Fluticasone Propionate

过敏性鼻炎（Allergic Rhinitis, AR）是一种由IgE介导的鼻黏膜炎症性疾病，多发于春季花开之时，是一种常见的慢性疾病，主要症状包括鼻塞、流涕、打喷嚏、鼻痒等，这些症状不仅影响患者的生活质量，还可能对学习和工作效率产生负面影响。药物分类及作用机制研究表明，通过药物治疗、免疫治疗和预防措施可以有效控制过敏性鼻炎的症状，常用的药物有以下几类：抗组胺药：当过敏原进入人体后，肥大细胞释放组胺，组胺与H1受体结合，引发血管扩张、腺体分泌增多等过敏反应，导致鼻塞、流涕、打喷嚏等症状。抗组胺药通过与组胺竞争性结合H1受体，阻断组胺的致敏作用，从而缓解症状。此外，部分抗组胺药还能抑制炎症介质释放，减轻鼻腔黏膜的炎症反应，同时具有一定的中枢抑制作用，可缓解瘙痒和打喷嚏等不适。抗组胺药主要作用于组胺H1受体，对其他类型的组胺受体（如H2、H3、H4受体）影响较小，具有一定特异性，典型代表药物有氯雷他定、西替利嗪等。鼻用糖皮质激素：该药物治疗过敏性鼻炎的作用机制主要包括抗炎、抗过敏和抗水肿作用，一般通过抑制炎症介质的释放，减少鼻黏膜的炎症反应，从而缓解鼻塞、流涕、打喷嚏等症状。此外，它还能通过调节免疫功能（如诱导调节性T细胞的活化），进一步抑制过敏反应，典型代表药物有丙酸氟替卡松、糠酸莫米松等。肥大细胞稳定剂：该药物主要通过稳定肥大细胞膜，防止其在过敏原刺激下脱颗粒，减少组胺和其他炎性物质的释放，从而缓解喷嚏、流涕、鼻痒等症状。此外，部分肥大细胞稳定剂还具有一定的免疫调节作用，能够减轻鼻腔黏膜的炎症反应，典型代表药物有色甘酸钠、曲尼司特等。白三烯受体拮抗剂：白三烯是过敏反应中的关键炎性介质，它们会导致血管扩张、血管通透性增加、黏膜充血和肿胀，从而引起鼻塞、流涕等症状，白三烯受体拮抗剂通过选择性地与白三烯受体结合，阻止白三烯发挥作用，从而减轻炎症反应和过敏症状。此外，这类药物还具有一定的抗炎和免疫调节作用，可以进一步缓解过敏性鼻炎的症状。典型代表药物有孟鲁司特、扎鲁司特等。药物竞争市场格局基于PDB药物综合数据库展开分析，国内院端放大板块显示，2020年至2024年，过敏性鼻炎治疗药物市场呈现一个波动起伏的状态，2021年—2023年整个市场规模呈现缩减趋势，2023年已缩减至82.14亿元，而2024年回升84.75亿元，同比增长率达到3.17%。图：2020年-2024年过敏性鼻炎治疗药物市场规模来源：PDB药物综合数据库国内院端放大板块，中国医药工业信息中心过敏性鼻炎用药的产品格局也出现了巨大变化，其中，糠酸莫米松鼻喷雾剂的市场份额实现了大幅提升，从4.26%增长到10.38%，跃居市场首位，2024年销售额更是达到了8.79亿。吸入用丙酸倍氯米松混悬液的市场份额也实现了快速增长，从1.35%攀升至6.75%，成功跻身市场前三。相比较之下，孟鲁司特钠片的市场份额增长相对平缓，而注射用胸腺法新、注射用甲泼尼龙琥珀酸钠的市场份额则出现了大幅缩减，注射用胸腺法新的降幅更是超过了10%，痛失榜一宝座。图：2020年、2024年过敏性鼻炎治疗药物市场竞争格局来源：PDB药物综合数据库国内院端放大板块，中国医药工业信息中心TOP3产品分析糠酸莫米松鼻喷雾剂糠酸莫米松鼻喷雾剂是一种用于治疗过敏性鼻炎的鼻用糖皮质激素，可通过抑制炎症细胞（如肥大细胞、嗜酸性粒细胞等）的活化和迁移，减少炎症介质及过敏反应介质的生成和释放，从而减轻鼻腔黏膜的炎症反应及过敏反应的发生，同时可以抑制IL-4和IL-5的合成和释放、减少血管通透性，缓解病症。糠酸莫米松鼻喷雾剂是由默沙东公司（美国、加拿大称为默克）研发的。该药物的商品名为Nasonex，最早于1997年获得美国食品药品监督管理局（FDA）批准上市，用于治疗成人、12岁及以上青少年鼻部变态反应。2003年，先灵葆雅的糠酸莫米松鼻喷雾剂获准进入我国市场，商品名为内舒拿。2011年，浙江仙琚制药股份有限公司新获首仿，商品名为逸青。据PDB药物综合数据库分析，2024年，国内获批上市且在售的糠酸莫米松鼻喷雾剂仅有内舒拿和逸青两款，Organon Pharma（默沙东子公司）以55%的市场份额拔得头筹，仙琚制药略逊色一点，市场份额达到了45%，目前两款药物均被纳入了医保报销目录，属于国家乙类医保。图：2024年糠酸莫米松鼻喷雾剂企业竞争格局来源：PDB药物综合数据库国内院端放大板块，中国医药工业信息中心孟鲁司特钠片孟鲁司特钠片是由默沙东制药公司研发的，作为一种白三烯受体拮抗剂（CysLT拮抗剂），可通过特异性抑制气道中的半胱氨酰白三烯受体，减少炎症反应，从而改善哮喘和过敏性鼻炎患者的症状。孟鲁司特钠片已进入医保目录，属于医保乙类药品，目前国内有7家企业可以生产孟鲁司特钠片，但仅有上海安必生制药技术有限公司的孟鲁司特钠片（商品名：舒宁安）被纳入“4+7”试点带量采购（开始于2019年1月），可以看到，集采后中标企业的销售额占比大幅提升，2021年销售额占比更是达到了66.89%。图：孟鲁司特钠片集采前后院端销售额变化来源：PDB药物综合数据库国内院端放大板块，中国医药工业信息中心吸入用丙酸倍氯米松混悬液吸入用丙酸倍氯米松混悬液是由意大利凯西制药公司Chiesi Farmaceutici S.p.A.研发的，丙酸倍氯米松作为一种强效的糖皮质激素，经雾化吸入的方式直接作用于呼吸道，可有效地抑制炎症反应，减轻呼吸道黏膜的肿胀和炎症，对钠潴留及肝糖原异生作用较弱，无明显的全身性不良反应，尤其适合长期使用。目前，该药物已经进入了国家医保目录，属于医保甲类。传统药物注射用胸腺法新、注射用甲泼尼龙琥珀酸钠市场份额的下降也反映出了市场竞争的激烈，与注射用胸腺法新相比，注射用甲泼尼龙琥珀酸钠市场份额缩减幅度较小，与其被纳入第七批国采密不可分，越来越多新药的出现也会进一步促进市场更迭，将更多好用的药物推入临床。小结据统计，2025年Q1就已有新型过敏性鼻炎治疗药物获批上市：司普奇拜单抗，于2月7日获得CDE批准上市，是目前全球唯一获批治疗季节性过敏性鼻炎的IL-4Rα单抗药物。该药物由康诺亚自主研发，是一种针对白介素4受体α亚基（IL-4Rα）的高效、人源化单克隆抗体，注射给药，可通过靶向IL-4Rα，双重阻断白介素4（IL-4）及白介素13（IL-13）这两种引发2型炎症的关键细胞因子，有效遏制疾病进展。过敏性鼻炎的治疗需结合药物选择与科学预防策略，越来越多新药的产生将为过敏性鼻炎患者带来更多的治疗选择。END如需获取更多数据洞察信息或公众号内容合作，请联系医药地理小助手微信号：pharmadl001

