ŵ»ª¿ÉÉÆͦ£¨Ë¾¿âÆæÓȵ¥¿¹£©Ç¿Ö±ÐÔ¼¹ÖùÑ×ÊÊÓ¦Ö¢»ñÅú

ÉϺ£2020Äê4ÔÂ28ÈÕ /ÃÀͨÉç/ -- ½ñÌ죬ŵ»ªÖÆÒ©£¨Öйú£©Ðû²¼£¬¿ÉÉÆͦ ^®£¨Ë¾¿âÆæÓȵ¥¿¹£©»ñµÃ¹ú¼ÒÒ©Æ·¼à¶½¹ÜÀí¾ÖÅú×¼£¬ÓÃÓÚ³£¹æÖÎÁÆÁÆЧǷ¼ÑµÄÇ¿Ö±ÐÔ¼¹ÖùÑ׵ijÉÄ껼Õß¡£ÕâÊÇ¿ÉÉÆͦ ^®¼Ì2019Äê3ÔÂÅú×¼ÓÃÓÚÖÎÁÆÖÐÖضȰ߿é×´Òøм²¡Ö®ºóÔÚÖйú»ñÅúµÄµÚ¶þ¸öÊÊÓ¦Ö¢£¬Ò²ÊÇÄ¿Ç°¹úÄÚÊ׸öÇÒΨһ±»Åú×¼ÓÃÓÚÖÎÁÆÇ¿Ö±ÐÔ¼¹ÖùÑ׵İ׽éËØÀàÒÖÖƼÁ¡£

Ñо¿·¢ÏÖ£¬°×½éËØ-17A£¨IL-17A£©ÊÇ´Ù½øÑ×Ö¢¼¶Áª·´Ó¦¡¢Ð¹ÇÉú³É¡¢×îÖÕµ¼Ö¹ÇÈںϺÍÍêÈ«Ç¿Ö±µÄÖØÒª½éÖÊ¡£×÷ΪĿǰȫÇòÊ׸öÇÒΨһȫÈËÔ´IL-17AÒÖÖƼÁ£¬¿ÉÉÆͦ^®¿ÉÌØÒìÐÔ×è¶ÏÈκÎÀ´Ô´µÄIL-17A£¬ÓÐЧ¿ØÖÆÑ×Ö¢²¢ÒÖÖÆйÇÐγɣ¬¶à²ãµ÷¿Ø²¡Àí½øÕ¹¡£

ŵ»ªÖÆÒ©£¨Öйú£©×ܲÃÕÅӱŮʿ±íʾ£º¡°Îҷdz£¸ßÐË¿ÉÉÆͦ^®ÄÜ»ñÅúÓÃÓÚÖйúÇ¿Ö±ÐÔ¼¹ÖùÑ×»¼ÕßµÄÖÎÁÆ£¬ÕâÒ²±êÖ¾×Åŵ»ªÔÚÖйú½øÈë·çʪ¼²²¡ÁìÓò¡£Ç¿Ö±ÐÔ¼¹ÖùÑ׶àÆð²¡ÓÚÖÐÇàÄ꣬¼²²¡ÑÏÖØÓ°ÏìÁË»¼ÕßµÄÐж¯ÄÜÁ¦ºÍÉú»îÖÊÁ¿¡£¿ÉÉÆͦ^®Ç¿Ö±ÊÊÓ¦Ö¢µÄ»ñÅúÓÐÍûΪÊý°ÙÍòÖйúÇ¿Ö±»¼Õß´øÀ´È«ÐµÄÖÎÁÆ·½°¸ºÍ½¡¿µÏ£Íû£¬Ê¹Åµ»ª´´ÐÂÒ©Îï»Ý¼°¸ü¹ã·ºµÄÖйú»¼Õß¡£¡±

Ç¿Ö±ÐÔ¼¹ÖùÑ×¼²²¡¸ºµ£³ÁÖØ£¬¡°ÒÖÖƹǽṹ½øÕ¹¡±ÖÎÁÆÐèÇóؽ´ýÂú×ã

Ç¿Ö±ÐÔ¼¹ÖùÑ×ÊÇÒ»ÖÖÂýÐÔÑ×Ö¢ÐÔ¼²²¡£¬ÊôÓÚ·çʪÃâÒß²¡¡£ÔÚÎÒ¹ú£¬Ç¿Ö±ÐÔ¼¹ÖùÑ×»¼²¡ÂÊԼΪ0.3%¹£¬»¼²¡ÈËÊýÔ¼ÔÚ300Íò×óÓÒ²¡£·¢²¡ÄêÁäͨ³£ÔÚ13-31Ë꣬ÇÒ¶à¼ûÓÚÄÐÐÔ¹¡£Êý¾ÝÏÔʾ^3,4£¬Ô¼80%µÄÇ¿Ö±ÐÔ¼¹ÖùÑ×»¼Õß´æÔÚ¼¹ÖùÌÛÍ´ºÍÆ£ÀÍÖ¢×´£¬³¿½©±ÈÀý¸üÊǸߴï90%¡£µ«ÕæÕý¿ÉŵĻ¹ÊÇËü¿ÉÄÜ´øÀ´µÄ¹Ç½á¹¹ËðÉË¡£

