Kelun-Biotech’s Product Tagitanlimab Approved for Marketing for Second Indication in China

---Jan. 21 2025, Chengdu, China---

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the “Company”) announced that the Company received marketing authorization in China from the National Medical Products Administration (NMPA) for the innovative programmed cell death ligand 1 (PD-L1)-directed humanized monoclonal antibody (“mAb”) tagitanlimab (formerly KL-A167) used in combination with cisplatin and gemcitabine for the first-line treatment of patients with recurrent or metastatic nasopharyngeal cancer (NPC).

The approval is based on a randomized, double-blinded, placebo controlled, multi-center, phase III clinical study evaluating the efficacy and safety of tagitanlimab in combination with cisplatin and gemcitabine versus placebo in combination with cisplatin and gemcitabine for the treatment of recurrent or metastatic NPC, which was led by Professor Shi Yuankai of the Cancer Hospital Chinese Academy of Medical Sciences as the principal investigator.

According to the study results, tagitanlimab used in combination with cisplatin and gemcitabine for the first-line treatment for recurrent or metastatic NPC could achieve better progression-free survival (PFS), higher objective response rate (ORR) and extended duration of response (DoR) compared with chemotherapy, and all patients could benefit regardless of PD-L1 expression. The median PFS for tagitanlimab in combination with chemotherapy was not reached compared to 7.9 months for placebo in combination with chemotherapy (HR=0.47, 95% CI: 0.33-0.66, p<0.0001), and the risk of disease progression and death was reduced by 53%; ORR is 81.7% vs 74.5%; median DoR was 11.7 vs 5.8 months (HR=0.48, 95% CI: 0.32-0.70), which has nearly doubled compared to placebo arm; currently the median overall survival (OS) was still not mature, however the beneficial trend for OS of tagitanlimab in combination with chemotherapy has already been observed (HR=0.62, 95％CI: 0.32-1.22), and its risk of death was reduced by 38% . Tagitanlimab also showed a manageable safety profile.

This is the second indication approved in China for tagitanlimab. Previously, the NMPA had approved the marketing of tagitanlimab monotherapy for the treatment of patients with recurrent or metastatic NPC who had failed treatment after prior 2L+ chemotherapy.

Dr. Micheal Ge, CEO of Kelun-Biotech said, “We are pleased that the second indication of our self-developed PD-L1 monoclonal antibody was successfully approved for marketing and demonstrated statistically significant and clinically meaningful improvements in PFS. For domestic NPC patients, tagitanlimab has realized a breakthrough in therapeutic coverage and innovation from the backline to the frontline, which once again strongly validates the excellent strength of Kelun-Biotech's new drug research and development. In the future, the company will continue to focus on unmet clinical needs, source innovation, and explore more and more excellent clinical therapeutic solutions to benefit more patients.”


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/.