Xiansheng Pharmaceutical (02096): SIM0709 (TL1a/IL-23p19 bispecific antibody) was approved for clinical trials by the German regulatory authorities and ethics committee

According to Zhitong Finance App, Xiansheng Pharmaceutical (02096) announced that the TL1A/IL-23p19 bispecific antibody sim0709 independently developed by the Group has been approved by the German Paul-Ehrlich-Institut (German Federal Institute for Vaccines and Biomedicine) and the competent ethics committee, and will officially launch a phase I clinical trial for healthy participants. SIM0709 and Boehringer Ingelheim are promoting global development. The target indication is inflammatory bowel disease (IBD).

SIM0709 is a long-acting humanized bispecific antibody independently developed by the Group based on its own multi-specific antibody platform. SIM0709 can simultaneously target tumor necrosis factor ligand superfamily members 15 (TL1A) and interleukin-23 (IL-23), thereby blocking the two core pathways involved in the occurrence and progression of inflammatory bowel disease, so as to break through the efficacy bottlenecks of existing single-target IBD therapies. SIM0709 showed excellent pharmacodynamic synergy in both in vitro primary cell experiments and in vivo animal experiments, even superior to the combined use of two single drugs.

In January 2026, Xiansheng Pharmaceutical Co., Ltd. (Jiangsu Xiansheng), a subsidiary of the group, signed an exclusive licensing agreement with Boehringer Ingelheim. According to the terms of the license agreement, Boehringer Ingelheim will receive exclusive global rights of SIM0709 outside of Greater China, and the Group will be entitled to receive a down payment of 42 million euros, as well as payments of up to 1,016 million euros based on R&D progress, regulatory approval and commercialization milestones. In addition, the Group also has the right to charge tiered royalties for net sales outside of Greater China.