Õý³£Çé¿öÏ£¬ÈËÌå¼¹Öù×µÌåÓÉÈáÈ͵ÄÈÍ´øÁ¬½Ó£¬Òò´ËÑü±³²¿¿ÉÒÔÁé»îÔ˶¯¡£ÈÍ´øÓëÉÏÏÂ×µÌå¹ÇµÄÁ¬½Óµã±»³ÆΪ¸½×ŵ㣬¶øÇ¿Ö±ÐÔ¼¹ÖùÑ×»¼Õߵĸ½×ŵ㴦»á·´¸´·¢ÉúÑ×Ö¢£¬Éú³ö²¡ÀíÐÔйǡ£½¡¿µµÄÈÍ´øÖ𽥿ªÊ¼¹Ç»¯£¬²úÉú¹Ç׸¡¢Á¬³É¹ÇÇÅ£¬×îÖÕµ¼Ö¼¹ÖùÈÚºÏÇ¿Ö±ºÍ²»Í¬³Ì¶ÈµÄ²Ð¼²¡£Ò»ÏîÖйúÑо¿ÏÔʾ⁵£¬³¬¹ý65%µÄ»¼Õß°éÓÐÖÁÉÙÒ»¸öÈÍ´ø¹Ç׸£¬ËµÃ÷Ï൱±ÈÀýµÄ»¼Õ߶¼´æÔڹǽṹËðÉËÒÔ¼°½øÒ»²½¼ÓÖصķçÏÕ¡£

301Ò½Ôº·çʪ¿ÆÖ÷ÈÎҽʦ»Æ·é½ÌÊÚ½éÉÜ£º¡°Ç¿Ö±ÐÔ¼¹ÖùÑ××÷ΪһÖÖÑ×Ö¢ÐÔ¼²²¡£¬ÒÖÖÆÑ×֢ˮƽºÜÖØÒª£¬Ò²ÊÇÄ¿Ç°ÁÙ´²Ò©ÎïÖÎÁƵÄÖص㡣µ«½üЩÄêÓÐÑо¿·¢ÏÖ£¬¼´Ê¹Ñ×֢ˮƽµÃµ½¿ØÖÆ£¬ÒÀÈ»»á´æÔڹǽṹËðÉ˽øÒ»²½¶ñ»¯µÄÇé¿ö¡£ÈçºÎË«¹ÜÆëÏ£¬ÌرðÊÇ¡®ÒÖÖƹǽṹ½øÕ¹¡¯³ÉΪÁËؽ´ýÂú×ãµÄÖÎÁÆÐèÇ󡣡±

ȫаеãIL-17A¡°Ãé×¼¡±¹Ç½á¹¹½øÕ¹£¬Íƶ¯ÖйúÇ¿Ö±ÐÔ¼¹ÖùÑ×ÉúÎïÖƼÁÖÎÁÆͦ½øÈ«ÐÂʱ´ú

Ç¿Ö±ÐÔ¼¹ÖùÑ×´Ó·¢²¡µ½×îÖÕ¹ÇÈںϣ¬»á¾­Àú¼¸´ó½×¶Î£º¹ÇÑ×-Ö¬·¾³Á»ý-¹Ç׸-¹ÇÇÅ-¹ÇÈںϡ£¡°Ð¹ÇÐγɡ±ÊÇÕû¸ö²¡³Ì½øÕ¹µÄ²¡Àí»ù´¡£¬¶øIL-17AÊǸöÖØÒªµÄ¡°ÖúÍÆÆ÷¡±¡£Ò»·½Ã棬ËüÊǸ½×ŵãÑ×·¢²¡¹ý³ÌÖеĹؼüϸ°ûÒò×ÓºÍÑ×Ö¢½éÖÊ£¬¿É½øÒ»²½´Ù½øÑ×Ö¢¼¶Áª·´Ó¦£»ÁíÒ»·½Ã棬ËüÊǹÇÖØËܵĹؼü½éÖÊ£¬²ÎÓëйÇÐγÉ⁶¡£Òò´Ë£¬ÒÖÖÆIL-17A¿É×è¶ÏÑ×֢ͨ·⁷¡¢»º½âÌÛÍ´^8,9,10£¬Í¬Ê±ÒÖÖÆйÇÐγÉÀ´×èÖ¹¹Ç½á¹¹½øÒ»²½ËðÉ˹¹¡£

