羅欣藥業(yè)與奧地利Marinomed公司簽署許可協(xié)議，引進(jìn)Budesolv?布地奈德溶液型鼻噴劑

發(fā)布時(shí)間：2021年10月21日 瀏覽次數(shù)：

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中國上海-2021年10月21日，羅欣藥業(yè)集團(tuán)股份有限公司（簡稱“羅欣藥業(yè)”或“公司”）子公司山東羅欣藥業(yè)集團(tuán)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(xié)議》，山東羅欣將獲得Budesolv^?布地奈德溶液型鼻噴劑在大中華區(qū)（包括中國大陸、香港和澳門特別行政區(qū)、臺(tái)灣地區(qū)）的獨(dú)家開發(fā)、生產(chǎn)和商業(yè)化的權(quán)利。該合作有利于進(jìn)一步豐富羅欣藥業(yè)的產(chǎn)品線，鞏固公司在呼吸系統(tǒng)疾病領(lǐng)域的優(yōu)勢(shì)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(zhì)激素布地奈德新型劑，屬于激素類鼻噴霧劑，目前國內(nèi)外暫未上市銷售。Budesolv^?是首個(gè)基于Marinomed公司的專有技術(shù)平臺(tái)Marinosolv^?開發(fā)的水溶型鼻噴劑，Budesolv^?已成功完成歐洲上市申請(qǐng)所必需的關(guān)鍵性III期臨床。關(guān)鍵性III期臨床試驗(yàn)證實(shí)，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(shí)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(fā)病率高、病程長、易反復(fù)發(fā)作的慢性疾病。數(shù)據(jù)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(shù)據(jù)來自《國際過敏和鼻科學(xué)論壇》）。根據(jù)IQVIA及米內(nèi)網(wǎng)數(shù)據(jù)，2020年度激素類鼻噴霧劑全球市場規(guī)模為21.5億美元（以出廠價(jià)計(jì)算），國內(nèi)百張床位以上醫(yī)院及零售藥店市場規(guī)模合計(jì)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(jù)許可協(xié)議條款，山東羅欣將支付給Marinomed總計(jì)200萬美元的首付款，并根據(jù)研發(fā)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(xù)，隨著布地奈德混懸型鼻噴劑的上市，羅欣藥業(yè)將根據(jù)該產(chǎn)品在大中華區(qū)的銷售情況，按照實(shí)際年凈銷售額分級(jí)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(zhí)行官Andreas Grassauer博士表示：“我們很榮幸能與羅欣藥業(yè)這樣一家在中國享有盛名的企業(yè)成為合作伙伴，并為基于Marinosolv^?技術(shù)平臺(tái)的合作感到十分自豪。羅欣藥業(yè)擁有豐富的創(chuàng)新產(chǎn)品研發(fā)及商業(yè)化經(jīng)驗(yàn)，而Budesolv^?是首個(gè)使用Marinosolv^?平臺(tái)開發(fā)的藥物，劑量減少85%的同時(shí)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(yōu)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(yè)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(tǒng)疾病領(lǐng)域一直是羅欣藥業(yè)關(guān)注的核心疾病領(lǐng)域之一，借助Marinomed獨(dú)特的創(chuàng)新產(chǎn)品研發(fā)平臺(tái)，結(jié)合羅欣藥業(yè)研產(chǎn)銷為一體的全產(chǎn)業(yè)鏈優(yōu)勢(shì)，我們相信在不久的將來，與Marinomed杰出的科學(xué)團(tuán)隊(duì)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(guān)于Marinomed

About Marinomed

Marinomed Biotech AG是奧地利一家以科學(xué)為基礎(chǔ)著眼于全球已上市治療產(chǎn)品的生物制藥公司，是維也納證交所主板上市企業(yè)。公司基于其兩大專利技術(shù)平臺(tái)聚焦于創(chuàng)新產(chǎn)品的開發(fā)，Marinosolv^?技術(shù)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(tái)主要用于呼吸病毒感染的創(chuàng)新健康產(chǎn)品的開發(fā)，Carragelose^?產(chǎn)品已在40多個(gè)國家及地區(qū)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(guān)于羅欣藥業(yè)

About Luoxin Pharmaceutical

羅欣藥業(yè)集團(tuán)股份有限公司（簡稱“羅欣藥業(yè)”，002793.SZ）是集藥品研發(fā)、生產(chǎn)、貿(mào)易及醫(yī)療健康服務(wù)為一體的大型醫(yī)藥企業(yè)集團(tuán)，始創(chuàng)于1988年，在中國山東、上海、成都等地建有研發(fā)生產(chǎn)基地，員工約6000余名。羅欣藥業(yè)以“傳遞健康”為使命，專注于解決消化、呼吸、抗腫瘤等疾病領(lǐng)域未滿足的臨床需求，提高藥物和醫(yī)療健康服務(wù)的可及性。

羅欣藥業(yè)已上市豐富且有競爭力的產(chǎn)品組合，核心產(chǎn)品處于消化、呼吸疾病用藥市場領(lǐng)先地位。公司多個(gè)產(chǎn)品被列入“國家重點(diǎn)新產(chǎn)品計(jì)劃”、“國家火炬計(jì)劃”、“重大新藥創(chuàng)制”等科技重大專項(xiàng)。公司自2006年開始連續(xù)進(jìn)入中國制藥工業(yè)百強(qiáng)企業(yè)，自2011年以來連續(xù)被評(píng)為中國醫(yī)藥研發(fā)產(chǎn)品線最佳工業(yè)企業(yè)，是國家重點(diǎn)高新技術(shù)企業(yè)、國家技術(shù)創(chuàng)新示范企業(yè)、全國工業(yè)質(zhì)量標(biāo)桿企業(yè)，多次獲得國家科學(xué)技術(shù)進(jìn)步二等獎(jiǎng)。

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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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