Hansoh Pharma’s NDA for HS-10568 Injection Accepted by China’s NMPA

Bulletin Express06-10 18:44

Hansoh Pharmaceutical Group Company Limited (Hansoh Pharma) disclosed that the National Medical Products Administration (NMPA) formally accepted the New Drug Application (NDA) for HS-10568 Injection on 9 June 2026. The candidate, also known by collaborator code SHR6508, targets secondary hyperparathyroidism in adult chronic kidney disease patients undergoing hemodialysis.

HS-10568 is an allosteric modulator of the calcium-sensing receptor (CaSR). By enhancing the receptor’s sensitivity to extracellular calcium, the therapy is designed to curb excessive parathyroid hormone secretion, addressing a major complication in dialysis-dependent CKD.

The filing marks a milestone in Hansoh Pharma’s late-stage pipeline and underscores management’s strategic focus on innovative treatments within renal-related disorders. The Board, led by Chairlady Zhong Huijuan, released the information via a voluntary announcement to the Hong Kong Stock Exchange on 10 June 2026.

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