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抗C型肝炎病毒新藥 伏拉瑞韋(Furaprevir)

開發階段

台灣完成二期臨床試驗。試驗結果顯示22位完成12周治療的慢性C型肝炎患者治癒率SVR12達91%,其中20位具有IL28B_CC基因型患者的治癒率SVR12高達95%。

在中國與宜昌東陽光長江藥業合作開發新型C肝純口服免干擾素新藥,中國二期臨床已收案並治療完成,目標於2019年開展三期臨床試驗。


業務發展

1.2016年,太景與宜昌東陽光長江藥業簽署合作,於中國設立合資公司,共同開發C肝全口服新藥。

2.太景以伏拉瑞韋(Furaprevir)大中華區專利所有權作價技術入股,取得合資新公司「東莞東陽光太景醫藥硏發有限責任公司」股權之相關程序及驗資作業已於2017年中完成,貢獻太景逾10億台幣收益。

3.太景與中國合作夥伴大陸宜昌東陽光長江藥業合作開發新型C肝純口服免干擾素新藥,太景的伏拉瑞韋(Furaprevir)合併東陽光藥的依米他韋(Yimitasvir)兩藥聯用已完成中國二期臨床試驗之治療,預計2019年展開三期臨床試驗。


研發成果

1.獲科專補助2,952萬元進行臨床前開發計畫

2.獲科專補助5,814萬元進行一期臨床試驗

3.目前全球共已取得99件專利保護,涵蓋歐盟、美國、台灣、中國大陸、日本、南非、澳洲、紐西蘭等主要市場

4.榮獲2015年台灣衛福部與經濟部新藥研發獎勵銅質獎

5.榮獲2015年生策會之國家新創獎企業組研發技術類金獎

6.榮獲2016年中國化學會頒發年度「化學技術獎章」

7.榮獲2017年傑出生技產業獎「年度創新獎」

8.榮獲2017年衛福部經濟部「藥物科技研究發展獎銅質獎」


Presentations


APASL STC 2018

A Randomized, Doubled-blinded, Placebo-controlled, Dose-escalated Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Furaprevir in Healthy Chinese Volunteers. Xiao-Min Li, Su-Mei Xu, Cheng-Yuan Tsai, Li-Wen Chang, Ping-Sheng Xu.

Furaprevir/ Yimitasvir for Treatment-naïve Chinese Patients with Genotype 1 HCV: an On-going, Open-label, Phase II Study. Jun Quan, Xin-Yue Chen, You-Wen Tan, Yue-Min Nan, Jia Shang, Chih-Ming Chen, Li-Wen Chang, Lai Wei.

Two Novel Hepatitis C Virus Antivirals, Furaprevir and Yimitasvir in Healthy Chinese Volunteers: A Drug-Drug Interaction Study. Su-Min Xu, Xiao-Min Li, Cheng-Yuan Tsai, Xing-An Wang, Li-Wen Chang, Ping-Sheng Xu

Combination of Furaprevir and Yimitasvir Demonstrated Synergistic Antiviral Effects without Interaction in vivo. Cheng-Yuan Tsai, Yi-Fen Chen, Chih-Ming Chen, Xinan Wang, Yingjun Zhan, Philip Huang, Ming-Chu Hsu.


APASL STC 2016

Over 3 Logs of Reductions in HCV RNA in GT-1/2/4/6 Subjects with 3 Doses of TG-2349. Shih-Jer Hsu, Chau-Ting Yeh, Tarek Hassanein, Suzanne Kim, Tsung-Hui Hu, Chun-Jen Liu, Chen-En Tsai, Chih-Ming Chen, Li-Wen Chang, Chu-Chung Lin, Chi-Hsin R. King, Ming-Chu Hsu.

RVR of 92% Achieved by 12 Weeks of TG-2349 Plus PEGIFN/RBV in GT-1b Subjects. Ming-Lung Yu, Shih-Jer Hsu, Chau-Ting Yeh, Chao-Hung Hung, Chih-Lang Lin, Ming-Yao Chen, Pei-Jer Chen, Yi-Hsiang Huang, Pin-Nan Cheng, Chih-Ming Chen, Edward Kuo, Li-Wen Chang, Chu-Chung Lin, Chi-Hsin R. King, Ming-Chu Hsu.

