Hengrui ：HS-10568 marketing application submitted
On June 10, the CDE official website showed that the Category 1 new drug HS-10568 Injection has been submitted for marketing approval. Based on public information and clinical trial progress, the Insight database speculates that the submitted indication is for chronic kidney disease patients on maintenance hemodialysis with secondary hyperparathyroidism.
HS-10568 (SHR6508) is a calcium-sensing receptor (CaSR) allosteric modulator that increases receptor sensitivity to extracellular calcium, thereby reducing the secretion of parathyroid hormone (PTH).
In December 2025, Hansoh Pharma entered into a license agreement with Hengrui Medicine for this drug. Under the agreement, Hansoh Pharma obtained the rights to develop, manufacture, and commercialize SHR6508 in China (excluding Hong Kong, Macau, and Taiwan), with the right to further sublicense under the terms of the agreement. In consideration, Hansoh Pharma paid Hengrui an upfront payment of RMB 30 million, potential regulatory and commercial milestone payments of up to RMB 190 million, as well as tiered royalties at single-digit percentages on future potential net product sales.
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