Drugs / IBI363
Trials 19
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT06610799 | Oct 2024 → Jun 2025 overdue | — | Xiangdong Cheng | Recruiting | No outcome recorded |
| Phase 1 | NCT06468098 | Jun 2024 → Jun 2025 overdue | cancer | Innovent Biologics (Suzhou) Co. Ltd. | Recruiting | No outcome recorded |
| Phase 1 | NCT06717880 | Jul 2023 → Jul 2025 overdue | cancer | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | No outcome recorded |
| Phase 1 | NCT05460767 | Aug 2022 → Mar 2024 | lymphoma | Innovent Biologics (Suzhou) Co. Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT05290597 | Aug 2022 → Jan 2026 overdue | lymphoma | Innovent Biologics (Suzhou) Co. Ltd. | Active not recruiting | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT07361991 | Mar 2026 → Sep 2028 expected | — | The First Affiliated Hospital of Zhengzhou University | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07342725 | Jan 2026 → Dec 2027 expected | malignant pancreatic neoplasm | Ruijin Hospital | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07307053 | Jan 2026 → Jan 2029 expected | high grade malignant neoplasm, metastatic neoplasm | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06081907 | Dec 2023 → Dec 2026 expected | neoplasm | Hunan Province Tumor Hospital | Recruiting | No outcome recorded |
| Phase 210 trials | ||||||
| Phase 2 | NCT07402070 | Feb → Dec 2026 expected | non-small cell lung carcinoma | Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07408635 | Jan 2026 → Jun 2028 expected | non-small cell lung carcinoma | Shanghai Pulmonary Hospital, Shanghai, China | Recruiting | No outcome recorded |
| Phase 2 | NCT07289048 | Dec 2025 → Dec 2027 expected | small cell lung carcinoma | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07325630 | Nov 2025 → May 2026 overdue | — | Zhejiang Cancer Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07124793 | Aug 2025 → Sep 2026 overdue | — | Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07122687 | Aug 2025 → Nov 2026 expected | non-small cell lung carcinoma | Innovent Biologics (Suzhou) Co. Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT06797297 | Feb 2025 → Mar 2026 overdue | melanoma | Innovent Biologics (Suzhou) Co. Ltd. | 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 | NCT06281678 | Apr 2024 → Mar 2026 overdue | colorectal cancer, melanoma, non-small cell lung carcinoma, renal cell carcinoma | Innovent Biologics (Suzhou) Co. Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT06081920 | Oct 2023 → Jun 2025 overdue | melanoma | Innovent Biologics (Suzhou) Co. Ltd. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 19
| Date | Issuer | Release |
|---|---|---|
| 2026-06-01 | Innovent Biologics (Suzhou) Co. Ltd. | Results 2026 ASCO | Innovent Presents Long-Term Follow-up Results from the PoC Study of IBI363 (TAK-928) (PD-1/IL-2α-bias bispecific fusion protein), Showing Robust Survival Benefits in Advanced Immunotherapy-Resistant Non-Small Cell Lung Cancer innoventbio.com ↗
After long-term follow-up, IBI363 monotherapy demonstrated strong overall survival (OS) with a long tail effect in IO-resistant squamous NSCLC and adenoNSCLC |
| 2026-06-01 | Innovent Biologics (Suzhou) Co. Ltd. | Results 2026 ASCO | Innovent Presents Preliminary PoC Data of IBI363 (TAK-928) PD-1/IL-2α-bias bispecific fusion protein) in First-line Advanced NSCLC innoventbio.com ↗
IBI363 in combination with chemotherapy demonstrated encouraging efficacy signals and manageable safety in the first-line treatment of NSCLC with PD-L1 negative or low expression. |
| 2026-05-22 | Innovent Biologics (Suzhou) Co. Ltd. | Results 2026 ASCO Abstract Highlights | Innovent Announces Preliminary PoC data of IBI363 in Combination with Chemotherapy as First-line Treatment for Advanced NSCLC, Showing Encouraging Efficacy Signals and Favorable Safety innoventbio.com ↗
