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 20 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
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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. |
| 2018 | OBI-3424 obtained the qualification as the orphan drug for hepatocellular carcinoma (HCC) treatment from US Food and Drug Administration (FDA). |
| 2018 | The medical equipment clinical research application (IDE) of OBI-822 passed the examination and approval of US Food and Drug Administration. |
| 2018 | Product patent of OBI-3424 “DNA alkylating agent” was approved by IP Australia. |
| 2018 | OBI-3424 obtained the qualification as the orphan drug for Acute Lymphoblastic Leukemia (ALL) treatment from US Food and Drug Administration (FDA). |
| 2018 | Product patent of OBI-822 “Compound and Component of Carbohydrate Vaccine and Its Use” was approved by Taiwan Patent Office. |
| 2018 | The medical equipment clinical research application (IDE) of OBI-888 passed the examination by US Food and Drug Administration (FDA), and was approved to be used in Cohort Expansion Phase of OBI-888 phase I human clinical trial. |
| 2018 | OBI-888 obtained the qualification as the “orphan drug” for pancreatic cancer treatment from US Food and Drug Administration (FDA). |
| 2019 | Published in the journal of the national academy of sciences (PNAS) in cooperation with academia sinica, the paper proves that the Globo series is closely related to the survival of cancer cells, which provides an important theoretical basis for haoding Globo series to target new anti-cancer drugs. |
| 2019 | Poster at the annual meeting of the American association for cancer research (AACR): Obi-888 and obi-999 (a new single antibody drug and a new antibody small molecule drug complex called ADC) are the first to be developed. Their mechanism of action, antineoplastic efficacy, drug metabolism and pharmacokinetic characteristics are also discussed. |
| 2019 | Passive immunity monoclonal antibody new drug OBI-888 had completed the assessment of major safety indicators for phase I human clinical trial, the safety and tolerance of OBI-888 were good, and there were no major safety concerns. |
| 2019 | The Globo H antibody-drug conjugate OBI-999 was approved by US Food and Drug Administration (FDA) to carry out phase I/II human clinical trial. |
| 2019 | The results of Adagloxad Simolenin (OBI-822) ovarian cancer phase II clinical trial cooperated with Taipei Mackay Memorial Hospital were announced, generally speaking, the safety and tolerance of this vaccine were acceptable. |
| 2019 | Globo H antibody-drug conjugate OBI-999 obtained the qualification as the “orphan drug” for pancreatic cancer treatment from US Food and Drug Administration (FDA). |
| 2020 | Globo H antibody-drug conjugate OBI-999 obtained the qualification as the “orphan drug” for gastric cancer treatment from US Food and Drug Administration (FDA). |
| 2020 | OBI-888, a new passive immune monoclonal antibody, was approved by the Taiwan Food and Drug Administration of the Ministry of Health and Welfare for the first/second phase human clinical trials. |
| 2020 | The new botulinum toxin preparation OBI-858 was approved by the Taiwan Food and Drug Administration of the Ministry of Health and Welfare for the first phase of human clinical trial. |
| 2020 | OBI-866, an active immune anticancer drug, was approved by the Taiwan Food and Drug Administration of the Ministry of Health and Welfare for the first phase of human clinical trial. |
| 2020 | It increased capital and issued 10,693,000 shares in exchange for 53,466,000 common shares of Amaran Biotechnology Inc. to shareholders of Amaran Biotechnology Inc., and acquired 67% equity of Amaran Biotechnology December 31st, 2020 is the benchmark date of share exchange. |
| 2020 | We received a reply from the US Food and Drug Administration (FDA) on the application for medical equipment clinical research (IDE) in the first/second stage of population expansion of human clinical trials of a new precursor chemotherapy drug OBI-3424, which can be used in the first/second stage of population expansion of human clinical trials without approval. |
| 2021 | It signed a global cosmetic medicine licensing agreement with Obigen Pharma, Inc. “OBI-858 new botulinum toxin preparation”. |
| 2021 | OBI-3424, a new precursor chemotherapy drug, has completed the safety evaluation of the first phase of clinical dose increment trial, and plans to launch the second phase of clinical population expansion trial. |
| 2021 | The phase I clinical cohort expansion trial of a new active immune anti-cancer drug OBI-833 was completed, and the implementation of phase II clinical trial was planned. |
| 2021 | The active immune anti-cancer drug OBI-822 (Adagloxad Simolenin) was approved by South African Health Products Regulatory Authority, COFEPRIS of Mexico, and DIGEMID of Peru for the phase III human clinical trial. |
| 2021 | A Taiwan invention patent of OBI-858 “Botulinum toxin type A compound, its formulation and usage” was obtained. |
| 2021 | The new drug OBI-999, as a Globo H antibody small molecule drug complex, was approved by Taiwan Food and Drug Administration (TFDA) of the Ministry of Health and Welfare for phase II human clinical trial. |
| 2021 | A Taiwan invention patent of OBI-866 “Immune/therapeutic glycan composition and its usage” was obtained. |
| 2021 | The Company signed “Trop2 Monoclonal Antibody” License Agreement with Biosion, Inc. and obtained the global exclusive rights of this product beyond Chinese mainland, Hong Kong and Macao. |
| 2022 | The active immune anticancer drug OBI-822 (Adagloxad Simolenin) was approved by the Polish Drug Registration Office for phase III human clinical trial. |
| 2022 | The animal test results of the self-made COVID-19 BCVAX showed that it could produce high-titer antibody, and have a neutralizing effect o various COVID-19 variants. |
| 2022 | The active immune anticancer drug OBI-822 (Adagloxad Simolenin) was approved by the Brazil National Health Surveillance Agency for phase III human clinical trial. |
| 2022 | The Company signed license agreements of OBI-833 and OBI-999 in China (including Hong Kong and Macao) with Odeon and obtained special shares from Odeon Therapeutics (Cayman) Limited. |
| 2022 | The new active immune anti-cancer drug OBI-833 was reviewed by Taiwan Food and Drug Administration (TFDA) of the Ministry of Health and Welfare and then approved for phase II human clinical trial. |
| 2022 | Invention patent of OBI-999 Conjugated Biomolecules and Pharmaceutical Components and Methods was approved by Taiwan. |
| 2022 | The medical product patent of active immune anti-cancer drug OBI-822 “Cancer Immunotherapy of Immune Activation or Immunoregulation via Globo Series Antigen” was approved by United States Patent and Trademark Office (USPTO). Meanwhile, the invention patent of OBI-866 “Immune/Theraputic Glycan Composition and Its Usage” was approved by United States Patent and Trademark Office (USPTO). |
| 2023 | The new bi-specific antibody anti-cancer drug AP505 of the Subsidiary AP Biosciences, Inc. was approved by US Food and Drug Administration (FDA) for phase I human clinical trial. |
| 2023 | The new precursor chemotherapy drug OBI-3424 was approved by Taiwan Food and Drug Administration (TFDA) of the Ministry of Health and Welfare for phase II human clinical trial. |