Drugs / NBL-015
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT05153096 | Apr 2022 → Dec 2025 | cancer | NovaRock Biotherapeutics, Ltd | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2021-09-02 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - NBL-015 OBTAINS CLINICAL TRIAL APPROVAL IN CHINA irasia.com ↗
The board of directors (the “Board”) of CSPC Pharmaceutical Group Limited (the “Company”, together with its subsidiaries, the “Group”) is pleased to announce that Shanghai Novarock Biopharmaceutical Co., Ltd.*ʮ̡, a subsidiary of the Company, has obtained approval granted by the National Medical Products Administration of the People’s Republic of China to conduct clinical trial for NBL-015 in China. |
| 2021-05-25 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - NBL-015 OBTAINS CLINICAL TRIAL APPROVAL IN THE U.S. irasia.com ↗
NBL-015, a fully human antibody drug discovered and developed by NovaRock Biotherapeutics Limited, a subsidiary of the Company, has obtained approval of its Investigational New Drug Application (IND) from the U.S. Food and Drug Administration (FDA). |
| 2021-05-24 | NovaRock Biotherapeutics, Ltd | Regulatory NovaRock Biotherapeutics Announces FDA Approval of IND Application for NBL-015 novarockbio.com ↗ |
| 2021-04-09 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory INVESTIGATIONAL NEW DRUG NBL-015 GRANTED ORPHAN-DRUG DESIGNATION BY THE U.S. FDA irasia.com ↗
The board of directors (the “ Board”) of CSPC Pharmaceutical Group Limited (the “ Company ”, together with its subsidiaries, the “Group”) is pleased to announce that the antibody drug NBL-015, a Claudin 18.2 eADCC antibody independently developed by Novarock Biotherapeutics Limited (“ NovaRock”), a subsidiary of the Company in the United States, was granted orphan-drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of gastric cancer, including cancer of gastroesophageal junction. |
| 2021-04-07 | NovaRock Biotherapeutics, Ltd | Regulatory NovaRock Receives Orphan-Drug Designation by the U.S. FDA for NBL-015 – a Fully Human Antibody Targeting Claudin-18.2 for the Treatment of Gastric Cancer novarockbio.com ↗
NovaRock Biotherapeutics Ltd announced today that their investigational new drug, NBL-015, a Claudin18.2 eADCC antibody, was granted Orphan-Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of gastric cancer, including cancer of gastroesophageal junction. |
| 2020-12-03 | NovaRock Biotherapeutics, Ltd | Regulatory NovaRock Receives Orphan-Drug Designation by the U.S. FDA for NBL-015 – a Fully Human Antibody Targeting Claudin-18.2 for the Treatment of Pancreatic Cancer novarockbio.com ↗
NBL-015, has been granted Orphan-Drug Designation by the U.S. Food and Drug Administration (FDA), for the treatment of pancreatic cancer. |
| 2020-12-02 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - INVESTIGATIONAL NEW DRUG NBL-015 GRANTED ORPHAN-DRUG DESIGNATION BY THE U.S. FDA irasia.com ↗
The board of directors (the “ Board”) of CSPC Pharmaceutical Group Limited (the “ Company ”, together with its subsidiaries, the “ Group”) is pleased to announce that the antibody drug NBL-015, independently developed by NovaRock Biotherapeutics Limited, a subsidiary of the Company in the United States, was granted orphan-drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer. |
All press releases naming this drug 7 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | NBL-015 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05153096 ↗ |
| Known as | Nbl-015 (anti-claudin18.2 mab) | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314994 ↗ |
| Route | Intravenous | “NBL-015 by intravenous infusion” NCT05153096 ↗ |