Hansoh Pharma's HS-20093 Granted Breakthrough Therapy Designation for Lung Cancer
Key Insights
Hansoh Pharmaceutical (search)'s HS-20093, an antibody-drug conjugate (ADC) targeting B7-H3 (search), has received Breakthrough Therapy designation from both the NMPA and the US FDA.
The designation is for the treatment of extensive-stage small cell lung cancer (search) (ES-SCLC), addressing a critical unmet need in relapsed or refractory cases.
Hansoh has partnered with GSK, granting them an exclusive worldwide license (excluding Mainland China, Hong Kong, Macau, and Taiwan) to develop and commercialize HS-20093.
Hansoh Pharmaceutical (search) Group's antibody-drug conjugate (ADC), HS-20093, targeting B7-H3 (search), has been granted Breakthrough Therapy designation by both the National Medical Products Administration (NMPA) in China and the US FDA for the treatment of extensive-stage small cell lung cancer (search) (ES-SCLC). This regulatory milestone highlights the potential of HS-20093 to address a significant unmet need in patients with relapsed or refractory ES-SCLC.
Breakthrough Therapy Designation
The Breakthrough Therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies. The designation for HS-20093 underscores the promise of this ADC in treating ES-SCLC, a particularly aggressive form of lung cancer (search) with limited treatment options upon relapse.
Collaboration with GSK
Hansoh Pharmaceutical (search) has entered into a licensing agreement with GSK, granting GSK exclusive worldwide rights (excluding Mainland China, Hong Kong, Macau, and Taiwan) to develop, manufacture, and commercialize HS-20093. This collaboration leverages GSK's global reach and expertise in oncology drug development to potentially bring HS-20093 to a broader patient population.
Hansoh's Focus on Innovation
Hansoh Pharmaceutical (search) has strategically shifted its focus from generic drugs to innovative medicines. Revenue from innovative medicines now accounts for more than 75% of the company's total revenue, a significant increase from 18% in FY20. This transition reflects Hansoh's commitment to research and development (R&D) and its ability to bring novel therapies to market. In the first half of 2024, Hansoh reported a 44.2% year-over-year increase in total revenue, driven primarily by innovative drugs and collaborative products.
R&D Investment and Pipeline
Hansoh Pharmaceutical (search)'s success is underpinned by substantial investment in R&D. In the first half of 2024, R&D spending increased by 28.7% year-over-year, reaching RMB1.2 billion, or 18.4% of total revenue. The company has over 50 clinical trials underway for more than 30 innovative drugs, demonstrating a robust pipeline of potential new therapies. Key drugs in development include treatments for type 2 diabetes (search), adult obesity (search), immunoglobulin A nephropathy (search), membranous nephropathy (search), advanced non-small cell lung cancer (search) (NSCLC), and psoriasis (search).