Akeso's 2024 First Half Interim Results: Expanding Global Lead in IO Bispecific Antibodies, Advancing New Therapies, and Accelerating Commercialization | The Manila Times

Approval of ivonescimab for 2L+ EGFRm NSCL; HARMONi-A is the only phase III study that demonstrates significant benefit across all subgroups for PFS, and is also the only study to achieve the primary endpoint while showing a positive trend in OS benefit; HARMONi-A study presented in an oral presentation at ASCO 2024 and published in JAMA.
Ivonescimab vs. pembrolizumab for 1L PD-L1 positive NSCLC showed significant positive results; sNDA prioritized by NMPA; HARMONi-2 study featured as Late-Breaking Abstract-Plenary Oral at WCLC 2024. Ivonescimab to become the new standard treatment for first-line lung cancer, offering patients a novel and superior "chemotherapy-free" option.
The Phase III trial of ligufalimab (CD47, AK117) for first-line head and neck squamous cell carcinoma (vs. pembrolizumab) has begun, making it the first CD47 mAb to enter Phase III for solid tumors.
Phase III trial of pulocimab (AK109, VEGFR-2) plus cadonilimab for PD-1/L1-resistant gastric cancer underway, cadonilimab aims to provide a new option for IO-resistant cancers, showcasing its potential as next-generation cancer immunotherapy.
Cadonilimab's sNDAs for advanced gastric and cervical cancers accepted, showing broad benefit and addressing the need for effective treatments in tumors with low or negative PD-L1 expression.
12 products are in Phase lll clinical trials or commercial stage; 17 pivotal/Phase III trials for cadonilimab and ivonescimab completed/ongoing.
6 new phase III trials added, including ivonescimab for first-line biliary tract cancer (vs. durvalumab), head and neck squamous cell carcinoma (vs. pembrolizumab), pancreatic cancer, and cadonilimab for IO-resistant gastric cancer.
IND application received for AK138D1, the first differentiated ADC product.
H1 net product sales recorded RMB939.4 million.

HONG KONG, Aug. 29, 2024 /PRNewswire/ -- Akeso, Inc. (9926.HK) reported its interim results, highlighting the Company's continued innovation and commercial execution. The Company has solidified its lead in cancer immunotherapy bispecific antibodies with the successful market approval of cadonilimab(PD-1/CTLA-4) and ivonescimab(PD-1/VEGF). In the first half of 2024, 4 new drugs were launched, and applications for market approval were submitted for 7 indications across 5 new drugs, and 12 products are in Phase lll clinical trials or commercial stage. Over 20 phase III clinical trials have been completed or are in progress.

Akeso is propelling forward with innovative therapies to drive global oncology treatment advancements: 6 novel bispecific antibodies have entered clinical trials, and the Company's first differentiated ADC, AK138D1, is now in clinical development. Upcoming are new drugs featuring ADCs, bispecific ADCs, trispecific antibodies, and other novel targets and mechanisms.