Fluorouracil

CHENGDU, China I January 20, 2025 I Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the “Company”) has received marketing authorization in China from National Medical Products Administration (NMPA) for the programmed cell death ligand1(PD-L1)-directed innovative humanized monoclonal antibody (“mAb”) tagitanlimab (formerly KL-A167) (科泰莱®) for the treatment of patients with recurrent or metastatic nasopharyngeal cancer (NPC) who have failed after prior 2L+ chemotherapy. This is the world’s first PD-L1 monoclonal antibody approved for the treatment of NPC. The approval is based on a single-arm, multi-center, phase II clinical study in patients with recurrent or metastatic NPC who have failed after prior 2L+ systematic therapies, led by Professor Shi Yuankai of the Cancer Hospital Chinese Academy of Medical Sciences as the principal investigator, to evaluate the efficacy and safety profile of tagitanlimab monotherapy. As of the data cutoff date, the median follow-up time was 21.7 months, 132 patients entered full analysis set (FAS) totally, the independent review committee (IRC)-assessed objective recovery rate (ORR) was 26.5%, the duration of recovery (DoR) was 12.4 months and the median overall survival (OS) was 16.2 months. Meanwhile, tagitanlimab showed a manageable safety profile, where the incidence of grade 3 immune-related adverse event (irAEs) was 3.9% and no grade 3 above irAE was observed. Data from these clinical studies have been published in The Lancet Regional Health-Western Pacific [1] Dr. Micheal Ge, CEO of Kelun-Biotech said, “It is a great pleasure to share with you the significant moment of the successful approval of tagitanlimab for the domestic market, which is yet another proof of Kelun-Biotech’s excellence in the field of innovative drug discovery and development. The excellent efficacy and safety results achieved by tagitanlimab mark a significant progress and breakthrough in our exploration of the frontiers of medical science and technology. At the same time, we are also actively advancing our multi-strategy clinical development blueprint, aiming to deeply explore the potential of tagitanlimab in combination with ADC assets as an early-line treatment and maximize the clinical value of our oncology pipeline, with a view to reaching a wider group of patients and providing highly effective and safe therapeutic options for Chinese patients” About NPC The 2022 GLOBOCAN data showed that there were more than 120,000 new cases of nasopharyngeal cancer globally [2] , 51,000 new cases of nasopharyngeal cancer and 28,400 deaths in China [3] . According to the 2021 CSCO guidelines, the 1L treatment regimen for non-locally treatable recurrent or metastatic nasopharyngeal cancer is based on platinum-containing combination chemotherapy, and the 2L treatment is based on monotherapy. The 5-year survival rate of patients with recurrent or metastatic nasopharyngeal cancer is 18.5%, with a median OS of 22.1 months [4] , and there is still an unmet clinical need to improve the clinical benefit of this group of patients, especially those who develop metastases after treatment. In recent years, immunotherapy has provided more therapeutic options for tumor patients and has become an effective way to treat patients with nasopharyngeal carcinoma. 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 key innovative drug projects, of which 2 projects have been approved for marketing, 2 projects are in the NDA stage, and more than 10 projects are in the clinical stage. The company has established one of the world’s leading proprietary ADC platforms, OptiDC™, and has 1 ADC project approved for marketing, 1 ADC project in NDA stage, and multiple ADC or novel ADC projects in clinical or preclinical research stage. For more information, please visit https://kelun-biotech.com/. Reference [1]. Shi, Yuankai, et al. Lancet Reg Health West Pac. 2022 0ct 10:31:100617. [2]. GLOBOCAN (2022).WHO, Global Cancer Observatory. [3]. Journal of the National Cancer Center 4(2024)47-53. [4].Hong S, Huang Y, Yang Y, et al. (2020)] GEM20110714: Final overall survival results of the phase III study of firstline gemcitabine plus cisplatin versus fluorouracil plus cisplatin in recurrent or metastatic nasopharyngeal carcinoma. SOURCE: Sichuan Kelun-Biotech Biopharmaceutical Co.