Grape King Bio : Announcement that the Company has applied to FDA for a Phase II clinical trial review in humans.(IND)

 Announcement that the Company has applied to FDA
for a Phase II clinical trial review in humans.(IND)

1.Date of occurrence of the event:2022/02/11
2.Company name:GRAPE KING BIO LTD.
3.Relationship to the Company (please enter "head office" or
  "subsidiaries"):The Company itself
4.Reciprocal shareholding ratios:NA
5.Cause of occurrence: GKAC, a new botanical drug under development by the
 Company,02/11 has applied to the US Food and Drug Administration(USFDA) for
 a Phase II clinical trial review (IND number: 160609) for non-alcoholic
 steatohepatitis in humans.
6.Countermeasures:None.
7.Any other matters that need to be specified:
 A.Name or code name of new drug research and development: GKAC
 B.Use: Phase II human trial for safety and efficacy evaluation in patients
 with non-alcoholic steatohepatitis. The trial used a randomized,
 double-blind and placebo-controlled design.
 C.All R&D stages expected to be carried out: Oral dosage form/Phase II
 clinical trials.
 D.The current research and development stage:
 a.Submit application/approved/not approved/results of each phase of human
   clinical trials (including interim analysis): Submit application
 b.Risks faced by the company and countermeasures for those without
   permission from the competent authority of the target business:
   Not applicable
 c.Those who have been approved by the competent authority of the target
   business, future business direction:Not applicable
 d.The accumulated R&D expenses that have been invested: As it involves
   information on future international licensing negotiations and in order to
   avoid affecting the licensing amount and protect the rights and interests
   of investors, for the time being expenses will not be disclosed.
 E.The next stage of research and development will be carried out:
 a.Estimated completion time:It depends on the review time of the USFDA
   authority.
 b.Expected obligations: The new plant drug is being independently developed
   by Grape King Bio whom own 100% of the patent rights. It only needs to
   complete and pass relevant clinical trials to apply for a marketing
   license.
 F.Market situation：According to the Report Ocean Agency forecast, the
 global NASH(non-alcoholic steatohepatitis) drug market size is expected
 to reach US$21.478 billion by 2025, with a CAGR of 58.4% from 2021 to 2025.
 G.The new botanical drug development process is long, the investment is high
 ,and there is no guarantee that it will be successful, which may put this
 investment at risk. Investors should make sensible judgments and invest
 prudently.