Zhejiang-Based Zoli Pharma Enters the 3-Billion-Yuan Esomeprazole Injection Market as AstraZeneca Loses Majority Share

Recently, the official website of the National Medical Products Administration (NMPA) indicated that Zhejiang Jolly Pharmaceutical Co., Ltd.'s Esomeprazole Sodium for Injection has been approved for production under a Class 6 generic drug application. Data from Menet shows that in 2020, sales of esomeprazole injections at public medical institutions in China exceeded 3 billion RMB. There are over 30 manufacturers producing this product, with AstraZeneca holding the largest market share.

Esomeprazole is the S-enantiomer of omeprazole and belongs to the proton pump inhibitor (PPI) class. It effectively inhibits gastric acid secretion. Compared with other proton pump inhibitors, it is characterized by rapid, sustained, and stable acid suppression, along with a lower incidence of adverse reactions.

Recent Sales Trends of Esomeprazole Injection in China's Public Healthcare Institution Terminal

Source: Competitive Landscape of China's Public Medical Institutions Terminal

Data from Menet shows that in 2020, terminal sales of esomeprazole injection at China's public medical institutions (including urban public hospitals, county-level public hospitals, urban community health centers, and township health centers) exceeded RMB 3 billion. Over 30 manufacturers produce this product, including AstraZeneca, Chia Tai Tianqing Pharmaceutical Group, Jiangsu Aosaikang Pharmaceutical, Langtian Pharmaceutical (Hubei), and Yangtze River Pharmaceutical Group, with AstraZeneca holding the largest market share. Notably, in recent years, as domestic pharmaceutical companies have ramped up their efforts, AstraZeneca's market share has gradually declined from monopolizing the market in 2015 to 51% in 2019, dropping below 50% in 2020.

Currently, nine enterprises, including Chia Tai Tianqing Pharmaceutical Group, Jiangsu Ask Pharmaceutical, Jiangsu Chia Tai Fenghai Pharmaceutical, and Liaoning Haisco Pharmaceutical, have passed the consistency evaluation for this product. The supplementary applications for consistency evaluation from eight enterprises, including Yichang HEC Changjiang Pharmaceutical and Yangtze River Pharmaceutical Group, are under regulatory review and approval. Additionally, marketing authorization applications from nearly 20 enterprises, such as Sichuan Pharmaceutical Formulation, Sinopharm Group Rongsheng Pharmaceutical, and Changchun Haiyue Pharmaceutical, are currently under review. Among them, six enterprises submitted applications under the Class 4 generic drug classification; upon approval, these will be deemed to have passed the consistency evaluation.

Source: Official Website of the National Medical Products Administration, MENET Database