(Bloomberg) — A newly approved Chinese drug for Alzheimer’s will start clinical trials in the U.S. and Europe next year as the country’s first novel therapy for the incurable disease seeks global legitimacy.
Shanghai Green Valley Pharmaceutical Co. plans to recruit around 2,046 patients with mild-to-moderate Alzheimer’s for trials at 200 sites across North America, Europe and Asia Pacific for 18 months, the company’s Vice President Li Jinhe said on Sunday.
The drug, called Oligomannate, was granted conditional approval in China last month. It comes in a 150mg capsule and went on sale in the country on Dec. 29. Patients will need take three capsules twice a day, according to the drug’s package insert. A week’s treatment costs 895 yuan ($128).
Green Valley announced these plans in a press conference in Beijing on Sunday, nearly two months after making global headlines for saying it got approval from China’s regulator for the first new Alzheimer’s drug in 17 years. The neuro-degenerative disease has baffled global drug makers, who have invested billions of dollars into more than 190 experimental drugs with little to show for it.
The Shanghai-based firm, unknown outside of China, is facing skepticism that it could have so quickly achieved something that’s eluded western pharmaceutical giants for decades.