UBI Pharma Inc. (6562.TW) was established in July 2014 as a subsidiary spun off from United Biomedical, Inc., Asia. Our main focus is on developing, manufacturing (CMO), contract manufacturing and development services (CDMO) for protein drugs and specialty pharmaceuticals. In June 2021, we achieved a significant milestone by gaining approval to be listed on the OTC market of the Taiwan Stock Exchange. Our headquarters are located in Hukou Township, Hsinchu County, Taiwan. We're particularly proud of being the first in Asia, excluding Japan, to receive approval from the U.S. FDA for our needle-filling production line, highlighting our dedication to quality and innovation. With our roots in the UBI Group's innovative spirit and the strong heritage of international pharmaceutical companies, UBI Pharma Inc. brings a range of unique technologies, including patented long-acting protein drug development platform and patented formulations for single-chain Fc fusion proteins and injectable dosage forms. At UBI Pharma Inc., we're committed to researching and producing improved biopharmaceuticals (Biobetters) and Specialty Injectables. By combining our pharmaceutical expertise with outstanding clinical research resources, we've established an integrated model for research and production (ONE-stop) services. Throughout our history, our mission remains constant：to drive innovation in the pharmaceutical industry, provide top-quality products and services, and offer effective solutions for various health challenges, contributing to the achievement of SDGs 3 (Good Health and Well-being). Looking ahead, we're excited about future successes and achievements. We aim to continue making substantial contributions to the biopharmaceutical sector and strive to become a leader in the field of medicine, playing a vital role in the global marketplace.
The company accepted third-party verification of ISO 14064-1 greenhouse gas emissions and removal by Gray International Verification Company on October 21st and 25th, and obtained a third-party verification statement on November 8th.
Announcement that our company's product Leuprolide Acetate Injection has obtained the US ANDA drug license approval.
The company's expanded factory's sterile injection (sterile vial line-2) has passed the GMP inspection of Taiwan's Ministry of Health and Welfare.
The company underwent an on-site review by the TTQS assessment committee on September 11, 2024, and was notified on September 20 that the company passed the TTQS talent development quality management system assessment (enterprise organization version) and obtained the bronze medal certification, which affirms the company's The quality and ability of company training.
Our company's "Single-Chain Immunoglobulin Fusion Protein Technology Platform" has been approved by the European Patent Office. This technology is applied to our proprietary product UB-853 and has already obtained patents in the United States, China, Japan, Taiwan, India, Australia, Malaysia, Singapore, Canada, and Hong Kong. Patent applications are currently under review in South Korea, New Zealand, and Brazil.
Our company has passed the GMP inspection conducted by the UK MHRA, with the inspection report indicating no significant deficiencies. The result of the report is "compliant."
UBIP received the official PMDA factory inspection report, passed the GMP inspection by the Japanese PMDA.
UBIP's Single-Chain Immunoglobulin Fusion Proteins Platform has received approval from the United States Patent and Trademark Office. This cutting-edge technology is being utilized in our products - UB-551 and UB-853. The platform has secured patents in markets including China, Japan, Taiwan, India, Australia, Malaysia, and Hong Kong, while awaiting review for patents in Korea and Singapore.
Announcement for Submitting the three-in-one combination tablet (NDF01) for the treatment of HIV infection to TFDA for Registration of Medicinal Products.
UBI Pharma Inc. has received two prestigious awards at the 20th National Brand Yushan Awards：the Best Product Category Award for its HIV Combination Tablet (NDF01) and the Outstanding Corporate Leader Award for its Chairman and CEO.
UBI Pharma Inc. has signed an exclusive licensing and sales agreement with OU RUI Biotechnology Co., Ltd. for the investment in and distribution rights of UB-851 biosimilar drug for the treatment of renal anemia in eleven Muslim countries.
UBI Pharma Inc. Hsinchu plant passed the routine cGMP inspection of the US FDA and received the official factory inspection report (EIR, Establishment Inspection Report).
UBI Pharma Inc., the only injectable drug manufacturer in Taiwan passes the SMDC inspection in Ukraine.
Announcement Voriconazole for Injection, 200mg/vial (Single-Dose Vial), a sterile lyophilized powder injection ANDA has been approved by US FDA.
Announcement Levetiracetam, an epilepsy drug, has been approved by the Malaysian government.
The new combination antiretroviral drug NDF01 for HIV/AIDS has completed bioequivalence testing.
Received the bronze medal in the Talent Development Quality Management System (Enterprise Edition) of the Taiwan Technical and Quality Skills (TTQS) program by the Ministry of Labor's Bureau of Labor Development.
Completed the final data analysis of the Phase III human clinical trials for the biosimilar drug UB-851, a recombinant human erythropoietin.
Announced the approval of Taiwan's ANDA (Abbreviated New Drug Application) for our company's product, 50 mg Caspofungin Acetate for Injection.
Announced the approval of the U.S. ANDA (Abbreviated New Drug Application) for our company's Caspofungin Acetate for Injection in both 50 mg and 70 mg strengths.
