力拓藥品新藍海，因華擬加快布局國際市場 MoneyDJ新聞 2015-07-23 07:50:58 記者 新聞中心 報導 因華生技(4172)以新劑型新藥研發與利基型學名藥開發為核心，掌握OralPAS(自微乳化奈米技術)平台，成功將大分子藥成分改良成口服、並達到良好吸收率，將過往只能透過針劑輸入人體的藥劑轉換成口服劑型；公司並表示，後續營運將以「癌症、感染、免疫及特殊用藥」四大領域為主軸，持續輸出產品及技術，以製劑技術為核心競爭力搶佔國際市場，挑戰成為亞洲區新藥與新劑型開發領導廠商。 因華指出，透過公司旗下OralPAS技術平台開發出的Gemcitabine抗癌藥物口服劑型，目前已在美國及台灣同步進行第一期人體臨床試驗，預計完成後，僅需進行小規模第二期人體臨床試驗，即可快速進入第三期人體臨床試驗。因華之口服新劑型不僅可降低原注射劑型之化療副作用，提升患者之生活品質，亦可降低醫療成本；其上市後，可望逐步取得取代原注射劑型，並應用於新適應症之市場，給予更多癌症患者幫助，預估潛在市值超越20億美元。 而因華也宣佈C08001新劑型新藥正式進入台灣臨床三期。因華表示，研發團隊專精於劑型的改良，目前針對治療高血壓、心衰竭、左心室功能不全伴隨心肌梗塞的藥物-Carvedilol，成功將服藥頻率從一天兩次改良成為一天一次給藥的緩釋錠劑；目前C08001在台灣已經進入臨床三期階段，並已獲得美國、中國大陸及台灣等各國專利。C08001為因華新劑型新藥添上歷史性的紀錄，預估全球潛在市值超過6億美元。在因華產品線中，核磁共振(MRI)顯影劑產品目前已達成從技術開發、原料藥生產到下游通路銷售之垂直整合，成功跨越原廠之高技術門檻，佈局國際市場。因華表示，除嘉多明已進入美國ANDA（藥證申請）階段，嘉多視健亦準備申請歐美藥證中，自2015至2016年底，預計將完成更多品項顯影劑之開發，成為全球唯一可以提供全品項、全方位解決方案的企業。在今年生技展中，因華也將首度公開展示顯影劑成品及未來產品線規劃，展現其在MRI顯影劑領域之高度技術及競爭優勢。 此外，因華表示，公司亦長期關注於罕見疾病之治療，對於罕見疾病用藥的開發不遺餘力；旗下之因飛諾(Inpheno)在2013年取得外銷專用許可證後，2015年又陸續取得美國及歐洲之製程專利，持續拓展全球專利佈局；未來除了持續關注罕見疾病用藥的開發外，更將以實際行動來關懷罕見疾病。
Bendamustine plus rituximab versus CHOP plus rituximab as first-line treatment for patients with indolent and mantle-cell lymphomas: an open-label, multicentre, randomised, phase 3 non-inferiority trial Published Online: 20 February 2013; New England Journal of Medicine (NEJM)
Background Rituximab plus chemotherapy, most often CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone), is the first-line standard of care for patients with advanced indolent lymphoma, and for elderly patients with mantle-cell lymphoma. Bendamustine plus rituximab is effective for relapsed or refractory disease. We compared bendamustine plus rituximab with CHOP plus rituximab (R-CHOP) as first-line treatment for patients with indolent and mantle-cell lymphomas. Methods We did a prospective, multicentre, randomised, open-label, non-inferiority trial at 81 centres in Germany between Sept 1, 2003, and Aug 31, 2008. Patients aged 18 years or older with a WHO performance status of 2 or less were eligible if they had newly diagnosed stage III or IV indolent or mantle-cell lymphoma. Patients were stratified by histological lymphoma subtype, then randomly assigned according to a prespecified randomisation list to receive either intravenous bendamustine (90 mg/m2 on days 1 and 2 of a 4-week cycle) or CHOP (cycles every 3 weeks of cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, and vincristine 1·4 mg/m2 on day 1, and prednisone 100 mg/day for 5 days) for a maximum of six cycles. Patients in both groups received rituximab 375 mg/m2 on day 1 of each cycle. Patients and treating physicians were not masked to treatment allocation. The primary endpoint was progression-free survival, with a non-inferiority margin of 10%. Analysis was per protocol. This study is registered with ClinicalTrials.gov, number NCT00991211, and the Federal Institute for Drugs and Medical Devices of Germany, BfArM 4021335. Findings 274 patients were assigned to bendamustine plus rituximab (261 assessed) and 275 to R-CHOP (253 assessed). At median follow-up of 45 months (IQR 25–57), median progression-free survival was significantly longer in the bendamustine plus rituximab group than in the R-CHOP group (69·5 months [26·1 to not yet reached] vs 31·2 months [15·2–65·7]; hazard ratio 0·58, 95% CI 0·44–0·74; p<0·0001). Bendamustine plus rituximab was better tolerated than R-CHOP, with lower rates of alopecia (0 patients vs 245 (100%) of 245 patients who recieved ≥3 cycles; p<0·0001), haematological toxicity (77 [30%] vs 173 [68%]; p<0·0001), infections (96 [37%] vs 127 [50%]); p=0·0025), peripheral neuropathy (18 [7%] vs 73 [29%]; p<0·0001), and stomatitis (16 [6%] vs 47 [19%]; p<0·0001). Erythematous skin reactions were more common in patients in the bendamustine plus rituximab group than in those in the R-CHOP group (42 [16%] vs 23 [9%]; p=0·024). Interpretation In patients with previously untreated indolent lymphoma, bendamustine plus rituximab can be considered as a preferred first-line treatment approach to R-CHOP because of increased progression-free survival and fewer toxic effects. Funding Roche Pharma AG, Ribosepharm/Mundipharma GmbH.
Bendamustine was first synthesized in 1963 by Ozegowski and Krebs in East Germany (the former German Democratic Republic). Until 1990 it was available only in East Germany. East German investigators found that it was useful for treating chronic lymphocytic leukemia, Hodgkin's disease, non-Hodgkin's lymphoma, multiple myeloma and lung cancer. Bendamustine received its first marketing approval in Germany, where it is marketed under the tradename Ribomustin, by Astellas Pharma GmbH's licensee, Mundipharma International Corporation Limited. It is indicated as a single-agent or in combination with other anti-cancer agents for indolent non-Hodgkin's lymphoma, multiple myeloma, and chronic lymphocytic leukemia. SymBio Pharmaceuticals Ltd holds exclusive rights to develop and market bendamustine HCl in Japan and selected Asia Pacific Rim countries. In March 2008, Cephalon received approval from the United States Food and Drug Administration to market bendamustine in the US, where it is sold under the tradename Treanda, for treatment of chronic lymphocytic leukemia. In October 2008, the FDA granted further approval to market Treanda for the treatment of indolent B-cell non-Hodgkin's lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.[6]