OR WAIT null SECS
© 2025 MJH Life Sciences™ , Pharmaceutical Technology - Pharma News and Development Insights. All rights reserved.
AC-201 is being developed in a novel, oral formulation as a potent inhibitor that binds to the pseudo kinase domain, JH2, of TYK2/JAK1.
Shanghai-based Fosun Pharma has reached an agreement with Accro Bioscience to exclusively develop, manufacture and commercialize Accro’s highly selective tyrosine kinase 2 (TYK2)/Janus kinase 1 (JAK1) inhibitor candidate, AC-201, in Greater China, which includes the Chinese mainland and the special administrative regions of Hong Kong and Macau (1).
AC-201 has been developed with the aim of treating multiple immune-mediated inflammatory diseases. Fosun Pharma said the small-molecule candidate is being developed in a novel, oral formulation, and is a potent inhibitor that binds to the pseudo kinase domain, JH2, of TYK2/JAK1 (1). There is minimal effect on the JAK2/JAK2 signaling pathway, according to Fosun Pharma.
Fosun Pharma said that AC-201 has completed a Phase II clinical trial in patients with moderate to severe plaque psoriasis in which all dose groups met primary and key secondary endpoints after 12 weeks of treatment (1).
The announcement of this agreement as August 2025 comes to a close amplifies some of the other therapies for inflammatory indications that are coming to market.
On Aug. 6, 2025, Celltrion announced that FDA approved its application for an expanded indication of tocilizumab-anoh (brand name Avtozma), its intravenous therapy, to include the treatment of cytokine release syndrome in adults and pediatric patients 2 years of age and older (2). Tocilizumab-anoh is a biosimilar to Actemra (tocilizumab) and originally received FDA approval in January 2025 for treating multiple inflammatory indications, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and coronavirus COVID-19 (3).
Sanofi reported on Aug. 14, 2025 that the European Medicines Agency had granted orphan designation to rilzabrutinib, an investigational oral Bruton’s tyrosine kinase inhibitor, for the treatment of IgG4-related disease (i.e., that which affects immunoglobulin G4) (4). According to Sanofi, rilzabrutinib is being investigated across multiple rare immune-mediated and inflammatory diseases. It also has orphan designations for treating immune thrombocytopenia in the United States, European Union, and Japan, as well as for warm autoimmune hemolytic anemia, sickle cell disease, and IgG4-RD in the US.
“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.” Xingli Wang, MD, PhD, co-president of Fosun Pharma and CEO of the Global R&D Center, said in a press release (1). “Fosun Pharma remains committed to introducing and developing innovative therapies with breakthrough significance to address unmet medical needs. This partnership will further enrich our pipeline in the immunology and inflammation field ... We look forward to working closely with the Accro team to drive the success of this product and provide high-quality treatment options for patients in China and around the world.”
"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,” Xiaohu Zhang, PhD, co-founder and CEO of Accro Bioscience, said in the release (1).
Fosun Pharma is also collaborating with BioNTech as one of that company’s partners in developing next-generation messenger RNA therapeutics (5).
Under the agreement for AC-201, Accro Bioscience is entitled to a total payment of RMB 80 million (US$11.2 million), which includes an upfront payment of RMB 60 million (US$8.4 million) and a milestone payment of RMB 20 million (US$2.8 million) upon completion of manufacture technology transfer, as well as up to RMB 76 million (US$10.66 million) in development milestone payments (1).
1. Fosun Pharma. Fosun Pharma Gains Exclusive Rights for Accro's Novel Small-Molecule Drug Candidate AC-201 in Greater China. Press Release. Aug. 29, 2025.
2. Celltrion. FDA Approves Expanded Indication for Avtozma (tocilizumab-anoh) Intravenous (IV) Formulation in Cytokine Release Syndrome (CRS). Press Release. Aug. 7, 2025.
3. Celltrion. US FDA Approves Celltrion's Avtozma (tocilizumab-anoh), a Biosimilar to Actemra. Press Release. Jan. 30, 2025.
4. Sanofi. Sanofi’s Rilzabrutinib Earns Orphan Designation in the EU for IgG4-Related Disease. Press Release. Aug. 14, 2025.
5. Barton, C. Looking Beyond mRNA-based COVID-19 Vaccines to Innovative Therapeutics. PharmTech.com, June 24, 2025.