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羅欣藥業 傳遞健康

山東羅欣藥業(ye)集團股份有限公(gong)司(si)招標公(gong)告

羅欣藥業 傳遞健康

羅欣藥業 傳遞健康

企業資訊

羅欣藥業與奧地利Marinomed公司簽署許可協議,引進Budesolv?布地奈德溶液型鼻噴劑

發布時間:2021年(nian)10月21日 瀏覽次數:
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中國(guo)上海-20211021日,羅(luo)(luo)欣藥(yao)業集團股份(fen)有(you)限公(gong)(gong)司(si)(簡稱“羅(luo)(luo)欣藥(yao)業”或“公(gong)(gong)司(si)”)子公(gong)(gong)司(si)山東羅(luo)(luo)欣藥(yao)業集團股份(fen)有(you)限公(gong)(gong)司(si)(簡稱“山東羅(luo)(luo)欣”)與(yu)奧地利Marinomed Biotech AG(簡稱“Marinomed”)簽署《許可協議》,山東羅欣將獲得(de)Budesolv?布地(di)(di)奈德溶液型鼻噴(pen)劑在(zai)大(da)中華區(qu)(qu)(包括中國大(da)陸、香港和澳門(men)特別行政區(qu)(qu)、臺灣地(di)(di)區(qu)(qu))的獨家開發、生產(chan)和商業化(hua)的權(quan)利(li)。該合作有利(li)于進一步豐富羅欣藥業的產(chan)品線,鞏固公司在(zai)呼(hu)吸系統疾病(bing)領域的優勢地(di)(di)位(wei)。

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(ji)素布地(di)奈德新型(xing)劑,屬于(yu)激(ji)素類鼻(bi)噴霧劑,目前國內外暫未上市(shi)銷售(shou)。Budesolv?是首個基于(yu)Marinomed公司(si)的(de)專有(you)技術平臺(tai)Marinosolv?開發的水(shui)溶(rong)型(xing)鼻噴劑,Budesolv?已成功完成歐洲上(shang)市申請所必需的關(guan)鍵性III期臨(lin)床。關鍵性III期臨床(chuang)試(shi)驗證實,與市(shi)售的Rhinocort? Aqua 64(布地奈德(de)混(hun)懸(xuan)型鼻噴劑(ji))相比,用藥(yao)劑(ji)量降低了85%,療效不劣于(yu)Rhinocort? Aqua 64,起效更快,給藥3小時癥狀明顯(xian)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(guo)敏性(xing)鼻(bi)(bi)炎的(de)治療。過(guo)敏性(xing)鼻(bi)(bi)炎是(shi)發病(bing)率高、病(bing)程長(chang)、易反復發作的(de)慢性(xing)疾病(bing)。數據(ju)顯示,過(guo)去(qu)6年間中國過敏性鼻炎患病率從11.1%升高到(dao)了17.6%(數據來自《國際過敏和鼻科(ke)學論壇》)。根據(ju)IQVIA及米內網數(shu)據,2020年度激(ji)素類鼻噴(pen)霧(wu)劑全球(qiu)市場規模為21.5億美(mei)元(以出廠價(jia)計(ji)算(suan)),國內百張床位(wei)以上醫院及零售藥店(dian)市場規模(mo)合計(ji)為(wei)13.05億元人民幣(bi)。

