By Fineline Cube 
CSPC Pharmaceutical Group Limited (HKG: 1093) today announced that the National Medical Products Administration (NMPA) of China has accepted its New Drug Application (NDA) for Efmedaglutide Alfa Injection, a Category 1 therapeutic biological product intended for long‑term weight management in overweight or obese adults when combined with diet control and increased physical activity.
Key Highlights
| Item | Detail |
|---|---|
| Company | CSPC Pharmaceutical Group Limited (1093.HK) |
| Product | Efmedaglutide Alfa Injection |
| Regulatory Status | NMPA NDA accepted (Category 1 therapeutic biological) |
| Indication | Long‑term weight management in overweight/obese adults |
| Administration | Once‑weekly recombinant hGLP‑1‑Fc fusion protein injection |
| Clinical Evidence | Phase 3 pivotal trial; Phase 3 trials in type 2 diabetes ongoing |
Product Profile
- Mechanism of Action – Selective binding to GLP‑1 receptors, suppressing appetite and reducing food intake.
- Metabolic Benefits – Glucose‑dependent blood‑sugar lowering, improved cardiovascular and metabolic parameters.
- Dosing – Fast, simple dose‑escalation; target maintenance dose reached within 4 weeks.
- Safety – Favorable safety and tolerability; lower incidence of gastrointestinal AEs and treatment discontinuation compared with marketed comparators.
Clinical Trial Evidence
| Study | Population | Primary Outcome | Key Secondary Outcomes |
|---|---|---|---|
| Phase 3 Pivotal | Overweight/obese adults with ≥1 weight‑related comorbidity | Significant body‑weight reduction vs. placebo | Waist circumference, fasting glucose, blood pressure, lipid profile – all markedly improved |
| Phase 3 (Diabetes) | Patients with type 2 diabetes | Ongoing | Aims to evaluate weight, glycaemic control, cardiovascular outcomes |
Market Significance
- First‑in‑class hGLP‑1‑Fc therapy for chronic weight management in China.
- Rapid dose escalation and once‑weekly dosing improve patient adherence.
- Competitive advantage through superior safety profile and comprehensive metabolic benefits.
About CSPC Pharmaceutical Group
CSPC Pharmaceutical Group Limited is a leading Chinese biopharmaceutical company specializing in the research, development, and commercialization of innovative therapeutic biologics. The company has a robust pipeline across oncology, metabolic disease, and rare disorders, with a strong emphasis on global regulatory approval and market expansion.
Forward‑Looking Statements
This release contains forward‑looking statements regarding regulatory approvals, clinical trial outcomes, and market potential. These statements are based on current expectations and are subject to risks, uncertainties, and changes in market conditions.-Fineline Info & Tech