Drugs / TRASTUZUMAB BOTIDOTIN
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | Her2-receptor negative breast cancer | — | “In May 2023, Kelun-Biotech submitted an NDA to the NMPA for another core product, A166 (HER2 ADC), targeting 3L+ advanced HER2+ BC.” kelun-biotech.com ↗ “the registration applications of Sutera (A166), Datatelec (A140) and Jatatelec (SKB264) were formally accepted by CDE successively” kelun-biotech.com ↗ |
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05311397 | Aug 2018 → Apr 2026 | female breast carcinoma | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03602079 | Jul 2018 → Jan 2022 | Gaucher ichthyosis restrictive dermopathy, HER2 positive breast carcinoma, breast mucinous carcinoma, cervical cancer +18 | Klus Pharma Inc. | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT07299825 | Sep 2024 → Sep 2027 expected | HER2 positive breast carcinoma | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT05346328 | Jun 2022 → Dec 2023 | breast cancer | Fudan University | Unknown | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT06968585 | Jul 2023 → Nov 2026 expected | HER2 positive breast carcinoma | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2025-10-19 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Results Kelun-Biotech Presents Positive Phase 3 Data for Trastuzumab Botidotin Compared to T-DM1 at 2025 ESMO kelun-biotech.com ↗
Median PFS was significantly longer in trastuzumab botidotin than in T-DM1 (11.1 months vs 4.4 months; HR: 0.39, 95% CI, 0.30-0.51, p<0.0001). |
| 2025-10-17 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Regulatory Kelun-Biotech’s Core product Trastuzumab Botidotin Approved for Marketing by NMPA for HER2-positive BC kelun-biotech.com ↗ |
| 2025-01-07 | Klus Pharma Inc. | Regulatory Kelun-Biotech’s HER2 ADC Trastuzumab botidotin (A166) Second NDA Accepted By NMPA kluspharma.com ↗ |
| 2022-05-29 | Klus Pharma Inc. | Results Updates for A166 (HER2 ADC) will be presented at 2022 ASCO Annual Meeting kluspharma.com ↗
According to the results, the objective response rate (ORR) of the 4.8 mg/kg group was 73.9%, the median PFS was 12.3 months, and the adverse reactions were manageable. |
| 2021-05-20 | Klus Pharma Inc. | Results Kelun-Biotech Will Present Updates for A166 at ASCO kluspharma.com ↗
The ORR in the 4.8 and 6.0 mg/kg cohorts were 59.1% (13/22) and 71.4% (10/14), respectively. |
| 2018-05-07 | Lunan Better Pharmaceutical Co., LTD. | Regulatory 新时代药业PD-1单抗临床申请获得承办 lunan.com.cn ↗
5月4日，四川科伦药业发布公告，称公司控股子公司 KLUS Pharma Inc. 收到FDA书面通知，允许抗体偶联药物（Antibody Drug Conjugate，ADC）“注射用 A166”开展药物临床试验。 |
All press releases naming this drug 7 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | TRASTUZUMAB BOTIDOTIN | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314782 ↗ |
| Known as | A166 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03602079 ↗ |
| Known as | Trastuzumab botidotina | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314782 ↗ |
| Known as | Trastuzumab botidotine | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314782 ↗ |
| Route | Intravenous | “Patients will receive study drug as a single IV infusion.” NCT03602079 ↗ |
| Target | ERBB2 | “Receptor tyrosine-protein kinase erbB-2 binding agent” CHEMBL5314782 ↗ |