Three PK, Mirabellon will be the first imitation of Huadong Medicine

Recently, the listing application of Hangzhou East China Pharmaceutical Group 4 generic drug " Milaberon Sustained Release Tablets " (relevant acceptance number is CYHS1900699) changed its status at NMPA to "Under Approval", and it is expected that it will be officially approved soon and become a domestic Approved the first domestic-made Mirabegron sustained-release tablet
.

Mirabegron (Myrbetriq) is a selective β3-adrenergic receptor agonist developed by Astellas for the treatment of overactive bladder (OAB) including urinary incontinence, urgency and frequent urination.
, Its sustained-release tablets were first approved in Japan in September 2011 (trade name Betanis), in the United States in June 2012 (trade name Myrbetriq), and in Europe in December 2012 (trade name Betmiga) )
.

In March 2021, Myrbetriq was approved by the FDA to expand the indication population to pediatric patients, becoming the first product of its kind approved by the FDA to treat children's NDO.

Up to now, nearly 18 million adult patients with urinary system diseases have received Myrbetriq treatment worldwide
.

According to Astellas’ financial report, Myrbetriq’s sales have been increasing year by year since its listing.

In China, the original Mirabegron sustained-release tablets were approved in China in October 2017 under the trade name Betani
.

In 2020, Mirabellon successfully entered the 2020 National Medical Insurance List through medical insurance negotiations

According to the Insight database, many domestic companies are currently deploying the Mirabegron generic drug market.
Among them, Hangzhou East China Pharmaceutical Group, Nanjing Zhengda Tianqing and Sichuan Guowei Pharmaceutical have successively submitted Mirabegron sustained-release tablets 4 generic drugs.
Listing application
.

In addition, Ruiyang Pharmaceuticals, Jiangsu Huayang Pharmaceuticals, Shenzhen Wanle Pharmaceuticals and Jiangxi Shanxiang Pharmaceuticals are in the BE trial phase, and Aixian Pharmaceutical is in the phase III clinical trial phase

This time, Huadong Medicine's application for Mirabegron sustained-release tablets has entered the administrative approval stage first, and it is very likely that it will obtain the qualification for the first imitation of Mirabegron
.

       Huadong Medicine is a pharmaceutical company established in 1993 that integrates R&D, manufacturing, sales and commerce.
Its product portfolio and product pipeline mainly involve the fields of oncology, immunology, nephrology and diabetes
.

In October last year, Huadong Medicine reached a strategic cooperation and obtained the latter's Mirvetuximab Soravtansine's exclusive clinical development and commercialization rights in Mainland China, Hong Kong, Macau and Taiwan

       In addition to the deployment of innovative drugs, Huadong Medicine has already begun to enter the medical aesthetics market.
In 2013, it won the domestic exclusive agency of Hyaluronic Acid from South Korea's LG company, Yiwan.
The following year, Yiwan was listed in China.
According to Huachuang Securities Research Report, Yiwan Wan Wan's market share in 2021 is about 20%, and it will bring about 1 billion yuan in revenue to Huadong Medicine
.

       In recent years, Huadong Medicine has entered the medical aesthetics market more fiercely.
In 2018, it acquired Sinclair, an established British medical aesthetic company at a high price of 1.
49 billion yuan, and obtained the latter's product pipelines such as girl needles, high-end hyaluronic acid, and embedding products
.

In 2019, Huadong Medicine reached a cooperation agreement with R2 in the United States to obtain the distribution rights of its F1, F2 medical devices and their future improvements in 34 Asia-Pacific countries including mainland China, Japan, and South Korea