BIOKIN PHARMACEUTICAL(SH:688506) Ge Long Hui·2026-01-20 10:59Core Viewpoint - The acceptance of the new drug application (NDA) for the innovative dual-target antibody-drug conjugate (ADC) drug, iza-bren (BL-B01D1), by the National Medical Products Administration (NMPA) marks a significant milestone for the company and represents a shift in China's role in global pharmaceutical innovation [1][4][12]. Group 1: Drug Development and Regulatory Milestones - The drug iza-bren has received NDA acceptance for two indications within two months, first for nasopharyngeal cancer and now for esophageal squamous cell carcinoma [1]. - The drug has been included in the priority review process by the Center for Drug Evaluation (CDE), which will expedite its market entry [5]. - Iza-bren is the first ADC to achieve positive results in both progression-free survival (PFS) and overall survival (OS) in a Phase III trial for esophageal cancer, highlighting its potential as a groundbreaking treatment [5][6]. Group 2: Clinical Need and Market Opportunity - Esophageal cancer is a major health issue in China, with approximately 224,000 new cases annually, accounting for 43.8% of global cases [4]. - Current treatment options for advanced esophageal squamous cell carcinoma are limited, particularly after the failure of first-line therapies, creating a significant unmet clinical need [4]. - Iza-bren aims to address this gap by providing a new treatment option for patients who have failed prior PD-1/PD-L1 therapy [4]. Group 3: Strategic Value and Competitive Advantage - The dual-target mechanism of iza-bren, which targets both EGFR and HER3, enhances its efficacy and reduces off-target toxicity, establishing a scientific basis for its broad anti-tumor potential [8]. - The company has over 40 ongoing clinical trials in the U.S. and China, covering various cancers, which demonstrates its extensive clinical development strategy [8]. - A significant partnership with Bristol-Myers Squibb (BMS) worth up to $8.4 billion underscores the global recognition and potential of iza-bren [9]. Group 4: Future Growth and Innovation - The commercialization strategy for iza-bren includes filling clinical gaps in esophageal and nasopharyngeal cancers, as well as exploring its use in combination with existing therapies for broader indications [10]. - The company has developed a robust innovation engine with multiple platforms, ensuring a continuous pipeline of new drugs beyond iza-bren [10]. - The success of iza-bren represents a broader trend of Chinese pharmaceutical companies moving from imitation to original innovation, marking a new era in China's pharmaceutical industry [12].