歐盟批准第一仿製單抗Inflectra (Hospira 取得韓國Celltrion授權) !!

欧盟批准首个生物仿制单抗药物 发布时间：2013-10-16 来源：药品资讯网信息中心9月，Hospira公司的生物仿制药通过了欧盟审批，该药是欧盟批准的首个单克隆抗体类（mAb）生物仿制药物。欧盟委员会（EC）是根据欧洲药品管理局6月底给出的建议，决定批准Hospira公司的药品Inflectra上市的。Inflectra是强生和默克公司的英利昔单抗药物Remicade的生物仿制药。与传统的化学药品不同，生物制剂含有从活组织提取的不能复制的蛋白质。而生物仿制药物难以开发是因为需要通过很多实验来证明药物的有效性。这种英利昔的生物仿制药最初是由韩国Celltrion公司开发的，它是首个通过欧洲药品管理局的生物仿制药监管途径审批的药品。在欧洲开发的生物仿制药物均被视作现有生物药物的替代品。2012年主要用于治疗类风湿性关节炎的英利昔单抗在欧洲销售额达20亿美元。据Hospira公司估计，到2020年生物仿制单抗药在欧洲将累积到204亿欧元的资金，其中法国、德国和英国的累积额预期最高。2009年，Hospira公司与韩国生物制药公司Celltrion公司达成协议，当时Celltrion公司正在开发8种单克隆抗体仿制药物。在协议中，Hospira获得Inflectra在欧洲和独立国家联合体（CIS）国家，美国、加拿大、澳大利亚和新西兰的销售权限，并将在全欧洲对该药实施专利保护。

Hospira Gains First Biosimilar Approval in EU  Therapeutic developed with Celltrion will compete with Remicade.MICHAEL FITZHUGH The Burrill Report  September 10, 2013"Inflectra is the first of eight biosimilars that Hospira agreed to develop and market with South Korea-based Celltrion in 2009." The European Commission approved Hospira's Inflectra, Europe's first biosimilar antibody for inflammatory diseases, putting it into competition with Janssen's blockbuster Remicade. The medicine will offer doctors, patients, and health systems a more affordable treatment option, says Hospira, though the company did not benchmark its price against Remicade, saying that pricing for it has not been established and may vary by country. Though generic drugs can offer savings of up to 90 percent on the cost of branded equivalents, savings from biosimilars are expected to be in the range of 20 to 30 percent."For over a decade biologic medicines have been pivotal in treating a range of inflammatory conditions, so the granting of marketing authorization in Europe is a major milestone for Inflectra, and for the future of biologic therapy," says Stan Bukofzer, Hospira's corporate vice president and CMO. Inflectra is the first of eight biosimilars that Hospira agreed to develop and market with South Korea-based Celltrion in 2009. Hospira has exclusive rights to market the therapy in Europe, North America, Australia, and New Zealand. The companies agreed to collaborate on manufacturing and supply while independently commercializing any approved biosimilars under each party's own brand name. In June, the European Medicines Agency recommended approval for the Celltrion version of the biosimilar under the name Remsima. Both Remsima and Inflectra contain the same known active substance, infliximab. Following the EMA's recommendation, Beata Stepniewska, acting director general of the European Generic Medicines Association, called it "a key milestone in the history of medicines in the EU." She said biosimilar medicines "provide real opportunities to reduce the cost of treatment with biopharmaceuticals without compromising the quality of healthcare that is delivered." Just like Remicade, Inflectra has been approved to treat rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis.

脊損癱瘓希望?! 全球最大脊髓損傷臨床試驗: 永生StemCyte幹細胞 超吸睛!!

