Drugs / IBI351
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 | 2023-11-24 | “the New Drug Application (NDA) for IBI351 (KRAS G12C inhibitor) has been accepted by the Center for Drug Evaluation (CDE)” innoventbio.com ↗ |
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT05699993 | Mar → Oct 2023 | — | Innovent Biologics (Suzhou) Co. Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05626179 | Feb → Mar 2023 | — | Innovent Biologics (Suzhou) Co. Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05688124 | Feb → Oct 2023 | — | Innovent Biologics (Suzhou) Co. Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05504278 | Sep 2022 → May 2025 overdue | non-small cell lung carcinoma | Innovent Biologics (Suzhou) Co. Ltd. | Recruiting | No outcome recorded |
| Phase 1 | NCT05497336 | Aug 2022 → Aug 2023 | colorectal cancer | Innovent Biologics (Suzhou) Co. Ltd. | Unknown | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT07198841 | Nov 2025 → Sep 2027 expected | non-small cell lung carcinoma | Guangdong Association of Clinical Trials | Recruiting | No outcome recorded |
| Phase 2 | NCT06959589 | May 2025 → May 2027 expected | metastatic malignant neoplasm in the colon | Second Affiliated Hospital, School of Medicine, Zhejiang University | Enrolling by invitation | No outcome recorded |
News releases announcing trial results or a regulatory action · 28
| Date | Issuer | Release |
|---|---|---|
| 2026-04-08 | Genfleet Therapeutics (Shanghai) Inc. | Results Lancet Oncology | 劲方医药KROCUS研究II期数据发表，为全球首个KRAS+EGFR双重抑制一线NSCLC治疗方案 genfleet.com ↗
劲方医药KROCUS研究（氟泽雷塞联合西妥昔单抗）的II期临床研究成果，近日于肿瘤学刊物The Lancet Oncology (《柳叶刀-肿瘤学》，影响因子35.9)发表。 |
| 2025-12-07 | Genfleet Therapeutics (Shanghai) Inc. | Regulatory 首个国产获批KRAS G12C抑制剂氟泽雷塞（达伯特®）纳入新版国家医保药品目录 genfleet.com ↗
劲方医药（2595.HK）宣布公司首个上市产品氟泽雷塞（达伯特® ,KRAS G12C 抑制剂）已纳入《国家基本医疗保险、工伤保险和生育保险药品目录（2025年）》（国家医保药品目录），用于治疗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。 |
| 2025-07-09 | Genfleet Therapeutics (Shanghai) Inc. | Regulatory 氟泽雷塞第二项NDA获批：首款国产KRAS G12C抑制剂在澳门上市，治疗晚期非小细胞肺癌 genfleet.com ↗
劲方医药宣布KRAS G12C抑制剂达伯特®（氟泽雷塞片，GFH925/IBI351）已由中国澳门特别行政区药物监督管理局批准上市。 |
| 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. |
| 2024-09-29 | Genfleet Therapeutics (Shanghai) Inc. | Results 氟泽雷塞（KRAS G12C抑制剂）单药治疗晚期结直肠癌最新数据登陆2024年CSCO大会口头报告 genfleet.com ↗
600mg BID剂量组48例受试者确认的ORR为45.8%（22/48），DCR为89.6%（41/48）；中位PFS随访时间11.3个月，中位PFS为8.2个月。 |
| 2024-09-10 | Genfleet Therapeutics (Shanghai) Inc. | Results 氟泽雷塞单药II期注册性研究最新数据登陆2024年世界肺癌大会（WCLC）口头报告 genfleet.com ↗
独立影像学评审委员会（IRRC）评估的确认客观缓解（ORR）为49.1%，达到了预设的主要终点；疾病控制率（DCR） 为90.5%。 |
| 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。 |
| 2023-12-01 | Genfleet Therapeutics (Shanghai) Inc. | Results GFH925单药治疗NSCLC注册性研究达到主要终点、数据入选ESMO Asia重磅摘要报告，单药治疗CRC最新数据同期发布 genfleet.com ↗ |
| 2023-12-01 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent Presents Clinical Data Update of IBI351 (KRAS G12C Inhibitor) Monotherapy in Lung Cancer and Colorectal Cancer at ESMO Asia Congress 2023 innoventbio.com ↗
IBI351 demonstrated encouraging antitumor activity. |
| 2023-11-24 | Genfleet Therapeutics (Shanghai) Inc. | Regulatory 国内首个KRAS G12C抑制剂（GFH925）新药上市申请获正式受理并纳入优先审评 genfleet.com ↗
劲方医药宣布GFH925 (IBI351）新药上市申请（NDA）已获得国家药品监督管理局药品审评中心受理、并纳入优先审评程序，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）患者。 |
| 2023-11-24 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory China’s First NDA for a KRAS G12C Inhibitor: Innovent Announces the National Medical Products Administration of China Has Accepted and Granted Priority Review Designation to the New Drug Application for IBI351 innoventbio.com ↗ |
| 2023-10-10 | Genfleet Therapeutics (Shanghai) Inc. | Results 劲方医药蝉联胡润全球瞪羚企业、全国工商联医药业最具影响力榜单 genfleet.com ↗
GFH925、西妥昔单抗联合疗法一线治疗非小细胞肺癌的欧洲多中心Ib/II期试验已完成Ib期受试者入组；多例受试者总体疗效评估达到部分缓解，其中一例颅内非靶病灶达到完全缓解。 |
| 2023-06-06 | Genfleet Therapeutics (Shanghai) Inc. | Results ASCO现场：GFH925单药治疗晚期结直肠癌临床数据首次公布，展示良好安全性耐受性及初步疗效 genfleet.com ↗
劲方医药宣布GFH925（IBI351）单药治疗晚期结直肠癌的两项临床研究汇总分析结果，首次在2023年美国临床肿瘤学会（ASCO）年会上公布。 |
