Drugs / D-1553
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT06233916 | Dec 2023 → Jan 2024 | — | InventisBio Co., Ltd | Completed | No outcome recorded |
| Phase 1 | NCT06105255 | May 2023 → Feb 2024 | — | InventisBio Co., Ltd | Completed | No outcome recorded |
| Phase 1/26 trials | ||||||
| Phase 1/2 | NCT06435455 | Jul 2024 → Sep 2027 expected | — | Suzhou Genhouse Bio Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT05379946 | Oct 2022 → Dec 2027 expected | cancer | InventisBio Co., Ltd | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT06166836 | Oct 2022 → Dec 2027 expected | neoplasm | InxMed (Shanghai) Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05492045 | Sep 2022 → Jun 2024 | non-small cell lung carcinoma | InventisBio Co., Ltd | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT05383898 | Mar 2021 → Nov 2023 | non-small cell lung carcinoma | InventisBio Co., Ltd | Completed | No outcome recorded |
| Phase 1/2 | NCT04585035 | Oct 2020 → Apr 2024 overdue | non-small cell lung carcinoma | InventisBio Co., Ltd | Active not recruiting | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT07318649 | Dec 2025 → Dec 2026 expected | — | Suzhou Genhouse Bio Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT07174908 | Sep 2025 → Sep 2028 expected | non-small cell lung carcinoma | InxMed (Shanghai) Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT06300177 | Mar 2024 → Oct 2026 expected | non-small cell lung carcinoma | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 22
| Date | Issuer | Release |
|---|---|---|
| 2026-08-28 | InxMed (Shanghai) Co., Ltd. | Results 《柳叶刀-肿瘤学》发表Ifebemtinib联合治疗结直肠癌II期成果，III期临床IND申请已提交 inxmed.com ↗
Part 2-随机对照研究：ifebemtinib联合格索雷塞组对比格索雷塞单药组的ORR为38.9%（95% CI: 17.3-64.3）vs 16.7%（95% CI: 3.6-41.4），联合组较单药组的ORR绝对提高22.2%个百分点。 |
| 2026-07-09 | InxMed (Shanghai) Co., Ltd. | Results 《柳叶刀-呼吸医学》发表Ifebemtinib联合格索雷塞治疗一线KRAS G12C突变阳性非小细胞肺癌Ib/II期临床研究结果 inxmed.com ↗
在所有接受研究治疗且至少有1次治疗后疗效评估的31例可评估患者中，ORR为87.1%（27/31）。 |
| 2025-12-11 | InventisBio Co., Ltd | Results 靶向KRAS G12C，格索雷塞实现胰腺癌治疗新突破 inventisbio.com ↗
在22例可评估患者中，经确认的客观缓解率（ORR）达到45.5%，疾病控制率（DCR）高达86.4%。 |
| 2025-12-11 | InventisBio Co., Ltd | Results 格索雷塞长期随访数据公布，为肺癌治疗带来持续希望 inventisbio.com ↗
分析显示，客观缓解率达到48.1%，疾病控制率高达87.8%。 |
| 2025-08-12 | InxMed (Shanghai) Co., Ltd. | Results 结直肠癌再获优异疗效，应世生物Ifebemtinib拟三度纳入突破性治疗品种 inxmed.com ↗
结果显示：ifebemtinib+garsorasib组对比garsorasib单药组的ORR为44.4% vs 16.7%，DCR为100.0% vs 77.8%，mPFS为7.7个月 vs 4.0个月。 |
