Member Profile
OBI Pharma, Inc.
OBI Pharma, Inc. was first established in 2002 as a wholly-owned subsidiary of Optimer Pharmaceuticals, a US public company. On May 15th, 2012, OBI was approved as a public company (Stock Code: 4174) and successfully obtained its subsequent up-listing in the emerging market and the over-the-counter market on December 12th, 2012 and March 23rd, 2015, respectively.
OBI Pharma Inc. positions its focus around new drug development to challenge current unmet medical needs. Through innovative and effective novel therapies, OBI strives to improve people’s health and the quality of life as part of its corporate social responsibility.
In the past 18 years, OBI Pharma Inc. actively involves in research and development, including building a strong R&D team and innovating on onco-immunotherapy. With many patented technologies and platforms in hand, OBI Pharma Inc. is committed to the development of carbohydrate-based novel therapies. Development of diverse pipeline products goes with the goal to market a brand that is “Made-in-Taiwan.”
Product Pipelines
Company Milestones
| 2010 | OBI-822 Phase II/III Clinical Trial for metastatic breast cancer begins in Taiwan. |
| 2015 | OBI Pharma IPO in Taiwan Taipei Exchange. |
| 2015 | OBI-833-001 IND Approval by TFDA. |
| 2015 | OBI Pharma Enters Exclusive Agreement with MSD for Rights to DIFICID® (fidaxomicin) in Taiwan. |
| 2016 | Pharma Reports Topline Results from OBI-822/821 Randomized Controlled Phase 2/3 Clinical Trial in Patients with Metastatic Breast Cancer. |
| 2016 | OBI Pharma Granted OBI 833 Patents for Taiwan and Australia. |
| 2017 | OBI Pharma has met with the Office of Tissues and Advanced Therapies (OTAT) of the US Food and Drug Administration (FDA) for its End-of-Phase 2 (EOP2) meeting for Adagloxad Simolenin (OBI-822). |
| 2017 | China FDA approves Clinical Trial Application for Adagloxad Simolenin (OBI-822) Phase III Study. |
| 2018 | The U.S. Food and Drug Administration (FDA) cleared an investigational new drug (IND) application for a Phase I study of a monoclonal antibody (OBI-888) that targets Globo H, a glycolipid antigen. We have started enrolling patients with locally advanced or metastatic solid tumors of all types. |
| 2018 | The U.S. Food and Drug Administration (FDA) cleared an investigational new drug (IND) application for a Phase I/II study of OBI-3424, a first-in-class DNA alkylating agent that targets cancers that overexpress the aldo-keto reductase 1C3 (AKR1C3) enzyme.OBI plans to enroll patients with local solid tumors, including hepatocellular carcinoma (HCC) and castrate-resistant prostate cancer (CRPC) in the expansion phase of this study. |
| 2018 | The investigational new drug (IND) application for the global, multi-country, multi-center Phase III study of OBI-822 for breast cancer was submitted to the US FDA on May 22, 2018. This study is expected to start enrollment in Q3 2018. |