Mr. Max Chan appointed as the VP of Finance and the Company Spokesperson
Ms. Joanna Meng retires as Chief Operating Officer. OBI Pharma appoints Mr. Max Chan as the new Chief Operating Officer
Received Grade A for TIPS Management
Received Gold Award at the BioTaipei
OBI-822 received the 11th Taiwan National Innovation Award
Received the “Best Investment Award” at the Venture Capital Star event hosted by Venture Capital Association
Appointed Amy Huang as the General Manager
Established full subsidiary OBI PHARMA LIMITED in Hong Kong
Approved as a public company by the Security and Futures Bureau of Financial Supervisory Commission R.O.C.
Appointed Amy Huang as Chief Operating Officer, and Dr. Tony Yu as Chief Scientific Officer
Received Gold Award of the Taiwan Healthcare and Agricultural Biotech Industries Innovation and Excellence
Officially registered as a biotechnology company with Taiwan's Ministry of Economic Affairs
Dr. Youe-Kong Shue appointed as the CEO
OBI founded as a subsidiary of Optimer Pharmaceuticals with Dr. Michael Chang as the chairman
Received FDA clearance of IND application for a Phase I study of a monoclonal antibody cancer immunotherapy (OBI-888).
Received FDA clearance of OBI-3424 IND application for a Phase I/II study targeting AKR1C3 solid tumors.
Granted FDA Orphan Drug Designation for OBI-3424 for the Treatment of Hepatocellular Carcinoma (HCC).
Investigational Device Exemption (IDE) for the development of Adagloxad Simolenin (OBI-822) was approved by the US Food and Drug Administration (FDA) for its use in OBI-822 Phase III Clinical Trial.
Received notice from patent attorney’s office that product patent for OBI-3424 named “DNA alkylating agents” has been approved by IP Australia.
Granted FDA Orphan Drug Designation for OBI-3424 for the Treatment of Acute Lymphoblastic Leukemia (ALL).
Received Taiwan FDA clearance of Adagloxad Simolenin (OBI-822) for a Phase III clinical study.
Received notice from patent attorney’s office that product patent for OBI-822 named “Compound and Compositions of Carbohydrate Vaccine and Uses Thereof” has been approved by Taiwan Intellectual Property Office.
Attended EOP2 meeting with the FDA
China FDA approved Clinical Trial Application for Adagloxad Simolenin Phase III Study.
Obtained approval from CFDA to enter OBI-822 Phase III Clinical Trial
OBI-833 fulfilled the primary safety requirements of Phase I clinical trial for US and Taiwan
USPTO approved the patent application for OBI-888 “Antibodies, pharmaceutical compositions and uses thereof.”
Presentation on OBI-3424 at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics.
OBI Pharma reports topline results from OBI-822/821 Randomized Controlled Phase 2/3 Clinical Trial in Patients with Metastatic Breast Cancer
Expert Meeting on OBI-822-001 Study held in London
Presented OBI-822-001 trial data at ASCO in Chicago
Result of Phase 2/3 Clinical Trial of OBI-822 was published in ASCO Post
Sponsored an Adagloxad Simolenin (OBI-822) Satellite Symposium at the 2016 ESMO Annual Meeting
OBI-833 patent granted in Taiwan and Australia
OBI-833-001 IND approved by TFDA
Completed patient enrollment of Phase 2/Phase 3 Clinical Trial for OBI-822 Active Immunotherapy for Metastatic Breast Cancer
Obtained approval from US FDA to enter OBI-833 Clinical Trial
Partnered with Mackay for the development and clinical planning of immunotherapy for ovarian cancer
Obtained approval from India DCGI, South Korea KFDA, and Taiwan TFDA to enter OBI-822 Clinical Trial
Received NDA approval for DIFICID™ in Taiwan
OBI-822 selected by the TFDA for the ECFA Program, a preferential trade agreement between China and Taiwan
US FDA and Hong Kong DH approved OBI-822 to enter OBI-822 Clinical Trial for metastatic breast cancer
TFDA granted New Drug Priority Review and exemption requiring a Bridging Study Evaluation (BSE) for DIFICID™
Submitted DIFICID™ NDA to the TFDA
Participated in Acadamia Sinica's National Research Program for Biopharmaceuticals for the development of OBI-868
Obtained the exclusive development right of OBI-833, a new generation cancer immunotherapy, and OBI-868, a novel cancer diagnosis technology, from Academia Sinica
TFDA approved OBI-822 to enter Phase II/III Clinical Trial
Taiwan's Center for Drug Evaluation granted OBI priority review for OBI-822 (formerly known as OPT-822)
Acadamia Sinica published research data in PNAS, noting the high expression of Globo series antigens on cancer cells
Partnered with Academia Sinica on carbohydrate molecules synthesis and glycan array development
Optimer Pharmaceuticals (NASDAQ:OPTR) initiated a DIFICID™ Phase III clinical trial
Completed the statistical analysis of DIFICID™ (Fidaxomicin) CDI epidemiology in Taiwan
Manufacturing of DIFICIDTM drug supply for phase I/II clinical trial in Taiwan
Capital increase for new shares to transfer to ABPROTIX INC.
OBI acquired TH-3424 and renames it OBI-3424
ThioBridge™ licensing agreement with Abzena (AIM: ABZA)
Signed contract for the manufacturing of OBI-858 with Pharmacore
Signed Non-Binding Letter of Intent for OBI Pharma, Inc., to issue new shares to AbProtix, Inc., in exchange for an up to 70% stake in AP Biosciences
Licensed the Taiwan marketing right of DIFICID® (fidaxomicin) to MSD
Signed exclusive licensing agreement to use synthetic carbohydrate technology of Academia Sinica for improvement of OBI-822 production
Completed health insurance payment agreement for DIFICID™ to be included in the healthcare coverage
Obtained the marketing right of DIFICID™ in Taiwan
Obtained global marketing right of OBI-822 (formerly known as OPT-822) from Optimer Pharmaceuticals
Attended the 36th J.P. Morgan Annual Healthcare Conference
Presentation on new drug development at investor conference hosted by Masterlink Securities
Attended the Credit Suisse Asian Investment Conference
Attended the 2018 industry forum hosted by Masterlink Securities
Attended the 2017 Asia Pacific Healthcare Forum, hosted by Goldman Sachs
Attended Citi’s 2017 Global Healthcare Conference
Dr. Michael Chang re-elected as the Chairman of the Board
Completed IPO on Taipei Exchange main board
Allen Chao elected as an independent director by the Board; establishment of the Audit Committee by the three independent directors
Elected Dr. Youe-Kong Shue as the Vice Chairman and Principal, Global Clinical Operations and Planning
Re-elected Dr. Michael Chang as the CEO
OBI listed as an Emerging Company in Taiwan's GreTai Securities Market
Optimer relieved from the Board of Directors due to the release of more than half of its elected shares
Elected Tamon Tseng as the Chairman
Optimer Pharmaceuticals completed IPO on NASDAQ (NASDAQ:OPTR)