Three Chinese Pharma Giants — Yangtze River Pharmaceutical, Shanghai Xinyi Wanxiang, and Hainan Linling — Receive Simultaneous Approval for Simvastatin Tablets

Recently, the official website of the National Medical Products Administration (NMPA) announced that the Simvastatin Tablets manufactured by Yangzijiang Pharmaceutical Group Sichuan Hairong Pharmaceutical Co., Ltd., SHANGHAI SINE WANXIANG PHARMACEUTICALS CO.,LTD., and Hainan Hailing Chemipharma Corporation Ltd. were all approved on the same day via supplementary applications, having passed the consistency evaluation. Data from Menet shows that in 2020, the combined sales revenue of Simvastatin Tablets at the terminal level of public medical institutions and urban physical pharmacies in China exceeded RMB 1 billion.

Data indicates that simvastatin tablets are lipid-lowering agents indicated for primary hypercholesterolemia, including heterozygous familial hypercholesterolemia, hyperlipidemia or mixed hyperlipidemia, homozygous familial hypercholesterolemia, coronary heart disease with hypercholesterolemia, and pediatric patients with heterozygous familial hypercholesterolemia. The original manufacturer of this product is Merck & Co., Inc.; it was approved for import into China in 2000, and the license holder is MSD.

Source: Menet One-Click Search

According to data from Menet, the combined sales of simvastatin tablets at terminals of Chinese public medical institutions (including urban public hospitals, county-level public hospitals, urban community health centers, and township health centers) and urban physical pharmacy terminals in China exceeded RMB 1 billion in 2020. The simvastatin tablet market is highly competitive, with more than 70 manufacturers.

Source: MED2.0 China Drug Evaluation Database

Regarding the consistency evaluation, eight manufacturers have passed the evaluation for Simvastatin Tablets. Among them, seven companies, including Zhejiang Jingxin Pharmaceutical, Hisun Pfizer Pharmaceuticals, and Yangzijiang Pharmaceutical Group Sichuan Hairong Pharmaceutical Co., Ltd., obtained approval through supplemental applications. Xiamen Lizhuo Pharmaceutical obtained approval for production under Class 4 generic drug application, which is deemed equivalent to passing the consistency evaluation.

Source: Official Website of the National Medical Products Administration, Menet Database