三生製藥與三星Bioepis簽訂生物類似藥合作協議 中國瀋陽2019年1月7日電 /美通社/ 中國領先的生物製藥企業三生製藥(01530.HK)今天宣佈與三星Bioepis(「Samsung Bioepis」)達成一項合作協議，將在中國大陸（不包括香港、澳門和台灣地區）進行三星Bioepis多個生物類似藥在研產品的臨床研發和商業化，其中包括貝伐珠單抗的生物類似藥在研產品SB8。「三星Bioepis具有全球市場領先的生物製品研發和生產實力，結合三生製藥在中國的整合平台優勢，雙方將為中國患者提供安全且可負擔的生物治療方案。三生製藥期待通過此次與三星Bioepis的合作來加快SB8在中國的臨床研發，擴大三生製藥在腫瘤領域的產品組合。」三生製藥董事長兼首席執行官婁競博士表示，「三生製藥將通過內部研發和戰略合作，繼續加強其在生物製藥領域的領導地位，更快地將高質量的急需產品推向中國和國際市場。」「非常高興能將我們的生物類似藥業務拓展到中國，也很期待我們的生物類似藥產品在為廣大患者提供高質量的醫療服務中起到重要作用。我們有信心通過與三生製藥的合作，將三星Bioepis成熟的開發平台和三生製藥強大的商業化平台相結合，從而達成我們的目標。」三星Bioepis董事長兼首席執行官 Christopher Hansung Ko表示，「三星Bioepis將繼續加強產品管線，拓展產品在全世界患者和醫療系統的可及性，實現我們的持久承諾。」根據協議，三星Bioepis將負責產品的生產和供應，並與三生製藥開展一系列合作包括在中國的臨床開發、註冊和商業化。三星Bioepis將從三生製藥獲得預付款和產品供應收入，並將有資格獲得相關臨床和監管的里程碑付款。目前進一步的財務條款沒有被披露。據瞭解，貝伐珠單抗生物類似藥在中國的適應症將針對轉移性結直腸癌和非小細胞肺癌。國家癌症中心數據顯示，2015年我國結直腸癌新發病例37.6 萬，死亡病例19.1 萬（發病率26.6/每十萬人，死亡率13.5/每十萬人）；結腸癌的發病率上升顯著，且城市地區遠高於農村，多數患者發現時已屬於中晚期；而肺癌是中國發病率和死亡率最高的癌症，2015年新發病例73.3萬人，死亡病例61.0萬人。（發病率51.9/每十萬人，死亡率43.2/每十萬人），其中超過90%的肺癌病例為非小細胞肺癌。
關於三生製藥 三生製藥是一家綜合性生物科技公司，在腫瘤、自身免疫性疾病、腎病、代謝性疾病、皮膚病等生物製藥領域處於市場領先地位。三生製藥致力於建立一個創新產品管線，目前擁有超過30個在研產品。三生製藥的生產能力涵蓋重組蛋白、單克隆抗體和化學合成分子，在瀋陽、上海、杭州、深圳和意大利科莫設有生產基地。請訪問www.3sbio.com獲取更多信息。
關於三星Bioepis 三星Bioepis成立於2012年，是一家致力於實現人人都能享受醫療保健的生物製藥公司。通過產品開發的創新和對質量的堅定承諾，三星Bioepis立志成為世界領先的生物製藥公司。三星Bioepis持續發展豐富的生物類似物在研管線，涵蓋免疫、腫瘤學、眼科和血液學等一系列治療領域。三星Bioepis是三星生物制劑(Samsung Biologics）和百健公司（Biogen）的合資企業。更多信息請訪問:www.samsungbioepis.com。
關於貝伐珠單抗 貝伐珠單抗是一種重組人源化單克隆抗體，2004年成為第一個臨床應用的血管生成抑制劑。它的問世是基於人類血管內皮生長因子(VEGF)的發現，VEGF是一種刺激血管生長的蛋白質。貝伐珠單抗於2004年首次在美國獲得批准，用於與標準化療聯合使用治療轉移性結直腸癌。此後，貝伐珠單抗被批准用於某些肺癌、腎癌、卵巢癌等。在2010年第一季度，貝伐單抗在中國被批准用於轉移性結直腸癌（mCRC）。截至2016年1月，該藥物已獲批用於 非小細胞（型）肺癌（NSCLC）在中國上市。相關鏈接 :http://www.3sbio.com
Partnership with 3SBio follows successful biosimilar commercialization partnerships in the European and US markets with Biogen and Merck, also known as MSD outside of the United States and Canada. January 06, 2019 06:00 PM Eastern Standard Time INCHEON, Korea--(BUSINESS WIRE)--Samsung Bioepis Co., Ltd. today announced that its rapidly growing biosimilar business will expand into mainland China through a licensing agreement with 3SBio Inc. The agreement covers multiple biosimilar candidates from Samsung Bioepis, including SB8, a biosimilar candidate referencing AVASTIN® 1 (bevacizumab). "At Samsung Bioepis, we will continue to demonstrate our enduring commitment to biosimilars by further strengthening our pipeline and widening their availability for patients and healthcare systems across the world." Under the agreement, Samsung Bioepis and 3SBio will collaborate across a number of areas, including clinical development, regulatory registration and commercialization in China. Samsung Bioepis will receive upfront and milestone payments, as well as royalties on sales. Additional financial details were not disclosed. "We are very excited to expand our biosimilar business into China, where we hope to see our biosimilars play an important role in widening patient access to high-quality healthcare. We are confident we will achieve this goal through our partnership with 3SBio, which brings together Samsung Bioepis' proven development platform with 3SBio's strong commercialization platform," said Christopher Hansung Ko, President and Chief Executive Officer, Samsung Bioepis. "At Samsung Bioepis, we will continue to demonstrate our enduring commitment to biosimilars by further strengthening our pipeline and widening their availability for patients and healthcare systems across the world." Established in February 2012, Samsung Bioepis currently has four biosimilars approved and marketed across Europe, which include the anti-TNF trio of BENEPALI™ (etanercept), FLIXABI™ (infliximab) and IMRALDI™ (adalimumab), as well as an oncologic biosimilar, ONTRUZANT® (trastuzumab). In the United States, the company has one biosimilar approved and marketed, RENFLEXIS® (infliximab), with both SB5 (adalimumab) and SB3 (trastuzumab) biosimilar candidates currently under regulatory review. In total, over 100,000 patients across the world are currently under treatment with Samsung Bioepis' biosimilars, with over 6 million doses administered.
About 3SBio Inc. 3SBio is a fully-integrated biotechnology company in China with market-leading biopharmaceutical franchises in oncology, auto-immune diseases, nephrology, metabolic diseases and dermatology. 3SBio is focused on building an innovative product pipeline, with over 30 products candidates under development. 3SBio's manufacturing capabilities include recombinant proteins, monoclonal antibodies and chemically- synthesized molecules, with production centers in Shenyang, Shanghai, Hangzhou, Shenzhen and Cuomo, Italy. Please visit www.3sbio.com for additional information.
About Samsung Bioepis Co., Ltd. Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology and hematology. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. For more information, please visit: www.samsungbioepis.com. 1 Avastin® is a registered trademark of Genentech Inc. Contacts Mingi Hyun +82-31-8061-1594 mingi.hyun@samsung.com
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