China gives conditional OK to its first self-developed Alzheimer’s drug

BEIJING: China has granted conditional approval to its first self-developed treatment for Alzheimer's disease, a move that may point to revived opportunities in a therapeutic area where drugmakers have burned billions of dollars without yielding a validated new drug.

Oligomannate, which uses extract from marine brown algae as raw material, received a conditional green light to treat mild-to-moderate level AD, the National Medical Products Administration (NMPA) said in a statement on its website late on Saturday.

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An effective treatment for Alzheimer's, which is estimated in 60per cent-70per cent of around 50 million dementia cases worldwide, could become one of the best-selling drugs globally.

"Trial results demonstrated that Oligomannate statistically improved cognitive function in mild-to-moderate AD patients as early as week 4 and the benefit was sustained at each follow-up assessment visit," Shanghai Green Valley Pharmaceuticals, which developed the drug along with two academic institutions in China, said in a statement.

The outlook for a cure is clouded with theoretical uncertainties and high-profile failures. Pharmaceutical giants including Johnson & Johnson, Merck and Pfizer have ditched their projects on unsatisfactory data.

Biogen last month revived its plans to seek U.S. approval for its aducanumab treatment after announcing in March that it would terminate two large clinical trials for the drug. But some analysts believed FDA approval is highly unlikely.

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China is fast-tracking approval for innovative drugs at home in a bid to offer more and cheaper options to patients, as many in the rapidly aging country struggle to find alternatives to costly treatments sold by multinational pharmaceutical firms for chronic diseases.

In an August overhaul to its drug administration law, Beijing saidRead More – Source