Drugs / TAB008
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | — | 2020-09-03 | “On 3 September 2020, the Biologics License Application for TAB008 was accepted by the National Medical Products Administration.” biodlink.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT05427305 | Oct 2017 → Mar 2020 | — | BioDlink Biopharm Co., Ltd. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2021-12-01 | BioDlink Biopharm Co., Ltd. | Regulatory TOT BIOPHARM Announces NMPA Granted Marketing Approval for Pusintin® (TAB008, Bevacizumab Injection) in China biodlink.com ↗
Pusintin® is the first antibody drug of TOT BIOPHARM approved for marketing. |
| 2020-11-22 | BioDlink Biopharm Co., Ltd. | Results TOT BIOPHARM Unveils Results of Phase III Clinical Trial of TAB008（Bevacizumab Injection）in ESMO ASIA for the First Time biodlink.com ↗
The experiments showed that: The ORR for TAB008 group and reference bevacizumab were 55.957% and 55.720% respectively, demonstrating similarity in primary efficacy endpoint; |
| 2020-04-21 | BioDlink Biopharm Co., Ltd. | Results TOT BIOPHARM Self-Developed Biological Drug TAB008 (Pusintin®) Meets Primary Endpoint in Phase III Clinical Trial biodlink.com ↗ |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2021-12-01 | BioDlink Biopharm Co., Ltd. | TOT BIOPHARM Announces NMPA Granted Marketing Approval for Pusintin® (TAB008, Bevacizumab Injection) in China biodlink.com ↗ |
| 2020-11-22 | BioDlink Biopharm Co., Ltd. | TOT BIOPHARM Unveils Results of Phase III Clinical Trial of TAB008（Bevacizumab Injection）in ESMO ASIA for the First Time biodlink.com ↗ |
| 2020-04-21 | BioDlink Biopharm Co., Ltd. | TOT BIOPHARM Self-Developed Biological Drug TAB008 (Pusintin®) Meets Primary Endpoint in Phase III Clinical Trial biodlink.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | TAB008 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05427305 ↗ |
| Route | Intravenous | “Patients received TAB008 or bevacizumab-EU 15 mg/kg intravenously plus paclitaxel/carboplatin for 4-6 cycles” NCT05427305 ↗ |