Cefixime

Talicia is now covered by Humana's Part D Plan, providing access to Talicia for H. pylori therapy to more than eight million additional Medicare lives, without requiring prior therapeutic steps or authorization The recently updated American College of Gastroenterology (ACG) Clinical Guideline lists Talicia as a first-line option for treatment of H. pylori infection. Talicia continues to be the most prescribed branded H. pylori therapy by U.S. gastroenterologists Additionally, new data describing the foundations for Talicia's recent FDA-approved label change to a more convenient three-times daily (TID) "breakfast, lunch, and dinner" dosing routine, supporting patient adherence, has been published in the Journal of Clinical Pharmacology The published data describe the use of physiologically-based pharmacokinetic (PBPK) modeling and simulation to demonstrate pharmacokinetic equivalence of the TID regimen to the previous every 8-hour (Q8H) dosing regimen H. pylori infection affects approximately 35% of the U.S. adult population and is classified by the World Health Organization (WHO) as a Group 1 carcinogen, being the strongest known risk factor for gastric cancer and a major risk factor for peptic ulcer disease RALEIGH, N.C. and TEL-AVIV, Israel, Jan. 21, 2025 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the coverage of Talicia by Humana's Part D Plan, providing access to Talicia for H. pylori therapy to more than eight million additional Medicare lives, without the requirement for prior therapeutic steps or authorizations, for both treatment-naïve and treatment-experienced patients, effective as of January 1, 2025. "There is broad recognition of the clinical efficacy of Talicia and the recently updated American College of Gastroenterology (ACG) Clinical Guideline, listing Talicia as a first-line treatment option. Talicia is the only FDA-approved low-dose rifabutin-based therapy for the eradication of H. pylori, and continues to be the most prescribed branded H. pylori therapy by U.S. gastroenterologists1," said Rick D. Scruggs, President and Chief Commercial Officer of RedHill Biopharma, Inc. "We are pleased that coverage in the Medicare arena is growing as the Part D payers recognize the importance of treating H. pylori with the right therapy the first time and look forward to expanding coverage in Medicare." The Company also announced the publication of new data in The Journal of Clinical Pharmacology2. The published data describe the foundations for Talicia's recently FDA-approved label change to a more convenient three-times daily (TID) with food (at least 4 hours apart, e.g., breakfast, lunch, and dinner) dosing routine, further simplifying the patient experience and supporting increased patient adherence. The result of a successful collaboration with Certara, the published study utilized Certara's Simcyp™ Simulator for physiologically-based pharmacokinetic (PBPK) modeling and simulation to demonstrate pharmacokinetic equivalence in plasma and within the stomach for all three of Talicia's components, regardless of dosing TID or Q8H. These data support the provision of a more patient-friendly Talicia regimen and further demonstrate RedHill's ongoing commitment to enhanced patient experience and outcomes. "Treating H. pylori infection is challenging and often requires patients to take multiple different pills multiple times a day. Simplified dosing regimens improve patient adherence. In the treatment of H. pylori infection, adherence to dosing is critical for optimizing patient outcomes, while also mitigating against the development of bacterial resistance. Therefore, it