OBI Pharma, Inc.
OBI Pharma, Inc. is a bio-pharmaceutical company, based in Nangang District, Taipei, Taiwan.
In 2018 it announced that its drug, OBI-3424, has been granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of Hepatocellular Carcinoma.
History
The company was founded by Micheal N.Chang on April 29, 2002. It was formerly a subsidiary of Optimer Pharmaceuticals.On 9 Feb 2007, its parent company Optimer Pharmaceuticals can buy/sell on Nasdaq Stock Exchange. At that time, its share price was US$8.50 per share.
On 15 May 2012, OBI Pharma, Inc. was approved to become a public company in Taiwan.
On 23 Mar 2015, it can do transaction formally on OTC in Taiwan R.O.C.
On February 8, 2022: OBI Pharma announced the development of its COVID-19 vaccine, BCVax.
2023, BCVax received approval from Taiwan’s Food and Drug Administration for a Phase I clinical trial.
2023, Anticancer drug OBI-3424 was approved by TFDA for a Phase II clinical trial. In the same year, OBI Pharma developed its proprietary ADC platforms, including a cysteine-based conjugation platform and GlycOBI™.
2023, OBI Pharma obtained ISO/IEC 27001 certification for information security management.
2023, OBI Pharma and its subsidiary, OBIGEN Pharma Biotech, signed an exclusive global medical use license agreement for OBI-858.
2023, OBI Pharma signed a licensing agreement with Ablexis, LLC for the global rights to the "Nectin4 human antibody sequence."
On December 29, 2023: Kung-Yee Liang succeeded as Chairman of OBI Pharma.
On January 31, 2024: The Phase III trial of Adagloxad Simolenin and OBI-821 for triple-negative breast cancer completed its first interim analysis, with the Data and Safety Monitoring Board recommending continuation.
On March 11, 2024: OBI Pharma’s board decided to halt patient enrollment in the OBI-3424 Phase II trial, while collaboration with international partners continued.
On June 12, 2024: OBI-992, a TROP2-targeted ADC, received U.S. FDA approval for a Phase I/II clinical trial to evaluate its safety and efficacy in solid tumors.
On August 7, 2024: OBI-992 was granted U.S. FDA orphan drug designation for gastric cancer, including gastroesophageal junction adenocarcinoma.
On September 24, 2024: OBI-992 was shortlisted for the "2024 Most Promising Clinical Candidate" at the 11th World ADC Awards.
On October 13, 2024: OBI Pharma’s partner, Ascentawits, presented Phase II interim results for AST-3424 at the CSCO meeting, receiving an "Outstanding Paper Award."
On December 11, 2024: OBI Pharma received the Sports Enterprise Certification from Taiwan’s Ministry of Education for the second time.
On December 23, 2024: OBI Pharma signed marketing and material transfer agreements with Japan’s GlyTech to promote GlycOBI® ADC technology in Japan’s biopharma industry.
On March 12, 2025: OBI Pharma won the "Most Promising ADC Clinical Candidate in Taiwan" award at the ADC Asia Congress 2025 in Singapore.
On March 18, 2025: OBIGEN Pharma, an OBI Pharma subsidiary, appointed OBI Pharma CEO Heidi Wang as Chairman, succeeding Frank Chen, who resigned.
On March 26, 2025: OBI Pharma received the "Most Promising Immunotherapy Pipeline" award from the Taiwan Bio-Excellence Awards.