- Date of occurrence of the event: Nov 25, 2019
- Company name: OBI Pharma, Inc.
- Relationship to the Company (please enter “head office” or “subsidiaries”): Head office
- Reciprocal shareholding ratios: Not Applicable
- Name of mass media: Economy Daily News, version A10 of Nov 24, 2019 and version A2 of Nov 25, 2019
- Content reported: “OBI …the most high-profile active immunotherapy, OBI-822, has been approved to proceed Phase III human clinical studies by the US, China, etc since 2017. The fastest progress of this clinical studies is the breast cancer therapy that has been on Phase III. Expected to evaluate primary endpoint in 2023.”; “OBI …. OBI-3424 has received two qualifications of Orphan Drug Designation.”
- Cause of occurrence: Supplementary station on news article
- Countermeasures: The triple-negative breast cancer, TNBC, as indication for Phase III human clinical studies of active immunotherapy, Adagloxad Simolenin (OBI-822), has been approved to proceed by Drug Administrations of Taiwan, the US, Australia, Hong Kong, Ukraine, and Russia. Now, actively recruiting. Please refer to MOPS, Supplementary statement regarding the news article by the investor and the other news media, on Jun 27, 2019 for the progress of China regulatory review.
Link for clinical study information: https://www.clinicaltrials.gov/ct2/show/NCT03562637
The novel prodrug, OBI-3424, has received hepatocellular carcinoma, HCC, and acute lymphoblastic leukemia, ALL, of Orphan Drug Designation qualifications from FDA.
Please refer to MOPS for all updates regarding new drug development.
- Any other matters that need to be specified: 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.