Drugs / Fulzerasib
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | non-small cell lung carcinoma | — | “信达生物提交的fulzerasib单药治疗晚期NSCLC新药上市申请，已于2023年11月获得国家药品监督管理局药品审评中心受理” genfleet.com ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 24 trials | ||||||
| Phase 2 | NCT07581912 | Apr 2026 → Dec 2028 expected | colorectal cancer | Zhejiang University | Recruiting | No outcome recorded |
| Phase 2 | NCT07463677 | Mar 2026 → May 2028 expected | non-small cell lung carcinoma | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07492342 | Jan 2026 → Mar 2027 expected | acute myeloid leukemia, KRAS gene mutation, non-small cell lung carcinoma | Jianxing He | Recruiting | No outcome recorded |
| Phase 2 | NCT06936644 | Apr 2025 → Apr 2027 expected | respiratory system cancer | Shanghai Chest Hospital | Not yet recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT07601048 Comparator | Jun 2026 → May 2028 expected | — | Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2025-12-07 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory Innovent Announces Inclusion of Seven Innovative Drugs including TYVYT New Indication and SYCUME in China's National Reimbursement Drug List innoventbio.com ↗
We are pleased with the NRDL inclusion of our seven innovative therapies this year. |
| 2025-07-09 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory Dupert® Becomes First China-Originated KRAS G12C Inhibitor Approved in Macau for Advanced NSCLC innoventbio.com ↗
Recently, China's first domestically developed KRAS G12C inhibitor, Dupert® (Fulzerasib Tablets), has been officially approved for marketing by the Pharmaceutical Administration Bureau (ISAF) of the Macau Special Administrative Region of China. |
| 2024-09-10 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent Delivers Oral Presentation of Updated Results from a Pivotal Phase 2 Study of Dupert®（Fulzerasib）in Patients with Advanced Non-Small Cell Lung Cancer Harboring KRAS G12C Mutation innoventbio.com ↗
The confirmed objective response rate (ORR) assessed by the Independent Radiology Review Committee (IRRC) was 49.1% (95% CI: 39.7-58.6). |
| 2024-08-21 | Genfleet Therapeutics (Shanghai) Inc. | Regulatory 国内首个KRAS G12C抑制剂获批上市：达伯特®（氟泽雷塞）正式获批治疗晚期非小细胞肺癌 genfleet.com ↗
劲方医药宣布国家药品监督管理局通过优先审评程序批准KRAS G12C抑制剂达伯特®（氟泽雷塞片，GFH925/IBI351）上市；本品单药疗法适用于至少接受过一种系统性治疗的KRAS G12C突变型晚期非小细胞肺癌 （NSCLC）成人患者。 |
| 2024-08-21 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory China’s First Approved KRAS G12C Inhibitor: Innovent Announces the Approval of Dupert®（Fulzerasib）by the National Medical Products Administration of China innoventbio.com ↗
As China’s first approved KRAS G12C inhibitor, Dupert® is Innovent’s eleventh product in its commercial portfolio and is anticipated to soon benefit more lung cancer patients with the KRAS G12C mutation. |
| 2024-06-02 | Genfleet Therapeutics (Shanghai) Inc. | Results 一线肺癌, 欧洲研究者, 数据入选ASCO突破性研究口头报告：劲方/信达fulzerasib联合疗法跻身KRAS疗法国际第一梯队 genfleet.com ↗
劲方医药宣布fulzerasib (GFH925/IBI351, KRAS G12C抑制剂)联合西妥昔单抗一线治疗非小细胞肺癌（NSCLC）的II期临床研究数据，首次在2024年美国临床肿瘤学会（ASCO）年会上公布。 |
All press releases naming this drug 15 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Fulzerasib | “The advanced or metastatic non-small cell lung cancer patients with KRAS G12C mutation will receive the combination of fulzerasib (IBI351) with ivonescimab (AK-112) in...” NCT06936644 ↗ |
| Known as | IBI351 | “The advanced or metastatic non-small cell lung cancer patients with KRAS G12C mutation will receive the combination of fulzerasib (IBI351) with ivonescimab (AK-112) in...” NCT06936644 ↗ |
| Action | Inhibit | “KRAS G12C inhibitor monotherapy” NCT07581912 ↗ |
| Modality | Small molecule | — CHEMBL5314463 ↗ |
| Route | Oral | “600 mg orally twice daily” NCT07492342 ↗ |
| Target | KRAS | “KRAS G12C inhibitor monotherapy” NCT07581912 ↗ |