Henlius (02696.HK): The NMPA approved the new indication for first-line treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with Hanseyru single-chain injection in combination with chemotherapy.

Gelonghui Finance · Dec 3 17:33

Henlius announced on December 3rd that the National Medical Products Administration (NMPA) has approved the company's independently developed innovative anti-PD-1 monoclonal antibody, Hansoh Injection (Sulili Monoclonal Antibody Injection), for the first-line treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that is unresectable and negative for epidermal growth factor receptor (EGFR) gene mutations and anaplastic lymphoma kinase (ALK) negativity.

This approval was mainly based on a randomized, double-blind, multicenter phase 3 clinical study. The study results showed that Hansoh Injection combined with chemotherapy (carboplatin-pemetrexed) significantly prolonged the progression-free survival (PFS) compared to chemotherapy (carboplatin-pemetrexed) as first-line treatment for advanced non-squamous non-small cell lung cancer (NSCLC), meeting the predefined efficacy standards, and demonstrated good safety with no new safety signals observed.

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复宏汉霖(02696.HK)：国药监局批准汉斯状(斯鲁利单抗注射液)联合化疗用于局部晚期或转移性非鳞状非小细胞肺癌(NSCLC)的一线治疗新适应症的上市注册申请(NDA)

Henlius (02696.HK): The NMPA approved the new indication for first-line treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with Hanseyru single-chain injection in combination with chemotherapy.

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