Cinacalcet: The growth rate is 143%, the patent period expires, and the domestic imitation is up again!
Cinacalcet, the first drug in a new class of calcimimetic compounds, was approved by the FDA in 2004 for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease (CKD) undergoing dialysis ( SHPT).
The original research Cinacalcet was developed by NPS Pharmaceuticals Inc, and then licensed to Amgen and Kyowa Fermentation Kirin Co., Ltd., and was first approved for listing in the United States in March 2004 under the trade name Sensipar; in December of the same year, it was approved for listing in Europe. Name Mimpara.
In 2015, Cinacalcet's sales exceeded 1 billion U.S. dollars. In 2018, Cinacalcet's global sales were 1.774 billion U.S. dollars. In recent years, the growth rate of Sensipar/Mimpara has slowed down, but it is still in a growth trend. With reference to its sales data, it can be seen that Cinacalcet Hydrochloride plays an important role in the global pharmaceutical market.
c Cinacalcet core patent US6011068 expires on March 8, 2018. It was too late and it was fast. On the same day, the products of two generic drug companies, AUROBINDO PHARMA LTD and CIPLA, were approved by the FDA. Up to now, a total of 18 generic drug companies (including Tentative Approval) have been approved in the United States.
In 2014, Cinacalcet entered the Chinese market under the trade name: Gaiping. At present, the domestic market is still dominated by Concord Fermented Kirin, accounting for 98.37%, and Jiangsu Jiayi Pharmaceutical accounts for 1.63%. In 2019, the sales of urban public hospitals were 115 million yuan, a year-on-year increase of 90.22%; the first half of 2020 has already harvested 112 million yuan, an increase of 142.98% compared with the same period, and the increase is expected!
With the expiration of patents, domestic companies have accelerated the listing of generic drugs. Jiangsu Jiayi is at the forefront. Its new 4 types of cinacalcet hydrochloride tablets were approved for listing in April 2020, and won the first imitations. The first company to pass the evaluation; in October of the same year, Hebei Yikang Pharmaceutical followed closely behind and became the second company to be approved for the production of this product and deemed to have passed the evaluation; since 2021, there have been Nanjing Hengsheng, Fujian Haixi, and Beijing Three Baiao companies have been approved for review.
It can be seen that, for this international heavyweight product, domestic companies have responded quite quickly.
In December 2020, Gai Ping (Concord Fermented Kirin) passed the medical insurance renewal and became a national medical insurance Class B drug. With the advantages of medical insurance coverage, Cinacalcet has gradually shown a trend of rapid growth in China, and the market prospects are promising.
About Cina Kasse
Cinacalcet is the first approved oral calcimimetic that activates calcium receptors in the parathyroid glands, thereby reducing the secretion of parathyroid hormone (PTH).
For SHPT patients who are not suitable for parathyroidectomy or have failed surgery, cinacalcet has a good effect, can significantly reduce the serum level, and the incidence of adverse reactions is not high. It is expected to become an important treatment for such patients.
About secondary hyperparathyroidism (SHPT)
SHPT is a common and severe decompensation disease in chronic kidney disease (CKD) patients undergoing dialysis treatment. It is one of the important manifestations of mineral metabolism disorders and an important pathological basis that directly leads to cardiovascular complications in CKD patients.
The results of the 2012 Chinese epidemiological survey showed that the number of patients with end-stage renal disease in China is about 2 million, the dialysis rate is less than 20%, and the conversion rate of SHPT in patients with mineral and bone metabolism disorders (CKD-MBD) is close to 50% . The dialysis rate in developed countries (the United States, Europe, Japan) is 90%.
It can be predicted that the number of people with SHPT in my country in the future will release greater room for growth as the level of diagnosis, testing, and treatment of chronic kidney disease improves.
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