Drugs / Pegylated somatropin
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT01339182 | Jan 2011 → Aug 2012 | — | Xiamen Amoytop Biotech Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT01613573 | Mar → Oct 2010 | pituitary deficiency | Changchun GeneScience Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT01342146 | May 2006 → Jan 2007 | pituitary deficiency | Changchun GeneScience Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2024-08-21 | Changchun GeneScience Pharmaceutical Co., Ltd. | Regulatory Jintrolong® New Dosage Form of Long-acting Somatropin Injection Approved genscigroup.com ↗
August 20th, 2024, Shanghai-GenSci has announced that the New Drug Application for Jintrolong® Polyethylene Glycol Recombinant Human Somatropin Injection (hereinafter referred to as PEG-rhGH) has received approval from the Center for Drug Evaluation, NMPA. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-08-21 | Changchun GeneScience Pharmaceutical Co., Ltd. | Jintrolong® New Dosage Form of Long-acting Somatropin Injection Approved genscigroup.com ↗ |
| 2024-05-17 | Changchun GeneScience Pharmaceutical Co., Ltd. | Jintrolong® PEG-rhGH from GenSci highlighted at ECE 2024 genscigroup.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Pegylated somatropin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01613573 ↗ |
| Known as | Jintrolong | “Long-acting PEGylated recombinant human growth hormone (Jintrolong) for children with growth hormone deficiency: phase II and phase III multicenter, randomized studies.” PMID 28566441 ↗ May 2017 |
| Modality | Protein / enzyme biologic | “The purpose of the multicenter, randomized, open-label, controlled phase II study is to determine whether pegylated recombinant human growth hormone is effective in the...” NCT01342146 ↗ |
| Route | Subcutaneous | “s.c, single dose of pegylated-Somatropin, 10mcg/kg” NCT01339182 ↗ |