NPMA Accepts Kelun-Biotech's Second NDA for SKB264 in EGFR-Mutant NSCLC

On August 20, 2024, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech", 6990.HK) announced that their new drug application (NDA) for sacituzumab tirumotecan (sac-TMT) had been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China. This acceptance is based on positive results from the pivotal OptiTROP-Lung03 study, marking a significant step in the treatment of non-small cell lung cancer (NSCLC).

The OptiTROP-Lung03 study is a multi-center, randomized clinical trial that evaluates the efficacy of sac-TMT monotherapy administered at 5mg/kg every other week as an intravenous injection. This study compares sac-TMT to docetaxel for patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutant NSCLC who have not responded to EGFR-tyrosine kinase inhibitor (TKI) therapy and platinum-based chemotherapy. The results of the study showed that sac-TMT delivered a statistically significant and clinically meaningful improvement in both objective response rate (ORR) and progression-free survival (PFS) compared to docetaxel.

Lung cancer is primarily categorized into non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), with NSCLC being the most prevalent, accounting for approximately 80%-85% of all lung cancers. The molecular profile of NSCLC patients in China differs from those in Western populations, with EGFR mutations being a common variant found in around 40%-50% of lung adenocarcinoma cases in China. According to the 2024 CSCO guidelines, EGFR-TKIs are the recommended treatment for stage IV EGFR-mutant NSCLC. However, after resistance to EGFR-TKIs, the main first-line therapy shifts to platinum-containing chemotherapy. Current treatments are inefficient for those who have failed EGFR-TKIs and platinum-based chemotherapy, with single-agent chemotherapy being the standard care. Docetaxel, a commonly used single-agent chemotherapy, has an ORR of 3.2%-10.8%, a median PFS of about two months, and a median overall survival (OS) of approximately six to eight months. This highlights the urgent need for new treatments to improve patient survival rates.

Kelun-Biotech's NDA for sac-TMT represents a critical advancement for patients with locally advanced or metastatic EGFR-mutant NSCLC who have exhausted previous treatment options. Notably, this is the second NDA for sac-TMT accepted by the NMPA. Earlier, on August 14, 2024, the NMPA had announced that the application would be included in the priority review and approval process. Previously, an NDA for sac-TMT for patients with locally advanced or metastatic triple-negative breast cancer (TNBC) who had undergone at least two prior systemic therapies was also accepted by the NMPA.

Dr. Junyou Ge, CEO of Kelun-Biotech, expressed great honor in having the second NDA for sac-TMT accepted. He emphasized the company's commitment to innovation-driven development, focusing on pioneering technologies and new treatment methods for major diseases. Kelun-Biotech aims to address unmet medical needs through the development of new drugs with unique advantages and global potential. The company is dedicated to enhancing its drug development capabilities, improving research and development efficiency, and advancing clinical research to explore and validate the clinical value of its core projects. Dr. Ge reaffirmed the company's dedication to excellence and its contribution to global oncology health.

Kelun-Biotech is a subsidiary of Kelun Pharmaceutical (002422.SZ) specializing in the R&D, manufacturing, commercialization, and global collaboration of innovative biological and small molecule drugs. The company focuses on critical areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, with over 30 ongoing innovative projects. Among these, more than 10 are in the clinical stage, and 4 are in the NDA stage. The company is conducting several global trials across multiple regions, including China, Europe, and the United States. Kelun-Biotech has developed the proprietary ADC platform, OptiDC™, and has advanced five ADC projects to the clinical stage, with two in the NDA stage and several in preclinical development.