Tyemvers: Advanced European Botulinum Toxin Type A

Introducing Tyemvers®: The Next Generation in Aesthetic Neurotoxin Therapy

Tyemvers® (CKDB-501A), developed by CKD Bio, represents a significant advancement in botulinum toxin type A formulations. Engineered for purity, safety, and efficacy, Tyemvers® offers a sophisticated solution for medical professionals seeking exceptional results in the temporary improvement of moderate to severe glabellar lines. Our innovative approach, from strain selection to final formulation, prioritizes patient well-being and consistent clinical outcomes.

Key Characteristics & Advantages of Tyemvers®:

• Exclusive European Strain (X58540): Tyemvers® is derived from the unique Clostridium botulinum strain X58540, sourced from a European institution and registered in the GenBank (National Library of Medicine, Accession No.: CP068960). This well-characterized strain forms the foundation of our product's consistent performance.

• 100% Animal-Origin Free Manufacturing Process: Setting a new standard in safety, Tyemvers® is produced using a completely animal-origin free process. This includes the use of 1st and 2nd vegan media (plant-based) for culture, and the exclusion of animal-derived components such as casein, peptone, ribonucleases, and notably, Human Serum Albumin (HSA). This meticulous approach minimizes the risk of potential contamination and hypersensitivity reactions associated with animal-derived substances, including the potential for anaphylaxis linked to HSA.

• Exceptional Purity & Potency: Tyemvers® boasts an outstanding purity profile of ≥ 99.9%, consisting of the 100% 19S (900kDa) toxin complex, as confirmed by HPLC analysis. This high level of purity contributes to its predictable efficacy and favorable safety profile.

  $$\text{Potency of Tyemvers®}\ge 3.0\times 10^7\text{ units/mg}$$

  This specific activity ensures a potent formulation designed for reliable results.

• L-histidine as a Stabilizer: Tyemvers® utilizes L-histidine as a stabilizer, which also offers antioxidant effects. This contributes to the product's stability and quality throughout its shelf life. Sucrose is also included in the formulation.

• Clinically Proven Efficacy for Glabellar Lines: Extensive Phase III clinical trials (Double-blinded, Randomized, Active Control Comparative, Multicenter-designed) have evaluated the safety and efficacy of Tyemvers® (CKDB-501A) for the improvement of moderate to severe glabellar lines, compared to Botox Inj.

  • Significant Improvement: Investigator-assessed improvement rates demonstrated strong efficacy. For instance, at Week 4, Tyemvers® showed an 80.69% improvement rate (proportion of subjects with ≥2-point improvement in glabellar line severity from baseline) compared to 70.83% for Botox®, proving non-inferiority.
  • Consistent results were observed across various assessment points and by subject assessment.

• Favorable Safety & Tolerability Profile: The Phase III clinical trials confirmed an excellent safety profile for Tyemvers®.

  • Adverse drug reaction rates were statistically comparable to Botox®.
  • Importantly, no neutralizing antibody (ADA) formation was observed in subjects treated with Tyemvers® (0 out of 146 subjects).
  • The absence of HSA further enhances its safety profile by reducing the risk of associated allergic reactions.

• Excellent Stability: Tyemvers® has demonstrated robust stability:

  • Room Temperature Stability: Stable for 12 months at 25 ± 2°C.
  • Accelerated Stability: Stable for 2 months under accelerated conditions at 40 ± 2°C. This offers convenience in storage and handling for practitioners.