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抗細菌感染新藥 奈諾沙星(Nemonoxacin)

開發階段

已完成口服劑型社區型肺炎(community-acquired bacterial pneumonia,簡稱CABP或CAP)及糖尿病足感染(diabetic foot infection,簡稱DFI)美國IND二期臨床試驗。

已完成口服劑型社區型肺炎(CAP)台灣及中國之三期臨床試驗。

奈諾沙星注射劑型已申請中國新藥查驗登記NDA ,台灣三期臨床解盲成功正準備申請NDA。


研發成果

1.獲得共十一種不同的專利保護,其中已獲得與申請中將近200項,專利行使範圍包括美國、歐盟、加拿大、中國大陸、韓國、澳洲、台灣等地,專利最長可以保護到西元2029年

2.獲科專補助台幣9,832萬元進行二期臨床試驗

3.獲科專補助台幣880萬元進行三期臨床試驗

4.榮獲2010年經濟部業界開發產業技術計畫-卓越研發成果獎

5.在2012年7月將中國地區製造及銷售權利授權予浙江醫藥股份有限公司,收到簽約金800萬美元,未來可依研發進度,向浙江醫藥收取里程碑款,以及依奈諾沙星在中國區之銷售淨額收取權利金

6.奈諾沙星獲得國家新創獎及台北生技獎技術移轉獎金獎

7.在2014年1月將俄羅斯、獨立國協以及土耳其等市場授權予俄羅斯藥廠R-Pharm。

8.在2016年8月將拉丁美洲17國市場授權予墨 西哥醫藥集團Productos Científicos。


業務發展

1.已取得台灣衛福部核發之藥品許可證,現正申請健保核價,行銷已委由在抗生素領域有超過三十年經驗的文德藥業負責。

2.在奈諾沙星上市後,搭配合作夥伴中國浙江醫藥經驗豐富之行銷團隊,及其抗細菌感染藥物之銷售渠道,共同執行奈諾沙星在中國之行銷策略,加速銷售高原期的來臨。

3.奈諾沙星口服劑型在2013年12月中,獲美國FDA認定屬於可對抗具抗藥性細菌等病原體之「抗感染藥品」(Qualified Infectious Disease Product,簡稱QIDP)資格 ,並獲美國FDA給予「快速通道」(Fast Track)待遇。獲得QIDP之藥品可獲得額外5年獨賣許可,若加上NCE(創新化合物)之5年專賣期,即長達10年。另外FDA授予的「快速通道」待遇,將讓奈諾沙星擁有優先審查之資格,有利於加速藥物上市時間。太景與太景之授權伙伴,將可因此受惠。


Presentations

2007 ICAAC

In Vitro Metabolism and Interaction of Nemonoxacin (TG-873870) on Human Hepatic CYP3A4 – Poster A-27 C. P. CHOW, C. Y. TSAI, C. F. YEH, S. J. CHEN.

Phototoxicity of Nemonoxacin (TG-873870) in Hairless Mice – Poster A-28 C. P. CHOW, C. SAMBUCO, A. M. HOBERMAN.

Cardiovascular Safety Evaluation of Nemonoxacin (TG-873870) in Dogs and Monkeys – Poster B-823 C. P. CHOW, C. Y. TSAI, Y. M. CHEN.

In Vitro Antibacterial Activity of Nemonoxacin (TG-873870), a New Non-Fluorinated Quinolone, against Clinical Isolates – Poster E-1635 T. L. LAUDERDALE, Y. R. SHIAU, J. F. LAI, H. C. CHEN, C. H. R. KING.


2007 IDSA

Single-Dose Safety, Tolerability, and Pharmacokinetics of Nemonoxacin (TG-873870), a Novel Potent Broad-Spectrum Non-Fluorinated Quinolone, in Healthy Volunteers – Poster 439 L. LIN, K. M. CHIU, T. K. CHUNG.

Multiple-Dose Study to Access the Safety, Tolerability and Pharmacokinetics of Nemonoxacin (TG-873870), a Novel Potent Broad-Spectrum Non-Fluorinated Quinolone, in Healthy Volunteers – Poster 440 H. ZHANG, K. M. CHIU, T. K. CHUNG, H. C. TAN, L. LIN .

Analysis of Antibacterial Response of Nemonoxacin (TG-873870) Against Major Pathogens from Respiratory Tract and Skin Infections – Poster 441 S. J. CHEN, L. LIN, L. W. CHANG.


