Science & Technology-R&D Result

Providing innovative and affordable medicines

for all patients

Zhu, X., Ding, Y., Wang, Q. et al. HLX22, an anti-HER-2 monoclonal antibody, in patients with advanced solid tumors overexpressing human epidermal growth factor receptor 2: an open-label, dose-escalation, phase 1 trial. Invest New Drugs (2023). http://doi.org/10.1007/s10637-023-01338-7

Publications

A randomized phase 1 study to compare the pharmacokinetics, safety, tolerability and immunogenicity between HLX02, reference US- and EU-approved trastuzumab in healthy Chinese male volunteers
ASCPT 2022
A Phase 2 study of serplulimab plus HLX07 in patients with advanced head and neck tumours
ICHNO–ECHNO 2022
Issafras H, Fan S, Tseng C-L, Cheng Y, Lin P, Xiao L, et al. (2021) Structural basis of HLX10 PD-1 receptor recognition, a promising anti-PD-1 antibody clinical candidate for cancer immunotherapy. PLoS ONE 16(12): e0257972. http://doi.org/10.1371/journal.pone.0257972.
PLoS ONE
A phase 1 randomized study compare the pharmacokinetics, safety and immunogenicity of HLX04 to reference bevacizumab sourced from the United States, the European Union, and China in healthy Chinese male volunteers. Cancer Chemotherapy and Pharmacology.
Cancer Chemotherapy and Pharmacology
Efficacy, Safety, and Immunogenicity of HLX04 Versus Reference Bevacizumab in Combination with XELOX or mFOLFOX6 as First-Line Treatment for Metastatic Colorectal Cancer: Results of a Randomized, Double-Blind Phase III Study[J]. BioDrugs, 2021:1-14.
BioDrugs
Hou, MM., Ho, CL., Lin, HY. et al. Phase I first-in-human study of HLX07, a novel and improved recombinant anti-EGFR humanized monoclonal antibody, in patients with advanced solid cancers. Invest New Drugs (2021). http://doi.org/10.1007/s10637-021-01099-1
Invest New Drugs

Intellectual Property

Relevant Products	Patent Name	Patent Holder	Patent Number	Jurisdiction of Registration	Application Date	Expiry Date	Type
Platform Technology	Kit for detecting DNA residues of CHO cell and using method thereof	Henlius	ZL201110066745.4	Chinese mainland	2011-03-18	2031-03-18	Invention
Platform Technology	Method for detecting DNA content of CHO cells by probe	Henlius	ZL201110099204.1	Chinese mainland	2011-04-20	2031-04-20	Invention
Platform Technology	Eukaryotic expression vector and system for producing recombinant protein by using CHO cells	Henlius	ZL201210211812.1	Chinese mainland	2012-06-25	2032-06-25	Invention
HLX07	Anti-epidermal growth factor receptor (EGFR) antibodies	Henlius	ZL201580029644.6 HK1252789 J/4492 TWI689520 US10584171 AU2015266664 JP6691872 EP3148581 EP3613433 KR102366644 US11261255	Chinese mainland Hong Kong China Macao China Taiwan China The United States Australia Japan UK, GER, FR, ITA, ESP UK, GER, FR, ITA, ESP Korea The United States	2015-05-29	2035-05-29 2035-12-11	Invention
HLX10	Anti-programmed cell death protein 1 monoclonal antibody injection Anti-PD-1 antibodies	Henlius	ZL202010008058.6 HK40018285 ZA201901865 US11028173 RU2752832 JP7072576 ZL201780056868.5 TWI772326 KR102391338 IDP000083833	Chinese mainland Hong Kong China The United States South Africa Russia Japan Chinese mainland Taiwan China Korea Indonesia	2020-01-06 2017-09-09	2040-01-06 2037-09-08 2037-09-09 2037-09-09 2037-09-15 2037-09-09 2037-09-09	Invention
HLX53	AntiI-TIGIT antibodies and methods of use	Henlius	ZL202010024565.9 HK40013828	Chinese mainland Hong Kong China	2020-01-10	2040-01-10	Invention
Platform Technology	Online system for monitoring yield and quality of target protein	Henlius	ZL202020160862.1	Chinese mainland	2020-02-11	2030-02-10	Utility Model
Platform Technology	Online quantitative detection system for target protein	Henlius	ZL202020432845.9	Chinese mainland	2020-03-30	2030-03-29	Utility Model

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