Also known as: Innovent, Innovent Biologics
Innovent Biologics is a publicly listed Chinese biopharmaceutical company headquartered in Suzhou, Jiangsu. Founded in 2011, it develops antibody and other biotech therapies and later listed on the Hong Kong Stock Exchange. Its ticker is 1801 on SEHK.
AstraZeneca will report pivotal first-half data on sonesitatug vedotin in Claudin18.2 gastric cancer. The phase 3 Clarity-Gastric01 study is enrolling patients with ≥25% expression.
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.
The FDA has approved Bristol Myers Squibb's CAR-T therapy Breyanzi for relapsed/refractory marginal zone lymphoma, while a novel multiple myeloma drug candidate DTP3 advances to Phase 2 trials after showing promising early results. Both developments represent significant progress in blood cancer treatment, with the marginal zone lymphoma approval based on a 95.5% response rate and the myeloma drug demonstrating selective cancer cell killing without toxicity.
The multiple myeloma treatment landscape is rapidly expanding with over 75 companies developing 80+ pipeline therapies, while clinicians navigate evolving questions about transplant timing, quadruplet regimens, and minimal residual disease testing in newly diagnosed patients.
AIM ImmunoTech partners with Thermo Fisher to design Phase 3 trial for Ampligen in pancreatic cancer, while Innovent Biologics begins dosing patients in Phase 3 study of IBI354 for HER2-positive breast cancer.
A comprehensive market report reveals over 180 companies are developing more than 200 PD-1 and PD-L1 inhibitor drugs, with recent fast-track designations and successful Phase III trial results driving expansion in cancer immunotherapy.
Innovent Biologics has dosed the first participant in its pivotal Phase 3 HeriCare-Breast01 study evaluating IBI354, a HER2-targeted antibody-drug conjugate, as first-line treatment for unresectable locally advanced or metastatic HER2-positive breast cancer.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07412262 |
A Study of Chidamide Combined With Ivonescimab in the Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) With Acquired Resistance to Immunotherapy and High Yes-associated Protein (YAP) Expression |
NOT_YET_RECRUITING | PHASE2 |
| NCT07342725 |
Phase Ib/II Study to Evaluate the Safety and Efficacy of IBI363 in Combination With Chemotherapy as Second-Line Therapy for Unresectable Locally Advanced or Metastatic Pancreatic Cancer |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07061535 |
Sintilimab Combined With Tafolecimab and Chemotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer |
NOT_YET_RECRUITING | PHASE2 |
| NCT06936644 |
A Multicenter, Single-arm Phase II Study to Evaluate the Efficacy and Safety of Fulzerasib (IBI351) in Combination With Ivonescimab (AK-112) in First-line Treatment of Advanced or Metastatic Non-small Cell Lung Cancer Patients With KRAS G12C Mutation |
NOT_YET_RECRUITING | PHASE2 |
| NCT06292689 |
A Phase II, Single-arm, Multicenter, Prospective Study of Cardunolizumab in Recurrent or Metastatic Vulvar and Vaginal Cancer |
RECRUITING | PHASE2 |
| NCT06096909 |
Early Initiation of Tafolecimab for Patients With Acute Coronary Syndromeundergoing Percutaneous Coronary Intervention in Chinese Population |
NOT_YET_RECRUITING | NA |
| NCT05843292 |
Short-term Sintilimab in Combination With Taxane and Carboplatin for Neoadjuvant Therapy in Triple-negative Breast Cancer |
NOT_YET_RECRUITING | PHASE4 |
| NCT05385809 |
A Retrospective Study of Immunotherapy in Conversion Therapy of Unresectable Gastric Cancer |
UNKNOWN | |
| NCT04371796 |
Sintilimab (IBI308) in the Neoadjuvant Treatment of Patients With Resectable II-IIIA NSCLC |
UNKNOWN | PHASE2 |
| NCT03869034 |
HAIC Combined with PD-1 Inhibitor in Potentially Resectable Locally Advanced HCC |
ACTIVE_NOT_RECRUITING | PHASE2 |
