Brilliant Pharmaceuticals Intensifies Push into Oral Antidiabetic Market Amid 374% Surge in Originator Drug Sales

On July 8, BRILLIANT PHARMACEUTICALS submitted a Class 4 generic marketing application for empagliflozin tablets, which was accepted by the Center for Drug Evaluation (CDE). The company has accelerated its R&D expansion in the diabetes therapeutics field, with one new product approved for marketing in 2018 and another in 2021. Currently, marketing applications for two additional oral antidiabetic drugs are under regulatory review and approval.

Figure 1: Status of the Latest Submitted Products

Source: CDE Official Website

Empagliflozin is a sodium-glucose cotransporter 2 (SGLT-2) inhibitor jointly developed by Boehringer Ingelheim and Eli Lilly and Company, used as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. The originator product was approved for the Chinese market in September 2017. Since 2020, domestically produced generic versions have been successively approved and passed the consistency evaluation. In 2021, it was included in the catalog of the fourth national centralized volume-based procurement program.

In 2020, across the sales channels of urban public hospitals, county-level public hospitals, urban community health centers, and township health centers (collectively referred to as China's public medical institutions) and urban physical pharmacies in China, the combined sales of the originator empagliflozin tablets exceeded RMB 100 million, achieving a growth rate of 374.64%. With the implementation of the fourth round of national centralized drug procurement, Hansoh, Kelun, Chia Tai Tianqing, and Jiangsu Wanbang are expected to experience a significant surge in sales volume within China's public medical institution channel. Meanwhile, in the urban physical pharmacy channel, sales of empagliflozin tablets continue to grow steadily. Newly approved products that missed the national procurement window may initially focus on the retail market to establish a foothold.

Figure 2: Sales of Empagliflozin in Urban Physical Pharmacies in China (Unit: 10,000 RMB)

Source: MENET Chinese Urban Physical Pharmacy Terminal

Currently, four companies have obtained marketing approval for generic empagliflozin tablets produced in China. The Class 4 generic marketing applications for Yangzijiang Pharmaceutical Group Beijing Haiyan Pharmaceutical | Jiangsu Coast Pharmaceutical and Jiangsu Aosaikang Pharmaceutical are under regulatory review and approval. BRILLIANT PHARMACEUTICALS has now also entered the competitive landscape.

Table 1: Latest Status of BRILLIANT PHARMACEUTICALS' Diabetes-Related Medication Products

Source: MENET MED2.0 China Drug Evaluation Database

BRILLIANT PHARMACEUTICALS has obtained marketing approvals for three products in the antidiabetic sector, including Gliclazide Tablets (II), Alpha-Lipoic Acid Injection, and Metformin Hydrochloride Extended-Release Tablets. Alpha-Lipoic Acid Injection is indicated for sensory abnormalities caused by diabetic peripheral neuropathy, while Gliclazide Tablets (II) and Metformin Hydrochloride Extended-Release Tablets are oral antidiabetic agents. Currently, the company's Class 4 generic marketing authorization applications for Dapagliflozin Tablets and Linagliptin Tablets are under regulatory review. Empagliflozin Tablets are expected to become the company's fifth approved oral antidiabetic drug.

Source: CDE official website, Menet database