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Recently, according to NMPA's official website, Hengrui declared the three classes of generic drug Glon ammonium bromide injection application (acceptance number: CYHS1800093) has been in the "approval" state, is expected to be approved for listing in the near future.
drug is used intramyal or intravenously for gastrointestinal diseases or anesthesia.
(Source: NMPA) Hengrui will take the first imitation of ammonium Glon bromide as an anticholinel drug, which has a similar surrounding effect to Atomin.
can selectively act on the gastrointestinal tract, has a strong inhibitory gastric fluid secretion effect, can be directly used intramyal or intravenous injections, for gastrointestinal diseases or anesthesia.
product was developed by West-Ward Pharmaceuticals and was approved for sale in the United States in 1982.
currently in the U.S., major manufacturers of ammonium Glon bromide injections include Hikma, American Regent and others, with U.S. sales of about $180 million in 2017.
currently, only the Glon ammonium bromide tablets listed in China, there has not been a Glon ammonium bromide injection approved for the market.
, a total of four pharmaceutical companies have submitted applications for listing, namely Hengrui, Yuandong Bio, Jiabo Pharmaceuticals and Coastal Pharmaceuticals.
, Hengrui submitted a listing application for the Glon ammonium bromide injection in June 2018, the first pharmaceutical company to do so.
(Source: CDE) In September 2018, Hengrui's Glon bromide injection was included in the priority review on the grounds of "innovative drugs with clear therapeutic advantages" and was the only one to be included in the priority review.
(Source: CDE) (Source: CDE) It is worth noting that as early as November 2018, Huahai Pharmaceuticals' APPLICATION for ANDA for the Glon ammonium bromide injection was approved by the FDA, but Huahai has not yet submitted a domestic listing application.
(Source: Tidal.com)