Beijing Centergate Technologies (Holding) Co., Ltd. (CENTEK; SHE: 000931) announced that its subsidiary Duoduo Pharmaceutical Co., Ltd. has received a “Notification of Acceptance” from China’s National Medical Products Administration (NMPA) for the marketing authorization application of Calcium Dobesilate Capsules (0.5 g), a Category 4 chemical generic drug – marking the formal entry of the filing into the NMPA review stage.
Regulatory Milestone
| Item | Detail |
|---|---|
| Agency | National Medical Products Administration (NMPA), China |
| Applicant | Duoduo Pharmaceutical Co., Ltd. (subsidiary of Beijing Centergate Technologies, CENTEK; SHE: 000931) |
| Product | Calcium Dobesilate Capsules |
| Dosage Form & Strength | Capsule, 0.5 g |
| Application Type | Domestic generic drug marketing authorization – Chemical Drug Category 4 |
| Acceptance No. | CYHS2602461 |
| Conclusion | Application reviewed and accepted; now in NMPA review stage |
| Cumulative R&D Investment | RMB 4.7279 million (as of 30 September 2026) |
Drug Profile & Clinical Indications
- Indication – Microangiopathy: Treatment of diabetic microangiopathy – retinopathy and glomerulosclerosis (Kimmelstiel‑Wilson syndrome); and microvascular injury with increased capillary fragility and permeability, capillaropathy, and acrocyanosis of the hands and feet.
- Indication – Chronic Venous Insufficiency: Adjuvant treatment of chronic venous insufficiency (varicose vein syndrome) and its sequelae – post‑thrombotic syndrome, leg ulcers, stasis dermatitis (purpuric dermatitis), peripheral vascular stasis edema, and other congestive skin disorders.
- Mechanism: Calcium dobesilate exerts its protective effect by inhibiting capillary hyperpermeability, reducing blood hyperviscosity, and inhibiting platelet activation – an internationally recognized capillary protectant.
Product History
- Origin: Developed by Ebewe Pharma (Austria); first approved in the European Union in September 1980 under the brand name Doxium® (500 mg).
- International Footprint: Subsequently launched in Hungary, Türkiye, Malta, Portugal and other markets.
- China Introduction: The Ebewe‑manufactured calcium dobesilate capsules were introduced to China in 1992.
Market Impact & Outlook
- Competitive Positioning: Centergate stated that, if approved, the generic would strengthen Duoduo Pharmaceutical’s market competitiveness and exert a positive impact on the company’s operating performance.
- Long‑Standing Demand: With more than three decades of clinical use in China and broad indications spanning diabetic microvascular complications and chronic venous disease, calcium dobesilate addresses a sizeable, chronically treated patient population.
- Review Stage Risk: Acceptance does not guarantee approval – the application must now complete NMPA technical review, and the company will disclose subsequent progress in accordance with regulatory requirements.
- Timeline: Review duration and approval timing were not disclosed; investors are advised to exercise caution regarding investment risk.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding the NMPA review, approval timeline, and commercialization prospects of Calcium Dobesilate Capsules. Actual results may differ materially due to risks including review outcomes, manufacturing and quality requirements, competitive dynamics, and market adoption.-Fineline Info & Tech
