Aska Pharmaceutical's PPI New Drug Nears Approval: A Major Addition to Its RMB 4-Billion Portfolio

Recently, the marketing authorization application for Jiangsu Aosaikang Pharmaceutical Co., Ltd.'s dexlansoprazole for injection, a Class 2.2 new drug, has entered the "under review" status. Takeda Pharmaceutical Company Limited's dexlansoprazole is currently available only in oral formulations and generated global sales of 55.6 billion yen (approximately USD 500 million) in 2020. At present, no imported or generic versions of this product have been approved in the Chinese market.

Figure 1: Information on Products Recently Entering the Approval Process

Source: NMPA Official Website

Dexlansoprazole is a proton pump inhibitor and the R-enantiomer of lansoprazole. Takeda Pharmaceutical Company Limited's dexlansoprazole enteric-coated capsules were first marketed in the United States in 2009 for the treatment of all grades of erosive esophagitis and for the maintenance treatment of non-erosive reflux esophagitis and associated symptoms.

Figure 2: Global Sales of Takeda Pharmaceutical Company Limited's Dexlansoprazole (Unit: Million JPY)

Source: MENET Multinational Listed Companies Sales Database

According to Menet data, Takeda Pharmaceutical's global sales of dexlansoprazole consistently exceeded ¥60 billion annually from 2016 to 2019. However, due to the pandemic's impact on the global economy in 2020, sales declined to ¥55.6 billion (approximately $500 million) last year.

Table 1: Market Share of Aosaikang's PPI Formulations

Source: Menet Competitive Landscape of China's Public Medical Institution Terminal Market

Data from Menet shows that Aosaikang's current PPI preparations primarily cover five major products. Over the past three years, the combined terminal sales at urban public hospitals, county-level public hospitals, urban community centers, and township health centers in China (collectively referred to as China's public medical institutions) have consistently exceeded RMB 4 billion, firmly solidifying its leading position in China's PPI preparations market.

Jiangsu Aosaikang Pharmaceutical Co., Ltd. has become the No. 1 company in the omeprazole market, the No. 2 in the rabeprazole and lansoprazole markets, and the No. 3 in the esomeprazole market. As Takeda Pharmaceutical Company Limited's dexlansoprazole has yet to enter the Chinese market, Aosaikang has developed Dexlansoprazole for Injection as a Class 2 new drug based on its pharmacological profile. This product is intended for the treatment of acute upper gastrointestinal bleeding and other conditions where oral therapy is not feasible. Should Aosaikang successfully obtain regulatory approval, it will secure a first-mover advantage and further consolidate its market leadership.

Table 2: Product Information for the Marketing Authorization Application of Dexlansoprazole

Source: MENET MED2.0 China Drug Evaluation Database

Currently, Chinese pharmaceutical companies maintain a highly proactive stance toward dexlansoprazole. As early as 2018, Chia Tai Tianqing submitted a marketing application for dexlansoprazole enteric-coated capsules but received approval only for clinical trials. In the injectable segment, Sunho (China) Biopharmaceutical was the first to file for marketing approval in 2019, but has since been overtaken by Jiangsu Aosaikang Pharmaceutical Co., Ltd. Additionally, over ten Chinese pharmaceutical companies have submitted and obtained approval for clinical trials of new dexlansoprazole-related formulations.

Source: NMPA official website, MENET database

Review data statistics are current as of August 12. Please advise of any errors or omissions.