Drugs / IBI301
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | non-Hodgkin lymphoma | 2019-06-27 | “Based on the clinical data, the new drug application (NDA) of IBI301 was accepted by the NMPA in June 2019 and has been granted priority review status.” innoventbio.com ↗ “the National Medical Products Administration (NMPA) has accepted its new drug application (NDA) for IBI301” innoventbio.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02945215 | Dec 2016 → Mar 2019 | B-cell neoplasm | Innovent Biologics (Suzhou) Co. Ltd. | Completed | No outcome recorded |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT02867566 | Aug 2016 → Sep 2019 | diffuse large B-cell lymphoma | Innovent Biologics (Suzhou) Co. Ltd. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2019-09-20 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent Provides Update on Two Studies of IBI301 (Rituximab Biosimilar) in the Treatment of CD20-positive Lymphoma at Annual Meeting of CSCO innoventbio.com ↗
Both studies directly compared IBI301 with rituximab and achieved the intended primary endpoint. |
| 2019-06-27 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory NMPA Accepts New Drug Application for IBI301, a Biosimilar Product Candidate of Rituximab (MabThera/Rituxan) innoventbio.com ↗
Innovent Biologics, Inc. (Innovent) (HKEX: 01801) and Eli Lilly and Company (“Lilly”) jointly announced today that the National Medical Products Administration (NMPA) has accepted its new drug application (NDA) for IBI301, a co-developed biosimilar product candidate of rituximab (MabThera/Rituxan). |
| 2019-05-08 | Innovent Biologics (Suzhou) Co. Ltd. | Results Two Clinical Studies with the Anti-CD20 Monoclonal Antibody IBI301, a Biosimilar Candidate to Rituximab (MabThera/Rituxan), Met Primary Endpoints innoventbio.com ↗ |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2019-09-20 | Innovent Biologics (Suzhou) Co. Ltd. | Innovent Provides Update on Two Studies of IBI301 (Rituximab Biosimilar) in the Treatment of CD20-positive Lymphoma at Annual Meeting of CSCO innoventbio.com ↗ |
| 2019-06-27 | Innovent Biologics (Suzhou) Co. Ltd. | NMPA Accepts New Drug Application for IBI301, a Biosimilar Product Candidate of Rituximab (MabThera/Rituxan) innoventbio.com ↗ |
| 2019-05-08 | Innovent Biologics (Suzhou) Co. Ltd. | Two Clinical Studies with the Anti-CD20 Monoclonal Antibody IBI301, a Biosimilar Candidate to Rituximab (MabThera/Rituxan), Met Primary Endpoints innoventbio.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | IBI301 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02945215 ↗ |
| Modality | Monoclonal antibody | “IBI301 is a recombinant chimeric murine/human anti-CD20 monoclonal antibody” PMID 33751401 ↗ Mar 2021 |
| Route | Intravenous | “IBI301: 375 mg/m2, IV” NCT02867566 ↗ |