By Fineline Cube 
Suzhou HemaCell Therapeutics, a platelet‑regeneration‑focused cell‑therapy developer, announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has approved a new drug clinical trial application (IND) for its allogeneic megakaryocyte injection.
Product Highlights
| Feature | Detail |
|---|---|
| Therapeutic Indication | Thrombocytopenia caused by cancer therapy |
| Platform | Allogeneic megakaryocyte injection |
| Key Advantages | • Low cost • High safety profile • No gene‑editing required • Long‑lasting efficacy • Minimal side‑effects |
Regulatory Milestone
- First IND approval for an allogeneic megakaryocyte product in China.
- Second product of HemaCell to receive formal clinical‑trial approval; the company’s autologous megakaryocyte injection already secured FDA IND approval.
Strategic Implications
- Positions HemaCell as a pioneer in platelet‑regenerative cell therapy.
- Expands the global portfolio of cell‑based solutions for oncology‑related cytopenias.
- Provides a scalable, cost‑effective alternative to platelet transfusions and recombinant growth‑factor therapies.
Next Steps
- Initiate Phase I/II clinical trials to evaluate safety, tolerability, and platelet‑count restoration efficacy in patients undergoing chemotherapy or hematologic malignancy treatment.
- Leverage the CDE approval to explore parallel regulatory pathways in the United States and Europe.-Fineline Info & Tech