China Approves First New Alzheimer’s Drug in 17 Years
Shanghai Green Valley Wins China Approval for Alzheimer's Drug
(Bloomberg) -- China approved a drug to treat Alzheimer’s made by a Shanghai-based pharmaceutical company, the first new therapy endorsed for the disease in 17 years and a major breakthrough in the country’s push to become a leader in scientific research.
The National Medical Products Administration said in a statement on Saturday that it granted conditional approval to Oligomannate. In trials, the drug statistically improved cognitive function in patients suffering from mild to moderate Alzheimer’s as early as week four, Shanghai Green Valley Pharmaceuticals said in a statement.
The drug is slated to be available in China by the end of 2019, Green Valley said, and joins only a handful of Alzheimer’s-related therapies worldwide. There are currently no globally approved treatments to slow or stop the neuro-degenerative disease, which is the most common cause of dementia in the U.S. and robs people of their ability to remember and to perform basic tasks.
Green Valley said it plans to apply for marketing authorization in “selected countries following the China launch.” It will start global clinical trials early next year, with sites in the U.S., Europe and Asia.
The Shanghai-based drug maker is not publicly listed, but other Chinese pharmaceutical companies working on Alzheimer’s treatments soared in Monday trading after the news. Zhejiang Jingxin Pharmaceutical Co. and Jiangsu Lanfeng Bio-chemical Co. climbed the 10% limit in Shenzhen after both slid last week.
Chasing a Cure
Pharmaceutical companies around the world have spent billions of dollars over decades chasing a cure for Alzheimer’s, with little to show for their efforts. Last month, in another potential breakthrough, Cambridge, Massachusetts-based Biogen Inc. said it would ask U.S. regulators to approve an experimental therapy after new analysis of data from two failed trials showed promising results.
Green Valley’s drug is unusual in that it does not target beta amyloid, a protein that forms clumps of plaque in the brain and is thought to be a cause of the disease. After years of failure, a backlash has grown over the pharmaceutical industry’s fixation on the compound as the key to a cure.
The Shanghai drug is a low molecular acid oligosaccharide compound extracted from marine brown algae, according to the Chinese regulator’s statement. The regulator said it needs further studies on the drug’s pharmacology, safety and effectiveness after it’s launched.
Green Valley’s drug has the potential to be a major boost to China’s efforts to become a global leader in medical research.
The country is also trying to establish a healthcare system that offers top-of-the-line medicines at low cost. In the past few years, China has invested billions into public hospitals and revamped its approval system to affirm new drugs quickly, sometimes ahead of the U.S. and Europe.
To contact the reporters on this story: Dong Lyu in Beijing at dlyu3@bloomberg.net;Rachel Chang in Hong Kong at wchang98@bloomberg.net
To contact the editors responsible for this story: Sebastian Tong at stong41@bloomberg.net, ;Rachel Chang at wchang98@bloomberg.net, Jim Silver, Angus Whitley
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