Hansoh Pharmaceutical Gets NMPA Approval for HIF-2α Inhibitor HS-10516 Clinical Study

China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for its Category 1 candidate drug, HS-10516. The trial will evaluate the small-molecule hypoxia-inducible factor 2α (HIF-2α) inhibitor as a potential treatment for renal cell carcinoma (RCC).

Licensing Agreement with NiKang Therapeutics
In May 2022, Hansoh entered into a licensing agreement with US-based NiKang Therapeutics Inc., securing the development and commercialization rights to HS-10516 in China, including Hong Kong, Macau, and Taiwan. This agreement positions Hansoh to leverage its expertise in developing HS-10516 for the treatment of RCC within the region.

Preclinical Studies and Potential Efficacy
Prior to the clinical trial approval, HS-10516 has undergone preclinical studies that demonstrated promising biological and pharmacokinetic (PK) characteristics. These studies suggest that HS-10516 may offer excellent efficacy as a treatment for RCC, a type of kidney cancer that requires innovative therapeutic options.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry