New Market For Homemade Alzheimer'S Disease: Efficacy, Market Test, Prevention Of Alzheimer'S Disease

A few days ago, Ocean University of China, Shanghai Institute of Chinese Academy of Sciences and Shanghai Green Valley research and development GV-971 (mandew sodium capsule, trade name "nine phase I") was granted conditional listing for Alzheimer's disease, namely Alzheimer's disease. In November 4th, the related concept stocks welcomed the carnival. Jingxin pharmaceutical and blue Feng biochemical price limit opened.

But contrary to the capital market boom, there are four arguments in the industry: first, whether the observation period of the drug test is long enough and whether it has sustained curative effect; two, pharmacologically, the nine stage one is not based on the main causes of Alzheimer's disease; the last point is that the green Valley company has been wearing an evil spirit because of its anticancer drug.

At present, the pathogenesis of Alzheimer's disease is still unclear, but the most representative theoretical hypothesis is the A beta amyloid protein hypothesis and the Tau protein hypothesis. However, the clinical research on these two hypotheses failed. Recently, more and more hypotheses, such as glucose metabolism disorder, chronic inflammation and gut gut axis, have emerged. The gut gut hypothesis is the theoretical mechanism of "nine phases and one".

"To put it simply, at the present stage, the main reason is that the cause of Alzheimer's disease is the toxicity of protein aggregation to the central nervous system, and the mechanism of" nine phase I "is only the cause of polymerization. It is neither the direct cause nor the main cause of Alzheimer's disease. Secondly, the time selection of the 3 phase clinical study for 36 weeks is rather subtle, which is different from the observation period of more than one year in the past, so it is still questionable whether it has long-term validity. A Southern China pharmaceutical researcher told the twenty-first Century economic report.

New drugs need market test

In fact, Alzheimer's disease has been regarded as the "Pearl of the crown" by the pharmaceutical research and development sector because of its huge market demand. Famous pharmaceutical companies at home and abroad have invested heavily. Since 2002, pharmaceutical companies have invested $about 200000000000 in the development of new drugs for Alzheimer's disease. However, in over 200 clinical studies, there are few successful products. High investment, high risk and high failure rate have become the characteristics of new drug development for Alzheimer's disease.

So, this time approved the conditional listing of China's new drug GV-971?

According to the announcement of the State Administration of drug control, the drug is used for mild to moderate Alzheimer's disease and improves cognitive function. The drug is a low molecular weight oligosaccharide derived from marine brown algae extract. It is an innovative medicine developed by China and has its own intellectual property rights. It is supported by the state's major new drug discovery technology.

At the same time, "the State Food and drug administration requires the applicant to continue to carry out research on pharmacological mechanisms and long-term safety effectiveness after listing, improve the analysis method of oligosaccharides, and submit relevant test data on time."

What is "seaweed extract" and "low molecular acidic oligosaccharide compound"?

"That is to say, the core ingredient of this medicine is extracted from seaweed, not a single component, but a natural extract. The active ingredients commonly used by general chemicals are very clear. " A scientist who developed this kind of drug in the industry explained in an interview with the economic news reporters in twenty-first Century. "The nine phase one" is a mixture with complicated ingredients. So it may encounter quality control problems in production: how to ensure the stability of each batch? Consistency between different batches is difficult. "

The above State Drug Administration's approval also mentioned that applicants are required to improve their analytical methods. "It also reflects that the analytical technology of this drug may not be mature enough, which may bring difficulties to quality control."

The industry's doubts about the "nine phase one" mostly focus on the design, data and efficacy of clinical trials. "The key is that the clinical data of the nine phase I is inadequate." The above researchers believe that.

According to the Green Valley News Release: a total of 1199 subjects participated in the 1, 2, and 3 phase clinical trials of the drug. The 3 phase clinical trial was conducted by the affiliated mental health center of Shanghai Jiaotong University School of Medicine and Peking Union Medical College Hospital, and was conducted in 34 three grade A hospitals nationwide, and 818 patients were observed taking medicine. The whole clinical trial is run by Ai Kunwei, a new drug development outsourcing service.

