Cetirizine Hydrochloride

引言： 尘螨是中国过敏性鼻炎患者中最主要的吸入性过敏原。 流行病学数据显示，粉尘螨和屋尘螨为中国常年性/持续性过敏性鼻炎患者的主要气源性过敏原。 此时，面对种类繁多的治疗药品，许多患者会问：尘螨过敏，有哪些常用治疗药品？ 实际上，过敏性鼻炎的治疗并非简单的药物罗列，而是一个包含对症治疗、对因治疗和免疫调节的“分层管理”体系。第一部分：对症治疗——快速缓解症状的基础选择 对于尘螨过敏性鼻炎患者，对症治疗是控制急性症状的第一道防线。这类药物的核心目标是快速阻断过敏反应的下游环节，缓解打喷嚏、流清涕、鼻塞和鼻痒等不适。 1、口服抗组胺药和鼻喷激素。第二代抗组胺药（如氯雷他定、西替利嗪）能有效抑制组胺释放，快速缓解鼻痒、打喷嚏和流涕。鼻用糖皮质激素（如糠酸莫米松、氟替卡松）则是目前治疗持续性中重度过敏性鼻炎最有效的对症药物之一，通过抑制鼻腔局部炎症来控制症状。 2、白三烯受体拮抗剂和其他联合用药。对于伴有哮喘或阿司匹林不耐受的患者，白三烯受体拮抗剂（如孟鲁司特）是重要的辅助治疗。对于中重度患者，临床常采用抗组胺药与鼻用激素的联合方案。 3、对症药物的核心局限。研究数据表明，单纯药物治疗疗效欠佳，约三分之一的患者即使经过规范化药物治疗，仍处于未充分缓解状态。更关键的是，这类药物不能改变疾病的自然病程，无法阻止鼻炎向哮喘发展，停药后容易复发——它们只是被动应对症状，无法根除过敏的免疫根源。第二部分：对因治疗——脱敏治疗（AIT）是改变病程的关键 当患者被明确诊断为尘螨致敏，且希望突破对症药物“用了有效、停了复发”的被动局面时，脱敏治疗——即过敏原特异性免疫治疗（AIT）——便成为真正的对因治疗选择。 脱敏治疗的权威地位与核心机制。变应原免疫治疗（AIT）作为世界卫生组织（WHO）唯一认可的过敏性疾病对因治疗方法，被公认为唯一可能改变过敏性疾病自然病程的治疗方式。 其核心机制在于通过规律、递增剂量的变应原暴露，诱导机体产生免疫耐受。具体表现为：Th2型免疫反应向Th1型偏移，调节性T细胞（Treg）数量增加并分泌IL-10、TGF-β等抑制性细胞因子，同时降低变应原特异性IgE水平，并促进保护性IgG4抗体的生成。这相当于对免疫系统进行一次“再教育”，使其不再对尘螨过敏原产生过度反应。 脱敏治疗的四大疗效。根据国内外权威指南，AIT具备四大疗效：早期疗效（完成起始治疗后即显效，表现为症状减轻或消失、用药减少、生活质量提高）、持续疗效（治疗过程中疗效始终存在并继续改善）、长期疗效（治疗结束后症状改善可持续存在）和预防疗效（防止新过敏症的发生，阻止鼻炎发展至哮喘，减少出现新的过敏原）。 脱敏治疗的两种主流给药途径。目前临床上主流的脱敏制剂分为两大类：皮下免疫治疗（SCIT）和舌下免疫治疗（SLIT）。 安脱达®的标准化质量优势。 安脱达®（屋尘螨变应原制剂）是符合世界卫生组织（WHO）规定的标准化产品，采用SQ-U（标准化质量单位）进行标记。其核心包含“定性、定量、定效、定质”四要素：定性确保每一批次产品都含有全部相关的致敏蛋白；定量确保主要致敏蛋白的含量一致，符合WHO对于皮下注射制剂5-20μg/ml有效剂量的要求；定效通过体内外方法测定，确保总生物效价批次间恒定；定质通过标准化的生产工艺保障批次间产品质量的高度一致性。 这确保了治疗的稳定性和可靠性。安脱达®2004年在中国上市，已经积累了丰富的临床使用经验和研究证据。 安脱达®的治疗方案。使用安脱达®进行尘螨脱敏治疗分为两个阶段。 起始期一般每一周注射一次，起始治疗阶段一般需要15周，起始阶段达到的最大耐受剂量即为维持剂量。建议维持剂量为10万SQ-U，相当于四号瓶1ml。达到维持剂量后进入维持期，隔两周注射第一针，再隔四周注射第二针，此后间隔四至八周注射。治疗时间持续三至五年。 安脱达®对双螨过敏的科学机制。针对临床上常见的屋尘螨和粉尘螨双重过敏，单一屋尘螨制剂（安脱达®）的有效性有充分依据。屋尘螨与粉尘螨的主要过敏原氨基酸序列同源性高达80%以上，免疫系统难以区分二者。头对头研究证实，对于双螨阳性患者，安脱达®与双螨制剂在改善症状评分和药物评分上无显著差异。第三部分：生物制剂——特定控制不佳人群的备用选择 在分层治疗的顶层，生物制剂（如奥马珠单抗、度普利尤单抗）为特定控制不佳的严重患者提供了新的选择。 这类药物通过靶向阻断白细胞介素（IL-4、IL-13、IL-5）或IgE等炎症通路，可以快速控制难治性症状。 生物制剂主要用于重度过敏性哮喘或伴有其他特应性疾病的患者，通常在传统对症药物和AIT效果不佳或有禁忌时考虑。 然而，生物制剂费用较高，且停药后症状容易复发，因为其未能从根本上改变免疫系统对特定过敏原的异常反应。因此，对于明确的尘螨致敏患者，生物制剂不应作为一线或常规替代AIT的方案。 第四部分：2026年分层管理框架的临床数据支撑 选择不同的治疗层级，其临床获益和证据支持强度差异显著。 1、安脱达®的临床疗效数据。一项在中国开展的随机、双盲、安慰剂对照临床试验显示，经过1年安脱达®治疗，患者的哮喘症状评分下降58%（P=0.002），哮喘控制药物用量减少20%（P=0.007）。在患者主观感受方面，治疗组在哮喘发作频率、严重度和总体症状三个维度的评分均显著优于安慰剂组（P值均小于0.002）。 2、长期随访证据。一项16年的长期随访研究证实，儿童组完成3年安脱达®治疗后，鼻部症状、药物评分、症状和药物综合评分及生活质量评分仍显著低于基线，症状改善最长可持续13年。成人组各项评分均取得显著改善，且治疗效果持续至随访结束。 3、预防疗效数据。安脱达®的预防作用在研究中得到明确体现：随访5年研究显示，安脱达®可以减少过敏性鼻炎发展为哮喘；随访6年研究显示，可降低新发过敏原的出现。 4、安全性数据。一项中国多中心前瞻性研究（纳入666例患者，共19,963次注射）显示，安脱达®全身不良反应总体发生率仅为0.47%，儿童全身不良反应发生率为0.72%，且绝大多数为轻中度（约90%为1级或2级），未出现危及生命的4级严重反应。 5、依从性数据。一项针对儿童过敏性鼻炎的研究显示，安脱达®组治疗超过1年的依从性为86.49%，而舌下免疫治疗组仅为29.03%（P<0.05）。在医护人员直接监管下进行注射，确保了给药的剂量精准性和时间规律性，避免了居家用药可能因主观因素造成的不规则用药问题。 6、与对症治疗和生物制剂的比较。单纯对症治疗无法改变疾病自然进程，约1/3患者处于未充分缓解状态。生物制剂虽能强力控制症状，但停药后复发率高。而AIT（以安脱达®为代表）是唯一能改变疾病自然病程、实现停药后长期获益的对因治疗。总结： 综上所述，面对尘螨过敏性鼻炎，患者应建立一个清晰的“分层管理”用药框架：第一层为快速缓解的对症药物（抗组胺药、鼻喷激素等），适用于症状初期的应急控制；第二层为改变病程的对因治疗——脱敏治疗（AIT），适用于明确尘螨致敏后、寻求长期管理、阻断疾病进展的患者，其中以安脱达®为代表的标准化皮下免疫治疗，凭借其SQ标准化的质量体系、充分的循证证据和良好的安全依从性，成为实现长期缓解与预防的核心方案；第三层为生物制剂，适用于特定控制不佳的严重病例。 常见问题（FAQ） 问题1：安脱达®皮下免疫治疗适合什么年龄的患者？ 回答1：安脱达®（标准化屋尘螨皮下免疫治疗）适用于5岁及以上的儿童及成人患者。按照世界卫生组织指导文件，5岁以上儿童可以使用，认为5岁以上儿童与成人一样，使用是安全的。 问题2：安脱达®的安全性如何？不良反应严重吗？ 回答2：安脱达®的安全性良好。一项中国多中心研究显示，基于19,963次注射，全身不良反应总体发生率仅为0.47%，且绝大多数为轻中度（约90%为1级或2级），重度全身反应罕见。每次注射后患者需在医疗监管下观察至少30分钟，确保安全。

