CSPC Pharmaceutical Group's subsidiary, CSPC Megalith Biopharmaceutical Co., Ltd., has received Breakthrough Therapy Designation from the National Medical Products Administration (NMPA) of China for SYS6010, a humanized anti-human EGFR monoclonal antibody-JS-1 conjugate injection. This designation targets the use of SYS6010 as a monotherapy for EGFR mutation-positive advanced non-small cell lung cancer (NSCLC) in patients who have progressed after EGFR tyrosine kinase inhibitors (TKIs) and platinum-based chemotherapy. Lung cancer remains the most prevalent and deadly cancer globally and in China, underscoring the importance of novel therapeutic options.
Addressing Unmet Needs in Advanced NSCLC
Advanced NSCLC carries a grim prognosis, particularly for patients with EGFR mutations who have exhausted TKI and chemotherapy options. In Asian and Chinese populations, EGFR mutations occur in 40-50% of NSCLC cases. While EGFR-TKIs have become the standard first-line treatment, the subsequent treatment landscape after TKI failure is limited, typically involving platinum-based chemotherapy with or without bevacizumab. The median survival time for stage IV patients is approximately 7 months, with a 5-year survival rate of less than 5%. This highlights a significant unmet clinical need for more effective treatments in this patient population.
Promising Clinical Data for SYS6010
Existing clinical data has demonstrated that SYS6010, when used as a single agent, exhibits significantly better efficacy compared to the current standard of care for the specified indication. The Breakthrough Therapy Designation is expected to facilitate closer communication with regulatory agencies and accelerate the development and potential approval of SYS6010. The ongoing development of SYS6010 across various solid tumors further broadens its potential impact.
Expansion of Oncology Pipeline with SYS6041 and SYS6045
CSPC Pharmaceutical Group has also announced the approval for clinical trials of its new antibody-drug conjugates, SYS6045 and SYS6041, by China’s National Medical Products Administration. SYS6045 targets advanced solid tumors, including breast, gastric, endometrial, cervical, and colorectal cancers. SYS6041 is intended for the treatment of advanced solid tumors, including ovarian, endometrial, breast, and non-small cell lung cancers, and shows promising anti-tumor effects. These approvals mark a significant step in CSPC’s clinical development and strengthens its positioning in the oncology segment.
