西達本胺看好 華上新藥上市添利基 2016-02-04 18:40:29 經濟日報 劉美恩華上生技醫藥（創櫃代號:7427）技轉深圳微芯生物公司周邊T細胞淋巴癌口服新藥（PTCL）「西達本胺」，並與微芯生物締結為戰略性合作夥伴，共同發展西達本胺在台生產製造，進行台灣PTCL之新藥藥品查驗登記，將取得PTCL藥證在台灣上市，造福病患。華上生醫總經理陳嘉南表示，西達本胺是中國的原創新藥，歷時12年研發，在2014年取得中國新藥PTCL藥證，是第一個在中國上市治療復發及難治性之周邊T細胞淋巴癌 (Peripheral T- cell Lymphoma, PTCL)口服新藥。華上生醫在2013年取得微芯生物的技轉授權，雙方也將同步開啟西達本胺中國與台灣兩岸臨床試驗，拓展其他新適應症應用，特別是在非小細胞肺癌以及乳癌兩個臨床三期試驗。未來，華上生醫將有機會取得西達本胺在台灣第二、三個新藥適應症之藥證。陳嘉南指出，微芯生物在2007年將西達本胺的全球市場（大中華、台灣、香港及澳門除外）授權給美國HUYA公司，今年2月日本第四大藥廠衛采製藥看好西達本胺發展潛力，以2.8億美元技轉金，向美國HUYA公司取得日本、南韓與東南亞的專利所有權。這意味著國際醫藥界已肯定「西達本胺」的競爭優勢，以此次授權金額來估算，西達本胺在台灣至少有新台幣數億元的市場價值，給予華上生醫的發展有很好的利基點。微芯生物研發副總裁寧志強博士表示，西達本胺是中國藥物研發從仿製走向原始創新和「重大新藥創制」國家科技重大專項的指標性成果。有別於目前歐美上市的Folotyn （2009年） 、Istodax （2011年）與 Beleodaq （2014年），是具亞選擇性抑制HDACs (HDAC1,2,3,10)，以華人為主的周邊T細胞淋巴癌亞型為臨床試驗對象，有較長半衰期，又是口服方式投予，副作用低且藥價更是只有歐美PTCL藥物的1/10，極具潛力。除了西達本胺外，華上生醫持續投入奈米金藥物傳輸平台Vaucarrin研究，開發AGDC，利用奈米金具有高乘載、高生物相容特性，與標靶和治療藥物結合，發展出Gbm12401，有效優化傳統化療藥物的缺點，讓Doxorubicin結合標靶Trastuzumab用於治療Her2/neu高表現的乳癌。AGDC的發展可強化藥物的投遞精準度、增加療效、減少藥量與副作用產生外，亦可延伸與醫藥大廠合作，共同優化各類產品，開創奈米金新劑型藥物AGDC新紀元。
HUYA, Eisai sign exclusive license agreement for HBI-8000 in Japan and other Asian countries
Published on February 1, 2016 at 4:29 AM · HUYA Bioscience International (HUYA) President, CEO, Executive Chairman & Founder Dr. Mireille Gillings announced that Eisai Co., Ltd. has acquired from HUYA an exclusive license agreement for HBI-8000 in Japan, South Korea, Thailand, Malaysia, Indonesia, Philippines, Vietnam and Singapore. HBI-8000 is the first approved oral class I-selective histone deacetylase (HDAC) inhibitor, which is now in various stage of development globally for Non-Hodgkin's Lymphoma (NHL) in Japan and solid tumors including Immuno-Oncology in the United States. The product was recently granted orphan drug designation by Japan's Ministry of Health, Labour and Welfare based on the estimated size of the Japanese PTCL patient population, existing data as well as the clinical development plan for Japan. HUYA will complete the development of HBI-8000 for NHL in Japan for commercialization by Eisai who will hold exclusive rights to develop future indications such as solid tumors in the licensed territory. Eisai will pay HUYA an upfront and milestones up to $280M plus royalties on net sales. HUYA will manufacture and supply the product to Eisai for commercialization and other future development. Mutation or amplification of HER2 gene may lead to lung cancer
Study provides new insights into breast cancer metastasis Researchers identify new targets that may help prevent and cure colon cancer. "This collaboration aligns with Eisai's drive to contribute to patients in our focused field of oncology. Eisai and HUYA will cooperate to develop and commercialize this HDAC inhibitor which we hope to deliver to the market as a treatment that will fulfill the diverse needs of, and bring about benefits for, patients with cancer and their families" said Mr. Terushige Iike, Chief Product Creation Officer of Eisai Product Creation Systems. "We are delighted to enter into this partnership with Eisai. Our excitement about HBI-8000 increases almost daily, particularly as we are also demonstrating important immunological properties for this oral product with exemplary safety. Patients with both liquid and solid tumors will benefit as our precision medicine team develops 8000 to its full potential" said Dr. Mireille Gillings, President, CEO & Executive Chairman of HUYA. "The license reinforces our vision of leveraging clinical data generated within Asia using the Tripartite Cooperation Treaty to expand into other countries such as Japan and Korea. Eisai's global strength in oncology will help ensure the drug's path to regulatory approval."
