Yangtze River Pharma Submits Application for First Generic Edoxaban Tosylate Tablet Amid Surging Demand for Antithrombotic Drug

On January 14, YANGTZE RIVER PHARMACEUTICAL GROUP NANJING PHARMACEUTICAL.CO.,LTD submitted a Class 4 generic drug marketing application for Edoxaban Tosylate Tablets. Currently, there is no domestically produced generic version of this product in the Chinese market. HAINAN SIMCERE PHARMACEUTICAL CO., LTD and Chia-TaiTianqing have both filed for production, and their applications are under review. The competition for the first generic approval is becoming increasingly intense.

Edoxaban is a selective Xa factor inhibitor developed by Daiichi Sankyo. It was first approved in Japan in 2011 for the treatment of venous thromboembolism, and later received approvals for multiple new indications. In 2020, its global sales reached 154.1 billion yen (approximately 1.3 billion US dollars).

The original product was approved to enter the Chinese market by the end of 2018. Data from the Menet database shows that in the first half of 2021, the sales growth rate of the original product at the terminals of urban public hospitals, county-level public hospitals, urban community health centers, and township health centers in China (referred to as Chinese public medical institutions) reached an astonishing 54,766.67%, indicating a market potential that cannot be underestimated.

Currently, the products of the "sandaban" class that have been marketed in China include Apixaban Tablets, Rivaroxaban Tablets, and Edoxaban Tosylate Tablets. Among them, the domestically produced generic versions of Apixaban Tablets and Rivaroxaban Tablets have already been approved for marketing in China. In recent years, Edoxaban Tosylate Tablets have also attracted several leading domestic pharmaceutical companies to compete for the first generic approval. YANGTZE RIVER PHARMACEUTICAL GROUP NANJING PHARMACEUTICAL.CO.,LTD was the third company to file for production. Ultimately, who will secure the first generic approval remains to be seen.

Table 1: Top 5 Antithrombotic Drugs in the Retail Market

Source: MiNei Network China City Physical Pharmacy Terminal Competitive Landscape

Figure 1: Sales of Rivaroxaban in the Past Three Years (Unit: Billion Yuan)

Source: MiNei Network's Competitive Landscape of Physical Pharmacies in Chinese Cities

It is reported that direct thrombin inhibitors play an important role in the treatment, prevention, and management of thromboembolic diseases, addressing the shortcomings of traditional drugs such as heparin and warfarin. Data from the Mening Network shows that among the top five antithrombotic drugs in retail pharmacies in Chinese cities in 2021E, only rivaroxaban maintained a positive growth trend. Additionally, apixaban also entered the top ten, with direct thrombin inhibitors emerging as representatives of new oral antithrombotic drugs.

YANGTZE RIVER PHARMACEUTICAL GROUP obtained the production approval for Rivaroxaban Tablets in 2020, and in 2021, it received approval for Apixaban Tablets, both of which were approved under the new classification and are considered to have passed the evaluation. Once Edoxaban Tosylate Tablets are approved for marketing, YANGTZE RIVER PHARMACEUTICAL GROUP, holding three major potential products, will unleash new vitality in the antithrombotic drug market.

Source: CDE official website, MiNeiNet database