| 2023-06-06 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent Presents Phase 1 Clinical Data of IBI351 (KRASG12C Inhibitor) as Monotherapy for Metastatic Colorectal Cancer at the 2023 ASCO Annual Meeting innoventbio.com ↗
Of 42 evaluable subjects at 600mg BID, ORR was 42.9% (18/42), confirmed ORR was 31.0% (13/42), DCR was 88.1% (37/42). |
| 2023-05-15 | Genfleet Therapeutics (Shanghai) Inc. | Regulatory 首个KRAS G12C抑制剂纳入晚期结直肠癌突破性疗法！GFH925再获一项CDE突破性疗法认定 genfleet.com ↗
劲方医药宣布IBI351（劲方产品代号GFH925）已被国家药品监督管理局药品评审中心（CDE）纳入突破性治疗药物品种（BTD）名单，拟用于至少接受过两种系统性治疗的KRASG12C突变型的晚期结直肠癌患者。 |
| 2023-05-15 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory Innovent Receives NMPA Breakthrough Designation for IBI351 (KRASG12C Inhibitor) as Monotherapy for Previously Treated Advanced Colorectal Carcinoma innoventbio.com ↗ |
| 2023-04-19 | Genfleet Therapeutics (Shanghai) Inc. | Results GFH925单药最新临床研究数据入选2023 AACR口头报告 genfleet.com ↗
劲方医药宣布GFH925（IBI351）单药治疗实体瘤I期临床研究 (NCT05005234)的最新数据，在美国癌症研究协会年会（2023 AACR）以口头报告形式公布。 |
| 2023-04-19 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent Announces Updated Data of Phase 1 Clinical Trial for IBI351 (KRASG12C Inhibitor) as Monotherapy for Solid Tumors at the AACR Annual Meeting 2023 innoventbio.com ↗
ROCKVILLE, Md. and SUZHOU, China, April 18, 2023 — Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, today announced the updated results of IBI351 (GFH925) (KRASG12C inhibitor) from a Phase 1 clinical trial (NCT05005234) in an oral presentation at the 2023 American Association for Cancer Research (AACR) Annual Meeting. |
| 2023-03-01 | Genfleet Therapeutics (Shanghai) Inc. | Regulatory 劲方医药欧洲多中心一线非小细胞肺癌疗法试验获批，开启GFH925联合西妥昔单抗Ib/II期研究 genfleet.com ↗
劲方医药宣布，公司自主研发的GFH925抑制剂（KRAS G12C抑制剂）获得欧洲药品管理局（EMA）许可，将联合默克爱必妥®（西妥昔单抗注射液）用于治疗晚期非小细胞肺癌患者的Ib/II期临床试验。 |
| 2023-01-05 | Genfleet Therapeutics (Shanghai) Inc. | Regulatory GFH925（KRAS G12C抑制剂）获CDE突破性疗法认定，治疗晚期非小细胞肺癌患者 genfleet.com ↗
劲方医药宣布IBI351 （劲方产品代号GFH925）已被中国国家药品监督管理局（NMPA）药品评审中心（CDE）纳入突破性治疗药物品种名单（BTD），拟定用于治疗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患者。 |
| 2023-01-05 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory Innovent Announces NMPA’s Breakthrough Therapy Designation for IBI351 (KRASG12C Inhibitor) as Monotherapy for Previous Treated Advanced Non-small Cell Lung Cancer innoventbio.com ↗
Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for IBI351 (GFH925) for the treatment of advanced non-small cell lung cancer patients with KRASG12C mutation that have received at least one prior line of systemic therapy. |
| 2022-11-12 | Genfleet Therapeutics (Shanghai) Inc. | Results 2022 CSCO | GFH925（KRAS G12C抑制剂）单药I期试验最新结果公布 genfleet.com ↗
劲方医药宣布GFH925（IBI351）单药治疗实体瘤的Ia期临床研究的最新数据 (NCT05005234)，在2022年中国临床肿瘤学会（CSCO）年会上以口头报告形式公布。 |
| 2022-11-12 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent Presents Clinical Data of Phase Ia Study for IBI351 (KRASG12C Inhibitor) as Monotherapy for Solid Tumors at the 2022 Chinese Society of Clinical Oncology (CSCO) Annual Meeting innoventbio.com ↗
Of 55 evaluable NSCLC patients, 28 achieved partial response (PR), with investigator assessed ORR 50.9% and DCR 92.7%. |
| 2022-06-05 | Genfleet Therapeutics (Shanghai) Inc. | Results GFH925单药疗法I期临床研究壁报亮相2022 ASCO年会 genfleet.com ↗
初步数据显示GFH925（IBI351）单药在KRASG12C突变的晚期实体瘤中展示出了良好的安全性和令人鼓舞的疗效。 |
| 2022-06-05 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent Presents Clinical Data of Phase I Study for IBI351 (KRASG12C Inhibitor) as Monotherapy for Solid Tumors at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting innoventbio.com ↗
Of 21 patients (including 16 non-small cell lung cancer and 5 colorectal cancer) having at least 1 tumor assessment per RECISTv1.1, 9 achieved PR, with investigator assessed ORR 42.9% and DCR 81%. |
All press releases naming this drug 29 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | IBI351 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05497336 ↗ |
| Action | Inhibit | “inhibitor of KRAS G12C” NCT05504278 ↗ |
| Modality | Small molecule | “orally available small molecule inhibitor” NCT05504278 ↗ |
| Route | Oral | “IBI351 is administered orally” NCT05497336 ↗ |
| Target | KRAS | “inhibitor of KRAS G12C” NCT05504278 ↗ |