Core Viewpoint - A Chinese innovative drug, iza-bren, has received breakthrough therapy designations from both the FDA and the Chinese drug regulatory authority, showcasing significant potential in lung cancer treatment, particularly highlighted by a 100% objective response rate (ORR) at the WCLC 2025 conference [2][3][4]. Group 1: Clinical Data and Breakthroughs - The Phase II clinical trial of iza-bren combined with Osimertinib for treating EGFR-mutant non-small cell lung cancer (NSCLC) reported a 100% ORR, the highest recorded for first-line treatments in this category [3][5]. - The trial included 40 patients at a specific dosage of 2.5 mg/kg, which is now the recommended dose for subsequent Phase III studies [3][7]. - The treatment demonstrated a significant tumor reduction, with a median tumor shrinkage of nearly 57% from baseline, indicating a strong potential for long-term control of the disease [5][6]. Group 2: Future Research and Development - The ongoing Phase III study aims to compare the efficacy and safety of the combination therapy against Osimertinib alone, with primary endpoints focusing on progression-free survival (PFS) and secondary endpoints on overall survival (OS) [7][8]. - The study has received regulatory approval and is actively enrolling patients, with the first patient enrolled in February 2023 [7][9]. Group 3: Market Position and Global Collaboration - The collaboration with BMS (Bristol-Myers Squibb) is structured as a long-term joint development, retaining Chinese rights and supply chain control, which enhances the global clinical trial execution [9][10]. - Iza-bren is positioned as a leading antibody-drug conjugate (ADC) with unique dual-targeting capabilities, potentially setting a new direction in cancer combination therapies [10][11]. Group 4: Regulatory Recognition and Market Potential - Iza-bren has received multiple breakthrough therapy designations, which expedite its development and review process, allowing for faster patient access upon approval [13][14]. - The drug is expected to redefine treatment standards for EGFR-TKI resistant patients, with a median PFS of 12.5 months reported, significantly higher than existing therapies [11][12]. Group 5: Industry Impact - The advancements of iza-bren signify that Chinese innovative drug companies are now competing at the global forefront, with the potential to reshape treatment paradigms across various cancer types [14].