Drugs / PL-5
PL-5
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | 继发性创面感染 | 2024-12-25 | “12月24日,国家药监局药品审评中心(CDE)官网公示,普莱医药1类新药培来加南喷雾剂上市申请获得受理。” cttq.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT06189638 | Jan 2024 → Apr 2027 expected | ulcer of lower limbs | Jiangsu ProteLight Pharmaceutical & Biotechnology Co., Ltd. | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2026-06-22 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Regulatory 独家合作!FIC多肽抗菌新药普亦克®获批上市 cttq.com ↗
6月22日,国家药品监督管理局(NMPA) 官网显示,全球首创(FIC)的加南类抗感染药物——培来加南喷雾剂(普亦克®)在国内获批上市,用于治疗由表皮葡萄球菌、溶血葡萄球菌、鲍曼不动杆菌导致的Ⅰ度或浅Ⅱ度烧烫伤继发创面感染。 |
| 2024-12-25 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Regulatory 普莱医药抗菌肽产品培来加南申报上市,正大天晴已获中国独家合作权 cttq.com ↗
12月24日,国家药监局药品审评中心(CDE)官网公示,普莱医药1类新药培来加南喷雾剂上市申请获得受理。 |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-06-22 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | 独家合作!FIC多肽抗菌新药普亦克®获批上市 cttq.com ↗ |
| 2024-12-25 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | 普莱医药抗菌肽产品培来加南申报上市,正大天晴已获中国独家合作权 cttq.com ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | PL-5 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06189638 ↗ |
| Known as | AMP Peptide PL-5 | “Phase II Study to Evaluate Efficacy and Safety of AMP Peptide PL-5 in Mild Infections of Diabetic Foot Ulcers” NCT06189638 ↗ |
| Known as | Antimicrobial Peptide PL-5 | “A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Antimicrobial Peptide PL-5 Topical Spray in Patients With Mild...” NCT06189638 ↗ |
| Modality | Peptide | “Antimicrobial Peptide PL-5” NCT06189638 ↗ |
| Route | Topical | “Antimicrobial Peptide PL-5 Topical Spray” NCT06189638 ↗ |