Another Alzheimer's disease drug approved! Within half a year, four oral drugs of memantine hydrochloride have been approved

(Health Times reporter Li Chaoran) on June 15, Jingxin Pharmaceutical announced that it recently received the "Drug Registration Certificate" of the chemical drug "Memantine Hydrochloride Sustained-Release Capsule" [specification 28mg] approved by the State Food and Drug Administration, and it was regarded as passing the consistency evaluation of the quality and efficacy of generic drugs.

The Market Potential for Alzheimer's Disease is enormous

Within half a year, four oral drugs of memantine hydrochloride have been approved

Memantine hydrochloride is a non-competitive N-formyl-D-aspartic acid (NMDA receptor antagonist) with low to moderate affinity for moderate to severe Alzheimer's dementia. At present, the common oral dosage forms of memantine hydrochloride are mainly tablets, extended-release capsules and oral solutions.

Among them, the original research drug of Memantine Hydrochloride Extended-Release Capsules was developed by Meerz and Forest Laboratories LLC in Germany, and Lingbei Pharmaceutical in Denmark obtained product authorization and was approved for marketing in the United States in June 2010. The original manufacturer of memantine hydrochloride tablets is also The Danish Lingbei Pharmaceutical. The trade name is "Ebeshen", which was approved for listing in China at the end of 2006.

In recent years, a number of domestic memantine hydrochloride generic drugs have been approved for listing, the most recent one was on June 7, the federal pharmaceutical drug memantine hydrochloride tablets were approved and passed the consistency evaluation.

According to the database of the Food and Drug Administration, the domestic enterprises that have been approved for listing Memantine Hydrochloride Sustained Release Capsules include Chengdu Wandong Biologics, Hainan Herui Pharmaceutical, and Jiangsu Changtai Pharmaceutical, of which Yuandong Biologics is the first approved enterprise in China, which was approved in November 2020, and Jingxin Pharmaceutical, which has just been approved, is the fourth approved enterprise.

The domestic enterprises that have been approved for listing meijing hydrochloride tablets include Puluo Pharmaceutical, CSPC Ouyi Pharmaceutical, Ruiyang Pharmaceutical, Zhuhai Federal Pharmaceutical, Hunan Dongting Pharmaceutical, etc. Among them, Zhuhai Federal Pharmaceutical's Mei diamond hydrochloride tablets generic drug was listed in 2013, which is the first domestic generic drug enterprise of Meijingo hydrochloride. In addition, there are more than ten pharmaceutical companies' oral preparations of memantine hydrochloride in the review and approval.

The sales amount of memantine hydrochloride tablets exceeded 531 million yuan in 2019

The price of a single tablet of CSPC Ouyi Pharmaceutical is only 0.165 yuan

According to data from the intranet, in the terminal data of urban public hospitals, county-level public hospitals, urban community centers and township health centers (referred to as China's public medical institutions), the sales amount of memantine hydrochloride tablets in 2019 was 531 million yuan, an increase of 15.27% year-on-year; among them, the original research manufacturer Danish Lingbei accounted for more than 90%, and the sales amount was 450 million yuan, an increase of 9.32% year-on-year. In 2020, the oral preparation of memantine hydrochloride was sold for about 560 million yuan in public hospitals in Chinese cities.

With the listing of a number of domestic generic drugs, the current generic drug market share has exceeded half. In August 2020, memantine hydrochloride tablets were selected as the third batch of national centralized procurement varieties, 4 domestic pharmaceutical companies participated in the bidding, the winning bid results showed that the largest decline was CSPC Ouyi Pharmaceutical Co., Ltd. U.S. acid memantine tablets (10mg), a drop of up to 98%, reported at 9.88 yuan a box, the price of a single tablet was only 0.165 yuan.

In the past two years, the oral preparation of memantine hydrochloride has been frequently approved and entered the national collection, highlighting the potential huge drug demand for Alzheimer's disease in China. China's first "China Alzheimer's disease patient diagnosis and treatment status survey report" shows that the current Alzheimer's disease patients have exceeded 10 million, according to the Capital Medical University Xuanwu Hospital Professor Jia Jianping team survey, in 2015 China's Alzheimer's disease caused by the total socio-economic burden reached 167.74 billion US dollars, is expected to reach 2.54 trillion US dollars by 2030.

Since the discovery of Alzheimer's disease for more than 100 years, there have been only 5 drugs used for clinical treatment in the world, and the clinical benefits are not obvious. Memantine hydrochloride is suitable for moderate to severe Alzheimer's type of dementia, can improve the cognitive dysfunction of dementia patients, China's first original Alzheimer's disease drug mannit sodium was approved for marketing in November 2019, for mild to moderate Alzheimer's disease, can improve patient cognitive function.

On June 7 this year, the U.S. Food and Drug Administration approved the listing of aducanumab developed by the US biotechnology company Bojian, which is the first drug for the underlying cause of Alzheimer's disease, which is not only for symptoms, but also caused great controversy, and many scholars believe that its clinical benefits are still uncertain, and the trial data is not convincing.