Seaweed has been a long-term favourite as an ingredient in Traditional Chinese Medicine (TCM). The marine algae is trusted to treat skin disorders, reduce swelling, provide relief from bronchitis and inhibit the growth of some types of cancerous tumours. What’s more it might even arrest the pace of degeneration from Alzheimer’s disease, according to Shanghai-based Green Valley Pharmaceutical.
Its newest drug, which harnesses seaweed, has just been approved to go on sale on December 29. Known as GV-971, it doesn’t claim to work like its predecessors, which target beta amyloid, a protein that creates clumps of plaque blamed for interfering with neural signalling in the brains of Alzheimer’s sufferers. Rather, its beneficial effects come from regulating microbes in a patient’s guts.
The theory is that an imbalance in intestinal microbiota produces immune cells that infiltrate the brain and aggravate the neuroinflammation associated with Alzheimer’s. Sodium oligomannate, a sugar derived from seaweed’s brown algae, then remodels the gut’s microbiology and reduces the accumulation of neuroinflammatory cells, according to a study published in September by Geng Meiyu, the chief inventor of the drug.
“Trial results demonstrated that oligomannate statistically improved cognitive function in mild-to-moderate Alzheimer’s patients as early as week four and the benefit was sustained at each follow-up assessment visit,” Green Valley said in a statement, noting that its phase III trial for the therapy enrolled 818 patients across 34 trial sites in China for a period of 36 weeks.
Research started 22 years ago, costing Rmb3 billion ($427.24 million) in total.
The new product came as a surprise to the medical community at large because only five drugs for treating Alzheimer’s have been developed since the disease was formally discovered in 1906. Worse, no new treatment has been launched in the last 17 years as pharmaceutical giants such as Eli Lilly, Johnson & Johnson, Merck and Pfizer all failed to yield results from their shared focus on fighting beta amyloid.
Backed by hundreds of billions of dollars, more than 320 drugs have failed clinical trials in the past two decades.
Green Valley’s GV-971 is expected to be available nationwide by the end of this year. The rollout of the drug elsewhere isn’t likely until after 2025, however, as the company will start another phase III study early next year – this time in the US, Europe and the rest of Asia in preparation for regulatory filings globally.
Meanwhile, 40 acres of land in Shanghai’s Pudong New Area has been carved out for its new manufacturing facility. Construction is set to be completed in three years, supporting production that could provide treatments for 2 million patients.
Alzheimer’s currently accounts for 60-70% of 50 million dementia cases worldwide, according to the World Health Organisation. Around 9.5 million Chinese were diagnosed with Alzheimer’s last year and that number is growing by about a million people annually (see WiC367 for more on the country’s growing Alzheimer’s crisis).
Although the new drug offers a ray of hope to millions of Chinese suffering from Alzheimer’s, some observers are still sceptical about its efficacy. Regulators are watching closely as well: the absence of long-term carcinogenicity tests explains why approvals for sale are conditional, says Time Finance, a Guangzhou-based news outlet, adding that Green Valley has yet to complete the full suite of pathology and toxicology testing.
Green Valley’s previous conduct has also come up for comment. Since 2001 it has been accused of false advertising at least 800 times over claims that its lingzhi mushroom product fights cancer, according to China Economic Times, a state-owned newspaper.
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