A newly approved Chinese drug for Alzheimer’s will start clinical trials in the United States and Europe next year as the country’s first novel therapy for the incurable disease seeks global legitimacy.

Shanghai Green Valley Pharmaceutical 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 yesterday.

The drug, called Oligomannate, was granted conditional approval in China last month. It went on sale in the country yesterday.

Green Valley announced these plans in a press conference in Beijing yesterday, 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.

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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 scepticism that it could have so quickly achieved something that’s eluded western pharmaceutical giants for decades.

“It’s totally understandable for our drug to be questioned,” said Green Valley chairman Lyu Songtao. “We are confident because we see clear benefits from patients in the clinical trials.”

The conditional approval requires the drugmaker to conduct further studies on how the drug works and its long-term safety and efficacy.

The company also said it plans to invest $3bn (€2.7bn) in the next 10 years for such investigations.

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