巅峰国际

Serplulimab (anti-PD-1 mAb) in combination with chemotherapy can be used for the treatment of ESCC, ES-SCLC. The Phase 3 clinical studies of Serplulimab in combination with chemotherapy for the treatment of Neo/adj. LS-SCLC is on the fast track. Phase 3 clinical studies for sqNSCLC, ES-SCLC and LS-SCLC are global multi-centre trials. 

China NMPA Accepts NDA and Grants Priority Review to Serplulimab for Neo-/Adjuvant Treatment of Gastric Cancer.

It is the first dual mAbs combination therapy to receive IND approval from the NMPA for the treatment of advanced solid tumours. Subject enrollment has been completed in a Phase 2 clinical trial for the treatment of advanced HCC. First patients have been dosed in a Phase 3 clinical trial for the treatment of nsNSCLC and a Phase 2/3 clinical trial for mCRC in China.

The Company's second dual mAbs combination therapy. It is for the treatment of SCCHN. The first patient was dosed in China in a Phase 2 clinical trial for the treatment of recurrent or metastatic SCCHN.

The Phase 2 IND application of serplulimab in combination with HLX07 for the treatment of solid tumours was granted by the NMPA.

The first subject dosed of a Phase 2 study of serplulimab combined with HLX07 in first-line EGFR high expression sqNSCLC patients.

Henlius is also actively exploring combination therapies involving ADCs with immunotherapy to encourage progress in the next wave innovation of “IO+ADC”. The first subject has been dosed for a phase 1b/2 clinical trial of HLX43 in combination with novel anti-PD-1 mAb serplulimab.

HLX14, recombinant anti-RANKL human monoclonal antibody injection, a denosumab biosimilar.
It is potentially indicated for the treatment of postmenopausal women with OP at high risk for fracture.

Approved in the U.S. and the EU. Trade name: BILDYOS^®, BILPREVDA^® in the U.S. and the EU.  Marketing applications are under review in Canada.

HLX11 is a recombinant anti-human epidermal growth factor receptor 2 (HER2) subdomain II humanized monoclonal antibody injection.It can be potentially used in combination with trastuzumab and chemotherapy for adjuvant treatment and neoadjuvant treatment for patients with HER2-positive BC and HER2-positive metastatic BC.

Approved in the U.S. Trade name: POHERDY®  in the U.S. Marketing applications are under review in the EU, Canada and China.

HLX04-O, recombinant anti-VEGF humanised monoclonal antibody injection. 

It is indicated for wet age-related macular degeneration (wAMD). HLX04-O was granted Phase 3 clinical study approvals in Australia, the United States, Singapore and the EU countries such as Latvia, Hungary and Spanish. In April 2022, the first patient in Australia and Latvia was dosed in the global multicentre phase 3 clinical trial, respectively. 

Marketing application have been accepted for review in China.

HLX22-GC-301, a phase 3 clinical study aims to evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy for the first-line treatment of patients with HER2-positive metastatic GC/GEJC has been approved for clincial trial in China, the U.S., Japan, Australia, EU Germany and Korea, and has completed its first patient dosing globally. In addition, HLX22-BC201, a phase 2 clinical trial of HLX22 in combination with trastuzumab deruxtecan (T-DXd) has also completed the first patient dosing for the treatment of HER2-low, hormone receptor (HR)-positive locally advanced or metastatic breast cancer. 

The first chinese patient has been dosed for phase 3 mrct (ELAINE-3) on ER+/HER2- breast cancer of HLX78. The clinical trial is also recruiting subjects in the United States, Canada, the European Union, in addition to other countries and regions.

HLX07, recombinant anti-epidermal growth factor receptor (EGFR) humanised monoclonal antibody injection independently researched and developed as biobetter. 

It was granted IND approvals to be evaluated in clinical trials in China and the United States. It demonstrated favorable safety and tolerability profile in a prospective, open-label, dose-escalation Phase 1 clinical study (HLX07FIH, NCT02648490) for the treatment of advanced solid tumours. Tumour response was observed in this study and preliminary efficacy of HLX07 was established.

HLX43 is a novel PD-L1-targeting ADC, comprised of a high-affinity humanized IgG1 mAb targeting PD-L1 conjugated with a novel cytotoxic payload through cleavable linkers, with the drug-to-antibody ratio is about 8. As of now, Phase 2 global multi-regional clinical trials of HLX43 have been initiated in China, the U.S., Japan, and Australia, with the first subjects dosed in China and the U.S.
Granted ODD by the U.S. FDA in Thymic Epithelial Tumors (TETs).

HLX6018 is a novel anti-GARP/TGF-β1 monoclonal antibody (mAb). Its IND application has been approved by the National Medical Products Administration (NMPA) for the treatment of idiopathic pulmonary fibrosis (IPF). HLX6018 is the first innovative product of Henlius in the treatment field of chronic inflammatory diseases. As of now, no mAb targeting GARP/TGF-β1 has been approved for marketing globally.

HLX79 is a first-in-class human sialidase enzyme therapeutic developed from Palleon’s EAGLE glycan editing platform. It is expected that the combination of HANLIKANG and HLX79 will benefit patients with active glomerulonephritis.

HLX17, recombinant anti-PD-1 humanized monoclonal antibody injection, a pembrolizumab biosimilar. It is to be potentially used for the treatment of indications that reference pembrolizumab has been approved, including melanoma, non-small cell lung cancer, esophageal cancer, head and neck squamous cell cancer, colorectal cancer, hepatocellular carcinoma, biliary tract cancer, triple-negative breast cancer, microsatellite instability-high or mismatch repair deficient cancer, and gastric cancer, etc. Its IND application was approved by the National Medical Products Administration (NMPA) .