Two More Chinese Pharma Firms Pass Evaluation for Acarbose Tablets, Intensifying Competition in the Oral Antidiabetic Drug Market

　　【Pharmaceutical Network Market Analysis】Diabetes is a metabolic disease, and the number of diabetes patients in China is enormous. According to the latest data released by the International Diabetes Federation (IDF) in 2021, the number of diabetes patients in China has reached 140 million. In other words, one out of every 10 people may be a diabetes patient.
 

Overall, there remains a significant unmet demand among diabetes patients in China, indicating a vast market potential for hypoglycemic drugs. Consequently, faced with the enormous market for diabetes medications, numerous pharmaceutical companies are actively positioning themselves, leading to increasingly fierce competition. However, at the same time, driven by increased R&D investment, expedited drug approval processes, and strong capital support, there has been a continuous stream of news regarding the launch of new hypoglycemic drugs in the domestic market in recent years.
 

Recently, the website of the National Medical Products Administration showed that Chongqing Yaoyou Pharmaceutical Co., Ltd.'s Acarbose Tablets and China Resources Saike Pharmaceutical Co., Ltd.'s Acarbose Tablets were both approved on the same day as Category 4 generics, which are considered to have passed the quality and efficacy consistency evaluation.
 

It was reported that on the evening of March 21, China Resources Double-Crane announced that recently, its wholly-owned subsidiary, China Resources Saike Pharmaceutical Co., Ltd. (hereinafter referred to as "China Resources Saike"), received the "Drug Registration Certificate" (Certificate No.: 2022S00199) for Acarbose Tablets issued by the National Medical Products Administration, approving the production of the drug.
 

Public data shows that Acarbose Tablets were originally developed by Bayer AG. They were first launched in Germany in 1990 and have become one of the major products in the field of diabetes medications. As a fundamental treatment for hyperglycemia, the drug demonstrates excellent efficacy in lowering postprandial blood glucose levels and is considered a key oral hypoglycemic medication. It can reduce the risk of cardiovascular disease, and the product has proven to be effective over the long term with a high level of safety. It is mainly used for treating Type 2 diabetes and reducing postprandial blood glucose in individuals with impaired glucose tolerance. Data indicates that in 2020, the total sales of Acarbose Tablets in Chinese public medical institutions and physical retail pharmacies in Chinese cities exceeded 4 billion yuan.
 

Currently, 15 companies in China possess the production approval for Acarbose Tablets. Among them, 13 companies, including Shandong Lukang Pharmaceutical, CSPC Ouyi Pharmaceutical, Hunan Qianjin Xiangjiang Pharmaceutical, and Lepu Pharmaceutical, have passed the evaluation. Additionally, five companies, such as Beijing Jingfeng Pharmaceutical Group, Zhejiang Haixiang Pharmaceutical, and Guizhou Tianan Pharmaceutical, have submitted their applications for market approval, which are currently under review.
 

Analysts believe that although the competition in the acarbose tablets market is becoming increasingly fierce with more and more companies entering, acarbose remains one of the major oral hypoglycemic drugs with annual sales exceeding 1 billion yuan based on recent years' sales performance. In the future, as the 2017 edition of the National Reimbursement Drug List upgrades acarbose from Category B to Category A, import substitution will accelerate. The industry expects that the market share of the original research company, Bayer, will decrease year by year, while the market share of local enterprises will gradually increase.
 

Taking the in-hospital sales data from the first three quarters of 2021 as an example, Bayer accounted for only 43%, while Hangzhou Zhongmei Huadong Pharmaceutical and Luye Pharmaceutical together captured over 55% of the market share. In the future, with the continuous efforts of local enterprises, their share in this market is expected to keep expanding.
 

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