Linaclotide

精彩内容近日，青峰医药申报的4类仿制药盐酸决奈达隆片获批生产并视同过评。2024年至今，公司有18个品种获批生产并视同过评（3个首仿），目前总过评品种数已增加至44个（10个首家/独家），7大“光脚”品种备战第十一批集采。近年来，青峰医药以研发驱动为发展战略，2款1类新药获批上市，还有8款1类新药在国内处于申请临床及以上阶段；12个品种以新注册分类申报在审，其中有7个暂无首仿（含剂型首仿）获批。大丰收！拿下1款1类新药、3个首仿3月25日，青峰医药自主研发的化药1类新药玛舒拉沙韦片(GP681)获批上市，适用于既往健康的12岁及以上青少年和成人单纯性甲型和乙型流感患者的治疗，不包括存在流感相关并发症高风险的患者。据悉，该药是国内获批的首款国产流感病毒聚合酶酸性蛋白(PA)抑制剂，同时也是江西首个获批上市的化学药1类创新药。3月18日及11日，青峰医药申报的仿制药吡仑帕奈口服混悬液、口服溶液用盐酸万古霉素获批生产并视同过评，均为国内首仿+首家过评。米内网数据显示，2024年中国三大终端六大市场（统计范围详见本文末）万古霉素销售额超过20亿元。以审评结论日期计，2024年以来青峰医药在国内有1款1类新药获批上市，18个品种获批生产并视同过评，涉及抗肿瘤、抗癫痫、抗病毒、抗血栓形成、高血压、咳嗽感冒、抗细菌、抗贫血等细分领域。2024年以来青峰医药获批上市的品种来源：米内网中国申报进度（MED）数据库18个品种2024年在中国三大终端六大市场的销售额合计超过130亿元，其中硝苯地平控释片接近50亿元，罗沙司他胶囊超23亿元，贝前列素钠片、奥拉帕利片、瑞戈非尼片等超10亿元。上述品种中，青峰医药有多个品种为国内首批获批上市，其中吡仑帕奈口服混悬液、口服溶液用盐酸万古霉素、布立西坦片为国内首仿+首家过评，吡仑帕奈片国产第2家获批，伊布替尼胶囊、罗沙司他胶囊国产第3家获批，甲磺酸艾立布林注射液国产第4家获批等。值得一提的是，美索巴莫注射液是青峰医药首个获批生产的肌肉-骨骼系统化药，硫酸镁注射液为公司首款获批生产的矿物质补充剂。米内网数据显示，近年来中国三大终端六大市场肌肉-骨骼系统药物（化药）、矿物质补充剂（化药）销售额均分别超过400亿元、200亿元。44个品种过评！7大光脚品种备战第11批集采截至目前，青峰医药有44个品种过评或视同过评，其中吡仑帕奈口服混悬液、口服溶液用盐酸万古霉素、布立西坦片、甲磺酸多沙唑嗪缓释片、拉考沙胺注射液、甲苯磺酸索拉非尼片、艾司奥美拉唑镁肠溶片、拉考沙胺片、恩替卡韦胶囊、恩替卡韦分散片等为首家或独家过评（含并列）。青峰医药过评品种来源：米内网一致性评价进度数据库44个品种涵盖9个治疗大类，集中在抗肿瘤和免疫调节剂（10个）、神经系统药物（10个）、全身用抗感染药物（8个）等治疗领域。在过往开展的国家集采中，青峰医药累计有18个品种中选，其中在第十批国采中顺利中选了7个品种。此外，目前公司还有15个过评品种暂未纳入国采，其中有7个已满足7家及以上的充分竞争条件，包括5个口服常释剂型、1个注射剂、1个缓释控释剂型。青峰医药过评但未纳入国采且已满足入围门槛的品种注：销售额低于1亿元用*代替来源：米内网综合数据库从市场规模看，罗沙司他口服常释剂型、奥拉帕利口服常释剂型2个品种2024年在中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端的销售额均超过10亿元，目前分别有17家、9家企业符合申报资格。从获批日期看，贝前列素钠片为青峰医药2025年1月新获批品种，罗沙司他胶囊、奥拉帕利片、恩扎卢胺软胶囊、美索巴莫注射液均为2024年获批品种，磷酸特地唑胺片、甲磺酸多沙唑嗪缓释片为2023年获批品种，目前公司在上述7个品种中所占的市场份额均为0。8款1类新药在路上！7个品种抢首仿据悉，青峰医药以研发驱动为发展战略，聚焦未满足的临床需求，每年以不低于年销售额10%的资金投入研发，专注于高价值、差异化的药品，形成了全球化、全链条的创新研发体系。3月25日，青峰医药自主研发的化药1类新药玛舒拉沙韦片(GP681)获批上市，适用于既往健康的12岁及以上青少年和成人单纯性甲型和乙型流感患者的治疗，不包括存在流感相关并发症高风险的患者。III期临床研究显示，该药可有效缩短流感症状缓解时间并快速清除病毒，同时具有良好的安全性和耐受性。2023年10月，青峰医药自主研发的中药1.2类新药枳实总黄酮片获批上市，该药具有行气消积、散痞止痛的功效，适用于功能性消化不良，症见餐后饱胀感、早饱、上腹烧灼感和上腹疼痛等。据不完全统计，目前青峰医药在国内有8款1类新药处于申请临床及以上阶段，集中在抗肿瘤药、抗感染药2大治疗领域。米内网数据显示，2024年中国三大终端六大市场抗肿瘤药（化药+生物药）、全身用抗感染药（化药+生物药）市场规模均超过1000亿元。青峰医药国内部分在研1类新药来源：米内网综合数据库仿制药方面，除了已获批/主动撤回品种，目前青峰医药有12个品种以新注册分类申报上市/临床，包括4个神经系统药物、4个抗肿瘤和免疫调节剂、2个消化系统及代谢药、1个皮肤病用药、1个全身用激素类制剂(不含性激素和胰岛素)。青峰医药新分类申报且在审的品种来源：米内网中国申报进度（MED）数据库7个品种在国内暂无仿制药获批，包括利那洛肽胶囊、布立西坦口服溶液、布立西坦注射液、阿贝西利片、拉米地坦片、依伏卡塞片、瑞卢戈利片。其中，阿贝西利是礼来开发的一种周期蛋白依赖性激酶4和6(CDK4和CDK6)的抑制剂，2024年全球销售额超过53亿美元。资料来源：米内网数据库、公司公告等注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；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4月30日，如有疏漏，欢迎指正！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

BOSTON--(BUSINESS WIRE)--Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a biotechnology company developing and commercializing life-changing therapies for people living with gastrointestinal (GI) and rare diseases, today announced it reiterates its full year 2025 LINZESS U.S. net sales and total Ironwood revenue guidance and raises its adjusted EBITDA guidance. Ironwood plans to report full first quarter 2025 results in early May. “Today, we are reiterating our full-year 2025 LINZESS U.S. net sales and total Ironwood revenue guidance. In the first quarter of 2025, we saw continued strong prescription demand growth of 8% year-over-year, which was offset by anticipated pricing headwinds as well as a change in estimate of AbbVie gross-to-net rebate reserves, which was refined to reflect rebates owed for units dispensed in the first quarter of 2025. We do not expect first quarter LINZESS U.S. net sales results or this change in estimate to impact the full-year results,” said Tom McCourt, chief executive officer of Ironwood. “In addition, we have