1.Date of occurrence of the event:2021/03/31
2.Company name:ONENESS BIOTECH CO., LTD.
3.Relationship to the Company (please enter ”head office” or ”subsidiaries”):head office
4.Reciprocal shareholding ratios:NA
5.Cause of occurrence:
The Company received a notice from the US Food and Drug Administration (US FDA) today that the new drug for diabetic foot ulcers (research code: ON101)under IND for phase 3 trial in the US,has been granted the Fast Track Designation after review in 60 calendar days.This designation will enable Oneness to gain access to FDA’s assistance with facilitating new drug registration process of ON101 in US.
6.Countermeasures:None
7.Any other matters that need to be specified:
(1)According to 21 U.S. Code § 356, the Fast Track provides a review process to expedite the development of a drug which a.intends to treat a serious condition or life-threatening disease; b.has the potential to address the unmet medical need based on its available clinical and non-clinical data.
(2)The Company’s second phase III clinical trial is to be conducted in the United States (protocol number: ON101CLCT04). Upon receipt of the Fast Track Designation, the Company can maintain in close communication with the US FDA during the execution of Phase III clinical trial by having face-to-face meetings or written consultations, which will help expedite the drug development process.
(3)The Fast Track Designation will entitle the Company to rolling review where relevant documents required for new drug registration can be submitted for review. This will shorten the regulatory timeline after the phase 3 trial completes.
(4)Drugs with Fast Track Designation are also eligible to apply for accelerated approval and priority review when submitting the new drug application (NDA), which is beneficial to the drug for early launch.
(5)US FDA requested the Company to develop and publish Expanded Access Policy in 15 days after the designation is granted according to Section 561A(f)(2)of Federal food, drug and cosmetic Act. This provides the diabetic foot ulcer patients who are not able to obtain comparable or satisfactory alternative therapies with an access to ON101 treatment before ON101 is granted market approval.
(6)It takes considerable time and expenses to develop a new drug of which success can’t be guaranteed. Investors shall bear such investment risk that warrants careful assessment before making investment decisions.