Nanjing Zhengda Tianqing's Mirabegron Sustained-Release Tablets Nearing Approval, Targeting a $1.5 Billion Market

Recently, Chia-TaiTianqing's mirabegron sustained-release tablets, filed as a Category 4 generic drug, have entered the administrative approval stage and are expected to be approved for marketing soon. Mirabegron is a selective β3-adrenergic receptor agonist with global sales of 163.6 billion yen in 2020 and has been included in the second batch of the encouraged generic drug list.

Mirabegron, a selective β3-adrenergic receptor agonist developed by Astellas, is primarily used to treat urinary urgency, frequency, and incontinence caused by overactive bladder. The product was first approved for marketing in Japan in September 2011 and received approval for marketing in China in December 2017.

Since its launch, the global market for Mirabegron has been on a yearly upward trend. In 2020, the global sales of Astellas' Mirabegron Sustained-Release Tablets reached 163.6 billion yen (approximately 1.538 billion US dollars, based on the average exchange rate in 2020). Data from Menet shows that the Mirabegron market in China is in the development stage, with terminal sales in Chinese urban physical pharmacies exceeding 15 million yuan in 2020, representing a year-on-year increase of 152.34%.

Sales of Mirabegron in Chinese Urban Physical Pharmacy Terminals (Unit: Ten Thousand Yuan)

Source: Terminal Competition Pattern of Physical Pharmacies in Chinese Cities by Menet

Currently, six companies in China have submitted generic registration applications for Mirabegron Sustained-Release Tablets, including Zhejiang Huayi Pharmaceutical, Chia-TaiTianqing, Qilu Pharmaceutical, CSPC, Sichuan Guowei Pharmaceutical, and Shenzhen Wanle Pharmaceutical.

On April 13, 2021, Zhejiang Huayi Pharmaceutical's Mirabegron Sustained-Release Tablets were approved for marketing, becoming the first generic version in China. The registration status of this product by Chia-TaiTianqing has changed to "under review." If approved smoothly, it will be considered as meeting the standards and become the second domestically produced version in China.

Data source: MiNeiNet database, NMPA

Note: The Mennic City Physical Pharmacy Terminal Competition Pattern Database covers physical pharmacies in 297 prefecture-level cities and above across China (excluding physical pharmacies in counties, villages, and towns), providing continuous monitoring of all product categories. This is an expanded version of the city physical pharmacy database. The sales figures mentioned above are calculated based on the average retail price of products at the terminal.