OBI filled application of Phase 1 human clinical study for Novel Botulinum Toxin preparation, OBI-858, to TFDA

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OBI filled application of Phase 1 human clinical study for Novel Botulinum Toxin preparation, OBI-858, to TFDA

  1. Date of occurrence of the event: Jun 10, 2020
  2. Company name: OBI Pharma Inc.
  3. Relationship to the Company (please enter “head office” or “subsidiaries”): Head office
  4. Reciprocal shareholding ratios: Not applicable
  5. Cause of occurrence: OBI filled application of Phase 1 human clinical study for Novel Botulinum Toxin preparation, OBI-858, to TFDA.
  6. Countermeasures: None
  7. Any other matters that need to be specified:

(1) Name of the new drug: Novel Botulinum Toxin preparation, OBI-858

(2) Uses: The new clostridium botulinum toxin preparation is expected to be use in medication and cosmetology.

(3) Planned development: Phase I, II, III clinical trial and NDA

(4) Ongoing development:

       A. Filed application/ Granted/ Denied: Filed application of Phase 1 human clinical studies to TFDA

       B. Risk and countermeasures for denied applications: Not applicable

       C. Outlook for granted applications: Not applicable

       D. Total invested capital: To be kept confidential to avoid complications in future negotiation of licensing deals, and as for the best interest of shareholders.

(5) Next phase of development: Phase 1 human clinical study

       A. Next phase of development: expected to complete in 2021, the actual schedule will be adjusted according to the timeline.

       B. Expected obligation: None

(6) Current market: According to Global Market Insights, the cosmetic and medicinal markets for Botulinum Toxin products are about US$4.7 billion in 2018. The Compound Annual Growth Rate (CAGR) is expected to be 9.1%, and the global market is expected to be US$8.5 billion by 2025. Up to date, about 8-9 competitors have entered the market. The novel botulinum toxin, OBI-858, is expected to be use in medication and cosmetology.

(7) New drug development is a long process associated with high costs. It is not a guaranteed success, which may increase the risk of investment. Investors shall make prudent judgments and investments.