| 2025-06-24 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Results 喜讯！格索雷塞治疗晚期或转移性结直肠癌研究结果荣登国际权威期刊STTT cttq.com ↗
结果表明[1]，格索雷塞单药或联合西妥昔单抗治疗晚期或转移性CRC均显示出良好的抗肿瘤活性。 |
| 2025-06-17 | InventisBio Co., Ltd | Results 格索雷塞治疗晚期或转移性结直肠癌研究结果荣登STTT inventisbio.com ↗
确认的ORR和DCR分别为45.2%（95% CI，29.8–61.3）和92.9%（95% CI，80.5–98.5）。 |
| 2024-11-11 | InventisBio Co., Ltd | Regulatory Officially Approved. Anfangning (KRAS G12C Inhibitor Garsorasib) Receives Market Authorization from the National Medical Products Administration (NMPA) of China inventisbio.com ↗ |
| 2024-11-11 | InventisBio Co., Ltd | Regulatory 正式获批！安方宁®（KRAS G12C抑制剂格索雷塞）获得中国国家药品监督管理局批准上市 inventisbio.com ↗
2024年11月8日，益方生物自主研发的KRAS G12C抑制剂安方宁®（格索雷塞，D-1553）获得中国国家药品监督管理局批准上市，用于治疗至少接受过一种系统性治疗的KRAS G12C突变型的晚期非小细胞肺癌（NSCLC）成人患者。 |
| 2024-11-11 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Regulatory 正大天晴今年第四款1类创新药！KRAS G12C靶向药格索雷塞获批上市 cttq.com ↗
11月8日，国家药监局官网显示，正大天晴联合开发的KRAS G12C抑制剂格索雷塞片（商品名：安方宁）获批准上市，适用于治疗至少接受过一种系统性治疗的鼠类肉瘤病毒癌基因（KRAS）G12C 突变型的晚期非小细胞肺癌（NSCLC）成人患者。 |
| 2024-09-10 | InventisBio Co., Ltd | Results 2024 WCLC | Latest Progress of Garsorasib (D-1553) in Treating KRAS G12C-Mutant Lung Cancer: Phase 2 Study Updates inventisbio.com ↗
During the event, Professor Li Ziming from Shanghai Chest Hospital presented the latest results from the Phase 2 study of Garsorasib (D-1553) in treating KRAS G12C-mutant non-small cell lung cancer (NSCLC) through an oral presentation. |
| 2024-09-10 | InventisBio Co., Ltd | Results 2024 WCLC | Garsorasib（D-1553）治疗KRAS G12C突变肺癌的2期研究最新进展 inventisbio.com ↗
IRC确认的ORR为52.0%（64/123，95% CI，42.8-61.1），DCR为88.6%（109/123，95% CI，81.6-93.6）。 |
| 2024-06-13 | InventisBio Co., Ltd | Regulatory Garsorasib (D-1553) New Indication Added to Breakthrough Therapy Designation Program inventisbio.com ↗
Recently, Garsorasib (D-1553), developed by InventisBio, has been once again included in the Breakthrough Therapy Designation (BTD) program by the National Medical Products Administration (NMPA). |
| 2024-06-13 | InventisBio Co., Ltd | Regulatory Garsorasib（D-1553）新适应症被纳入突破性治疗药物程序 inventisbio.com ↗
近日，garsorasib（D-1553片）再度被国家药品监督管理局药品审评中心（CDE）纳入突破性治疗药物程序（BTD）。 |
| 2024-06-11 | InventisBio Co., Ltd | Results Garsorasib (D-1553) Phase II Study Results for Lung Cancer Published in Prestigious International Journal inventisbio.com ↗
On June 11, 2024, the Phase II study results of Garsorasib (D-1553) for KRAS G12C-mutant non-small cell lung cancer (NSCLC) were published in The Lancet Respiratory Medicine, one of the world’s most prestigious medical journals (Impact Factor: 76.2). |