The 36 week 3 phase clinical study showed that nine phase 1 could significantly improve cognitive impairment in patients with mild to moderate Alzheimer's disease. Compared with placebo group, the cognitive function improved significantly, and the cognitive function scale (ADAS-Cog) score improved by 2.54 points (p< 0.0001). In the nine phase, the cognitive function of one pair of patients had the characteristics of quick onset, continuous and steady improvement, and good safety. The incidence of adverse events was similar to that of the placebo group. Green Valley pointed out.

However, there are several controversies in the above clinical trials: first, the design of clinical trials. "The nine phase one is totally different from the design currently made by international companies. It is both symptomatic and therapeutic. The so-called treatment is aimed at really changing the course of disease, such as delaying the development of disease or preventing or reversing it. But in the field of Alzheimer's disease, no one dare to reverse it.

The two is the effect. The nine phase, the 3 phase of the clinical trial took 36 weeks to achieve the effect of "improving cognition", but "foreign clinical trials are usually at least 18 months or more."

The three is the research and development mechanism of the drug. According to the Green Valley company, "the nine phase I can improve the intestinal flora balance, inhibit the abnormal increase of specific metabolites of intestinal flora, reduce peripheral and central inflammation, reduce the deposition of beta amyloid protein and Tau protein over phosphorylation, thereby improving cognitive dysfunction." but the mechanism of reducing central inflammation and improving cognition through intestinal microflora "may still be questioned by most neuroscience researchers." An industry researcher told reporters.

"The pathogenesis is unclear, the cause of the disease is complex, the course is long and the secret is the main reason for the development of Alzheimer's disease drugs. At present, there are mainly three hypotheses in the academic field: the starch protein cascade hypothesis, the APOE4 hypothesis and the Tau protein hypothesis. But the hypothesis is only a hypothesis. The real etiology and pathogenesis are not yet determined. It is inevitable that a new drug in the Green Valley is controversial, but whether it is effective or not can be tested in the future global market. " A private pharmaceutical industry in Shenzhen analyzed the twenty-first Century economic report reporter.

According to Lv Songtao, chairman of Green Valley pharmaceuticals, the first round of communication between Green Valley and the US Food and Drug Administration FDA (around GV-971) has ended. It will take time for the US market to be approved.

Special Chinese market

In the field of Alzheimer's disease treatment in China, mainstream medicine has been different from overseas.

According to the PDB sample hospital database, the Chinese characteristics of oxetam, citicoline, brain protein hydrolysate, and Changchun's West have occupied the vast majority of the market for Alzheimer's disease in China, while donepezil, Kabbala ting and memantine account for less than 25% of the sales. This means that many Chinese Alzheimer's patients have not yet used drugs such as memantine and Donay Patsy, which have been marketed in the United States for many years.

But it is worth noting that in July this year, the first batch of national key surveillance and rational drug list published by the health protection committee included oxa, brain protein hydrolysate and Changchun saetin. This also means that the domestic market for Alzheimer's disease will usher in a "shuffle". In the past, the lack of clinical data to support effective drugs will be replaced.

Donepezil, Kabbala ting and memantine have already gone through the patent period. Under the new medicine policy of consistency evaluation and quantity purchase, many domestic generic drug companies have already laid out three of them.

At present, more than 10 domestic pharmaceutical companies have received the approval of donepezil, and Huahai has passed the conformance evaluation. It is now at the same level as that of the original research, while Kabbala Ting has only received approval from Jingxin pharmaceutical company. In addition, it has been researched by Novartis.

"In the future, in addition to continuous investment in the field of Alzheimer's disease, the cost war of generic drugs companies will also be triggered. But for the public, it must be clear that drugs at the present stage still tend to slow down symptoms. Although the exploration of the central nervous system has never been stopped, the prevention of Alzheimer's disease by sleep protection, proper use of the brain and rational exercise seems to be a more realistic way for human beings to fight against Alzheimer's disease at this stage. The pharmaceutical research and development people said.