Kun Pharmaceutical Group's hydrochloric acid Fassudier injection received a drug registration certificate approved by NMPA

Today, Kun Pharmaceutical Group announced that it has recently received the State Drug Administration issued on the hydrochloric acid Fashudir injection "drug registration certificate" (certificate number: 2020S00855).
the following specifics: 1. General name of the drug: saline Fashudir injection English name: Fasudil Hydrochloride Injection Main ingredient: saline Fashudir dosage form: injection specification: 2ml:30mg Application: Drug registration (drug registration) Domestic production) Registration classification: original chemical Class 6 drug validity period: 36 months drug approval number: national drug code H20203680 adaptive: improve and prevent cerebrovascular spasms and caused by cerebral ischemic symptoms after subcavity hemorrhage of the cobwebs.
According to the announcement, the hydrochloric acid Fashudir and its injections were jointly developed by Asahi Cheng of Japan and Nagoya University, and were listed in Japan in 1995 and In China in 2001, respectively, mainly for the improvement of symptoms of ischemia cerebrovascular disease caused by cerebrovascular spasms and so on after the cervical hemorrhage of the cobwebs.
2004 Asahi into Japan to expand the hydrochloric acid Fashudir treatment of cerebral thrombosis, for the acute period of cerebral thrombosis (within 48 hours of onset).
the European Medicines Agency in July 2020 approved fashudir hydrochloric acid as an orphan drug for the treatment of "non-traumatic cobweb hemorrhage".
According to the Guidelines for the Diagnosis and Treatment of Subcultural Hemorrhage in The Chinese Cobwebs 2019, subcultural hemorrhage (SAH) refers to a stroke in which blood flows into the subclinic cavity of the cobwebs after a ruptured blood vessel at the bottom of the brain or on the surface of the brain, accounting for 5% to 10% of all strokes.
hydrochloric acid Fashudir injections are classified as Class B varieties in the national medical insurance catalogue, and according to the pharmaceutical network hospital sales database, the annual sales of hydrochloric acid Fashudir injections in 2017-2019 were about RMB300 million to RMB400 million.
, china has products including the original Research Japan Asahi Chemical Co., Ltd., Tianjin Red Day Pharmaceutical Co., Ltd., Shanxi Pude Pharmaceutical Co., Ltd. and other enterprises approved for listing and sale.
The raw material of this medicine is produced by Kun Pharmaceutical Group, and in January 2020 was approved for production by CDE registration, as of the date of the announcement, Kun Pharmaceutical Group has invested about RMB12.503 million in research and development costs for the production registration of hydrochloric acid Fashudir API and injection fluids.
source: Kun Pharmaceutical Group Corporate Announcement