Junhem Biopharma Completes First Patient Dosing in Phase III Trial of Recombinant Botulinum Toxin Type A for Post-Stroke Upper Limb Spasticity

Today,Junhe Alliance Biopharmaceutical (Hangzhou) Co., Ltd. (hereinafter referred to as “Junhe Alliance Bio”)Announced that the clinical study of the company’s innovatively developed, independently intellectual property-owned injectable recombinant botulinum toxin type A for upper limb spasticity in adults after stroke has successfully completed the enrollment of the first subject at the lead site, Huashan Hospital Affiliated to Fudan University, marking the official launch of research in China on the use of recombinant botulinum toxin type A in the neurological field for treating patients with upper limb spasticity after stroke.

This clinical study is being conducted at 20 Grade A tertiary hospitals across China. The company will continue to adhere to the established research plan, steadily advance the clinical trial process, and strive to bring more significant clinical improvements and therapeutic hope to patients with upper limb spasticity after stroke.

Xu Kui, CEO of Junhe Alliance Biopharmaceutical"The completion of enrollment of the first subject in the clinical trial for the indication of upper limb spasticity following adult stroke marks a significant step forward in the company's scientific research and development in the field of serious medical care. We expect this product to bring benefits to numerous patients in the future, providing them with better treatment options."

Junhe Alliance Biopharmaceutical’s recombinant botulinum toxin type A, positioned as the “new-generation botulinum toxin” amid the industry’s major development trends, has previously received approval to initiate clinical trials for the indication of moderate to severe glabellar lines in adults. The Phase II clinical study has been completed, and the product is poised to enter Phase III clinical trials.

The market entry barriers for the botulinum toxin industry in China are relatively high, with limited formal supply and low market penetration currently. The higher-order structure of type A botulinum toxin is extremely complex, posing numerous challenges to its research and development, including the significant difficulty of recombinant expression and stringent requirements for purification technologies. Junhe Alliance’s recombinant type A botulinum toxin product utilizes recombinant technology rather than traditional extraction methods, resulting in a product with a single active component, a single subtype, high purity, and high potency.

characteristics such as high batch-to-batch consistency, ensuring greater safety in clinical applications. Furthermore, its product potency meets the highest international quality standards (European), positioning it as a next-generation alternative to currently marketed botulinum toxin products both domestically and internationally.

From a global market share perspective, botulinum toxin type A products account for 50% of the market in both consumer healthcare and serious medical fields. In China, the approved indications for marketed botulinum toxin products in serious medical applications, such as treating upper limb spasticity after stroke in adults, remain relatively limited. This represents an underexplored blue ocean market. Furthermore, with continuous advancements in medical technology, an increasing number of new indications are under development. Junhe Alliance Biopharmaceutical recognizes the potential of botulinum toxin type A products in the serious medical sector and has strategically initiated clinical development to lay the foundation for expanding into more serious medical indications.

Junhe Alliance is a high-tech enterprise specializing in synthetic biology, with its products applied in the fields of endocrinology, neurological therapy, skin anti-aging, and next-generation biomedical materials. The company’s product pipeline is comprehensively structured around both consumer healthcare and serious medical care, guided by market demands and aimed at improving patients’ quality of life. Its key products under development include recombinant human type I collagen, recombinant human type III collagen, recombinant botulinum toxin type A, recombinant human growth hormone injection, and long-acting recombinant human growth hormone. Leveraging years of experience in R&D and industrialization, Junhe Alliance possesses core technologies and platforms covering the entire product development lifecycle, establishing a comprehensive system for technology and product development.