2008 ICAAC/IDSA

Comparative Antistaphylococcal activity of Nemonoxacin, a Novel Broad-spectrum Quinolone – Poster C1-189 G. A. PANKUCH, K. KOSOWSKA-SHICK, P. MCGHEE, C. R. KING , P. C. APPELBAUM .

In Vivo Efficacy of Nemonoxacin in a Mouse Protection Model – Poster B-1005 C. H. HSU, L. LIN, R. LEUNK, D. REICHART.

In Vivo Efficacy of Nemonoxacin in a Mouse Pulmonary Infection Model – Poster B-056 C. H. HSU, L. LIN, R. LEUNK, D. REICHART.

Efficacy and Safety of Nemonoxacin versus Levofloxacin for the Treatment of Community-Acquired Pneumonia – Poster L-678 D. J. VAN RENSBURG, R. P. PERNG, L. LIN, H. ZHANG .

In Vitro Resistance Development to Nemonoxacin for Streptococcus pneumonia – Poster F1-2055 C. R. KING, L. LIN, R. LEUNK.

Fertility and Early Embryonic Developmental Toxicity of Nemonoxacin after Oral Administration to Rats – Poster F1-2056 C. H. HSU, Y. M. CHEN, C. P. CHOW.

Activity of Nemonoxacin, an Investigational C8-methoxy Non-fluorinated Quinolone Against Gram-Positive Cocci Obtained From Canadian Hospitals: CANWARD 2007 – Poster F1-2057 G. G. ZHANEL, M. LAING, M. DECORBY, K. NICHOL, C.H.R. KING, H. ADAM, D. J. HOBAN.

Activity of Nemonoxacin, an Investigational C8-methoxy Non-fluorinated Quinolone, Against Gram-Negative Bacilli Obtained From Canadian Hospitals: CANWARD 2007 – Poster C1-1957 N. LAING, M. DECORBY, K. NICHOL, C.H.R. KING, H. ADAM, D. J. HOBAN, G. G. ZHANEL.

In Vitro Activity of Nemonoxacin (TG-873870), a Novel Non-Fluorinated Quinolone, against Clinical Isolates of Streptococcus pneumoniae in Taiwan – Poster C2-254 P. R. HSUEH, C. KING.

In Vitro Activity of Nemonoxacin against Helicobacter pylori – Poster C2-3931 P.R. HSUEH, J. C. YANG, C. KING.


2008 WPCCID

A Randomized, Double-Blind, Comparative, Multiple-Center Study of Nemonoxacin versus Levofloxacin for the Treatment of Community-Acquired Pneumonia – Poster PS1-069 H. ZHANG, R. P. PERNG, D. J. J. VAN RENSBURG, L. LIN, H. C. TAN, L. W. CHANG.

Mutant Prevention Concentration of Nemonoxacin (TG-873870), a Novel Non-Fluorinated Quinolone, against Staphylococcus aureus – Poster PS1-066 Y. LIU, Z. LI, R. WANG, Z. ZHAO, M. C. HSU.

Comparative Antistaphylococcal activity of Nemonoxacin, a Novel Broad-spectrum Quinolone – Poster PS1-063 G. A. PANKUCH, K. KOSOWSKA-SHICK, C. R. KING , P. C. APPELBAUM.

In Vitro Antibacterial Activity of Nemonoxacin (TG-873870), a New Non-fluorinated Quinolone, Against Gram-Positive Pathogens – Poster PS1-065 T. L. LAUDERDALE, J. F. LAI, Y. R. SHIAU, H. C. CHEN, C. H. R. KING.

In Vitro Activity of Nemonoxacin (TG-873870) against Staphylococcus aureus, Enterococci, and Streptococcus pneumoniae with Various Resistant Phenotypes in Taiwan – Poster PS1-068 P. R. HSUEH, J. J. LU, C. H. R. KING.


2010 ICAAC

Nemonoxacin for Treating Diabetic Foot Infections: An Open-Label, Single-Arm, Multiple-Center Study – Poster L1-344 B. A. LIPSKY, M. GANI, L. ROGERS, J. S. HWANG, D. T. CHUNG, C. Y. TSAI, L. W. CHANG, Y. T. CHANG, C. H. R. KING, M. C. HSU.


2013 ICAAC

In Vitro Activity of Nemonoxacin, a Novel Quinolone Antibiotic, against Chlamydia pneumonia – Poster E-1182 K. CHOTIKANATIS, S. A. KOHLHOFF, M. R. HAMMERSCHLAG.


