Akeso (09926): J.P. Morgan sees ESMO’26 BTC data as a potentially major validation catalyst for Akeso’s ivonescimab.

Overview

This report examines whether Phase 3 biliary tract cancer data could broaden confidence in Akeso’s ivonescimab beyond non-small-cell lung cancer. J.P. Morgan argues that the HARMONi-GI1 readout at ESMO’26 could be a meaningful near-term catalyst and maintains Overweight on Akeso.

Core views

J.P. Morgan identifies the HARMONi-GI1 Phase 3 biliary tract cancer (BTC) study as an important validation test for ivonescimab outside non-small-cell lung cancer. Akeso has reported that the trial met its primary overall-survival endpoint in August. The study compares ivonescimab plus chemotherapy with durvalumab plus chemotherapy in 682 patients, against the standard of care in first-line BTC, and the detailed data are due as a late-breaking abstract at ESMO’26 on 25 October. The institution sees a credible path to an overall-survival hazard ratio of 0.6 or below. Its reasoning starts with Akeso’s China Phase 2 BTC data presented at ASCO’24, where ivonescimab plus chemotherapy produced median progression-free survival of 8.5 months and median overall survival of 16.8 months in 22 patients, with median follow-up of 13.8 months. J.P. Morgan contrasts this with the Chinese extended cohort of TOPAZ-1, in which median progression-free and overall survival were 4.7 and 9.1 months, respectively. Assuming linear overall-survival curves and reproduction of the Phase 2 survival benefit in Phase 3, the report estimates that HARMONi-GI1 could reach an overall-survival hazard ratio at or below 0.6. The report cautions that cross-trial comparisons require care, but argues that the Phase 2-versus-TOPAZ-1 survival gap is meaningful. It also considers the China-specific benchmark appropriate because BTC regional survival dynamics differ from lung cancer: Western patients in TOPAZ-1 had median overall survival of 12.8 months versus 9.1 months for the China cohort. By comparison, global Phase 3 BTC studies showed more modest survival benefits for PD-(L)1 approaches: overall-survival hazard ratios were 0.74 in TOPAZ-1 for Imfinzi plus chemotherapy versus chemotherapy and 0.83 in KEYNOTE-966 for Keytruda plus chemotherapy versus chemotherapy. Confirmation of an overall-survival hazard ratio of 0.6 or below would therefore, in J.P. Morgan’s view, be clearly positive and reinforce confidence in ivonescimab’s PD-1/VEGF bispecific mechanism. J.P. Morgan also highlights the relative share-price setup. Summit, Akeso’s partner, had risen more than 30% over the preceding 30 days while the XBI was slightly down; Akeso had risen about 11% while the HSHCI was flat. The institution interprets this as suggesting potential upside for Akeso over the following 30–60 days. Beyond ESMO, the report flags the 14 November PDUFA and the HARMONi-3 squamous-cohort Phase 3 readout as subsequent catalysts. J.P. Morgan acknowledges risks around both. It considers FDA approval in second-line-plus EGFR NSCLC in November difficult because HARMONi did not meet overall survival, one of its co-primary endpoints. However, it notes that Summit’s June-2026 cutoff analysis at WCLC’26 showed an overall-survival hazard ratio of 0.76 in both the intention-to-treat and Western populations, versus 0.79 and 0.98, respectively, at the April-2025 cutoff. For HARMONi-3, it expects final progression-free-survival hazard ratio of around 0.7, does not expect the first interim overall-survival analysis to meet its threshold because of very small alpha spending, but believes final overall survival will be positive. The longer-term investment case rests on broader commercialization of Akeso’s bispecific-antibody portfolio. J.P. Morgan expects AK104 indication expansion in China to generate about RMB7 billion of peak sales, while AK112’s inclusion in the NRDL could support China peak sales above RMB7 billion. It also expects AK112’s competitive efficacy profile versus Keytruda and leadership in PD-(L)1/VEGF to support ex-China peak sales of more than US$5 billion. The HK$125 Dec-2027 target price is derived from a DCF model using estimated free cash flow through 2034, a 3.0% terminal growth rate, and a 9.6% WACC.

Analysis framework

J.P. Morgan assesses the upcoming HARMONi-GI1 readout by comparing Akeso’s Phase 2 BTC survival results with the China cohort of TOPAZ-1 and with global first-line BTC trial outcomes. It then considers regional survival differences, upcoming regulatory and clinical catalysts, portfolio sales potential, and a DCF-based valuation.

Methodology notes

• Valuation methodsDCF (Discounted Cash Flow)

  Discounted cash flow valuation

  The report values Akeso by estimating free cash flow through 2034 and discounting it using a 9.6% WACC, with a 3.0% terminal growth rate, to derive its HK$125 target price.

• Other

  Cross-trial survival benchmarking

  The report compares median survival and hazard ratios across BTC studies to frame the possible HARMONi-GI1 outcome, while explicitly noting the limitations of cross-trial comparisons.

Asset mapping & comparison

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

• Akeso (9926.HK)

  Primary covered company; the report links valuation and potential share-price upside to ivonescimab clinical catalysts and portfolio commercialization.

  Strengths

  Potentially differentiated ivonescimab efficacy, planned AK104 and AK112 market expansion, and significant China and ex-China peak-sales potential.

  Weaknesses

  FDA approval in second-line-plus EGFR NSCLC in November is considered difficult because HARMONi did not meet a co-primary overall-survival endpoint.

  Comparison

  The report compares BTC survival evidence with TOPAZ-1 and KEYNOTE-966 and notes that Akeso had risen about 11% versus a flat HSHCI, while partner Summit had risen more than 30%.

  Risks

  Pipeline development setbacks and AK104 or AK112 sales below J.P. Morgan expectations.

Key data

• HARMONi-GI1 trial sizen=682Phase 3 first-line BTC study comparing ivonescimab plus chemotherapy with durvalumab plus chemotherapy.
• Akeso Phase 2 BTC median progression-free survival8.5 monthsIvonescimab plus chemotherapy in 22 patients.
• Akeso Phase 2 BTC median overall survival16.8 monthsReported with 13.8 months of median follow-up.
• Chinese TOPAZ-1 median overall survival9.1 monthsUsed as J.P. Morgan's relevant China benchmark.
• Potential HARMONi-GI1 overall-survival hazard ratio0.6 or belowJ.P. Morgan estimate assuming Phase 2 survival benefit is reproduced in Phase 3.
• Target priceHK$125.00Dec-2027 target based on DCF valuation.
• DCF assumptions9.6% WACC; 3.0% terminal growth rateFree cash flow is estimated through 2034.

Impact & implications

J.P. Morgan believes a strong HARMONi-GI1 survival result would validate ivonescimab’s potential in BTC and strengthen confidence in its PD-1/VEGF bispecific mechanism beyond lung cancer. The report views the ESMO presentation, November PDUFA, and HARMONi-3 data as the main near-term events shaping the investment case.

Risks

• Pipeline development setbacks could undermine the rating and price target.
• AK104 or AK112 sales could fall below J.P. Morgan’s expectations.
• The PDUFA and HARMONi-3 catalysts carry clinical and regulatory risk.

What to watch

• The HARMONi-GI1 late-breaking abstract at ESMO’26 on 25 October, particularly whether overall-survival hazard ratio is 0.6 or below.
• The 14 November PDUFA decision for ivonescimab in second-line-plus EGFR NSCLC.
• The HARMONi-3 squamous-cohort Phase 3 progression-free- and overall-survival readouts.
• Commercial progress for AK104 and AK112, including AK112 NRDL inclusion.