Betapharma Submits First Domestic ANDA for Dacomitinib Tablets; Pfizer's Sales Surge by 240%

On January 12, BRILLIANT PHARMACEUTICALS was the first to submit a Class 4 generic drug marketing application for dacomitinib tablets. Pfizer's dacomitinib tablets were officially approved for marketing in China in 2019 and successfully negotiated to enter the National Reimbursement Drug List (NRDL) by the end of 2021. This product is the only targeted lung cancer drug proven to have overall survival benefits in the Asian population.

Figure 1: Latest Product Application by BRILLIANT PHARMACEUTICALS

Source: CDE official website

Pfizer's Dacomitinib was officially approved for marketing in China in May 2019. It can be used as a single agent for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitutions. This product is the only targeted therapy drug with clinical trial results demonstrating overall survival (OS) benefits at the 21L858R site and in the Asian population.

Figure 2: Sales of Pfizer's Dacomitinib Tablets in the Retail Market (Unit: Billion Yuan)

Source: MiNeiNet China City Physical Pharmacy Terminal Pattern

Data from MiNe Network shows that after Dacomitinib tablets entered the Chinese market, they quickly gained sales in physical pharmacies in Chinese cities. In 2020, sales exceeded 110 million yuan with a growth rate of up to 240%, and it is estimated that in 2021, they will achieve new sales of 190 million yuan.

Earlier, this product had not yet been included in the medical insurance. In 2020, the sales revenue of dacomitinib tablets in China's urban public hospitals, county-level public hospitals, urban community health centers, and township health centers (referred to as the terminal of China’s public medical institutions) was around 50 million yuan. As the product successfully entered the 2021 National Medical Insurance Negotiation Catalog, 2022 will mark the beginning of its increased adoption in hospitals.

Figure 3: Top 20 Protein Kinase Inhibitor Varieties in the 2021E Retail Market

Source: MiNeiNet Chinese Urban Physical Pharmacy Terminal Pattern

In recent years, BRILLIANT PHARMACEUTICALS has continued to launch new products in the field of protein kinase inhibitors. In October 2021, it obtained the production approval for Lenvatinib Mesylate Capsules, and the recently submitted Dacomitinib Tablets will become the company's second tyrosine kinase inhibitor product. According to data from Menet, in 2021, both Lenvatinib and Dacomitinib ranked among the top 20 protein kinase inhibitor varieties in the terminal market of physical pharmacies in Chinese cities, showing promising market potential.