Rapid antiviral response with TG-2349 plus PegIFN-RBV in naïve GT-1b subject: an interim analysis. Ming-Lung Yu, Shih-Jer Hsu, Chau-Ting Yeh, Ming-Yao Chen, Pei-Jer Chen, Yi-Hsiang Huang, Pin-Nan Cheng, Tsung-Hui Hu, Chih-Ming Chen, Li-Wen Chang, Chu-Chung Lin, Felice Sheen, Chi-Hsin R. King, Ming-Chu Hsu.

TG-2349 three-day monotherapy with significant antiviral activity in Caucasian and East Asian HCV Subjects. Chau-Ting Yeh, Tarek Hassanein, Suzanne Kim, Shih-Jer Hsu, Tsung-Hui Hu, Chun-Jen Liu, Chen-En Tsai, Chih-Ming Chen, Li-Wen Chang, Chu-Chung Lin, Chi-Hsin R. King, Ming-Chu Hsu.


EASL 2016

Higher genetic barrier revealed in HCV GT-1b/2/4/6 subjects than GT-1a patients – a proof of concept trial of TG-2349 (Furaprevir). Chau-Ting Yeh, Tarek Hassanein, Suzanne Kim, Shih-Jer Hsu, Tsung-Hui Hu, Chun-Jen Liu, Chen-En Tsai, Chih-Ming Chen, Li-Wen Chang, Chu-Chung Lin, Chi-Hsin R. King, Ming-Chu Hsu.

TG-2349, a potent protease inhibitor, plus PegIFN/RBV provides excellent virological responses for harder-to-treat subpopulations of HCV-1b non-cirrhotic patients. Ming-Lung Yu, Shih-Jer Hsu, Chau-Ting Yeh, Chao-Hung Hung, Ming-Yao Chen, Pei-Jer Chen, Yi-Hsiang Huang, Pin-Nan Cheng, Chih-Ming Chen, Li-Wen Chang, Chu-Chung Lin, Felice Sheen, Chi-Hsin R. King, Edward Kuo, Ming-Chu Hsu.


AASLD 2014

The Antiviral Profile of TG-2349, a novel HCV Protease Inhibitor with Pan-Genotypic Activity Chih-Ming Chen, Yi-Fen Chen, Chu-Chung Lin, Chi-Hsin R. King, Ming-Chu Hsu.

Evaluation of TG‐2349, a Novel HCV Protease Inhibitor with Pan‐Genotypic Activity, in Replicon‐Mouse Models with Luciferase. Ying‐Huey Huang, Chih‐Ming Chen, Hung‐Ming Hsu, Chu‐Chung Lin, Chi‐HsinR. King, and Ming‐Chu Hsu.


AIMECS 2013

Design and Discovery of Potent and Pan-genotypic HCV NS3/4A Protease Inhibitors. Chu-Chung Lin, Chen-Fu Liu, Kuang-Yuan Lee, Pei-Chin Cheng, Yo-Chin Liu, Pin Lo, Hung-Chuan Chen, Chih-Ming Chen, Richard King, and Ming-Chu Hsu.

TG-2349, a Novel HCV Protease Inhibitor with Pan-genotypic Activity. Chih-Ming Chen, Hsiao-Chao Chien, Chia-Hui Wang, Yi-Fen Chen, Chen-Fu Liu, Chu-Chung Lin, Richard King, and Ming-Chu Hsu.

TG-2349, a potent HCV NS3/4A protease inhibitor, showed in vivo efficacy in mice. Ying-Huey Huang, Hsiao-Wen Lin, Chu-Chung Lin, Chi-Ming Chen, Chi-Hsin R. King, Ming-Chu Hsu.


AASLD 2013

A Phase I/IIa Study of Safety, Tolerability, and Pharmacokinetic Profiles of TG-2349, a Pan-Genotypic HCV Protease Inhibitor, in Healthy East Asian and Caucasian Subjects, and its Antiviral Activity in Chronic Hepatitis C Patients Chen-En Tsai, Li-Wen Chang, Yu-Ting Chang, Chiung-Yuan Hsu, Chih-Ming Chen, Cheng-Yuan Tsai, Chu-Chung Lin, Chi-Hsin R. King, Chun-Jen Liu, Ding-Shinn Chen, Ming-Chu Hsu.