Povidone-Iodine

编辑：子非鱼 9月24日，广州GPO发出《关于广东云南省际联盟集中带量采购相关药品信息预填报工作的公告》，公告显示，按照国家医保局工作部署，广东、云南两省拟分别牵头开展部分化学药品省际联盟集中带量采购，现开展相关药品信息预填报工作，预填报时间：9月28日09:00-10月15日18:00。 本次共梳理形成68个化学药通用名、合计274个申报品规的预填报清单，其中广东牵头35个品种（136个品规）、云南牵头33个品种（138个品规），标志着本轮联盟集采正式进入企业信息归集与需求摸排阶段。 填报资质与材料要求全面收紧 公告明确，本次信息填报覆盖四类主体：参比制剂、过评仿制药（含视同过评）、未过评仿制药（含未开放一致性评价通道品种），即所有合规上市品种均可参与，不存在过评门槛限制。但企业需提交的证明材料较以往更为细化。 除基础企业、药品注册信息外，必须上传GMP符合性检查证明（进口药需公证翻译）、近5年内跨24个月以上的上市销售放行记录、关联股权关系证明、知识产权无侵权承诺、年度产能声明等全套材料。 其中知识产权条款惩戒力度明确：申报截止前未提交无侵权承诺的产品，已挂网的将予以撤网、未挂网的协议期内不再受理挂网申请。 品种结构长尾特征显著，特殊品类集中入围 从清单结构看，本轮集采明显跳出过往国采聚焦大口服、大注射剂的传统范围，呈现“长尾专科药+外用/特殊剂型为主”的特征： 1、外用制剂占比突出。他克莫司、吡美莫司、莫匹罗星、夫西地酸、卡泊三醇等皮肤科软膏剂合计超40个品规，氯己定、聚维酮碘、依沙吖啶、炉甘石等外用消毒/护理液体剂超60个品规，是本轮清单中剂型占比最高的板块。 2、儿童与口服液体剂扩容明显。氨酚麻美、左西替利嗪、丙卡特罗、西甲硅油、二甲硅油、小儿氨酚黄那敏颗粒等儿科常用液体制剂合计超40个品规，基层门诊、儿科用药成为本轮集采重点摸排方向。 3、高值与特殊属性品种纳入值得关注。碘[125I]密封籽源（放射性医用药品）、肝素封管注射液、两性霉素B脂质体注射剂、白消安注射剂、阿昔替尼口服常释剂型、泊沙康唑口服液体剂等重症、罕见病、肿瘤靶向、特殊诊疗用药均在清单内，其中放射性籽源、院内封管液这类长期未进入集采视野的院内配套制剂首次纳入省际联盟采购范围。 行业影响 本次预填报是后续医疗机构报量、正式竞价的前置环节，企业填报的品规范围将直接进入医院需求选择池，漏报、错报会直接影响后续中选资格与平台挂网权限。 从品种选择趋势看，继生物药、中成药之后，化药集采的下沉方向已明确转向院外常用、小众专科、外用与儿童制剂这类“长尾市场”，过往这类品种因单品市场规模有限、企业数量分散长期未被集采覆盖，未来将逐步成为地方联盟集采的常态化挖掘对象。 对企业而言，需提前梳理GMP、产能、历史销售等佐证材料，重视知识产权合规，避免因信息不全错失参与资格。最终正式采购范围、竞价规则仍以后续发布的正式采购公告为准。 声明：本公众号内容旨在为医药行业人士提供行业动态，并不构成任何就医/用药/购药/投资建议，内容也不保证完整性和准确性，你看到此内容并不意味着你是本公众号的特定读者，请谨慎阅读。 关注公众号，获取可靠、专业的资讯和分析内容

NASHVILLE, Tenn., July 20, 2026 (GLOBE NEWSWIRE) -- Harrow (Nasdaq: HROW), a leading provider of ophthalmic disease management solutions in North America, today announced the presentation of three studies supporting IHEEZO ® (chloroprocaine HCl ophthalmic gel 3%), a broadly labeled low viscosity ocular anesthetic gel, and BYOOVIZ ® (ranibizumab-nuna) i , an FDA-approved biosimilar referencing LUCENTIS ii (ranibizumab) at the American Society of Retina Specialists (ASRS) 2026 Annual Meeting. Collectively, the presentations expand the growing body of clinical and real-world evidence supporting Harrow's retina portfolio and reinforce Harrow’s commitment to generating quality evidence that strengthens physician confidence, improves patient experience, and supports long-term product adoption and innovation. “ASRS is one of the premier scientific meetings in retina, and we're excited to share data that continues to strengthen the foundation supporting our growing retina franchise,” said Mark L. Baum, Chief Executive Officer of Harrow. “We believe durable commercial success is built on strong clinical evidence, generated before FDA-approval, and then robust supportive data sets subsequently produced. These studies further expand the evidence supporting IHEEZO while adding to the growing body of real-world experience for BYOOVIZ, reflecting our long-term commitment to retina specialists and the patients they treat.” One presentation highlighted interim findings from an investigator-initiated, prospective, randomized study of 150 patients comparing IHEEZO versus subconjunctival lidocaine. While these preliminary data represent an early look at the data, investigators observed encouraging trends toward less post-procedure pain, a better post-injection patient experience, and fewer ocular symptoms through 24 hours following intravitreal injection among patients treated with IHEEZO. Harrow believes these early findings provide an encouraging signal supporting further investigation in a larger patient population. Importantly, Harrow continues to enroll QUELL, a prospective, randomized, multi-center clinical trial of approximately 236 subjects that is being conducted under an active Investigational New Drug (IND) application. QUELL is designed to generate robust clinical evidence evaluating post-injection pain, patient experience, procedural performance, and safety in a substantially larger patient population, with topline data expected in the fourth quarter of 2026. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Another real-world study retrospectively evaluated whether IHEEZO's proprietary low-viscosity gel formulation interferes with antisepsis when used with chlorhexidine before intravitreal injection. Across nearly 20,000 injections, investigators observed no evidence of an increased endophthalmitis risk compared with a legacy tetracaine/povidone-iodine preparation. Although retrospective and not intended to demonstrate statistical superiority, the findings provide further confidence that physicians can realize the patient-experience benefits of IHEEZO's low-viscosity gel formulation without introducing additional procedural risk associated with antisepsis. “These studies help build the scientific foundation supporting IHEEZO,” said Amir Shojaei, Chief Scientific Officer of Harrow. “The early interim randomized data suggest the potential to improve the patient experience, while the large real-world analysis provides reassuring evidence regarding procedural safety. We look forward to completing enrollment in QUELL, which we believe will provide the most comprehensive evaluation of IHEEZO in retina to date.” Finally, Samsung Bioepis presented interim findings from a large-scale, real-world post-marketing surveillance study of BYOOVIZ. Full results from this study are being announced jointly with Samsung Bioepis today. “Between the continued expansion of the clinical evidence supporting IHEEZO, the recent launch of BYOOVIZ, and the ongoing growth of our retina franchise, we believe Harrow is increasingly well-positioned as a trusted long-term partner to retina specialists,” Baum concluded. “We appreciated the opportunity to engage with physicians throughout ASRS and look forward to sharing additional updates later this year.” IHEEZO ® (chloroprocaine hydrochloride ophthalmic gel) 3%, for topical ophthalmic use INDICATIONS AND USAGE IHEEZO is an ester anesthetic indicated for ocular surface anesthesia. