HONGKONG, China I February 10, 2025 I
A. INTRODUCTION
This announcement is made by Shanghai Henlius Biotech, Inc. (the “Company”) on a voluntary basis to inform the shareholders and potential investors of the Company about the latest business development of the Company. The board of directors (the “Board”) of the Company is pleased to announce that, recently, the first patient has been dosed in a phase 2 clinical study of HLX43 for injection (antibody-drug conjugate targeting PD-L1 with novel DNA topoisomerase I inhibitor) (“HLX43”) in patients with recurrent/metastatic esophageal squamous cell carcinoma (ESCC) in mainland China (excluding Hong Kong, Macau and Taiwan regions, the same as below). After the conditions are met, the Company also plans to initiate phase 2 clinical trials for the treatment of potential indications such as cervical cancer, hepatocellular carcinoma, nasopharyngeal carcinoma, head and neck squamous cell carcinoma and non-small cell lung cancer.
B. CLINICAL TRIAL DESIGN AND OBJECTIVES
This study is a phase 2 clinical trial designed to evaluate the efficacy and safety of different doses of HLX43 in patients with recurrent/metastatic esophageal squamous cell carcinoma (ESCC) who have failed or are intolerant to first-line standard treatment. Eligible subjects will receive HLX43 every 3 weeks (Q3W). The primary objective of this study is to assess the clinical efficacy of HLX43 in recurrent/metastatic ESCC. Secondary objectives include evaluating safety and tolerability, pharmacokinetic characteristics and immunogenicity, and potential predictive biomarkers.
C. ABOUT HLX43
HLX43 is an antibody-drug conjugate (ADC) targeting PD-L1 developed by the Company through conjugating the novel DNA topoisomerase I inhibitor payload – peptide linker, licensed-in from MediLink Therapeutics (Suzhou) Co., Ltd. in November 2022, with antibody targeting PD-L1 independently developed by the Company, which is designed for the treatment of advance/metastatic solid tumours. In October 2023, application for phase 1 clinical trial of HLX43 for the treatment of advanced/metastatic solid tumours was approved by the National Medical Products Administration (“NMPA”), and the first patient has been dosed in such trial in November 2023 in mainland China. In November 2023, application for phase 1 clinical trial of HLX43 for the treatment of advanced/metastatic solid tumours was approved by the United States Food and Drug Administration (FDA). In December 2024, application for phase 1b/2 clinical trial of HLX43 for the monotherapy or combination therapy of advanced/metastatic solid tumours was approved by the NMPA. In January 2025, the application for phase 1b/2 clinical trial of HLX43 in combination with HANSIZHUANG (serplulimab injection) for the
D. MARKET CONDITION
As at the date of this announcement, no antibody-drug conjugate targeting PD-L1 has been approved for marketing globally.
SOURCE: Henlius Biotech
Post Views: 196
HONGKONG, China I February 10, 2025 I
A. INTRODUCTION
This announcement is made by Shanghai Henlius Biotech, Inc. (the “Company”) on a voluntary basis to inform the shareholders and potential investors of the Company about the latest business development of the Company. The board of directors (the “Board”) of the Company is pleased to announce that, recently, the first patient has been dosed in a phase 2 clinical study of HLX43 for injection (antibody-drug conjugate targeting PD-L1 with novel DNA topoisomerase I inhibitor) (“HLX43”) in patients with recurrent/metastatic esophageal squamous cell carcinoma (ESCC) in mainland China (excluding Hong Kong, Macau and Taiwan regions, the same as below). After the conditions are met, the Company also plans to initiate phase 2 clinical trials for the treatment of potential indications such as cervical cancer, hepatocellular carcinoma, nasopharyngeal carcinoma, head and neck squamous cell carcinoma and non-small cell lung cancer.
B. CLINICAL TRIAL DESIGN AND OBJECTIVES
This study is a phase 2 clinical trial designed to evaluate the efficacy and safety of different doses of HLX43 in patients with recurrent/metastatic esophageal squamous cell carcinoma (ESCC) who have failed or are intolerant to first-line standard treatment. Eligible subjects will receive HLX43 every 3 weeks (Q3W). The primary objective of this study is to assess the clinical efficacy of HLX43 in recurrent/metastatic ESCC. Secondary objectives include evaluating safety and tolerability, pharmacokinetic characteristics and immunogenicity, and potential predictive biomarkers.
C. ABOUT HLX43
HLX43 is an antibody-drug conjugate (ADC) targeting PD-L1 developed by the Company through conjugating the novel DNA topoisomerase I inhibitor payload – peptide linker, licensed-in from MediLink Therapeutics (Suzhou) Co., Ltd. in November 2022, with antibody targeting PD-L1 independently developed by the Company, which is designed for the treatment of advance/metastatic solid tumours. In October 2023, application for phase 1 clinical trial of HLX43 for the treatment of advanced/metastatic solid tumours was approved by the National Medical Products Administration (“NMPA”), and the first patient has been dosed in such trial in November 2023 in mainland China. In November 2023, application for phase 1 clinical trial of HLX43 for the treatment of advanced/metastatic solid tumours was approved by the United States Food and Drug Administration (FDA). In December 2024, application for phase 1b/2 clinical trial of HLX43 for the monotherapy or combination therapy of advanced/metastatic solid tumours was approved by the NMPA. In January 2025, the application for phase 1b/2 clinical trial of HLX43 in combination with HANSIZHUANG (serplulimab injection) for the
D. MARKET CONDITION
As at the date of this announcement, no antibody-drug conjugate targeting PD-L1 has been approved for marketing globally.
SOURCE: Henlius Biotech
Post Views: 196
