Grand Medicine is expected to win the first imitation of Cinacalcet Hydrochloride

Original: dopine At present, four kinds of generic drug listing applications (acceptance No cyhs1700687) of sinakase hydrochloride tablets of Jiangsu Jiayi Pharmaceutical Co., Ltd are in "under review and approval" As the only domestic enterprise whose generic drug listing application of sinakase hydrochloride tablets has been included in the priority review list, Jiayi pharmaceutical is expected to take the lead in obtaining the first generic of sinakase hydrochloride and compete with the original research drug Geping Sinacase hydrochloride is an oral calcium sensitive receptor agonist, which can reduce the levels of parathyroid hormone, calcium, phosphorus and calcium phosphorus product by enhancing the sensitivity of receptor to calcium level in blood flow The drug was developed by NPs pharmaceuticals in the United States, As early as March 2004, it was approved to be listed in the United States by Amgen development, with the trade name of sensipar In December of the same year, it was approved to be listed in Europe, with the trade name of mimpara In 2007, it was developed by Concorde fermentation Kirin Pharmaceutical Co., Ltd and approved in Japan, with the trade name of regpara In June 2014, it was approved to be listed in China (produced by Concorde fermentation Kirin Pharmaceutical Co., Ltd.), with the trade name of Geping Approved indications for sinacase hydrochloride in the United States include secondary hyperparathyroidism (SHPT) in dialysis patients with chronic kidney disease, hypercalcemia in patients with parathyroid cancer, and hypercalcemia in patients with primary hyperparathyroidism In Japan and China, the approved indication of sinacase hydrochloride is SHPT in patients with chronic kidney disease (CKD) Since its listing, sales of sinakase have been increasing year by year According to the 2012 financial report of Amgen, the sales of sensipar / mimpara reached US $950 million, and it is expected that the global sales of sinakase hydrochloride in that year will exceed US $1 billion In recent years, the growth rate of sensipar / mimpara has slowed down, but it is still in the trend of growth, as shown in the table below (unit: US $100 million) Referring to the sales data of sensipar / mimpara, it can be seen that sinacase hydrochloride plays an important role in the global pharmaceutical market At present, there are only sinakasai hydrochloride tablets produced by kylin Co., Ltd in China, and in 2017, sinakasai hydrochloride tablets entered the national medical insurance catalog In recent years, the sales volume of sinakase hydrochloride in key provinces and cities in China has grown rapidly (see the figure below), and the sales volume in the first half of 2019 is as high as 21.52 million yuan, with a very good market prospect According to insight database, Geping (25mg / tablet) won the bid in many provinces in China, with the lowest bid price around 346 yuan / box The core patent of sinacasil hydrochloride in the United States has expired in March 2018, and the formula patent has expired in 2026 However, the FDA has approved a number of generic drugs It is worth mentioning that the sensipar generic launched by TIWA in 2018 has gained tens of millions of dollars in sales in a few days However, Amgen reached a settlement with TIWA later, and TIWA's generic drug probably won't be listed before 2021 In response to the impact of generics, Amgen not only filed patent lawsuits against some generics companies, but also launched a new generation of kidney disease drug, parabiv, which is also a calcium mimetic, which has been approved by FDA and EMA for SHPT treatment of chronic kidney disease (CKD) patients undergoing hemodialysis treatment, and the drug only needs to be used three times a week at the end of each dialysis Intravenous administration is better than that of sensipar (sensipar needs to be taken orally once a day) In China, according to insight database, there are also many enterprises in this field Among them, Jiayi pharmaceutical is the first one to submit the listing application with "new 4 categories" in August 2018 In October 2018, Jiayi pharmaceutical was publicized by the drug review center as the priority variety for review The reason is "the first application for drug production one year before the expiration of patent" At present, the listing application of sinacase hydrochloride of Jiayi medicine has completed the clinical on-site inspection and production on-site inspection, which is in the first round of development and supplement status, and is expected to be approved in the first quarter of 2020 In addition, Jiangsu Jiayi Pharmaceutical Co., Ltd has four ingredients in the stage of application for listing, of which apixaban and rivaroxaban are worthy of mentioning Both of them are clotting factor Xa inhibitors, and are heavy-duty products in the anticoagulant market At present, generic drugs have been approved in China reference material: [1] Amgen's financial report in recent years