Company reports fourth quarter and full year 2024 XHANCE net revenue of $22.4 million and $78.2 million, increases of 13% and 10% compared to prior year periods Company reports 23% prescription growth from third quarter 2024 to fourth quarter 2024 YARDLEY, Pa., March 26, 2025 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today reported financial results for the quarter and year ended December 31, 2024, and provided recent operational highlights. Fourth Quarter 2024 and Recent Highlights New Prescriptions (NRx) and Total Prescriptions (TRx)An inflection in prescription demand first observed in September 2024 NRx continued in fourth quarter 2024 and extended to TRx. NRx increased 12% from approximately 25,600 in third quarter 2024 to approximately 28,700 in fourth quarter 2024. TRx increased 23% from approximately 63,900 in third quarter 2024 to approximately 78,500 in fourth quarter 2024. Fourth Quarter 2024 Financial Results RevenuesThe Company reported $22.4 million in net revenue from sales of XHANCE during the three-month period ended December 31, 2024, an increase of 13% compared to $19.9 million during the three-month period ended December 31, 2023. For the twelve-month period ended December 31, 2024, the Company reported $78.2 million in net revenue from sales of XHANCE, an increase of 10% compared to $71.0 million during the twelve-month period ended December 31, 2023. Costs and expenses and net lossFor the three-month and twelve-month periods ended December 31, 2024, research and development expenses were $0.8 million and $3.9 million, respectively. Selling, general and administrative expenses were $19.3 million and $83.5 million during the three-month and twelve-month periods ended December 31, 2024, respectively. In total, SG&A plus R&D expenses increased by $2.2 million, to $87.3 million for the twelve-month period ended December 31, 2024 when compared to the twelve-month period ended December 31, 2023 total of $85.1 million. Income from operations was for the three-month period ended December 31, 2024, was $0.4 million. This is the first three-month period in which the Company reported income from operations. The net loss for the three-month period ended December 31, 2024 was $0.4 million, or $0.04 per share (basic and diluted). The net loss for the twelve-month period ended December 31, 2024 was $21.5 million, or $2.12 per share (basic and diluted). Balance SheetThe Company had cash and cash equivalents of $84.5 million as of December 31, 2024. OptiNose, Inc.Condensed Consolidated Statement of Operations(in thousands, except share and per share data)(Unaudited) Three Months Ended Year Ended December 31, December 31, 2024 2023 2024 2023 Revenues: Net product revenues $22,418 $19,865 $78,226 $70,987 Total revenues 22,418 19,865 78,226 70,987 Costs and expenses: Cost of product sales $1,954 $2,131 $7,231 $8,633 Research and development 772 1,286 3,855 5,303 Selling, general and administrative 19,338 18,960 83,459 79,799 Total costs and expenses 22,064 22,377 94,545 93,735 Income (loss) from operations 354 (2,512) (16,319) (22,748)Other (income) expense 714 7,455 5,222 12,735 Net (loss) $(360) $(9,967) $(21,541) $(35,483)Net loss per share of common stock, basic and diluted $(0.03) $(1.33) $(2.12) $(4.75)Weighted average common shares outstanding, basic and diluted 11,635,909 7,487,465 10,156,745 7,472,035 OptiNose, Inc.Condensed Consolidated Balance Sheet Data(in thousands) December 31 December 31, 2024 2023 Cash and cash equivalents $84,485 $73,684 Other assets 44,300 34,045 Total assets $128,785 $107,729 