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Golidocitinib Approved in China as First-in-class JAK1 Only Inhibitor for Treatment of Relapsed or Refractory Peripheral T-Cell Lymphoma

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Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, today announced that the National Medical Products Administration of China has approved golidocitinib for the treatment of adult patients with relapsed or refractory (r/r) peripheral T-Cell lymphoma (PTCL) whose disease has progressed on or were refractory to at least 1 prior systemic therapy. To date, golidocitinib is the first and only approved Janus kinase 1 (JAK1) selective inhibitor for r/r PTCL patients globally.

PTCL is a heterogeneous group of aggressive T-cell/natural killer (NK) cell non-Hodgkin lymphomas (NHL). Patients with PTCL face an extremely high risk of disease relapse even if they achieved tumor remission following first-line conventional therapy.

The outcome for relapsed or refractory patients is extremely poor, with a 3-year survival rate of 23% and a median overall survival (mos.) of 5.8 months. Although couple of drugs have been granted conditional approval by regulatory agencies in the relapsed or refractory setting, their single agent activities have been modest, with objective response rates (ORRs) lower than 30%.

Golidocitinib was approved based on findings from JACKPOT8 Part B (JACKPOT8B) study, the multinational pivotal study to evaluate the efficacy and safety of golidocitinib in r/r PTCL as a monotherapy. The primary endpoint was the objective response rate (ORR), assessed by an independent review committee (IRC).

Full analysis of the study was simultaneously published in The Lancet Oncology and presented in oral session at the 65th American Society of Hematology Annual Meeting and Exposition.

In JACKPOT8B study, golidocitinib demonstrated superior and durable antitumor efficacy and a favorable safety profile in r/r PTCL patients, compared with existing treatment options. At the data cut-off date August 31, 2023, the ORR was 44.3% including a complete response (CR) rate of 23.9% per IRC. Tumor responses were observed across various PTCL subtypes. The median duration of response (mDoR) was 20.7 months and 53.8% of patients were still responding.

“Golidocitinib features novel mechanism and unique molecular design, positioning it as the first oral JAK1 only inhibitor for the treatment of r/r PTCL. Multiple studies have clearly demonstrated its favorable pharmacokinetic properties and significant clinical benefit,” said Jun Zhu, MD, PhD at the Department of Lymphoma, Peking University Cancer Hospital and Institute, the leading principal investigator of the JACKPOT8B study, “Golidocitinib achieved an ORR of 44.3% and a DoR of 20.7 months in r/r PTCL. It’s approval and market launch provide a much needed option for doctors to treat PTCL patients.”

Dizal was the first to identify and validate targeting the JAK/STAT pathway as a promising therapeutic approach for PTCL, leading to the development of golidocitinib as the world’s first JAK1 only inhibitor. With > 200 to 400-fold selectivity over other JAK family members and ideal pharmacokinetic properties, golidocitinib exerts potent antitumor efficacy with a favorable safety profile.

“We are thrilled to bring golidocitinib, the world’s first JAK1 only inhibitor, to patients in China, marking the second approved innovative drug from Dizal,” said Xiaolin Zhang, PhD, CEO of Dizal. “Golidocitinib yields good antitumor efficacy across different subtypes of PTCL, which differentiate golidocitinib from other targeted therapies. At Dizal, we aspire to discover and develop first-in-class and groundbreaking new medicines to address unmet medical needs around the world. With the US FDA Fast Track designation, we are expediting global development of golidocitinib to bring this exciting drug to patients worldwide.”

With superior efficacy and safety profile, golidocitinib has been widely acknowledged at prestigious international congresses including ASCO, EHA, ICML, and ASH, with six oral presentations over four consecutive years. The results of the multinational study JACKPOT8 were published in Annals of Oncology and The Lancet Oncology.

Golidocitinib is currently the first and only Janus kinase 1 (JAK1) selective inhibitor being evaluated for the treatment of r/r PTCL. In June 2024, golidocitinib was approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (r/r PTCL).

At the data cut-off date of August 31, 2023, golidocitinib has demonstrated robust and durable anti-tumor efficacy, with an ORR of 44.3%. More than 50% of the patients with tumor remission achieved a complete response with a CRR of 23.9%. Per IRC assessment, mDoR reached 20.7 months.

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 its NDA and granted Priority Review for the treatment of r/r PTCL. The Phase I clinical data of golidocitinib (JACKPOT8 PART A) was published in Annals of Oncology (Impact Factor: 51.8), and global pivotal trial data of golidocitinib for the treatment of r/r PTCL (JACKPOT PART B) was published in The Lancet Oncology (Impact Factor: 54.4).

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