The preliminary results showed that IBI363 combined with PDC demonstrated encouraging efficacy signals in the first-line treatment of NSCLC with PD-L1 negative or low expression. |
| 2026-05-22 | Innovent Biologics (Suzhou) Co. Ltd. | Results 2026 ASCO Abstract Highlights: Innovent Biologics' IBI363 (PD-1/IL-2α-bias bispecific fusion protein) Demonstrates Robust Survival Benefits in Long-Term Follow-up of PoC Study in Advanced Immunotherapy-Resistant Non-Small Cell Lung Cancer innoventbio.com ↗
Updated data from this PoC study conducted in China, showed that after extended follow-up, IBI363 continued to demonstrate a manageable long-term safety profile in IO-resistant NSCLC. |
| 2026-05-11 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory Innovent Announces IBI363 (PD-1/IL-2α-bias Bispecific Fusion Protein) Received Third NMPA Breakthrough Therapy Designation for MSS/pMMR Metastatic Colorectal Cancer innoventbio.com ↗ |
| 2025-08-25 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory Innovent Biologics Announces U.S. FDA IND Approval for the First Global MRCT Phase 3 Study (MarsLight-11) of IBI363 (PD-1/IL-2α-bias) in Squamous Non-Small Cell Lung Cancer innoventbio.com ↗
This IND clearance follows recent positive feedback from the U.S. FDA at the End-of-Phase 2 (EOP2) meeting. |
| 2025-06-30 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent Biologics Showcases “Dual Innovations” at Oncology R&D Day, Pioneering the Future of Cancer Treatment with Next-Generation IO and ADC Platforms innoventbio.com ↗
At ASCO 2025, IBI363 demonstrated breakthrough potential in three hard-to-treat tumor types, with a long tailing effect in prolonged survival benefits: |
| 2025-06-05 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory Innovent’s IBI363 (PD-1/IL-2α-bias Bispecific Antibody Fusion Protein) Receives Second NMPA Breakthrough Therapy Designation for Immuno-resistant Squamous Non-Small Cell Lung Cancer innoventbio.com ↗ |
| 2025-06-04 | Innovent Biologics (Suzhou) Co. Ltd. | Results 2025 ASCO Oral Presentation: Innovent Biologics Announces Updated Data of IBI363 (First-in-class PD-1/IL-2α-bias Bispecific Antibody Fusion Protein) from the Phase 1 PoC Clinical Study in Advanced Non-small Cell Lung Cancer innoventbio.com ↗
A manageable safety profile, encouraging efficacy, and trends in long-term survival benefits have been observed in both immunotherapy-resistant squamous non-small cell lung cancer (NSCLC) and wild-type lung adenocarcinoma. |
| 2025-06-02 | Innovent Biologics (Suzhou) Co. Ltd. | Results 2025 ASCO Oral Presentation: Innovent Biologics Announces Updated Date of IBI363 (First-in-class PD-1/IL-2α-bias Bispecific Antibody Fusion Protein) from Phase 1 Clinical Studies in Advanced Colorectal Cancer innoventbio.com ↗
IBI363 demonstrated encouraging response and overall survival benefit in the context of colorectal cancer, which is typically considered an immunologically ‘cold’ tumor, supports its unique mechanism of actions （MoA） of turning “cold tumor” into “hot tumor”. |
| 2025-06-01 | Innovent Biologics (Suzhou) Co. Ltd. | Results ASCO 2025 Oral Presentation: Innovent Biologics Announces Updated Data of IBI363 (First-in-class PD-1/IL-2α -bias Bispecific Antibody Fusion Protein) from Phase 1 and 2 Clinical Studies on Immunotherapy-treated Advanced Malignant Melanoma innoventbio.com ↗
At this year's ASCO meeting, IBI363 reported encouraging Phase 1/2 clinical data in the first three indications explored—non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and melanoma—focusing on IO-resistant and cold tumors. |
| 2025-03-31 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory Innovent Receives NMPA Breakthrough Therapy Designation for IBI363 (PD-1/IL-2α-bias Bispecific Antibody Fusion Protein) in Melanoma innoventbio.com ↗
