01 November 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.
About Hansoh
Hansoh Pharma is a leading pharmaceutical company in Greater China driven by innovation. It is committed to the treatment of major diseases in the areas of oncology, anti-infections, CNS diseases, metabolic diseases, as well as autoimmune diseases, and is dedicated to improving human health through continuous innovation. To date, Hansoh Pharma has launched 7 innovative drugs to form a diverse commercial portfolio. Hansoh Pharma has been ranked among the top 100 global pharmaceutical companies and the top 3 best industrial enterprises in China in terms of pharmaceutical R&D pipeline for several years, and is a national key high-tech enterprise and a national technology innovation demonstration enterprise. Hansoh Pharma was listed on the Stock Exchange of Hong Kong in June, 2019 (stock code: 03692.HK). For more information, please visit www.hspharm.com.
Statements
Hansoh Pharma does not recommend the use of any unapproved drugs or indications. Medical info in this release is for informational and news reporting only and is not for advertising purposes. Don't use it for health care or diagnosis.
Forward-Looking Statements
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Reference：
i.SEER Explorer Surveillance Research Program, US National Cancer Institute, accessed 23 January 2024.
ii.Topotecan USPI accessed 11 March 2024.
