China-based Akeso Biopharma (HKG: 9926) released its 2022 financial report, highlighting significant growth in product sales. The company reported RMB 1.104 billion (USD 159.97 million) in product sales, representing a 422% year-on-year (YOY) increase.
Product Sales and Market Approvals
The innovative bispecific antibody cadonilimab (AK104), targeting programmed death-1 (PD-1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), earned a market nod and generated RMB 546 million (USD 79.1 million) in the first six months of commercialization. Additionally, the PD-1 inhibitor penpulimab (AK105) brought in RMB 558 million (USD 80.86 million) in sales, up 164% YOY. Penpulimab received market approval in January 2023 for the treatment of first-line locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) in combination with chemotherapy.
Licensing Deal and R&D Expenditure
Akeso also struck a USD 5 billion licensing deal with US-based Summit Therapeutics Inc. (NASDAQ: SMMT), granting exclusive rights to its bispecific antibody ivonescimab in the United States, Europe, Canada, and Japan. A USD 500 million upfront payment has been made as of the time of writing. During the period, research and development (R&D) expenditures totaled RMB 1.323 billion (USD 191.7 million).
Clinical Trials and Future Prospects
Akeso has 6 products undergoing a total of 14 pivotal Phase III clinical trials, with 6 having completed enrollment. Regulatory Phase III clinical studies for cadonilimab in first-line cervical cancer, first-line gastric cancer, and hepatocellular carcinoma are progressing well. A Phase III clinical study for ivonescimab combined with chemotherapy in advanced non-squamous NSCLC with EGFR-TKI resistant EGFR mutation has completed enrollment. Additionally, IL-12/IL-23 AK101 and ebronucimab are in Phase III clinical studies for moderate and severe psoriasis and hypercholesterolemia, respectively, with market approval filings expected in 2023.
Financial Strength
Akeso is well-positioned financially, with RMB 5 billion (USD 724.6 million) in cash on hand to accelerate clinical development and commercialization efforts.-Fineline Info & Tech
