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.
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 |
|---|---|---|---|
| NCT07602855 |
A Study of Risvutatug Rezetecan in Combination With Ivonescimab in Participants With Advanced Solid Tumors (EMBOLD PanTumour-103) |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07594522 |
A Study of Ivonescimab in People With Non-Small Cell Lung Cancer |
RECRUITING | PHASE1/PHASE2 |
| NCT07560124 |
A Study of AK138D1 Alone or in Combination With Ivonescimab in Advanced Breast Cancer |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07535463 |
A Study of Ivonescimab, Chemotherapy, and Stereotactic Radiosurgery for People With Non-Small Cell Lung Cancer |
RECRUITING | PHASE1/PHASE2 |
| NCT07535437 |
A Study of Ivonescimab in Combination With Dato-DXd or Osimertinib in People With Non-Small Cell Lung Cancer |
RECRUITING | PHASE1/PHASE2 |
| NCT07516925 |
A Study of Ivonescimab in People With Leiomyosarcoma |
RECRUITING | PHASE2 |
| NCT07472478 |
Phase II Neoadjuvant Study of Garsorasib Followed by Ivonescimab Plus Chemotherapy in Resectable Stage IIA-IIIB KRAS G12C-Mutant NSCLC (GIVEN Study) |
NOT_YET_RECRUITING | PHASE2 |
| NCT07405190 |
Ivonescimab Alone And With Carboplatin/Pemetrexed For NSCLC |
NOT_YET_RECRUITING | PHASE2 |
| NCT07397338 |
Study of RAS(ON) Inhibitors in Combination With Ivonescimab in Patients With Solid Tumors |
RECRUITING | PHASE1/PHASE2 |
| NCT07394218 |
ctDNA-guided Treatment Decision-making |
RECRUITING | PHASE2 |
