Announcement on behalf of OBIGEN that TFDA clears OBI-858’s IND application for Phase II human clinical trial

1.Date of occurrence of the event:2024/05/02
2.New drug name or code:OBI-858 Novel Botulinum Neurotoxin
3.Indication:
OBI-858, an in-house developed novel botulinum neurotoxin (BoNT) product, is
planned for aesthetic and therapeutic uses. Patents for its special
molecular weight have been granted in Taiwan, Australia, New Zealand, Japan
and Russia.
4.Planned development stages:
Phase II, III clinical trial, and Biologics License Application (BLA)
5.Current development stage:
(1)Application submission/approval/disapproval/each of clinical trials
(include interim analysis): OBIGEN announces TFDA clearance of IND
application for a phase II human clinical trial evaluating OBI-858
treatment for subjects with moderate to severe frown.
(2)Once disapproved by competent authority or each of clinical trials
(include interim analysis) results less than statistically significant
sense, the risks & the associated measures the Company may occur:
Not applicable
(3)After obtaining official approval or the results of statistically
significant sense, the future strategy: Proceed to Phase II human
clinical trial
(4)Accumulated investment expenditure incurred: For negotiation on potential
licensing deals in the future, and for the best interest of shareholders,
this information is kept confidential temporarily.
6.Upcoming development plan: Phase II clinical trial
(1)Estimated date of completion: 2025.
(2)Estimated responsibilities: Clinical trial related R&D expenses
7.Market situation: According to Research And Markets, Botulinum Toxins global
market size was estimated at USD 5.6 billion in 2022, and is expected to
grow at a CAGR of 8.8% to reach USD 11 billion by 2030. The novel botulinum
toxin, OBI-858, is expected to be used in therapeutic and aesthetic
indications.
8.Any other matters that need to be specified(the information
disclosure also meets the requirements of Article 7, subparagraph 8
of the Securities and Exchange Act Enforcement Rules, which brings
forth a significant impact on shareholders rights or the price of
the securities on public companies.):None.
9.New drug development requires long process, vast investments and with
no guarantee in success which may pose investment risks. The investors
are advised to exercise caution and conduct thorough evaluation.