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January 18, Jianyou shares announcement, subsidiary Jianjin pharmaceutical products recently received the State Drug Administration on the approval of the issuance of injectable benzodiamestin hydrochloride (specification: 25mg, 100mg) drug registration certificate notice (drug approval number: national drug code H20213019, national drug code H20213020).
injection of benzodiaxine hydrochloride, an alkane agent primarily used for chronic lymphocytic leukemia (CLL) and B-cell non-Hodgkin's lymphoma (NHL), was first marketed in the United States in 2008 (trade name: TREANDA® ), the applicant is CEPHALON, the specification is 25mg/bottle, 100mg/bottle, of which 100mg specification of the original drug was approved in China in 2018, 25mg specification is only Zhengda Tianqing Pharmaceutical Group Co., Ltd. a generic drug listed.
25 mg and 100 mg of benzodiaxate for injections were provisionally approved by the U.S. FDA in April 2020 (see company's announcement on the Shanghai Stock Exchange, no. 2 020-014), the domestic drug market application was accepted by the State Drug Administration in 2019, July 9, 2020 by the State Drug Administration Drug Review Center into the list of priority review varieties.
, the product project has invested about RMB11.7515 million in research and development.