is important to use an effective therapy that is most likely to eradicate H. pylori infection at the first attempt," said Colin W. Howden, MD, Professor Emeritus, University of Tennessee College of Medicine, and co-author of the paper. "These important data, and the retention of Talicia's pharmacokinetic profile across dosing regimens, support the change to a more simplified TID dosing schedule. Talicia's efficacy, tolerability, and resistance profile, along with its convenient all-in-one formulation and TID dosing, further support its inclusion as an empirically prescribed first-line option in the 2024 ACG Clinical Guideline on the treatment of H. pylori infection3." About H. pylori H. pylori is a bacterial infection that affects approximately 35%4 of the U.S. population, with an estimated two million patients treated annually3. Worldwide, around 66% of the population has H. pylori infection5, which is classified by the World Health Organization (WHO) as a Group 1 carcinogen. It remains the strongest known risk factor for gastric cancer6 and a major risk factor for peptic ulcer disease7 and gastric mucosa-associated lymphoid tissue (MALT) lymphoma8. More than 27,000 Americans are diagnosed with gastric cancer annually9. Eradication of H. pylori is becoming increasingly difficult, with current therapies failing in approximately 25-40% of patients who remain H. pylori-positive due to high resistance of H. pylori to antibiotics – especially clarithromycin – which is still commonly used in standard combination therapies10. About Talicia® Talicia is the only low-dose rifabutin-based therapy approved for the treatment of H. pylori infection and is designed to address the high resistance of H. pylori bacteria seen with other antibiotics. More specifically, the high rates of H. pylori resistance to clarithromycin have led to significant increases in treatment failures with clarithromycin-based therapies and are a strong public health concern, as highlighted by the ACG, FDA and the WHO in recent years. Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole). In November 2019, Talicia was approved by the U.S. FDA for the treatment of H. pylori infection in adults. In the pivotal Phase 3 study, Talicia demonstrated 84% eradication of H. pylori infection in the intent-to-treat (ITT) group vs. 58% in the active comparator arm (p<0.0001). Minimal to zero resistance to rifabutin, a key component of Talicia, was detected in RedHill's pivotal Phase 3 study. Further, in an analysis of data from this study, it was observed that subjects who were confirmed adherent11 to their therapy had response rates of 90.3% in the Talicia arm vs. 64.7% in the active comparator arm12. Talicia is eligible for a total of eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is also covered by U.S. patents which extend patent protection until 2034 with additional patents and applications pending and granted in various territories worldwide. Patients should check coverage details with their health plan. TALICIA: INDICATION AND IMPORTANT SAFETY INFORMATION Talicia is a three-drug combination of omeprazole, a proton pump inhibitor, amoxicillin, a penicillin-class antibacterial, and rifabutin, a rifamycin antibacterial­­, indicated for the treatment of Helicobacter pylori infection in adults. