Who We Are

OBI-992 obtained the qualification as the “Orphan Drug Designation” for gastric cancer treatment from US Food and Drug Administration (FDA).

OBI-992 TROP2 ADC has been granted by US FDA to proceed to Phase I/II human clinical trial.

Adagloxad Simolenin (OBI-822)/OBI-821, receives a positive 1st interim analysis recommendation, suggesting the continuation of the Phase III TNBC trial.

OBI announced the termination of OBI-3424-001 trial while continuing the collaboration of OBI-3424 with partners.

Licensed “Nectin-4 Human Antibody” rights from Ablexis, LLC.

Licensed the worldwide therapeutic rights of OBI-858 to OBIGEN.

Achieved ISO/IEC 27001 International Information Security Certification.

Developed twp distinct ADC technology platforms: cysteine-based conjugation platform and glycan ADC platform (GlycOBI™).

OBI-3424 was approved by Taiwan Food and Drug Administration (TFDA) of the Ministry of Health and Welfare for phase II human clinical trial.

The COVID-19 vaccine, BCVax, has been granted by TFDA to proceed to Phase I clinical trial.

OBI announced termination of BCVax, OBI-866, and OBI-999.

Adagloxad Simolenin (OBI-822) was approved to carry out phase III human clinical trial in Poland and Brazil.

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.

OBI decided to terminate the OBI-888 phase II clinical trial inclusion in advance as the drug manufacturing yield was under expectation, and will carry out new development strategies after further developing the second-generation antibodies and optimizing the purification process.

OBI signed a global cosmetic medicine licensing agreement with Obigen Pharma, Inc. "OBI-858 new botulinum toxin preparation" to license the rights for R&D of cosmetic medicine indications and obtained 62.17% shares. Obigen has become OBI’s subsidiary.

The phase I clinical cohort expansion trial of OBI-833 was completed, and the implementation of phase II clinical trial was planned.

Adagloxad Simolenin (OBI-822) was approved to carry out phase III human clinical trial in South Africa, Mexico and Peru.

OBI has entered into an exclusive license agreement of an anti-TROP2 humanized monoclonal antibody, BSI04702, for worldwide rights excluding China, Hong Kong and Macao, with Biosion, Inc.

OBI-3424 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.

OBI-999 was approved by Taiwan Food and Drug Administration (TFDA) of the Ministry of Health and Welfare for phase II human clinical trial.

Adagloxad Simolenin (OBI-822) was approved to carry out phase III human clinical trial in South Korea and China.

OBI acquired 67% equity of Amaran Biotechnology. December 31st, 2020 is the benchmark date of share exchange.

OBI-999 awarded 2020 International Innovation Awards.

OBI-999 obtained the qualification as the “orphan drug” for gastric cancer treatment from US Food and Drug Administration (FDA).

OBI-888 was approved by the Taiwan Food and Drug Administration of the Ministry of Health and Welfare for the first/second phase human clinical trials.

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.

OBI-866 was approved by the Taiwan Food and Drug Administration of the Ministry of Health and Welfare for the first phase of human clinical trial.

Adagloxad Simolenin (OBI-822) was approved to carry out phase III human clinical trial in Ukraine and Russia.

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.

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).

Adagloxad Simolenin (OBI-822) was approved to carry out phase III human clinical trial in Taiwan, Australia, US, and Hong Kong.

OBI-888 passed the human clinical trial examination (IND) by US Food and Drug Administration (FDA)(IND).

OBI-3424 was approved by US Food and Drug Administration (FDA) to carry out phase I/II human clinical trial.

OBI-3424 obtained the qualification as the orphan drug for hepatocellular carcinoma (HCC) and Acute Lymphoblastic Leukemia (ALL)treatment from US Food and Drug Administration (FDA).

OBI-888 obtained the qualification as the “orphan drug” for pancreatic cancer treatment from US Food and Drug Administration (FDA).

OBI-3424 awarded 2018 International Innovation Awards.

Adagloxad Simolenin (OBI-822) was approved by China Food and Drug Administration (CFDA) on phase III clinical trial.

Signed contract with Threshold Pharmaceuticals from California, purchased the micromolecule first-in-class TH-3424, and renamed it into OBI03424, it will be developed into the potential therapy treating cancers of high AKR1C3 enzyme performance, becoming the new force in the product lines of OBI.

In order to improve product competitiveness and new drug development capacity, it was planned to exchange shares with AbProtix, Inc., shareholder of AP Biosciences. OBI acquired 67% equity of AP Biosciences. The base date for stock swap was January 10, 2018.

OBI Pharma Reports Topline Results from OBI-822/821 Randomized Controlled Phase 2/3 Clinical Trial in Patients with Metastatic Breast Cancer.

OBI Pharma IPO in Taiwan Taipei Exchange.

Awarded Taipei Biotech Awards Innovation Gold Medal Award.

OBI-833-001 IND Approval by TFDA.

Announced to exclusively license the product development and selling right of DIFICID™ in Taiwan to American merchant Merck Sharp & Dohme.

Awarded 2014 National Innovation Awards.

US FDA approved to carry out clinical trial for the new generation active immunity anti-cancer drug (OBI-833).

Awarded Outstanding Biotech Awards "Greatest Potential Award".

OBI Pharma (Shanghai) Limited was established.

Established US subsidiary OBI PHARMA USA, INC.

Approved by the Securities and Futures Bureau, Financial Supervisory Commission, the Executive Yuan to become the public company.

Hong Kong subsidiary OBI Pharma Limited was established.

Drug Controller General of India and Korea Food and Drug Administration (KFDA)approved OBI-822 clinical trial license.

Taiwan Food and Drug Administration (TFDA) approved OBI-822, the active immunity anti-cancer drug treating metastatic advanced breast cancer to enter into phase III clinical trial.

Taiwan Department of Health issued medicament license for the new antibiotic drug DIFICID® (Fidaxomicin), and approved it to come into Taiwan market.

Awarded Taiwan Biomedical and Agricultural Industries Innovation and Excellence Ceremonies Gold Award.

OBI-822 Clinical Trial for metastatic breast cancer began in the US and Hong Kong.

OBI Pharma acquired the selling right of DIFICID™ in Taiwan.

Taiwan Ministry of Economic Affairs approved OBI Pharma Inc. as the new biotechnological drug company.

OBI-822 Phase II/III Clinical Trial for metastatic breast cancer begins in Taiwan.

OBI-822 licensing fully transferred to OBI from Optimer Pharmaceuticals.

OBI Pharma, Inc. was established by American merchant Optimer Pharmaceuticals, Inc. OBI Pharma is the subsidiary 100% invested by American merchant Optimer Pharmaceuticals, Inc., upon the establishment, and the founder and Chairman was Michael N. Chang.