History
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12/01 UB-421 was granted with 2022 Innovation and Excellence Award 10/21 UBP received the honor of “Taiwan Biopharma Excellence Awards 2022” 08/29 NIH recognizes the potency of UB-421 against multi-drug resistant HIV and receives the FDA approval to conduct a phase 2 clinical trial with UB-421 08/02 Journal of Clinical Investigation (JCI) published results of UB-221’s preclinical and clinical Phase I study. 05/26 UBP receives IND approval from TFDA for a phase 2 study of UB-221 in adults with Chronic Spontaneous Urticaria. 11/08 Bioanalytical laboratory received certificate from TFDA for GLP inspection. 08/17 UBP received IND approvals from Taiwan FDA and China NMPA for two phase 2 studies with UB-421 monotherapy and in Combination with Chidamide to evaluate the application in HIV functional cure. 07/13 China NMPA approved the IND of a larger phase 2 trial with multi-dosing UB-621 to demonstrate optimal clinical efficacy in treatment of recurrent genital herpes. 06/20 China NMPA approved the IND of a proof of concept phase 2 trial for UB-421 in combination with Chidamide, a latent reverse agent, for reduction of HIV reservoir. 01/01 UBP received “Badge of Accredited Healthy Workplace”. 11/06 China NMPA approved the IND of UB-621’s Phase 2 trial in China. 09/17 UBP received Certificate of TTQS Enterprise ver. -Silver medal. 08/21 UBP Received IND Approval from China NMPA for a Phase 3 Trial with UB-421 in Patients with Multi-Drug Resistance (MDR) HIV-1 infection. 08/05 UBP Received Approval from Taiwan FDA for a Phase 1 Trial with UB-421 Subcutaneous Formulation in HIV-1 Infected Patients. 04/27 UBP Received Approval from TFDA for a Phase 3 Trial with UB-421 in Patients with Multi-Drug Resistance (MDR) HIV-1 infection. 03/20 UBP received approval from China NMPA for a phase 1 trial with Anti-IgE mAb UB-221 in Healthy Volunteers. 03/06 Received China NMPA Approval for a Phase 2 Trial to evaluate UB-421’s efficacy on reduction of HIV reservoirs in ART stabilized HIV patients. 01/01 UBP received Badge of Accredited Healthy Workplace. 09 The newly constructed 2,000L commercial scale biologics manufacturing facility in Hukou, Taiwan has been successfully inspected by Taiwan Food and Drug Administration (FDA) and granted with PIC/S GMP certificate. 06 United BioPharma Receives US FDA Approval for UB-621 Phase 2 Trial in Recurrent Genital Herpes Patients. 05 The company received Investigational New Drug (IND) approval from China National Medical Products Administration (NMPA) to conduct a multi-nation, multi-center phase 3 clinical trial with UB-421 substitution monotherapy for HIV-infected adults who are on a stable treatment course of antiretroviral therapy (ART). 05 The company has obtained U.S. FDA’s approval to conduct a clinical trial with UB-421 in the USA, under the protocol entitled “A Multicenter, Single-Arm, 24-Week Study of UB-421 in Combination with Optimized Background Therapy (OBT) Regimen in Patients with Multi-Drug Resistant (MDR) HIV-1 Infection.” 04 UB-421’s clinical phase II results were published in the New England Journal of Medicine (NEJM) with the article name: “Effect of Anti-CD4 Antibody UB-421 on HIV-1 Rebound after Treatment Interruption”. 12 UBP received approval from TFDA for UB-421 (anti CD4 mAb) phase II, proof of concept, trial in HAART stabilized HIV patients for functional cure. 12 UBP received approval from TFDA for UB-221(anti-IgE mAb) phase I clinical trial. 11/21 UBP received Certificate of TTQS Enterprise ver. -Silver medal. 11 UBP filed IND for UB-621(anti-HSV-gD mAb) phase II clinical trial with US FDA. 10 UBP filed IND with TFDA for UB-421 phase II, proof of concept trial in HAART stabilized HIV patients for functional cure. 08/09 UBP chose to delist the company’s shares on the Taiwan Emerging Stock Market of the Taipei Exchange and to relist on a foreign stock exchange. 07 UBP’s third generation Monoclonal anti-IgE antibody was awarded the Bronze Medal by Taipei City Government in its 2018 Annual Biotechnology Forum. 07 UBP entered into strategic partnership with Covance, a global contract research organization (CRO) providing drug preclinical animal testing services. 06 Filed IND for UB-221(an anti-IgE mAb) Phase I clinical trial for treatment of chronic spontaneous urticaria (CSU) with TFDA. 03 UBP entered into a strategic partnership with IQVIA, an international leading contract research organization (CRO) providing services in clinical trials. 03 UBP received IND approval from Thailand FDA for UB-421 (anti-CD4 mAb) Phase III trial for HAART substitution in HAART stabilized HIV patients. 01 UBP received an award for its Bioprocess Innovation at the 2018 Asia-Pacific Bioprocess Excellence Award Ceremony. 11 UBP received IND approval from TFDA for UB-421 (anti-CD4 mAb) Phase III trial for HAART substitution in HAART stabilized HIV patients. 11 UBP was awarded the “Exemplary Biohazard Laboratory Management System” by Taiwan Centers for Disease Control and Prevention (Taiwan CDC). 09 UBP subsidiary, UBP greater China (Yangzhou) Co., Ltd, UBP-YZ, was established. 09 UBP received IND approval from TFDA for UB-921 (anti-HER2 mAb) Phase I clinical trial. 06 UBP’s subsidiary, UBP greater China (Shanghai) Co., Ltd, UBP-SH, was established. 06 UBP received the 2017 “Outstanding Biotechnology Corporation Award” at the BioTaiwan forum. 04 TFDA approved the phase II trial report of UB-421. 02 Phase II trial data of UB-421 was presented at the late breaker session at CROI 2017. 02 President Dr. Mei-June Liao received the recognition for “Bioprocessing Executive of the Year” at the 2017 Asia-Pacific Bioprocessing Excellence Forum. 02 UBP won the Advanced Development of Innovative BioMolecules Award at the 2017 Asia-Pacific Bioprocessing Excellence Forum. 01 Filed IND for UB-421 phase III clinical trial (HAART substitution) in HAART stabilized HIV patients with TFDA. 12 Filed IND with TFDA for UB-921 (Anti-HER2 mAb) phase I clinical trial in healthy volunteers. 12 UBP received certificate of occupancy for its eight-story (20,000 sq meter) headquarter building based in Hukou, Hsinchu county designed for administrative, R&D and large scale protein drug manufacturing activities. 10 UBP received Certificate of TTQS Enterprise ver. -Threshold. 08 UBP entered into a licensing agreement with UBI US Holdings LLC and UBI IP Holdings, both as subsidiaries of United Biomedical, Inc (UBI), for the exclusive US and ROW (ex-Asia) rights for development and commercialization of UB-421. 12 UB-421 for HIV treatment won the 12th National Innovation Prize given by Taiwan Biotechnology Strategic Planning Association. 11 IND submission of a phase I clinical trial for UB-621, an Anti-HSV-gD mAb, was approved by Taiwan Food and Drug Administration (TFDA). 06 United BioPharma received approval from Taiwan Food and Drug Administration (TFDA) for UB-421 Phase II clinical trial HAART substitution therapy in HAART stabilized HIV patients. 02 Filed an IND submission of a phase II clinical trial for HAART substitution therapy in HAART stabilized HIV patients, with Taiwan Food and Drug Administration (TFDA). 12 UB-421 (an anti CD4 mAb) received Gold Medal for 2014 Pharmaceutical Technology Research and Development, jointly awarded by Ministry of Economic Affairs and Ministry of Health, Taiwan. 12 Filed an IND submission of a phase I clinical trial for UB-621, an anti-HSV-gD mAb, with Taiwan Food and Drug Administration (TFDA). 12 United BioPharma Licensed in an a mAb product 8D6 for treatment of Allergic Diseases including Asthma, from Academia Sinica. 11 Completion of phase IIa clinical trial of UB-421, an anti-CD4 mAb, in treatment of naïve HIV patients. 09 United BioPharma was selected by Taiwan government’s Industrial Cooperation Program (ICP) as the funding recipient to execute the technology transfer process from GE Healthcare for the Single Use Disposal system in biological manufacturing. 09/19 United BioPharma was listed on the Taiwan Emerging Stock Market (Stock code: 6471). 09 Anti-CD4 mAb drug candidate UB-421 won the Gold Medal Prize for Innovative Research and Development given by Taipei City Government in its 2014 Annual Biotechnology Forum for Taipei Biotechnology Award. 05 Establishment of UBP’s Clinical Research Center at the Hsinchu Biomedical Science Park. 01/16 UBP held its opening ceremony on the 36th floor Auditorium of Taipei 101 building. 10/30 Establishment of a strategic alliance between UBP and Formosa Biomedical Technologies/the Chang-Gun Memorial Hospital of the Formosa Plastic Group. 09/30 Establishment of United BioPharma (UBP) through spinoff from its parent company United Biomedical, Asia (UBI Asia).