Our company has been listed on the emerging stock market.
Announced the unblinding and analysis results of the interim data from the Phase III human clinical trials of our erythropoietin product UB-851.
Announced the approval of the U.S. ANDA (Abbreviated New Drug Application) for our company's Desmopressin Acetate Injection.
Announced that our Hsinchu facility has passed the routine inspection for Good Manufacturing Practice (GMP) by the Ministry of Health and Welfare.
Announced the approval of Taiwan's ANDA (Abbreviated New Drug Application) for our company's Olanzapine for Injection 10 mg.
Announced receipt of the notification of the pharmaceutical foreign manufacturer accreditation certificate issued by the Ministry of Health, Labour and Welfare of Japan.
Announced the approval of the U.S. ANDA (Abbreviated New Drug Application) for our company's Desmopressin Acetate Injection.
Announced the cessation of trading of our company's stock on the emerging stock market starting from November 8th, 2019.
Announced the acquisition of the U.S. patent certificate for our company's "RECOMBINANT PROTEIN" technology platform.
Announced that our sterile injection production line has received the official Good Manufacturing Practice (GMP) inspection report (EIR) from the U.S. FDA.
Announced that our innovative long-acting erythropoietin UB-852 has passed the review of the Taiwan Food and Drug Administration (TFDA) and has been granted approval to proceed with the Phase I human clinical trials.
Announced the acquisition of the patent certificate for our company's "Recombinant Protein" technology platform in the People's Republic of China.
Announced that our cream formulation production line has received the official inspection report (EIR) from the U.S. FDA.
Announced that our Hsinchu facility's cream formulation production line has received the official inspection report (EIR) from the U.S. FDA.
Announced the addition of a new dosage form (Freeze-Dried Injection) that has passed the Good Manufacturing Practice (GMP) inspection by the Ministry of Health and Welfare.
Announced receipt of the official inspection report (EIR) from the U.S. FDA.
UBIP B-Raf anti-cancer targeted new drug UB-941 has won the 15th National Innovation Award.
張秀蓮 and 陳啟祥 respectively assume the positions of Chairperson and General Manager at UBIP.
UBIP's "RECOMBINANT PROTEIN" technology platform has obtained a patent certificate from the European Union.
UBIP has been honored with the 15th Taiwan Golden Root Award.
UBIP collaborates with the American company Qiji to establish a multifunctional protein drug production base in Yangzhou.
UBIP's sterile products from the Hsinchu plant have obtained GMP certification from Japan's PMDA and accreditation as a pharmaceutical foreign manufacturer by Japan's Ministry of Health.
UBIP was honored to be received by the President, who commended its innovative research and development achievements and outstanding contributions to healthcare.
UBIP was honored with the Top Ten Potential Enterprises and Innovation Design Award at the 13th Golden Torch Awards.
UBIP's innovative erythropoietin UB-852 and innovative interferon α8 UB-551 were awarded the National Brand Award for Best Product Category, as well as the Yushan Award, at the 13th National Brand Awards.
UBIP's anti-cancer targeted drug, B-Raf kinase inhibitor UB-941, has passed the Investigational New Drug (IND) review for human clinical trials by the U.S. Food and Drug Administration (FDA).
UBIP's B-Raf kinase inhibitor UB-941 was awarded the Annual Innovation Award at the 2016 Outstanding Biotechnology Industry Awards.
The Phase III clinical trial of human erythropoietin UB-851 has been granted financial support by the Ministry of Economic Affairs under its scientific and technological project.
The Biotechnology Development Center has granted authorization for the acquisition of the B-Raf kinase inhibitor anti-cancer targeted drug (UB-941).
UBIP held a presentation on its operations upon its listing on the emerging stock market.
Research and Development Center Vice General Manager, Peng Wenjun, representing UBIP, was honored to be received by the President, who commended the company's achievements in new drug development and brand management.
The Phase I clinical trial report of human erythropoietin UB-851 has been approved by the Ministry of Health and Welfare for archival purposes.
Human erythropoietin UB-851 has entered Phase III clinical trials.
UBIP has obtained regulatory approval for its initial public offering.
Received the National Brand Yushan Award, Outstanding Enterprise Award, and National First Prize.
The Phase III clinical trial of human erythropoietin UB-851 has been submitted for review.
Obtained the Certificate of Good Manufacturing Practice for Medicinal Products (PIC/S GMP Certificate).
The Taiwan Food and Drug Administration (TFDA) has approved the renaming of UBIP Hsinchu Plant 2 to Lianya Hsinchu Plant with a letter of record.
Obtained the Manufacturing and Sales License for Pharmaceutical Manufacturers.
The biosimilar drug for human erythropoietin UB-851 has completed Phase I clinical trials.
Taiwan Biomedical Technology Corporation Limited has invested and become a key strategic partner.
Factory registration obtained.
UBIA split its monoclonal antibody drug business and chemical pharmaceutical business to establish UBIP.