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The first and only dual-acting interleukin-23 inhibitor approved in active ulcerative colitis, TREMFYA® showed highly statistically significant rates of endoscopic remission at one year in the pivotal QUASAR program1,2,3,4,5 TREMFYA® is now approved for the treatment of plaque psoriasis, active psoriatic arthritis and ulcerative colitis HORSHAM, Pa., Sept. 11, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug Administration (FDA) has approved TREMFYA® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC), a chronic disease of the large intestine in which the lining of the colon becomes inflamed. TREMFYA® is the first and only approved fully-human, dual-acting monoclonal antibody 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 UC.1,2,3,4,5 "Treatment with TREMFYA resulted in significant improvement in the chronic symptoms of ulcerative colitis, and importantly, normalization in the endoscopic appearance of the intestinal lining," said David T. Rubin, MD, Director, Inflammatory Bowel Disease Center, University of Chicago Medicine, and lead investigator for the QUASAR program. "Today's approval of TREMFYA builds on the clinical and well-established safety profile of this IL-23 inhibitor and marks a significant step forward in the treatment of this chronic inflammatory disease." The UC approval is supported by data from the pivotal, ongoing Phase 2b/3 QUASAR study evaluating the efficacy and safety of TREMFYA® in adult patients with moderately to severely active UC who experienced an inadequate response or who demonstrate intolerance to conventional therapy, other biologics and/or JAK inhibitors.6 Highlights from QUASAR showed: 50% of patients receiving TREMFYA® 200 mg subcutaneous (SC) maintenance every four weeks (q4w) and 45% of patients receiving TREMFYA® 100 mg SC every eight weeks (q8w) achieved primary endpoint of clinical remission at week 44 compared to 19% placebo-treated patients (p<0.001). 34% (200 mg) and 35% (100 mg) of patients achieved endoscopic remission at one year with TREMFYA® SC maintenance therapy compared to 15% placebo-treated patients (p<0.001). "There is a significant need for new UC therapies that offer meaningful improvements in symptoms and the promise of remission, both overall clinical remission as well as delivering visible healing of the colon through endoscopic remission," said Christopher Gasink, MD, Vice President, Medical Affairs, Gastroenterology & Autoantibody, Johnson & Johnson Innovative Medicine. "In the QUASAR clinical program, TREMFYA demonstrated high reported rates of endoscopic remission at one year of treatment, continuing to raise the bar for efficacy in the treatment of this inflammatory bowel disease." For the treatment of UC, TREMFYA® is administered as a 200 mg induction dose intravenously at weeks zero, four and eight by a healthcare professional. The recommended maintenance dosage is 100 mg administered by SC injection at week 16, and every 8 weeks thereafter, or 200 mg administered by SC injection at week 12, and every 4 weeks thereafter. The SC maintenance dose can be self-administered by the patient or administered by a caregiver using TREMFYA® after proper training. Use