藥華 開發 Oraxol(口服紫杉醇)/ Oratecan(口服喜樹鹼) (licensed by Kinex)

藥華藥新藥P1101具發展潛力，長線看好精實新聞 2014-04-01 11:19:15 記者 編輯中心 報導依據國內法人對藥華藥(6446)之最新研究報告指出，新一代PEG長效型α干擾素新藥P1101，已取得歐盟EMA及美國FDA真性紅血球增多症的孤兒藥資格認定，加上在歐洲第三期臨床試驗預計年底完成，長線看好P1101發展。藥華藥為國內新藥研發公司，以原創性長效型蛋白質藥物研發PEG技術平台及高難度小分子合成藥物技術等為基礎，公司研發之新藥主要用來對抗血液腫瘤、慢性肝炎感染、惡性皮膚病以及其他癌症。目前新藥產品包含新一代PEG長效型α干擾素新藥P1101、抗腫瘤藥品Oraxo等。新一代PEG長效型α干擾素新藥P1101是以PEG平台製成的單一化合物高純度蛋白質新藥，具有長效與副作用低等優點。主要用於治療罕見血液疾病、肝炎等疾病，已取得歐盟EMA及美國FDA真性紅血球增多症的孤兒藥資格證定，並在歐洲、美國、台灣、大陸、日本等國家申請專利。此外，公司2009年授權給奧地利AOP，目前AOP在歐洲已完成真性紅血球增生症第二期臨床試驗，第三期臨床試驗預計年底完成。另於台灣進行C型肝炎基因體第一型第二期臨床試驗，預計年底完成，而C型肝炎基因體第二型則於2013年開始進入第三期臨床試驗。抗腫瘤藥品Oraxo可分為Oraxol(口服紫杉醇)和Oratecan(口服喜樹鹼)，是2014年2月由美國水牛城Kinex製藥授權，在台灣和新加坡開發，為對抗乳癌、卵巢癌、大腸癌等癌症一線用藥。傳統給藥的方式是透過靜脈注射，容易使病人體內藥物濃度突然升高，而導致貧血及白血球指數低下，引發感染等嚴重併發症。而公司開發的口服劑型，經實驗證明藥物濃度在人體可平穩上升而且能維持較久，而且副作用較輕微。廠房部份，公司在台中科學園區興建符合GMP 與PIC/s標準的蛋白質藥廠，是目前國內唯一符合歐盟法規的蛋白質藥廠以及亞洲區少數能生產人體臨床第三期試驗蛋白質藥廠，為了滿足新藥上市後需求，初期年產能規劃為百萬針，預計2015年將投資新廠二、三期。展望未來，藥華藥所產之新藥潛在市場價值上看百億元，且皆握有完整藥權，具對外授權權利，前景可期。

Kinex and PharmaEssentia Expand Drug Development Partnership Kinex Pharmaceuticals and PharmaEssentia Corporation (Taiwan) announced today the execution of a new licensing agreement granting PharmaEssentia exclusive development and commercial rights to Oraxol and Oratecan in Taiwan and Singapore.  Kinex will receive an upfront payment, milestones, and royalties.  PharmaEssentia has also committed to conducting clinical studies in Taiwan to contribute to the global registration programs for Oraxol and Oratecan. The companies currently have a licensing agreement in place in certain Asian territories for the dermatology preparations of Kinex's dual Src/Pretubulin Inhibitor, KX01. Oraxol and Oratecan are two of many compounds that could be developed by Kinex and its partners through the Orascovery program.  Orascovery is based on an important platform technology developed by Hanmi Pharmaceuticals using compound HM30181A, a potent and selective P-glycoprotein (PGP) pump inhibitor.   Suppression of the PGP pump allows certain clinically important compounds (such as paclitaxel, irinotecan, and others), which would normally be effluxed back into the gastrointestinal tract and excreted, to enter the bloodstream and become bioavailable through oral administration.  Importantly, HM30181A is a very potent PGP inhibitor that is not systemically absorbed. Dr. Rudolf Kwan, Chief Medical Officer of Kinex said, "PharmaEssentia has both the leadership strength and development expertise to help accelerate the global registration programs for Oraxol and Oratecan.   They are a recognized leader in the biotechnology sector in Asia. We are confident that our combined efforts will lead to even more rapid development successes for Oraxol, Oratecan and KX01." "Based on existing treatment algorithms, we believe these compounds can bring unique benefits to the global healthcare system including, of course, Taiwan and Singapore," stated Dr. Ko-Chung Lin, CEO, PharmaEssentia.  Importantly, we believe these late stage products can be on the market in 2-3 years.  It is clear that patients and doctors need additional options when treating challenging diseases like cancer.  PharmaEssentia is excited to help create these new options as part of the Kinex, Hanmi and ZenRx team.""We are pleased to be working with the accomplished PharmaEssentia team to accelerate the development of Oraxol and Oratecan," observed Dr. Wing-Kai Chan, Kinex's Head of Clinical Operations, Asia/Pacific.  "Working with their team in Taiwan and Singapore has many synergies with our clinical and preclinical work that is ongoing or planned in Korea, China, Hong Kong and New Zealand.  These regional collaborations are a key driver of our development strategy.  Further, we believe these efforts will allow us to add new compounds to our pipeline over time as our various platforms and products are proven out in a clinical setting." Kinex recently announced that the first patient had been dosed in its Phase Ib Oraxol study in the US.  Further, Oraxol is in PII studies in Korea and will commence a PI in New Zealand in 2014. Oratecan has completed a PI trial in Korea with very encouraging results.  Clinical studies of Oraxol and Oratecan to date suggest that these potent, oral versions of paclitaxel and irinotecan will impact a broad spectrum of cancers. Kinex has global development and commercialization rights for Oraxol and Oratecan, excluding Korea, Japan and India that are owned by Hanmi, New Zealand and Australia which were licensed to Zenith Technology Corporation and Taiwan and Singapore which were licensed to PharmaEssentia. Flint Besecker, CFO and Board Director of Kinex added, "Expanding our relationship with PharmaEssentia is highly consistent with our global development and regulatory strategy.  It allows us to further leverage our existing platform technologies and drug candidates with a group of experienced drug developers.  PharmaEssentia brings meaningful infrastructure and resources to Kinex's expanding global development programs.  We believe such partnerships will allow us to produce significant data and commercialize important products in the most time and cost efficient manner." Dr. Ching-Leou Teng, Chairperson of PharmaEssentia and formerly with US FDA and ISIS Pharmaceuticals, concluded, "Kinex has been an excellent  partner to PharmaEssentia and it has been very productive working with them on the KX01 dermatology program.   We are impressed with the growing pool of data for Oraxol and Oratecan and the Kinex team has established an innovative regulatory pathway to registration which we are very excited about.  Kinex's strategy could potentially allow initial commercialization of these excellent oncology products in Taiwan and Singapore in as short as 2-3 years."