Drugs / HS-10241
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 | 2026-02-27 | “Dalmelitinib Mesylate Tablets in combination with Aumolertinib Mesylate Tablets (Ameile 阿美乐 ® ), has been accepted by the National Medical Products Administration (NMPA) of China” hspharm.com ↗ “甲 磺 酸 达 麦 利 替 尼 片（以 下 简 称“达 麦 利 替 尼”）联 合 甲 磺 酸 阿 美 替 尼 片（以 下 简 称“阿 美 替 尼”）上 市 许 可 申 请（NDA）获 中 国 国 家 药 品 监 督 管 理 局(NMPA)受 理” hansoh.cn ↗ |
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT06823245 | Feb → Jul 2025 overdue | non-small cell lung carcinoma | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT05430386 | Jan 2022 → Dec 2023 | non-small cell lung carcinoma | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT04477057 | Jun 2019 → Dec 2020 | cancer | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT03243643 | Aug 2017 → Jul 2019 | cancer of unknown primary site | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT02977364 | Nov 2016 → Nov 2018 | carcinoma | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT02759640 | Sep 2016 → Mar 2018 | neoplasm | Atridia Pty Ltd. | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT06110663 | Dec 2023 → Dec 2024 | non-small cell lung carcinoma | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2026-03-29 | Hansoh BioMedical R&D Company | Results ELCC 2026 | 翰森制药达麦利替尼联合阿美替尼治疗EGFR TKI治疗后伴MET扩增的晚期NSCLC的Ib期研究结果发布 hansoh.cn ↗
在115例EGFR TKI治疗后伴MET扩增且疗效可评估的NSCLC患者中，中位无进展生存期（PFS）为7. 4个月，中位总生存期（OS）为25. 4个月. |
| 2026-03-27 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Results ELCC 2026 | HANSOH PHARMA PRESENTED RESULTS OF DALMELITINIB (HS-10241, A HIGHLY SELECTIVE MET-TKI) COMBINED WITH AUMOLERTINIB FROM A PHASE IB STUDY IN PATIENTS WITH MET-AMPLIFIED ADVANCED NSCLC POST EGFR TKI hspharm.com ↗
In 115 efficacy-evaluable NSCLC patients with MET-amplification post EGFR TKI treatment, median PFS was 7.4 months and median OS was 25.4 months. |
| 2026-02-27 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Regulatory HANSOH PHARMA ANNOUNCES THE NEW DRUG APPLICATION OF DALMELITINIB MESYLATE TABLETS WAS ACCEPTED BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION hspharm.com ↗ |
| 2026-02-27 | Hansoh BioMedical R&D Company | Regulatory 翰森制药丨创新药甲磺酸达麦利替尼片上市许可申请获NMPA受理 hansoh.cn ↗ |
| 2023-03-03 | Hansoh BioMedical R&D Company | Results 权威发布 | 翰森制药1类创新药MET抑制剂I期临床数据在JTO子刊发表 hansoh.cn ↗
本 次 发 表 的I期 剂 量 递 增 研 究 结 果 显 示，HS-10241的 安 全 耐 受 性 良 好. |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-03-29 | Hansoh BioMedical R&D Company | ELCC 2026 | 翰森制药达麦利替尼联合阿美替尼治疗EGFR TKI治疗后伴MET扩增的晚期NSCLC的Ib期研究结果发布 hansoh.cn ↗ |
| 2026-03-27 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | ELCC 2026 | HANSOH PHARMA PRESENTED RESULTS OF DALMELITINIB (HS-10241, A HIGHLY SELECTIVE MET-TKI) COMBINED WITH AUMOLERTINIB FROM A PHASE IB STUDY IN PATIENTS WITH MET-AMPLIFIED ADVANCED NSCLC POST EGFR TKI hspharm.com ↗ |
| 2026-02-27 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | HANSOH PHARMA ANNOUNCES THE NEW DRUG APPLICATION OF DALMELITINIB MESYLATE TABLETS WAS ACCEPTED BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION hspharm.com ↗ |
| 2026-02-27 | Hansoh BioMedical R&D Company | 翰森制药丨创新药甲磺酸达麦利替尼片上市许可申请获NMPA受理 hansoh.cn ↗ |
| 2023-03-03 | Hansoh BioMedical R&D Company | 权威发布 | 翰森制药1类创新药MET抑制剂I期临床数据在JTO子刊发表 hansoh.cn ↗ |
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 | HS-10241 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05430386 ↗ |
| Action | Inhibit | “HS-10241 is a potent and selective small molecule c-Met kinase inhibitor” NCT02759640 ↗ |
| Modality | Small molecule | “potent and selective small molecule c-Met kinase inhibitor” NCT02759640 ↗ |
| Route | Oral | “HS-10241 will be administered orally once daily.” NCT02759640 ↗ |
| Target | MET | “C-met Kinase Inhibitor HS-10241” NCT02977364 ↗ |