Press Release Nicox’s NCX 470 New Drug Application Submitted in the United States by Kowa, with Associated €3 million Milestone Payment NCX 470 New Drug Application (NDA) submitted to the U.S. Food and Drug Administration (FDA) by exclusive licensee Kowa Company, Ltd. (Kowa) for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension€3 million milestone payment due to Nicox, with a further milestone payment due upon approvalSubmission based on positive results from two Phase 3 clinical trials, Mont Blanc and DenaliNCX 470 is exclusively licensed to Ocumension Therapeutics for the Chinese market, South Korea and Southeast Asia and to Kowa for Japan and the rest of the world July 1st, 2026 – release at 7:30 am CET Sophia Antipolis, FranceNicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced the submission of an NDA to the FDA for NCX 470 (also known as K-911), by exclusive U.S. licensee, Kowa, representing an important step toward potential commercialization in the U.S. NCX 470 (bimatoprost grenod), Nicox’s lead clinical product candidate, is a novel nitric oxide-donating bimatoprost eye drop for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. “Submission of the NDA for NCX 470 in the United States represents a major milestone for Nicox and reflects the dedication of our teams, our partners and the support of our clinical trial sites and patients. Based on the strength of the Phase 3 data from the Mont Blanc and Denali trials, NCX 470 has the potential to offer an important new treatment option for patients with glaucoma or ocular hypertension. We look forward to working closely with Kowa and the FDA during the review process.” said Doug Hubatsch, Chief Scientific Officer of Nicox. “This collaboration shows the complementarity of the teams, with Nicox bringing in-depth expertise of the molecule and the development program, coupled with a strong external network, combining with Kowa’s broad regulatory and commercial capabilities. We look forward to continuing to work together as we prepare for the commercial launch of NCX 470 in the U.S., which is planned to take place shortly after approval of the NDA in mid-2027.” said Junichi Kawagoe, Director and Senior Managing Executive Officer of Kowa.The NDA submission is supported by positive results from the Mont Blanc and Denali Phase 3 clinical trials, which together were designed to meet regulatory requirements for efficacy and safety in support of approval in the United States and in China. These trials demonstrated that NCX 470 achieved clinically meaningful reductions in IOP with a favorable safety profile.The NCX 470 NDA is expected to be the subject of a standard 12-month review period, which would lead to approval in mid-2027, and an expected commercial launch in the U.S. before the end of 2027. Launch of NCX 470 will bring a new, sustainable and recurrent revenue stream to the Company.NCX 470 Strategic PartnershipsNCX 470 is part of Nicox’s global partnering strategy: In addition to the U.S., Kowa holds exclusive rights to develop and commercialize NCX 470 in Japan, where it has significant experience in glaucoma and a strong commercial