Also known as: AK112, SMT112
Ivonescimab is a first-in-class PD-1/VEGF bispecific immunotherapy antibody developed by Akeso with a dual tumor immunotherapy and anti-angiogenesis mechanism. It has received China NMPA marketing approval for EGFR-mutated advanced/metastatic non-squamous NSCLC after EGFR-TKI progression, and also as monotherapy for first-line PD-L1-positive NSCLC. Global phase III studies are ongoing.
Akeso reported overall survival benefit for ivonescimab plus chemotherapy in Phase III lung cancer study. The company enrolled first patient in Phase Ib/II trial of next-generation HER3 ADC AK138D1 for advanced breast cancer. Akeso also received China approval to start Phase II trials for AK139 bispecific antibody.
January and March 2026 drug pipeline updates included Phase 3 results, Fast Track designations and Priority Review decisions across multiple disease areas. Mavacamten, teplizumab-mzwv, anifrolumab, AXS-05, gedatolisib and AFTX-201 were among the programs with notable milestones.
China's regulatory reforms since 2015 have streamlined clinical trial and drug approval processes, accelerating development of advanced therapies like CAR-T and bispecific antibodies. These changes have boosted investor confidence and created opportunities for global pharmaceutical partnerships with Chinese biotech companies that have innovative pipelines but lack international marketing capabilities.
Summit Therapeutics will participate in three investor conferences in March 2026, following FDA acceptance of its BLA for ivonescimab in lung cancer with a PDUFA date of November 14, 2026.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07765433 |
Testing the Addition of Ivonescimab Combined With Standard Chemotherapy Compared to the Usual Chemotherapy and Immunotherapy Treatment for Patients With Advanced Biliary Tract Cancer |
NOT_YET_RECRUITING | PHASE2/PHASE3 |
| NCT07753824 |
A Phase II Study of Ivonescimab Combined With Intraperitoneal Paclitaxel in Patients With High-Grade Metastatic Appendiceal Adenocarcinoma (AA) |
NOT_YET_RECRUITING | PHASE2 |
| NCT07743632 |
Neoadjuvant Angiogenesis-Targeting Bispecific Chemoimmunotherapy for TNBC |
NOT_YET_RECRUITING | PHASE2 |
| NCT07743138 |
STOMP OUT: A Phase 2 Study To Evaluate The Effects Of Ivonescimab In Patients With Unresectable/Metastatic Adrenocortical Carcinoma (ACC) Or Unresectable Pheochromocytoma/Paraganglioma (PPGL) |
NOT_YET_RECRUITING | PHASE2 |
| NCT07655570 |
Pilot Study of Ivonescimab in Advanced/Metastatic Cutaneous Angiosarcoma |
NOT_YET_RECRUITING | PHASE2 |
| NCT07630077 |
Trastuzumab Rezetecan(SHR-A1811) Combined With Ivonescimab (AK112) in Locally Advanced or Metastatic Non-small Cell Lung Cancer Harboring HER2 Gene Abnormalities |
NOT_YET_RECRUITING | PHASE2 |
| NCT07623356 |
A Study of AK138D1 Alone or in Combination With Ivonescimab in Advanced Non-Small Cell Lung Cancer |
RECRUITING | PHASE1/PHASE2 |
| NCT07619339 |
A Study of Tepotinib and Ivonescimab in People With Non-Small Cell Lung Cancer |
RECRUITING | PHASE1 |
| NCT07614646 |
Evaluate the Safety, Tolerability, and Preliminary Efficacy of EVM14 in Combination With Ivonescimab in Sq-NSCLC Patients |
NOT_YET_RECRUITING | PHASE1 |
| NCT07602855 |
A Study of Risvutatug Rezetecan in Combination With Ivonescimab in Participants With Advanced Solid Tumors (EMBOLD PanTumour-103) |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
