Drugs / JMT103
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | bone giant cell tumor | 2022-06-22 | “BIOLOGIC LICENSE APPLICATION FOR JMT103 ACCEPTED BY THE NMPA” irasia.com ↗ |
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT04630522 | Oct 2020 → Mar 2023 | metastatic carcinoma in the bone | Shanghai JMT-Bio Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03550508 | May 2018 → Aug 2019 | bone neoplasm | Shanghai JMT-Bio Inc. | Unknown | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04198480 | Apr 2020 → Oct 2021 | humoral hypercalcemia of malignancy | Shanghai JMT-Bio Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 22 trials · 1 met primary | ||||||
| Phase 2 | NCT05397938 | Jun → Jul 2022 | glucocorticoid-induced osteoporosis | Shanghai JMT-Bio Inc. | Unknown | No outcome recorded |
| Phase 2 | NCT05278338 | Apr 2022 → Dec 2023 | postmenopausal osteoporosis | Shanghai JMT-Bio Inc. | Unknown | Met primary |
| Phase 31 trial | ||||||
| Phase 3 | NCT06221072 | Apr 2024 → May 2027 expected | metastatic carcinoma in the bone | Shanghai JMT-Bio Inc. | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2023-09-06 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory (REVISED) VOLUNTARY ANNOUNCEMENT - BIOLOGIC LICENSE APPLICATION FOR NARLUMOSBART FOR INJECTION (JMT103) APPROVED BY THE NMPA irasia.com ↗
The Product is the first IgG4 subtype fully human monoclonal antibody against RANKL obtaining marketing approval in the world. |
| 2023-09-06 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - BIOLOGIC LICENSE APPLICATION FOR NARLUMOSBART FOR INJECTION (JMT103) APPROVED BY THE NMPA irasia.com ↗
The Product is the first IgG4 subtype fully human monoclonal antibody against RANKL obtaining marketing approval in the world. |
| 2022-06-22 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - BIOLOGIC LICENSE APPLICATION FOR JMT103 ACCEPTED BY THE NMPA irasia.com ↗
BIOLOGIC LICENSE APPLICATION FOR JMT103 ACCEPTED BY THE NMPA |
| 2022-03-21 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Results VOLUNTARY ANNOUNCEMENT - CLASS 1 NEW DRUG JMT103 MEETS PRE-DEFINED ENDPOINTS IN THE PIVOTAL CLINICAL TRIAL FOR THE TREATMENT OF UNRESECTABLE OR SURGICALLY DIFFICULT GIANT CELL TUMOR OF BONE irasia.com ↗ |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-09-06 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | (REVISED) VOLUNTARY ANNOUNCEMENT - BIOLOGIC LICENSE APPLICATION FOR NARLUMOSBART FOR INJECTION (JMT103) APPROVED BY THE NMPA irasia.com ↗ |
| 2023-09-06 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | VOLUNTARY ANNOUNCEMENT - BIOLOGIC LICENSE APPLICATION FOR NARLUMOSBART FOR INJECTION (JMT103) APPROVED BY THE NMPA irasia.com ↗ |
| 2022-06-22 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | VOLUNTARY ANNOUNCEMENT - BIOLOGIC LICENSE APPLICATION FOR JMT103 ACCEPTED BY THE NMPA irasia.com ↗ |
| 2022-03-21 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | VOLUNTARY ANNOUNCEMENT - CLASS 1 NEW DRUG JMT103 MEETS PRE-DEFINED ENDPOINTS IN THE PIVOTAL CLINICAL TRIAL FOR THE TREATMENT OF UNRESECTABLE OR SURGICALLY DIFFICULT GIANT CELL TUMOR OF BONE irasia.com ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | JMT103 | “JMT103 is recombinant fully human anti-RANKL monoclonal antibody.” NCT03550508 ↗ |
| Action | Inhibit | “JMT103 demonstrated strong activity through blocking RANKL receptor” NCT03550508 ↗ |
| Modality | Monoclonal antibody | “JMT103 is a novel, full human IgG4 monoclonal antibody targeting RANKL.” NCT03550508 ↗ |
| Route | Subcutaneous | “JMT103 was administered subcutaneously in the upper arm, upper thigh, or abdomen.” NCT03550508 ↗ |
| Target | TNFSF11 | “a novel fully humanized receptor activator of nuclear factor kappa-B ligand (RANKL)-targeting monoclonal antibody” PMID 35992822 ↗ Aug 2022 |