Drugs / FHND9041
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 | 2026-02-06 | “甲磺酸奥达替尼胶囊（Adonertinib，FHND9041）的新药上市申请，已正式获得国家药品监督管理局药品审评中心（CDE）受理。” ctfh.com.cn ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06521034 | Jun 2019 → May 2021 | non-small cell lung carcinoma | Yongchang Zhang | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT06759857 | Aug 2021 → Mar 2025 overdue | non-small cell lung carcinoma | Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd. | Enrolling by invitation | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2026-02-06 | Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd. | Regulatory 正大丰海首个自主研发1类创新药奥达替尼上市申请获CDE受理 ctfh.com.cn ↗
近日，江苏正大丰海制药有限公司自主研发的1类创新药—— 甲磺酸奥达替尼胶囊（Adonertinib，FHND9041） 的新药上市申请，已正式获得国家药品监督管理局药品审评中心（CDE）受理。 |
| 2021-05-08 | Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd. | Regulatory 我司自主研发抗肿瘤一类新药FHND9041胶囊获批开展关键性Ⅲ期临床试验 ctfh.com.cn ↗
近日，我公司收到国家药监局药品审评中心书面答复，正式批准我司一类新药FHND9041胶囊开展关键性Ⅲ期临床试验。 |
| 2018-08-21 | Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd. | Regulatory 正大丰海首个自主研发1类创新药FHND9041 喜获临床试验批件 ctfh.com.cn ↗
日前，江苏正大丰海制药有限公司首个自主研发的抗肿瘤1类新药“FHND9041”获得国家药品监督管理局（CNDA）颁发的药物临床试验批件，批准进行I、II、III期临床试验。 |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-02-06 | Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd. | 正大丰海首个自主研发1类创新药奥达替尼上市申请获CDE受理 ctfh.com.cn ↗ |
| 2021-05-08 | Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd. | 我司自主研发抗肿瘤一类新药FHND9041胶囊获批开展关键性Ⅲ期临床试验 ctfh.com.cn ↗ |
| 2018-08-21 | Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd. | 正大丰海首个自主研发1类创新药FHND9041 喜获临床试验批件 ctfh.com.cn ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | FHND9041 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06759857 ↗ |
| Action | Inhibit | “FHND-9041 capsule is a novel third-generation EGFR inhibitor targeting EGFR-sensitive mutations.” NCT06521034 ↗ |
| Route | Oral | “Participants will take an 80 mg oral dose once daily until disease progression, intolerable toxicity, or meeting other study-defined discontinuation criteria.” NCT06759857 ↗ |
| Target | EGFR | “FHND-9041 capsule is a novel third-generation EGFR inhibitor targeting EGFR-sensitive mutations.” NCT06521034 ↗ |