National Investigators' Meeting for Kelun-Biotech's Innovative TROP2-ADC SKB264 OptiTROP-Breast03 Phase III Registrational Clinical Study Successfully Held

(“Kelun-Biotech” or the “Company”, SEHK: 6990.HK), an innovative TROP2-ADC (SKB264, MK-2870), a randomized, open, multicenter study to evaluate the efficacy of SKB264 in the first-line treatment of chemotherapy in patients with recurrent or metastatic non-resectable triple-negative breast cancer (TNBC) in advanced stages. SKB264 comparing investigator-selected chemotherapy for the first-line treatment of patients with non-surgically resectable recurrent or metastatic triple-negative breast cancer (TNBC) to a randomized, open, multicenter Phase III registry-based clinical study in patients with advanced-stage, non-systemic-treatment-na?ve PD-L1-negative TNBC (the “OptiTROP Breast03 (“OptiTROP Breast03” or “the Study”) was successfully held in Hefei.   This study a clinical trial evaluating SKB264 comparing investigator-selected chemotherapy first-line for the treatment of patients with non-operable resectable recurrent or metastatic triple-negative breast cancer (Protocol No. SKB264-III-11), with the national lead research center being the Affiliated Cancer Hospital of Fudan University, the lead researcher being Prof. Zhi-Min Shao, and the clinical registry numbers being: CTR20240413, NCT06279364, and is currently being rapidly pushed into the group.   Professor Zhimin Shao, Chairman of the conference, said, “It is a great honor to lead the registrational clinical study of ColumboTech SKB264 in triple negative breast cancer. Currently, TNBC is a hot area of clinical research. We believe that based on the excellent performance of TROP2 ADC SKB264 reported in first-line as well as second-line and above treatment of advanced TNBC in triple-negative breast cancer in the previous phase, SKB264 can achieve better clinical results in the first-line treatment of triple-negative breast cancer in China. We sincerely thank all the experts for their active participation in this trial, and hope that through our joint efforts and professional wisdom, we can make positive contributions to this clinical study, and look forward to SKB264 receiving marketing approval as soon as possible for the benefit of more patients”.   Dr. Ge Junyou shared, “Kelun is the world's largest manufacturer of infusion solutions in terms of production scale, the world's largest manufacturer of antibiotic intermediates in terms of production scale, and a leading head enterprise of pharmaceutical innovation in China. Kelun-Biotech carries the champion gene of the Group and adheres to innovation at source.SKB264 is the first TROP2 ADC-like drug in China to enter Phase III and enter NDA registration.SKB264's NDA filing for TNBC backline treatment has been accepted by the State Drug Administration, and the drug has been recognized as a breakthrough therapy by four organizations, and has initiated a number of clinical studies in different indications in addition to TNBC. The drug has also received four breakthrough therapeutic recognitions. We look forward to working together to rapidly advance the OptiTROP Breast03 study and accelerate the marketing process for this indication, which will benefit more breast cancer patients. Thank you for the great support from all the experts!”   Professor Cao Min from Hunan Cancer Hospital shared his detailed experience in terms of center overview and enrollment, case sharing, screening and enrollment process management, and internal and external multi-party collaboration.   Professor Liang Yan from Jiangsu Provincial People's Hospital shared detailed experience from center enrollment, case sharing, subjects in group management and management of common adverse events.   Professor Fan Lei from Fudan University Cancer Hospital gave a detailed presentation on the program design and implementation details of the project.   Under the chairmanship of Prof. Zhimin Shao and Dr. Xiaoping Jin, Chief Medical Officer of Clonbuterol, all the participating experts had a full and enthusiastic discussion on the study design, enrollment criteria of the study population, and the study process, and reached a consensus.   Professor Wang Zhonghua and Prof. Shao Zhimin from the Affiliated Cancer Hospital of Fudan University summarized the meeting at the end and thanked all the experts who participated in the investigator meeting. The investigators' meeting came to a successful conclusion, officially starting a brand-new journey for the OptiTROP Breast03 study. Clonbuterol has been exploring the advantageous areas of ADC technology in depth, and continues to promote the deepening layout of SKB264 clinical research. SKB264 first-line treatment of non-surgically resectable locally advanced, recurrent or metastatic PD-L1 TNBC has also been recognized by the BTD, and Clonbuterol will efficiently and qualitatively complete the registry study, and make joint efforts with the first-line clinical force to bring more hope and gospel to global tumor patients. Gospel.   About Kelun-Biotech:   Kelun-Biotech （ 6990.HK ） is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing innovative projects in major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, including over 10 projects in the clinical stage and 4 projects in the NDA stage with several global trials being conducted simultaneously in multiple countries, including China, Europe, and the United States. The company has established one of the world’s leading proprietary ADC platforms, OptiDC?, and has 5 ADC projects in the clinical stage (2 of which are in the NDA stage) and several projects in the preclinical stage. For more information, please visit https://kelun-biotech.com/ .

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