Jingxin Enters with a Product of Two Specifications: A Sketch of the Rosuvastatin Market in China

The Rosuvastatin Calcium Tablets of two specifications (5mg/10mg) of Zhejiang Jingxin Pharmaceutical passed the consistency evaluation in the middle of February 2018, wherein, the 5mg specification is the first tablet of its kind passing the consistency evaluation in China. The Rosuvastatin Calcium Tablets of 10mg specification of Chiatai Tianqing appeared in the list of first batch of pharmaceutical products passing the generic drug quality and efficacy consistency evaluation in China published by CFDA at the end of December 2017, which is the first product of its kind passing the consistency evaluation in China.

Rosuvastatin Calcium Tablets is a core product of Zhejiang Jingxin, and its approval this time marks that Jingxin Pharmaceutical is in the first tier on the rosuvastatin market of China with Chiatai Tianqing.

Rosuvastatin: super-statin

Originally developed by AstraZeneca, Rosuvastatin Calcium Tablets was approved by FDA in 2003 to reduce risks of stroke, atrial fibrillation, and arterial revascularization of patients, and is praised as a "super-statin" owing to characteristics of potent, quick, and safe lipid lowering.

Currently, there is huge market space for the drugs for cardiovascular diseases: according to statistics, the number of relevant patients reaches 290 million in China, and the prevalence is in the rising stage. Statins dominate among the multiple lipid-lowering products. The proportion of statins in the lipid-lowering products exceeded 84% in 2016, wherein, the atorvastatin and rosuvastatin were the major products on the statins market.

Market pattern in China

The Rosuvastatin Calcium Tablets under AstraZeneca was approved to enter the Chinese market in 2006, with the trade name of Crestor of which the patent has expired. By the date of this article, pharmaceutical enterprises with the production approval for Rosuvastatin Calcium Tablets in China include: Lunan Better Pharmaceutical, Zhejiang Jingxin Pharmaceutical, and Jiangsu Chiatai Tianqing, etc., with the main dosage forms of tablet, capsule, and dispersible tablet.

Wherein, enterprises with the production approval for both API and preparation include Zhejiang Jingxin Pharmaceutical, Zhejiang Hisun Pharmaceutical, and Jiangsu Chitai Tianqing; Lunan Better possesses rosuvastatin calcium dispersible tablet, tablet, and capsule at the same time, and upon this unique advantage, the market shares of its products are rapidly growing.

According to the sales data in public hospitals of key cities in China provided by menet.com, the sales of rosuvastatin calcium were RMB 664 million in 2016, growing by 10.91% year on year, wherein, the Crestor under AstraZeneca accounted for 69.8%, followed by Ruizhi under Lunan Better, accounting for 14.01%, and then followed by Jingnuo of Zhejiang Jingxin, and Tuotuo of Jiangsu Chiatai Tianqing, separately accounting for 7.86% and 6.11%.

Future competition

Lunan Better has the largest market share of rosuvastatin calcium upon Ruizhi series among Chinese pharmaceutical enterprises, wherein, Ruizhi 5mg is the featured product specification of Lunan Better, with the market share in China exceeding 70% among products of its specification and kind. It’s reported that the clinical BE test of the 10mg product of Lunan Better has been completed. Lunan Better is expected to be the next pharmaceutical enterprise very likely to pass the consistency evaluation of Rosuvastatin Calcium Tablets.

From the perspective of those having passed the consistency evaluation, Chiatai Tianqing is approved the 10mg variety, and Zhejiang Jingxin is approved both the 5mg and 10mg products. Both Chiatai Tianqing and Zhejiang Jingxin have the conditions and confidence to expand the market shares of their products with the help of the favorable policies as they are gradually implemented, especially the approved 5mg product of Zhejiang Jingxin seems to be one of the strong competitors of Lunan Better’s 5mg Ruizhi in the future.

In particular, the imported product Crestor still dominates the rosuvastatin calcium market in China; therefore, the Chinese-produced products of its kind should work hard. Anyway, it seems to be only an event with high probability to be time-tested that the Chinese-produced rosuvastatin calcium tablets will gradually expand the scope of import substitution and reshape the market pattern in China in the long term.

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