Drugs / CAN103
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | Gaucher ichthyosis restrictive dermopathy | 2024-11-13 | “the Chinese National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for CAN103” canbridgepharma.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT05447494 | Jul 2022 → Nov 2024 | Gaucher disease type I, Gaucher disease type III | CANbridge (Suzhou) Bio-pharma Co., Ltd. | Unknown | Met primary |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2025-03-13 | CANbridge (Suzhou) Bio-pharma Co., Ltd. | Regulatory CANbridge Announces that Velaglucerase-beta for Injection Successfully Passed the Pre-approval inspection and Pre - marketing GMP Compliance Inpection for the Pilot Biological Product of Divided manufacturing canbridgepharma.com ↗
CANbridge Pharmaceuticals Inc. (1228.HK) , a global biopharmaceutical company, with a foundation in China, committed to the research, development and commercialization of transformative therapies to treat rare disease, announced today that velaglucerase-beta for injection, with its wholly - owned subsidiary, CANbridge (Shanghai) Life Sciences Ltd. as the holder, successfully passed the Pre-approval inspection and pre - marketing GMP compliance inspection for the pilot biological product of Divided manufacturing. |
| 2024-11-13 | CANbridge (Suzhou) Bio-pharma Co., Ltd. | Regulatory CANbridge Pharmaceuticals CAN103 New Drug Application (NDA), for Gaucher disease, Accepted by China’s National Medical Products Administration canbridgepharma.com ↗
CANbridge Pharmaceuticals Inc. (1228.HK), a global biopharmaceutical company, with a foundation in China, committed to the research, development and commercialization of transformative therapies to treat rare diseases, announced today that the Chinese National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for CAN103 (velaglucerase-beta for jnjection) for the treatment of Gaucher disease (GD). |
| 2024-09-30 | CANbridge (Suzhou) Bio-pharma Co., Ltd. | Regulatory CANbridge Pharmaceuticals’ CAN103 for Gaucher Disease Granted Priority Review Status by CDE of the NMPA canbridgepharma.com ↗
CAN103 (velaglucerase-beta) for Gaucher disease has been granted priority review status by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA). |
| 2024-08-19 | CANbridge (Suzhou) Bio-pharma Co., Ltd. | Results CANbridge Reports Positive Topline Data from CAN103 Pivotal Trial for Gaucher Disease in China, Plans NDA Filing in Q4 2024 canbridgepharma.com ↗
The results demonstrate that the study successfully met its primary efficacy endpoint, showing a statistically significant mean percentage reduction from baseline in spleen volume at nine months for both the 60 U/kg dose (P<0.0001) and the lower 30 U/kg dose (P<0.001). |
| 2021-10-20 | CANbridge (Suzhou) Bio-pharma Co., Ltd. | Regulatory CANbridge Pharmaceuticals CAN103 Investigational New Drug Application Approved in China for Treatment of Gaucher Disease canbridgepharma.com ↗ |
| 2021-08-02 | CANbridge (Suzhou) Bio-pharma Co., Ltd. | Regulatory CANbridge Pharmaceuticals CAN103 Investigational New Drug Application Accepted by China’s National Medical Products Administration canbridgepharma.com ↗ |
All press releases naming this drug 10 releases
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 | CAN103 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05447494 ↗ |
| Route | Intravenous | “administered intravenously every other week for 37 weeks” NCT05447494 ↗ |