Dizal Announces China CDE Acceptance of New Drug Application for Golidocitinib for Relapsed or Refractory PTCL

News provided by

Sep 14, 2023, 05:07 ET

SHANGHAI, Sept. 14, 2023 /PRNewswire/ -- Dizal today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for golidocitinib for the treatment of relapsed or refractory peripheral T-cell lymphoma (r/r PTCL).

"We are thrilled that our NDA for golidocitinib has been accepted, marking our second successful NDA submission in 2023," said Xiaolin Zhang, Ph.D., Chairman and CEO of Dizal, "Golidocitinib, as a first-in-class JAK1-only inhibitor, has demonstrated a superior efficacy and safety profile. We believe it will provide a much-needed treatment option for patients with this challenging disease. At Dizal, we aspire to discover and develop differentiated therapeutics for the treatment of cancer and immunological diseases."

The JAK/STAT signaling pathway plays a vital role in the pathogenesis and progression of various hematologic malignancies, including T-cell malignancies. Golidocitinib, as the first and currently the only JAK1-only inhibitor in the NDA stage for r/r PTCL, shows promising potential in inhibiting tumor growth and proliferation by targeting the JAK/STAT pathway.

The NDA submission for golidocitinib is supported by data from the JACKPOT8 PARTB study, a multinational, pivotal study to evaluate the efficacy and safety of golidocitinib in patients with r/r PTCL. The primary endpoint of the study, objective response rate (ORR) assessed by an independent review committee (IRC), reached 44.3%, with a complete response rate (CRR) of 23.9%. Anti-tumor efficacy was observed across different PTCL subtypes and irrespective of the patients' prior treatment history. The majority of treatment-related adverse events (TRAEs) could be monitored and well managed in the clinic. These findings highlight the superior efficacy and safety of golidocitinib, positioning it as a potential breakthrough therapy for patients with r/r PTCL. Furthermore, the clinical significance of golidocitinib has been widely acknowledged at prestigious conferences such as ASCO, EHA, ICML, and ASH with five oral presentations for four consecutive years. Recently, the Phase I clinical data of golidocitinib for the treatment of r/rPTCL (JACKPOT8 PARTA) was published in the esteemed peer-reviewed journal, Annals of Oncology (Impact Factor: 51.8).

About golidocitinib (DZD4205)

Golidocitinib is the first-in-class Janus kinase 1 (JAK1) only inhibitor currently being evaluated in a global, multicenter pivotal study (JACKPOT8 PARTB) in r/r PTCL. At the data cut-off date of February 16, 2023, Golidocitinib has demonstrated robust and durable anti-tumor activity, with an ORR of 44.3% and a CRR of 23.9%. More than 50% of the patients with tumor remission achieved a complete response. The median relative dose intensity was 100%. Golidocitinib was granted Fast Track Designation by the U.S. FDA for the treatment of r/r PTCL in February 2022. In September 2023, the CDE accepted the NDA for the treatment of r/r PTCL. And the Phase I clinical data of golidocitinib for the treatment of r/r PTCL (JACKPOT8 PARTA) was published in Annals of Oncology (Impact Factor: 51.8).

About Dizal

Dizal is a biopharmaceutical company, dedicated to the discovery, development and commercialization of differentiated therapeutics for the treatment of cancer and immunological diseases. The company aims to develop first-in-class and groundbreaking new medicines, and further address unmet medical needs around the world. Deep-rooted in translational science and molecular design, it has established an internationally competitive portfolio of five clinical-stage assets with two leading assets in global pivotal studies and one already launched.

To learn more about Dizal, please visit www.dizalpharma.com, or follow us at Linkedin or Twitter.

Forward-Looking Statements

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", and "intend" and similar expressions, as they relate to Dizal, are intended to identify certain forward-looking statements. Dizal 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 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'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's competitive environment, and political, economic, legal, and social conditions.

Dizal, the Directors, and the employees of Dizal assume (a) no obligation to correct or update the forward-looking statements contained on this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turnout to be incorrect.

Contacts

Investor Relations: [email protected]

Business Development: [email protected]

SOURCE Dizal Pharmaceutical