HUYA、 Eisai 符號專用許可證協議 HBI-8000 的在日本和其他亞洲國家Published on February 1, 2016 at 4:29 AM · HUYA 生物科學國際 (HUYA) 總統、 CEO、行政主席 & 創建者米雷耶 Gillings 博士宣佈 Eisai Co.，有限公司從 HUYA 獲取了 HBI-8000 的一個專用許可證協議在日本、韓國、泰國、馬來西亞、印度尼西亞、菲律賓、越南和新加坡。 HBI-8000 是第一種被審批的口頭選件類我有選擇性的組蛋白 deacetylase (HDAC) 抗化劑，全球性地現在進入發展多種階段在日本 (NHL)和固定的腫瘤的非Hodgkin's 淋巴瘤的包括免疫腫瘤學在美國。 這個產品由在日本 PTCL 患者人數基礎上的估計的範圍和福利的日本的衛生部最近授予孤立的藥物標識、人工，現有數據以及臨床發展計劃的日本。HUYA 將由在被准許的領土將暫掛專有權開發將來的表示例如固定的腫瘤的 Eisai 完成 HBI-8000 的發展 NHL 的在商品化的日本。 Eisai 在前面將支付 HUYA 和重要事件至 $280M 加上淨銷售量的皇族。 HUYA 將製造并且提供產品給商品化和其他將來的發展的 Eisai。「此協作與 Eisai 的驅動器在我們的集中的領域對齊造成患者的腫瘤學。 Eisai 和 HUYA 將合作開發和把我們希望傳送到這個市場作為處理將滿足不同的需要的，并且達到的此 HDAC 抗化劑商業化，患者有癌症和他們的系列的」說 Terushige Iike， Eisai 產品創建系統的首席產品創建軍官先生的福利。「我們高興開始與 Eisai 的此合夥企業。 特別地因為我們也展示此口頭產品的重要免疫學屬性以模範安全性，我們的關於 HBI-8000 的興奮幾乎每日增加。 患者以液體和固定的腫瘤將有益於，我們的精確度醫學小組開發 8000 對其潛能」說米雷耶 Gillings，總統， HUYA 的 CEO & 執行委員主席博士。 「這個許可證加強利用臨床數據我們的遠見被生成在亞洲使用三方合作條約擴展到其他國家(地區) 例如日本和韓國。 Eisai 的全球力量在腫瘤學方面將幫助保證藥物的路徑到規則核准」。來源 HUYA 生物科學國際
HUYA Bioscience International Announces Orphan Drug Designation for HBI-8000 in Japan HBI-8000 granted orphan drug designation for peripheral T-cell lymphoma in Japan San Diego, CA, USA – December 22, 2015 –HUYA Bioscience International (HUYA), Founder, CEO & Executive Chair, Dr. Mireille Gillings today announced that the Ministry of Health, Labour and Welfare (MHLW) granted HBI-8000 orphan drug designation in Japan for peripheral T-cell lymphoma (PTCL). HBI-8000 is a novel class I-selective oral histone deacetylase (HDAC) inhibitor with immunomodulatory effects regulating antitumor activity, as well as repression of genes associated with drug resistance. The product is currently completing a Phase 1 open-label, dose escalation trial in Japan to evaluate the safety and pharmacokinetics of HBI-8000 in Japanese patients with non‑Hodgkin's lymphoma (NHL). The orphan drug designation was based on the estimated size of the Japanese PTCL patient population, the non-clinical and clinical studies as well as the clinical development plan in Japan."The breadth of activity of HBI-8000 is now emerging strongly as more studies are conducted. The orphan drug designation for PTCL is an important demonstration of efficacy to combat a devastating unmet need." said Dr. Mireille Gillings, Founder, CEO & Executive Chair of HUYA. "With the orphan drug designation, HBI-8000 should benefit from a priority review for marketing authorization and a 10-year market exclusivity as well as financial incentives." Under the Tripartite Cooperation Treaty between China, South Korea and Japan and given the recent approval of the drug for the treatment of PTCL in China, HUYA launched development of HBI-8000 in Japan for NHL. The Company plans to begin a Phase 2 registration trial in 2016 based on the Pharmaceutical and Medical Devices Agency's (PMDA) acceptance of HUYA's accelerated development strategy for Japan.
About Peripheral T-cell Lymphoma Peripheral T-cell lymphoma (PTCL) represents an aggressive subset of non-Hodgkin's lymphomas (NHLs) that encompasses a broad range of diverse but rare mature lymphomas of T-cell or NK-cell origin. Regardless of subtype, cases of PTCL share aggressive clinical behavior, refractoriness to conventional chemotherapy, and poor overall prognoses. In Japan, the incidence of PTCL is approximately 25% of all malignant lymphomas. According to the most recent patient statistical survey conducted by Japan's Ministry of Health, Labour and Welfare (MHLW), the number of patients with malignant lymphoma is estimated at approximately 55,000, with an estimated PTCL number of about 14,000 patients. Treatment advances in PTCL have been slow compared to other lymphomas and relapse occurs after treatment with most of the current therapies, with few effective options for salvage therapies.
