Akeso, Inc

Akeso is recognized as one of China’s emerging and innovative biopharmaceutical companies, strongly emphasizing developing and commercializing first-in-class and best-in-class biologic therapies. The company's rapid growth and robust R&D capabilities have gained attention, particularly in antibody-based drug development. Founded nearly a decade ago, this relatively small biotech firm made headlines with its lung cancer treatment, Ivonescimab. Developed and tested in China, Ivonescimab stunned the industry by outperforming Merck’s blockbuster cancer drug, Keytruda. In clinical trials, patients treated with Ivonescimab experienced a progression-free survival of 11.1 months before their tumors began to grow again, nearly double the 5.8 months observed in patients receiving Keytruda. Since Keytruda has generated over $130 billion for Merck and is considered the gold standard in cancer treatment, these results have positioned Akeso as a rising force in the global biopharma landscape.

“Akeso Inc. is introducing a new lung cancer treatment to the U.S. market, following study results indicating its drug outperforms Merck & Co. Inc.'s Keytruda.”

Ivonescimab

Mechanism of Action: Antibody-dependent cell cytotoxicity; Programmed cell death 1 receptor antagonists; T lymphocyte stimulants Drug Class: Bispecific antibodies Originator: Akeso Biopharma Indication: Non-small cell lung cancer Trial: HARMONi-2 trial

Ivonescimab has demonstrated superior clinical efficacy over pembrolizumab, showing a statistically significant and clinically meaningful improvement in progression-free survival (PFS) as first-line therapy for PD-L1–positive advanced non-small cell lung cancer (NSCLC). In the HARMONi-2 study, ivonescimab reduced the risk of disease progression or death by 49%, attributed to its bispecific design that targets both PD-1 and VEGF pathways—offering a dual mechanism distinct from pembrolizumab’s PD-1 inhibition alone.

However, despite these promising clinical outcomes, ivonescimab currently lags far behind pembrolizumab in market performance. Pembrolizumab’s entrenched position, broad multi-indication approvals, and Merck’s global commercialization network ensure its continued revenue dominance in the near term. While ivonescimab may represent a strong emerging competitor, pembrolizumab remains the benchmark therapy in this space.

Forecasted market revenue of Ivonescimab (2026- 2028)

Fig 2a: Market revenue of Ivonescimab

Forecasted market revenue of Keytruda (2025- 2028)

Fig 2b: Market revenue of Keytruda

Market revenue of Akeso, Inc

Akeso, Inc. demonstrated consistent revenue growth through 2023, reaching its highest earnings that year, driven largely by strong sales of its innovative drug, cadonilimab (a PD-1/CTLA-4 bispecific antibody), following its launch in June 2022. The company also saw increased revenue contributions from other products and reported its first profit in the first half of 2023. However, for the full year ending December 31, 2024, Akeso reported a sharp decline in financial performance. Revenue dropped by 53.08% year-over-year, and gross profit fell by 58.23%, resulting in a net loss of RMB 501.1 million. This downturn was primarily attributed to the absence of a major upfront payment received in 2023 from its collaboration with SUMMIT, which had significantly boosted the previous year’s earnings. Akeso, Inc. reported revenue of CNY 1,411.54 million (approximately ₹16.5 billion INR, based on the September 2025 exchange rate of 1 CNY ≈ 11.7 INR). The company expects full-year 2025 revenue to be higher.

“Akeso, Inc. achieved record revenue and its first profit in 2023 driven by cadonilimab sales, but reported a sharp financial decline in 2024 due to the absence of a one-time upfront payment, with revenue expected to recover in 2025.”

