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On October 14, CDE official website data show that Yangzijiang Pharmaceutical Group declared the fluorobilofen injection class 3 imitation listing application was accepted.
the product is currently only Beijing Ted Pharmaceuticals (China Biopharmaceutical Subsidiary) and Wuhan Da'an Pharmaceuticals received approval, is the first batch of national collection catalog varieties.
figure 1: Yangzijiang Pharmaceutical Group's fluorobilofen injection registration source: CDE official website Mienet data show that in China's urban public hospitals, county-level public hospitals, urban community centers and township hospitals (referred to as China's public medical institutions terminal chemical anti-inflammatory drugs and anti-rheumatoid drug market, fluorobiolofen is top3 varieties, 2017 and 2018 sales of more than 2 billion yuan.
In December 2018, the first batch of national collection opened the bid, fluorobilofen injections for the catalogue varieties, the 4-7 pilot phase by Beijing Ted Pharmaceuticals (China Biopharmaceutical Subsidiary) exclusive bid, in the subsequent expansion of the alliance stage, Wuhan Da'an Pharmaceuticals also joined the war.
, due to the large price reduction of the product, affecting the overall sales situation, the product in 2019 in China's public medical institutions terminal sales declined significantly.
until 2017, fluobilofen ester injection is the exclusive product of Beijing Ted Pharmaceuticals, Wuhan Da'an Pharmaceutical's 3 types of imitations were approved to enter the market in 2018 and began to split the food market, with the help of the national collection of thrust, in 2019 Wuhan Da'an Pharmaceutical market share rose to 6.57 percent.
figure 2: Currently under review for the fluorobilofen injection imitation listing application source: Minet MED2.0 China drug review database fluorobiolofen injection by virtue of market advantages, attracted a number of domestic pharmaceutical companies into the market, in addition to the newly accepted Yangzijiang, Guangdong Jiabo Pharmaceuticals, Sichuan Colum Pharmaceuticals and other 5 companies declared three types of generic listing applications are also in the review and approval.
source: MiNet database, CDE official website.