By Fineline Cube 
Jiangxi Jemincare Group (SHA: 603222) announced that its Class 2.2 and Class 2.4 new drug application for JMX-2005 Injection has been approved by the National Medical Products Administration (NMPA) for clinical trials. The drug is intended to improve ischemic symptoms—such as resting pain and ulcers—caused by Peripheral Artery Disease (PAD).
Regulatory Milestone & Drug Profile
| Attribute | Details |
|---|---|
| Company | Jiangxi Jemincare Group (603222.SH) |
| Product | JMX-2005 Injection |
| Approval | NMPA clinical trial approval (Class 2.2, Class 2.4) |
| Indication | Ischemic symptoms from PAD (resting pain, ulcers) |
| **Mechanism | Sustained‑release liposome formulation with subcutaneous “drug reservoir” |
Disease Burden & Unmet Medical Need
Peripheral Artery Disease (PAD):
- Prevalence: Affects 45 million patients in China; severe stages impact 5‑10% of cases
- Clinical Impact: Chronic resting pain, non‑healing ulcers, amputation risk in advanced disease
- Quality of Life: Severely impairs patient mobility and daily functioning
- Current Standard: Limited pharmacologic options; surgical revascularization for severe cases only
Technology Innovation: Sustained-Release Liposome Platform
| Feature | Innovation | Clinical Benefit |
|---|---|---|
| Formulation | Advanced liposome encapsulation | Controlled‑release characteristics |
| Delivery | Subcutaneous injection | Creates localized “drug reservoir” at injection site |
| Release Profile | Slow, continuous drug release | Extends dosing interval |
| Patient Impact | Reduced injection frequency | Improved compliance for chronic PAD management |
Market Context & Competitive Landscape
| Parameter | Market Insight |
|---|---|
| PAD Drug Market | China market valued at ¥8 billion (US$1.1 billion), growing at 6% CAGR |
| Sustained‑Release Gap | No approved sustained‑release injectables for PAD ischemic symptoms |
| Innovation Status | First liposome‑based PAD therapy in China; offers disease‑modifying potential |
| Pipeline Position | Jemincare’s lead asset in vascular disease franchise |
| Regulatory Path | Class 2.2/2.4 designation accelerates review; potential priority review if Phase 2 data positive |
Strategic Outlook & Next Steps
- Clinical Development: Phase 1 trial initiation expected Q1 2026; safety and PK evaluation in healthy volunteers
- Manufacturing: In‑house liposome production facility will scale to support pivotal trials
- Pipeline Expansion: Platform technology applicable to other ischemic diseases (diabetic foot ulcers, critical limb ischemia)
- Revenue Potential: Analysts project ¥500‑800 million (US$70‑110 million) peak China sales if approved
- Global Strategy: NMPA approval may support IND filings in US/EU via manufacturing comparability data
Forward‑Looking Statements
This brief contains forward‑looking statements regarding JMX‑2005 development timelines, clinical outcomes, and market potential. Actual results may differ due to clinical, regulatory, and competitive uncertainties.-Fineline Info & Tech