the lowest effective recommended dosage to maintain therapeutic response. The QUASAR results reinforced the well-established safety profile of TREMFYA® including in the treatment of patients with UC. This FDA approval marks the third indication approved for TREMFYA®, which builds on Johnson & Johnson's nearly 30-year legacy of immunology innovation. TREMFYA® first received approval in the U.S. in July 2017 for the treatment of adult patients with moderate-to-severe plaque psoriasis and received subsequent approval for adults with active psoriatic arthritis in July 2020.3 In June 2024, Johnson & Johnson submitted a supplemental Biologics License Application (sBLA) to the FDA seeking approval of TREMFYA® for the treatment of adult patients with moderately to severely active Crohn's disease. Editor's Notes: CD64+ cells are the predominant source of IL-23 in UC. Cells not expressing CD64 may also contribute to IL-23 production but to a lesser extent.1,2 "Only" based on approved selective IL-23 inhibitors for moderately to severely active UC as of September 2024.3,4,5 Based on in vitro studies in an inflammatory monocyte model.1 Clinical remission was defined as a Mayo stool frequency subscore of 0 or 1 and not increased from induction baseline, a Mayo rectal bleeding subscore of 0, and a Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy.6 Endoscopic remission (normalization) was defined as a Mayo endoscopic subscore of 0.6 Dr. Rubin is a paid consultant for Johnson & Johnson. He has not been compensated for any media work. TREMFYA® is not approved for the treatment of adults living with Crohn's disease in the U.S. ABOUT THE QUASAR PROGRAM (NCT04033445 ) QUASAR is a randomized, double-blind, placebo-controlled, parallel group, multicenter Phase 2b/3 program designed to evaluate the efficacy and safety of TREMFYA®, a selective IL-23 inhibitor, in adult patients with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to conventional therapy (e.g., thiopurines or corticosteroids), prior biologics and/or JAK inhibitors (i.e., tumor necrosis factor-alpha antagonists, vedolizumab, or tofacitinib).3 QUASAR included a Phase 2b dose-ranging induction study, a confirmatory Phase 3 induction study, and a Phase 3 maintenance study. Efficacy, safety, pharmacokinetics, immunogenicity, and biomarkers are assessed at specified time points.6 The most common adverse reactions (>2%) in patients with UC who received TREMFYA® and at a higher rate of placebo in the induction study were respiratory tract infections. The most common adverse reactions (>3%) in patients with UC who received TREMFYA® and at a higher rate of placebo in the maintenance study were injection site reactions, arthralgia, and upper respiratory tract infection. ABOUT ULCERATIVE COLITIS Ulcerative colitis (UC) is a form of inflammatory bowel disease (IBD) that causes inflammation in the digestive tract and can result in damage to the colon lining. It is the result of the immune system's overactive response. Patients can experience a range of unpredictable symptoms, which may include loose and more frequent bowel movements, rectal bleeding or bloody stool, persistent diarrhea, abdominal pain, loss of appetite, weight loss, and fatigue.7 Patients with UC also have increased rates of depression.8 More than one million people in the U.S. are living with UC, making it one of the largest populations globally affected by this disease, and the prevalence continues to rise.9,10,11 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 cell 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 approved in the U.S., 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 adult patients with active psoriatic arthritis. Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA®. For more information, visit: . 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: 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: Do not take 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 , by calling 1-877-311-8972, or emailing [email protected]. 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, 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 or call 1‐800‐FDA‐1088. Dosage Forms and Strengths: TREMFYA® is available in a 100 mg/mL prefilled syringe and One-Press patient-controlled injector for subcutaneous injection, a 200 mg/2 mL prefilled syringe and prefilled pen (TREMFYA® PEN) for subcutaneous injection, and 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 or at . Follow us at @JanssenUS and @JNJInnovMed. Janssen Research & Development, LLC, Janssen Scientific Affairs, LLC. and Janssen Biotech, Inc. are all 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 TREMFYA®. 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 Janssen Research & Development, LLC, Janssen Scientific Affairs, LLC. and Janssen Biotech, Inc. and/or 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2023, 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 , or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Scientific Affairs, LLC. and Janssen Biotech, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments. 1 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. 2 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 3 TREMFYA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 4 Skyrizi® [Prescribing Information]. North Chicago, IL: AbbVie, Inc. 5 OmvohTM [Prescribing Information]. Indianapolis, IN: Eli Lilly and Company. 6 Clinicaltrials.gov. A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis (QUASAR). Identifier: NCT04033445. Accessed September 2024. 7 Crohn's & Colitis Foundation. What is ulcerative colitis? Accessed September 2024. 8 Yuan X, Chen B, Duan Z, et al. Depression and anxiety in patients with active ulcerative colitis: crosstalk of gut microbiota, metabolomics and proteomics. Gut Microbes. 2021;13(1):1987779. doi: 10.1080/19490976.2021.1987779 9 Lewis, JD, et al. Incidence, prevalence and racial and ethnic distribution of inflammatory bowel disease in the United States. Gastroenterology. 2023;165:1197-1205. 10 Shivashankar R, Tremaine WJ, Harmsen WS, et al. Incidence and prevalence of Crohn's disease and ulcerative colitis in Olmsted County, Minnesota from 1970 through 2010. NIH external link. Clin Gastroenterol Hepatol. 2017;15(6):857-863. doi:10.1016/j.cgh.2016.10.039. 11 Le Berre C, Honap S, Peyrin-Biroulet L. Ulcerative colitis. Lancet. 2023;402(10401):571-584. doi: 10.1016/S0140-6736(23)00966-2 SOURCE Johnson & Johnson WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

