China's Innocare Plunges 20% After US FDA Suspends Trial of Lifeline MS Drug
Dou Shicong
DATE:  Dec 26 2022
/ SOURCE:  Yicai
China's Innocare Plunges 20% After US FDA Suspends Trial of Lifeline MS Drug China's Innocare Plunges 20% After US FDA Suspends Trial of Lifeline MS Drug

(Yicai Global) Dec. 26 -- Innocare Pharma's shares dived by the daily limit after studies of expanded use of the Chinese firm's first and only product were halted in the United States due to liver damage reported in clinical trial participants with multiple sclerosis.

Innocare's stock price [SHA: 688428] fell 20 percent to close at CNY12.49 (USD1.80), but the shares are still up nearly 13 percent since the firm listed its equity on Shanghai's Star Market in September.

People signing up for phase II trial of Orelabrutinib have suffered liver damage so the US Food and Drug Administration has suspended the study, the Beijing-based drug developer said in a statement on Dec. 23, adding that it has paused recruiting people outside the States to participate in the trials.

Innocare will closely cooperate with the FDA to solve the issue, including the implementation of more sound safety measures, it said. The company will continue assessing the potential of the Bruton tyrosine kinase inhibitor in treating people with MS, a chronic disease that affects the central nervous system.

Orelabrutinib is the only commercial product of Innocare which was founded in 2015. In December 2020, the BTK inhibitor was approved by China's medicine regulator to be tested to treat patients with Non-Hodgkin's lymphoma, a type of cancer that starts in white blood cells, according to the firm's website.

From January to September, Innocare posted a net loss of CNY834 million (USD119.7 million) with CNY442 million in revenue. Meanwhile, sales of Orelabrutinib more than doubled to CNY400 million from a year ago.

Editor: Emmi Laine, Xiao Yi

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Keywords:   Innocare Pharma,Orelabrutinib,FDA