has granted Breakthrough Therapy Designation (BTD) for IBI363 |
| 2025-02-17 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory Innovent Receives Second Fast Track Designation from the U.S. FDA for IBI363 (PD-1/IL-2α-bias Bispecific Antibody Fusion Protein) in Squamous Non-Small Cell Lung Cancer innoventbio.com ↗
This designation applies to the treatment of unresectable, locally advanced, or metastatic squamous non-small cell lung cancer (sqNSCLC) that has progressed following anti-PD-(L)1 immune checkpoint inhibitor therapy and platinum-based chemotherapy. |
| 2024-09-18 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent Announces Clinical Data of IBI363 (First-in-class PD-1/IL-2α-bias Bispecific Antibody Fusion Protein) Combined with Bevacizumab in Advanced Colorectal Cancer at the 2024 ESMO Congress innoventbio.com ↗
A total of 35 subjects received treatment of IBI363 combined with bevacizumab, demonstrating promising anti-tumor efficacy with good tolerability and safety |
| 2024-09-11 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent Delivers Oral Presentation on Phase 1 Clinical Data of IBI363 (First-in-class PD-1/IL-2α-bias Bispecific Antibody Fusion Protein) in Advanced Non-small Cell Lung Cancer at the 2024 WCLC innoventbio.com ↗
In the group of 125 patients having at least one post-baseline tumor assessment, the overall ORR was 20.8% and DCR was 74.4%. |
| 2024-09-04 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory Innovent Receives Fast Track Designation from the U.S. FDA for IBI363 (PD-1/IL-2α-bias Bispecific Antibody Fusion Protein) as Monotherapy for Advanced Melanoma innoventbio.com ↗
the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its PD-1/IL-2α-bias Bispecific Antibody Fusion Protein (R&D code: IBI363), for the treatment of unresectable locally advanced or metastatic melanoma |
| 2024-06-19 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent Reports Oncology Pipeline Updates at Investor Meeting innoventbio.com ↗
IBI363: First-in-class PD-1/IL-2 α-bias bispecific antibody fusion protein shows promising anti-tumor efficacy across multiple cancer types, including in immunotherapy-treated and ‘cold’ tumors, signaling the emergence of a potential next-generation IO therapy |
| 2024-06-14 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent Delivers Oral Presentation on Clinical Data of IBI363 (First-in-class PD-1/IL-2α-bias Bispecific Antibody Fusion Protein) in Advanced Non-small Cell Lung Cancer and Other Solid Tumors at the 2024 ESMO Virtual Plenary innoventbio.com ↗
Especially in the IO-treated squamous NSCLC, IBI363 has demonstrated strong anti-tumor effects, which could potentially be the next breakthrough in this area. |
| 2024-06-02 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent Presents Phase 1 Clinical Data of First-in-class PD-1/IL-2α Bispecific Antibody Fusion Protein (IBI363) in Melanoma, Colorectal Cancer and other Solid Tumors at the 2024 ASCO Annual Meeting innoventbio.com ↗
In 11 evaluable patients with BTC, 1 patient (IO-failed) had confirmed partial response (cPR), 9 patients (including 6 patients with tumor regression) had stable disease (SD) and 1 patient had progressive disease (PD). |
All press releases naming this drug 27 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 19 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | IBI363 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07124793 ↗ |
| Action | Inhibit | “checkpoint blockade” NCT05460767 ↗ |
| Modality | Protein / enzyme biologic | “a mutated IL-2 cytokine fused to an anti-PD-1 antibody” NCT05290597 ↗ |
| Route | Intravenous | “IBI363 will be administered as an intravenous (IV) infusion every 2 weeks or every 3 weeks.” NCT06281678 ↗ |