Sino Biopharmaceutical (HKG:1177) said the Phase III study of Benmelstobart combined with two other drugs for advanced squamous non-small cell lung cancer achieved positive results, allowing it to obtain China's consent to file a marketing application.
The combination of Benmelstobart Injection with chemotherapy and Anlotinib Hydrochloride Capsules was tested against Tislelizumab Injection with chemotherapy as a first-line treatment for advanced squamous non-small cell lung cancer (sq-NSCLC).
The Independent Data Monitoring Committee determined that the primary study endpoint of progression-free survival (PFS) has met the protocol's predefined superiority threshold, Sino Biopharm said.
The Chinese drugmaker said it will submit the marketing application "in the near future," according to a Friday filing with the Hong Kong bourse.
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