Akeso
Chinese biotech making bispecific antibody cancer drugs, led by ivonescimab and cadonilimab.
On the record
Checkpoint: FDA PDUFA decision on partner Summit Therapeutics' ivonescimab BLA
The call
Akeso sits ahead on clinical data and China revenue, with its US future riding on a single FDA decision and a cash-strapped partner.
Akeso is a Chinese biotech company that develops and sells cancer immunotherapy drugs. Three of its drugs have been approved and are generating over 3 billion yuan in yearly revenue, growing fast. The company's main drug, ivonescimab, has beaten Merck's Keytruda in clinical trials on key measures. However, Akeso faces an enormous challenge: Merck, Bristol Myers Squibb, Pfizer, and AbbVie are all racing to develop similar or better combination cancer drugs, and they have spent billions of dollars on these efforts. The biggest question mark is whether the FDA will approve ivonescimab in the United States by November 2026, and whether Akeso's U.S. partner Summit Therapeutics has enough money to make it to that approval date.
Why
01
AI pressure: AI drug-design labs like Isomorphic Labs, Insilico Medicine, Xaira Therapeutics. AI-driven molecule design could speed up rivals' antibody pipelines, but none has produced an approved competing drug yet. Could AI do the core job? Unlikely.
02
Bigger players: Merck, Pfizer, Bristol Myers Squibb/BioNTech, AbbVie in PD-1/VEGF bispecifics. Four Western giants have Phase III PD-1/VEGF bispecific trials running, chasing the same first-line lung cancer market ivonescimab leads. Could a giant copy it? Probably.
03
What protects it. Patents, China NRDL reimbursement on all three approved drugs, and real-world data from over 70,000 treated patients that rivals can't yet match.
What would change this call
FDA PDUFA decision on ivonescimab BLA due Nov 14, 2026. Approval or rejection determines Akeso's access to the US market via partner Summit.
Summit Therapeutics discloses refinancing or cash runway update before depletion. Shows whether Akeso's US commercialization partner can fund the launch.
Pfizer or BMS/BioNTech publish head-to-head OS data for their PD-1/VEGF bispecifics in NSCLC. Would show whether rivals can match or beat ivonescimab's survival data.
Summit Therapeutics discloses refinancing or cash runway update before depletion. Shows whether Akeso's US commercialization partner can fund the launch.
Pfizer or BMS/BioNTech publish head-to-head OS data for their PD-1/VEGF bispecifics in NSCLC. Would show whether rivals can match or beat ivonescimab's survival data.
Key numbers
- FY2025 revenue RMB 3,033.1M, up 51.48% YoY
- Ivonescimab treated 70,000+ patients commercially in China
- HARMONi-6: 34% lower death risk (HR 0.66) vs PD-1 plus chemo
Named risks
- FDA could reject Summit's ivonescimab BLA at Nov 14 2026 PDUFA decision.
- Summit Therapeutics has under 1 year cash runway as of July 2026, threatening US commercialization partner.
- Four Western rivals (Pfizer, BMS/BioNTech, Merck, AbbVie) fund competing PD-1/VEGF bispecifics in Phase III.
- Market cap already down 8-14% from 2025 peak, reflecting repricing of clinical/regulatory risk.
- Sharply conflicting third-party headcount estimates create uncertainty about actual company scale.
Rivals, as read in July 2026
| Rival | Direction | Evidence |
|---|---|---|
| Pfizer | contesting | Licensed rival PD-1/VEGF bispecific for $1.25B upfront, May 2025, launching Phase III trials |
| Bristol Myers Squibb / BioNTech | contesting | BMS committed up to $11B+ to co-develop rival bispecific pumitamig, June 2025 |
| Merck (Keytruda) | losing to | Ivonescimab beat Keytruda on PFS in HARMONi-2, Sept 2024, and OS in HARMONi-6, May 2026 |
| Merck (own bispecific MK-2010) | contesting | Licensed rival PD-1/VEGF bispecific from LaNova for $588M upfront, Nov 2024 |
| AbbVie | contesting | Licensed rival bispecific RC148 from RemeGen, 2026 |
Questions people ask
- Is Akeso profitable in 2026?
