One To Watch

Akeso

Company Overview

A Chinese biopharmaceutical company whose PD-1/VEGF bispecific antibody ivonescimab has become the first single agent to beat pembrolizumab head-to-head in a randomized Phase III lung cancer trial, reshaping the global IO landscape. Akeso, Inc. (HKEX: 9926) is headquartered in Zhongshan, Guangdong Province, and focuses on the discovery, development, manufacturing, and commercialization of innovative antibody drugs, with bispecific antibodies as its defining franchise. Its commercial portfolio now spans multiple approved indications in China, and its partnered global program is generating pivotal data that Western oncology cannot ignore.

Headquarters and Global Presence

Akeso is headquartered in Zhongshan, Guangdong Province, China, with operations spanning discovery research, clinical development, and commercial manufacturing. Its ex-China rights for ivonescimab are held by Summit Therapeutics, which is running global registrational trials across the United States, Canada, Europe, and Japan.

Founding and History

Dr. Michelle Xia (Xia Yu) founded Akeso in 2012 and continues to serve as Chairwoman, President, and CEO. The company listed on the Hong Kong Stock Exchange in April 2020, establishing a public capital base that has since been supplemented by a US$250 million share placement in October 2024. The December 2022 licensing deal with Summit Therapeutics — worth up to US$5 billion including milestones — was the commercial inflection point that signaled ivonescimab's global ambitions.

Therapy Areas and Focus

Akeso's primary focus is oncology, with its two commercial assets targeting lung cancer and cervical cancer — both areas where PD-1 monotherapy has hit clear efficacy ceilings. The strategic logic is IO intensification: using bispecific antibodies to simultaneously engage two mechanistically distinct pathways rather than layering separate agents with additive toxicity. Cadonilimab's success in cervical cancer and ivonescimab's lung cancer readouts both validate the premise that dual checkpoint or checkpoint-plus-angiogenesis blockade can outperform PD-1 monotherapy in meaningful patient populations.

Technology Platforms and Modalities

Akeso's proprietary ACE platform generates bispecific Tetrabody antibodies — molecules engineered to bind two distinct targets simultaneously while retaining a conventional antibody format. The platform underpins both ivonescimab's simultaneous PD-1 and VEGF blockade and cadonilimab's concurrent PD-1 and CTLA-4 inhibition. Akeso frames its long-term strategy as IO 2.0 plus ADC 2.0 — building out antibody-drug conjugates alongside bispecifics as the next commercial layer. The anti-CD47 antibody ligufalimab, showing mid-stage survival signals in acute myeloid leukemia, hints at how far the platform reach extends beyond the current flagship programs.

Key Pipeline and Programs

Ivonescimab (AK112) is a first-in-class PD-1/VEGF bispecific antibody and the most closely watched asset in Akeso's portfolio. It has multiple approved indications in China and is running 15 Phase III trials globally, including 5 multiregional studies and 7 head-to-head comparisons against PD-1 or PD-L1 therapies. The HARMONi-2 Phase III in PD-L1-positive advanced NSCLC showed ivonescimab monotherapy achieved a median PFS of 11.14 months versus 5.82 months for pembrolizumab — the first randomized Phase III win over Keytruda as a single agent. The HARMONi-6 Phase III (AK112-306) in first-line squamous NSCLC, reported May 31, 2026, delivered both an OS benefit (HR 0.66; P=0.0017) and a PFS benefit (HR 0.60; P<0.0001) versus tislelizumab plus chemotherapy across 532 patients regardless of PD-L1 status — the first Phase III in lung cancer to achieve dual OS and PFS superiority over a PD-1 plus chemotherapy backbone; data were selected for the ASCO 2026 Plenary Session. Summit's multiregional HARMONi Phase III in post-third-generation TKI EGFR-mutant NSCLC showed a statistically significant PFS benefit (HR 0.52; median 6.8 vs 4.4 months). Cadonilimab (AK104) is a PD-1/CTLA-4 bispecific and the world's first approved dual immune checkpoint inhibitor, holding three NMPA approvals including a June 2025 clearance for first-line all-comer cervical cancer. A global Phase II registrational trial (COMPASSION-36, AK104-225) in PD-1-resistant hepatocellular carcinoma received both NMPA and FDA clearance in August 2025. Ligufalimab is an anti-CD47 antibody in mid-stage development, with May 2026 data suggesting a survival benefit in newly diagnosed AML patients ineligible for intensive chemotherapy — a signal that matters given how thoroughly the CD47 field has disappointed previously.