Five-years market revenue of Akeso, Inc (2021-H12025)

Fig 3: Market revenue of Akeso, Inc

Akeso Inc.: Unveiling a Robust Pipeline Driving Innovation

Akeso Inc. has been in the news for its oncology pipeline, with the bispecific antibodies ivonescimab (AK112) and cadonilimab (AK104) drawing significant attention. Akeso Inc. boasts a robust and diversified pipeline, with a strong focus on oncology drugs across various stages of development. This is followed by promising candidates in immunology and metabolic diseases. Among its upcoming therapies is Gumokimab, a key asset expected to launch in China for the treatment of psoriasis and ankylosing spondylitis, further reinforcing Akeso’s commitment to addressing unmet medical needs

Oncology- Strengths and Highlights

1. Strong Breadth and Depth

  • 17 active oncology assets, spanning monoclonal antibodies (mAbs), bispecific antibodies (BsAbs), and ADCs (antibody-drug conjugates).
  • Broad coverage of major immune-oncology pathways: PD-1, CTLA-4, VEGF/VEGFR, TIGIT, CD47, CD73, and emerging targets (HER3, Trop2, CLDN18.2).

2. Leading BsAb Platform

  • High innovation focus with multi-target bispecific antibodies (PD-1/CTLA-4, PD-1/VEGF, PD-1/LAG-3, TIGIT/TGF-β, CLDN18.2/CD47, etc.).
  • BsAbs positioned to overcome resistance seen with monotherapies and enhance efficacy across tumor types.
  • Notably, Cadonilimab and Ivonescimab have advanced to pivotal/late-stage trials in multiple tumor settings.

3. Multiple Late-Stage Assets

  • Cadonilimab (PD-1/CTLA-4): Progressed into Phase III / pivotal studies in gastric, cervical, and colorectal cancers. Demonstrates first-mover advantage in BsAb immunotherapy space.
  • Ivonescimab (PD-1/VEGF): Advanced into pivotal development for NSCLC and EGFR-TKI progressed disease. Dual inhibition of PD-1 and VEGF may yield synergistic anti-tumor effects.
  • Penpulimab (PD-1 mAb): Advanced to late-stage in HCC, NPC, and NSCLC, with a path toward NDA or registration in select markets.

4. Broad Tumor Indications

  • Coverage across solid tumors and hematologic malignancies — including NSCLC, HCC, gastric, colorectal, cervical, pancreatic, thyroid, and head & neck cancers.
  • Early exploration in hematologic cancers (AML, MDS, cHL) through ligufalimab (CD47) and AK129 (PD-1/LAG-3).

5. Emerging Modalities

  • Strong R&D expansion into ADCs (e.g., AK138D1 – HER3 ADC, AK146D1 – Trop2/Nectin 4 ADC), leveraging targeted cytotoxic delivery.
  • This signals a next-generation diversification beyond checkpoint inhibition.

Metabolism & Auto-Immunity Portfolio – Strengths and Highlights

1. Balanced Immunology Expansion

  • A growing autoimmune and inflammatory disease pipeline with 7 active assets.
  • Covers cardiometabolic (PCSK9) and immune-mediated disorders (IL-12/23, IL-17, IL-4Rα) — mirroring successful biologic classes.

2. Late-Stage Readiness

  • Ebronucimab (PCSK9 mAb): Approved for primary hypercholesterolemia and mixed dyslipidemia, showcasing commercial maturity and validation of biologic development capability.
  • Ebdarokimab (IL-12/23 mAb) and Gumokimab (IL-17 mAb): In Phase II–III for ulcerative colitis, psoriasis, and ankylosing spondylitis, aligning with global standards (similar to ustekinumab, secukinumab).

3. Expanding Multi-Specific Antibody Capabilities

  • Development of bispecific antibodies (BsAbs) in immunology: AK139 (IL-4Rα/ST2) and AK150 (IL-T2/IL-T4CSF1R) — targeting complex immune signaling for respiratory and dermatologic indications. Reflects platform versatility across therapeutic areas.

Strategic Strengths at a Glance

Akeso's pipeline demonstrates exceptional scientific breadth, strategic balance between innovation and late-stage assets, and technological scalability. The oncology portfolio, especially Cadonilimab, Ivonescimab, and Penpulimab, positions the company as a front-runner in bispecific immuno-oncology. Simultaneously, the autoimmune segment provides a commercial safety net and diversification.

The combined strength indicates a company transitioning from clinical innovator to global immunotherapy leader, with cross-platform synergies supporting long-term competitiveness and value creation.

Pharma Insight Reports

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