burst! The first imitation of lanthanum carbonate will be approved soon

On February 21, according to the nmpa website, the application for listing of six generic Lanthanum Carbonate Chewable Tablets of Hunan Mingrui Pharmaceutical Co., Ltd has been approved According to the timeline of the evaluation of the drug in insight database, it is expected that the possibility of approval is very high If approved, Hunan Mingrui Pharmaceutical Co., Ltd will be the first enterprise in China to win the first imitation of lanthanum carbonate Lanthanum carbonate (trade name: fosrenol) is a calcium free and resin free phosphate binder developed by shire and approved for the control of hyperphosphatemia in patients with chronic renal failure undergoing dialysis Compared with the traditional phosphate binders, lanthanum carbonate is more effective and safer It can not only reduce the level of phosphate in patients' serum, but also can not lead to the increase of blood calcium and other serious side effects It should be noted that lanthanum carbonate should be taken with or immediately after a meal in order to combine the phosphate in food more effectively Lanthanum carbonate chewable tablets were approved in Japan as early as March 2009 (Shire authorized lanthanum carbonate to Bayer in December 2003 Yakuhin), which was approved by the US FDA in 2004 for the treatment of hyperphosphatemia in patients with end-stage renal disease (ESRD), was approved in China in October 2012 for the treatment of hyperphosphatemia in patients with chronic renal failure on hemodialysis or continuous ambulatory peritoneal dialysis (CAPD), the trade name is foslino Later, shire launched lanthanum carbonate granules and lanthanum carbonate powder, among which lanthanum carbonate powder was approved by FDA in September 2014 The dosage form can be poured on apple pie and other foods to take with food, making it more convenient to use At present, lanthanum carbonate provides a new and simpler treatment for up to 1.4 million patients undergoing dialysis in the world According to the data of mienei.com, from 2013 to 2017, the annual sales growth rate of lanthanum carbonate chewing tablets in China's hospitals is over 100%, and the market scale is expected to reach 800 million yuan in 2022 However, at present, the market of lanthanum carbonate in China is monopolized by shire According to insight database, in addition to Hunan Mingrui pharmaceutical, there are two domestic enterprises applying for listing lanthanum carbonate chewable tablets according to four types of generic drugs (see the table below for details) In addition, Chengdu Shengdi Pharmaceutical Co., Ltd has applied for the generic listing of lanthanum carbonate granules As for hyperphosphatemia, hyperphosphatemia refers to the situation that the concentration of phosphate in the blood of patients is higher than the normal level, without obvious symptoms, but the high concentration of phosphate in the blood for a long time will affect the deposition of calcium and phosphorus, cause hypocalcemia, then cause secondary hyperthyroidism, renal osteopathy, etc., and may also cause serious cardiovascular complications Hyperphosphatemia is a common and serious disease in patients with chronic kidney disease (CKD) undergoing dialysis At present, phosphorus bond is the only approved treatment method for hyperphosphatemia The traditional phosphorus bond includes calcium carbonate, calcium acetate and aluminum hydroxide, while the new generation of phosphorus bond without calcium aluminum includes lanthanum carbonate and hydrochloric acid / sviram carbonate According to insight database, at present, there are only three components approved for the treatment of hyperphosphatemia in China, namely calcium acetate, lanthanum carbonate and sveram Among them, sweram is a kind of polymer that will not be absorbed by human body, and it does not contain metal and calcium It can reduce blood phosphorus by carrying its own amino group in intestinal tract, and combining ion exchange and hydrogen bond with phosphoric acid molecules And at present, only jianzan bio's carbonated siram tablet (trade name: novele) has been approved for listing in China However, according to statistics, as many as 50% of the patients can not reach and maintain the target serum phosphorus level even though they take the phosphorus bond, the field still needs new treatment drugs It is worth looking forward to that tenapanor, an inhibitor developed by ardelyx company to inhibit the local sodium / hydrogen exchange protein 3 (NHE3) in the gastrointestinal tract, has reached the main research end point in the critical phase 3 trial for the treatment of hyperphosphatemia in dialysis patients with chronic kidney disease (CKD), while Fosun medicine also obtained ardelyx's information on tenapanor in the region (including Mainland China and Hong Kong) in December 2017 In addition, the registration of clinical trials of tenapanor tablet for the treatment of hyperphosphatemia in dialysis patients with end-stage renal disease has been accepted by the State Food and Drug Administration in November 2019 In addition, tenapanor has been approved by FDA for the treatment of constipated irritable bowel syndrome, and its clinical trial application for the treatment of constipated irritable bowel syndrome has also been accepted by CDE.