About HBI-8000 HBI-8000 is a member of the benzamide class of histone deacetylase (HDAC) inhibitors designed to block the catalytic pocket of Class I HDACs. HBI-8000 is an orally bioavailable, low-nanomolar inhibitor of cancer-associated HDAC enzymes with favorable pharmacology and safety profiles. HBI-8000 inhibits cancer-associated Class I HDAC1, HDAC2, HDAC3, as well as Class IIb HDAC10 at nanomolar concentrations and stimulates accumulation of acetylated histones H3 and H4 in tumor cells. Studies with human-derived tumor cell lines have demonstrated that HBI-8000 inhibits the growth of many tumor cell lines via multiple mechanisms of action, including epigenetic regulation of tumor cell growth and apoptosis, immunomodulatory effects regulating antitumor activity, as well as repression of genes associated with drug resistance. To date, HBI-8000 has been dosed in various types of hematological and solid tumors in several clinical trials, including a Phase 1 trial completed in the United States.
About HUYA Bioscience International HUYA is the leader in enabling and accelerating the global development of novel biopharmaceutical product opportunities originating in China. Extensive collaborations are established with Chinese biopharmaceutical, academic and commercial organizations to speed development and value creation in worldwide markets for China-sourced product candidates. With the largest Chinese compound portfolio covering all therapeutic areas, HUYA has emerged as the partner-of-choice for maximizing the value of biopharmaceutical innovation in China. HUYA has offices in the U.S., Japan, South Korea and eight strategic locations across China. With the largest team of scientists working with Chinese innovators, HUYA identifies and advances promising drug candidates globally. HUYA was awarded the Asia-Pacific Stevie® Award in the Health Products and Services & Pharmaceuticals category and a Gold Stevie Award in the Woman of the Year 2015 American Business Award category. For more information, please visit www.huyabio.com
HUYA Bioscience International Completes First Cohort In Phase 1 Clinical Trial Of HBI-8000 In Japan Second cohort underway in non-Hodgkin's lymphoma patients. San Diego, CA, USA – March 19, 2015 –HUYA Bioscience International (HUYA) has completed the first cohort in a Phase 1 clinical trial in Japan of its cancer drug HBI-8000, a novel oral histone deacetylase (HDAC) inhibitor. This follows acceptance by the Pharmaceutical and Medical Devices Agency (PMDA) of the company's accelerated development strategy in Japan. The Phase 1 open-label, dose escalation trial is evaluating the safety and pharmacokinetics of HBI-8000 in Japanese patients with non Hodgkin's lymphoma. The first cohort received HBI-8000 tablets twice weekly, with no dose-limiting toxicities observed. The second cohort is now underway with a higher dose. The trial is designed to establish a maximum tolerated dose (MTD) to proceed to Phase 2 trials for the treatment of adult T-cell leukemia/lymphoma (ATL) and peripheral T-cell lymphoma (PTCL) in Japan."This is an exciting milestone in the global development of this novel cancer treatment as a monotherapy in hematological cancers or as a combination therapy in solid tumors," said Mireille Gillings, Ph.D., CEO of HUYA. "The initiation of clinical trials of HBI-8000 in Japan follows the recent approval of the drug by the Chinese FDA; in China, the drug is known as chidamide, and is being developed in that country by Shenzhen Chipscreen Biosciences." The clinical development of HBI-8000 in Japan leverages clinical data from Chinese clinical trials through the Tripartite Cooperation on Health between China, South Korea and Japan. Shenzhen Chipscreen Biosciences recently announced the approval of chidamide in China as the world's first oral HDAC inhibitor for the treatment of relapsed or refractory PTCL. HUYA holds exclusive rights to chidamide (HBI-8000) worldwide, excluding China, and is developing the compound for hematological malignancies and solid tumors.
About HBI-8000 (chidamide) HBI-8000 (chidamide) is a member of the benzamide class of histone deacetylase (HDAC) inhibitors designed to block the catalytic pocket of Class I HDACs. HBI-8000 is an orally bioavailable, low-nanomolar inhibitor of cancer-associated HDAC enzymes with favorable pharmacology and safety profiles. HBI-8000 inhibits cancer-associated Class I HDAC1, HDAC2, HDAC3, as well as Class IIb HDAC10 at nanomolar concentrations and stimulates accumulation of acetylated histones H3 and H4 in tumor cells. Studies with human-derived tumor cell lines have demonstrated that HBI-8000 inhibits the growth of many tumor cell lines via multiple mechanisms of action, including epigenetic regulation of tumor cell growth and apoptosis, immunomodulatory effects such as activation of NK- and CD8 T-cell-mediated antitumor activity, as well as repression of genes associated with drug resistance. To date, HBI-8000 has been dosed in various types of hematological and solid tumors in several clinical trials, including a Phase 1 trial completed in the United States.
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