Graul A I，Cruces E，Stringer M

·全球藥訊·
GLOBAL PHARMACEUTICAL INFORMATION

2014年全球新藥研發(fā)報告
——第一部分：新藥和生物制品（Ⅲ）

Graul A I，Cruces E，Stringer M

編者按：本刊自2013年起連續(xù)2年分期譯載了湯森路透公司獨家授權(quán)的“全球新藥研發(fā)報告”，該報告一經(jīng)刊出，就因內(nèi)容全面、資料權(quán)威、視角獨到、數(shù)據(jù)翔實、時效性強(qiáng)廣受好評。讀者紛紛來函索要單行本，眾多藥企高層對該報告也高度關(guān)注。

本期“全球藥訊”欄目繼續(xù)刊登“2014年全球新藥研發(fā)報告”第一部分。

2014的新藥批準(zhǔn)和上市年終報告顯示醫(yī)藥行業(yè)的活躍性持續(xù)保持在高位。截至2014年12月23日，共有55個新藥和生物制品首次上市。此外，29個重要的延伸性新藥（新處方、新復(fù)方或已上市藥物的新適應(yīng)證）也在2014年上市。在這些新上市的藥物中，最多的是抗感染藥物，有11個新藥和生物制品。它們大多用于多藥耐藥菌引發(fā)的感染或丙肝的治療。美國再一次成為這些新上市藥物最青睞的市場，該國是2014年半數(shù)以上新上市藥物的首選地區(qū)。不過，日本在2014年開發(fā)上市新藥的能力顯著增強(qiáng)，多年來首次超越歐盟。另一重要成果是：2014年上市的新藥和生物制品中有15個獲得罕見病用藥資格，5個獲得突破性治療藥物資格，以及3個獲得合格傳染病產(chǎn)品（QIDP)資格。另外，2014年還有19個產(chǎn)品首度獲批，將于2015年初上市。

上市新藥；新藥批準(zhǔn)；延伸性新藥；首創(chuàng)藥物

表2列出了2014年首次上市的新藥、生物制品及 其延伸性產(chǎn)品，表3為這些新藥的市場前景。

續(xù)表2

續(xù)表2

續(xù)表2

表3 2014年上市的部分新藥、生物制品及延伸性新藥的預(yù)估市場規(guī)模Table3 Estimated market size for selected new drugs and biologics and new line extensions launched in 2014

續(xù)表3

續(xù)表3

續(xù)表3

續(xù)表3

續(xù)表3

續(xù)表3

續(xù)表3

續(xù)表3

[1]Morgenthaler T I, Lee-Chiong T, Alessi C,et al.Practice parameters for the clinical evaluation and treatment of circadian rhythm sleep disorders.An American Academy of Sleep Medicine report[J].Sleep, 2007, 30(11): 1445-1459.

[2]Yamada T, Saito H, Fujieda S.Present state of Japanese cedar pollinosis: the national affliction[J].J Allergy Clin Immunol,2014, 133(3): 632-639.

[3]Lozano R, Naghavi M, Foreman K,et al.Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010[J].Lancet,2012, 380(9859):2095-2128.

[4]Coyne K S, LoCasale R J,,et al.Opioid-induced constipation in patients with chronic noncancer pain in the USA, Canada, Germany,and the UK: descriptive analysis of baseline patient-reported outcomes and retrospective chart review[J].Clinicoecon Outcomes Res,2014, 6: 269-281.

[5]IDF Diabetes Atlas, 6th edition (international Diabetes Federation, 2013)[EB/OL].http://www.idf.org/sites/default/fles/ eN_6e_Atlas_Full_0.pdf.

[6]Antimicrobial resistance: tackling a crisis for the health and wealth of nations.The review on antimicrobial resistance-chaired by Jim O’Neill.December 2014[EB/OL].http://amr-review.org/sites/default/files/ AMr%20 review%20Paper%20-%20Tackling%20a%20crisis%20for%20the%20 health%20and%20wealth%20of%20nations_1.pdf.

[7]Hepatitis C.Fact sheet No164(world Health Organization,updated April 2014)[EB/OL].http://www.who.int/mediacentre/factsheets/fs164/en/.

[8]Globocan 2012: Estimated cancer incidence, mortality and prevalence worldwide in 2012 (international Agency for research on Cancer)[EB/ OL].http://globocan.iarc.fr/Default.aspx.

[9]Polycythemia vera facts(Leukemia & Lymphoma Society, revised June 2012)[EB/OL].http://www.lls.org/content/ nationalcontent/ resourcecenter/freeeducationmaterials/mpd/pdf/polycythemiavera.pdf.

（待續(xù)）

原文來源：Drugs of Today,2015,51(1):37-87

A Report of New Drugs Research and Development in 2014——Part I:New Drugs & Biologics (III)

Graul A I, Cruces E, Stringer M

A year-end wrap-up of new drug approvals and launches reveals that activity in the pharmaceutical industry continues at a high level, with 55 new drugs and biologics introduced on their frst markets in 2014 (as of December 23,2014).Additionally, 29 important new line extensions (new formulations, new combinations or new indications for previously marketed products) also reached their frst markets during the year.The most active therapeutic group in terms of new launches was anti-infective therapies, with 11 new drugs and biologics launched, most for the treatment of multidrug-resistant bacterial infections or hepatitis C.The most active market for new launches was again the U.S., site of more than half of all new launches in 2014.However new launch activity increased considerably last year in Japan, which actually pulled ahead of the E.U.For the frst time in many years.In another important new development,15 of the new drugs and biologics launched last year had orphan drug status, 5 had breakthrough therapy designation and 3 had Qualifed Infectious Disease Product (QIDP) status.Another 19 products were approved for the frst time during the year but not yet launched by close of this article, most are slated for launch in the frst months of the new year.

new drug launch; new drug approval; line extension; frst-in-class drug

R97

A

1001-5094（2015）04-0305-16