Zejing Pharma disclosed the latest clinical trial data of jacktinib hydrochloride

Recently, Suzhou Zejing Biopharmaceutical issued an announcement that it received the "Notice of the Drug Review Center on Initiating the On-site Verification of the Registration of Jacktinib Hydrochloride Tablets" (No.: No. HCY20221168) and the "Notice of the Drug Review Center on Initiating the Verification of Clinical Trial Data of Jacktinib Hydrochloride Tablets" (No.: No.HCL20220561) issued by the Center for Drug Evaluation (CDE), according to the relevant provisions of the Measures for the Administration of Drug Registration. The Food and Drug Inspection Center (CFDI) of the State Medical Products Administration will initiate drug registration verification (pharmacy, clinical) for jacktinib hydrochloride tablets declared and registered by the company.

Jacktinib hydrochloride is a new JAK inhibitor drug independently developed by Zejing Pharmaceutical, which belongs to Class 1 new drugs, and the company has independent intellectual property rights of the product. Jacktinib has a significant inhibitory effect on Janus kinases including JAK1, JAK2, JAK3 and TYK2, and has the strongest inhibitory effect on JAK2 and TYK2. In addition, jacktinib can also reduce hepcidin transcription, improve iron metabolism imbalance, increase hemoglobin, reduce the incidence of anemia in patients with myelofibrosis and reduce transfusion dependence by inhibiting activin receptor 1 (ACVR1) activity.

In September 2022, Zejing Pharmaceutical submitted a new drug application (NDA) for jacktinib hydrochloride tablets to the National Medical Products Administration (NMPA); In October 2022, the company received the "Notice of Acceptance" approved and issued by the NMPA, and the new drug application submitted by the company for jacktinib hydrochloride tablets was accepted.

A Phase III clinical trial of jacktinib hydrochloride tablets for the treatment of intermediate- and high-risk myelofibrosis (protocol number: ZGJAK016) enrolled a total of 105 subjects after the interim analysis data of the trial was reviewed by the Independent Data Monitoring Committee (IDMC). It was judged that the results of this interim analysis reached the primary efficacy endpoint preset by the protocol. Results of interim analysis of ZGJAK016 clinical trial: the proportion of subjects whose spleen volume was reduced from baseline by ≥ 35% at 24 weeks assessed by independent imaging (IRC) (primary efficacy result SVR35), 72.3% and 17.4% in the Bid group with 100mg of Metrotinib hydrochloride tablets and 17.4% in the Bid group with hydroxyurea tablets 0.5g Bid, respectively, with statistically significant differences between groups (p<0.0001), and the sensitivity analysis results were consistent with the main analysis results. For relevant data, please refer to the "Announcement on Voluntary Disclosure of Main Data of Phase III Clinical Trials of Jacktinib Hydrochloride Tablets for the Treatment of Medium and High-Risk Myelofibrosis" (Announcement No. 2022-075) disclosed by the Company on October 17, 2022. Detailed data on this clinical trial will be presented at subsequent academic meetings.