Shanghai Henlius Biotech

Single-Patient EA Policies/Criteria Henlius is a global biopharmaceutical company with the vision to offer high-quality, affordable, and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases, and ophthalmic diseases.

HLX42, a novel antibody-drug conjugate (ADC) that targeting epidermal growth factor receptor (EGFR)，is one of the first ADC candidates of Henlius to enter into clinical development. HLX42 is designed to overcome the resistance of current EGFR-targeted therapies and to provide more effective treatment options to fulfill the unmet clinical needs. HLX42 is to be investigated as a single agent in a Phase I trial for the treatment of solid tumors, including EGFR-mutated non-small cell lung cancer that progressed on a third-generation EGFR tyrosine kinase inhibitor.

Expanded Access is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational therapy for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.

Henlius understands the interest of patients in accessing HLX42 outside of clinical trials for potentially life-threatening diseases, however we do not provide any Expanded Access programs for HLX42 at this time.

Henlius recognizes the need for Expanded Access programs and will revise this policy based on data from future clinical trials.