About Us

Part of the global pharmaceutical UBI Group, UBI Pharma consolidates the Group’s established values and builds a strong foundation of technology and production in the manufacture of pharmaceuticals, providing world-class pharmaceutical quality products. We develop innovative products such as non-monoclonal antibodies, novel small molecule drugs, and specialty injectables.

Major Milestones

Learn more about our corporate governance, financial and investor information from the material information announcements posted on the Market Observation Post System.

Milestones in 2023

Dec 15
UBIP received the official PMDA factory inspection report, passed the GMP inspection by the Japanese PMDA.
 
Dec 05
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.
 

Oct 31

Announcement for Submitting the three-in-one combination tablet (NDF01) for the treatment of HIV infection to TFDA for Registration of Medicinal Products.
 
 
Oct 25
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.
 
Spe 14
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.
 
 
Spe 4
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).
 
July 24
UBI Pharma Inc., the only injectable drug manufacturer in Taiwan passes the SMDC inspection in Ukraine.
 
March 10
Announcement Voriconazole for Injection, 200mg/vial (Single-Dose Vial), a sterile lyophilized powder injection ANDA has been approved by US FDA.
 
February 7
Announcement Levetiracetam, an epilepsy drug, has been approved by the Malaysian government.
 
2023
2022

Milestones in 2022

November 25
UBI Pharma completed the bioequivalence study and data analysis for anti-HIV new formulation new drug NDF01.
 
November 17
UBI Pharma passed the TTQS(Talent Quality-management System) assessment and received the bronze medal.
 
January 20
Completed the Clinical Study Report for biosimilar drug UB-851 recombinant human erythropoietin phase III clinical trial.


Milestones in 2021

November 22
Announcement that Caspofungin Acetate for Injection 50 mg ANDA was approved by TFDA.
 
October 5
Announcement that Caspofungin Acetate for Injection 50 mg & 70 mg ANDA was approved by US FDA.
 
June 23
UBI Pharma was listed in the Emerging Board of Taipei Exchange Market under the ticker of “6562”
 
June 11
Announcement that erythropoietin UB-851 Phase III clinical trial data unblinding and analysis results.
 
2021
2020

Milestones in 2020

September 22
Announcement that the company's product Desmopressin Acetate Injection ANDA has been approved by US FDA.
 
May 28
UBI Pharma passed the routine inspection of Good Manufacturing Practice (GMP) by Taiwan Ministry of Health and Welfare(TFDA).
 
April 14
Announcement that the company's own product Olanzapine for Injection 10 mg (Olanzapine for Injection 10 mg) ANDA has been approved by TFDA .
 
February 17
Announcement Desmopressin Acetate Injection ANDA has been approved by US FDA.
 

Milestones in 2019

October 24
Announcement to terminate trading on the Taipei Exchange Emerging Market from November 8, 2019.
 
September 26
Announcement "RECOMBINANT PROTEIN" technology platform obtained US patent certificate.
 
August 13
Received the U.S. FDA official Establishment Inspection Report (EIR) for GMP compliance of the sterile injectable production.
 
June 10
The innovative long-acting erythropoietin UB-852 passed the review from TFDA and was approved to execute the phase I clinical trials.
 
March 13
Announcement that "recombinant protein" technology platform has obtained the patent certificate of the People's Republic of China.
 
March 6
Received the U.S. FDA official Establishment Inspection Report (EIR) for the ointment/cream production (supplementary announcement).
 
March 4
Received the U.S. FDA official Establishment Inspection Report (EIR) for the ointment/cream production.
 
January 18
The newly-developed dosage form (lyophilized powder for injection) passed the GMP inspection by the Ministry of Health and Welfare, Taiwan.
 
January 16
Received the U.S. FDA official Establishment Inspection Report (EIR).
 
2019
2018

Milestones in 2018

December 4
The novel B-Raf targeted anticancer drug UB-941 received the 15th National Innovation Award.
 
October 3
Ms. Hsiu-Lien Chang and Mr. Chei-Hsiang Chen served as the chairman and general manager of UBI Pharma.
 
May 17
UBI Pharma was issued the EU patent certificate for the Recombinant Protein technology platform.
 
May 11
UBI Pharma received the 15th Taiwan Golden Root Award.
 
March 3
In partnership with the U.S. General Electric Company, UBI Pharma began the construction of a production facility for multifunctional protein drugs in Yangzhou, China.
 

Milestones in 2017

December 7
Production of sterile products at the Hsinchu Plant passed the GMP inspection by the Japan PMDA, and received the Accreditation Certificate of Foreign Drug Manufacturer issued by the Ministry of Health, Labor and Welfare, Japan.
 
2017
2016

Milestones in 2016

December 14
The President commended UBI Pharma’s achievements in innovative developments and outstanding contributions to medical science.
 
November 29
UBI Pharma was recognized as one of the “Top 10 Outstanding Companies of the Year” and received the Innovative Design of the Year award at the 13th Golden Torch Awards.
 
October 27
UBI Pharma’s innovative erythropoietin UB-852 and interferon α8 UB-551 received the 13th National Brand Yushan Award, including the National First Prize for Best Product.
 
August 15
Obtained the U.S. FDA IND approval for the novel anticancer drug B-Raf targeted kinase inhibitor UB-941.
 
July 25
UBI Pharma’s B-Raf targeted kinase inhibitor UB-941 received the “Innovation of the Year” award at the 2016 Taiwan BIO Awards.
 
July 11
Received a grant from the Technology Development Programs of the Ministry of Economic Affairs for the phase III clinical trial of the human erythropoietin UB-851
 
February 18
Obtained the license from the Development Center for Biotechnology for the anticancer drug UB-941 B-Raf targeted kinase inhibitor.
 
January 22
UBI Pharma was listed in the Emerging Board of Taipei Exchange Market under the ticker of “6562”.
 

Milestones in 2015

December 30
Vice President of the R&D Center, Dr. Wen-Chun Peng was commended by the President on behalf of UBI Pharma for the company’s outstanding achievements in the development of new drugs and brand management.
 
December 25
Obtained the approval of the Ministry of Health and Welfare for the Clinical Study Report of the phase I clinical trial of the human erythropoietin UB-851.
 
December 22
The human erythropoietin UB-851 entered the phase III clinical trial.
 
November 17
UBI Pharma received the approval of the competent authority for public offering.
 
October 28
Received the National Brand Yushan Award, including the Outstanding Enterprise Prize and National First Prize.
 
July 28
Submitted the application to begin the phase III clinical trial of the human erythropoietin UB-851.
 
June 23
Obtained the Certificate for Good Manufacturing Practice (PIC/S GMP certificate).
 
May 8
Obtained the pharmaceutical manufacturer license.
 
April 30
Completed the phase I clinical trial of the UB-851 human erythropoietin biosimilar drug.
 
January 27
Formosa Biomedical Technology Co., Ltd. joined and became an important strategic partner.
 
January 23
UBI Pharma obtained factory registration.
 
2015
2014

Milestones in 2014

July 31
UBI Pharma was spin off and established from the non-monoclonal antibody drug and chemical pharmaceutical business from United Biomedical, Inc., Asia.