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Recently, NMPA official website data show that the Central and Eastern China's Sigletin metformin tablets (I.) category 4 imitation listing applications into the "approval" state, is expected to usher in good news in the near future.
Sigletin metformin, the original product of Mercadone, will have global sales of more than US$2 billion in 2019, and Dongshuangli Pharmaceuticals won the "First Imitation plus First Review" in August this year.
Figure 1: The registration progress of Sigletin metformin tablets (I.) in eastern China and the United States Source: NMPA's official website, Sigletin metformin, is a complementary anti-sugar drug compound preparation for diet and exercise therapy, used in patients with type 2 diabetes who are still poorly controlled by metformin monodrugs or are receiving a combined treatment of both.
the drug was originally developed by Mercadon, which will have global sales of more than $2 billion in 2019.
Figure 2: Sales of Sigletin Metformin in China's public medical institutions Terminal Source: Minet China's public medical institutions terminal competition pattern Meshadong's Sigretin metformin was approved to enter the Chinese market in 2012, 201 Sales have increased rapidly since entering the national health insurance catalogue in 9 years, with terminals in China's urban public hospitals, county-level public hospitals, urban community centers and township hospitals (China's public medical institutions) exceeding 100 million yuan, with an increase of more than 50% in the first half of 2020.
Table 1: Current market for Siglitatin metformin product source: Mi net one-click search in August this year, The East Sunshine Drug's Siglitin metformin tablets took the first domestic imitation, one of the specifications and Mercedon's Siglitin metformin tablets (II.), and a new specification was approved for listing.
if East China is successfully approved this time, it will become the second and second in China.
Table 2:2020 To date, East China Pharmaceuticals has been approved for production of products Source: MED2.0 China Drug Review Database MiNet data show that since 2020, East China Pharmaceuticals has two new products Approved, involving anti-tumor and immunomodulants, reproductive urinary systems and sex hormone drugs, if this Segritin metformin tablets (I.) successfully approved, it will become the company's first approved oral anti-sugar drugs this year.
addition, the company's other compound sugar-lowering drug metformin Engli (I.) of the four types of imitation listing applications are being reviewed and approved, is also expected to bring new promotion to the company.
source: NMPA official website, MiNet database