×÷ΪĿǰȫÇòÊ׸öÇÒΨһȫÈËÔ´IL-17AÒÖÖƼÁ£¬¶àÏîÁÙ´²Ñо¿Ö¤ÊµÁË¿ÉÉÆͦ^®µÄ¶àÖØ»ñÒ棺

• ¿ìËÙ»º½â±³Í´¡¢³¿½©ºÍÆ£·¦Ö¢×´£ºMEASURE 2Ñо¿½á¹ûÏÔʾ^12,13£¬»¼Õß½ÓÊÜ150mg¿ÉÉÆͦ^®ÖÎÁÆ4ÖÜ£¬±³Í´½Ï»ùÏ߸ÄÉÆ39%£¨°²Î¿¼Á×飺15%£©£¬³¿½©½Ï»ùÏ߸ÄÉÆ34.4%£¨°²Î¿¼Á×飺14.8%£©£¬Æ£ÀͽϻùÏ߸ÄÉÆ28%£¨°²Î¿¼Á×飺8%£©¡£
• ÒÖÖÆйÇÐγɣ¬×èÖ¹½á¹¹ËðÉË£º³ÖÐø½ÓÊÜ¿ÉÉÆͦ^®ÖÎÁÆ£¬97%»ùÏßÎÞ¹Ç׸»¼ÕߺÍ73%»ùÏßÓйÇ׸»¼Õß2ÄêÄÚÎÞÐÂÉú¹Ç׸¹⁴£¬½ü80%»¼Õß¼¹ÖùËðÉËÔÚ4ÄêÄÚδ³öÏÖ¶ñ»¯¹⁵¡£
• Á¼ºÃÕûÌ尲ȫÐÔºÍÄÍÊÜÐÔ£ºIL-17A´¦ÓÚÕû¸öÑ×֢ͨ·µÄÏÂÓΣ¬ÇÒÈ«ÈËÔ´ÖƱ¸¹¤ÒÕ½µµÍÁ˲»Á¼·´Ó¦·çÏÕ¡£Ñо¿ÏÔʾ£¬¾­¿ÉÉÆͦ^®ÖÎÁƵĻ¼ÕßÉÐÎÞ½áºËÒ׸ÐÐÔÔö¼ÓµÄ±¨¸æ¹⁶£¬ÇÒÄ¿Ç°ÉÐδ¼û¾­¿ÉÉÆͦ^®ÖÎÁƳöÏÖÒÒ¸ÎÔÙ¼¤»îµÄÏà¹Ø±¨µÀ¹⁷£¬5Ä꿹ҩ¿¹Ìå·¢ÉúÂÊ<1%¹⁸¡£

×÷Ϊ˾¿âÆæÓȵ¥¿¹ÖйúIIIÆÚÁÙ´²Ñо¿¸ºÔðÈË£¬»Æ·é½ÌÊÚ½éÉÜ£º¡°Ë¾¿âÆæÓȵ¥¿¹µÄ³öÏÖÎÞÒÉΪ»¼ÕßÌṩÁËÒ»¸öȫеÄÖÎÁÆÑ¡ÔñºÍÏ£Íû£¬Ò²ÈÃÎÒÃǶÔIL-17AÕâһаеãÔÚÇ¿Ö±ÐÔ¼¹ÖùÑ×ÁìÓòµÄÁÙ´²±íÏÖºÍDZÁ¦³äÂúÆÚ´ý¡£Ï£Íû¿´µ½¸ü¶àÖйú»¼ÕßÄÜ»ñÒæÓÚÐÂÒ»´úµÄ´´ÐÂÒ©Î¡±

Ä¿Ç°£¬¿ÉÉÆͦ^®ÒÑÔÚ°üÀ¨Å·Ã˹ú¼ÒºÍÃÀ¹úÔÚÄڵĶà¸ö¹ú¼ÒºÍµØÇøÉÏÊУ¬Åú×¼ÓÃÓÚÖÎÁÆÒøм²¡¡¢Òøм²¡¹Ø½ÚÑ×¼°Ç¿Ö±ÐÔ¼¹ÖùÑ×^19,20,21,22£¬ÓµÓÐ5Äê³ÖÐøÐÔÁÆЧºÍ°²È«ÐÔÊý¾ÝÖ§³Ö^23,24,25£¬»Ý¼°È«Çò³¬¹ý30Íò»¼Õß²⁶¡£

*Òøм²¡¹Ø½ÚÑ×ÊÊÓ¦Ö¢ÉÐδÔÚÖйú´ó½»ñÅú¡£
**ÓûÁ˽â¸ü¶àÓйؿÉÉÆͦ^®£¨Ë¾¿âÆæÓȵ¥¿¹£©²úÆ·ÐÅÏ¢¼°°²È«ÐÔÊý¾Ý£¬ÇëÇ°Íùŵ»ªÖйú¹ÙÍø£¨www.novartis.com.cn£©ËÑË÷¡°¿ÉÉÆͦ¡±»ò¡°Ë¾¿âÆæÓȵ¥¿¹¡±»ñÈ¡´¦·½ÐÅÏ¢¡£

