Drugs / IBI310
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | colorectal carcinoma | 2025-02-24 | “New Drug Application (NDA) for ipilimumab injection (anti-CTLA-4 monoclonal antibody; R&D Code: IBI310) has been accepted” innoventbio.com ↗ |
Trials 18
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT05363722 | May 2022 → Apr 2023 | hepatocellular carcinoma | Shanghai Zhongshan Hospital | Unknown | No outcome recorded |
| Phase 1 | NCT05118334 | Nov 2021 → Jul 2022 | non-small cell lung carcinoma | Innovent Biologics (Suzhou) Co. Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04945421 | Jul 2021 → Apr 2022 | — | Innovent Biologics (Suzhou) Co. Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04868760 | May 2021 → May 2022 | — | Innovent Biologics (Suzhou) Co. Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03545971 | Sep 2018 → Sep 2021 | cancer | Innovent Biologics (Suzhou) Co. Ltd. | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT07714317 | Jul 2026 → Jul 2027 expected | hepatocellular carcinoma | Shanghai Zhongshan Hospital | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT05653180 | Mar → Dec 2023 | biliary tract cancer | Innovent Biologics (Suzhou) Co. Ltd. | Unknown | No outcome recorded |
| Phase 1/2 | NCT04202601 | Dec 2019 → Sep 2022 | gastroesophageal adenocarcinoma | Peking University | Unknown | No outcome recorded |
| Phase 26 trials · 1 missed | ||||||
| Phase 2 | NCT07410975 | Jan 2026 → Jun 2028 expected | non-small cell lung carcinoma | Shanghai Pulmonary Hospital, Shanghai, China | Recruiting | No outcome recorded |
| Phase 2 | NCT06620822 | Sep 2024 → Sep 2026 overdue | non-small cell lung carcinoma | Shanghai Pulmonary Hospital, Shanghai, China | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06580574 | Sep 2024 → Jun 2029 expected | colon carcinoma, gastric cancer | Peking University | Recruiting | No outcome recorded |
| Phase 2 | NCT05165407 | Jul 2022 → Sep 2025 overdue | neuroendocrine neoplasm | Peking University | Recruiting | No outcome recorded |
| Phase 2 | NCT04590599 | Dec 2020 → Nov 2023 | cervical cancer | Innovent Biologics (Suzhou) Co. Ltd. | Completed | Missed primary |
| Phase 2 | NCT04258111 | Aug → Oct 2020 | colorectal cancer | Innovent Biologics (Suzhou) Co. Ltd. | Terminated | No outcome recorded Stop: Business |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT07490262 | Mar 2026 → Dec 2027 expected | hepatocellular carcinoma | Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. | Recruiting | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT05890742 | May 2023 → Apr 2028 expected | — | Innovent Biologics (Suzhou) Co. Ltd. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04720716 | Feb 2021 → Dec 2025 | hepatocellular carcinoma | Innovent Biologics (Suzhou) Co. Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT04277663 | Apr 2020 → Feb 2023 | acral lentiginous melanoma | Innovent Biologics (Suzhou) Co. Ltd. | Terminated | No outcome recorded Stop: Business |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2025-12-25 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory China's First Domestic Anti-CTLA-4 Monoclonal Antibody, Innovent's TABOSUN® (Ipilimumab N01 Injection) Received NMPA Approval innoventbio.com ↗
TABOSUN® (ipilimumab N01 injection) has been approved in combination with TYVYT® (sintilimab injection) for the neoadjuvant treatment of patients with stage IIB-III resectable microsatellite instability-high or mismatch repair deficient (MSI-H/dMMR) colon cancer. |
| 2025-02-24 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory NMPA Accepts NDA and Grants Priority Review Designation to Innovent’s Ipilimumab Injection, China’s First Domestic CTLA-4 Inhibitor, in Combination with Sintilimab as Neoadjuvant Treatment for Colon Cancer innoventbio.com ↗
the New Drug Application (NDA) for ipilimumab injection (anti-CTLA-4 monoclonal antibody; R&D Code: IBI310) has been accepted by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) and granted Priority Review designation[1] |
| 2024-06-03 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent Delivers Oral Presentation of Clinical Data of A Randomized Controlled Phase 1b Study Evaluating IBI310 (Anti-CTLA-4 Monoclonal Antibody) in Combination with Sintilimab as Neoadjuvant Treatment of Colon Cancer at 2024 ASCO Annual Meeting innoventbio.com ↗
For per-protocol set, the pathologic complete response (pCR) rates in IBI310 plus sintilimab arm were significantly improved than sintilimab alone arm（0% vs 47.7%, p=0.0007）. |
| 2022-04-14 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory Innovent Receives NMPA Breakthrough Designation for IBI310, the Anti-CTLA-4 Monoclonal Antibody, Combined with Sintilimab in Advanced Cervical Cancer Treatment innoventbio.com ↗
the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for IBI310 in combination with sintilimab for the treatment of patients with recurrent or metastatic cervical cancer. |
| 2022-04-11 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent Release Phase 1 Results of IBI322 (anti-PD-L1/CD47 bispecific antibody) in patients with advanced solid tumors at AACR Annual Meeting 2022 innoventbio.com ↗
20 patients with various advanced solid tumors at active doses of IBI310 ≥10 mg/kg group were evaluable per RECISTv1.1, 4 achieved PR, with investigator assessed ORR 20%. |
| 2020-06-03 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent Announces the Preliminary Results of the Anti-CTLA-4 Monoclonal Antibody IBI310 in a Phase 1 Clinical Study innoventbio.com ↗
There were no dose limiting toxicities (DLTs) in both phases, and the dose expansion in Phase 1b is currently ongoing. |
All press releases naming this drug 9 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 18 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | IBI310 | “This is a phase 1b/II, open label, multicenter study of IBI310 (Anti-CTLA4 mAb) in combination with Sintilimab in patients with recurrent/metastatic Nasopharyngeal Carcinoma...” NCT04945421 ↗17“Sintilimab 200mg, ivgtt, q21d; IBI310 1mg/kg, ivgtt, q42d; Lenvatinib 8mg (starting from 4mg), po, qd” NCT06580574 ↗ “Drug: IBI310 1 mg/kg Q6W on Day 1 by IV infusion” NCT04202601 ↗ |
| Action | Inhibit | “anti-CTLA-4 antibody” NCT04258111 ↗ |
| Modality | Monoclonal antibody | “IBI310 (Anti-CTLA4 mAb)” NCT04945421 ↗ |
| Route | Intravenous | “IBI310 0.3mg/kg intravenous every 3 weeks” NCT03545971 ↗ |
| Target | CTLA4 | “anti-CTLA-4 antibody” NCT04258111 ↗ |