
Akeso 2026 Interim Results: Strong Commercialization Momentum; IO2.0+ Global Strategy Redefining Clinical Standards; Bispecific Advancement in ADC, I&I and Alzheimer's
PRNewsWire
公開日時: Aug 28, 2026, 11:44 AM GMT+9
Sentiment Analysis
HONG KONG , Aug. 27, 2026 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced its 2026 interim results. During the reporting period, the Company achieved record-high drug sales revenue, further advanced its global immuno-oncology (IO) 2.0 strategy, progressively built its IO2.0 + ADC2.0 therapeutic matrix, and continued orderly development of bispecific antibodies in major chronic disease areas, including autoimmune, respiratory, and central nervous system (CNS) disorders Commercialization Reaches Record High Commercial sales revenue for the first half of 2026 reached approximately RMB 1,803.2 million , representing a 28.7% increase year-over-year. As of the reporting date, the Company's total cash and cash equivalents, together with other short-term financial assets, stood at RMB 9,160.0 million . By the end of 2025, all 12 indications across the Company's five self-commercialized innovative drugs had been included in China's National Reimbursement Drug List (NRDL). These include two non-small cell lung cancer (NSCLC) indications for ivonescimab (PD-1/VEGF bispecific antibody) and three cervical and gastric cancer indications for cadonilimab (PD-1/CTLA-4 bispecific antibody). NRDL inclusion has significantly expanded market coverage and patient access. In August 2026, the National Medical Products Administration (NMPA) approved ivonescimab in combination with chemotherapy for the first-line treatment of advanced squamous non-small cell lung cancer (sq-NSCLC), providing a new growth driver for commercialization. Since the beginning of 2026, the Company has continued to strengthen its commercialization capabilities, with steady progress in market access, coverage, and penetration. These efforts lay a solid foundation for the sustained release of innovative drug value in the second half of the year and beyond. IO2.0 Global Strategy Advances Following the approvals of ivonescimab and cadonilimab - two first-in-class immuno-oncology (IO) cornerstone therapies - Akeso has continued to advance the Company's global IO2.0+ strategy. The Company is building a bispecific antibody-based IO therapeutic matrix designed to treat multiple tumor types through combining different types of therapy. Biliary tract cancer: In August 2026, the Phase III clinical study of ivonescimab plus chemotherapy versus durvalumab plus chemotherapy for the first-line treatment of advanced biliary tract cancer met its primary endpoint of overall survival (OS), demonstrating clinically meaningful and statistically significant OS benefit. This regimen represents a major advancement in first-line treatment of biliary tract cancer. Squamous NSCLC: In August 2026, ivonescimab plus chemotherapy received NMPA approval for first-line treatment of sq-NSCLC. Based on the HARMONi-6 study, this is the first regimen to achieve dual positive OS and progression-free survival (PFS) results versus a PD-1 monoclonal antibody plus chemotherapy in a randomized, double-blind Phase III trial. Ivonescimab combination therapy marks a significant advance in first-line sq-NSCLC treatment. EGFR-TKI-resistant NSCLC: In July 2026, an updated analysis of the global multicenter Phase III HARMONi study demonstrated continued OS improvement (HR = 0.76). The OS hazard ratio in Western patients was also 0.76, highly consistent with the China-conducted HARMONi-A study (HR = 0.74, P = 0.02). The Biologics License Application (BLA) for this indication is currently under review by the U.S. Food and Drug Administration (FDA). The HARMONi-A study is the first immuno-oncology trial globally to achieve dual positive OS and PFS results with both clinical benefit and statistical significance in this setting. Ivonescimab combination therapy represents a major advancement in the treatment of EGFR-TKI-resistant non-squamous NSCLC. PD-L1-positive NSCLC: In the HARMONi-2 study, ivonescimab became the first therapy globally to demonstrate positive results versus pembrolizumab in a Phase II...
Source: PRNewsWire
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