Hansoh Pharma Gains NMPA Breakthrough Therapy for HS-20093 in Lung Cancer Treatment
Saturday, November 02, 2024
Hansoh Pharmaceutical announced that its in-house developed antibody-drug conjugate (ADC) HS-20093 has been granted Breakthrough Therapy Designation by China’s National Medical Products Administration (NMPA).
HS-20093 is a novel ADC targeting B7-H3, consisting of a fully-humanised monoclonal antibody linked to a topoisomerase inhibitor (TOPOi) payload.
Lung cancer is among the most widespread cancers globally. Approximately 70% of small-cell lung cancer cases are diagnosed at an extensive stage, meaning the disease has spread beyond the lungs to other parts of the body. ES-SCLC is notably challenging to treat, with a five-year survival rate of around 3%.
This designation recognises HS-20093’s potential as a treatment for extensive-stage small-cell lung cancer (ES-SCLC) in patients who have undergone standard first-line therapy, including platinum-based chemotherapy with immunotherapy.
Most ES-SCLC patients experience a relapse post-initial treatment, and the median survival for relapsed cases remains low at approximately 5-6 months with current standard treatments.
The drug is currently in Phase III trials in China for small-cell lung cancer and in earlier stages of study (Phases I and II) for sarcoma, head and neck cancers, oesophageal squamous cell carcinoma, and other solid tumours.
Hansoh Pharma entered a license agreement with GlaxoSmithKline (GSK) in December 2023, granting GSK exclusive rights outside of the Chinese Mainland, Hong Kong, Macau, and Taiwan to develop, manufacture, and commercialise HS-20093 (also known as GSK5764227).
GSK is currently conducting a global Phase I clinical trial for the drug and received a Breakthrough Therapy Designation from the US FDA in August 2024 for treating relapsed or refractory ES-SCLC patients.
Source: hspharm.com
