【 Pharmaceutical network industry trends 】The simplified new drug application (ANDA) is the generic drug application in the United States. According to relevant U.S. laws and regulations, the application for FDA review and approval means that the applicant can produce and sell the product in the U.S. market.
In recent years, with the normalization of centralized procurement, pharmaceutical enterprises such as Yiling Pharmaceutical have further improved the market competitiveness of generic drugs. At the same time, these pharmaceutical enterprises are also accelerating their "going to sea" pace.
It is reported that for the US market, Yiling Pharmaceutical currently has 12 ANDA numbers, and another 2 are under review. ANDA products approved by the US FDA include acyclovir capsules, celecoxib capsules, felodipine sustained-release tablets, lamotrigine sustained-release tablets, acyclovir tablets, anastrozole tablets, ciprofloxacin tablets, letrozole tablets, memantine hydrochloride tablets, paroxetine tablets, valaciclovir tablets, and pregabalin capsules. The treatment fields mainly cover anti-tumor, anti-virus and other fields.
Among them, celecoxib is a new generation of non steroidal anti-inflammatory and analgesic drug. It can inhibit the production of prostaglandins by selectively inhibiting cyclooxygenase-2 (COX-2) to achieve anti-inflammatory and analgesic effects. Celecoxib capsule is the original product of Pfizer, which was listed in the United States in 2002 and is held by GD SEARLE LLC. The main manufacturers of Celecoxib capsules in the United States are Apotex, Mylan, Teva, etc. IMS database data shows that the sales volume of Celecoxib capsules in the US market in 2018 is about US $189.31 million.
Lisinopril tablets are mainly used to treat essential hypertension and renovascular hypertension. Lisinopril tablet was approved for listing in the United States in 1988, and it is the original product of AstraZeneca. American licensees include Alvogen Malta Operations Ltd., and major generic drug manufacturers include Casi, Ascent, etc. The sales volume of lisinopril tablets in the US market in 2019 is about 131.39 million US dollars.
Valaciclovir is mainly used to treat herpes zoster, herpes simplex virus infection, and prevent (inhibit) the recurrence of herpes simplex virus infection. Valaciclovir tablets were developed by GlaxoSmithKline and listed in the United States in 1995. The main manufacturers of valaciclovir tablets in the United States are Sandoz, Mylan, Teva, etc. The sales volume of valaciclovir tablets in the US market in 2018 was about 186 million US dollars.
Paroxetine tablet is a selective central nerve serotonin reuptake inhibitor, which can increase the concentration of serotonin in the synaptic space and play an antidepressant role. Paroxetine tablets were developed by GlaxoSmithKline and approved for marketing in the United States in December 1992. The sales of paroxetine tablets in the US market in 2018, 2019 and 2020 were about 47 million US dollars, 42 million US dollars and 33 million US dollars respectively.
It is worth mentioning that the company also said that it has reached agency cooperation with several American agents, and some products have been sold in the American market. At the same time, the company is still actively seeking in-depth cooperation with foreign pharmaceutical enterprises around the world, and continues to introduce new ANDA products.
In addition to actively "going to sea", the company also used the priority review policy of "Europe and the United States common line" declaration to transfer the ANDA products approved by the US FDA to China, which can help the company rapidly expand its generic product line. Currently, letrozole tablets, anastrozole tablets and celecoxib capsules have been successfully approved in China, and will promote more European and American approved products to be transferred to China in the future.
As the company has successively obtained the sales qualification of varieties in the US market, and the promotion of "Europe and the United States common line", it may have a positive impact on the company's expansion in the US and Chinese markets. The 2023 annual report shows that the company has realized an operating revenue of 10.318 billion yuan, and R&D investment of 935 million yuan, accounting for more than 9% of the revenue.
Disclaimer: In any case, the information or opinions expressed in this document do not constitute investment advice to anyone.