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS IHEEZO is contraindicated in patients with a history of hypersensitivity to any component of this preparation WARNINGS AND PRECATIONS Not for Injection or Intraocular Administration. Corneal Injury Due to Insensitivity. Corneal Opacification For Administration by Healthcare Provider: IHEEZO is not intended for patient self-administration ADVERSE REACTIONS Most common adverse reaction is mydriasis (approximately 25%) Please see full Prescribing information BYOOVIZ ® (ranibizumab-nuna) injection, for intravitreal use is a biosimilar to LUCENTIS (ranibizumab injection) INDICATIONS AND USAGE BYOOVIZ, a vascular endothelial growth factor (VEGF) inhibitor, is indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (AMD) Macular Edema Following Retinal Vein Occlusion (RVO) Myopic Choroidal Neovascularization (mCNV) IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Ocular or periocular infections Hypersensitivity WARNINGS AND PRECAUTIONS Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients should be monitored following the injection Increases in intraocular pressure (IOP) have been noted both pre- and post intravitreal injection There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors ADVERSE REACTIONS The most common adverse reactions (reported more frequently in ranibizumab treated subjects than control subjects) are conjunctival hemorrhage, eye pain, vitreous floaters, and increased IOP Please see full Prescribing Information About Harrow Harrow, Inc. (Nasdaq: HROW) is a leading provider of ophthalmic disease management solutions in North America, offering a comprehensive portfolio of products that address conditions affecting both the front and back of the eye, such as dry eye disease, wet (or neovascular) age-related macular degeneration, cataracts, refractive errors, glaucoma and a range of other ocular surface conditions and diseases of the retina. Harrow was founded with a commitment to deliver safe, effective, accessible, and affordable medications that enhance patient compliance and improve clinical outcomes. For more information about Harrow, please visit harrow.com and connect with us on LinkedIn . About Samsung Bioepis Co., Ltd. Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, neurology, and endocrinology. For more information, please visit and follow us on LinkedIn and X . Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such “forward-looking statements.” Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include, among others, risks related to: liquidity or results of operations; our ability to successfully implement our business plan, develop and commercialize our products, product candidates and proprietary formulations in a timely manner or at all, identify and acquire additional products, manage our pharmacy operations, service our debt, obtain financing necessary to operate our business, recruit and retain qualified personnel, manage any growth we may experience and successfully realize the benefits of our previous acquisitions and any other acquisitions and collaborative arrangements we may pursue; competition from pharmaceutical companies, outsourcing facilities and pharmacies; general economic and business conditions, including inflation and supply chain challenges; regulatory and legal risks and uncertainties related to our pharmacy operations and the pharmacy and pharmaceutical business in general, including the ongoing communications with the U.S. Food and Drug Administration relating to compliance and quality plans at our outsourcing facility in New Jersey; physician interest in and market acceptance of our current and any future formulations and compounding pharmacies generally. These and additional risks and uncertainties are more fully described in Harrow’s filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2025, and other filings with the SEC. Such documents may be read free of charge on the SEC's web site at sec.gov. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Harrow undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances after the date they are made, or to reflect the occurrence of unanticipated events. Contacts: Mike Biega Vice President of Investor Relations and Communications mbiega@harrowinc.com 617-913-8890 i Byooviz is a trademark of Samsung Bioepis Co., Ltd. ii Lucentis is a trademark of Genentech, Inc.