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Providing innovative and affordable medicines
for all patients

Supported by our strong talent base and our fully integrated R&D platform, we have developed, and continued to expand a comprehensive product pipeline of multiple late-stage biologics candidates and bio-innovative drugs, with significant potential for a variety of PD-1/PD-L1 based immuno-oncology combination therapies.


Until now, we have completed IND/CTA filings of 13 products and 2 combination therapies with 23 indications and obtained 29 successful IND/CTA approvals (19 approvals from mainland China; 3 from the United States; 3 from Taiwan, China; each 1 from the European Union, Ukraine, Philippines and Australia). HLX01 (rituximab injection), our first product, has been granted approval by the NMPA as the first approved biosimilar in China. Moreover, HLX03 has received a New Drug Application (NDA) acceptance from NMPA.

Intellectual Property
Relevant
Products
Patent Name Patent Holder Patent Number Jurisdiction of
Registration
Application
Date
Expiry Date
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
Platform Technology Method for detecting DNA content of CHO cells by probe Henlius ZL201110099204.1 Chinese mainland 2011-04-20 2031-04-20
HLX07

Anti-Epidermal growth factor receptor (EGFR) antibodies

Henlius ZL201580029644.6
HK1252789
J/4492
TWI689520
US10584171
AU2015266664
JP6691872
EP3148581

Chinese mainland

Hong Kong China

Macao China

Taiwan China

The United States

Australia

Japan

UK, GER, FR, ESP

2015-05-29 2035-05-29
Serplulimab Injection

Anti-programmed cell death protein 1 monoclonal antibody injection


Anti-PD-1 antibodies

Henlius



Henlius
ZL202010008058.6
HK40018285

US11028173
ZA201901865

Chinese mainland

Hong Kong China


The United States

South Africa

2020-01-06
2020-01-06

2017-09-09
2017-09-09
2040-01-06
2040-01-06

2037-09-09
2037-09-09
HLX20

Anti-PD-L1 Antibodies and variants


Henlius ZA201902533

South Africa

2017-10-14 2037-10-14
Publications
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