With the postponement of marriage and childbearing age, more and more people are in sub-health conditions, and the increasing pressure of life, the incidence of infertility in China has also increased year by year: according to the "survey report on the status of infertility in China", the incidence of infertility in China has risen from 2.5% to 3% 20 years ago to 12.5% to 15%.
Progesterone, as an auxiliary reproductive drug, is a natural steroid hormone secreted by ovary, placenta and adrenal gland. In vivo, it can transform the proliferative endometrium through estrogen into the secretory phase, provide favorable conditions for the implantation of pregnant eggs and the nutrition of early embryos, and maintain pregnancy.
At this moment, you may have guessed that one of the protagonists of this "Hongjie said project" is "progesterone vaginal sustained release gel", and the 8% (90mg) specification of this product is produced by only one company in China.
Basic product information
Progesterone vaginal sustained release gel was developed by Columbia research laboratories. Watson company obtained the sales right in the U.S. market through a milestone payment. Merck Serono, as the global partner of Columbia research laboratories, obtained the sales right in markets other than the United States.
FDA approved the listing of progesterone vaginal sustained release gel of Watson company in May, 1997. The trade name is crinone, and the specification is 8% (90mg); Watson later transferred the rights and interests of crinone to Allergan, and FDA approved the listing of progesterone vaginal sustained release gel of Allergan in July 1997, with specifications of 4% (45mg) and 8% (90mg). The progesterone vaginal sustained-release gel of Merck xuelanuo was approved to be listed in the European Union through decentralized review in February 1999. The trade names are crinone 4%, crinone 8% vaginalgel, and the specifications are 4% (45mg) and 8% (90mg).
Nmpa approved the import of progesterone vaginal sustained-release gel from Merck xuelanuo company in December 2008. The trade name is xuenuotong, and the specification is 8% (90mg). In July 2016, the Japan food and Drug Administration approved Merck's progesterone vaginal sustained-release gel, with the trade name of onecrinone and the specification of 8% (90mg).
Common name: progesterone vaginal sustained release gel
English Name: progesterone sustained release vaginal gel
Trade name: Sinone
Original research enterprise: Merck snow
Indications: it is used for the supplementary treatment of progesterone in assisted reproductive technology
Ingredient: Progesterone
Molecular formula: c21h30o2
Development specification: 8% (90mg)
Usage and dosage: vaginal administration, once a day, 90mg (1 piece). In case of pregnancy, continue treatment until the placenta has autonomous function, up to 10-12 weeks. See the imported original research manual for the specific use method.
Market potential
Progesterone vaginal sustained-release gel is not listed in the 2021 medical insurance catalogue and 2018 basic drug catalogue. According to the data of Intranet, the lowest bid price of progesterone vaginal sustained-release gel in recent one year was 69.19 yuan / piece, and progesterone vaginal sustained-release gel was not included in the centralized purchase.
According to the data of public hospitals in the city of MI nei, progesterone belongs to progesterone drugs. The market scale of this kind of drugs fell slightly in 2020 due to the epidemic, and the sales in other years were in an upward state. The sales in the first half of 2021 was about 1.56 billion yuan, and the sales in this year is expected to exceed 3 billion yuan. There are four kinds of progesterone drugs on sale in China, of which progesterone accounts for 52% of the market share, and the market share of the other three drugs adds up to less than 50%. It can be seen that progesterone plays an important role in the progesterone drug market. In addition, in China, only the original research company Merck shirano has been approved for sale, leaving a large market space for the imitation company.
