONi-A study; target price implies substantial upside.

  Weaknesses

  OS did not meet the primary endpoint in the April 2025 analysis; approval still depends on subsequent detailed data and regulatory judgment.

  Comparison

  The current OS HR for both the overall ITT population and the Western patient subgroup in HARMONi is 0.76, close to the 0.74 in the HARMONi-A study.

  Risks

  Sales growth or ramp-up below expectations, weaker-than-expected ivonescimab PFS data, failure in new drug development.

• Summit Therapeutics SMMT US

  Akeso's overseas partner, which disclosed the additional HARMONi analysis; marked as Not rated in the report.

  Strengths

  The disclosed additional analysis provided a more positive OS signal.

  Weaknesses

  Nomura does not assign a rating, and further detailed data still need to be disclosed and validated.

  Comparison

  Its overseas HARMONi data are compared with Akeso's China HARMONi-A data.

  Risks

  The regulatory decision and detailed data disclosure may affect the market's assessment of the probability of approval for the indication.

Key data

• RatingBuyThe rating remains unchanged.
• Target priceHKD 142.50Based on the DCF model, with WACC at 10.8% and terminal growth rate at 4%.
• Closing priceHKD 98.90Price date is July 22, 2026.
• Implied upsideapproximately 44.1%Calculated based on the target price of HKD142.50 and the closing price of HKD98.90.
• HARMONi OS HR0.76In the additional analysis in June 2026, both the overall ITT population and the Western patient subgroup were at 0.76.
• Previous overall ITT OS HR0.79 / 0.78From the primary analysis in April 2025 and another analysis in September 2025, respectively.
• Previous Western patient subgroup OS HR0.98 / 0.84From the analyses in April 2025 and September 2025, respectively.
• Median follow-up time for Western patient subgroup23.2 monthsThe previous two analyses were 9.2 months and 13.7 months, respectively.
• HARMONi-A OS HR0.74Conducted by Akeso in China; the report considers it broadly comparable to the current HARMONi result.
• PDUFA action day2026-11-14Corresponding to the 2L+ EGFRm NSCLC after 3rd gen TKI indication.
• Valuation multiple3.7x FY35F salesFY35F sales are forecast at CNY22.4bn.

Impact & implications

This OS HR improvement is a positive catalyst for Akeso, mainly because it raises the probability of approval for the ivonescimab-related indication and supports Nomura's maintained Buy rating and target price, which implies meaningful upside from the current share price. However, the report emphasizes that more detailed clinical data are still awaiting disclosure at academic conferences, and regulatory approval remains uncertain.

Risks

• Sales growth or sales ramp-up may be weaker than expected.
• ivonescimab PFS data may be weaker than expected.
• Failure in new drug development.
• Detailed OS/PFS data disclosed later may not support the current positive interpretation.
• There is uncertainty around the regulatory approval outcome.

What to watch

• Detailed HARMONi OS/PFS data to be disclosed at upcoming academic conferences.
• The PDUFA action day on November 14, 2026 and the regulatory decision.
• The stability of OS HR after further extension of follow-up time for the Western patient subgroup.
• Commercial sales ramp-up of ivonescimab.
• Further progress in out-licensing more molecules.