Updates on company’s negotiable securities for investors’ informationMarch 23, 2020
The active cancer immunotherapy OBI-822, Adagloxad Simolenin, has been granted by Ministry of Food and Drug Safety of South Korea to proceed Phase III human clinical studyApril 10, 2020
- Date of occurrence of the event: Apr 06, 2020
- Company name: OBI Pharma Inc.
- Relationship to the Company (please enter “head office” or “subsidiaries”): Head Office
- Reciprocal shareholding ratios: No applicable
- Cause of occurrence:
Due to the tense situation of Novel Coronavirus Disease (COVID-19), OBI has participated in Global Biotechnology emergency responses. After consulting with experts, OBI has decided to pause the recruitment of Global Phase III clinical study for 3 months to reduce the workload of medical institutions and centralize resources to defeat the virus. Patients who have already participated in the clinical study will not be affected and will continue to receive treatments. When epidemic gets controlled, we will re-evaluate the situation and re-start recruitment of Global Phase III clinical study.
Except OBI-822, other OBI products on clinical studies have minor impacts because small number of medical institutes are participated and will stay on the schedules. OBI will evaluate the change of environment to plan in rolling- wave and adjust research progress related to the products.
- Countermeasures: None
- 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 study, new drug registration approval
(4) Ongoing development:
A. Results of clinical trial (include interim analysis)/ Critical events occurred to affect new drug development: please refer to cause of occurrence 5.
B. 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: please refer to cause of occurrence (5).
(6) Current market: According to public research report of IQVIA, the global market for anti-tumor drugs is about US$150 billion in 2018, the largest among the top 10 categories. OBI-822 is still in clinical development; its indications will be evaluated based on unmet medical needs, product opportunities, and company portfolio.
(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.