SIMCERE PHARMA (02096.HK): SIM0709 trial cleared in Germany

On 9 November 2026, SIMCERE PHARMA (02096.HK) said Germany cleared its TL1A/IL-23p19 bispecific antibody SIM0709 for a phase I trial in healthy volunteers.
Key Highlights:
  • SIM0709 is a long-acting humanised bispecific antibody targeting TL1A and IL-23, blocking two core pathways in the onset and progression of IBD.
  • Under the January 2026 licence, Boehringer Ingelheim holds ex-Greater China rights, with a EUR 42 million upfront payment and up to EUR 1.016 billion in milestones.

NewTimeSpace News: On 9 November 2026, Simcere Pharmaceutical Group Limited (Stock Code: 02096) said SIM0709, an in-house TL1A/IL-23p19 bispecific antibody, was cleared by Germany's Paul-Ehrlich-Institut and the competent ethics committee to start a phase I trial in healthy volunteers. SIM0709 is being developed globally with Boehringer Ingelheim for inflammatory bowel disease (IBD).

The announcement shows SIM0709 is a long-acting humanised bispecific antibody built on the company's multispecific platform targeting TL1A and IL-23, blocking two core IBD pathways to break the efficacy ceiling of single-target therapies; it showed superior synergy in vitro and in vivo, beating the two single agents combined. Under a January 2026 exclusive licence, Boehringer Ingelheim holds global rights outside Greater China, with Simcere receiving a EUR 42 million upfront payment, up to EUR 1.016 billion in milestones and tiered royalties on ex-Greater China net sales.

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