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

Publications

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). https://doi.org/10.1007/s10637-023-01338-7
Investigational New Drugs
An J, Li X, Wang J,et al. Efficacy and safety of serplulimab plus nab-paclitaxel in previously treated patients with PD-L1–positive advanced cervical cancer: a phase II, single-arm study. Front. Immunol (2023) . 14:1142256. doi: 10.3389/fimmu.2023.1142256
Frontiers in Immunology
Wei K, Kou Y, Kan H, et al. Biosimilars: navigating the regulatory maze across two worlds[J]. Trends in Biotechnology, 2023.
Trends in Biotechnology
Song, Y., Zhang, B., Xin, D. et al. First-line serplulimab or placebo plus chemotherapy in PD-L1-positive esophageal squamous cell carcinoma: a randomized, double-blind phase 3 trial[J]. Nat Med 29, 473–482 (2023). https://doi.org/10.1038/s41591-022-02179-2
Nature Medicine
Updated results of first-line serplulimab versus placebo combined with chemotherapy in extensive-stage small-cell lung cancer: an international multicentre phase 3 study (ASTRUM-005)
ESMO-Asia 2022
First-line serplulimab versus placebo in combination with chemotherapy in PD-L1-positive oesophageal squamous cell carcinoma (ASTRUM-007): a randomised, double-blind, multicentre phase 3 study
ESMO-Asia 2022

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