精彩内容 华海药业2024上半年业绩再创新高，有券商预计全年营业收入有望突破100亿元。今年一季度在重点省市公立医院终端，公司的磷酸奥司他韦胶囊大涨597%、左乙拉西坦注射用浓溶液大涨394%，公司的医药制剂业务日渐火爆。2024年至今，公司陆续拿下16个新产品，目前有40个高端仿制药报产在审。创新药方面，注射用HB0052和HB0046注射液在今年首次获批临床，目前公司有12款1类新药、3款2类新药正在积极推进临床，未来可期。 神经系统药物领军！5个畅销品种大涨超100% 华海药业2024上半年营业收入为51.28亿元，同比增长19.43%，净利润达7.49亿元，同比增长31.60%。据悉，公司业绩创新高的原因包括了新产品持续导入并逐步上量，积极推进全球销售网络布局，成本控制能力、综合竞争实力及盈利能力进一步增强等。有券商预计，华海药业2024年全年的营业收入有望突破100亿元，净利润可达13亿元。 图1：华海药业2024年Q1的大类格局情况来源：米内网重点省市公立医院药品终端竞争格局 神经系统药物、全身用抗感染药物、心脑血管系统药物、呼吸系统用药已成为华海药业4大拳头领域，2024年Q1在重点省市公立医院终端的合计市场份额超过95%。从增长情况来看，公司的神经系统药物2024年Q1增速为39.17%，全身用抗感染药物增速为30.75%，心脑血管系统药物微跌1.94%，呼吸系统用药暴涨169.76%。 表1：华海药业2024年Q1产品TOP20中销售正增长的产品情况来源：米内网重点省市公立医院药品终端竞争格局 2024年Q1在重点省市公立医院终端，华海药业TOP20产品中有5个增长率超过100%。呼吸系统用药复方甲氧那明胶囊增长了169.76%，全身用抗感染药物磷酸奥司他韦胶囊（2022年获批）大涨596.65%，神经系统药物左乙拉西坦片（2020年获批）和左乙拉西坦注射用浓溶液（2022年获批）分别增长了146.70%、394.08%，心脑血管系统药物缬沙坦氢氯噻嗪片（2022年获批）增长率为189.95%，公司近几年获批的新产品正在持续爆发活力。 3大市场新突破，国采中标产品大放异彩 米内网数据显示，2024年至今华海药业已陆续拿下了16个新产品，涉及6个大类（10个亚类）。3个畅销品类市场迎来了大突破，非布司他片是公司首款获批的抗痛风制剂，枸橼酸托法替布片是公司首款获批的免疫抑制剂，在抗帕金森氏病药市场，华海药业的多巴丝肼片在2024年2月获批，随后在5月份拿下了甲磺酸雷沙吉兰片。 表2：华海药业2024年至今获批的新产品（按批文统计）来源：米内网中国申报进度（MED）数据库 截至2024年9月9日，华海药业及子公司过评（含视同过评）产品达70个。公司在半年报中提到，以一致性评价和集采为契机大力拓展国内市场，华海药业从4+7城市试点至第九批国采（不含第六批胰岛素专项）已中标产品达23个。 表3：华海药业已中标产品2024年Q1的市场情况来源：米内网重点省市公立医院药品终端竞争格局 中标产品持续放量，公司所占的市场份额迅速攀升，领军地位越趋明显。2024年Q1在重点省市公立医院终端，华海药业已成为赖诺普利片、盐酸帕罗西汀片、缬沙坦片、阿立哌唑口崩片的龙头药企，成为氯沙坦钾片、厄贝沙坦氢氯噻嗪片、福辛普利钠片、安立生坦片、盐酸多奈哌齐片、奥氮平口崩片、盐酸舍曲林片的TOP2企业，成为厄贝沙坦片、利培酮片、伏立康唑片的TOP3企业。 第十批国采是2024年医药界的大事件之一，一直备受市场瞩目，目前华海药业已过评且暂未纳入国采的产品中有12个产品的竞争企业（原研+过评）≥5家，包括了拉莫三嗪片、左乙拉西坦缓释片、利格列汀片、磷酸西格列汀片、西格列汀二甲双胍片(Ⅱ)、盐酸艾司洛尔注射液、盐酸美金刚口服溶液、多巴丝肼片、托拉塞米片、甲磺酸雷沙吉兰片、注射用盐酸表柔比星、富马酸卢帕他定片，这些产品均为公司在2020-2024年按新分类获批的新产品，“光脚产品”有望迎来新的爆发期。 40个新品冲刺上市，17款新药在路上 华海药业在2024年半年报中提到，公司在国内的制剂研发战略由“抢集采”向“仿创结合、抢先上市”转变，目前公司报产在审的新产品有40个，均为化药仿制药。 表4：2022年至今华海药业及子公司申报上市并在审的新产品来源：米内网中国申报进度（MED）数据库 公司将在抗炎药和抗风湿药、止血药、脑血管治疗用药、止泻药和肠道抗炎/抗感染药、心脏病治疗用药、胃肠解痉药和抗胆碱药和胃动力药、抗贫血制剂7个亚类市场迎来新突破。 此外，目前国内市场上暂无二甲双胍恩格列净片(Ⅴ)、达格列净二甲双胍缓释片(Ⅰ)、达格列净二甲双胍缓释片(Ⅲ)、达格列净二甲双胍缓释片(Ⅳ)、坎地沙坦酯氢氯噻嗪片的国产仿制药获批（按产品名统计），华海药业将参与上述5个产品的国内首仿争夺。 表5：华海药业部分在研的重磅新药来源：公司半年报、米内网中国临床试验数据库 在创新药研发方面，华海药业以研发国内首创、同类最优的小分子创新药为目标，聚焦中枢神经系统疾病、代谢相关疾病、肿瘤相关疾病等领域。半年报中提到，公司有多个创新药已处于关键临床，有望在未来2-3年内实现商业化，为公司多元化增长提供助力。 2024年4月及7月，生物药1类新药注射用HB0052和HB0046注射液首次获批临床，适应症均为晚期实体肿瘤。注射用HB0052是靶向CD73抗原的第三代抗体偶联药物，有望成为新一代肿瘤治疗药物；HB0046注射液则是一款双特异性抗体，由抗CD39的VHH（重链可变区）片段和抗CD73的单抗连接而成。 HB0017注射液是以白介素-17A（IL-17A）为靶点的单克隆抗体，该新药在中重度斑块状银屑病患者中开展的关键III期临床试验于2024年3月顺利完成了首例受试者入组给药，截至目前已完成全部患者的入组。 HB0025注射液是可同时靶向VEGF与PD-L1的双特异性融合蛋白，在晚期非小细胞肺癌、子宫内膜癌、肾癌、结直肠癌等瘤种都显示了积极的疗效信号，目前该新药的II期临床正在积极推进中。 HB0034注射液是靶向IL-36R（白介素-36受体）的人源化IgG1型单克隆抗体，临床重点开发的适应症是泛发性脓疱型银屑病，该新药关键II期临床在2024年3月完成首例受试者入组给药。 收获近百个ANDA文号，15个产品居TOP1 华海药业作为国内制药企业拓展国际市场的先导企业，在美国市场已形成包括自主销售、大批发商、终端连锁店和商业公司等多渠道的营销体系，销售网络基本覆盖美国大中型药品采购商，在国际医药市场树立了中国制药的品牌形象。今年以来，公司陆续拿下6个产品的ANDA文号，截至目前公司的ANDA文号（含暂时性批准）接近百个。 表6：华海药业今年以来获得的ANDA文号（含暂时获批）来源：公司公告 公司在半年报中提到，新产品持续导入赋能美国制剂业务强劲发展动力，从治疗领域、用药可及度、研发技术等多维度为公司加速美国市场拓展提供了强大的产品梯队。数据显示，公司在美国市场销售的被纳入统计的58个产品中，有32个产品的市场份额占有率位居前三，其中15个产品市场份额占有率位居第一。 资料来源：公司半年报及公告、米内网数据库注：米内网重点省市公立医院化学药终端竞争格局数据库是以20+省市，近700家样本省市公立医院的化学药采购数据为基础，对化学药全品类进行连续监测的样本省市样本医院数据库；上述销售额以产品在终端的平均零售价计算。数据统计截至9月9日，如有疏漏，欢迎指正。 本文为原创稿件，转载请注明来源和作者，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