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On October 19, 2017, Hengrui Pharmaceuticals' application for drug registration submitted to the Food and Drug Administration of Jiangsu Province was accepted.
Plaxo hydrochloric acid is a dopamine receptor excitant that relieves movement disorders in patients with Parkinson's disease through dopamine receptors in the excitable symposia and is used to treat signs and symptoms of adult idiopathic Parkinson's disease.
, developed by German company Boehringer Ingelheim, was first released in the United States in 1997 under the name Mirapex and is used to treat Parkinson's disease.
February 2010, the FDA approved The Boehringer Ingelheim's development of a hydrochloric acid Praxo slow-release tablet called Mirapex ER, which has since been approved for listing in several countries, including the European Union.
August 2014, Bronger Ingham International Trade (Shanghai) Co., Ltd.'s hydrochloric acid Praxo slow-release tablets were approved for import by the State Food and Drug Administration in the specifications of 0.375 mg, 0.75 mg, 1.5 mg, 3 mg, 4.5 mg, for the treatment of Parkinson's disease.
In addition to Hengrui Pharmaceuticals, Zhejiang Jingxin similar products have been approved for listing, and 12 enterprises, including Chengdu Baiyu, Chengdu Kanghong, Beijing BeidaWeixin Bio, etc., have submitted ANDA applications, and have not yet seen the approval information.
2019 global sales of approximately $219 million, according to the Evaluate Pharma database.
, the product has invested a cumulative total of about 18.32 million yuan in research and development.
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