Lepu Pharma's Combination Antihypertensive Drug Valsartan and Amlodipine Tablets (I) Enters Administrative Approval Stage

Recently, Lepu Pharmaceutical's Valsartan and Amlodipine Tablets (I), submitted as a Category 4 generic drug, have entered the administrative approval stage and are expected to be approved for marketing soon. Valsartan and Amlodipine Tablets (I) is a combination antihypertensive drug, with total sales exceeding 2.5 billion yuan in Chinese public medical institutions and retail pharmacies in Chinese cities by 2020.

The original research enterprise of Valsartan and Amlodipine Tablets (I) is Novartis. It is a single-pill combination formulation composed of the angiotensin receptor blocker valsartan and the calcium channel blocker amlodipine, suitable for patients whose blood pressure is not adequately controlled by monotherapy with either valsartan or amlodipine.

Data from Menet shows that in 2020, the total sales of Valsartan and Amlodipine Tablets (I) at China's urban public hospitals, county-level public hospitals, urban community health centers, and township health centers (referred to as Chinese public medical institutions), as well as retail pharmacies in Chinese cities, exceeded 2.5 billion yuan.

Whether in medical institutions or physical pharmacies, the market size of Valsartan and Amlodipine Tablets (I) shows an increasing trend year by year. Notably, in recent years, the sales growth rate of Valsartan and Amlodipine Tablets (I) in urban physical pharmacies in China has exceeded 20%. In 2020, the sales reached 428 million yuan, a year-on-year increase of 27.56%, and it is expected that the sales in 2021 will exceed 500 million yuan.

Sales of Valsartan and Amlodipine Tablets (I) in Physical Pharmacies in Chinese Cities (Unit: 10,000 Yuan)

Source: MiNei Network's Competitive Landscape of Physical Pharmacies in Chinese Cities

Although nine local companies in China have received approval for the production of Valsartan and Amlodipine Tablets (I) and are considered to have passed the evaluation, more than ten pharmaceutical companies still have their marketing applications under review. The registration status of this product by Lepu Pharmaceutical has been changed to "under approval," and if approved smoothly, it will be considered as having passed the evaluation.

Data source: MiNeiNet database, NMPA