Investor Presentaiton
Innovative R&D - Biopharmaceuticals Core Pipeline
Therapeu
tic Area
Product
Target/MOA
Indication
Pre-Clinical
IND
Phase 1
Phase 2
Phase 3
NDA
Anti-tumor
HLX101
(Serplulimab)
XKGbio
+Chemo
PD-1
Squamous non-small cell lung cancer 1L
Extensive-stage small cell lung cancer 1L
Metastatic esophageal squamous-cell carcinoma 1L
Limited-stage small cell lung cancer
Neo-/adjuvant treatment of gastric cancer
Non-squamous non-small cell lung cancer 1L
+Bevacizumab PD-1+VEGF Hepatocellular carcinoma 1L
+HLX07
PD-1+EGFR
Metastatic colorectal cancer 1L
Squamous-cell carcinoma of the head and neck 2L
Squamous non-small cell lung cancer 1L
VEGF Wet age-related macular degeneration
+Trastuzumab HER2+HER2 Gastric cancer
HLX04-02
ESSEX IZRE
HLX22
HLX07
EGFR
HLX11 (Pertuzumab)
3 ORGANON
HER2
HLX05 (Cetuximab)
4
Bingze EGFR
HLX12 (Ramucirumab)
VEGFR2
HLX20
PD-L1
Solid tumors (non-small cell lung cancer,
esophageal carcinoma, etc.)
Breast cancer
Metastatic colorectal cancer and
squamous-cell carcinoma of the head and neck
Gastric cancer, metastatic non-small cell lung cancer
and metastatic colorectal cancer
Solid tumors
Note 1: granted KG Bio to develop and commercialize HLX10 in 10 countries in Southeast Asia
Global multi-center clinical trial, NDA accepted by NMPA in September 2021
Granted FDA Orphan-drug Designation in April 2022
Global multi-center clinical trial; First subject had been dosed in Chinese Mainland in May 2022;
First subject had been dosed in January 2022
First subject had been dosed in Chinese Mainland Phase 3 clinical trial in November 2021;
First subject had been dosed in Latvia Phase 3 clinical trial in April 2022
Initiated Phase 2 clinical trial in Chinese Mainland in September 2021
Approved to enter clinical trials by FDA
Initiated Phase 3 clinical trial in Chinese Mainland in April 2022
Phase 1 clinical trial in Australia
Note 2: granted ESSEX an exclusive license to develop, manufacture, and commercialize HLX04 in human ophthalmic therapeutic use
Note 3: granted Organon exclusive global commercialization rights except for China
Note 4: granted Jingze Biotech to commercialize HLX05 in China
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Note 5: last update on 29th August 2022View entire presentation