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Pipeline

이전 버튼 다음버튼

H. CIN1 medicine & M. cervical cancer treatment vaccine

Treatment or early examination of cervical diseases “First in its Class”

  • Efficacy Test
  • Toxicity Test
  • Clinical Test
Platform technology HumaMAX® MucoMAX®
Target disease CIN1(BLS-H01) CIN2/3(BLS-M07)
Stage of disease progress Normal/HPV infected LSIL 1) HSIL 2)
Treatment mechanism Cells infected by the HPV Virus
-> Prevents virus proliferation byusing BLS-H01 which has an antivirus effect
Virus-infected cervical epithelial cells create abnormal cells
as time passes,even leading to deformation of the
intraepithelial tissues -> Disease treatment via inducing immunoreactions
  • LSIL : Low-grade squamous intraepithelial lesions
  • HSIL: High-grade squamous intraepithelial lesions

Clinical Test

BLS-M07

Outcome
  • Since August 2017, Clinical Phase 2b has been in progress with 16 testing agencies
  • Goal of clinical tests : To prove the effectiveness of the medicine developed by Bioleader, compared to the above drug
  • Currently in a stage to check whether or not there is 75% treatment effectiveness, shown from Phase 1 and 2a, is meaningful from a statistical point of view
Market scale
  • The global market estimated to be worth KRW 3.5 trillion, ‘First-in-class’ globally innovative new medicine
  • Currently, no treatment options other than "conization" exist for stage 3 cervical cancer and, if a woman becomes pregnant after a conization procedure,
    the likelihood of side effects such as premature birth and miscarriage as well as recurrences of cancer are high, which makes the development of an effective
    medicine a pressing issue
Competitiveness
  • The best “First-in-its-Class” medicine among a group of similar drugs
  • Immunotherapy-based oral intestinal coating capsule : Convenience in administration and reduced psychological burden on the patients in the face of a treatment
  • Mechanism to induce mucosal CTL immunity, which is the most ideal means by which to treat cervical mucosal disease : "Inducing antigen-specific immunity"
    by absorbing antigens into a body through intestinal mucosa with lactic acid bacteria as the transporter
Strategy
  • Achieve meaningful effects during Clinical Phase 2b and then proceed with global clinical trials
  • About 250,000 people around the world die from cervical cancer every year
  • CIN1 medicine [BLS-H01] and cervical cancer treatment vaccines [BLS-M07] are a Total Solution for HPV infections