Pharma Focus Europe

Haisate Pharmaceuticals announced that the US FDA approved its Phase III clinical trial of TC Ointment, the world's first new plant small molecule drug for the treatment of psoriasis vulgaris

Tuesday, May 23, 2023

Hessate Pharmaceuticals announced today through its wholly-owned research institution Guangzhou Psoriasis Research Institute (PRIG) that based on the completed Phase IIb of the new drug in the United States Clinical trial (NCT03372811), the US Food and Drug Administration (FDA) has approved the initiation of a multi-center phase III clinical trial study of TC ointment, an investigational new drug (IND), in the treatment of patients with psoriasis vulgaris.

"The US FDA approved us to start the IND-III clinical trial, which is another important milestone in the final research and development stage of the company after successfully completing the phase IIb clinical trial of the world's first plant small molecule new drug for the treatment of psoriasis." Introduced by CEO Yang Liping

A randomized, double-blind, placebo-controlled, multi-center clinical trial of this new drug in the treatment of psoriasis vulgaris in the United States is about to start to further prove the effectiveness and safety of this world-class new natural plant small molecule drug. Chief Physician (Professor) Yang Liping, Managing Director of PRIG and CEO of Hessite Pharmaceuticals, said: "The approval of the IND-III clinical trial in the United States is an important milestone in the development of new drugs. The Phase IIb clinical trial results of the treatment also benefited from the multi-center clinical trial results of a new psoriasis drug in China approved by the China National Medical Products Administration (NMPA)! Our IND new drug TC ointment is a new topical treatment drug, which passed A breakthrough therapy targeting a variety of autoimmune signaling pathways to treat patients with psoriasis, aiming to address the unmet medical needs of patients and improve their long-term quality of life. With the US Food and Drug Administration Phase 3 clinical trial Approved, we are one step closer to enabling TC to successfully benefit millions of patients suffering from this disease around the world. We hope that TC will become the world's first first-line topical treatment botanical medicine, and also the first FDA-approved marketed herbal medicine. Three botanicals."

Haisate Pharmaceuticals is currently continuing to promote its global licensing strategy with biotech pharmaceutical partners, striving to release the market potential of this product as soon as possible.

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