Drugs / SHR-A2009
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | EGFR突变非鳞状非小细胞肺癌 | 2026-07-30 | “2026年7月，基于 首个Ⅲ期临床研究SHR-A2009-301 的结果，瑞康芦泽妥塔单抗用于治疗经EGFR TKI治疗后进展的EGFR基因突变阳性的局部晚期或转移性非鳞状非小细胞肺癌成人患者的上市申请获受理。” hengrui.com ↗ “收到国家药品监督管理局下发的《受理通知书》，公司自主研发的1类新药注射用瑞康芦泽妥塔单抗的药品上市申请获受理” hengrui.com ↗ |
Trials 12
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT07414953 | Mar 2026 → Apr 2027 expected | lung cancer | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT05394818 | Jul 2022 → Apr 2024 | neoplasm | Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05114759 | Jan 2022 → Dec 2026 expected | cancer | Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT06222879 | Feb 2024 → Oct 2026 expected | breast cancer | Shandong Suncadia Medicine Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06092268 | Oct 2023 → Dec 2025 | cancer | Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Unknown | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT07863167 | Oct 2026 → Dec 2028 expected | non-small cell lung carcinoma | Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06649331 | Oct 2024 → Sep 2026 overdue | triple-negative breast carcinoma | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT06465238 | Jun 2024 → Jun 2026 overdue | non-small cell lung carcinoma | Henan Cancer Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05594095 | Dec 2022 → Dec 2025 overdue | female breast carcinoma, hormone receptor-positive breast cancer | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT03736863 | Dec 2019 → Jun 2021 overdue | esophageal cancer | The First Affiliated Hospital of Zhengzhou University | Recruiting | No outcome recorded |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT07183189 | Oct 2025 → Nov 2032 expected | non-small cell lung carcinoma | Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06671379 | Nov 2024 → Dec 2026 expected | non-small cell lung carcinoma | Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Active not recruiting | Met primary |
| Comparator or background therapy1 trial | ||||||
| Phase 1/2 | NCT06474455 Background | Jul 2024 → Jun 2029 expected | cancer | Shanghai Hengrui Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2026-09-16 | Jiangsu HengRui Medicine Co., Ltd. | Results 2026 WCLC｜恒瑞医药十余项肺癌领域研究亮相国际舞台 hengrui.com ↗
在SHR-A2009队列中，8例患者中有2例获得临床获益：1例确认PR和1例SD，均为既往经治的EGFR突变患者，且PFS均超过9个月。 |
| 2026-09-14 | Jiangsu HengRui Medicine Co., Ltd. | Regulatory 恒瑞HER3 ADC创新药注射用瑞康芦泽妥塔单抗非小细胞肺癌适应症纳入突破性治疗品种名单 hengrui.com ↗
近日，恒瑞医药子公司苏州盛迪亚生物医药有限公司的HER3抗体偶联药物（ADC）创新药注射用瑞康芦泽妥塔单抗（研发代号：SHR-A2009）被国家药品监督管理局药品审评中心纳入突破性治疗品种名单，适应症为联合贝伐珠单抗治疗既往经表皮生长因子受体（EGFR）酪氨酸激酶抑制剂（TKI）治疗失败的EGFR突变局部晚期或转移性非鳞状非小细胞肺癌（NSCLC）患者。 |
| 2026-07-30 | Jiangsu HengRui Medicine Co., Ltd. | Regulatory 恒瑞HER3 ADC创新药注射用瑞康芦泽妥塔单抗用于EGFR突变晚期非小细胞肺癌上市申请获受理 hengrui.com ↗
近日，恒瑞医药子公司苏州盛迪亚生物医药有限公司收到国家药品监督管理局下发的《受理通知书》，公司自主研发的1类新药注射用瑞康芦泽妥塔单抗的药品上市申请获受理，适应症为：用于经表皮生长因子受体（EGFR）酪氨酸激酶抑制剂（TKI）治疗后进展的EGFR基因突变阳性的局部晚期或转移性非鳞状非小细胞肺癌（NSCLC）成人患者的治疗。 |
| 2026-04-01 | Jiangsu HengRui Medicine Co., Ltd. | Results 2026 ELCC︱恒瑞医药4款创新药共7项肺癌研究亮相国际舞台 hengrui.com ↗
SHR-A2009联合阿美替尼用于一线和二线及以上 EGFR 突变阳性 NSCLC治疗展现出可控的安全性与具有前景的抗肿瘤活性。 |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-09-16 | Jiangsu HengRui Medicine Co., Ltd. | 2026 WCLC｜恒瑞医药十余项肺癌领域研究亮相国际舞台 hengrui.com ↗ |
| 2026-09-14 | Jiangsu HengRui Medicine Co., Ltd. | 恒瑞HER3 ADC创新药注射用瑞康芦泽妥塔单抗非小细胞肺癌适应症纳入突破性治疗品种名单 hengrui.com ↗ |
| 2026-07-30 | Jiangsu HengRui Medicine Co., Ltd. | 恒瑞HER3 ADC创新药注射用瑞康芦泽妥塔单抗用于EGFR突变晚期非小细胞肺癌上市申请获受理 hengrui.com ↗ |
| 2026-04-01 | Jiangsu HengRui Medicine Co., Ltd. | 2026 ELCC︱恒瑞医药4款创新药共7项肺癌研究亮相国际舞台 hengrui.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SHR-A2009 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06474455 ↗ |
| Modality | Other / unclassified | “SHR-A2009 (HER3 ADC)” NCT06649331 ↗ |
| Route | Intravenous | “SHR-A2009 8mg/kg, iv, Q3W,” NCT03736863 ↗ |