Biyopharma Announces CDE IND Approval for BY002, Advancing into Clinical Development for Acute Migraine Treatment

BIOPHARMA recently announced that its independently developed innovative biologic drug, BY002, has officially received approval for its Investigational New Drug (IND) application from the Center for Drug Evaluation (CDE) of the National Medical Products Administration. This milestone marks the formal entry of BY002 into clinical development and underscores the company’s sustained capacity for breakthroughs in the field of innovative therapeutics for neurological disorders.

This marks another regulatory milestone for BY002 in China, a key global pharmaceutical market, following the approval of its Investigational New Drug (IND) application by the U.S. FDA in January 2026. This achievement signifies that the candidate drug has been authorized to conduct clinical studies in both China and the United States, officially entering a new phase of global development.

BY002 is a dual-epitope VHH fusion protein targeting the calcitonin gene-related peptide (CGRP) receptor, intended for the acute treatment of migraine. By simultaneously binding to distinct key epitopes on the receptor, this molecule achieves potent blockade of the CGRP signaling pathway. It features rapid onset of action, sustained efficacy, and favorable tissue penetration, offering the potential to provide patients with a superior therapeutic option.

According to the World Health Organization (WHO)'s Global Burden of Disease (GBD) report, migraine is the second most common neurological disorder causing disability, second only to stroke.。A 2024 study in *The Lancet Neurology* showed that there are approximately 1.14 billion migraine sufferers worldwide.However, current treatment options are limited and plagued by issues such as slow onset of action, limited efficacy, or poor adherence. BY002 has demonstrated significant advantages in preclinical studies through its unique molecular design. In non-human primate models, BY002 rapidly inhibited CGRP-mediated cutaneous blood flow responses within 2 hours post-administration and sustained its pharmacological effects for several days, exhibiting excellent pharmacodynamic properties.

Furthermore, BY002 demonstrated high receptor-blocking activity in in vitro studies, with its cAMP inhibition potency superior to that of marketed drugs in the same class. In terms of safety, existing GLP toxicology study results indicate good tolerability, laying a solid foundation for subsequent clinical trials.

BIOPHARMA is dedicated to developing innovative biologics with global competitiveness, with a primary focus on neurological disorders and related fields. The company has established a comprehensive product pipeline for migraine, ranging from acute treatment (BY002) to chronic and refractory prevention (BY003, BY004), and is actively expanding into multiple therapeutic areas, including metabolic diseases and autoimmune disorders.

Looking ahead, BIOPHARMA will continue to advance the clinical development of BY002, accelerate R&D progress for its subsequent pipeline, and drive more innovative therapies into the global market.

BIOPHARMA is a biotechnology company focused on the research and development of innovative biologics, dedicated to developing differentiated therapeutic solutions for complex disease mechanisms through advanced antibody engineering and an AI-driven design platform. The company has built a diversified product pipeline covering migraine, metabolic diseases, and autoimmune disorders, committed to addressing unmet clinical needs worldwide.