Dizal Pharmaceutical Receives U.S. FDA Fast Track Designation for DZD4205 (Golidocitinib) for the Treatment of Refractory or Relapsed Peripheral T-Cell Lymphoma

On February 18, 2022 Dizal Pharmaceutical Co., Ltd. (SHEX:688192) ("Dizal"), reported that the U.S. Food and Drug Administration ("FDA") has granted Fast Track Designation to DZD4205 (Golidocitinib) for the treatment of patients with Refractory or Relapsed Peripheral T-Cell Lymphoma (r/r PTCL) (Press release, Dizal Pharma, FEB 18, 2022, View Source [SID1234608331]).

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"Relapsed or refractory peripheral T-cell lymphoma is an aggressive and rare type of non-Hodgkin lymphoma. Patients with r/r PTCL are often associated with poor prognosis. Couple years ago, our translational science team first identified JAK1 as a potential target for PTCL treatment. Based on the finding, we launched clinical studies to test the hypothesis. Now, we have patient data which validated our translational science finding. This is a great example of translational science-driven drug development." said Dr. Xiaolin Zhang, Chief Executive Officer at Dizal. "The FDA Fast Track Designation for DZD4205 is an important milestone and we look forward to working closely with the U.S. FDA to potentially bring this treatment to our patients."

Fast track is a process designed by U.S. FDA to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier [1].

About DZD4205 (Golidocitinib)

DZD4205 (Golidocitinib) is an orally available, potent, and JAK1-specific inhibitor. The preliminary data from an ongoing phase I/II study in r/r PTCL shows that 21 (42.9%) out of the 49 patients have achieved tumor response.

Dizal is conducting Phase II pivotal clinical trials in the U.S., China, Australia, South Korea and other countries and regions.