美商永生StemCyte明年初申請上櫃 搶食100億美元醫療商機 工商即時 潘臆涵 2013年10月11日 22:03 生技掛牌風潮持續熱燒，美商永生StemCyte參加脊髓損傷臨床試驗二期成績亮眼，目前為工業局第一家批准的海外生技公司，若回台掛牌，也將創美商生技公司來台掛牌的首例。脊髓損傷幹細胞療法明年臨床三期試驗若成功，將搶食全球100億美元醫療商機。擁有10多年生技創投經驗的美科Amkey Ventures創辦人李家榮表示，12年前因為看到StemCyte選擇在美國醫學中心收集嬰兒臍帶血，優先開發公捐血庫的經營模式，再透過NMDP(全國骨髓捐贈計劃)進行配對，提供需要做骨髓移植或血液疾病患者治療使用，在初創階段就看上這家公司的潛力。李家榮指出，一般成人的幹細胞需要6個配位點都吻合才能進行配對，嬰兒臍帶血的幹細胞活性最強，只需要4個配位點，因此配對成功機率較高。目前半數以上的血癌患者都改採幹細胞療法，累計已有超過1,500個治療血癌成功經驗。美商永生執行長王嘉宗表示，永生今年1~9月營收逾2千萬美金，全年營收預估在2800萬美金以上，明年可望挑戰5千萬美金。公司主要業務有三項，營收目前來自公捐及私存血庫業務，幹細胞研究治療部分仍未獲利，但幹細胞療法通過後，將能為公司開拓新的營收來源，預估全球慢性脊損治療市場高達100億美元。今年6月底全球最大的脊髓損傷臨床試驗公布臨床二期試驗報告顯示，有75%的患者在有限度的輔助之下能夠步行，成績另生醫界矚目，永生是唯一參與該臨床試驗的臍帶血銀行；明年將展開第三期臨床試驗，若成功將能造福全球數百萬因脊損而癱瘓的病患。此外，幹細胞治療慢性中風，在台灣臨床二期報告也有85％的病患獲得改善，明年也將展開第三期臨床試驗。目前主要股東包括富邦金控集團、科威特政府基金、美商美科AmKey創投、美商梧桐創投、美商中經合創投、華南金控創投、統一國際開發、中鋼旗下的台安生技、台陽集團、德欣及中加等知名創投機構。營運長呂志鋒表示，永生和其他臍帶血銀行最大的差異在於獨特的公捐私存整合經營模式，已經提供超過1,800單位臍帶血，給全球270家以上醫學中心移植使用，代表永生的實際配對經驗豐富，已得到醫學中心的認證。而一般的私存單位未來如需使用，還將面臨品質按政的問題，且對於如先天性遺傳疾病的患者，後續如需幹細胞治療，真正能用的是經過配對後具健康基因的他人幹細胞，而非當初自己保存下來的嬰兒臍帶血。此外，公司也花費10億台幣建立公捐血庫，高達3萬筆的公捐資料庫，目前為私營單位「全球第一」，美國聯邦政府也已連續7年委託永生建立血庫資料，公司已獲得工業局的正式審核通過，未來將以科技事業申請上櫃。

新加坡ASLAN來台上市? 新陳創投/晨興/千驥 挹注US$22M 開發口服胃癌新

藥(phase II2 completed, ASLAN001, a small-molecule pan-HER inhibitor)

星國創新藥公司 想來台上市 2013-10-12 01:51 工商時報 【記者杜蕙蓉／台北報導】生技市場活絡，吸引外商爭相來台掛牌，新加坡創新藥開發公司ASLAN規畫來台上市，該公司最近完成第二輪增資，成功募得美金2,200萬元，參與團隊包括千驥創投、晨興創投和新陳創投等。ASLAN原本投資團隊包括BioVeda Capital和 Sagamore Bioventures，這次新增的投資夥伴中，香港晨興是亞洲最大生技創投集團之一；而新陳創投則是安成藥董事長陳志明個人投資，資本規模1億美元；加上來自美國的千驥創投，也讓ASLAN的股東背景備受矚目。ASLAN表示，本次募得資金將用來進行臨床中的新藥開發，包括作用在胃癌的廣泛性表皮因子受體抑制劑ASLAN001，該藥物現正執行多國多中心的第二期b階段臨床人體試驗 （phase IIb），且已被證實有正面效果的二期試驗結果。此次募資也有助於ASLAN與其他藥廠建立授權合作關係。ASLAN的執行長Carl Firth博士表示，該公司未來至少可再完成5個試驗，以達到概念驗證（POC）的目的。千驥創投的董事長兼管理合夥人Jun Wu也表示，這三年ASLAN展現取得授權方面的卓越能力，同時透過創新和高效率的策略，將這些新的化合物發展到更具價值的階段。ASLAN主要業務係為全球市場研發創新的藥物。目前總部設立在新加坡，在台北亦設有辦公室。營運模式為自跨國大藥廠取得腫瘤和發炎相關疾病尚未進入臨床試驗，或於早期臨床試驗階段的新藥授權，並透過其在亞洲的高品質及高效率發展資源，將這些新藥物開發至較後期的臨床試驗。該公司目前已有3個藥物在臨床試驗發展階段。

