HANSOH PHARMA ANNOUNCES NMPA HAS GRANTED BREAKTHROUGH-THERAPY-DESIGNATED DRUGS FOR HS-20093
On November 1, 2024,Hansoh Pharmaceutical Group Co., Ltd. (Hansoh Pharma, 03692.HK), announces that the Group’s self-developed B7-H3-targeted antibody-drug conjugate (ADC) HS-20093 for injection has been approved to be included as Breakthrough-Therapy-Designated Drugs by the National Medical Products Administration (NMPA) of China, with the proposed indication being extensive stage small cell lung cancer (“ES-SCLC”) developed after standard first-line treatment (platinum doublet chemotherapy combined with immuno-therapy).
On December 20, 2023, the Group entered into a license agreement with GlaxoSmithKline Intellectual Property (No. 4) Limited (“GSK”), granting GSK an exclusive worldwide license (excluding the Chinese Mainland, Hong Kong, Macau, and Taiwan) to develop, manufacture and commercialize HS-20093 (also known as GSK5764227), which is currently undergoing global Phase I clinical trial by GSK. In August 2024, GSK announced that the US Food and Drug Administration granted Breakthrough Therapy Designation for GSK5764227 for the treatment of patients with ES-SCLC with disease progression on or after platinum-based chemotherapy (relapsed or refractory).
ABOUT HS-20093
HS-20093 is a novel B7-H3-targeted ADC composed of a fully-humanized anti-B7-H3 monoclonal antibody covalently linked to topoisomerase inhibitor (TOPOi) payload and being developed in China in clinical studies of small cell lung cancer in Phase III, and sarcoma, head and neck cancers, ESCC and other solid tumors in multiple Phase I and II studies.
ABOUT LUNG CANCER：
Lung cancer is one of the most common cancers worldwide. Of patients with small-cell lung cancer, 70% have extensive-stage disease meaning the cancer has spread throughout one or both lungs and/or to other parts of the body. ES-SCLC is an aggressive and difficult-to-treat cancer with limited treatment options. The 5-year survival rate is approximately 3%i. Most patients with ES-SCLC relapse after initial treatment and the median overall survival with current standard-of-care treatments for relapsed ES-SCLC is 5-6 monthsii.
Reference：
i.SEER Explorer Surveillance Research Program, US National Cancer Institute, accessed 23 January 2024.
ii.Topotecan USPI accessed 11 March 2024.
Hansoh Pharma is a leading innovation-driven pharmaceutical enterprise headquartered in China. With the mission of "continuous innovation for better life", the company focuses on major disease therapeutic areas such as oncology, anti-infectives, central nervous system (CNS), metabolism and immunology. Hansoh Pharma has launched 7 innovative drugs that generate product sales in China, with the revenue from innovative drugs and collaborative products exceeding 80%, forming a rich product pipeline. The company has consistently ranked among the top 100 global pharmaceutical companies and is recognized as one of the top 3 pharmaceutical R&D enterprises in China and is designated as a National Key High-Tech Enterprise and a National Technology Innovation Demonstration Enterprise. Hansoh Pharma was listed on the Hong Kong Stock Exchange in June 2019 (stock code: 03692.HK).
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