Akeso Inc. reported record commercial performance in the first half of 2025, with total sales increasing 49.20% to RMB 1,401.6 million compared to RMB 939.4 million in the same period last year. The Chinese biopharmaceutical company's growth was driven by expanded indications for its bispecific antibodies and their inclusion in China's National Reimbursement Drug List (NRDL).
The company's flagship asset, ivonescimab, achieved a major clinical milestone when the final overall survival (OS) analysis of the HARMONi-A Phase III trial demonstrated a statistically significant and clinically meaningful OS benefit. This represents the first Phase III final analysis for the PD-1/VEGF bispecific antibody, reinforcing its breakthrough value beyond progression-free survival endpoints.
Ivonescimab Demonstrates Global Consistency
During the reporting period, an interim analysis of the first global multicenter Phase III trial (HARMONi) showed strongly positive progression-free survival outcomes. With 38% of patients enrolled from Europe and North America, the intent-to-treat survival outcomes were highly consistent with those from the China-based HARMONi-A study, supporting ivonescimab's cross-regional efficacy and safety profile.
Ivonescimab has secured approval for first-line treatment of NSCLC following significant positive outcomes from HARMONi-2, a head-to-head Phase III trial against pembrolizumab monotherapy. The drug plus chemotherapy also demonstrated significant positive outcomes in another head-to-head Phase III study against tislelizumab plus chemotherapy in first-line squamous NSCLC.
The bispecific antibody is currently being evaluated in 13 registrational/Phase III trials, including eight for lung cancer and five for major tumors including cold tumors and IO-resistant indications. The extensive development program spans first-line triple-negative breast cancer, MSS/pMMR colorectal cancer representing about 95% of CRC cases, and first-line pancreatic cancer.
Cadonilimab Advances Global Development
Cadonilimab, the world's first approved immuno-oncology bispecific antibody, received approval for first-line treatment of cervical cancer, addressing a global gap in immunotherapy for PD-L1 negative patients. The drug is currently being evaluated in 10 global registrational/Phase III trials spanning first-line indications in major tumors, cold tumors, and IO-resistant diseases.
The company recently initiated COMPASSION-36, the first global multicenter registrational study of cadonilimab in combination with lenvatinib for second-line hepatocellular carcinoma treatment. This represents a significant milestone in the drug's international development and regulatory pathway.
Strategic "IO 2.0 + ADC 2.0" Platform
Akeso is leveraging its position as the only company globally with two approved immuno-oncology bispecific antibodies to advance next-generation ADC platforms. The company has progressed its novel bispecific ADC targeting Trop2/Nectin4 (AK146D1) and differentiated HER-3 ADC (AK138D1) into global clinical development.
Dr. Yu Xia, Founder, Chairwoman, President, and CEO of Akeso, stated: "Our first-in-class bispecific antibodies, cadonilimab and ivonescimab, position Akeso as a global leader in immuno-oncology bispecifics, reinforcing our pivotal role in shaping the future of cancer treatment."
Non-Oncology Portfolio Expansion
Beyond oncology, Akeso achieved significant milestones in autoimmune diseases. Ebronucimab (anti-PCSK9) received approval in China for hypercholesterolemia, affecting approximately 110 million patients in the country. Ebdarokimab (anti-IL-12/IL-23) was approved for psoriasis treatment, a condition affecting around 6.7 million patients in China.
Gumokimab (anti-IL-17) achieved positive results in a Phase III trial for active ankylosing spondylitis, while manfidokimab (anti-IL-4Rα) reported Phase III success in atopic dermatitis. New Drug Application submissions for these indications are currently underway.
Financial Performance and Global Expansion
Research and development expenses for the six months ended June 30, 2025 totaled RMB 731.2 million. The company maintained a strong financial position with total cash, cash equivalents, time deposits, and financial products of RMB 7,138.4 million as of June 30, 2025.
Notably, Akeso's proprietary PD-1 inhibitor penpulimab received U.S. FDA approval, marking the company's first internally developed innovative drug approved in the United States and the first biologic entirely led by a Chinese company to achieve U.S. FDA approval.
The company is implementing a dual-path strategy to maximize ivonescimab's global value: accelerating domestic commercialization and label expansion in China while simultaneously advancing global development in partnership with Summit Therapeutics.
