中國上海-2021年10月21日，羅欣藥業集團股份有限公司（簡稱“羅欣藥業”或“公司”）子公司山東羅欣藥業集團股份有限公司（簡稱“山東羅欣”）與奧地利Marinomed Biotech AG（簡稱“Marinomed”）簽署《許可協議》，山東羅欣將獲得Budesolv?布地奈德溶液型鼻噴劑在大中華區（包括中國大陸、香港和澳門特別行政區、臺灣地區）的獨家開發、生產和商業化的權利。該合作有利于進一步豐富羅欣藥業的產品線，鞏固公司在呼吸系統疾病領域的優勢地位。
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?為糖皮質激素布地奈德新型劑，屬于激素類鼻噴霧劑，目前國內外暫未上市銷售。Budesolv?是首個基于Marinomed公司的專有技術平臺Marinosolv?開發的水溶型鼻噴劑，Budesolv?已成功完成歐洲上市申請所必需的關鍵性III期臨床。關鍵性III期臨床試驗證實，與市售的Rhinocort? Aqua 64（布地奈德混懸型鼻噴劑）相比，用藥劑量降低了85%，療效不劣于Rhinocort? Aqua 64，起效更快，給藥3小時癥狀明顯緩解。
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?適用于過敏性鼻炎的治療。過敏性鼻炎是發病率高、病程長、易反復發作的慢性疾病。數據顯示，過去6年間中國過敏性鼻炎患病率從11.1%升高到了17.6%（數據來自《國際過敏和鼻科學論壇》）。根據IQVIA及米內網數據，2020年度激素類鼻噴霧劑全球市場規模為21.5億美元（以出廠價計算），國內百張床位以上醫院及零售藥店市場規模合計為13.05億元人民幣。
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.
根據許可協議條款，山東羅欣將支付給Marinomed總計200萬美元的首付款，并根據研發里程碑和銷售里程碑，支付不超過2000萬美元的里程碑付款。后續，隨著布地奈德混懸型鼻噴劑的上市，羅欣藥業將根據該產品在大中華區的銷售情況，按照實際年凈銷售額分級向Mainomed支付銷售提成。
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首席執行官Andreas Grassauer博士表示：“我們很榮幸能與羅欣藥業這樣一家在中國享有盛名的企業成為合作伙伴，并為基于Marinosolv?技術平臺的合作感到十分自豪。羅欣藥業擁有豐富的創新產品研發及商業化經驗，而Budesolv?是首個使用Marinosolv?平臺開發的藥物，劑量減少85%的同時起效更快。我們希望通過雙方的密切合作，為過敏性鼻炎患者提供更優的治療選擇。”
Dr. Andreas Grassauer, CEO of Marinomed, said, “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.”
羅欣藥業董事長兼CEO劉振騰表示：“我們非常期待與Marinomed的合作。呼吸系統疾病領域一直是羅欣藥業關注的核心疾病領域之一，借助Marinomed獨特的創新產品研發平臺，結合羅欣藥業研產銷為一體的全產業鏈優勢，我們相信在不久的將來，與Marinomed杰出的科學團隊的共同探索將卓有成效，攜手改善中國過敏性鼻炎患者的治療狀況。”
Ryan Liu, Chairman and CEO of Luoxin Pharmaceutical said, “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.”
關于Marinomed
About Marinomed
Marinomed Biotech AG是奧地利一家以科學為基礎著眼于全球已上市治療產品的生物制藥公司，是維也納證交所主板上市企業。公司基于其兩大專利技術平臺聚焦于創新產品的開發，Marinosolv?技術致力于增加難溶性藥物的溶解度及生物利用度將其制成水性溶液，Carragelose?平臺主要用于呼吸病毒感染的創新健康產品的開發，Carragelose?產品已在40多個國家及地區上市銷售。
Marinomed Biotech AG (Korneuburg, Austria) (VSE:MARI) is an Austrian biotech company targeting globally marketed therapeutics. The company is listed on the Main Board of the Vienna Stock Exchange. Marinosolv? focuses on the development of innovative products based on two patent-protected technology platforms. The Marinosolv? technology increases the solubility and bio-availability of compounds that are hardly soluble in aqueous formulations. The Carragelose? platform comprises innovative patent-protected products targeting viral infections of the respiratory tract and may also reduce the risk of an infection with SARS-CoV-2. Carragelose? is used as a virus blocker in nasal sprays, throat sprays, and lozenges, which are sold via international partners in over 40 countries.
關于羅欣藥業
About Luoxin Pharmaceutical
羅欣藥業集團股份有限公司（簡稱“羅欣藥業”，002793.SZ）是集藥品研發、生產、貿易及醫療健康服務為一體的大型醫藥企業集團，始創于1988年，在中國山東、上海、成都等地建有研發生產基地，員工約6000余名。羅欣藥業以“傳遞健康”為使命，專注于解決消化、呼吸、抗腫瘤等疾病領域未滿足的臨床需求，提高藥物和醫療健康服務的可及性。
羅欣藥業已上市豐富且有競爭力的產品組合，核心產品處于消化、呼吸疾病用藥市場領先地位。公司多個產品被列入“國家重點新產品計劃”、“國家火炬計劃”、“重大新藥創制”等科技重大專項。公司自2006年開始連續進入中國制藥工業百強企業，自2011年以來連續被評為中國醫藥研發產品線最佳工業企業，是國家重點高新技術企業、國家技術創新示范企業、全國工業質量標桿企業，多次獲得國家科學技術進步二等獎。
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Luoxin Pharmaceutical Group Stock Co., Ltd. (“Luoxin Pharmaceutical”, stock code: 002793.SZ ) is a healthcare conglomerate that is engaged in pharmaceutical research and development, manufacture, sales, and healthcare services. Founded in 1988, Luoxin Pharmaceutical has established R&D centers and manufacturing sites in Shandong, Shanghai and Chengdu, with a total of nearly 6,000 staff members. Luoxin Pharmaceutical is committed to bringing good health to more people and is focused on meeting the unmet medical needs in GI, respiratory and oncology, improving the accessibility of medicines and healthcare services.
Luoxin Pharmaceutical has a rich and competitive portfolio of products and the star products take the lead in GI and respiratory. Many products were listed in major science and technology projects, such as National Major New Product Plan, National Torch Plan as well as Major New Drug R&D. In addition, having been ranking among Top 100 Chinese Pharmaceutical Enterprises since 2006, and among Best Enterprises in Chinese Pharmaceutical R&D Pipelines since 2011, Luoxin Pharmaceutical was recognized as State Key High-tech Enterprise, State Technology Innovation Model Enterprise, National Industrial Quality Model Enterprise, and awarded with the 2nd prize in the State Sci. & Tech Progress many times.
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