Henlius (02696.HK) announced that the company's independently developed innovative anti-PD-1 monoclonal antibody 'Concerta' (Sululi monoclonal antibody injection) combined therapy with chemotherapy for a new indication in first-line treatment of non-small cell lung cancer (NSCLC) has recently been approved for marketing registration by the National Medical Products Administration.

The new indication for this treatment is the combination of Concerta with pemetrexed and cisplatin, used in the first-line treatment of locally advanced or metastatic non-squamous NSCLC that is unresectable and negative for epidermal growth factor receptor (EGFR) gene mutations and anaplastic lymphoma kinase (ALK) translocations. Study results have shown that Concerta combined with chemotherapy significantly prolongs progression-free survival (PFS) compared to first-line chemotherapy for advanced non-squamous NSCLC, meeting the predefined criteria for efficacy and demonstrating good safety with no new safety signals observed.

Henlius stated that it is actively advancing multiple global clinical trials of Concerta and related combination therapies, covering indications such as lung cancer, esophageal cancer, head and neck squamous cell carcinoma, colorectal cancer, and gastric cancer.