Conditional approval for China-developed Alzheimer’s therapy drug

2 min read
(Image credit: Pixabay / Arek Socha)

A new Alzheimer’s treatment developed by biotech firm Shanghai Green Valley Pharmaceuticals was granted conditional approval by Chinese regulators over the weekend, STAT reported.

Why it matters: The therapy could energize a stagnant Alzheimer’s drug landscape that has suffered repeated clinical failures from multiple large pharmaceutical companies. 

  • Any new drug that can effectively beat back the destructive effects of Alzheimer’s is usually assigned a peak sales estimate of $10 billion or more, according to Endpoints News.
  • While this could also be a win for China’s National Medical Products Administration, which fast-tracked the treatment’s conditional approval, scientists elsewhere are looking forward to seeing more complete data before drawing conclusions.

“It’s good to see that drug regulators in China are prioritizing emerging treatments for Alzheimer’s, but we do still need to see more evidence that this drug is safe and effective.”

⁠—Carol Routledge, director of research at Alzheimer’s Research UK

Details: Green Valley said that its drug, Oligomannate, improved cognitive function in patients with mild to moderate Alzheimer’s compared to a placebo in a Phase III trial conducted in China.  

  • Patients showed improvement as early as week four, with benefits continuing throughout the entire 36-week trial.  
  • Instead of trying to remove protein buildups in the brain like other experimental Alzheimer’s treatments, Oligomannate works by attempting to modulate the connection between the brain and the gut’s microbiome. 
  • The firm’s next trial will include US-based patients and should last twice as long as its first Phase III trial. 
  • Follow-up data will have to be submitted regarding the drug’s pharmacology and long-term safety and efficacy before it can be prescribed to patients.
  • Green Valley plans to begin production as soon as Nov. 7, and make it available nationwide by the end of the year. 

Context: It has been almost two decades since regulators approved an Alzheimer’s drug.

  • Research into the connection between the brain and the body’s microbiome is a relatively new endeavor, with scientists wondering how it might affect⁠—or even accelerate⁠—Alzheimer’s.
  • Green Valley, which was founded in 1997 and is headquartered in Shanghai’s Zhangjiang Science City, partnered with clinical research companies Iqvia and Signant Health for the Phase III trial. 
  • In another recent high-profile case, Massachusetts-based Biogen scrapped two Phase III studies on its Alzheimer’s treatment aducanumab, which relied on the amyloid hypothesis: the assumption that accumulation of the peptide anyloid beta in the brain is the main cause of Alzheimer’s.
  • China’s population is aging rapidly and the decline will be “unstoppable” after peaking in 2029, according to a government study, with a significantly higher percent of the population over the age of 65.