Baotai was approved by the NMPA to issue a bat1006 injection clinical trial notice

"Clinical Trial Notice" Basics Drug Name: BAT1006 Injection Dosage Form: Injection Specification: 150mg/5ml Application: Clinical Trial Applicant: Biopharmaceutical Co., Ltd. Acceptance Number: CXSL20002 Conclusion: In accordance with the Drug Administration Law of the People's Republic of China and the relevant provisions, after examination, the BAT1006 injection received on September 7, 2020 met the relevant requirements of drug registration and agreed to conduct clinical trials for the treatment of advanced malignancies.
BAT1006 injection is a monoantigen developed by Biopharmaceutical Co., Ltd., and its active ingredient is an antibody of target human skin growth factor-2 (HER2) expressed by Chinese hamster ovarian cells, which belongs to immunoglobulin IgG1. type, which can bind human HER2 extracellular protein domain II with high affinity specificity, block the heterogeneity of HER2 and other HER family parents (EGFR/HER3/HER4) and inhibit the proliferation and survival of tumor cells associated with HER2's activity.
antibody glycosylation modification of BAT1006 does not contain algal sugar, compared to ordinary IgG1 antibody, its recruitment of NK and other immune cells to kill tumor cells is more effective.
, a total of 5 anti-HER2 antibody classes and related drugs have been approved in China.
source: Beotai Enterprises Announcement