raised our full-year 2025 adjusted EBITDA guidance to greater than $105 million as we no longer plan to make certain apraglutide commercial launch planning investments and will shift our focus to the confirmatory Phase 3 trial, consistent with the recent FDA feedback.” Continued Strong Demand for U.S. LINZESS Prescription Demand: Total LINZESS prescription demand in the first quarter of 2025 was 53 million LINZESS capsules, an 8% increase compared to the first quarter of 2024, per IQVIA. U.S. Brand Collaboration : LINZESS U.S. net sales are provided to Ironwood by its U.S. partner, AbbVie Inc. (“AbbVie”). LINZESS U.S. net sales were $138.5 million in the first quarter of 2025, a 46% decrease compared to $256.6 million in the first quarter of 2024. Ironwood and AbbVie share equally in U.S. brand collaboration profits. Ironwood 2025 Financial Guidance. Ironwood is reiterating its 2025 U.S. LINZESS net sales and total revenue guidance and is raising its adjusted EBITDA financial guidance. Prior 2025 Guidance (February 2025) Updated 2025 Guidance (April 2025) U.S. LINZESS Net Sales $800 - $850 million High single digit prescription demand growth, more than offset by expected price erosion due to Medicare Part D redesign $800 - $850 million High single digit prescription demand growth, more than offset by expected price erosion due to Medicare Part D redesign Total Revenue1 $260 - $290 million $260 - $290 million Adjusted EBITDA2 >$85 million >$105 million 1 Ironwood’s U.S. collaborative arrangements revenue includes reimbursement from AbbVie for a portion of Ironwood’s commercial expenses related to sales of LINZESS in the U.S. The FY2025 total revenue guidance accounts for the impact of the reduction to Ironwood’s commercial expenses and corresponding reimbursement from AbbVie due to Ironwood’s strategic reorganization announced in January 2025. 2 Adjusted EBITDA is calculated by subtracting restructuring expenses, net interest expense, income taxes, depreciation and amortization and stock-based compensation, from GAAP net income. The exclusion of stock-based compensation from Adjusted EBITDA represents an update to our definition of Adjusted EBITDA, effective in the first quarter of 2025. For purposes of this guidance, we have assumed that Ironwood will not incur material expenses related to business development activities in 2025. Ironwood does not provide guidance on GAAP net income or a reconciliation of expected adjusted EBITDA to expected GAAP net income because, without unreasonable efforts, it is unable to predict with reasonable certainty the non-GAAP adjustments used to calculate adjusted EBITDA. These adjustments are uncertain, depend on various factors and could have a material impact on GAAP net income for the guidance period. Management believes this non-GAAP information is useful for investors, taken in conjunction with Ironwood’s GAAP financial statements, because it provides greater transparency and period-over-period comparability with respect to Ironwood’s operating performance. These measures are also used by management to assess the performance of the business. Investors should consider these non-GAAP measures only as a supplement to, not as a substitute for or as superior to, measures of financial performance prepared in accordance with GAAP. In addition, these non-GAAP financial measures are unlikely to be comparable with non-GAAP information provided by other companies. About Ironwood Pharmaceuticals Ironwood Pharmaceuticals (Nasdaq: IRWD) is a biotechnology company developing and commercializing life-changing therapies