Total current liabilities (1) $162,813 $176,524 Other liabilities 6,332 17,811 Total stockholders' deficit (40,360) (86,606)Total liabilities and stockholders' deficit $128,785 $107,729 (1) – All outstanding principal and fees payable upon maturity have been classified as a current liability in accordance with Generally Accepted Accounting Principles ("GAAP") because, as of the date hereof, the Company believes that it is probable that it will not maintain compliance with certain financial covenants contained in its Amended and Restated Note Purchase Agreement for at least the next 12-months. As a result, the Company's audited financial statements for the year ended December 31, 2024 (“2024 Audited Financial Statements”) will state that there is substantial doubt about the Company's ability to continue as a going concern (i.e., a "going concern" paragraph). Please refer to the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 (including the 2024 Audited Financial Statements) which will be filed after the issuance of this press release for additional information. About OptinoseOptinose is a specialty pharmaceutical company focused on serving the needs of patients cared for by ear, nose and throat (ENT) and allergy specialists. To learn more, please visit www.optinose.com or follow us on Twitter and LinkedIn. About XHANCEXHANCE is a drug-device combination product that uses the Exhalation Delivery System™ (also referred to as the EDS®) designed to deliver a topical steroid to the high and deep regions of the nasal cavity where sinuses ventilate and drain. XHANCE is approved by the U.S. Food and Drug Administration for both the treatment of chronic rhinosinusitis without nasal polyps (also called chronic sinusitis) and chronic rhinosinusitis with nasal polyps (also called nasal polyps) in patients 18 years of age or older. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS: Hypersensitivity to any ingredient in XHANCE. WARNINGS AND PRECAUTIONS: Local nasal adverse reactions, including epistaxis, erosion, ulceration, septal perforation, Candida albicans infection, and impaired wound healing, can occur. Monitor patients periodically for signs of possible changes on the nasal mucosa. Avoid use in patients with recent nasal ulcerations, nasal surgery, or nasal trauma until healing has occurred.Glaucoma and cataracts may occur with long-term use. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use XHANCE long-term.Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, contact dermatitis, rash, hypotension, and bronchospasm) have been reported after administration of fluticasone propionate. Discontinue XHANCE if such reactions occur.Immunosuppression and infections can occur, including potential increased susceptibility to or worsening of infections (e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infection; ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients.Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue XHANCE slowly.Assess for decrease in bone mineral density initially and periodically thereafter. ADVERSE REACTIONS: Chronic rhinosinusitis without nasal polyps: The most common adverse reactions (incidence ≥3%) are epistaxis, headache, and nasopharyngitis.Chronic rhinosinusitis with nasal polyps: The most common adverse reactions (incidence ≥3%) are epistaxis, nasal septal ulceration, nasopharyngitis, nasal mucosal erythema, nasal mucosal ulcerations, nasal congestion, acute sinusitis, nasal septal erythema, headache, and pharyngitis. DRUG INTERACTIONS: Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): Use not recommended. May increase risk of systemic corticosteroid effects. USE IN SPECIFIC POPULATIONS: Hepatic impairment. Monitor patients for signs of increased drug exposure.Please see full Prescribing Information, including Instructions for Use Cautionary Note on Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. All statements that are not historical facts are hereby identified as forward-looking statements for this purpose and include, among others, statements relating to the potential benefits of XHANCE; the potential benefits of the Exhalation Delivery System; the Company's belief that it is probable that it will not maintain compliance with certain financial covenants contained in its Amended and Restated Note Purchase Agreement for at least the next 12-months and the consequences thereof; and other statements regarding the Company's future operations, financial performance, financial position, prospects, objectives, strategies and other future events. Forward-looking statements are based upon management’s current expectations and assumptions and are subject to a number of risks, uncertainties and other factors that could cause actual results and events to differ materially and adversely from those indicated by such forward-looking statements including, among others: physician and patient acceptance of XHANCE for its new indication; the Company’s ability to maintain adequate third-party reimbursement for XHANCE (including its new indication); the prevalence of chronic sinusitis and market opportunities for XHANCE may be smaller than expected; the Company’s ability to efficiently generate XHANCE prescriptions and net revenues; unanticipated costs and expenses; the risk that the positive inflection in new XHANCE prescriptions starting in September does not continue and grow; the Company’s ability to comply with the covenants and other terms of its Amended and Restated Note Purchase Agreement; the Company’s ability to continue as a going concern; risks and uncertainties relating to intellectual property and competitive products; and the risks, uncertainties and other factors discussed under the caption "Item 1A. Risk Factors" and elsewhere in the Company’s most recent Form 10-K and Form 10-Q filings with the Securities and Exchange Commission – which are available at www.sec.gov. As a result, you are cautioned not to place undue reliance on any forward-looking statements. Any forward-looking statements made in this press release speak only as of the date of this press release, and the Company undertakes no obligation to update such forward-looking statements, whether as a result of new information, future developments or otherwise. Optinose Investor Contact Jonathan Neely jonathan.neely@optinose.com267.521.0531