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On June 11, Zejing Pharmaceutical issued an announcement stating that its Phase 2 clinical study (ZGJAK002) for the treatment of intermediate and high-risk myelofibrosis with its new class 1 drug Jectinib Hydrochloride Tablets (ZGJAK002) was successful and was selected for the 2021 European Society of Hematology Annual Meeting ( 2021 EHA) oral report
.
According to reports, the main researcher of this study, Professor Jin Jie from the Department of Hematology, the First Affiliated Hospital of Zhejiang University, will give an oral report on the detailed data of the study at the EHA conference
On June 11, Zejing Pharmaceutical issued an announcement stating that its Phase 2 clinical study (ZGJAK002) for the treatment of intermediate and high-risk myelofibrosis with its new class 1 drug Jectinib Hydrochloride Tablets (ZGJAK002) was successful and was selected for the 2021 European Society of Hematology Annual Meeting ( 2021 EHA) oral report
In this successful open, randomized, multi-center phase 2 clinical trial, a total of 104 middle- and high-risk myelofibrosis patients were enrolled, and they were randomly divided into two groups (52 cases in each) at 1:1, and they were given oral hydrochloric acid.
Jacketinib tablets 100 mg twice daily (BID) or 200 mg once daily (QD) until intolerable toxicity or disease progression occurs
.
The primary endpoints were: the proportion of patients whose spleen volume was reduced by ≥35% compared to baseline (SVR35) at 24 weeks of treatment (SVR35).
The results showed that the ratio of SVR35 in the 100mg BID group and 200mg QD group was 51.
9% (27/52) and 30.
8% (16/52), respectively, after treatment with Jieketinib hydrochloride tablets for 24 weeks.
The difference between the groups was statistically significant.
The group was significantly better than the 200mg QD group
.
After 24 weeks of treatment, a total of 87 patients experienced varying degrees of spleen volume reduction
In terms of safety, 97.
1% of all subjects had an adverse event (ADR), of which 36.
5% had an ADR ≥ grade 3
.
Twelve subjects withdrew from the study due to ADR
According to the announcement, this study shows that Jacketinib hydrochloride tablets have very good efficacy and safety in the treatment of middle and high-risk myelofibrosis.
The effectiveness of the 100mg BID group is significantly better than that of the 200mg QD group, and it can improve disease-related symptoms.
And increase hemoglobin levels
.
Jacketinib hydrochloride tablets are expected to become one of the preferred drugs for patients with intermediate and high risk of myelofibrosis
In addition to myelofibrosis, Zejing Pharmaceutical is carrying out other clinical studies of Jacketinib Hydrochloride Tablets in China.