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February 14, 2016 6:20 PM ET

Pharmaceuticals

Company Overview of TaiGen Biotechnology Co., Ltd.

Company Overview

TaiGen Biotechnology Co., Ltd., a pharmaceutical company, engages in the development of novel therapeutics for infectious diseases, cancer, and diabetes. It offers Nemonoxacina, a drug-resistant anti-infection drug for community acquired pneumonia, diabetic foot infection, skin infections, and nosocomial pneumonia; and stem cell mobilizer products to mobilize stem cells and progenitor cells from the bone marrow into peripheral circulation, as well as for chemosensitization treatment of leukemia patients. The company also provides hepatitis C virus protease inhibitors, anti-influenza drugs, anti-gram negative drugs, and bacteria drugs. TaiGen Biotechnology Co., Ltd. was founded in 2001 and is...

138 Shin Ming Road

7th Floor

Neihu Dist.

Taipei,  114

Taiwan

Founded in 2001

Phone:

886 2 8177 7072

Fax:

886 2 2796 3606

Key Executives for TaiGen Biotechnology Co., Ltd.

Founder, Executive Chairman, Chief Executive Officer, President and Member of Steering Committee
Senior Vice President of Research
Chief Commercial Officer - Asia, Product Development and Marketing General Manager Taigen Beijing Office
Vice President of Corporate Development
Vice President of Clinical Development
Compensation as of Fiscal Year 2015.

TaiGen Biotechnology Co., Ltd. Key Developments

TaiGen Biotechnology Launches Taigexyn(R) in Taiwan

TaiGen Biotechnology Company, Limited announced that together with its distribution partner, Holding Distribution, it has launched Taigexyn® (nemonoxacin) capsules in Taiwan, the first market where Taigexyn® is available. Taigexyn® is a novel non-fluorinated quinolone antibiotic for the treatment of bacterial infections with both oral (capsule) and intravenous formulations. TaiGen successfully completed multiple clinical trials (Phase 1-3) of Taigexyn® in community acquired pneumonia in Taiwan and mainland China and have filed for New Drug Application (NDA) of the oral formulation in both markets in March and April 2013 respectively. In December 2014, the Taiwan Food and Drug Administration approved the NDA and granted the new drug license for the oral formulation of Taigexyn® to TaiGen. Taigexyn® is out-licensed to Zhejiang Medicine in mainland China and to R-Pharm in Russia, Commonwealth Independent States, and Turkey.

TaiGen Biotechnology Company, Limited's Intravenous Taigexyn Achieves Primary Endpoint in Phase 3 Clinical Trial for Community Acquired Pneumonia

TaiGen Biotechnology Company, Limited that the intravenous formulation of Taigexyn has achieved the primary endpoint (clinical success rate at Visit 4 in the evaluable-mITT population) in the Phase 3 clinical trial of community acquired pneumonia (TG-873870-C-6). This trial was a randomized, double-blinded study comparing intravenous formulations of Taigexyn 500mg vs. levofloxacin 500 mg and has recruited 525 patients from Taiwan and mainlandChina. The clinical success rates for Taigexyn 500 mg and levofloxacin 500 mg were 92.8% and 87.0%, respectively, in evaluable-mITT subjects. Taigexyn® 500 mg was shown to be non-inferior to levofloxacin 500 mg in that the lower limit of the 95% CI of the treatment difference was greater than -10% (p<0.05). Based on these results, TaiGen will prepare for the filing of New Drug Application (NDA) with China'sFDA in 2016. Taigexyn® (nemonoxacin) is designated as a Class 1.1 new drug under China's FDA. It is a novel non-fluorinated quinolone with both oral and intravenous formulations. TaiGen have completed multiple clinical trials (Phase 1-3) for community acquired pneumonia in Taiwan and mainland China and have filed for NDA of the oral formulation in both markets in March and April 2013 respectively. The Taiwan FDA granted new drug license for the oral formulation of Taigexyn to TaiGen in January 2015.

TaiGen Biotechnology Announces Initiation of Burixafor Chemosensitization Clinical Trial in Acute Myeloid Leukemia in China

TaiGen Biotechnology Co., Ltd. announced the initiation of first burixafor trial in China. The study titled "A Phase I/II Study of Burixafor Plus Fludarabine and Cytarabine in Adults With Relapsed or Refractory Acute Myeloid Leukemia (AML)" is an open-label study to determine the safety and efficacy of burixafor in combination with two chemotherapeutic agents, fludarabine and cytaribine and will enroll up to 15 patients. In addition to maximum tolerated dose of burixafor, other efficacy endpoints such as complete response, disease free survival, and overall survival will also be evaluated. The study will be led by Prof. Wang JianXiang, a hematologist/oncologist at the Institute of Hematology and Blood Diseases Hospital in Tianjin under a clinical trial authorization for Class 1.1 new drug from China FDA.

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