It is learned from the GV-971 Global Strategic Launch and the First Gut-Brain Axis Forum hosted by Shanghai Institute of Materia Medica, Chinese Academy of Sciences (SIMM) on Dec. 29, 2019 that the innovative drug for Alzheimer’s disease (AD)-GV-971 (sodium oligomannurarate) has been officially marketed in China, which is priced at RMB895/box and has attracted much attention of the pharmaceutical practitioners. It is an original Class 1 new drug successfully developed by the research team led by Researcher Geng Meiyu from SIMM and through the joint efforts SIMM, Ocean University of China, and Shanghai Green Valley Pharmaceutical Co., Ltd. for a period of 22 years; it is the world’s first Class 1 new AD drug developed in China, which targets the gut-brain axis; it fills in gaps in the marketing of new drugs for AD for 17 years. This article sorts out the top 10 concerns of the AD patients and their families about this new AD drug.

I. Is the memory eraser a disease?

The memory eraser disease, i.e., senile dementia, also called AD, is a neurodegenerative cerebral disease that has a highly complex pathogenesis and is extremely difficult to cure.In 1906, Dr. Alois Alzheimer discovered the neurofibrillary tangles accompanied by neurodegeneration and many plaques on the cerebral cortex in the brain of senile dementia patients using brain slice staining techniques, therefore, such nervous system disease was later called Alzheimer’s disease. The research in recent years has proved that the imbalance of the intestinal flora is closely associated with AD and other nervous system diseases. According to scientists, AD has the following characteristic pathological changes: senile plaques deposited and formed by β-amyloid in the brain, and neurofibrillary tangles (NFTs) and neuron losses as a result of the hyperphosphorylation of the tau protein accompanied with glial cell proliferation. However, the pathogenesis and treatment of AD are still a global challenge.

II. How long did it take from the R&D to the marketing of the innovative drug GV-971?

From the time when the research team led by Researcher Geng Meiyu from SIMM started to research China’s first AD new drug GV-971 in 1997 to the official marketing of the drug in China on Dec. 29, 2019, it took 22 years. The R&D history of GV-971 is as shown in the following figure:

GV-971 R&D History

? 1997; The GV-971 research team led by Geng Meiyu discovered the active substance through drug screening

? July 2006; The research team received the clinical trial approval for GV-971

? Dec. 2007; The research team started Phase I clinical study of GV-971 in China

? Aug. 2013; The research team completed the Phase II clinical study of GV-971

? July 2018; The research team completed the Phase III clinical study of GV-971

? Nov. 2018; The new drug marketing application of GV-971 was accepted by the CDE

? Nov. 2, 2019; The NMPA officially approved the marketing of GV-971 (Sodium Oligomannurarate Capsules) in China

? Dec. 29, 2019; GV-971 is officially marketed in China

III. How were the clinical effects of the innovative drug GV-971?

The leading researchers of the Phase III clinical study of GV-971 in China systematically interpreted the clinical study data and results of GV-971 in public for the first time at the GV-971 Global Strategic Launch and the First Gut-Brain Axis Forum on Dec. 29, 2019. Since the start of the clinical study of GV-971 Alzheimer, there have been 1,199 Chinese subjects successively participating in Phase I, Phase II and Phase III clinical studies; wherein, the Phase III clinical study was conducted in 34 3A-grade hospitals in China as led and organized by Peking Union Medical College Hospital and Shanghai Mental Health Center affiliated to Shanghai Jiao Tong University School of Medicine and completed the medication observation of 818 subjects. The study was also the world’s first pure placebo-controlled study that lasted for 9 months in the AD drug area. According to the clinical study results, GV-971 reached a response rate of 78% and could continuously and significantly improve the patients’ cognitive function, with good safety and the adverse event rate equal to the placebo.

IV. What diseases can the innovative drug GV-971 treat?

It is used for mild to moderate AD, to improve patients’ cognitive function.

V. How long will it be for the innovative drug GV-971 to take effect?

According to the Phase III clinical study of GV-971, in the 36-week clinical study, patients could see improvement 4 weeks after taking the drug and see more significant improvement at the end of week 36. After the 36-week treatment, the benefits and risks of patients’ continued use of the product need to be reassessed by the doctors. Patients can consider continuing to use the product if the benefits are significant and they can tolerate the product; otherwise, they shall consider discontinuing the product.

VI. What is the cost of 1 treatment course of the innovative drug GV-971?

According to the Phase III clinical study of GV-971, in the 36-week clinical study, patients could see improvement 4 weeks after taking the drug, therefore, if 4 weeks mean 1 treatment course, according to the unit price of RMB895/box (150mg*14 capsules*3 plates), the cost of 1 treatment course of patients taking the drug twice daily and 3 capsules per time will be about RMB3,580.

VII. Where to buy the innovative drug GV-971?

GV-971 is a prescription drug. According to the information on the website of Shanghai Green Valley Pharmaceutical Co., Ltd., the drug can be bought upon prescriptions at MEDOFFERx and Sinopharm Group DTP pharmacies (Direct to Patient, i.e., pharmacies that directly provide more valuable professional services to patients).

VIII. Which are the key contents on the packaging box of the innovative drug GV-971?

Approval No.: GYZ Zi H20190031

Product name: Sodium Oligomannurarate Capsules （九期一）

Trade name: GV-971

Dosage form: Capsule

Specification: 150mg/capsule x 14 capsules/plate x 3 plates/box

Marketing authorization holder: Shanghai Green Valley Pharmaceutical Co., Ltd.

Manufacturer: Shanghai Green Valley Pharmaceutical Co., Ltd.

Manufacturer’s address: No. 886, Huijin Road, Qingpu District, Shanghai

Patients need to focus on key information such as indications, usage and dosage, storage, adverse reaction, contraindication, and notice.

IX. Will GV-971 be marketed overseas?

Shanghai Green Valley Pharmaceutical Co., Ltd. also announced today that they would invest USD3 billion in the future to support the global study of GV-971? after its marketing, including the real-world study, international multicenter Phase 3 clinical study "Green Memory", expanded indication study, and mechanism in-depth study, etc. According to Green Valley, they plan to complete the international multicenter Phase 3 clinical study in 2024 and strive to complete the global registration application of the new drug in 2025.

References

[1] www.greenvalleypharma.com/Cn/Index/pageView/catid/78.html

[2] newsxmwb.xinmin.cn/kechuang/2019/12/29/31628500.html

About the author:

Dishui Sinan, male, Senior Biomedical Engineer, basing on the quality management work in the bio-medicine industry, focusing on the bio-medicine industry, and wishing to talk in simple language about the specialized knowledge that is not simple and provide a knowledge compass to guide readers in the sea of knowledge

Editor's Note:

En-CPhI.CN is a vertical B2B online trade platform serving the pharmaceutical industry,

for any copyright disputes involved in the reproduced articles,

please email: Julia.Zhang@ubmsinoexpo.com to motify or remove the content.