Huahai's Shares Soar as Drugmaker Gets Permit to Resume Valsartan Sales in Europe
Liao Shumin
DATE:  Dec 19 2019
/ SOURCE:  yicai
Huahai's Shares Soar as Drugmaker Gets Permit to Resume Valsartan Sales in Europe Huahai's Shares Soar as Drugmaker Gets Permit to Resume Valsartan Sales in Europe

(Yicai Global) Dec. 18 -- Huahai Pharmaceutical's shares surged almost 6.2 percent after European regulators reinstated a key permit for the Chinese drugmaker's Valsartan, clearing the way for sales of the high blood-pressure treatment to restart in Europe.

The company's shares [SHA:600521] ended today at CNY19.14 (USD2.74) each, after earlier surging 9.4 percent. The benchmark Shanghai Composite index was off almost 0.2 percent. Huahai Pharmaceutical's stock price has climbed 73 percent so far this year.

Valsartan's certification of suitability, or CEP, was re-approved by the European Directorate for the Quality of Medicines & HealthCare on Dec. 16 and the drug will soon be qualified for export to the European Union again, Huahai Pharma said in a statement today, citing the EDQM's website.

The CEP was revoked in January after the European Medicines Agency said in July last year that it had found a carcinogen called N-nitrosodimethylamine in the drug and proceeded to recall it across the EU. In 2017 and 2018, Huahai exported CNY230 million (USD32.9 million) and CNY118 million worth of Valsartan to Europe, making up 4.6 percent and 2.4 percent of the firm's sales. That figure fell to zero in the first nine months of this year.

Huahai Pharmaceutical has improved and adjusted the production of the active ingredients in Valsartan in accordance with the EDQM's requirements, the Linhai, Zhejiang province-based company said. It has also implemented corresponding controlling measures.

In January, the EDQM also detected the carcinogenic impurity N-nitrosodimethylamine in Huahai's hypotensive drugs Irbesarta and Losartan Potassium. The CEPs for these drugs were also subsequently suspended but were reinstated on Oct. 15, according to a company statement on Oct. 16.

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Keywords:   Huahai Pharmaceutical,Valsartan