Hansoh Pharmaceutical Group's antibody-drug conjugate (ADC), HS-20093, targeting B7-H3, 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 (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 with limited treatment options upon relapse.
Collaboration with GSK
Hansoh Pharmaceutical 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 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'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, adult obesity, immunoglobulin A nephropathy, membranous nephropathy, advanced non-small cell lung cancer (NSCLC), and psoriasis.