| 2024-06-11 | InventisBio Co., Ltd | Results Garsorasib（D-1553）治疗肺癌II期研究结果荣登国际著名期刊 inventisbio.com ↗
该项研究数据表明：在既往接受过治疗且携带KRAS G12C突变的非小细胞肺癌（NSCLC）患者中，garsorasib显示出了较高的肿瘤缓解率和较长的缓解持续时间（ORR：50%，DCR：89%，中位DOR：12.8个月，中位PFS：7.6个月）。 |
| 2024-06-03 | InxMed (Shanghai) Co., Ltd. | Results 应世生物于ASCO 2024 公布FAK抑制剂联合一线治疗KRAS G12C突变非小细胞肺癌显著获益临床结果 inxmed.com ↗
客观缓解率（ORR） 达到 90.3%（95% CI: 74.3, 98.0），疾病控制率（DCR） 达到 96.8%（95% CI: 83.3, 99.9）。 |
| 2024-01-02 | InventisBio Co., Ltd | Regulatory 益方生物Garsorasib（D-1553）片新药上市申请获受理 inventisbio.com ↗
2023年12月29日，益方生物科技（上海）股份有限公司宣布公司自主研发的KRAS G12C抑制剂Garsorasib（D-1553）片的新药上市申请获得受理，用于既往经一线系统治疗后疾病进展或不可耐受的、并且经检测确认存在KRAS G12C突变的局部晚期或转移性非小细胞肺癌的治疗1。 |
| 2023-10-23 | InventisBio Co., Ltd | Results 2023 ESMO | Garsorasib（D-1553）在晚期胰腺癌中临床数据首次公布，展现有希望的疗效！ inventisbio.com ↗
结果显示，Garsorasib单药治疗在KRAS G12C突变的PCa患者中展现出良好的耐受性和临床活性，确认的客观缓解率（ORR）为35.7%（5/14），疾病控制率（DCR）为85.7%（12/14），中位无进展生存期为8.54个月（95%CI, 2.73, NA）。 |
| 2023-10-21 | InventisBio Co., Ltd | Results 2023 ESMO | Garsorasib+西妥昔单抗治疗KRAS G12C突变结直肠癌，疗效显著！ inventisbio.com ↗
数据显示：Garsorasib联合西妥昔单抗在既往经治的KRAS G12C突变结直肠癌患者中客观缓解率（ORR）达45%，中位无进展生存期（mPFS）为7.6个月。 |
| 2023-05-18 | InventisBio Co., Ltd | Results 益方生物KRAS G12C抑制剂D-1553临床前研究数据发表于Cancer Science inventisbio.com ↗
D-1553是一种强效的、选择性KRASG12C抑制剂，在体外和体内的临床前研究中均显示出对肿瘤生长的抑制作用，为其临床开发提供了证据支持。 |
| 2023-04-11 | InventisBio Co., Ltd | Results 再谱新篇！益方生物KRAS G12C抑制剂D-1553（Garsorasib）于JTO发布临床研究新进展 inventisbio.com ↗
研究结果显示，D-1553（Garsorasib）在携带KRAS G12C突变的非小细胞肺癌（NSCLC）患者中具有良好的安全性和抗肿瘤活性。 |
All press releases naming this drug 25 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | D-1553 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07318649 ↗ |
| Known as | garsorasib | “Garsorasib (D-1553), a highly potent and selective KRAS G12C inhibitor, has demonstrated promising anti-tumor activity and favorable safety profile in early clinical trials.” PMID 40523897 ↗ Jun 20252“Garsorasib is a novel KRASG12C inhibitor approved in China for patients with KRASG12C-mutated non-small-cell lung cancer (NSCLC).” PMID 42413526 ↗ Jul 2026 “D-1553 (garsorasib) is a potent and selective oral KRASG12C inhibitor.” PMID 36948246 ↗ Mar 2023 |
| Action | Inhibit | “Garsorasib (D-1553), a highly potent and selective KRAS G12C inhibitor” PMID 40523897 ↗ Jun 2025 |
| Route | Oral | “potential oral agent” NCT04585035 ↗ |
| Target | KRAS | “Garsorasib (D-1553), a highly potent and selective KRAS G12C inhibitor” PMID 40523897 ↗ Jun 2025 |