for people living with gastrointestinal (GI) and rare diseases. Ironwood is advancing apraglutide, a next-generation, long-acting synthetic GLP-2 analog being developed for short bowel syndrome patients who are dependent on parenteral support. In addition, Ironwood has been a pioneer in the development of LINZESS® (linaclotide), the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). LINZESS is also approved for the treatment of functional constipation in pediatric patients ages 6-17 years old. Building upon our history of innovation, we keep patients at the heart of our R&D and commercialization efforts to reduce the burden of diseases and address significant unmet needs. Founded in 1998, Ironwood Pharmaceuticals is headquartered in Boston, Massachusetts, with a site in Basel, Switzerland. We routinely post information that may be important to investors on our website at www.ironwoodpharma.com. In addition, follow us on X and on LinkedIn. About LINZESS (Linaclotide) LINZESS® is the #1 prescribed brand in the U.S. for the treatment of adult patients with irritable bowel syndrome with constipation (“IBS-C”) or chronic idiopathic constipation (“CIC”), based on IQVIA data. LINZESS is a once-daily capsule that helps relieve the abdominal pain, constipation, and overall abdominal symptoms of bloating, discomfort and pain associated with IBS-C, as well as the constipation, infrequent stools, hard stools, straining, and incomplete evacuation associated with CIC. LINZESS relieves constipation in children and adolescents aged 6 to 17 years with functional constipation. The recommended dose is 290 mcg for IBS-C patients and 145 mcg for CIC patients, with a 72 mcg dose approved for use in CIC depending on individual patient presentation or tolerability. In children with functional constipation aged 6 to 17 years, the recommended dose is 72 mcg. LINZESS is not a laxative; it is the first medicine approved by the FDA in a class called GC-C agonists. LINZESS contains a peptide called linaclotide that activates the GC-C receptor in the intestine. Activation of GC-C is thought to result in increased intestinal fluid secretion and accelerated transit and a decrease in the activity of pain-sensing nerves in the intestine. The clinical relevance of the effect on pain fibers, which is based on nonclinical studies, has not been established. In the United States, Ironwood and AbbVie co-develop and co-commercialize LINZESS for the treatment of adults with IBS-C or CIC. In Europe, AbbVie markets linaclotide under the brand name CONSTELLA® for the treatment of adults with moderate to severe IBS-C. In Japan, Ironwood's partner, Astellas, markets linaclotide under the brand name LINZESS for the treatment of adults with IBS-C or CIC. Ironwood also has partnered with AstraZeneca for development and commercialization of LINZESS in China, and with AbbVie for development and commercialization of linaclotide in all other territories worldwide. LINZESS Important Safety Information INDICATIONS AND USAGE LINZESS® (linaclotide) is indicated for the treatment of both irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in adults and functional constipation (FC) in children and adolescents 6 to 17 years of age. It is not known if LINZESS is safe and effective in children with FC less than 6 years of age or in children with IBS-C less than 18 years of age. IMPORTANT SAFETY INFORMATION WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE LINZESS is contraindicated in patients less than 2 years of age. In nonclinical studies in neonatal mice, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths due to dehydration. Contraindications LINZESS is contraindicated in patients less than 2 years of age due to the risk of serious dehydration. LINZESS is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. Warnings and Precautions LINZESS is contraindicated in patients less than 2 years of age. In neonatal mice, linaclotide increased fluid secretion as a consequence of age-dependent elevated guanylate cyclase (GC-C) agonism, which was associated with increased mortality within the first 24 hours due to dehydration. There was no age dependent trend in GC-C intestinal expression in a clinical study of children 2 to less than 18 years of age; however, there are insufficient data available on GC-C intestinal expression in children less than 2 years of age to assess the risk of developing diarrhea and its potentially serious consequences in these patients. Diarrhea In adults, diarrhea was the most common adverse reaction in LINZESS-treated patients in the pooled IBS-C and CIC double-blind placebo-controlled trials. The incidence of diarrhea was similar in the IBS-C and CIC populations. Severe diarrhea was reported in 2% of 145 mcg and 290 mcg LINZESS-treated patients and in <1% of 72 mcg LINZESS-treated CIC patients. In children and adolescents 6 to 17 years of age, diarrhea was the most common adverse reaction in 72 mcg LINZESS-treated patients in the FC double-blind placebo-controlled trial. Severe diarrhea was reported in <1% of 72 mcg LINZESS treated patients. If severe diarrhea occurs, dosing should be suspended and the patient rehydrated. Common Adverse Reactions (incidence ≥2% and greater than placebo) In IBS-C or CIC adult patients: diarrhea, abdominal pain, flatulence, and abdominal distension. In FC pediatric patients: diarrhea. Please see full Prescribing Information including Boxed Warning: https://www.rxabbvie.com/pdf/linzess_pi.pdf LINZESS® and CONSTELLA® are registered trademarks of Ironwood Pharmaceuticals, Inc. Any other trademarks referred to in this press release are the property of their respective owners. All rights reserved. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Investors are cautioned not to place undue reliance on these forward-looking statements, including statements about Ironwood’s ability to execute on its mission; Ironwood’s strategy, business, financial position and operations; Ironwood’s financial performance and results, and guidance, expectations related thereto and expected timing to provide full first quarter 2025 results; LINZESS prescription demand growth, LINZESS U.S. net sales growth, total revenue and adjusted EBITDA in 2025; Ironwood’s expectation that the change in AbbVie’s estimate of gross-to-net rebate reserves will impact the quarterly phasing of LINZESS U.S. net sales but not the full-year results; that moving forward, gross-to-net rebate reserves will continue to be based on rebates owed for units dispensed by channel in each applicable quarter; Ironwood’s expectation that rebates owed for units dispensed in subsequent quarters will offset the Q1 2025 change in estimate impact and will not have impact for the full year; ; and Ironwood’s plan to no longer to make certain commercial launch planning investments for apraglutide and to shift its focus to the confirmatory Phase 3 trial. These forward-looking statements speak only as of the date of this press release, and Ironwood undertakes no obligation to update these forward-looking statements. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement. Applicable risks and uncertainties include those related to the effectiveness of development and commercialization efforts by us and our partners; preclinical and clinical development, manufacturing and formulation development of linaclotide, apraglutide, IW-3300, and our other product candidates; the risk of uncertainty relating to pricing and reimbursement policies in the U.S., which, if not favorable for our products, could hinder or prevent our products’ commercial success; the risk that healthcare reform and other governmental and private payor initiatives may have an adverse effect upon or prevent our products’ or product candidates’ commercial success; the risk that apraglutide will not be approved by the FDA or other regulatory agencies; the risk that clinical programs and studies, including for linaclotide pediatric programs, apraglutide and IW-3300, may not progress or develop as anticipated, including that studies are delayed or discontinued for any reason, such as safety, tolerability, enrollment, manufacturing, economic or other reasons; the risk that findings from our ongoing and completed nonclinical studies and clinical trials may not be replicated in later trials or further data analyses and earlier-stage clinical trials may not be predictive of the results we may obtain in later-stage clinical trials or of the likelihood of regulatory approval; the risk of competition or that new products may emerge that provide different or better alternatives for treatment of the conditions that our products are approved to treat; the risk that we are unable to execute on our strategy to in-license externally developed products or product candidates; the risk that we are unable to successfully partner with other companies to develop and commercialize products or product candidates; the efficacy, safety and tolerability of linaclotide and our product candidates; the risk that the commercial and therapeutic opportunities for LINZESS, apraglutide or our other product candidates are not as we expect; decisions by regulatory and judicial authorities; the risk we may never get additional patent protection for linaclotide, apraglutide and other product candidates, that patents for linaclotide, apraglutide or other products may not provide adequate protection from competition, or that we are not able to successfully protect such patents; the risk that we are unable to manage our expenses or cash use, or are unable to commercialize our products as expected; the risk that the development of any of our linaclotide pediatric programs, apraglutide and/or IW-3300 is not successful or that any of our product candidates does not receive regulatory approval or is not successfully commercialized; outcomes in legal proceedings to protect or enforce the patents relating to our products and product candidates, including abbreviated new drug application litigation; the risk that financial and operating results may differ from our projections; developments in the intellectual property landscape; challenges from and rights of competitors or potential competitors; the risk that our planned investments do not have the anticipated effect on our company revenues; developments in accounting guidance or practice; Ironwood’s or AbbVie’s accounting practices, including reporting and settlement practices as between Ironwood and AbbVie; the risk that our indebtedness could adversely affect our financial condition or restrict our future operations; and the risks listed under the heading “Risk Factors” and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2024, and in our subsequent Securities and Exchange Commission filings.