Recent Developments

The HARMONi-6 OS readout on May 31, 2026 — reducing risk of death by 34% versus a PD-1 plus chemotherapy regimen — is the most consequential data point in Akeso's history, confirming that the PD-1/VEGF bispecific mechanism can improve hard survival outcomes at scale. Its selection for the ASCO 2026 Plenary Session, alongside more than 40 Akeso abstracts at the meeting, reflects the degree to which ivonescimab has moved from a China-centric curiosity to a global oncology conversation. Full-year 2025 commercial revenues reached RMB3,033.1 million, up 51.5% year on year, with cadonilimab having treated approximately 120,000 patients in China. The October 2024 US$250 million share placement and continued NRDL inclusion for all approved products underpin the balance sheet heading into a pivotal regulatory cycle.

Key Personnel

Dr. Michelle Xia (Xia Yu) serves as Chairwoman, President, and CEO; she founded Akeso in 2012 and has driven the company from a Guangdong startup to a multi-billion-dollar HKEX-listed biopharmaceutical business. Her dual role spanning R&D strategy and corporate leadership is characteristic of founder-led Chinese biotechs at this growth stage, which concentrates institutional knowledge but also succession risk.

Strategic Partnerships

The headline partnership is Akeso's December 2022 licensing agreement with Summit Therapeutics, granting Summit development and commercialization rights to ivonescimab in the US, Canada, Europe, and Japan for a US$500 million upfront payment and up to US$4.5 billion in milestones plus low double-digit royalties. Akeso retains China and rest-of-world rights, meaning it captures both the royalty stream from Summit's global program and the full commercial upside from what is now a rapidly growing domestic franchise. All approved products are listed on China's National Reimbursement Drug List, ensuring systematic payer access across indications.

FAQ Section

Akeso retained China and rest-of-world commercialization rights for ivonescimab while licensing the US, Canada, Europe, and Japan to Summit Therapeutics for a US$500 million upfront and up to US$4.5 billion in milestones. This means Akeso simultaneously harvests a growing domestic commercial business — RMB3 billion in 2025 sales — and a royalty plus milestone stream from Summit's global program. The structure also insulates Akeso from the full capital cost of running multiregional trials in Western markets while keeping it exposed to the upside.

VEGF suppresses immune infiltration into tumors by impairing dendritic cell maturation and promoting an immunosuppressive microenvironment, so blocking it alongside PD-1 addresses a distinct resistance mechanism that PD-1 inhibition alone leaves intact. The bispecific format may also preferentially concentrate activity at sites of co-expression, potentially improving the therapeutic index relative to combining two separate agents. The HARMONi-2 data — PFS of 11.14 versus 5.82 months against pembrolizumab — suggest this dual mechanism delivers measurable benefit rather than theoretical advantage.

A fixed-combination bispecific maintains a 1:1 stoichiometric ratio of the two targeting arms at the tumor site, whereas combining separate agents produces variable exposure profiles and independent toxicity curves. Akeso's Tetrabody format is engineered to retain full IgG-like stability and pharmacokinetics while engaging both targets simultaneously. Crucially, ivonescimab has now beaten a PD-1 inhibitor plus chemotherapy backbone on both PFS and OS endpoints in a head-to-head Phase III — evidence that goes beyond mechanistic plausibility.

HARMONi-6 enrolled 532 patients with locally advanced or metastatic squamous NSCLC regardless of PD-L1 status and compared ivonescimab plus platinum chemotherapy against tislelizumab — an approved PD-1 inhibitor — plus chemotherapy. Ivonescimab reduced the risk of death by 34% (OS HR 0.66; P=0.0017) and cut progression or death risk by 40% (PFS HR 0.60; P<0.0001). It is the first global Phase III in lung cancer to achieve statistically significant improvements in both OS and PFS versus a PD-1 plus chemotherapy control, which is a materially higher bar than PFS alone.

Cadonilimab has three approved indications in China across cervical cancer settings, and the COMPASSION-36 global Phase II registrational trial is now open in PD-1-resistant hepatocellular carcinoma following dual NMPA and FDA clearance in August 2025. Ligufalimab, an anti-CD47 antibody, is generating mid-stage survival data in newly diagnosed AML in patients unfit for intensive chemotherapy — a signal that, if confirmed, would extend Akeso's reach into hematologic malignancies. The company describes its strategy as IO 2.0 plus ADC 2.0, with antibody-drug conjugates representing the next development layer.

Akeso is already a commercial-stage business in China: 2025 revenues of RMB3,033.1 million represent 51.5% year-on-year growth, and cadonilimab alone has treated approximately 120,000 patients. The global regulatory inflection comes from Summit's program — specifically whether HARMONi-6's OS data, combined with Summit's multiregional HARMONi trial results in EGFRm NSCLC (PFS HR 0.52), are sufficient to support FDA filings in the US. HARMONi-6's ASCO 2026 Plenary presentation is a meaningful step toward Western regulatory credibility for the bispecific mechanism.

The near-term picture is unusually active, with several variables that could move materially in either direction:

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