SHANGHAI :
Hengrui Medicine Gets FDA Go-Ahead to Make, Market New Drug in US
Xu Wei
DATE:  Sep 05 2017
/ SOURCE:  Yicai
Hengrui Medicine Gets FDA Go-Ahead to Make, Market New Drug in US Hengrui Medicine Gets FDA Go-Ahead to Make, Market New Drug in US

(Yicai Global) Sept. 5 -- Jiangsu Hengrui Medicine Co. [SHA:600276] recently received an approval notice from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for a Cisatracurium Besylate Injection, Hengrui Medicine said yesterday.

The FDA approval means the applicant can produce and sell the product in the US market.

The Cisatracurium Besylate Injection is an auxiliary drug for general anesthesia or sedative in ICU that can relax skeletal muscles, and thus ease trachea cannulas and mechanical ventilation. It can be used in surgery and other procedures, as well as intensive care.

The similar product already in the US market, NIMBEX, was developed by AbbVie Inc. [NYSE: ABBV]. Hengrui Medicine is the third generic drug company to gain approval of this kind. The sales volume of this product in the US market reached USD51 million last year, the IMS database shows. It was USD172 million in China, per the announcement.

Hengrui Medicine has thus far input CNY12 million (USD1.82 million) into researching and developing the injection.

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Keywords:   MSCI,FDA,ANDA