Recently , Simcere Pharmaceutical (2096.HK) announced that it has entered into an exclusive licensing and collaboration agreement with Boehringer Ingelheim, a leading global pharmaceutical company, to jointly develop Simcere's self-developed TL1A/IL-23p19 bispecific antibody SIM0709 for the treatment of inflammatory bowel disease.

Under the agreement, Boehringer Ingelheim acquires global rights to the project outside of Greater China. Simcere Pharmaceutical will receive an upfront payment, plus payments of up to €1.058 billion based on success in development, registration, and commercial milestones, in addition to royalties from net sales outside of Greater China.

More than 3 million people worldwide are affected by inflammatory bowel disease (IBD). This disease can accompany patients throughout their lives and progresses continuously, often leading to frequent hospitalizations and surgeries, and severely impacting quality of life. Current medical treatments cannot completely prevent or reverse the disease and its complications, resulting in a significant unmet clinical need in this field. Through this collaboration, Simcere Pharmaceutical and Boehringer Ingelheim will jointly advance the development of innovative therapies, aiming to redefine effective treatments and improve the treatment and quality of life for patients worldwide.

SIM0709 is a long-acting humanized bispecific antibody developed by Simcere Pharmaceutical's multi-antibody technology platform. It can simultaneously target tumor necrosis factor-like cytokine 1A (TL1A) and interleukin-23 (IL-23), blocking two core pathways leading to the development and progression of inflammatory bowel disease. SIM0709 has demonstrated excellent synergistic effects in both in vitro primary cell experiments and in vivo animal experiments, even surpassing the combination of two single drugs.

“Inflammatory bowel disease affects a huge patient population, many of whom continue to experience disease progression and serious complications despite the use of existing anti-inflammatory therapies,” said Carine Boustany, Head of Innovation Center for the United States and Head of Global Research and Development for Immune and Respiratory Diseases at Boehringer Ingelheim. “We are excited to partner with Simcere Pharmaceutical to accelerate the development of this potentially life-changing innovative therapy.”

“SIM0709, developed by Simcere Pharmaceutical’s multi-antibody technology platform, has the potential to be a ‘first-in-class’ drug in the treatment of inflammatory bowel disease. Boehringer Ingelheim has accumulated extensive experience in the global immunotherapy field over the years, and we believe that this collaboration will lay a solid foundation for the global development of this molecule,” said Zhou Gaobo, Chief Investment Officer of Simcere Pharmaceutical. “We will work together to efficiently advance clinical development and bring innovative drugs that can improve prognosis to patients with inflammatory bowel disease around the world as soon as possible.”

Boehringer Ingelheim is a global leader in the treatment of immune and respiratory diseases, while Simcere Pharmaceutical has been developing its presence in the Chinese autoimmune disease field for many years, launching innovative products such as Aydercin (Ailamod). Simcere Pharmaceutical's self-developed interleukin-2 mutant fusion protein has entered Phase II clinical trials globally for the treatment of autoimmune diseases, with its overseas rights licensed to the Spanish company Almirall. This collaboration combines Simcere Pharmaceutical's innovative R&D capabilities with Boehringer Ingelheim's global development and commercialization advantages, and is expected to accelerate the accessibility of this potential innovative therapy for inflammatory bowel disease to patients worldwide.

This collaboration marks Simcere Pharmaceutical's second overseas licensing project for an innovative drug in the field of autoimmune diseases, and its fifth self-developed innovative drug early-stage project to achieve external technology licensing, with a total potential transaction value exceeding US$4.6 billion. In recent years, Simcere Pharmaceutical has continuously increased its R&D investment, accumulating approximately RMB 9 billion in R&D investment over the past five years. The proportion of revenue from innovative drugs has increased significantly from 45% in 2020 to 77% in the first half of 2025, demonstrating the initial success of its innovation transformation.