Drugs / SAF-189s
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 | 2025-03-10 | “Foritinib Succinate Capsules (project code: SAF-189, Foritinib), was accepted by the National Medical Products Administration (NMPA).” fosunpharma.com ↗ “The NDA for SAF‑189 (foritinib succinate capsules), an ALK inhibitor for non‑small‑cell lung cancer, has been accepted by the NMPA.” fosunpharma.com ↗ “the NDA for foritinib succinate capsules (SAF-189), Fosun Pharma’s Class 1 innovative drug, was accepted by the NMPA” fosunpharma.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT04237805 | Nov 2016 → Dec 2022 | cancer of unknown primary site, non-small cell lung carcinoma | Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2025-03-10 | Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. | Regulatory Fosun Pharma's Independently Developed Innovative Lung Cancer Drug Foritinib (SAF-189) Marketing Authorization Application Has Been Accepted by NMPA fosunpharma.com ↗
March 10, 2025– Recently,Fosun Pharma announced that the marketing authorization application for its independently developed new drug, foritinib Succinate Capsules (project code: SAF-189, foritinib, hereinafter referred to as "New Drug"), has been accepted by the National Medical Products Administration (NMPA). |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2025-03-10 | Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. | Fosun Pharma's Independently Developed Innovative Lung Cancer Drug Foritinib (SAF-189) Marketing Authorization Application Has Been Accepted by NMPA fosunpharma.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SAF-189s | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04237805 ↗ |
| Known as | foritinib | “We evaluated the efficacy and safety of foritinib, a novel ALK and ROS1 inhibitor, in patients with advanced ROS1-rearranged NSCLC.” PMID 39059398 ↗ Jul 2024 |
| Action | Inhibit | “SAF-189s potently inhibited ROS1 kinase and its known acquired clinically resistant mutants” PMID 32918045 ↗ Sep 2020 |
| Route | Oral | “oral foritinib succinate monotherapy” NCT04237805 ↗ |
| Target | ALK | “the new-generation ROS1/ALK inhibitor” PMID 32918045 ↗ Sep 2020 |
| Target | ROS1 | “the new-generation ROS1/ALK inhibitor” PMID 32918045 ↗ Sep 2020 |