East China Medicine (000963.SZ): Ornidazole tablets passed the consistency evaluation of generic drug quality and efficacy

On September 29, Gelonghui announced that Huadong Pharmaceutical (000963.SZ) announced that recently, Huadong Pharmaceutical (Xi'an) Bohua Pharmaceutical Co., Ltd. ("Xi'an Bohua"), a wholly-owned subsidiary of the Company, received the "Notice of Approval of Drug Supplementary Application" (Notice No. 2021B03181) approved and issued by the State Drug Administration, and the ornidazole tablets produced by Xi'an Bohua passed the consistency evaluation of generic drug quality and efficacy.

Ornidazole is the third generation of new nitroimidazole derivatives after metronidazole and tinidazole, which is used to treat a variety of diseases caused by anaerobic infections, diseases caused by trichomonas and Giardiasis infections in men and women, diseases caused by intestinal and hepatic amoebasis, intestinal and hepatic amoeba infections, and for the prevention and treatment of anaerobic infections after surgery in various disciplines. The original and intermediate metabolites of ornidazole are active and act on the DNA of anaerobic bacteria, amoebic worm, giardia and trichomoniasis cells, causing their spiral structures to break or block their transcriptional replication and cause death.

Ornidazole was first developed by the American Hoffer .M, and the Swiss Roche company was first listed in Europe in 1977 under the trade name "Tiberal®". After inquiry, the original ornidazole tablets have not been approved for marketing in China.

Ornidazole oral regular-release dosage forms have been included in the 2019 edition and 2020 edition of the National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog, and the medical insurance categories are all Class B.

Xi'an Bohua is the earliest pharmaceutical manufacturer in China to obtain the approval for the production of ornidazole APIs and tablets. Up to now, a total of 7 domestic enterprises have held ornidazole tablets production approvals, of which 4 have passed the consistency evaluation of generic drugs (including Xi'an Bohua). According to the intranet database, the sales of oral tablets ornidazole in 2020 will be about 196 million yuan, of which the sales revenue of ornidazole tablets of Xi'an Bohua is about 13.25 million yuan, and the market share is about 6.76%.

This article originated from Grand Gateway