(Alliance News) - AstraZeneca PLC said Thursday, together with Merck & Co, it has received marketing authorization from China's National Medical Products Administration for their Lynparza drug.
The drugmaker said the approval in China is based on the results from the Phase III SOLO-1 trial, which showed that Lynparza significantly reduced the risk of disease progression or death by 70% in women with BRCA-mutated advanced ovarian cancer following response to platinum-based chemotherapy.
The company said Lynparza, which is being jointly developed and commercialised by AstraZeneca and Merck, is currently approved in 65 countries, including the EU, US and Japan. China has the highest prevalence of ovarian cancer globally, with more than 52,000 new cases diagnosed in 2018, the company noted.
Roy Baynes, senior vice president and head of Global Clinical Development, chief medical officer, MSD Research Laboratories, said: "Today's approval of Lynparza reinforces the importance of patients knowing their BRCA mutation status at diagnosis.
"We are proud to provide a new option for the treatment of this devastating disease in China, and we will continue to collaborate with the Chinese government and healthcare organizations to provide Lynparza to patients who need it as quickly as possible.
In November, AstraZeneca said it would create a new global research & development centre and an artificial intelligence innovation centre, both in Shanghai, and a "first-of-its-kind" healthcare industrial fund with China International Capital Corp Ltd.
The company said the fund would support domestic companies and partners, and international companies looking to establish a presence in China.
AstraZenca shares were up 0.2% in London at 7,322.00 pence each on Thursday. Merck closed 1.5% higher in New York on Wednesday at USD88.67. The shares were flat in after hours trading.
By Loreta Juodagalvyte; loretajuodagalvyte@alliancenews.com
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Astrazeneca (AZN)