Suzhou, China, July 3, 2025—CStone Pharmaceuticals (“CStone,” HKEX: 2616), an innovation-driven biopharmaceutical company focused on oncology, today announced the first disclosure of the targets for two internally developed bispecific antibodies, aiming to address autoimmune/inflammatory diseases:
Both have best-in-class (BIC)/first-in-class (FIC) potential and have advanced to the preclinical candidate (PCC) nomination stage, preclinical data will be disclosed at international academic conferences. In addition, the Investigational New Drug (IND)-enabling studies are expected to commence in H2 2025.
Rationale & Value
CS2013 employs a differentiated molecular design to simultaneously block BAFF and APRIL—two essential ligands for B-cell/plasma cell development and survival. Preclinical studies demonstrate synergistic effects and superior pharmacokinetic (PK) properties over fusion proteins, including long half-life (supporting subcutaneous administration) with potential for less frequent dosing. CS2013 targets B-cell-mediated autoimmune diseases, including systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), IgA nephropathy (IgAN), and etc.
CS2015, a potential FIC bispecific antibody targeting both OX40L (a key ligand on immune effector cells) and TSLP (a critical alarmin secreted by epithelial cells), concurrently blocks two key ligands in Th2-mediated inflammatory signaling pathways. This novel mechanism provides a strategic approach for type 2 inflammatory diseases including atopic dermatitis (AD), asthma, etc. Compelling preclinical PK data also demonstrated extended half-life and subcutaneous delivery potential.
CEO Commentary
Dr. Jason Yang, CEO, President of R&D, and Executive Director at CStone, remarked:
"The autoimmune and inflammatory diseases field represents a significant unmet medical need worldwide—characterized by diverse disease types, large patient populations, and often lifelong treatment requirements—making it the second-largest therapeutic market after oncology.
At CStone, CS2013 offers potential therapeutic advantages over existing monoclonal antibodies through the synergistic blockade of two clinically validated targets, while CS2015 introduces a novel mechanism of action. Together, these candidates reflect our strategic expansion into non-oncology therapeutic pipelines and mark a pivotal step toward achieving CStone’s vision: ‘To pioneer and enhance global patient health through innovation.’ "
About CStone
CStone (HKEX: 2616), established in late 2015, is an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies. Dedicated to addressing patients’ unmet medical needs in China and globally, the Company has made significant strides since its inception. To date, the Company has successfully launched 4 innovative drugs and secured approvals for 16 new drug applications (NDAs) covering 9 indications. The company’s pipeline is balanced by 16 promising candidates, featuring potentially first-in-class or best-in-class antibody-drug conjugates (ADCs), multispecific antibodies, immunotherapies and precision medicines. CStone also prides itself on a management team with comprehensive experiences and capabilities that span the entire drug development spectrum, from preclinical and translational research to clinical development, drug manufacturing, business development, and commercialization.
For more information about CStone, please visit: www.cstonepharma.com.
IR contact: ir@cstonepharma.com
PR contact: pr@cstonepharma.com
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