Hengrui Medicine unit wins approval for kidney disease drug

Chengdu Shengdi Pharmaceutical Co., a subsidiary of Jiangsu Hengrui Medicine Co., Ltd., announced it has received approval from the National Medical Products Administration for its Palicalcitol Soft Capsules. This drug is approved for the prevention and treatment of secondary hyperparathyroidism (SHPT) in adults with stage 3-4 chronic kidney disease (CKD). The approval follows a cumulative research and development investment of approximately RMB 57.94 million for the project.

Palicalcitol Soft Capsules are a synthetic vitamin D analogue that inhibits parathyroid hormone (PTH) secretion by binding to vitamin D receptors, thereby lowering serum PTH levels. This treatment addresses SHPT, a prevalent and severe complication in CKD patients, often manifesting early in the disease progression.

The drug, which comes in 1µg and 2µg specifications, marks Jiangsu Hengrui Medicine as the first generic drug enterprise in China to obtain approval for this particular formulation, effectively passing the consistency evaluation for generic drug quality and efficacy. The original drug, developed by AbbVie, was approved by the FDA in May 2005 but had not yet been launched in China.