Milestone! NMPA Conditionally Approves Green Valley Pharma's Alzheimer’s Drug GV-971 (Sodium Oligomannate)
On November 2, 2019, the National Medical Products Administration granted conditional approval to GV-971, a new drug for the treatment of Alzheimer’s disease developed by Shanghai Green Valley Pharmaceutical Co., Ltd.®(Sodium Oligomannate, code name: GV-971) marketing application for mild to moderate Alzheimer's disease to improve patients' cognitive function.
This drug is a low-molecular-weight acidic oligosaccharide compound derived from marine brown algae extract. It is an innovative drug independently developed in China with independent intellectual property rights, and has received support from the National Major Science and Technology Special Project for Significant New Drug Development for nine consecutive phases.®Approved for market launch in mainland China through the priority review and approval process, this drug represents the world’s first commercialization, filling a 17-year gap without new drug approvals in this field. As China’s original innovation and the world’s first Alzheimer’s disease treatment targeting the gut-brain axis, it will provide a new therapeutic option for the vast population of patients with Alzheimer’s disease.
Alzheimer's disease is primarily characterized by symptoms such as cognitive and behavioral impairments and psychiatric abnormalities, ranking as the third leading cause of disability and mortality among the elderly, following cardiovascular and cerebrovascular diseases and malignant tumors.
There are currently at least 50 million Alzheimer’s disease patients worldwide, and this number is projected to reach approximately 150 million by 2050. In 2018, global costs for treatment and care already amounted to one trillion US dollars, imposing a heavy burden on patients’ families and society.
China has approximately 10 million patients with Alzheimer’s disease, the highest number worldwide. With the accelerating aging of the population, the number of patients in China is projected to reach 40 million by 2050.
Over the more than 100 years since Alzheimer’s disease was discovered, only five drugs have been approved for clinical treatment worldwide, with limited clinical benefit. Over the past two decades, major pharmaceutical companies around the world have invested hundreds of billions of dollars in developing new therapies for Alzheimer’s disease, and more than 320 drug candidates that entered clinical trials have failed.
GV-971®This original new drug was successfully developed through the sustained efforts over 22 years by a research team led by Professor Geng Meiyu of the Shanghai Institute of Materia Medica, Chinese Academy of Sciences, in collaboration with Ocean University of China, the Shanghai Institute of Materia Medica (Chinese Academy of Sciences), and Shanghai Green Valley Pharmaceutical Co., Ltd.
A total of 1,199 subjects participated in Jiuyi.®Phase I, II, and III clinical trials. The Phase III clinical trial was conducted by 34 tertiary Grade A hospitals across China, led by the Shanghai Mental Health Center affiliated with Shanghai Jiao Tong University School of Medicine and Peking Union Medical College Hospital. Medication observation was completed for a total of 818 subjects. The entire clinical trial was managed by IQVIA (formerly Quintiles), the world’s largest new drug research and development outsourcing service provider.
Results from the 36-week Phase III clinical study indicate that Jiuqi Yi®Significantly improves cognitive impairment in patients with mild to moderate Alzheimer's disease. Compared with the placebo group, the primary efficacy endpoint of cognitive function showed significant improvement, with a 2.54-point improvement in the Alzheimer's Disease Assessment Scale–Cognitive Subscale (ADAS-Cog) score (p < 0.0001). Jiuqi Yi®It demonstrates rapid onset and sustained, robust improvement in patients' cognitive function, with a favorable safety profile and an incidence of adverse events comparable to that of the placebo group.
The National Medical Products Administration requires the applicant to continue post-marketing studies on pharmacological mechanisms and long-term safety and efficacy, improve analytical methods for oligosaccharides, and submit relevant trial data on schedule.
According to Professor Geng Meiyu, a principal investigator at the Shanghai Institute of Materia Medica, Chinese Academy of Sciences, and the lead inventor of this drug, preclinical mechanistic studies indicate that GV-971® improves cognitive impairment by restoring gut microbiota homeostasis, inhibiting the abnormal accumulation of specific gut microbial metabolites, reducing peripheral and central inflammation, and decreasing β-amyloid deposition and tau hyperphosphorylation. This unique mechanism of action, which targets the gut-brain axis, provides a deeper understanding of GV-971®Provides an important scientific basis for clinical efficacy.
GV-971®Professor Xiao Shifu, the lead principal investigator of the Phase III clinical trial and a professor at the Shanghai Mental Health Center affiliated with Shanghai Jiao Tong University School of Medicine, stated, “Current pharmacological treatments for Alzheimer’s disease are symptomatic, with limited therapeutic options available, and they cannot delay or halt disease progression. Based on GV-971”®“With its novel mechanism of action and unique clinical efficacy profile, we believe this drug can offer a new therapeutic option for Alzheimer’s disease.”
GV-971®Professor Zhang Zhenxin, a neurology expert at Peking Union Medical College Hospital and the lead principal investigator of the Phase III clinical trial, stated, “I have been engaged in dementia research for 50 years and have participated in multiple international multicenter drug studies, yet I have never found a satisfactory therapeutic agent for Alzheimer’s disease. GV-971®“The 36-week clinical trial results are encouraging, finally offering hope and a ray of light. We are sincerely delighted for patients and their families worldwide.”
Lu Songtao, Chairman of Green Valley Pharmaceutical Co., Ltd., stated, “‘Developing only the medicines most eagerly awaited by humanity’ is Green Valley Pharmaceutical’s enduring mission. We greatly look forward to GV-971”®It can deliver the long-awaited clinical benefits for the treatment of Alzheimer’s disease. The successful development of GV-971® would not have been possible without strong support from the state and research institutions at all levels, particularly thanks to the perseverance and unwavering dedication of the R&D team, represented by Researcher Geng Meiyu, over the past 22 years.
It is reported that Shanghai Green Valley Pharmaceutical Co., Ltd. has completed all preparations for production and sales, with the drug scheduled to be launched on the market within the year. Meanwhile, Green Valley will initiate Phase III clinical trials.®Post-marketing studies and real-world studies, with active advancement of international multi-center clinical trial projects, aiming to benefit patients worldwide as soon as possible. GV-971®Its research and development has been supported by grants from the National “863 Program,” the National Natural Science Foundation of China, the National “973 Program,” the National Major Special Project on “Major New Drug Development,” the Chinese Academy of Sciences’ Strategic Priority Research Program (Category A), and the Shanghai Municipal Science and Technology Program.
Source: Shanghai Institute of Pharmaceutical Industry, Pharmatimes