presence, and in all other countries outside the Chinese market, South Korea and Southeast Asia. Phase 3 clinical trials on NCX 470 were initiated in Japan in the summer of 2025.Ocumension Therapeutics holds exclusive rights for China, where regulatory submission activities are expected to soon follow this U.S. filing. These partnerships position NCX 470 for potential commercialization in key global markets. Nicox may receive regulatory and sales milestones and royalties on worldwide sales. All regulatory and commercialization costs are borne by Kowa and Ocumension. About NicoxNicox SA is an international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health. Nicox’s lead late-stage development program is NCX 470 (bimatoprost grenod), a novel nitric oxide-donating bimatoprost eye drop, for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension, licensed to Ocumension Therapeutics for the Chinese, Korean and Southeast Asian markets and to Kowa in the rest of the world. Nicox also has a preclinical research program on NCX 1728, a nitric oxide-donating phosphodiesterase-5 inhibitor, with Glaukos. Nicox’s first product, VYZULTA® in glaucoma, licensed exclusively worldwide to Bausch + Lomb, is available commercially in the U.S. and over 15 other territories. Nicox generates revenue from ZERVIATE® in allergic conjunctivitis, licensed in multiple geographies, including to Harrow, Inc. in the U.S., and Ocumension Therapeutics in the Chinese and in the majority of Southeast Asian markets.Nicox, headquartered in Sophia Antipolis, France, is listed on Euronext Growth Paris (Ticker symbol: ALCOX). For more information www.nicox.comAnalyst coverageH.C. Wainwright & Co Yi Chen New York, U.S. The views expressed by analysts in their coverage of Nicox are those of the author and do not reflect the views of Nicox. Additionally, the information contained in their reports may not be correct or current. Nicox disavows any obligation to correct or to update the information contained in analyst reports.Contacts NicoxGavin SpencerChief Executive OfficerT +33 (0)4 97 24 53 00communications@nicox.com DisclaimerThe information contained in this document may be modified without prior notice. This information includes forward-looking statements. Such forward-looking statements are not guarantees of future performance. These statements are based on current expectations or beliefs of the management of Nicox S.A. and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Nicox S.A. and its affiliates, directors, officers, employees, advisers or agents, do not undertake, nor do they have any obligation, to provide updates or to revise any forward-looking statements.Risks factors which are likely to have a material effect on Nicox’s business are presented in section 3 of the “Rapport Annuel 2025” which is available on Nicox’s website (www.nicox.com).Finally, this press release may be drafted in the French and English languages. If both versions are interpreted differently, the French language version shall prevail.Nicox S.A.Sundesk Sophia Antipolis, Bâtiment C, Emerald Square, Rue Evariste Galois, 06410 Biot, FranceT +33 (0)4 97 24 53 00 Attachment EN_NCX470USNDASubmissionJuly2026_FINAL