Drugs / HS-10365
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | RET fusion positive cancer | 2025-10-23 | “HS-10365胶囊上市许可申请（NDA）获国家药品监督管理局（NMPA）受理” hansoh.cn ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT06823258 | Feb → Jul 2025 overdue | non-small cell lung carcinoma | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05207787 | Nov 2021 → Apr 2024 | cancer | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT06147570 | Sep 2023 → Aug 2027 expected | non-small cell lung carcinoma | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2025-12-18 | Hansoh BioMedical R&D Company | Results ESMO ASIA|翰森制药瑞森替尼（HS-10365胶囊）用于治疗RET基因融合阳性的局部晚期或转移性NSCLC研究结果发布 hansoh.cn ↗ |
| 2025-12-10 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Results ESMO ASIA | HANSOH PHARMA ANNOUNCES RESULTS OF RESENCATINIB (HS-10365，A HIGHLY SELECTIVE RET INHIBITOR）FOR THE TREATMENT OF PATIENTS WITH RET-FUSION LOCALLY ADVANCED OR METASTATIC NSCLC hspharm.com ↗
Resencatinib (HS-10365) has demonstrated encouraging and durable antitumor efficacy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring rearranged during transfection (RET) gene fusions [1] . |
| 2025-10-23 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Regulatory CHINA NMPA ACCEPTS NEW DRUG APPLICATION FOR HS-10365 CAPSULES FOR THE TREATMENT OF RET FUSION-POSITIVE NSCLC hspharm.com ↗ |
| 2025-10-23 | Hansoh BioMedical R&D Company | Regulatory 翰森制药 | HS-10365胶囊上市许可申请获NMPA受理 hansoh.cn ↗
2025年10月23日，翰森制药集团有限公司（以下简称“翰森制药”，03692. HK）宣布，公司自主研发的高选择性转染重排（RET）抑制剂HS-10365胶囊上市许可申请（NDA）获国家药品监督管理局（NMPA）受理，用于治疗RET基因融合阳性的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者. |
| 2023-04-26 | Hansoh BioMedical R&D Company | Results 2023 AACR | 翰森制药1类创新药RET抑制剂I期临床数据首次发布 hansoh.cn ↗ |
| 2021-05-18 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Regulatory HS-10365 CAPSULES, HANSOH PHARMA’S INNOVATIVE DRUG, APPROVED FOR CLINICAL USE hspharm.com ↗
Recently, Jiangsu Hansoh Pharmaceutical Group Co., Ltd. ("Hansoh Pharma" or "Company") received the Notice of Approval for Clinical Trial of Drug from the National Medical Products Administration ("NMPA") |
All press releases naming this drug 6 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-12-18 | Hansoh BioMedical R&D Company | ESMO ASIA|翰森制药瑞森替尼（HS-10365胶囊）用于治疗RET基因融合阳性的局部晚期或转移性NSCLC研究结果发布 hansoh.cn ↗ |
| 2025-12-10 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | ESMO ASIA | HANSOH PHARMA ANNOUNCES RESULTS OF RESENCATINIB (HS-10365，A HIGHLY SELECTIVE RET INHIBITOR）FOR THE TREATMENT OF PATIENTS WITH RET-FUSION LOCALLY ADVANCED OR METASTATIC NSCLC hspharm.com ↗ |
| 2025-10-23 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | CHINA NMPA ACCEPTS NEW DRUG APPLICATION FOR HS-10365 CAPSULES FOR THE TREATMENT OF RET FUSION-POSITIVE NSCLC hspharm.com ↗ |
| 2025-10-23 | Hansoh BioMedical R&D Company | 翰森制药 | HS-10365胶囊上市许可申请获NMPA受理 hansoh.cn ↗ |
| 2023-04-26 | Hansoh BioMedical R&D Company | 2023 AACR | 翰森制药1类创新药RET抑制剂I期临床数据首次发布 hansoh.cn ↗ |
| 2021-05-18 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | HS-10365 CAPSULES, HANSOH PHARMA’S INNOVATIVE DRUG, APPROVED FOR CLINICAL USE hspharm.com ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HS-10365 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06147570 ↗ |
| Action | Inhibit | “HS-10365 is a small molecular, oral potent, selective RET inhibitor.” NCT05207787 ↗ |
| Modality | Small molecule | “HS-10365 is a small molecular, oral potent, selective RET inhibitor.” NCT05207787 ↗ |
| Route | Oral | “HS-10365 will be administered orally twice daily” NCT06147570 ↗ |
| Target | RET | “HS-10365 is a small molecular, oral potent, selective RET inhibitor.” NCT05207787 ↗ |