CSPC Group (01093): CPO 301 was granted the third fast-track qualification by the US FDA to treat adult patients with NSCLC

Zhitong Financial App News, Shiyao Group (01093) announced that a pioneering epidermal growth factor receptor (“EGFR”) antibody conjugate drug (ADC) CPO301 (also known as SYS6010 in China) has been granted the 3rd fast-track qualification by the US Food and Drug Administration (“FDA”) for treatment without EGFR mutations or other driver gene changes (AGA), and has been treated with platinum-containing chemotherapy and anti-PD- (L) 1 antibodies non-small cell lung cancer ( nsq-nsclc) adult patients.

Previously, CPO301 was granted two fast-track qualifications by the FDA: the first was granted in June 2023 to treat patients with EGFR mutant metastatic non-small cell lung cancer (“NSCLC”) patients who have relapsed/refractory after EGFR targeted therapy (third-generation EGFR inhibitors including osidinib), or who are unsuitable for EGFR targeted therapy; the second was granted in September 2024 to treat EGFR overexpression and metastasis or recurrence of disease progression or recurrence after receiving platinum-containing chemotherapy and anti-PD- (L) 1 treatment squamous non-small cells Lung cancer (sq-nsclc) patients.

Lung cancer is the cancer with the highest incidence rate and death rate in the world. It is estimated that there are about 2.5 million new cases and 1.8 million deaths worldwide every year. Activating EGFR gene mutations and EGFR protein overexpression are drivers of lung cancer, not only in patients with positive EGFR mutations, but also in histological subtypes without EGFR mutations but highly expressed wild EGFR protein, including squamous cell carcinoma and adenocarcinoma. CPO301's fast-track eligibility in all NSCLC subtypes is based on its encouraging clinical efficacy data, showing more potential activity than existing treatments for NSCLC and other tumor types.

CPO301 is a humanized monoclonal antibody optimized from cetuximab and conjugated to topoisomerase I inhibitors. Currently, the drug is undergoing simultaneous clinical research in China and the US. Fast track qualifications granted by the FDA will facilitate the development and registration process of CPO 301 in the US and worldwide.