全球首个！百利天恒核心双抗ADCIII期研究达预期 业内人士：说明了中国创新药资产的实力

Core Insights - Baili Tianheng's BL-B01D1 has become the world's first dual antibody-drug conjugate (ADC) to complete Phase III clinical trials, targeting recurrent or metastatic nasopharyngeal carcinoma after failure of PD-1/PD-L1 monoclonal antibody treatment and at least two lines of chemotherapy [1][4][5] - The successful Phase III trial may position nasopharyngeal carcinoma as the primary indication for BL-B01D1, with potential for additional indications such as esophageal cancer to be analyzed in mid-2025 [1][2][5] Company Developments - Baili Tianheng's BL-B01D1 achieved a major clinical endpoint in its Phase III trial, marking a significant milestone for the company and the dual ADC category [2][3] - The company has over 30 ongoing clinical trials for BL-B01D1, including 9 Phase III trials, with the nasopharyngeal carcinoma indication being recognized as a breakthrough therapy by the National Medical Products Administration (NMPA) in April 2024 [2][5] - In 2023, Baili Tianheng entered a partnership with BMS, which included a total transaction value of $8.4 billion for the rights to BL-B01D1, making it the first dual ADC licensed from China [3][5] Industry Context - The success of BL-B01D1 in Phase III trials is seen as a validation of the quality and potential of dual ADCs globally, highlighting the strength of Chinese innovative drug assets [1][5] - The number of dual ADCs entering clinical stages globally remains limited, with only a few others, such as TQB2102 and JSKN003, also in Phase III trials [5][6] - The dual targeting nature of BL-B01D1, which targets EGFR and HER3, positions it favorably in the competitive landscape, with broad anti-tumor activity demonstrated across multiple cancer types [5]