Shanghai, China, 9 November 2026 – Simcere Pharmaceutical Group Ltd. (“Simcere”) (HKEX: 2096) today announced that SIM0709, a TL1A/IL-23p19 bispecific antibody partnered with Boehringer Ingelheim, has received approval from Germany’s Paul-Ehrlich-Institut (PEI) and the competent German Ethics Committee to initiate a phase 1 clinical trial in healthy participants. SIM0709 was developed by Simcere and is being advanced globally with Boehringer Ingelheim. The target indication for SIM0709 is inflammatory bowel disease (IBD).
Globally, it is estimated that more than three million people are affected by IBD, a lifelong, progressive condition leading to frequent hospitalization and surgeries, significantly impacting patients‘ quality of life. Despite currently available anti-inflammatory therapies, many patients continue to progress and experience severe complications, leaving a clear unmet need.
"We are very pleased to see SIM0709 approved to initiate clinical studies in Europe, which is an important milestone in the global development of this new drug candidate" said Dr Aik GOH，Chief Medical Officer of Simcere. "We believe that the collaboration between Simcere and Boehringer Ingelheim will continue to efficiently advance this bispecific antibody and evaluate its potential to benefit IBD patients worldwide."
SIM0709 is a long-acting humanized bispecific antibody. It has been designed using Simcere’s proprietary multi-specific antibody platform to simultaneously target tumor necrosis factor ligand superfamily member 15 (TL1A) and interleukin-23 (IL-23). By blocking two core pathways that are implicated in the progression of IBD it could overcome the efficacy ceiling of current single-target therapies in IBD. In both in vitro primary cell studies and in vivo animal studies, SIM0709 demonstrated superior synergistic efficacy, outperforming the combination of the two corresponding monotherapies.
In January 2026, Simcere and Boehringer Ingelheim reached a license and collaboration agreement to co-develop SIM0709. Boehringer receives global rights to the asset, excluding greater China. Under the contract, Simcere is eligible to receive success-based development, regulatory and sales milestones up to EUR 1,058 million, as well as royalties on net sales outside of the Greater China territory.