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Sihuan receives Chinese drug registration approval for liver disease injection

Sihuan Pharmaceutical Holdings Group Ltd. has received drug registration approval from the National Medicinal Products Administration of China for its compound amino acid injection, the Beijing-based company said March 18.

The 500-milliliter injection is intended to prevent and treat hepatic encephalopathy, a liver condition that results in loss of brain function due to a buildup of toxins in the blood. It can also provide intravenous nutrition for acute liver disease patients.

According to Sihuan Pharmaceutical, the injection improves consciousness, liver function and blood ammonia in patients.

The current trend in clinical liver disease treatment is to replace the existing ordinary balanced amino acid injection with a compound amino acid injection containing 20 types of amino acid, Sihuan said. In China, compound amino acid injection sales were approximately 449 million yuan in 2017.

Sihuan's drug is the only fourth-generation, high-branched chain amino acid injection of this kind, the company said.