Guselkumab

精彩内容米内网数据显示，2024年中国零售药店终端（城市实体药店+网上药店）药品销售额超过3800亿元，其中化学药占比超过51%，中成药占比超过38%，生物药占比超过9%。29个化学药销售额超过10亿元，超50亿大品种领跑，10个品种涨逾10%；中成药TOP20中有16个超10亿元，独家品种霸屏，康恩贝、太极、扬子江上榜；生物药TOP20中有7个超10亿元，创新药“称王”，2个注射剂大涨。化学药：超50亿大品种领跑，10个品种涨逾10%近年来，中国零售药店终端化学药销售额逐年上涨，2024年突破2000亿元，占药品总销售额比重超过51%。TOP20一级集团中，阿斯利康以约4.7%的市场份额稳居首位，拜耳、华润医药依次位列第二、第三，市场份额约达4%。从销售额增速看，豪森药业涨超30%，辉瑞涨超20%，阿斯利康、正大制药、石药集团、远大健康、齐鲁制药等企业均涨超10%。从产品排名看，TOP29产品销售额均超过10亿元，其中，枸橼酸西地那非片以超50亿元领跑，位列第二、第三的维生素D滴剂、葡萄糖酸钙锌口服溶液均为营养素补充剂，分别属于维生素类、矿物质补充剂，销售额分别超过40亿元、30亿元。2024年中国零售药店终端销售额超10亿元的化学药注：标红为近5年来销售额持续正增长，标*为独家品种来源：米内网综合数据库从销售额增速看，19个品种呈正增长，甲磺酸阿美替尼片、达格列净片、沙库巴曲缬沙坦钠片涨幅均超过30%，其中甲磺酸阿美替尼片为29个超10亿品种中唯一一款独家品种；10个品种近5年来保持持续正增长，其中玻璃酸钠滴眼液销售额增速均达两位数。玻璃酸钠滴眼液是治疗干眼症的主要药物之一，目前已有50余家企业拥有该产品生产批文，其中46家已过评或视同过评。米内网数据显示，2023年玻璃酸钠滴眼液在中国零售药店终端的销售额突破10亿元，2024年进一步增长至超15亿元，在眼科化药产品排名中稳居首位。近年来中国零售药店终端玻璃酸钠滴眼液销售情况（单位：万元）来源：米内网格局数据库甲磺酸阿美替尼片是豪森药业自主研发的一款国产1类新药，目前已被纳入国家医保乙类目录，2023年在中国零售药店终端的销售额突破10亿元，同比增长38.86%；2024年进一步增长至超15亿元，同比增长39.14%。在抗肿瘤化药产品排名中，甲磺酸阿美替尼片近年来稳居第二位。近年来中国零售药店终端甲磺酸阿美替尼片销售情况（单位：万元）来源：米内网格局数据库中成药：11个独家品种霸屏，片仔癀、太极上榜2024年中国零售药店终端中成药销售额突破1500亿元，占药品总销售额比重超过38%。TOP20一级集团中，华润医药稳居首位，市场份额接近10%；国药集团、北京同仁堂、广药集团依次位列第二、第三、第四，市场份额均超过4%。从销售额增速看，真奥药业涨幅接近50%，华润医药、云南白药、仲景宛西制药等亦呈正增长。TOP20产品中有16个销售额超过10亿元，其中阿胶以超55亿元蝉联榜首，安宫牛黄丸以超47亿元紧接在后，感冒灵颗粒以超32亿元排位第三，独家品种片仔癀以超20亿元排位第四，2家企业在销的藿香正气口服液以超19亿元排位第五。2024年中国零售药店终端中成药TOP20产品注：标红为销售额增速超10%，标*为独家品种来源：米内网综合数据库阿胶近年来在中国零售药店终端的销售额有所波动，但始终稳居补气补血中成药销冠宝座。目前有40家企业的阿胶在销，从2024年厂家格局看，东阿阿胶以约49%的市场份额领跑，山东福牌阿胶以约25%的市场份额紧接其后，山东宏济堂制药以约13%的市场份额排位第三。此外，山东东滕阿胶表现亮眼，2024年销售额增速达135.45%。在2024年中国零售药店终端肝病中成药产品排名中，片仔癀药业的片仔癀稳居首位，市场份额超过46%，其另一款产品片仔癀胶囊排位第五。肝病用药是片仔癀药业的重点业务，2024年公司的肝病用药大卖超过53亿元，再创新高。2024年中国零售药店终端肝病中成药TOP5产品来源：米内网格局数据库TOP20产品中有11个为独家品种（含独家剂型），包括片仔癀（片仔癀药业）、京都念慈菴蜜炼川贝枇杷膏（京都念慈菴总厂）、复方阿胶浆（东阿阿胶）、肠炎宁片（康恩贝）、急支糖浆（太极集团）、蓝芩口服液（扬子江药业）、云南白药气雾剂（云南白药）、消痛贴膏（奇正藏药）、蒲地蓝消炎口服液（济川药业）等。生物药：创新药“称王”，2大注射剂涨逾50%近年来，中国零售药店终端生物药销售额均以两位数的增速持续上涨，2024年超过360亿元，占药品总销售额比重超过9%。TOP20一级集团中，诺和诺德稳居首位，销售额超过38亿元，占比突破10%；罗氏紧接其后，销售额超过23亿元；默沙东排位第三，销售额超过18亿元。从销售额增速看，正大制药涨超130%，诺和诺德、默沙东、诺华、强生、赛诺菲、信达生物、安进生物等均有两位数增长。TOP20产品中有7个年销超10亿元，其中人血白蛋白稳居首位，销售额超过28亿元；司美格鲁肽注射液以超20亿元紧接在后，同比增长约57%，较2023年提升1个位次；帕博利珠单抗注射液以超18亿元排位第三，同比增长约15%。2024年中国零售药店终端销售额生物药TOP20产品注：标红为销售额增速超10%，标*为独家品种来源：米内网综合数据库TOP20产品中有11个为独家品种（含独家剂型），其中有6个销售额增速均达两位数，分别为诺和诺德的司美格鲁肽注射液（+57%）、默沙东的帕博利珠单抗注射液（+15%）、诺华的司库奇尤单抗注射液（+28%）、赛诺菲的度普利尤单抗注射液（+35%）、强生的古塞奇尤单抗注射液（+88%）、信达生物的信迪利单抗注射液（+24%）。司美格鲁肽注射液是一款新型长效胰高糖素样肽-1(GLP-1)类似物，2021年4月获批进入中国市场，2023年在中国零售药店终端的销售额突破10亿元，2024年突破20亿元，市场潜力较大。目前国内已有超过20家企业在布局司美格鲁肽生物类似药，其中杭州九源基因、丽珠集团新北江制药、齐鲁制药、中美华东等企业的产品已报产在审。近年来中国零售药店终端司美格鲁肽注射液销售情况（单位：万元）来源：米内网格局数据库从药物类型看，20个产品中有14个为抗体药物，其中帕博利珠单抗注射液、度伐利尤单抗注射液、纳武利尤单抗注射液、替雷利珠单抗注射液、信迪利单抗注射液均属于PD-(L)1单抗，司库奇尤单抗注射液、度普利尤单抗注射液、古塞奇尤单抗注射液均为白细胞介素(IL)的“家庭成员”，卡度尼利单抗注射液为唯一一款双抗药物等。卡度尼利单抗注射液是康方生物开发的一款PD-1/CTLA-4双抗药物，首个适应症于2022年7月获批上市，目前已通过谈判纳入国家医保乙类目录，2023年在中国零售药店终端的销售额突破10亿元，2024年进一步增长至超11亿元。近年来中国零售药店终端卡度尼利单抗注射液销售情况（单位：万元）来源：米内网格局数据库注：米内网《中国城市实体药店药品终端竞争格局》，统计范围是：全国地级及以上城市实体药店，不含县乡村药店；《中国网上药店药品终端竞争格局》，统计范围是：全国网上药店所有药品数据，包括天猫、京东等第三方平台及私域平台上所有网上药店药品数据；上述销售额以产品在终端的平均零售价计算。免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦

TREMFYA ® demonstrated two and a half times greater ability to inhibit joint structural damage versus placebo in the Phase 3b APEX study More than 40% of TREMFYA®-treated patients across both dose groups achieved ACR50 at Week 24 Improvement in both joint and skin symptoms reinforce TREMFYA® as a first-line treatment option with a proven safety profile for adults with active psoriatic arthritis BARCELONA, June 11, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced findings from the Phase 3b APEX study showing that TREMFYA® (guselkumab) significantly reduced both signs and symptoms of active psoriatic arthritis (PsA) and inhibited progression of joint structural damage at 24 weeks compared to placebo.1 These data from a late-breaking abstract are among the 30 oral and poster presentations Johnson & Johnson is highlighting at the European Alliance of Associations for Rheumatology (EULAR) 2025 Congress. In the Phase 3b APEX study, TREMFYA® significantly inhibited progression of joint structural damage, including joint erosions and space narrowing, in patients with active PsA at Week 24 as assessed by the PsA modified van der Heijde-Sharp (vdH-S) score. The mean change from baseline to Week 24 in the modified van der Heijde-Sharp (vdH-S) score was 0.55 and 0.54 for patients receiving TREMFYA® every four weeks (Q4W) and every eight weeks (Q8W) respectively, compared with 1.35 in the placebo group (p=0.002 for Q4W and p<0.001 for Q8W dosing versus placebo, respectively). In the two TREMFYA® dose groups, 67% (Q4W) and 63% (Q8W) of patients experienced no radiographic progression, versus 53% in the placebo group.a,1 "In psoriatic arthritis, joint damage can begin early and progress quickly if left untreated, significantly impacting a patient's ability to move, work and maintain independence," said Philip J. Mease, MD, Director of Rheumatology Research at the Swedish Medical Center and study investigator.b "The results of the APEX study are promising as the data show guselkumab to be the only IL-23 inhibitor in its class that has inhibited the progression of structural damage in patients, providing new clinical insights for the psoriatic community and underscoring the need for safe, effective options that address the full burden of disease." TREMFYA® also improved both joint and skin symptoms in patients with active PsA. Significantly greater proportions of TREMFYA®-treated patients (67% for Q4W and 68% for Q8W) achieved American College of Rheumatology response criteria (ACR20c) at Week 24 versus 47% receiving placebo (p<0.001) More than twice as many patients treated with TREMFYA® achieved ACR50c (41% for Q4W and 42% for Q8W) versus 20% receiving placebo at Week 24.1 In assessing skin clearance, greater proportions of TREMFYA®-treated patients (73% for Q4W and 68% for Q8W) achieved an Investigator's Global Assessment (IGA) score of 0/1d (clear or almost clear skin) at Week 24 versus 31% receiving placebo.1 The data from the APEX study were consistent with the well-established safety profile of TREMFYA®, with no new safety signals identified.1 "With these results from the APEX study, TREMFYA has set a new bar for joint preservation as the only IL-23 inhibitor proven to significantly inhibit structural damage in active psoriatic arthritis, an inflammatory arthritis that can develop in up to 30% of people living with psoriasis," said Terence Rooney, Vice President, Rheumatology Disease Area Leader, Johnson & Johnson Innovative Medicine. "The efficacy and safety profile of TREMFYA offers psoriatic healthcare providers and patients an innovative option for disease control." TREMFYA® is the first and only fully-human, dual-acting monoclonal antibody approved to treat PsA that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including active psoriatic arthritis.2,3,4,5,6 Editor's