On May 13, the official announcement of Green Valley Pharmaceutical stated that due to the multiple influences of the new crown epidemic and the lack of financing, the company terminated the international multi-center phase III clinical study of Mannat Sodium Capsules ahead of schedule.
After the news came out, Rao Yi, President of Capital Medical University, posted on his personal account, once again bombarding Green Valley Pharmaceuticals, “Stopping the domestic sales of GV-971 is the first step to change course.” “If you think that the 971 pushed by Geng Meiyu and Lugu is the real medicine, there is no doubt that Geng Meiyu is a genius far surpassing Einstein’s in the field of biomedicine.”
GV-971 is the serial number of Mannat Sodium Capsule during research, and the trade name of the drug “Nine Phase One” is also based on the homophony of these three numbers. In 2019, Mannat Sodium Capsule was approved for marketing for the first time in China, but its clinical trial data and mechanism of action have been controversial in the academic community.
Previously, Rao Yi publicly stated that the research and development of sodium mannatide was fraudulent. In order to prove the effectiveness of the product, Green Valley Pharma started an international multi-center phase III clinical study in October 2020. At the end of 2021, Mannat Sodium Capsules entered the medical insurance through price negotiation.
Faced with the controversy, Geng Meiyu, the inventor of the drug, did not show weakness, and filed a lawsuit alleging that Rao Yi’s reputation was infringed. But in December last year, the court ruled against Geng Meiyu, arguing that legitimate academic debate and criticism should be allowed.
Now, the international multi-center Phase III clinical study of Mannat sodium capsules has been terminated early, and the controversy has returned to GV-971 itself.
Out of money, the international clinical phase III study is stopped in advance
Green Valley’s international Phase III clinical trial has a nice name called “Green Memory”. Green Valley did not disclose the loss caused by the termination of “green memory”, and also stated in the announcement that if conditions permit in the future, the research will be restarted.
Only, restarting is very difficult.
Green Valley launched the international multi-center Phase III clinical trial in November 2020, when it claimed to apply for global registration of new drugs within five years. Lvgu has established 162 clinical centers in 11 countries or regions, including the United States, Canada, Australia, and the Czech Republic.As of April 26 this year, a total of 1,308 cases had been screened and 439 patients were randomly enrolled, including those from North America. Group of 257 cases.
There is an Alzheimer’s Association in the United States that regularly publishes nationwide prevalence data each year. The latest data in 2022 shows that the total number of Alzheimer’s patients in the United States will reach 6.5 million. There is a huge contrast between the huge patient base and the very small enrollment of Green Valley Pharma.
Investigating the reason, Green Valley Pharma announced that the financing that the company has initiated was affected by the international situation and the cold winter of the capital market, and the funds could not be immediately available.
This also means: Planning to invest 5 years of clinical research, and now less than two years, Green Valley has no money.
When GV-971 was approved for marketing in China, Lv Songtao, chairman of Green Valley Pharmaceuticals, made a high-profile announcement that he would continue to invest 3 billion US dollars for further scientific research. The money will support GV-971 post-marketing real-world research, international multi-center Phase 3 clinical research, expanded indication research and in-depth mechanism research, etc.
Lv Songtao might actually have $3 billion in his hands at the time. According to what he said to the media: in 2014 and 2015, Green Valley’s core product Salvia Polyphenolate Injection achieved sales of 3 billion to 4 billion yuan, and saved 3 billion yuan in profit . According to the database of the State Food and Drug Administration, Salvia Polyphenolate Injection is a traditional Chinese medicine injection.
But if the $3 billion is dropped, Lu Songtao obviously hopes that the sodium mannatide capsules will sell well. However, the ideal is beautiful, and the reality is very skinny.
At the beginning of the approval, the price of each box of Mannat sodium capsules was 895 yuan, which is equivalent to 3,580 yuan per month. It is said that there has been a shortage of stocks. However, the actual sales data is not good. The PDB database shows that the total sales of the drug in sample hospitals across the country in 2021 is only 10.75 million yuan.
At the end of 2021, the price of Mannat sodium capsules will be reduced by 60% and it will be included in the National Medical Insurance Catalogue. Subsequently, news of Green Valley Pharmaceutical’s executives’ salary cuts and sales layoffs were reported. Finally, the company was terminated due to lack of money. International Multicenter Clinical Trials.
Alzheimer’s disease cannot be cured without reliable data
Trial discontinuation has a large impact on enrolled patients.
Green Valley stated in the announcement that it has communicated with regulatory agencies in various countries, all clinical investigators and various clinical trial service providers to stop all screening and enrollment work. Informed to ensure safe withdrawal for all subjects. And re-enable standard treatment as prescribed to minimize the impact.
The new crown epidemic has been in the world for three years, and the global clinical practice of many new drugs has been affected. Previously, Kanghong Pharmaceutical attributed the global clinical inadequacy of the ophthalmic drug Conbercept to the epidemic. However, Green Valley Pharmaceutical is the first company in recent years to publicly declare that clinical research has been stopped due to lack of money.
Poor curative effect may be the fundamental reason why these overseas drugs have stopped global clinical practice.
Sodium Mannat Capsule is a low-molecular-weight acidic oligosaccharide compound prepared from marine brown algae extract. Its therapeutic principle is the hypothesis of “brain-gut axis”: it eliminates intestinal bacteria Neuroinflammation induced by group disorders.
A doctor from a tertiary hospital in Beijing told the Health and Knowledge Bureau that researches in the neurological field around the world cannot fully understand the specific principles of human nerve conduction pathways. Therefore Clinical treatment is mostly symptomatic treatment. Alzheimer’s disease currently cannot be cured, only “delayed symptoms”.
It is because there is no cure that mannatide is approved as a treatment for Alzheimer’s disease. Many doctors believe that more clinical trial data are needed to prove that this drug has a clear effect.
Mannat sodium capsules have obtained the approval of the State Food and Drug Administration for “conditional listing”. According to the technical guidelines of the State Food and Drug Administration, the varieties that are conditionally marketed are “unlisted”. Can confirm that the product predicts clinical benefit”, or “the applicant fails to perform the required post-approval drug trials with due diligence”, the FDA may revoke the marketing authorization.
Therefore, Green Valley Pharma can not just say “no money” and can not do clinical trials, but must do, and produce effective results, Mannat sodium capsules can continue to sell smoothly.
Is it easier said than done to achieve results? Alzheimer’s disease has always been a research and development nightmare for major pharmaceutical companies. Giants such as Pfizer, Eli Lilly, Roche, and Johnson & Johnson have also tried to develop it, but most of them ended in failure. In April this year, Biogen voluntarily withdrew the application for the Alzheimer’s treatment drug in Europe due to poor clinical efficacy data of the drug. Bojian CEO resigned as a result.
Green Valley Pharma is in a dilemma: Continue to invest in the research and development of mannatide sodium, it is very likely that the bamboo basket will draw water, and now the research and development will be completely stopped, and maybe the batch number will be revoked. Lv Songtao claimed to have saved 3 billion yuan in profits. I don’t know if it has been spent, but at least “the global clinical trial investment of 3 billion US dollars” is definitely not available or unwilling to take out from Green Valley at present.
#Alzheimer’s#