China NMPA Approves Drugs for Treatment Solid Tumours

Shanghai Henlius Biotech, Inc. reported exploratory new drug applications for the novel EGFR-targeted antibody-drug conjugate (ADC) HLX42 and the novel PD-L1-targeted ADC for injection HLX43. By the National Medical Products Administration (NMPA) for the treatment of advanced/metastatic solid tumors. The company developed these two products in collaboration with MediLink Therapeutics and are the first Henlius ADC candidates to enter clinical development.

Considering that there are few ADC candidates targeting PD-L1, HLX43 is the first ADC targeting PD-L1 in China. In addition, Henlius has several other ADC/AXC candidates in preclinical development in its portfolio. EGFR belongs to the family of receptor tyrosine kinases and plays an important role in maintaining normal cell functions such as cell proliferation, differentiation and migration. EGFR mutation or over expression is considered to be closely related to the occurrence of various solid tumors, including non-small cell lung cancer (NSCLC), colorectal cancer (CRC), etc. Studies have shown that targeting EGFR is a viable strategy for anticancer therapy. Despite the great success of monoclonal antibodies targeting EGFR and 3rd generation EGFR tyrosine kinase inhibitors (TKIs), there remains a large unmet medical need for effective therapies for patients who do not respond to current therapies or who relapse after conventional therapy. ADC technology has developed tremendously in recent years and offers a new treatment option for tumor patients. EGFR-targeted ADC can overcome resistance to EGFR monoclonal antibodies and EGFR TKIs, which may bring clinical benefit to more patients with advanced NSCLC/CRC resistant or resistant to conventional EGFR-targeted therapy.