2014 ICAAC

Meeting the Threat of Antibiotic Resistance: In Vitro Activity, Clinical Efficacy and Safety of Nemonoxacin, a Novel Non-Fluorinated Quinolone with QIDP Status – Poster L-1748b C. E. TSAI, Z. HSU, C. H. R. KING, P. HUANG, L. W. CHANG, J. YUAN, J. CHANG, P. T. HUANG, M. C. HSU

Efficacy and Safety of Oral Nemonoxacin in Treatment of Community-Acquired Pneumonia: Results from a Randomized, Double-Blind, Multiple-Center, Phase III Comparison Study with Levofloxacin– Poster L-1748c Y. Y. ZHANG, S. L. CHENG, C. E. TSAI, Z. HSU, C. H. R. KING, P. HUANG, L. W. CHANG, J. YUAN, J. CHANG, P. T. HUANG, M. C. HSU


Selected Publications

Dose-Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Nemonoxacin (TG-873870), a Novel Potent Broad-Spectrum Non-Fluorinated Quinolone, in Healthy Volunteers Luke Lin, Li-Wen Chang, Cheng-Yuan Tsai, Ching-Hung Hsu, David T. Chung, William S. Aronstein, Funmi Ajayi, Barbara Kuzmak, and Robert A. Lyon Antimicrob Agents Chemother. 2010 Jan;45(1):405-10.

Multiple-Dose Safety, Tolerability, and Pharmacokinetics of Oral Nemonoxacin (TG-873870) in Healthy Volunteers David T. Chung, Cheng-Yuan Tsai, Shu-Jen Chen, Li-Wen Chang, Chi-Hsin R. King, Ching-Hung Hsu, Kit-Mui Chiu, Hao-Chen Tan, Yu-Ting Chang, and Ming-Chu Hsu Antimicrob Agents Chemother. 2010 Jan; 45(1):411-7.

Comparative in vitro activities of nemonoxacin, (TG-873870), a novel nonfluorinated quinolone, and other quinolones against clinical isolates Tsai-Ling Lauderdale, Yih-Ru Shiau, Jui-Fen Lai, Hua-Chien Chen, and Chi-Hsin R. King Antimicrob Agents Chemother. 2010 Mar; 54(3):1338-42.

Efficacy and safety of nemonoxacin versus levofloxacin for community-acquired pneumonia Dirkie J. J. van Rensburg, Reury-Perng Perng, Ismail H. Mitha, Andrè J.Bester, Joseph Kasumba, Ren-Guang Wu, Ming-Lin Ho, Li-Wen Chang, David T. Chung, Yu-Ting Chang,Chi-Hsin R. King, and Ming-Chu Hsu Antimicrob Agents Chemother. 2010 Oct;54(10):4098-106.

In vivo antibacterial activity of nemonoxacin, a novel non-fluorinated quinolone Li CR, Li Y, Li GQ, Yang XY, Zhang WX, Lou RH, Liu JF, Yuan M, Huang P, Cen S, Yu LY, Zhao LX, Jiang JD, You XF J Antimicrob Chemother. 2010 Nov;65(11):2411-5.

In vitro susceptibilities of clinical isolates of ertapenem-non-susceptible Enterobacteriaceae to nemonoxacin, tigecycline, fosfomycin and other antimicrobial agents Lai CC, Liu WL, Ko WC, Chen YH, Tan HR, Huang YT, Hsueh PR Antimicrob Agents Chemother. 2011 May; 55(5):2084-2091.

Pharmacokinetics and Pharmacodynamics of Nemonoxacin against Streptococcus pneumoniae in an In Vitro Infection Model. Liang W, Chen YC, Cao YR, Liu XF, Huang J, Hu JL, Zhao M, Guo QL, Zhang SJ, Wu XJ, Zhu DM, Zhang YY, Zhang J. Antimicrob Agents Chemother. 2013 Jul;57(7):2942-7.

Nemonoxacin (TG-873870) for treatment of community-acquired pneumonia. Lai CC, Lee KY, Lin SW, Chen YH, Kuo HY, Hung CC, Hsueh PR. Expert Rev Anti Infect Ther. 2014 Apr;12(4):401-17.

Review of nemonoxacin with special focus on clinical development. Qin X, Huang H. Drug Des Devel Ther. 2014 Jul 5;8:765-74.

Safety, tolerability, and pharmacokinetics of intravenous nemonoxacin in healthy chinese volunteers. Cao GY, Zhang J, Zhang YY, Guo BN, Yu JC, Wu XJ, Chen YC, Wu JF, Shi YG. Antimicrob Agents Chemother. 2014 Oct;58(10):6116-21.