{"id":78165,"date":"2026-09-02T15:11:07","date_gmt":"2026-09-02T07:11:07","guid":{"rendered":"https:\/\/flcube.com\/?p=78165"},"modified":"2026-09-02T15:11:08","modified_gmt":"2026-09-02T07:11:08","slug":"sys6010-earns-third-nmpa-breakthrough-therapy-designation-advancing-cspc-innovation-pharmaceuticals-egfr-adc-in-r-m-hnscc","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=78165","title":{"rendered":"SYS6010 Earns Third NMPA Breakthrough Therapy Designation, Advancing CSPC Innovation Pharmaceutical’s EGFR ADC in R\/M HNSCC"},"content":{"rendered":"\n

CSPC Innovation Pharmaceutical Co., Ltd.<\/strong> (SHE: 300765<\/a>) announced that SYS6010<\/strong>, its epidermal growth factor receptor (EGFR)-targeting antibody-drug conjugate (ADC), has been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE)<\/strong> of China’s National Medical Products Administration (NMPA)<\/strong>. The designation covers patients with recurrent or metastatic head and neck squamous cell carcinoma (R\/M HNSCC<\/strong>) who have failed prior immunotherapy and platinum-based chemotherapy.<\/p>\n\n\n\n

Regulatory Milestone<\/h2>\n\n\n\n
Agency<\/th>Approval Type<\/th>Product<\/th>Indication<\/th>Date<\/th>Next Steps<\/th><\/tr><\/thead>
NMPA \/ CDE<\/strong> (China)<\/td>Breakthrough Therapy Designation<\/td>SYS6010<\/strong><\/td>R\/M HNSCC<\/strong> after failure of prior immunotherapy and platinum-based chemotherapy<\/td>02 Sep 2026<\/td>Accelerated clinical development and regulatory review pathway in China<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

This marks the third Breakthrough Therapy Designation<\/strong> for SYS6010<\/strong>. The drug had previously received two BTDs from the CDE<\/strong> for:<\/p>\n\n\n\n