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Talicia and other antibacterial drugs, Talicia should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. IMPORTANT SAFETY INFORMATION Talicia contains omeprazole, a proton pump inhibitor (PPI), amoxicillin, a penicillin-class antibacterial and rifabutin, a rifamycin antibacterial. It is contraindicated in patients with known hypersensitivity to any of these medications, any other components of the formulation, any other beta-lactams or any other rifamycin. Talicia is contraindicated in patients receiving rilpivirine-containing products. Talicia is contraindicated in patients receiving delavirdine or voriconazole. Serious and occasionally fatal hypersensitivity reactions have been reported with omeprazole, amoxicillin and rifabutin. Drug-induced enterocolitis syndrome (DIES) has been reported with use of amoxicillin, a component of Talicia. Severe cutaneous adverse reactions (SCAR) (e.g., Stevens-Johnson syndrome (SJS), Toxic epidermal necrolysis (TEN)) have been reported with rifabutin, amoxicillin, and omeprazole. Additionally, drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported with rifabutin. Acute Tubulointerstitial Nephritis has been observed in patients taking PPIs and penicillins. Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range from mild diarrhea to fatal colitis. Talicia may cause fetal harm. Talicia is not recommended for use in pregnancy. Talicia may reduce the efficacy of hormonal contraceptives. An additional non-hormonal method of contraception is recommended when taking Talicia. Talicia should not be used in patients with hepatic impairment or severe renal impairment. Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs. These events have occurred as both new onset and exacerbation of existing autoimmune disease. The most common adverse reactions (≥1%) were diarrhea, headache, nausea, abdominal pain, chromaturia, rash, dyspepsia, oropharyngeal pain, vomiting, and vulvovaginal candidiasis. To report SUSPECTED ADVERSE REACTIONS, contact RedHill Biopharma INC. at 1-833-ADRHILL (1-833-237-4455) or FDA at 1-800-FDA-1088 or . Full prescribing information for Talicia is available at . About RedHill Biopharma RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on U.S commercialization and development of drugs for gastrointestinal diseases, infectious diseases and oncology. RedHill promotes the gastrointestinal drug Talicia®, for the treatment of Helicobacter pylori (H. pylori) infection in adults13. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anticancer, anti-inflammatory and antiviral activity, targeting multiple indications with U.S. government and academic collaborations for development for radiation and chemical exposure indications such as Acute Radiation Syndrome (ARS), a Phase 2/3 program for hospitalized COVID-19, and a Phase 2 program in oncology; (ii) RHB-107 ( upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19, with non-dilutive external funding covering the entirety of the RHB-107 arm of the 300-patient Phase 2 adaptive platform trial, and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; (iii) RHB-102, with potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; and (v) RHB-204, a Phase 3-stage program for pulmonary nontuberculous mycobacteria (NTM) disease. More information about the Company is available at / X.com/RedHillBio. Forward Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words and include, among others, statements regarding the potential effects of Talicia® in the treatment of Helicobacter pylori infection. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation: market and other conditions; the Company's ability to maintain compliance with the Nasdaq Capital Market's listing requirements; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk that acceptance onto the RNCP Product Development Pipeline will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for opaganib for any indication; the risk that observations from preclinical studies are not indicative or predictive of results in clinical trials; the risk that the FDA pre-study requirements will not be met and/or that the Phase 3 study of RHB-107 in COVID-19 outpatients will not be approved to commence or if approved, will not be completed or, should that be the case, that we will not be successful in obtaining alternative non-dilutive development funding for RHB-107; the risk that RHB-107's late-stage development for non-hospitalized COVID-19 will not benefit from the resources redirected from the terminated RHB-204 Phase 3 study, and that the Phase 2/3 COVID-19 study for RHB-107 may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional COVID-19 studies for opaganib and RHB-107 are likely to be required; the risk that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on April 8, 2024. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law. All information contained herein is the sole responsibility of RedHill Biopharma Ltd. Company contact: Adi Frish Chief Corporate & Business Development Officer RedHill Biopharma +972-54-6543-112 [email protected] Category: Commercial 1 IQVIA XPO Data on file 2 Vakil N, Howden CW, Shah SC, Chen KF, Offman E, Almenoff JS, Sheldon KL. Physiologically Based Pharmacokinetic Modeling and Simulation to Support a Change in the FDA-Labeled Dosing Frequency of RHB-105 Low-Dose Rifabutin Triple Therapy for Helicobacter pylori Eradication. J Clin Pharmacol. 2025 Jan 2. doi: 10.1002/jcph.6178. Epub ahead of print. PMID: 39745109. 3 Chey, William D. MD, FACG1; Howden, Colin W. MD, FACG2; Moss, Steven F. MD, FACG3; Morgan, Douglas R. MD, MPH, FACG4; Greer, Katarina B. MD, MSEpi5; Grover, Shilpa MD, MPH6; Shah, Shailja C. MD, MPH7. ACG Clinical Guideline: Treatment of Helicobacter pylori Infection. The American Journal of Gastroenterology 119(9):p 1730-1753, September 2024. | DOI: 10.14309/ajg.0000000000002968 4 Hooi JKY et al. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology 2017; 153:420-429. 5 6 Lamb A et al. Role of the Helicobacter pylori–Induced inflammatory response in the development of gastric cancer. J Cell Biochem 2013;114.3:491-497. 7 NIH – Helicobacter pylori and Cancer, September 2013. 8 Hu Q et al. Gastric mucosa-associated lymphoid tissue lymphoma and Helicobacter pylori infection: a review of current diagnosis and management. Biomarker research 2016;4.1:15. 9 National Cancer Institute, Surveillance, Epidemiology, and End Results Program (SEER). 10 Malfertheiner P. et al. Management of Helicobacter pylori infection - the Maastricht IV/ Florence Consensus Report, Gut 2012;61:646-664; O'Connor A. et al. Treatment of Helicobacter pylori Infection 2015, Helicobacter 20 (S1) 54-61; Venerito M. et al. Meta-analysis of bismuth quadruple therapy versus clarithromycin triple therapy for empiric primary treatment of Helicobacter pylori infection. Digestion 2013;88(1):33-45. 11 Defined as the PK population which included those subjects in the ITT population who had demonstrated presence of any component of investigational drug at visit 3 (approx. day 13) or had undetected levels drawn >250 hours after the last dose. 12 The pivotal Phase 3 study with Talicia® demonstrated 84% eradication of H. pylori infection with Talicia® vs. 58% in the active comparator arm (ITT analysis, p<0.0001). 13 Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: . Logo - SOURCE RedHill Biopharma Ltd. 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 近日有消息指，国家层面将在2025上半年开展第十一批药品集中采购，头孢类作为国采“常客”，再有两款重磅注射剂备战。2024年Q1-Q3在重点省市公立医院终端，头孢类的销售额继续下滑，TOP20品种大洗牌，6个昔日亿级品种跌落神坛。