notes: a. TREMFYA is not approved for Q4W dosing in the U.S. b. Dr. Philip J. Mease is a paid consultant for Johnson & Johnson. He has not been compensated for any media work.c. ACR20/50 response is defined as both at least 20/50 percent improvement from baseline in the number of tender and number of swollen joints, and a 20/50 percent improvement from baseline in three of the following five criteria: patient GA, physician GA, functional ability measure (HAQ-DI), patient-reported pain using a visual analog scale, and erythrocyte sedimentation rate or C-reactive protein.7d. The IGA is a five-point scale with a severity score ranging from 0 to 4, where 0 indicates clear, 1 is minimal, 2 is mild, 3 is moderate and 4 indicates severe disease.8 ABOUT THE APEX STUDY (NCT04882098) APEX is a multicenter, randomized, double-blind, placebo-controlled study in patients with active PsA who are biologic naïve and have had an inadequate response to standard therapies (e.g., csDMARDs, apremilast, and/or NSAIDs). The treatment duration includes a 24-week, double-blind, placebo-controlled period, followed by a 24-week active treatment period, followed by a 12-week safety follow-up period. For patients who agree to enter the long-term extension, an additional 2 years of active treatment period is scheduled prior to the final safety follow-up.9 ABOUT PSORIATIC ARTHRITIS Psoriatic arthritis (PsA) is a chronic, immune-mediated, inflammatory disease characterized by peripheral joint inflammation, enthesitis (pain where the bone, tendon and ligament meet), dactylitis (a type of inflammation in the fingers and toes that can result in a swollen, sausage-like appearance), axial disease and the skin lesions associated with plaque psoriasis (PsO).10,11,12 The disease causes pain, stiffness and swelling in and around the joints; it commonly appears between the ages of 30 and 50, but can develop at any age.13 Nearly half of patients with PsA experience moderate fatigue and about one-third suffer from severe fatigue as measured by the modified fatigue severity scale.14 In patients with PsA, comorbidities such as obesity, cardiovascular disease, anxiety and depression are often present.15 Studies show up to 30% of people with plaque PsO also develop PsA.11 ABOUT TREMFYA® (guselkumab) Developed by Johnson & Johnson, TREMFYA® is the first approved fully-human, dual-acting monoclonal antibody designed to neutralize inflammation at the cellular source by blocking IL-23 and binding to CD64 (a receptor on cells that produce IL-23). Findings for dual-acting are limited to in vitro studies that demonstrate guselkumab binds to CD64, which is expressed on the surface of IL-23 producing cells in an inflammatory monocyte model. The clinical significance of this finding is not known. TREMFYA® is a prescription medicine approved in the U.S. to treat: adults with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light). adults with active psoriatic arthritis. adults with moderately to severely active ulcerative colitis. adults with moderately to severely active Crohn's disease.16 TREMFYA® is approved in Europe, Canada, Japan, and a number of other countries for the treatment of adults with moderate-to-severe plaque psoriasis and for the treatment of adults with active psoriatic arthritis. Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA®. For more information, visit: www.tremfya.com. IMPORTANT SAFETY INFORMATION What is the most important information I should know about TREMFYA®? TREMFYA® is a prescription medicine that may cause serious side effects, including: Serious Allergic Reactions. Stop using TREMFYA® and get emergency medical help right away if you develop any of the following symptoms of a serious allergic reaction: o fainting, dizziness, feeling lightheaded (low blood pressure) o swelling of your face, eyelids, lips, mouth, tongue or throat o trouble breathing or throat tightness o chest tightness o skin rash, hives o itching Infections. TREMFYA® may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with TREMFYA® and may treat you for TB before you begin treatment with TREMFYA® if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with TREMFYA®. Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including: o fever, sweats, or chills o muscle aches o weight loss o cough o warm, red, or painful skin or sores on your body different from your psoriasis o diarrhea or stomach pain o shortness of breath o blood in your phlegm (mucus) o burning when you urinate or urinating more often than normal Liver problems. With the treatment of Crohn's disease or ulcerative colitis, your healthcare provider will do blood tests to check your liver before and during treatment with TREMFYA®. Your healthcare provider may stop treatment with TREMFYA® if you develop liver problems. Tell your healthcare provider right away if you notice any of the following symptoms: o unexplained rash o vomiting o tiredness (fatigue) o yellowing of the skin or the whites of your eyes o nausea o stomach pain (abdominal) o loss of appetite o dark urine Do not use TREMFYA® if you have had a serious allergic reaction to guselkumab or any of the ingredients in TREMFYA®. Before using TREMFYA®, tell your healthcare provider about all of your medical conditions, including if you: have any of the conditions or symptoms listed in the section "What is the most important information I should know about TREMFYA®?" have an infection that does not go away or that keeps coming back. have TB or have been in close contact with someone with TB. have recently received or are scheduled to receive an immunization (vaccine). You should avoid receiving live vaccines during treatment with TREMFYA®. are pregnant or plan to become pregnant. It is not known if TREMFYA® can harm your unborn baby.Pregnancy Registry: If you become pregnant during treatment with TREMFYA®, talk to your healthcare provider about registering in the pregnancy exposure registry for TREMFYA®. You can enroll by visiting www.mothertobaby.org/ongoing-study/tremfya-guselkumab, by calling 1-877-311-8972, or emailing MotherToBaby@health.ucsd.edu. The purpose of this registry is to collect information about the safety of TREMFYA® during pregnancy. are breastfeeding or plan to breastfeed. It is not known if TREMFYA® passes into your breast milk. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. What are the possible side effects of TREMFYA®? TREMFYA® may cause serious side effects. See "What is the most important information I should know about TREMFYA®?" The most common side effects of TREMFYA® include: respiratory tract infections, headache, injection site reactions, joint pain (arthralgia), diarrhea, stomach flu (gastroenteritis), fungal skin infections, herpes simplex infections, stomach pain, and bronchitis. These are not all the possible side effects of TREMFYA®. Call your doctor for medical advice about side effects. Use TREMFYA® exactly as your healthcare provider tells you to use it. Please read the full Prescribing Information, including Medication Guide, for TREMFYA® and discuss any questions that you have with your doctor. