Dizal Pharmaceutical Receives US FDA Fast Track Designation for DZD4205 (Golidocitinib) for the Treatment of Refractory or Relapsed Peripheral T-Cell Lymphoma – PRNewswire

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Fast Track Designation proves Dizal’s world leading capability of developing potential first-in-class and much needed therapy to cancer patients
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Feb 18, 2022, 07:00 ET
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SHANGHAI, Feb. 18, 2022 /PRNewswire/ — Dizal Pharmaceutical Co., Ltd. (SHEX:688192) ("Dizal"), today announced 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).
"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.
About Dizal Pharmaceutical
Dizal Pharmaceutical is a clinical stage, global biopharmaceutical company dedicated to discovery, development and commercialization of innovative medicines. Dizal has built world’s leading position in the translational science, new-drug molecular design and screening technology platform. It has developed a diversified portfolio of innovative therapies for the treatment of cancer, immunological diseases and chronic kidney diseases.
Forward looking statement
This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Dizal Pharma, are intended to identify certain of such forward-looking statements. Dizal Pharma does not intend to update these forward-looking statements regularly.
These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Dizal Pharma with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Dizal Pharma’s control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Dizal Pharma’s competitive environment and political, economic, legal and social conditions.
Dizal Pharma, the Directors and the employees of Dizal Pharma assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect.
Source
[1] U.S. Food and Drug Administration. Fast Track. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track. Accessed February 17, 2022.
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SOURCE Dizal Pharmaceutical
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