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The Efficacy Study of our product involves assessing its effects on Compound Muscle Action Potential (CMAP). When administered to a single muscle,the product exhibits contraction suppression and muscle palsy effects, which vary depending on the concentration of administration. Notably, our product demonstrated comparable efficacy to the well-known Botox liquor, and its muscle contraction inhibition was found to persist effectively at certain doses (5 units/kg).
Clinical Sample Production:
We meticulously produce clinical samples of our product to ensure its quality, safety, and efficacy. These samples undergo rigorous testing and analysis before advancing to further stages.
Clinical CRO Selection:
We prioritize the selection of experienced and reputable Clinical Contract Research Organizations (CROs) to conduct our clinical trials. Collaborating with established CROs ensures the reliability and accuracy of the study results.
IND Document Submission/Examination/Approval:
We compile and submit the Investigational New Drug (IND) documents to regulatory authorities for examination and approval. These documents provide detailed information on the product's safety, preclinical data, and proposed clinical trial protocols.
Permission for Export:
Clinical Trials (Phase I and II):
To evaluate the safety and efficacy of our product, we conduct comprehensive Phase I and II clinical trials on human participants. These trials are designed to assess the product's tolerability, dosage, and potential side effects.
We possess the Korean Good Manufacturing Practice (KGMP) license, signifying that our manufacturing processes adhere to stringent quality standards, ensuring the consistent production of safe and effective products.
Manufacturing Process, Domestic Patents, and PCTs:
Our product's manufacturing process is carefully developed, incorporating domestic patents and Patent Cooperation Treaty (PCT) protection. These measures safeguard our proprietary technology and ensure its exclusivity.
Domestic Patent for Drying Process:
We hold a domestic patent for our innovative drying process, optimizing the quality and stability of the final product.
Each vial of our product contains 100 units of Clostridium botulinum Toxin Type A (IHS), 0.5mg of Human Serum Albumin (EP), and 0.9mg of Sodium Chloride (EP). We utilize strains identified with Clostridium botulinum ATCC 3502, guaranteeing consistent and reliable performance.
Securing Stable Production Process Technology:
High Purity Undiluted Solution:
We are proud to produce an undiluted solution with a purity of more than 99%. This high purity enhances the product's efficacy and minimizes the risk of adverse reactions.
Low Incidence of Resistance:
Our product's unique formulation allows for small amounts of stock solution to be injected per vial, leading to a significantly low incidence of resistance within the same product group. This highlights our commitment to providing long-lasting and effective results.