Tides Express | Hansoh Pharma's ADC Drug HS-20093 Granted Breakthrough Therapy Designation by China's NMPA

November 20241 DayHansoh Pharmaceutical Group Company Limited (hereinafter referred to as "Hansoh Pharma", 03692.HK), a leading innovation-driven pharmaceutical company in China, announced today that HS-20093 Injection, a B7-H3-targeted antibody-drug conjugate (ADC) independently developed by the company, has been approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to be included in the "Breakthrough Therapy Designation". The proposed indication is for patients with extensive-stage small cell lung cancer (ES-SCLC) who have progressed after standard first-line treatment (platinum doublet chemotherapy combined with immunotherapy).）。

In December 2023, Hansoh Pharma entered into a licensing agreement with GlaxoSmithKline (GSK), granting GSK an exclusive global license (excluding mainland China, Hong Kong, Macao, and Taiwan) to develop, manufacture, and commercialize HS-20093 (also known as GSK5764227). This drug is currently undergoing a global Phase I clinical trial conducted by GSK. In August 2024, GSK announced that the U.S. Food and Drug Administration (FDA) had granted GSK5764227 Breakthrough Therapy Designation for the treatment of patients with extensive-stage small cell lung cancer (ES-SCLC) who progress during or after platinum-based chemotherapy (recurrent or refractory).

HS-20093 has successively received the FDA's "Breakthrough Therapy" designation and the NMPA's "Breakthrough Therapeutic Drug" designation, which is expected to further accelerate its development and approval process in China and globally. As a leading innovation-driven pharmaceutical company in China, Hansoh Pharma will continue to focus on independent research and international cooperation, efficiently advancing around unmet clinical needs.The research, development, and transformation of multiple globally leading technologies and innovative products have been successfully implemented, benefiting a wide range of patients.

AboutHS-20093

HS-20093 is a novel B7-H3-targeted ADC, composed of a fully human anti-B7-H3 monoclonal antibody covalently linked to a topoisomerase inhibitor (TOPOi) payload. It is currently undergoing Phase III clinical trials in China for small cell lung cancer.As well as multiple Phase I and Phase II clinical studies on sarcoma, head and neck cancer, esophageal cancer, and other solid tumors.

About Hansoh Pharma

Hansoh Pharma is a leading innovation-driven pharmaceutical enterprise in China, with subsidiaries including Hansoh Pharmaceuticals, Changzhou Hengbang Pharmaceuticals, and Hansoh Biologics. The company focuses on key areas such as anti-tumor, anti-infective, central nervous system, metabolism, and autoimmune diseases.In the field of treating major diseases such as epidemics, it is committed to improving the quality of human life through continuous innovation.