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Dosage Forms and Strengths: TREMFYA® is available as 100 mg/mL and 200 mg/2mL for subcutaneous injection and as a 200 mg/20 mL (10 mg/mL) single dose vial for intravenous infusion. ABOUT JOHNSON & JOHNSON At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at https://www.jnj.com/ or at https://innovativemedicine.jnj.com/ Follow us at @JNJInnovMed. Janssen Research & Development, LLC and Janssen Biotech, Inc. are Johnson & Johnson companies. CAUTIONS CONCERNING FORWARD-LOOKING STATEMENTS This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of nipocalimab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. REFERENCES 1 Mease PJ, et al. Inhibition of structural damage progression with guselkumab, a selective IL-23i, in participants with active PsA: Results through Week 24 of the phase 3b, randomized, double-blind, placebo-controlled APEX study. Presented at EULAR 2025, June 11-14. LB0010.2 Atreya R, Abreu MT, Krueger JG, et al. Guselkumab, an IL-23p19 subunit-specific monoclonal antibody, binds CD64+ myeloid cells and potentially neutralizes IL-23 produced from the same cells. Poster presented at: 18th Congress of the European Crohn's and Colitis Organization (ECCO); March 1-4, 2023; Copenhagen, Denmark. Poster P504.3 Kreuger JG, Eyerich K, Kuchroo VK. Il-23 past, present, and future: a roadmap to advancing IL-23 science and therapy. Front Immunol. 2024; 15:1331217. doi:10.3389/fimmu.2024.1331217.4 TREMFYA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.5 Skyrizi® [Prescribing Information]. North Chicago, IL: AbbVie, Inc.6 Omvoh™ [Prescribing Information]. Indianapolis, IN: Eli Lilly and Company.7 Felson, D. T., & LaValley, M. P. The ACR20 and defining a threshold for response in rheumatic diseases: too much of a good thing. Arthritis Research & Therapy, 2014:16(1), 101. https://doi.org/10.1186/ar44288 Simpson E, Bissonnette R, Eichenfield LF, et al. 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Available at: https://www.arthritis.org/health-wellness/about-arthritis/related-conditions/physical-effects/enthesitis-and-psa. Accessed March 2025.13 National Psoriasis Foundation. About Psoriatic Arthritis. Available at: https://www.psoriasis.org/about-psoriatic-arthritis/. Accessed March 2025.14 Husted J.A., et al. Occurrence and correlates of fatigue in psoriatic arthritis. Ann Rheum Dis, 2008:68(10), 1553–1558. Available at: https://doi.org/10.1136/ard.2008.098202. Accessed March 2025.15 Haddad A., Zisman D. Comorbidities in Patients with Psoriatic Arthritis. Rambam Maimonides Med J 2017 Jan 30;8(1):e0004. Available at: https://doi.org/10.5041/RMMJ.10279. Accessed March 2025.16 TREMFYA® Prescribing Information. Available at: https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/TREMFYA-pi.pdf Accessed March 2025. Media contact:Craig Stoltz cstoltz@its.jnj.com Investor contact:Lauren Johnsoninvestor-relations@its.jnj.com View original content to download multimedia:https://www.prnewswire.com/news-releases/new-data-show-tremfya-guselkumab-is-the-only-il-23-inhibitor-proven-to-significantly-inhibit-progression-of-joint-structural-damage-in-active-psoriatic-arthritis-302475588.html SOURCE Johnson & Johnson