China-based Changchun High & New Technology Industries (Group) Inc. (SHE: 000661) announced that its subsidiary Changchun GeneScience Pharmaceutical Co., Ltd. has received clinical approval from the National Medical Products Administration (NMPA) to test its megestrol for the prevention of chemotherapy-induced nausea and vomiting (CINV). The drug was developed by Twi Pharmaceuticals, Inc.

Collaboration with Twi Pharmaceuticals

GeneScience entered into a partnership with the Taiwan – based Twi Pharmaceuticals in 2024, becoming the sole general agent of the drug in mainland China, Hong Kong, Macau, and Singapore. Previously, megestrol was approved for cancer-related anorexia-cachexia syndrome.

Drug Features and Advantages

Megestrol, the first nanocrystalline oral suspension formulation approved in mainland China, offers superior solubility and bioavailability compared to traditional solid dosage forms. Its food-independent pharmacokinetic profile provides added convenience. The drug works synergistically through multiple mechanisms of action to prevent CINV and has demonstrated efficacy and safety in multiple clinical studies. It is also included in the CSCO clinical guidelines.

Significance of the Approval

The approval marks a significant step forward for Changchun High-Tech and GeneScience in expanding their presence in the oncology support care market. With the growing demand for effective CINV prevention therapies, megestrol has the potential to address an important unmet need for patients undergoing chemotherapy.-Fineline Info & Tech