Dizal (Jiangsu) Pharmaceutical Co Ltd’s golidocitinib was granted priority review designation by the China National Medical Products Administration (NMPA) in September 2023. As a result, golidocitinib is expected to evolve as a potential therapeutic option for peripheral T-cell lymphoma (PTCL), a type of non-Hodgkin lymphoma (NHL) in China upon receiving regulatory approval, says GlobalData, a leading data and analytics company.

The Priority Review designation for golidocitinib’s application was supported by data from the global, multi-center pivotal Phase I/II study (JACKPOT8 PARTB (NCT04105010)) as monotherapy in relapsed/refractory (r/r) PTCL as second-line/third-line therapy.

The current marketed drugs space for PTCL is occupied by Histone Deacetylase 1 inhibitors (coccidiostat), Topoisomerase II inhibitors (mitoxantrone hydrochloride), and Dihydrofolate Reductase inhibitors (pralatrexate). Golidocitinib stands out as the first and currently the only Janus kinase 1 (JAK1) selective inhibitor for the treatment of PTCL.

Nelluri Geetha, Pharma Analyst at GlobalData, comments: “Golidocitinib has good antitumor efficacy in different subtypes of peripheral T-cell lymphoma (PTCL), which is a group of heterogeneous diseases. Notably, two additional Phase II studies for golidocitinib are ongoing for PTCL as first and second-line therapy in China. The JAK1 inhibitor ivarmacitinib sulfate (planned for Phase I) is another drug in development for the treatment of PTCL by ‘The Cancer Hospital of Zhengzhou University’ in China.”

According to GlobalData’s Pharmaceutical Intelligence Center, the number of 5-year diagnosed prevalent cases of T-cell lymphomas in China is expected to increase at an annual growth rate (AGR) of 4.65% from 47,882 in 2022 to 64,413 in 2030. Therefore, there is an urgent need for novel and innovative treatment options to improve survival in this patient population.

Geetha concludes: “Golidocitinib is the only innovative drug to receive a priority review designation for PTCL in China. The drug exhibited an objective response rate (ORR) of 44.3% and a complete response rate (CRR) of 23.9%. More than 50% of the patients with tumor remission achieved a complete response. The longest duration of response (DoR) recorded was 16.8 months, asserting the drug’s ability to deliver enduring benefits. This presents an opportunity for Dizal Pharma to establish competition with existing anti-tumor drugs and is anticipated to become the second oral therapy for PTCL to penetrate the Chinese market.

“In addition, golidocitinib will be the second drug to enter the Chinese market from Dizal Pharma, the first being Schwartz (sunvozertinib), approved for non-small cell lung cancer (NSCLC).”