Drugs / A140
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | colorectal cancer | 2023-09-11 | “the registration applications of Sutera (A166), Datatelec (A140) and Jatatelec (SKB264) were formally accepted by CDE successively” kelun-biotech.com ↗ “A140 solution for infusion is the first cetuximab solution for infusion that filed an application for marketing in China.” kelun-biotech.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT04835142 | Dec 2020 → Mar 2023 | colorectal cancer | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2025-02-07 | Klus Pharma Inc. | Regulatory Kelun-Biotech’s Product Cetuximab N01 Injection Approved For Marketing By NMPA Of China kluspharma.com ↗
We are pleased that our third self-developed product, Cetuximab N01 Injection, has been successfully approved for domestic marketing after sacituzumab tirumotecan (sac-TMT) and tagitanlimab (formerly KL-A167). |
| 2023-09-11 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Regulatory The first of its kind in China! Kelun-Biotech's Cetuximab Solution for Infusion Accepted for market registration application by the National Medical Products Administration. kelun-biotech.com ↗
On September 11, 2023, Kelun-Biotech announced that the major product A140 solution for infusion (Cetuximab Solution for Infusion, trade name: Datalai?) was recently accepted for marketing application by the Center for Drug Evaluation of the National Medical Products Administration (acceptance number: CXSS2300075). |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-02-07 | Klus Pharma Inc. | Kelun-Biotech’s Product Cetuximab N01 Injection Approved For Marketing By NMPA Of China kluspharma.com ↗ |
| 2023-09-11 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | The first of its kind in China! Kelun-Biotech's Cetuximab Solution for Infusion Accepted for market registration application by the National Medical Products Administration. kelun-biotech.com ↗ |
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 | A140 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04835142 ↗ |
| Action | Inhibit | “EGFR inhibition” PMID 40737898 ↗ Jun 2025 |
| Route | Intravenous | “Drug A140:400 mg/m2（D1，iv）,250 mg/m2（qw，iv）” NCT04835142 ↗ |
| Target | EGFR | “EGFR inhibition” PMID 40737898 ↗ Jun 2025 |