Science & Technology-R&D Result

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.

13

Products
02

Combo Therapies
23

Indications
29

IND/CTA Approvals

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
HANSIZHUANG (Serplulimab Injection)	Anti-programmed cell death protein 1 monoclonal antibody injection Anti-PD-1 antibodies	Henlius	ZL20201232258.6 HK40018285 US11028173 ZA201901865 RU2752832	Chinese mainland Hong Kong China The United States South Africa Russia	2020-01-06 2017-09-09	2040-01-06 2037-09-08	Invention
HLX20	Anti-PD-L1 Antibodies and variants	Henlius	ZA2019/02533 US11274155	South Africa The United States	2017-10-14	2037-10-14 2038-02-03	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

Publications

Efficacy and safety of serplulimab (an anti-PD-1 antibody) combined with albumin-bound paclitaxel in patients with advanced cervical cancer who have progressive disease or intolerable toxicity after first-line standard chemotherapy
SGO 2022
A Phase 1 study comparing the pharmacokinetics, safety and immunogenicity between HLX12, a proposed ramucirumab biosimilar, with reference ramucirumab in healthy Chinese males
ASCPT 2022
A randomized phase 1 study evaluating the pharmacokinetic equivalence of proposed biosimilar HLX14 and denosumab in healthy Chinese volunteers
ASCPT 2022
A phase 1 study evaluating the bioequivalence between HLX11, a China-manufactured pertuzumab biosimilar candidate, and pertuzumab from three different sources in healthy Chinese male subjects
ASCPT 2022
A phase 1 study of serplulimab (a novel anti-PD-1 antibody) in combination with HLX04 (an anti-VEGF antibody) in patients with advanced solid tumors
ASCPT 2022
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

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