Fosun Pharma has entered into an exclusive licensing agreement with Accro Bioscience to develop, manufacture, and commercialize AC-201, a highly selective TYK2/JAK1 inhibitor, in Greater China including the Chinese mainland, Hong Kong SAR, and Macau SAR. The deal represents a significant expansion of Fosun's immunology and inflammation pipeline, with total potential payments reaching RMB 156 million ($21.8 million).
Clinical Development and Mechanism of Action
AC-201 is a novel, oral small-molecule inhibitor that demonstrates high selectivity for TYK2/JAK1 by binding to the pseudo kinase domain (JH2) of these targets. This selective binding mechanism results in minimal effect on the JAK2/JAK2 signaling pathway, potentially reducing safety concerns associated with broader JAK inhibition.
The compound has successfully completed a Phase II clinical trial in patients with moderate-to-severe plaque psoriasis. Results showed that all dose groups met the primary endpoint and key secondary endpoints after 12 weeks of treatment. Importantly, AC-201 demonstrated a favorable safety profile across all dose groups, with no adverse events leading to discontinuation or serious adverse events reported.
Financial Terms and Strategic Value
Under the licensing agreement, Accro Bioscience will receive an upfront payment of RMB 60 million ($8.4 million) and a milestone payment of RMB 20 million ($2.8 million) upon completion of manufacturing technology transfer. Additional development milestone payments of up to RMB 76 million ($10.66 million) are structured throughout the development process, along with commercial milestone payments and tiered royalties reaching double-digit percentages based on product sales in the licensed regions.
Accro retains global rights to develop, manufacture, and commercialize AC-201 outside of the Greater China territory, allowing the company to pursue parallel development strategies in other major markets.
Leadership Perspectives on Partnership
"We are delighted to enter into this collaboration with Accro. AC-201, as a highly selective TYK2/JAK1 inhibitor, demonstrates significant clinical potential in the treatment of autoimmune diseases," said Xingli Wang, Co-President of Fosun Pharma and CEO of the Global R&D Center. "This partnership will further enrich our pipeline in the immunology and inflammation field. Leveraging Fosun Pharma's established clinical development system and commercial network, we aim to accelerate the development and commercialization of AC-201 in Greater China."
Dr. Xiaohu Zhang, co-founder and CEO of Accro Bioscience, emphasized the strategic value of the partnership: "Fosun's extensive clinical development experience and commercialization capabilities will accelerate the development of AC-201 and enhance drug accessibility, bringing exceptional treatment options to patients with autoimmune diseases in the region as soon as possible."
Broader Pipeline Context
The AC-201 partnership represents one component of Accro Bioscience's clinical-stage portfolio, which includes three assets targeting regulated cell death mechanisms. The company's RIPK2 inhibitor AC-101 has completed Phase 1 studies in Australia and China and is currently in a Phase 1b trial for ulcerative colitis patients. Additionally, the RIPK1 inhibitor AC-003 has received FDA Orphan Drug Designation and is advancing through Phase 1b trials for acute graft-versus-host disease treatment.
For Fosun Pharma, the agreement aligns with the company's "4IN" strategy focusing on Innovation, Internationalization, Intelligentization, and Integration. The partnership strengthens Fosun's position in core therapeutic areas including immune-inflammatory disorders, complementing its existing focus on oncology and expanding its technological capabilities in small molecule development.
