Publicly listed Chinese biopharmaceutical company headquartered in Zhongshan, Guangdong, known for developing ivonescimab, a bispecific cancer antibody. The group traces its founding to 2012; the Cayman-incorporated listing vehicle was registered in 2020 and listed on the Hong Kong Stock Exchange (9926) in April 2020.
Clinical Trials
5
0 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2020
Unknown
5
100.0%
No approval data available
- Akeso's AK158D1, a next-generation bispecific antibody-drug conjugate targeting EGFR and TROP2, received Phase I clearance from China's NMPA Center for Drug Evaluation. - The trial will evaluate AK158D1 in patients with advanced malignant solid tumors, marking Akeso's fourth clinical-stage ADC candidate. - AK158D1 is Akeso's second bispecific ADC to enter the clinic, joining AK146D1, AK138D1 and AK157D1 in the company's ADC pipeline. - Preclinical studies showed potent anti-tumor activity and a favorable safety profile, with dual targeting designed to overcome limits of single-target ADCs.
- Updated Phase III HARMONi results presented at WCLC 2026 show ivonescimab plus chemotherapy achieved an overall survival hazard ratio of 0.76 in EGFR-mutated NSCLC. - With median follow-up extended to 23.2 months, western patients replicated the survival improvement previously seen in Asian patients, supporting regional consistency. - The Akeso-sponsored HARMONi-2 study reported ivonescimab monotherapy beat pembrolizumab on overall survival with a hazard ratio of 0.73 in PD-L1-positive NSCLC. - Summit's Biologics License Application for ivonescimab in this indication has an FDA PDUFA goal action date of November 14, 2026.
- Akeso's Phase III HARMONi-2 trial met its overall survival endpoint, with ivonescimab monotherapy cutting the risk of death by 27% versus pembrolizumab in first-line PD-L1-positive advanced NSCLC. - Median overall survival reached 30.8 months with ivonescimab versus 22.6 months with pembrolizumab (HR=0.73; 95% CI 0.57-0.95; P=0.009) at 36 months of median follow-up. - Benefit was most pronounced in PD-L1-high patients (TPS >=50%), where the hazard ratio was 0.58, corresponding to a 42% reduction in the risk of death. - No apparent increase in bleeding risk was observed among high-risk squamous patients, a population traditionally considered contraindicated for anti-VEGF therapy.
- Inovio Pharmaceuticals is awaiting an Oct. 30 FDA target action date for INO-3107, an investigational DNA medicine for HPV 6- and HPV 11-associated recurrent respiratory papillomatosis. - In the Phase I/II RRP-001 study, 72% of patients had a 50% to 100% surgery reduction in year one, rising to 86% in year two. - The BLA was filed under accelerated approval, but the FDA's file acceptance letter preliminarily questioned eligibility because an RRP product already holds full approval. - Inovio has completed pre-licensure inspections and expects labeling discussions in September, while a confirmatory trial design still requires FDA agreement.
- Akeso's bispecific antibody Ivonescimab outperformed MSD's Keytruda in a head-to-head Phase III clinical trial, drawing international attention to China's biopharmaceutical innovation. - The Greater Bay Area has emerged as a major biotech hub, with Zhongshan hosting over 650 biopharma companies and Guangzhou exceeding 6,500 firms with annual R&D spending above 3.8 billion yuan. - China now accounts for roughly one-third of innovative drugs in global development, with outbound licensing deals surpassing $130 billion in 2025 and nearly 20 innovative drugs approved from January to May. - Guangdong aims to grow its biopharmaceutical and health industry cluster to over 1 trillion yuan by 2027, supported by deeper AI-biomedicine integration and cross-regional regulatory coordination.
