The National Medical Products Administration gave conditional approval on November 2 to the market launch of GV-971, a new drug treating Alzheimer's disease developed by several Chinese teams including Green Valley Pharmaceutical Co Ltd.

The medicine has been found to be capable of treating mild-to-moderate Alzheimer's disease and can improve cognition, according to the National Medical Products Administration.

The administration required continued research on the drug’s pharmacological mechanism and long-term safety and effectiveness and improvement in the analysis method of oligosaccharide as well as timely submission of test data.

The market launch was approved after passing the prioritized review and approval procedure in the Chinese mainland, and filled a global blank in this area that has existed for the past 17 years.

The innovative medicine was developed by a group of scientists led by Geng Meiyu, lead researcher from the Shanghai Institute of Materia Medica working with the Ocean University of China and Green Valley Pharmaceutical Co Ltd, after 22 years of research efforts.

As the world’s first drug targeting the brain-gut axis for Alzheimer's disease patients, the Chinese-developed medicine will provide new treatment options.

According to Geng, GV-971 can improve cognitive dysfunction by remodeling the balance of intestinal flora, inhibiting the abnormal increase of specific metabolites of intestinal flora, reducing peripheral and central inflammation, and reducing β-amyloid protein deposition and Tau protein hyperphosphorylation.

This unique mechanism targeting the brain-gut axis provides an important scientific basis for better understanding of the drug’s efficacy.

A total of 1,199 patients received the phase I, II, and III clinical trials of the drug, which was managed by IQVIA, the world’s largest provider of new drug developments and research outsourcing services.

Phase III was organized by the Shanghai Mental Health Center Affiliated to the Medical School of Shanghai Jiaotong University as well as Peking Union Medical College Hospital and 34 3A-grade hospital nationwide, and involved 818 patients.

The 36-week-long clinical trial was proven to effectively improve cognition among mild-to-moderate Alzheimer's disease sufferers.

Compared with the group given a placebo, subjects’ main efficacy index and cognitive function improved significantly, and their score on the Alzheimer’s Disease Assessment Scale-Cognitive section, or ADAS COG, improved by 2.54 points (P < 0.0001).

The drug shows instant effect, continuous and stable improvement, and good safety. The incidence of adverse events was similar to that of the group given a placebo.

Green Valley Pharmaceutical Co Ltd is ready for the production and sales of the drug. It is expected to be released in China by the end of this year.

The total number of patients suffering from Alzheimer's disease worldwide might be as high as 50 million, of whom 10 million are Chinese. China has the highest incidence rate in the world.

By 2050 the global population with the disease might exceed 150 million, with 40 million sufferers in China.

Data show that in 2018, the cost of treatment and care reached trillions of dollars, which put a heavy burden on their families and society.

Alzheimer's disease patients usually have cognitive problems, behavioral and mental disorders. It is the third major cause of disability and death in the elderly after cardiovascular and cerebrovascular diseases and malignant tumors.

Since the discovery of Alzheimer's disease more than 100 years ago, there have been only five drugs for clinical treatment in the world, and their clinical benefits are not obvious.

In the past 20 years, the world's major pharmaceutical companies have invested hundreds of billions of dollars in Alzheimer's disease treatment research, and more than 320 of the drugs that entered clinical research failed.

The research and development of GV-971 received funding from the National 863 Program, the National Natural Science Foundation of China, the National 973 Program, the Major Project of National Science and Technology on New Drug Creation and Development, the strategic leading science and technology special project of CAS (Category A), and the science and technology support plan of Shanghai.

Source: Shanghai Institute of Materia Medica (SIMM), Chinese Academy of Sciences