Biyo Pharma completes ~￥100M Pre-A round financing, with its BY002 receiving FDA clearance to enter clinical trials

Biyo Pharma recently announced that its self-developed innovative biologic drug, BY002, has officially received approval from the U.S. Food and Drug Administration (FDA) to enter the clinical trial stage. This significant milestone marks international recognition by an authoritative regulatory agency for Biyo's achievements in innovative migraine treatment R&D, and also lays a solid foundation for the company's subsequent global clinical development.

BY002 is an innovative biologic drug for the treatment of acute migraine. Based on differentiated molecular design and mechanism of action, it aims to achieve breakthroughs in speed of onset, duration of efficacy, and tolerability. Previously, BY002 demonstrated clear pharmacological effects and a favorable safety profile in multiple in vitro and in vivo studies, as well as in non-human primate models. This FDA approval for clinical entry signifies the project's official transition into the human validation phase.

Concurrently, Biyo Pharma recently completed a Pre-A round of financing of nearly RMB 100 million. This round was led by Lapam Capital, with co-investment from Shanghai Healthcare Capital and Hangzhou Capital. Probe Capital acted as the exclusive financial advisor for this round. The raised funds will be primarily used to advance the clinical development of core pipelines, deepen platform technologies, and support international expansion. With BY002 entering the clinical stage, Biyo Pharma has now formally initiated its Series A financing process to support the parallel entry of multiple pipelines into key development phases.

Migraine is the second-ranked disease globally by years lived with disability (YLDs), following low back pain, which causes the highest disability burden worldwide. Among females under 50 years old, migraine is even the leading cause of disability burden. It is a disease that severely impacts patients' quality of life and imposes a high societal burden. A 2024 study in The Lancet Neurology indicated that there are approximately 1.14 billion migraine patients globally. In China, migraine also represents a large, yet long-neglected, chronic disease population, with an estimated 184 million cases. However, due to low public awareness, high rates of misdiagnosis, and non-standardized treatment pathways, the diagnosis rate among Chinese migraine patients remains below 20%.

Biyo Pharma is an innovative biopharmaceutical company focused on addressing significant unmet clinical needs in the nervous system and related areas, dedicated to developing globally competitive, differentiated biologic products. Currently, Biyo Pharma has established an innovative pipeline centered on migraine, covering indications such as acute migraine treatment and the prevention of chronic and refractory migraine, pioneering the use of multi-pathway mechanisms to develop next-generation drugs with durable and stable efficacy. Biyo Pharma has assembled an internationally leading portfolio of pain management assets. Given the urgent needs in European, American, and global clinical markets, the company possesses significant potential for further international market expansion.

Beyond its pain management projects, Biyo Pharma continues to strategically invest in several other key areas, including chronic pain, neurorestoration, metabolism, and immune inflammation. This provides the company with sustained innovation momentum and a pipeline reserve for its medium- to long-term development.

Moving forward, Biyo Pharma will remain committed to a clinical needs-oriented approach, with original mechanisms at its core, steadily advancing its global clinical and partnership strategy. Biyo Pharma is dedicated to providing truly clinically valuable innovative treatment options for patients worldwide.