Beijing News (Reporter Liu Xu) On January 29, Qilu Pharmaceutical announced that mirabegron sustained-release tablets, a drug for the treatment of overactive bladder (OAB), were approved for marketing by the National Medical Products Administration and deemed to have passed the consistency evaluation.
Mirabegron, developed by Astellas, is a selective β3-adrenergic receptor agonist primarily used to treat urgency, frequency, and incontinence caused by overactive bladder. The product was first approved for marketing in Japan in September 2011 and received approval in China in December 2017. Mirabegron sustained-release tablets are the first new mechanism of action drugs for overactive bladder approved domestically and internationally in nearly 30 years. It can be used alone or in combination with existing treatments for overactive bladder.
On April 13, 2021, Zhejiang Huayi Pharmaceutical's Mirabegron Sustained-Release Tablets were approved for marketing, becoming the first domestically produced generic version in China. Mirabegron Sustained-Release Tablets from Zhengda Tianqing Pharmaceutical, Shijiazhuang Pharmaceutical Group Zhongnuo Pharmaceutical, Shenzhen Wanle Pharmaceutical, and Sichuan Guowei Pharmaceutical have also been approved.
According to Astellas' financial report data, the market for Mirabegron has continued to grow in recent years. Global sales were approximately 8.84 billion yuan in 2021 and about 9.66 billion yuan in 2022, representing a year-on-year increase of 9.5%. According to the PharmaCloud database, hospital sales of Mirabegron Sustained-Release Tablets exceeded 30 million yuan in 2022, marking a year-on-year increase of 167%.
Proofread by Zhai Yongjun