- Akeso is not yet profitable on a net basis but is narrowing losses. FY2025 commercial revenue hit RMB 3,033.1 million, up 51.48% year over year, while adjusted EBITDA loss narrowed versus FY2024's RMB241.2 million loss, per Akeso's HKEX filing dated 2026-03-26.
- Could AI replace Akeso's business?
- No. Akeso's value sits in regulated wet-lab antibody discovery, GMP manufacturing, multi-year clinical trials, and China's NRDL reimbursement listings for cadonilimab, ivonescimab and penpulimab, none of which AI software can substitute as of the 2026-03-26 annual filing.
- Who is Akeso's biggest competitor?
- Pfizer, Bristol Myers Squibb/BioNTech, Merck and AbbVie are all funding rival PD-1/VEGF bispecific antibodies against Akeso's ivonescimab, with Pfizer paying $1.25B upfront (May 2025) and BMS committing up to $11B+ (June 2025) to challenge the same drug class.
- Who owns Akeso?
- Akeso is an independent public company listed on the Hong Kong Stock Exchange (9926.HK) since April 2020, founded on 2012-03-19 by Michelle Xia and three co-founders with under $3 million in early funding; it has no parent company.
- Does ivonescimab actually beat Keytruda?
- Yes in trial data. Ivonescimab beat Merck's Keytruda on progression-free survival in the HARMONi-2 trial (2024-09-08, confirmed by STAT News), and HARMONi-6 data presented 2026-05-31 showed a 34% reduction in risk of death versus a PD-1 plus chemo comparator.
- What is Akeso's relationship with Summit Therapeutics?
- Summit Therapeutics in-licensed ex-China rights to ivonescimab from Akeso in January 2023 and made a PIPE investment into Akeso in October 2025. As of 2026-07-24, Summit reportedly has less than one year of cash runway ahead of a Nov 14, 2026 FDA decision.
Timeline
- 2026-07-24Summit Therapeutics reports under 1 year cash runway ahead of Nov 14 2026 FDA PDUFA date for ivonescimab
- 2026-06-01Gumokimab (AK111, anti-IL-17) approved by NMPA for plaque psoriasis
- 2026-05-31HARMONi-6 data shows 34% reduction in risk of death vs PD-1 plus chemo, presented at ASCO Plenary
- 2026-03-26FY2025 results: RMB 3,033.1M revenue (+51.48% YoY), 3,761 employees (+23.9% YoY)
- 2025-12-31AK150, first trispecific antibody candidate, IND filed
- 2025-12-11Cadonilimab receives FDA clearance for global Phase III first-line gastric cancer trial
- 2025-10-01Summit Therapeutics makes PIPE investment into Akeso
- 2025-04-01Penpulimab receives FDA approval, Akeso's first US-approved product
- 2024-09-08Ivonescimab beats Keytruda on PFS in HARMONi-2 trial
- 2023-01-01Summit Therapeutics in-licenses ex-China rights to ivonescimab
Revision history
26 July 2026
First assessed. Defensible for now. The text above is fixed as of this date and is not edited afterwards.
In the same band
Sources
- Akeso 2025 Annual Results Announcement (2026-03-26)
- Akeso Reports Full-Year 2025 Financial Results (2026-03-26)
- Cadonilimab FDA Clearance (2025-12-11)
- Summit Therapeutics Q2 2026 Results (2026-07-24)
- Summit therapy beat Merck blockbuster Keytruda (2024-09-08)
- HARMONi-6 Results (2026-05-31)
- prnasia.com (2026-07-20)
- Akeso Biopharma 2026 Company Profile
- Market capitalization
- gurufocus.com
- Employee Count & Headcount Data (2026-06-29)
- ApexOnco (2026-05-20)