Junhem Biopharma Receives IND Approval for Recombinant Botulinum Toxin Type A in Adult Upper Limb Spasticity Following Stroke

Junhe Alliance Biopharmaceutical (Hangzhou) Co., Ltd.(hereinafter referred to as “Junhe Alliance Biopharma”) announced today that its independently developed injectable recombinant botulinum toxin type A has received the “Notice of Approval for Clinical Drug Trials” issued by the National Medical Products Administration, and is about to initiate clinical development in the field of serious medical conditions for the treatment of upper limb spasticity following stroke in adults.

From a global market perspective, type A botulinum toxin products demonstrate significant market potential and commercial value in both consumer healthcare and serious medical fields. Beyond the treatment of glabellar lines, type A botulinum toxin is more extensively applied overseas in clinical therapeutic areas such as ophthalmology, neurology, rehabilitation, and urology. Currently, the approved indications for botulinum toxin products marketed in China within the serious medical sector are relatively limited. Market promotion and adoption remain to be popularized, representing an underexplored blue-ocean market.

Junhe Alliance BiopharmaLeveraging its industry-leading synthetic biology platform and high-efficiency recombinant protein expression technology,It effectively addresses the biosafety concerns associated with traditional botulinum toxin cell lines, while the product offers multiple advantages, including high purity, low immunogenicity, favorable safety profile, and low production costs.The Company’s recombinant type A botulinum toxin, positioned as the “new-generation botulinum toxin” amid the broader industry trend, has previously received approval to conduct clinical trials for the indication of moderate to severe glabellar lines in adults. Its Phase II clinical study is now nearing completion, with Phase III trials set to commence shortly. The recent approval to initiate clinical trials for the indication of upper limb spasticity following adult stroke marks a new step forward in the Company’s efforts to expand into more serious medical applications.

Xu Kui, Chairman and CEO of Junhe Alliance Biopharmaceuticalstated: “The global botulinum toxin market is substantial and experiencing significant growth, with considerable market demand, room for expansion, and development potential in both consumer healthcare and serious medical fields. As biomanufacturing technologies continue to advance, the quality standards and applicable indications of botulinum toxin products will inevitably undergo continuous iteration. We will continue to actively promote the strategic deployment of recombinant type A botulinum toxin in both consumer healthcare and serious medical sectors, seize opportunities in this blue-ocean market, and drive the development of the botulinum toxin industry to benefit patients at large as soon as possible.”

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. Junhe Alliance has comprehensively structured its product pipeline around both consumer healthcare and serious medical care. Guided by market demand 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 recombinant long-acting 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.