中国上海-2021年10月21日，罗欣药业集团股份有限公司（简称“罗欣药业”或“公司”）子公司山东罗欣药业集团股份有限公司（简称“山东罗欣”）与奥地利Marinomed Biotech AG（简称“Marinomed”）签署《许可协议》，山东罗欣将获得Budesolv®布地奈德溶液型鼻喷剂在大中华区（包括中国大陆、香港和澳门特别行政区、台湾地区）的独家开发、生产和商业化的权利。该合作有利于进一步丰富罗欣药业的产品线，巩固公司在呼吸系统疾病领域的优势地位。
（SHANGHAI, China -- On October 21, 2021-- Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. (“Shandong Luoxin”), a subsidiary of Luoxin Pharmaceutical Group Stock Co., Ltd. (“Luoxin Pharmaceutical” or “the company”) , signed a licensing agreement with Austria-based Marinomed Biotech AG (“Marinomed”), whereby Shandong Luoxin will gain the exclusive rights for the development, manufacture, and commercialization of Budesolv® (Budesonide Nasal spray) in China (including Chinese mainland , Hong Kong and Macao SAR, Taiwan region). The signing of the license agreement will further expand Luoxin Pharmaceutical’s product line and enhance Luoxin’s competitive edge in the area of respiratory diseases.）
Budesolv®为糖皮质激素布地奈德新型剂，属于激素类鼻喷雾剂，目前国内外暂未上市销售。Budesolv®是首个基于Marinomed公司的专有技术平台Marinosolv®开发的水溶型鼻喷剂，Budesolv®已成功完成欧洲上市申请所必需的关键性III期临床。关键性III期临床试验证实，与市售的Rhinocort® Aqua 64（布地奈德混悬型鼻喷剂）相比，用药剂量降低了85%，疗效不劣于Rhinocort® Aqua 64，起效更快，给药3小时症状明显缓解。
（Budesolv®, a new formulation of the glucocorticoid budesonide, which is a steroid nasal spray and is not yet available for domestic and overseas market. Budesolv® is the first medication originating from Marinomed’s proprietary Marinosolv® platform. Budesolv® has successfully completed a pivotal Phase III clinical study, necessary for marketing authorization in Europe. The recently completed pivotal clinical trial successfully demonstrated non-inferiority of the Budesonide nasal spray when compared to Rhinocort® Aqua 64. Furthermore, the trial demonstrated that Budesolv® was equally effective with a 85 % reduction in dosage and showed significantly faster onset of action within 3 hours.）
Budesolv®适用于过敏性鼻炎的治疗。过敏性鼻炎是发病率高、病程长、易反复发作的慢性疾病。数据显示，过去6年间中国过敏性鼻炎患病率从11.1%升高到了17.6%（数据来自《国际过敏和鼻科学论坛》）。根据IQVIA及米内网数据，2020年度激素类鼻喷雾剂全球市场规模为21.5亿美元（以出厂价计算），国内百张床位以上医院及零售药店市场规模合计为13.05亿元人民币。
（Budesolv® is indicated for allergic rhinitis. Allergic rhinitis is a chronic disease with high rate of incidence, long duration and easy recurrence. Statistics reveal that over the past six years, the prevalence of allergic rhinitis in China has increased from 11.1% to 17.6% (data from the《International Forum of Allergy & Rhinology》). Statistics from IQVIA and MENET show that the global market size of steroid nasal spray in 2020 is US$2.15 billion (ex-factory price), and the total Chinese market size (domestic hospitals with more than 100 beds and retail pharmacies) is 1.305 billion yuan.）
根据许可协议条款，山东罗欣将支付给Marinomed总计200万美元的首付款，并根据研发里程碑和销售里程碑，支付不超过2000万美元的里程碑付款。后续，随着布地奈德混悬型鼻喷剂的上市，罗欣药业将根据该产品在大中华区的销售情况，按照实际年净销售额分级向Mainomed支付销售提成。
（Under the terms of the agreement, Shandong Luoxin shall pay to Marinomed an upfront payment in the amount of USD 2,000,000, and will pay to Mainomed development and sales milestone payments not to exceed $ 20 Million. Once budesonide nasal spray suspension has been launched, Shandong Luoxin will pay to Marinomed tiered royalties based on net sales.）
Marinomed首席执行官
Dr. Andreas Grassauer
我们很荣幸能与罗欣药业这样一家在中国享有盛名的企业成为合作伙伴，并为基于Marinosolv®技术平台的合作感到十分自豪。罗欣药业拥有丰富的创新产品研发及商业化经验，而Budesolv®是首个使用Marinosolv®平台开发的药物，剂量减少85%的同时起效更快。我们希望通过双方的密切合作，为过敏性鼻炎患者提供更优的治疗选择。
（We are honored to reach an agreement with a quality partner in the Chinese market like Luoxin Pharmaceutical and are proud of the partnership based on the Marinosolv® technology platform. Luoxin Pharmaceutical has rich experience in product innovation and commercialization, while Budesolv® is the first drug developed on the Marinosolv® platform, with a dosage reduction of 85% and faster efficacy. We hope to provide better treatment options for patients with allergic rhinitis through this close cooperation.）
罗欣药业董事长兼CEO
刘振腾
我们非常期待与Marinomed的合作。呼吸系统疾病领域一直是罗欣药业关注的核心疾病领域之一，借助Marinomed独特的创新产品研发平台，结合罗欣药业研产销为一体的全产业链优势，我们相信在不久的将来，与Marinomed杰出的科学团队的共同探索将卓有成效，携手改善中国过敏性鼻炎患者的治疗状况。
（We are looking forward to the cooperation with Marinomed. Respiratory disease is one of our key focus areas. Thanks to the combination of Marinomed’s unique innovative product research and development platform and Luoxin’s integrated whole industrial chain advantages in research, production and marketing, we believe that the joint exploration with Marinomed’s outstanding scientific team will pay off and help enhance the treatment of allergic rhinitis patients in China.）
