Nilestriol

Perimenopausal women often face troubles such as hot flashes and sweating, osteoporosis, and urogenital atrophy. Estrogen replacement therapy is one of the core solutions to improve these symptoms. Nilestriol is a long-acting estriol derivative and a potent oral estrogen drug. Its mechanism of action is that it selectively acts on the vagina and cervical canal, and has a relatively weak effect on the endometrium. It can not only effectively relieve various discomforts caused by low estrogen, but also reduce the risk of endometrial hyperplasia. Clinically, it is mainly used for the treatment of perimenopausal syndrome, senile vaginitis, urinary tract infection and other diseases, and can also be used to prevent postmenopausal osteoporosis. The applicable population is women with low estrogen-related symptoms around menopause.

As a clinically mature drug, nilestriol currently has a domestic market size of about 120 million yuan. Driven by the increasing demand for perimenopausal health management in recent years, its annual growth rate has maintained at around 6%. In terms of competitive landscape, there is no imported original research drug of this variety on the market, and the entire market is occupied by domestic generic drug enterprises. At present, there are 3 preparation enterprises approved for production in China, and the supply end of API is relatively concentrated, with only 2 enterprises holding API registration numbers. The overall market competition is relatively stable, and it has not been included in the scope of national centralized volume-based procurement.

Nilestriol was first developed and marketed by domestic pharmaceutical enterprises, and no foreign original research product has entered the Chinese market. The first domestic generic enterprise is Beijing Huasu Pharmaceutical Co., Ltd., with the trade name Weinian. At present, the main dosage form marketed in China is tablet, with specifications including 1mg, 2mg and 5mg. This preparation has been included in the National Essential Medicine List and is also a domestically recognized reference preparation. In terms of API registration, there are currently 2 API registration numbers in status A in China, all held by domestic enterprises, and the corresponding preparation products have been approved and marketed in China for many years. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for nilestriol API. The products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA. Most impurities are in sufficient stock. Spot orders submitted before 16:00 can be shipped on the same day, which can fully meet the supply demand of pharmaceutical enterprises for impurity reference standards in the whole process of API R&D, quality research and production.