Drugs / MIL60
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | 非小细胞肺癌, 转移性结直肠癌 | 2020-06-15 | “贝伐珠单抗注射液（MIL60）用于晚期、转移性或复发性非小细胞肺癌和转移性结直肠癌患者治疗的上市许可申请已获得国家药品监督管理局受理” bettapharma.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT03196986 | Aug 2017 → Aug 2019 | non-small cell lung carcinoma | Beijing Mabworks Biotech Co., Ltd. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2021-12-02 | Betta Pharmaceuticals Co., Ltd. | Regulatory 重磅！贝达药业贝伐珠单抗注射液获批上市 bettapharma.com ↗
贝伐珠单抗注射液（MIL60，商品名：贝安汀®）正式获批上市，获批的适应症为转移性结直肠癌和晚期、转移性或复发性非小细胞肺癌。 |
| 2020-06-15 | Betta Pharmaceuticals Co., Ltd. | Regulatory 贝达药业新药MIL60生物制品上市申请获受理 bettapharma.com ↗
贝伐珠单抗注射液（MIL60）用于晚期、转移性或复发性非小细胞肺癌和转移性结直肠癌患者治疗的上市许可申请已获得国家药品监督管理局受理（受理号：CXSS2000027）。 |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2021-12-02 | Betta Pharmaceuticals Co., Ltd. | 重磅！贝达药业贝伐珠单抗注射液获批上市 bettapharma.com ↗ |
| 2020-06-15 | Betta Pharmaceuticals Co., Ltd. | 贝达药业新药MIL60生物制品上市申请获受理 bettapharma.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | MIL60 | “Patients with non-progressive disease continued maintenance single-agent MIL60 until disease progression, or intolerable toxicity.” PMID 34841235 ↗ Nov 2021 |
| Route | Intravenous | “co-administered intravenously” NCT03196986 ↗ |