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 theInternational 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(kuan),山東羅欣將支付給(gei)Marinomed總計200萬美元的首(shou)付(fu)款,并根據研發(fa)里程碑和銷售里程碑,支付(fu)不(bu)超過2000萬(wan)美元的(de)里程碑付款。后續,隨著布地奈德混懸(xuan)型(xing)鼻噴劑的(de)上市,羅欣藥業將根(gen)據該產品在大(da)中華區的(de)銷售情(qing)況(kuang),按(an)照(zhao)實際年(nian)凈銷售額分(fen)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(xing)能(neng)與羅欣(xin)藥業(ye)這樣(yang)一家在中國享有盛名的企業(ye)成為合作(zuo)伙伴,并(bing)為基于Marinosolv?技術平臺的(de)合作感到十分自豪。羅(luo)欣藥業(ye)擁有(you)豐富的(de)創新(xin)產品研(yan)發及商業(ye)化經(jing)驗(yan),而Budesolv?是(shi)首個使(shi)用(yong)Marinosolv?平臺開發(fa)的藥物,劑量減少85%的(de)同時起效更(geng)快。我們希望(wang)通(tong)過(guo)雙方的(de)密切合作(zuo),為過(guo)敏性鼻炎患者(zhe)提供更(geng)優的(de)治療(liao)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(dong)事長兼CEO劉(liu)振騰表示(shi):“我(wo)們(men)非常期待與Marinomed的合作。呼(hu)吸系統疾病(bing)(bing)領域一直(zhi)是羅欣(xin)藥業(ye)關(guan)注的核(he)心疾病(bing)(bing)領域之一,借助Marinomed獨(du)特(te)的(de)創新產(chan)品研(yan)發平臺,結合羅欣藥業(ye)(ye)研(yan)產(chan)銷為一體的(de)全產(chan)業(ye)(ye)鏈優勢,我們相信(xin)在不久(jiu)的(de)將來(lai),與Marinomed杰出的(de)(de)科(ke)學(xue)團隊(dui)的(de)(de)共(gong)同探索(suo)將卓有(you)成效,攜(xie)手改善中國過敏性鼻炎患(huan)者的(de)(de)治療(liao)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(guan)于Marinomed

About Marinomed

Marinomed Biotech AG是(shi)奧(ao)地利一家以科學(xue)為基礎著眼于(yu)全球已上市治療產品(pin)的生物制藥公(gong)司(si),是(shi)維(wei)也納證交所主板上市企業。公(gong)司(si)基于(yu)其兩(liang)大專利技術(shu)平臺聚焦于(yu)創新產品(pin)的開發(fa),Marinosolv?技術(shu)致(zhi)力于增(zeng)加難(nan)溶(rong)(rong)性(xing)藥物的溶(rong)(rong)解度及(ji)生(sheng)物利用(yong)度將其制成水性(xing)溶(rong)(rong)液,Carragelose?平臺(tai)主要(yao)用于呼吸病(bing)毒感染的創新健(jian)康產(chan)品的開(kai)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(yu)羅欣藥業(ye)

About Luoxin Pharmaceutical

羅欣藥(yao)業集團股(gu)份有限公(gong)司(簡稱(cheng)“羅欣藥(yao)業”,002793.SZ)是集(ji)藥品研發、生產(chan)、貿易及(ji)醫(yi)療(liao)健康服務為一(yi)體(ti)的大型醫(yi)藥企業集(ji)團(tuan),始創(chuang)于1988年,在中國山東、上(shang)海、成都等地建(jian)有研發生產基地,員工約6000余名。羅欣藥(yao)業以“傳(chuan)遞健(jian)(jian)康”為(wei)使命,專注于解決消化、呼吸、抗腫瘤等疾(ji)病領域未(wei)滿(man)足的(de)(de)臨床(chuang)需求,提高藥(yao)物和醫療健(jian)(jian)康服務(wu)的(de)(de)可及性。

羅(luo)欣藥業(ye)已上市豐(feng)富且有(you)競爭力的產(chan)(chan)品(pin)(pin)組(zu)合(he),核心產(chan)(chan)品(pin)(pin)處于消化、呼吸疾(ji)病用(yong)藥市場領先地位(wei)。公司多個產(chan)(chan)品(pin)(pin)被列入“國(guo)家(jia)重(zhong)點新(xin)產(chan)(chan)品(pin)(pin)計劃”、“國(guo)家(jia)火炬計劃”、“重(zhong)大新(xin)藥創制”等科技重(zhong)大專(zhuan)項(xiang)。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(ping)為(wei)中國(guo)醫藥(yao)研發(fa)產品線最佳工業(ye)企業(ye),是國(guo)家重(zhong)點(dian)高新(xin)技術企業(ye)、國(guo)家技術創新(xin)示范企業(ye)、全國(guo)工業(ye)質量標桿(gan)企業(ye),多次獲得國(guo)家科學技術進步二等(deng)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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