Golidocitinib Capsules

On June 19, 2024, Digene Pharmaceuticals announced that the highly selective JAK1 inhibitor Golixitinib® (generic name: golixitinib capsules) developed by the company was officially approved by the China National Medical Products Administration (NMPA). The single drug is suitable for adult patients with relapsed or refractory peripheral T-cell lymphoma (r/r PTCL) who have received at least one line of systemic treatment in the past.
Golixitinib® was approved for marketing in China through priority review this time, based on the global key registration clinical study “JACKPOT8 Part B” (JACKPOT8 Part B, JACKPOT8B), which aims to evaluate the efficacy and safety of Golixitinib® in the treatment of r/r PTCL. The primary endpoint is the objective response rate (ORR) assessed by the independent imaging review committee (IRC). The results of the study were announced in the form of an oral report at the 65th American Society of Hematology (ASH) Annual Meeting in 2023, and were simultaneously published in Lancet Oncology (IF: 54.4).

The results of the study showed that Golidocitinib® monotherapy for r/r PTCL:

The ORR confirmed by IRC reached 44.3%, and the complete remission (CR) rate reached 23.9%, both of which were nearly twice that of previous targeted therapy regimens.
Tumor remission was observed in different subtypes of PTCL, meeting the treatment needs of PTCL subtypes that were not covered by previous drugs.
The median duration of remission (DoR) was as long as 20.7 months (the DoR of other existing therapies is less than 12 months).
Golidocitinib (DZD4205) is a highly selective Janus kinase 1 (JAK1) inhibitor and a new mechanism of treatment for PTCL that acts on the JAK/STAT pathway.
Peripheral T-cell lymphoma (PTCL) is a malignant tumor originating from post-thymic mature T/NK cells. It has the lowest survival rate among all non-Hodgkin’s lymphomas. The first-line standard treatment is CHOP-based quadruple chemotherapy. Patients who achieve remission after treatment have a very high risk of recurrence. The survival prognosis of r/r PTCL patients is extremely poor. Previous monotherapy for this group has extremely limited effects, with a 3-year survival rate of only 23% and a median overall survival (OS) of only 5.8 months. The bottleneck of clinical treatment urgently needs innovative breakthroughs.