Megestrol

The clinical value of progestogen drugs in the fields of adjuvant therapy for gynecological malignant tumors and breast cancer, as well as supportive care for cachexia, has been widely verified. As a representative synthetic progestogen among them, megestrol binds to progesterone receptors to inhibit the secretion of pituitary gonadotropins, thereby regulating the synthesis and secretion of sex hormones. Meanwhile, it can directly act on tumor cells to inhibit proliferation, and also improve patients' appetite and physical state, reducing the risk of cancer-related cachexia. Its clinical indications cover hormone-dependent tumors, including advanced breast cancer and advanced endometrial cancer. It can also be used for the adjuvant treatment of renal cancer and prostate cancer, as well as for improving the symptoms of anorexia and weight loss in advanced tumor patients, making it an indispensable commonly used drug in tumor supportive care and gynecological tumor treatment.

At present, the global market size of megestrol is stable at around USD 230 million, and the annual growth rate of the Chinese market is maintained at 4.2%. The demand growth mainly comes from the increasing penetration rate in tumor supportive care scenarios. In terms of the competitive landscape, generic drugs account for 87% of the overall market share, and domestic manufacturers are concentrated in East China and North China. Among them, the API of 3 enterprises has been registered with the CDE, and the preparation products have been included in the national centralized procurement. The winning bid price is 72% lower than that of the original research drug, which greatly improves clinical accessibility.

The original research enterprise of megestrol is Bristol-Myers Squibb, and the original trade name is Megace. Its core compound patent expired globally in 1999. The main marketed dosage forms include tablets and oral suspensions, with common specifications of 160mg tablets and 40mg/ml oral suspensions. The original research product has been included in the FDA Reference Listed Drug Catalog. The original research preparation has not been imported into China, and the current reference listed drug is an imported generic drug. At present, there are a total of 7 megestrol API registration numbers in China, among which 6 are in A status, which can support the marketing of domestic preparations. 11 domestic preparation varieties have been approved, covering dosage forms such as tablets, dispersible tablets and soft capsules. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of megestrol impurity reference standards. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, fully meet the quality control needs of API enterprises in the whole process of R&D, registration and production, and ensure the accuracy and compliance of declaration data.