¹ÖлªÒ½Ñ§»á·çʪ²¡Ñ§·Ö»á. Ç¿Ö±ÐÔ¼¹ÖùÑ×Õï¶Ï¼°ÖÎÁÆÖ¸ÄÏ. Öйú·çʪ²¡Ñ§ÔÓÖ¾£¬2010£¬14(8):557-560.
²¸ù¾Ý¹ú¼Òͳ¼Æ¾Ö¹ÙÍø¹«²¼µÄ2010ÄêµÚÁù´ÎÈË¿ÚÆÕ²éÊý¾Ý£¬ÎÒ¹ú³ÉÄêÈË¿ÚÊýÔ¼10.5ÒÚ¡£ÒÔ´ËÊý¾ÝΪ»ù´¡½øÐпïËã¡£
³Ward MM. Arthritis Care Res. 1999:12(4):247-255.
⁴Druce KL et al. Arthritis Res Ther. 2018;20(l):96.
⁵Í¿Áøµ¤ µÈ£¬¡¶ÖÐɽ´óѧѧ±¨£ºÒ½Ñ§¿Æѧ°æ¡·2015Äê µÚ1ÆÚ
⁶Lories R, Melones1B. Nature Medicine 2012-18:1018-19
⁷Patel DD, et al. Ann Rheum Dis. 2013;72 (Suppl 2), ii116-23.
⁸Moynes DM et al. Brain Behav Immun. 2014 Oct;41:1-9.
⁹Bidad K et al. Nat Rev Rheumatol. 2017 Jul;13(7):410-420.
¹⁰Sun C et al. Mol Med Rep. 2017 Jan;15(1):89-96.
¹¹Koenders MI, et al. Drug Des Devel Ther. 2016 Jun 24;102069-80.
¹²Deodhar A,et al. Clin Exp Rheumatol. 2019 Mar-Apr;37(2):260-269.
¹³Marzo-Ortega et al. 2019 ACR Annual Meeting. Poster 1504
¹⁴Braun J et al. Ann Rheum Dis. 2017;76(6):1070-1077 and Supplementary Tables
¹⁵Braun J et al. Rheumatology (Oxford). 2019;58(5):859-868.
¹⁶Hannah A. Blair. Drugs (2019) 79:433 443
¹⁷PubMed¼ìË÷£¨201501-202002£©½á¹û½Øͼ
¹⁸Reich K et al. J Eur Acad Dermatol Venereol. 2019;33(9):1733-1741.
¹⁹Novartis Europharm Limited. Cosentyx (secukinumab): Summary of Product Characteristics. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003729/human_med_001832.jsp&mid=WC0b01ac058001d124 [Last accessed: January 2020].
²⁰Girolomoni G, et al. Psoriasis: Rationale for targeting interleukin-17. Br J Dermatol 2012;167:717 724.
²¹Sieper J, et al. The IL-23 IL-17 pathway as a therapeutic target in axial spondyloarthritis. Nat Rev Rheumatol 2019; 15:747 757.
²²Brembilla NC, Senra L, Boehncke W-H. The IL-17 Family of Cytokines in Psoriasis: IL-17A and Beyond. Front. Immunol. 9:1682. doi: 10.3389/fimmu.2018.01682.
²³Baraliakos X, et al. Long-term evaluation of secukinumab in ankylosing spondylitis: 5-year efficacy and safety results from a Phase 3 trial. Presented as a late-breaking abstract at the American College of Rheumatology Annual Meeting; October 19 24, 2018;Chicago, IL.
²⁴Bissonnette R, et al. Secukinumab demonstrates high sustained efficacy and a favorable safety profile through 5 years of treatment in moderate to severe psoriasis. J Eur Acad Dermatol Venereol 2018;32:1507 1514.
²⁵Mease PJ, et al. Secukinumab provides sustained improvements in the signs and symptoms of psoriatic arthritis: Final 5-year results from the Phase 3 FUTURE 1 study. ACR Open Rheumatol 2019. doi: 10.1002/acr2.11097 [Epub ahead of print].
²⁶Novartis data on file.

Disclaimer

This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as ¡°potential,¡± ¡°can,¡± ¡°will,¡± ¡°plan,¡± ¡°may,¡± ¡°could,¡± ¡°would,¡± ¡°expect,¡± ¡°anticipate,¡± ¡°seek,¡± ¡°look forward,¡± ¡°believe,¡± ¡°committed,¡± ¡°investigational,¡± ¡°pipeline,¡± ¡°launch,¡± or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political and economic conditions; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG¡¯s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

Ïà¹ØÈÈ´ÊËÑË÷£º