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Medy-Tox Inc.
[Korea]
Address:
10F, 1694-10 Seocho 4-dong, Seocho-gu, Seoul 137-883 Korea
Phone:
82-2-34718319
Contact name:
Elin Ko , Manager
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Medy-Tox Inc.
 
Biopharmaceuticals

Botulinum Toxin Type A (Pharmaceutical, Medicine, Health)

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Botulinum Toxin Type A (Pharmaceutical, Medicine, Health)

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Feature

Our primary focus is on the biopharmaceuticals derived from the botulinum neurotoxin as therapeutics. As the first project, we developed a botulinum toxin type A product as injectables. We are also working on the development B & E products.

The specification of our product is equivalent and/or superior to those of other competitors. Especially, our extreme focus is on the highest quality control/assurance and the minimal variation of the toxin quantity in a vial.

Product Specification

  • Dosage Form: Inject able
  • Appearance: A White Lyophilized Cake
Composition in 1 Vial
  • Active Pharmaceutical Ingredient: 100 units*
  • Human Serum Albumin: 0.5 mg
  • Sodium Chloride: 0.9 mg
    * ICR Mouse LD50
What is Clostridium Botulinum?


  • Strict Anaerobe
  • Endospore former
  • Classified A, B, C1, C2, D, E, F, G
  • One of the most toxic microbes

Pharmaceutical Mechanism

Therapeutic Efficacy (Neuronox vs. Botox)
  • Application: Hemifacial spasm
  • Statistically equivalent between both products

Cosmetic Efficacy: EMG data

Left
Right
Source: CJ, Connexion, and Medy-Tox

Treatment with Medy-Tox's Botulinum Toxin Product

Before
After
Source: CJ, Connexion and Medy-Tox

Indications for Botulinum Pharmaceuticals
* Most of the following diseases have almost no appropriate therapies currently available.
1) Neurology
  • Blepharospasm
  • Cerebral Palsy
  • Cervical dystonia
  • Hemifacial spasm
  • Hemimasticatory spasm
  • Maseteric hypertrophy
  • Meige's syndrome
  • Muculi maseter spasm
  • Myoclonus
  • Myofascial pain syndrome
  • Myokymia
  • Paradoxic Jaw muscle activity
  • Plaltal myoclonus
  • Rigidity of progressive supranuclear palsy
  • Spasticity after stroke
  • Tremor
  • Trismus in cephalic tetanus
  • Upper extremities dystonia
3) Gastroenterology
  • Achalasia
  • Anal fissures
4) Gynaecology
  • Vaginismus
5) Urology
  • Bladder sphincter spasm
  • Detrusor sphincter dyssynergia
  • Prostate hyperplasia
6) Exocrine gland hyperactivity
  • Crocodile tears syndrome
  • Frey's syndrome
  • Hyperhidrosis
  • Relative hypersalivation
  • Rhinorrhea
2) Ophthalmology
  • Esotropia
  • Exotropia
  • Mixed strabismus
  • Multiple sclerosis
  • Myositic strabismus
  • Myopathic strabismus
  • Nystagmus
  • Oscillopsia
  • Paralytic strabismus
  • Protective ptosis
  • Strabismus after aphakia
7) Cosmetic uses
  • Hyperactive facial lines
  • Eye brow elevation
8) Orthopaedia surgery
  • Postoperative immobilization


Clinical Trials: Hemifacial Spasm

All the tests were carried out under the regulations of the KFDA(Korean Food & Drug Administion) equivalent to the ICH/WHO guidelines.

The title of the Phase III clinical trial is as follows.

"Double blinded, randomized, active drug comparative, parallel designed, multi-center, phase III clinical study for the safety and the efficacy of Meditoxin(tentative name) inj. in hemifacial spasm patients"

4 major University & General hospitals participated in the clinical trials. The results were excellent and concluded very successful by the Institutional Review Board of each hospital.




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