Updated on 28 May 2013 Aslan Pharma's phase II clinical trial with pan-HER inhibitor Aslan001 in gastric cancer reduced cell proliferation in gastric tumours that were either coexpressing EGFR and HER2 or that were HER2 amplified for gastric cancer patients - Aslan Pharma's phase II clinical trial with pan-HER inhibitor Aslan001 in gastric cancer reduced cell proliferation for Aslan rheumatoid arthritis drug A*Star identifies gastric cancer trigger ASLAN announces global license agreement with Almirall Singapore: Aslan Pharmaceuticals has revealed the results of its phase II clinical trial with Aslan001, a small-molecule pan-HER inhibitor, in gastric cancer. Aslan001 reduced cell proliferation in gastric tumors that were either coexpressing EGFR and HER2 or that were HER2 amplified. The pan-HER inhibitor was invented by Array BioPharma and licensed to Aslan in 2011. The phase II, open-label, multicenter study was conducted at Seoul National University Hospital, South Korea, and was designed to evaluate the biological activity of Aslan001 in patients with recurrent/metastatic gastric carcinoma whose tumors were HER2 amplified or coexpressing EGFR and HER2. The 23 patients, who had previously failed on one or more rounds of chemotherapy and, where eligible, trastuzumab, each received 500mg of Aslan001 orally twice daily as monotherapy for 28 days. Tumor biopsies taken before and after treatment were analysed using immunohistochemistry. In this heavily pretreated population, Aslan001 led to a downregulation of signalling pathways responsible for cell proliferation, and a reduction in cell survival and cell proliferation. Toxicities observed were consistent with other drugs in this class and the previously reported profile of this compound. Aslan intends to begin a randomized phase IIb study in gastric cancer and is exploring the use of Aslan001 in other indications. Dr Alan Barge, chief medical officer, Aslan, said that, "This is the first time a drug has shown activity in this patient population. The burden of gastric cancer is particularly severe in Asia. It is the most prevalent cancer in males in China, where it is estimated to affect over half a million people."

ASLAN Pharmaceuticals secures US$22M in Series B financing led by Cenova Ventures  (Ref: ASLAN Pharmaceuticals) October 10th, 2013 Singapore, 10 October 2013 – ASLAN Pharmaceuticals Pte Ltd announced today the completion of a Series B financing raising US$22 million. The financing was led by Cenova Ventures and included other new investors Morningside Group and XinChen Ventures. Existing investors BioVeda Capital and Sagamore Bioventures also participated in the round.Proceeds from the Series B will be used to fund ongoing clinical development of ASLAN's portfolio, including the phase 2b program for ASLAN001, a small-molecule pan-HER inhibitor being developed for gastric cancer that showed positive data in a phase 2 study completed earlier this year. The financing will also support the licensing of additional compounds in 2013 and 2014. "We are proud to have assembled such a strong group of investors from China, Taiwan and the US that can support the development of our portfolio through efficient and high quality clinical centres in the region," said Dr Carl Firth, CEO of ASLAN. "This round will allow us to complete at least five further studies and deliver robust proof of concept data on several of our programs." Jun Wu, Chairman and Managing Partner at Cenova Ventures said, "In the space of three years, ASLAN has demonstrated their ability to inlicense and progress novel compounds through creative and efficient development strategies. Though several companies have attempted similar models, ASLAN is the first to execute successfully, due largely to its team and network of partners."

About ASLAN  ASLAN Pharmaceuticals is a specialty pharmaceutical company that develops novel medicines for global markets, headquartered in Singapore. ASLAN licenses preclinical and early clinical compounds from global pharmaceutical companies, focusing on oncology and inflammation diseases, and uses the high quality and efficient development resources available across Asia to progress the drugs through clinical development. ASLAN currently has 3 drugs in clinical development, with the lead compound entering phase 2b for gastric cancer.

About Cenova  Cenova Ventures, founded in 2010 and located in Shanghai, is dedicated to China life sciences and healthcare investment. Cenova primarily focuses on emerging and growing companies with significant market potential in China life sciences sectors, including pharmaceuticals, biotech, medical devices, diagnostics, and healthcare services. The Cenova Venture Fund is managed by seasoned life science investment professionals, and the investment team combines experiences of successful venture start-up and venture investment, management of pre- and post-IPO companies, with proven capabilities to leverage global perspectives, local experiences and network to develop and implement business strategies that best fit specific situations in China.