近几年，太极集团、齐鲁制药、倍特药业逆势拼搏，成绩亮眼，济川药业等11家药企在2024年正式入局，9个重磅新品将迎来首家获批，市场新一轮激战备受瞩目。 头孢类市场“三连跌”！太极、齐鲁、倍特逆势拼搏 头孢类是临床常用药，一直是全身用抗细菌药最热门的小类，近几年在限输限抗、国采、地方集采等系列政策的影响下，该类药物的市场份额不断下滑。2024年Q1-Q3在重点省市公立医院终端，头孢类的销售额继续下滑，跌幅超过10%，在全身用抗细菌药市场的份额跌至38.33%，为近十年新低，形势十分严峻。 图1：近几年头孢类的销售情况（单位：万元）来源：米内网重点省市公立医院药品终端竞争格局 从用药途径来看，注射药品的占比依然在八成以上，2024年Q1-Q3销售额下滑了17.25%；内服药品的占比回升至12%以上，2024年Q1-Q3销售额大涨了33.46%。 在重点省市公立医院终端，头孢类的销售峰值出现在2017年，当年TOP10集团（二级，下同）合揽超过50%的市场，而2024年Q1-Q3的TOP10集团合揽的市场份额升至60%以上，市场集中度有了大幅提升。 表1：2017年及2024年Q1-Q3头孢类TOP5集团的变化情况来源：米内网重点省市公立医院药品终端竞争格局 太极集团在2017年排在TOP7集团，市场份额在3.02%。近几年太极集团的头孢类销售额有升有降，排名在2022年升上TOP3后一直稳守高位，2024年Q1-Q3的市场份额已超过了5%。 齐鲁制药的头孢类销售额则在2021年起迎来爆发期，最近四年的增长率分别为353.55%、301.19%、89.66%、56.69%，成功在2024年Q1-Q3升上TOP4集团，市场份额从2017年的0.18%一路狂飙至2.77%，发展势头勇猛。 倍特药业也是近几年的黑马之一，集团的头孢类在2018-2022年实现了快速增长，增长率分别为28.50%、55.09%、18.64%、88.31%、107.48%，市场份额在2022年升上2.62%。近两年倍特药业的头孢类销售额出现了下滑态势，但市场份额依然保持在2%以上，2024年Q1-Q3排在TOP8集团，2025年能否止跌回升，我们拭目以待。 6个亿级品种陨落，独家品种飞涨95%，最新TOP20出炉 2018年4+7城市试点为国家集中带量采购工作掀开序幕，头孢类作为临床常用药，每一批次均有涉及，据统计，前十批国采已涉及19个畅销品种，“以价换量”进一步加快市场洗牌。 表2：2017年及2024年Q1-Q3头孢类TOP20品种变化情况来源：米内网重点省市公立医院药品终端竞争格局 2017年TOP20品种合计市场份额为87.54%，仅1个品种市场份额超过10%，2024年Q1-Q3的TOP20品种合计市场份额超过93%，两个品种的市场份额在10%以上，品种的市场集中度也在不断提升。 对比2017年的TOP20品种，仅有头孢哌酮舒巴坦和拉氧头孢在2024年Q1-Q3的排名不变。2024年Q1-Q3头孢哌酮舒巴坦以24.47%的市场份额遥遥领先，注射用头孢哌酮钠舒巴坦钠在第八批国采（2023年4月）中标，该品种的销售额大跌了29.88%；2024年Q1-Q3拉氧头孢的市场份额保持在10%以上，销售额跌了26.32%，注射用拉氧头孢钠在第十批国采（2024年12月）中标，该品种后续会否“跌不停”，我们将继续观察。 六大潜力品种备受关注：头孢他啶阿维巴坦和头孢克洛跻身TOP10品种，2024年Q1-Q3的销售额增长率分别为26.26%、16.37%；独家品种头孢托仑匹酯的销售额2022年起连连暴涨，近三年的增长率分别为319.14%、141.36%、95.36%，2024年Q1-Q3排名TOP13；头孢泊肟酯2024年Q1-Q3销售额增长了21.78%，排名TOP14；头孢拉定和头孢曲松他唑巴坦位列TOP18、TOP20品种，两个品种2024年Q1-Q3的销售额有下滑。 图2：头孢他啶阿维巴坦的销售情况（单位：万元）来源：米内网重点省市公立医院药品终端竞争格局 辉瑞的注射用头孢他啶阿维巴坦钠在2019年进入中国市场，齐鲁制药在2021年拿下国内首仿+首家过评，2023年科伦药业的注射用头孢他啶阿维巴坦钠/氯化钠注射液拿下国内首仿+首家过评，目前国内市场上的头孢他啶阿维巴坦涉及两个产品，共14家竞争企业。 值得注意的是，6个亿级品种跌出了TOP20榜单：头孢克肟2017年销售额为4.0亿元，2024年Q1-Q3跌至3800万元，最新排名为TOP21；头孢西丁2017年销售额为5.4亿元，2024年Q1-Q3跌至2100万元，最新排名为TOP28；头孢孟多2017年销售额为5.3亿元，2024年Q1-Q3也跌至了2000万元，最新排名为TOP29；头孢甲肟2017年销售额为2.9亿元，2024年Q1-Q3跌至1400万元，最新排名为TOP30；头孢地嗪2017年销售额为3.0亿元，2024年Q1-Q3跌至500万元，最新排名为TOP33；头孢替唑2017年销售额为2.6亿元，2024年Q1-Q3跌至100万元，最新排名为TOP39……昔日畅销大品种跌落神坛，市场洗牌十分严重。 中药龙头入局抢食，葫芦娃、科伦抢重磅首仿 2015年开局，头孢类市场再迎7个新产品，包括了齐鲁制药的注射用头孢哌酮钠舒巴坦钠、瑞阳制药的注射用头孢他啶阿维巴坦钠、华润三九的注射用头孢唑肟钠、国药集团的头孢丙烯干混悬剂和头孢地尼颗粒、海南广升誉制药的头孢羟氨苄片、正大天晴药业集团的注射用头孢他啶阿维巴坦钠，该类药物市场持续有新的入局者。 表3：2024年获批的头孢类新产品情况来源：米内网中国申报进度（MED）数据库 据统计，2024年全年获批了49个头孢类新产品（按产品名+企业名统计），其中注射用头孢唑肟钠有11家企业新获批，是大热品种。 从企业集团来看，齐鲁制药共拿下8个新品遥遥领先，包括了头孢克肟颗粒、头孢地尼胶囊、头孢地尼颗粒、注射用盐酸头孢替安、头孢克洛干混悬剂、头孢泊肟酯片、头孢克洛胶囊、头孢泊肟酯干混悬剂。 值得注意的是，有11家药企在2024年正式入局头孢类市场，包括了中药龙头济川药业。2024上半年在中国三大终端六大市场，济川药业是中成药TOP10集团（二级），近几年公司在化药市场不断有新品获批，2024年12月公司的注射用头孢唑肟钠获批，成功为公司打开头孢类市场大门。 表4：即将上市的部分头孢类重磅新品来源：米内网中国申报进度（MED）数据库 据统计，2018年至今头孢类有120多个受理号申请上市在审，其中9个重磅新品即将迎来首家获批，包括了两个原研药注射用头孢洛生他唑巴坦钠和注射用头孢德罗。资料显示，注射用头孢洛生他唑巴坦钠在2014年获得FDA批准上市，注射用头孢德罗在2019年获得FDA批准上市，米内网预计上述两个产品有望在2025年下半年在中国获批。 目前市场上的头孢托仑匹酯制剂均为明治的独家产品，近三年在重点省市公立医院终端的销售额持续飞涨，市场潜力不容小觑。福安药业庆余堂制药、北京诚济制药、海南葫芦娃药业集团将争夺头孢托仑匹酯颗粒的国内首仿，而头孢妥仑匹酯片仅有福安药业庆余堂制药申报仿制上市在审，该品种国内首仿属谁，或将于2025年揭开谜底。 注射用头孢唑肟钠/氯化钠注射液是一款粉液双室袋产品，科伦药业已成为多室袋制剂的行业龙头，无论最终能否抢下国内首仿，都将为公司的产品线再添重磅一员。 国产1类新药方面，白云山制药总厂的1类新药注射用头孢嗪脒钠在2017年获批临床，该新药在2024年4月启动了敏感菌引起的社区获得性肺炎的II期临床，同年11月第一例受试者成功入组。 2025上半年启动第十一批国采，两款重磅注射剂备战 近日在国家医保局的新闻发布会上获悉，国家层面将在2025上半年开展第十一批药品集中采购，市场再度掀起热浪。 截至2025年1月20日，头孢类过评（含视同过评）的产品超过60个（按产品名统计，下同），前十批国采已有28个产品中标，目前竞争企业（过评+原研）≥7家的有注射用头孢唑肟钠和注射用头孢他啶阿维巴坦钠。 表5：竞争企业（过评+原研）≥7家的头孢类产品来源：米内网重点省市公立医院药品终端竞争格局 随着国产品牌陆续获批，注射用头孢他啶阿维巴坦钠在重点省市公立医院终端的销售额持续暴涨，2024年Q1-Q3原研企业辉瑞的市场份额跌至88.35%，齐鲁、科伦、南京优科制药等国内药企快速抢占市场，若该产品能纳入第十一批国采，国产品牌有望借力再创新佳绩。 资料来源：米内网数据库等注：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2025年1月20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