NMPA Approves New Indication Clinical Trial of Megestrol Acetate Oral Suspension

Recently, GenSci received approval from the National Medical Products Administration (NMPA) for the product registration clinical trial application of Megestrol Acetate Oral Suspension (Megaxia®). The trial will assess its use in preventing chemotherapy-induced nausea and vomiting (CINV).

Nausea and vomiting are common adverse reactions of anti-tumor therapy. Over 70% of patients undergoing anti-tumor therapy experience nausea and vomiting to varying degrees. Severe nausea and vomiting can lead to dehydration, electrolyte imbalances, and nutritional deficiencies. These complications can disrupt the patient's normal anti-tumor treatment schedule. It is clinically recognized that nausea is harder to control than vomiting. Significant unmet clinical needs remain in managing nausea, demanding the development of innovative treatment options.

Megaxia® is currently the first approved megestrol acetate oral suspension dosage form in mainland China. It received a Grade I recommendation in the "CSCO Guidelines for the Diagnosis and Treatment of Cancer Anorexia-Cachexia Syndrome" (2025 Edition). Compared to solid formulations, it offers higher solubility and bioavailability. Food intake has less impact on its pharmacokinetics, and it does not need to be taken with meals. Megestrol acetate can synergistically prevent CINV through multiple mechanisms of action. Multiple clinical studies have demonstrated its efficacy and safety. This indicates that megestrol acetate oral suspension combined with standard therapy has potential as a novel treatment approach for CINV.

This IND approval showcases GenSci's rich oncology pipeline matrix, with multiple drugs/indications currently in clinical stages. GenSci will continue to explore more possibilities for Megaxia® to bring better survival benefits to cancer patients.