The latest results of the 3rd Phase 3 study of Fuhong Han's Quto-Zhu single-resistance international multi-center were released.

At this year's ESMO Conference, Fu Hong Hanxuan shared the latest clinical data from the 3rd phase of the study of Quto Zhudan Anti-Hanquyou (R) (HLX02, EU Trade Name: Zercepac (R)) in the form of an electronic poster.
This is an independent development by Fuhong Hanxuan, the development process in strict compliance with China and the European Union biosynthic drug regulations, has been in July and August 2020 by the European Commission and China's State Drug Administration approved the listing, becoming the first china-EU dual-batch domestic single anti-biosynthic drugs.
HLX02 Phase 3 Clinical Trial (HLX02-BC01) led by Professor Xu Binghe, Director of the National Center for Clinical Research on New Drugs (Anti-Oncology) at the Oncology Hospital of the Chinese Academy of Medical Sciences, is a her2-positive re-treatment in untreated Phase 3 clinical trials in patients with developed or metastasis breast cancer were conducted in a multi-center, randomized, double-blind, parallel-controlled clinical trial designed to compare the efficacy, safety and pharmacogenetic properties of HLX02 in breast cancer patients with that of the original virultural monoantin (europeanly available).
649 patients in this trial (HLX02, N=324; EU-TZB, N=325).
results showed that in the total mitigation rate (ORRwk24) for 24 weeks at the main endpoint, orrwk24 in the HLX02 group was 71.3 percent and 71.4 percent in the original study group.
the HLX02 group, ORRwk24 was 74.2 per cent and the original study group was 73.2 per cent.
addition, the sub-group (Asia vs. Non-Asia, China vs. Non-China) analysis showed that the HLX02 group and the original research group ORRwk24 in different populations did not have statistical differences (p .gt;05), verified the HLX02 and the original study of the efficacy similarity of the single resistance.
In terms of secondary endpoints, there was no statistical difference in the secondary efficacy endpoints of the two treatment groups, such as clinical benefit rate (CBR), disease control rate (DCR), remission duration (DoR), progression-free lifetime (PFS), total lifetime (OS), etc.
addition, HLX02 is similar to the original study of the safety of monoantigen, including the incidence of drug-related heart disease.
In PopPK, a two-chamber model with a first-degree elimination rate, the results showed that there was no significant difference in steady-state exposure between HLX02 and curt bead monoantial resistance from different sources (AUCss and Cmax, ss differences were less than or equal to 13%).
effects of covariative variables (e.g. weight) on the pharmacodynamic exposure of HLX02 to those of different sources of curt bead monoantin.
Phase 3 clinical trial and PopPK model showed that HLX02 was equivalent to the efficacy, safety and pharmacogenetics of the original virultural bead monoantin in HER2-positive metastasis breast cancer patients.
press release, HLX02, as the first chinese-made qutoju single anti-biosynthetic drug approved, will provide alternative treatment options for patients worldwide.
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