Chinese drug maker Shanghai Green Valley launching US trial of Alzheimer’s treatment as it seeks global legitimacy

Name: Grandma with Alzheimer's rescued unharmed after climbing out of high-rise building
Uploaded: 2020-11-05T04:16:38.000Z
Duration: 1 min 5 s
Description: Grandma with Alzheimer's rescued unharmed after climbing out of high-rise building

The US$600 million global phase three trial aims to sign up 2,046 people across China, US and Europe, with the first 600 expected to join in next six months

The US FDA in April gave the nod to conduct large-scale trials on Green Valley’s treatment known as GV-971

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Shanghai Green Valley’s GV-971 therapy received Chinese regulatory approval last November, becoming the first approval worldwide in 17 years for a new drug to treat Alzheimer’s. Photo: Handout via Xinhua News

Bloomberg

Published: 12:16pm, 5 Nov 2020Updated: 12:16pm, 5 Nov 2020

A new Chinese therapy for Alzheimer’s is embarking on a much-anticipated US study – the latest bid to revive hopes in the multibillion-dollar search for an effective medicine against the incurable disease.

Shanghai Green Valley Pharmaceutical said this week that researchers have identified the first patient from a screening process for the US arm of the 4 billion yuan (US$600 million) global phase three trial. The US Food and Drug Administration in April gave the green light to study whether the drug can produce lasting cognitive improvement among patients in the mild and moderate stage of the debilitating neurodegenerative disorder.

The trial’s launch underscores the little-known Chinese drug maker’s ambition to seek global legitimacy for its therapy, which takes a radically new approach using brown algae to treat the disease. The medicine received China’s regulatory blessing last November, becoming the first approval worldwide in 17 years for a new drug treating Alzheimer’s, a disease that plagues 5.8 million in the US and nearly twice as many in China.

The trial seeks to sign up 2,046 people across China, the US and Europe, with the first 600 expected to enroll in the next six months. Dosing of patients will begin in four weeks, according to study researchers in the US.

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Grandma with Alzheimer's rescued unharmed after climbing out of high-rise building

With no medications currently able to change the course of the disorder, a successful drug could open a market worth as much as US$30 billion in the US alone, according to analysts at Sanford C. Bernstein. Pharmaceutical giants from AstraZeneca to Eli Lilly have spent billions of dollars over the years on more than 190 experimental drugs, only to see them fail one after another.

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