- Date of occurrence of the event: May 06, 2019
- Company name: OBI Pharma Inc.
- Relationship to the Company (please enter “head office” or “subsidiaries”): Head office
- Reciprocal shareholding ratios: N/A
- Cause of occurrence: Official letter was received from National Medical Products Administration (NMPA) of China regarding the request for clearance of Phase III clinical study of Adagloxad Simolenin (OBI-822), submitted on Jan 24, 2019. The request shall be resubmitted after supplementation. Adagloxad Simolenin (OBI-822) is an active cancer immunotherapy targeting Globo H; clearance of the Global Phase III studies (indication: TNBC) in the United States, Taiwan, Hong Kong, Australia, Ukraine and Russia was granted and has begun patient screening and enrollment. Korean and EU submission is ongoing.
- Countermeasures: OBI will resubmit the application for clearance of Global Phase III of Adagloxad Simolenin (OBI-822) after completing the required studies by NMPA (regarding CMC validation of raw material KLH)
- Any other matters that need to be specified:
(1)Name of the new drug: Adagloxad Simolenin (OBI-822)
(2)Uses: OBI-822 is a therapeutic cancer vaccine classified as active cancer immunotherapy. Globo H-KLH conjugate triggers immune response against hard-to-treat cancers once injected into the human system.
(3)Planned development: Phase III clinical trial and NDA
A.Filed application/ Granted/ Denied: To be resubmitted after supplementation
B.Risk and countermeasures for denied applications: OBI will resubmit the application for clearance of Global Phase III of Adagloxad Simolenin (OBI-822) after completing the required studies by NMPA (regarding CMC validation of raw material KLH)
C.Outlook for granted applications: N/A
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:
A.Expected timeline: Expect to evaluate the primary endpoint by 2023. The actual study timeline will be based on the progress of the clinical trial.
B.Expected obligation: Milestone royalty of US$1,000,000 to Optimer upon initiation of Phase III clinical trial; now in the request process.
(6)Current market: According to EvaluatePharma, the global market for anti-tumor drugs is about US$100.9 billion in 2017, the largest among the top 10 categories. However, OBI-822 is still in the clinical phase. The development of indications is based on the unmet medical needs where future development of the drug will be determined after a comprehensive consideration of the company’s overall product pipeline and strategy.
(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.