Supplementary HARMONi OS analysis turns positive; Nomura maintains Buy rating on Akeso

Overview

This report is Nomura's event commentary on Akeso (09926.HK), focusing on the supplementary OS analysis of the HARMONi study disclosed by overseas partner Summit Therapeutics. The new analysis showed an OS HR of 0.76 in both the overall ITT population and the Western patient subgroup, improving from the analyses in April 2025 and September 2025 and approaching the 0.74 reported in Akeso's HARMONi-A study in China.

Core views

Nomura believes that the improved OS HR increases the likelihood of regulatory approval for the indication of 2L+ EGFRm NSCLC after 3rd gen TKI, although more complete data from subsequent medical conferences and further validation are still required. The report maintains its Buy rating on Akeso and its HKD142.50 target price.

Analysis framework

The report compares changes in HARMONi's OS HR at different time points with the results of the HARMONi-A study in China, and assesses the probability of regulatory success based on PFS having met its primary endpoint, OS not having previously met its primary endpoint, extended follow-up, and the PDUFA timeline. For valuation, it uses a DCF model, with the target price based on a 10.8% WACC and a 4% terminal growth rate.

Methodology notes

• Valuation methodsDCF

  Discounted cash flow valuation

  The HKD142.50 target price is derived from a DCF model, with key assumptions including a 10.8% WACC and a 4% terminal growth rate.

• Clinical data interpretationOS HR trend comparison

  Improvement in the overall survival hazard ratio

  The report compares changes in OS HR in the supplementary analyses conducted in April 2025, September 2025, and June 2026, and references the 0.74 reported in HARMONi-A.

• Regulatory event trackingPDUFA milestone

  Regulatory decision timing

  Management noted that the PDUFA action date for the indication is November 14, 2026, making it an important milestone for monitoring subsequent approval expectations.

Asset mapping & comparison

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

• Akeso (09926.HK)

  The company covered by the report; HARMONi/ivonescimab are key value drivers.

  Strengths

  Improved OS HR, results close to HARMONi-A, PFS previously met its primary endpoint, and significant implied upside from the current price to the target price.

  Weaknesses

  OS previously failed to meet its primary endpoint, and more detailed data disclosure and regulatory review are still pending.

  Comparison

  The June 2026 HARMONi OS HR of 0.76 was close to the 0.74 reported in China's HARMONi-A study and improved from the two analyses in 2025.

  Risks

  Clinical data falling short of expectations, regulatory approval failure, a weaker-than-expected sales ramp, and failure of new drug development.

• Summit Therapeutics (SMMT.US)

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

  Strengths

  Advancing the overseas development and regulatory progress of HARMONi.

  Weaknesses

  The report does not assign a rating to SMMT, and detailed data remain pending.

  Comparison

  Its disclosed overseas HARMONi results were used for comparison with Akeso's HARMONi-A study in China.

  Risks

  Subsequent data interpretation or regulatory outcomes could affect expectations for the partnered asset.

Key data

• Overall ITT population OS HR0.76Supplementary analysis in June 2026; previously 0.79 in April 2025 and 0.78 in September 2025.
• Western patient subgroup OS HR0.76Supplementary analysis in June 2026; previously 0.98 in April 2025 and 0.84 in September 2025.
• Median follow-up in the Western patient subgroup23.2 monthsThe previous two analyses reported 9.2 months and 13.7 months, respectively.
• HARMONi-A OS HR0.74A study conducted by Akeso in China; the report considers it broadly comparable to the supplementary HARMONi analysis results.
• PDUFA action date2026-11-14The indication is 2L+ EGFRm NSCLC after 3rd gen TKI.
• Target priceHKD142.50Buy rating maintained; DCF model assumes a 10.8% WACC and a 4% terminal growth rate.
• Current priceHKD98.90As of July 22, 2026.

Impact & implications

If subsequent complete data confirm the improving OS trend, Akeso's core pipeline asset ivonescimab may see further strengthening in its overseas regulatory pathway and commercialization expectations, supporting the current Buy rating and target price. Near-term share-price catalysts mainly include the disclosure of more detailed clinical data and the November 2026 PDUFA milestone.

Risks

• More detailed OS/PFS data disclosures may be weaker than market expectations.
• ivonescimab-related PFS or OS results may fall short of expectations.
• Regulatory approval for the indication may fail or be delayed.
• The product's sales ramp may be weaker than expected.
• New drug development may fail or pipeline progress may fall short of expectations.
• Achievement of the target price may be affected by market and macroeconomic factors, as well as deviations from the company's earnings forecasts.

What to watch

• Complete HARMONi data disclosed at subsequent medical conferences.
• The November 14, 2026 PDUFA action date and regulatory conclusion.
• Whether OS HR in the overall ITT population and Western patient subgroup remains improved in more complete data.
• ivonescimab sales ramp-up and overseas commercialization progress.
• Akeso's subsequent molecule licensing transactions and pipeline development progress.