Jiangsu Hengrui Medicine Gains NMPA Approval for Five Drug Candidates, Including IL-17A mAb for Psoriasis

Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a prominent pharmaceutical company in China, has announced that it has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for a total of five drug candidates. This development marks a significant step in the company’s pipeline advancement.

Vunakizumab, an IL-17A monoclonal antibody (mAb), is designed to target autoimmune diseases linked to the IL-17 pathway. It has been approved for a Phase III clinical study to treat moderate to severe plaque psoriasis in children and adolescents aged 6-18 years old who are candidates for systemic therapy or phototherapy. Global IL-17A products include notable drugs such as Novartis’s Cosentyx (secukinumab), Eli Lilly’s Taltz (ixekizumab), and Biocad’s Efleira (netakimab).

SHR-1819, another candidate, is capable of blocking the interleukin pathway, inhibiting the conduction of downstream inflammatory signals, and improving the inflammatory state to control disease progression. It is approved for a Phase II/III study in nodular prurigo. A similar product in the market is Sanofi’s Dupixent (dupilumab), which is used to treat atopic dermatitis.

The remaining three candidates are slated for clinical studies in advanced or malignant tumors, with no direct competitors currently available in the Chinese market. SHR-3821 is an antibody drug, SHR-7787 is a Category 1 biologic product that activates T cells to target and kill malignant solid tumor cells, and HRS-4508 is a novel tyrosine kinase inhibitor (TKI), all of which show promise in their respective therapeutic areas.- Flcube.com

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