Hengrui Pharma(SH:600276) Xin Lang Cai Jing·2026-01-13 06:40Core Viewpoint - Heng Rui Medicine's SHR-1826 has been included in the list of breakthrough therapies by the National Medical Products Administration, targeting c-Met overexpressing non-small cell lung cancer (NSCLC) patients who have failed at least one line of systemic therapy [1][3]. Group 1: Product Development - SHR-1826 is an antibody-drug conjugate (ADC) targeting c-Met, designed for monotherapy in patients with locally advanced or metastatic non-squamous NSCLC [1][3]. - The total R&D investment for SHR-1826 has reached approximately 125.5 million yuan [1][3]. - A similar product, ABBV-399, received accelerated approval from the FDA in May 2025 for treating advanced/metastatic non-squamous NSCLC patients with high c-Met protein expression [1][3]. Group 2: Clinical Research Results - At the 2025 ASCO conference, phase I study results for SHR-1826 showed an objective response rate of 39.7% and a disease control rate of 94.8% among 58 evaluable NSCLC patients [2][4]. - Promising anti-tumor effects were observed across different c-MET expression levels and in patients with or without EGFR mutations [2][4]. - Multiple clinical studies are underway for SHR-1826, aiming to provide more treatment options for MET abnormal NSCLC patients [2][4]. Group 3: Technology Platform - The company has established a proprietary technology platform that includes ADCs, with the DXh technology ADC platform validated in over 5,000 patients across more than 15 tumor types in five major countries [2][4]. - As of November 2025, the company has one ADC product (Rui Kang Qu Tuo Zhu Single Antibody) approved for domestic use, with four key ADC molecules in phase III clinical trials and several innovative drug products targeting various solid tumor treatment areas [2][4].