Shanghai Henlius Biotech, Inc. announced that, recently, HLX42 for injection (antibody-drug conjugate targeting EGFR with novel DNA topoisomerase I inhibitor) ("HLX42") for the treatment of patients with advanced or metastatic EGFR-mutated non-small cell lung cancer whose disease has progressed on a third-generation EGFR tyrosine kinase inhibitor has been granted the Fast Track Designation (the "FTD") by the United States Food and Drug Administration (the "FDA"). Fast Track is a process designed by FDA to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Being granted the FTD means HLX42 is eligible to have: (1) more opportunities for meetings and written communication with FDA to obtain closer guidance in drug development, clinical trial design, etc.; (2) eligibility for Accelerated Approval and Priority Review, if relevant criteria are met; and (3) rolling Review, which means that completed sections of Biologic License Application (BLA) or New Drug Application (NDA) can be submitted for review by FDA, rather than waiting until every section is completed before the entire application can be reviewed.