PTCL represents a diverse group of aggressive non-Hodgkin lymphomas, with patients at a high risk of disease relapse. Credit: Nemes Laszlo / Shutterstock.

The National Medical Products Administration (NMPA) of China has approved Dizal’s golidocitinib for adults with relapsed or refractory (r/r) peripheral T-cell lymphoma (PTCL).

This is the first global approval of a Janus kinase 1 (JAK1) selective inhibitor for r/r PTCL patients whose disease has advanced following a minimum of one previous systemic therapy or who were refractory to this.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

PTCL represents a diverse group of aggressive non-Hodgkin lymphomas, with patients at a high risk of disease relapse.

The approval is based on the data from the multinational JACKPOT8 Part B study to assess the safety and efficacy of golidocitinib monotherapy in r/r PTCL patients. 

Objective response rate (ORR) was the trial’s primary endpoint.

Golidocitinib offered superior and lasting antitumor efficacy and had a favourable safety profile versus current treatments.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The ORR was 44.3% with a complete response rate of 23.9%, according to an independent review committee.

Patients across a range of PTCL subtypes experienced tumour responses, with a median duration of response of 20.7 months.

Notably, 53.8% of patients were still responding at the time of the analysis.

Dizal CEO Xiaolin Zhang said: “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.

“Golidocitinib yields good antitumour 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.”