The secondary hyperparathyroidism drug etacatide is reported to be produced in China

Recently, Amgen’s application for the marketing of "etecartide hydrochloride injection" was accepted by the CDE.

Secondary hyperparathyroidism (SHPT), referred to as secondary hyperparathyroidism, is one of the important manifestations of mineral metabolism disorders (MBD), referring to chronic renal insufficiency, intestinal malabsorption syndrome, Fanconi synthesis Symptoms and renal tubular acidosis, vitamin D deficiency or resistance, and pregnancy, breastfeeding and other reasons caused by high blood calcium, high blood phosphorus, and low blood magnesium make the parathyroid glands proliferate and hypertrophy after stimulation, and secrete excessive parathyroid glands Gland hormone (PTH), compensatoryly maintains blood calcium and blood phosphorus normal.

SHPT is a common complication of chronic kidney disease (CKD), among which hyperphosphatemia, the decrease of 1,25-dihydroxyvitamin D and the slight decrease of serum calcium caused by this are considered to be the main factors in the pathogenesis of SHPT.

At present, in addition to parathyroidectomy and interventional therapy, SHPT can also choose phosphorus binders (such as sevelamer), vitamin D, active vitamin D (calcitriol) and its analogs (such as alfa bone).

Among them, the original drug Cinacalcet is a calcium-sensitive receptor agonist developed by NPS Pharmaceuticals (later licensed to Amgen and Kyowa Fermented Kirin Pharmaceuticals), which enhances the sensitivity of calcium-sensitive receptors to calcium levels in the bloodstream.

Cinacalcet is the first oral calcium-sensitive receptor agonist approved by the FDA for the treatment of SHPT in adult CKD patients undergoing dialysis treatment.

The reported production of etelcalcetide (Parsabiv) is also a new type of calcium-sensitive receptor agonist, which can regulate the secretion of parathyroid glands from calcium-sensitive receptors on the surface of parathyroid main cells, thereby reducing the parathyroid glands.

It is worth mentioning that the head-to-head study (Study 20120360) between Etecartide (AMG416) and Cinacalcet (Sensipar) was successful in 2015.

Parsabiv is the successor of Sensipar/Mimpara.

In China, Etecartide was first applied for clinical trials in China in 2015.

In addition to cinacalcet and etecatide, another calcium-sensing receptor modulator evocalcet (Ivankaser, trade name Orkedia) is currently approved globally.

In addition, Tasly Pharmaceuticals in my country introduced a treatment drug AJT240 from Japan's EA Pharmaceutical Co.