Hengrui Pharmaceutical (01276): Drug marketing license application for injectable Ruikang luzetotamab was accepted by the State Drug Administration

Zhitong Finance App News, Hengrui Pharmaceutical (01276) issued an announcement. Recently, Suzhou Shengdia Biomedical Co., Ltd., a subsidiary of Jiangsu Hengrui Pharmaceutical Co., Ltd. (hereinafter referred to as the “Company”), received the “Notice of Acceptance” issued by the State Drug Administration (hereinafter referred to as the “State Drug Administration”), and the company's drug marketing license application for injectable Ruikang Luzetoltamab (SHR-A2009 for injections) was accepted by the State Drug Administration.

This listing is based on a randomized controlled, open, multicenter phase III clinical trial evaluating the efficacy and safety of injectable Ruikang lutazumab (R&D code: SHR-A2009) in patients with advanced EGFR mutation or metastatic non-small cell lung cancer who failed EGFRTKI treatment. Professor Wu Yilong of Guangdong Provincial People's Hospital was the main researcher in this study. 65 centers from all over the country participated, and a total of 498 subjects were enrolled. The primary end point of the study was Progression-Free Survival (PFS) for Blind Independent Center Assessment (BICR). Research results showed that injectable ruzetolatumab can significantly prolong patients' PFS compared to platinum-containing dual-drug chemotherapy.

Lung cancer is the second most common cancer worldwide and the leading cause of cancer-related deaths. In 2024, the number of new cases of lung cancer in China was about 1.176,000, and the death rate was about 743,300. The incidence rate and death rate ranked first among all cancers. NSCLC is the most common type of lung cancer, and most NSCLC patients are advanced when diagnosed. EGFR gene mutations are the most common driver gene mutation for NSCLC. For NSCLC patients with advanced EGFR mutations, EGFRTKI is the current first-line standard treatment, but patients will inevitably develop drug resistance after receiving EGFRTKI treatment. Treatment options after drug resistance are limited, and there are unmet clinical needs in this population.

SHR-A2009 for injection is an antibody-drug conjugate (ADC) targeting HER3. It can specifically bind to HER3 on the surface of tumor cells, then be endocytosed into cells and transported to lysosomes. Water releases free toxins and kills tumor cells. HER3 expression was found in various solid tumors. Among them, HER3 expression accounted for about 82.7% in NSCLC, and HER3 expression increased after EGFRTKI treatment. According to inquiries, there are no HER3-targeting ADCs approved to treat NSCLC in the world. Up to now, the total R&D investment for SHR-A2009 related projects for injectable use is about 330 million yuan.