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Future Plan

The next step for Uni Pharma is to strengthen its pipeline in Oncology area: additional Cancer diagnostic tests, cancer treatment of Radio Frequency Ablation and cancer therapeutic drug monitoring test. This allows Uni Pharma to enter the era of precision medicine by offering personalized test and treatment option for patients.


1. EZ-Detect:  EZ-Detect is a home-use test strip that is designed to detect blood in the stool that can be caused by bleeding ulcers, hemorrhoids, polyps, colitis, diverticulitis, fissures or cancer of the colon.

2. Ovascreen: Ovasceen is a point-of-care test that can detect CA125 combining HE4 antigen in plasma, serum or capillary blood. A combined determination of HE4 and CA125 allows to increase efficiency of ovarian cancer diagnostics during screening. 

3. Radio Frequency Ablation for thyroid cancer treatment: Radio Frequency Ablation treatment has treated liver caner successfully for many years. Additional indication like treating thyroid cancer is under regulatory filing. 

4. Saladax MyCare drug monitoring test for 5-FU, Docetaxel, Palitaxel, Imatinib: MyCare test supports pharmacokinetically-guided exposure optimization of cancer drugs that creates an individual dosing profile for each patient.


2013年,華宇藥品之營業金額隨著主力產品開發成果逐漸浮現,未來5年之產品輪廓已大致成形,簡述如下

  • Anti-adhensive product

    Adept(Baxter):自費消耗性醫療器材。防沾黏處置於婦產科手術、一般外科腹部手術已為臨床醫師所重視,市場價值日漸提昇,各品牌產品總產值已超越每年四億元。
  • In Vitro Diagnostic Kits

    Cervi-M:最新DNA甲基化診斷技術以監測子宮頸癌化評估,是婦產科醫師評估病患子宮頸癌風險之最佳利器,本檢測由TAF認證之日祥生命醫學實驗室進行檢測。


    Onko-Sure DR-70(AMDL):自費癌症診斷試劑。Onko-Sure DR-70是美國 FDA自1980年核准CEA(癌胚胎抗原)用於大腸直腸癌檢測後,近30年後唯一核准之大腸直腸癌術後追蹤及檢測之診斷試劑。


    Onko-Sure DR-70可提供65-96%之高敏感性及95%之特異性,對於經外科切除、化學治療與放射治療之癌症病患提供有意義之療效評估。


    Onko-Sure DR-70在全球上市狀態:
    2003 歐盟核准用於General cancer detection
    2006 我國核准用於General cancer detection
    2008 美國FDA核准用於大腸直腸癌術後追蹤
    2009 加拿大核准用於Lung cancer
    2009 韓國核准用於大腸直腸癌術後追蹤
    2010 亦獲得其他中南美洲國家核准上市


    Onko-Sure DR-70於2006取得衛生署醫療器材許可證,截至2013年7月底,已成功將本產品列入台大醫院、台北榮總、亞東醫院、馬偕醫院、國泰醫院、台中榮總、彰基醫院、中國醫大醫院、中山醫大醫院、台中澄清醫院、嘉義基督教醫院、義大醫院及高雄醫學院附設醫院。


    華宇藥品於2012年與原廠洽談計術移轉設立台灣為第二生產基地。取得製造技術及全亞洲獨家銷售權(包括日本、中國、東協諸國、澳洲、紐西蘭、印度、土耳其、伊朗等)。


    2014年7月華宇藥品成功取得國產Onko-Sure DR-70第二級體外診斷試劑許可證隨即於8月取得歐盟認證CE標章。2015年起開始出口供應中東及海灣國家使用於癌症篩檢及癌症術後追蹤。在中國市場亦於2014年11月完成包含健康人為對照組之多種癌症230例預試驗,預訂2015年展開1200例查驗登記臨床試驗。其他亞洲國家及紐澳市場亦依計劃開發中。華宇藥品持續投資於臨床試用與數據累積,希望累積更多臨床文獻。目前鎖定於大腸直腸癌(CRC)、肺癌(LC)、卵巢癌、乳癌及肝癌之療效評估與復發之預測。並希望至少累計2,000例以上之數據進行統計。

  • Personal Medicalcare and Cancer Therapy

    為因應個人化醫療之新觀念及減少癌症治療藥物個體差異,最大化藥品治療利益及最小化藥物不良反應,華宇藥品將對於臨床上普遍使用之癌症用藥提供劑量監測之服務。本系列服務將有助於根據病患個體差異提供達到治療劑量之預測,能將藥物不良反應降至最低且減少藥物之成本與浪費;另一方面亦確保病患藥物血中濃度達到治療劑量之監測。
  • Global patent and marketing right

    本產品已取得孤兒藥資格認定,並在進行查驗登記中,預期2015年即可取得上市核准。本產品新適應症也進行至臨床第二期,預訂在2016年將可完成第三期臨床試驗並取得上市許可。

Vision

Other than expanding our product pipeline into areas of various cancer detection tests, cancer ablation treatment and cancer therapeutic monitoring test, Uni Pharma also plans to set up in-house medical lab to provide better testing service. It is due to the importance of cancer detection and cancer treatment efficacy is no less than cancer drug development.

Uni Pharma is aimed to complete internal and external reviewing process by 2016 to file for Initial Public Offering at Taipei Exchange ( TPEx ) in 2017.


Successful public offering will increase visibility and transparency of Uni Pharma that would encourage Uni Pharma to become a more social- responsible company and attract better talent to join Uni Pharma. It is Uni Pharma’s mission to provide the best choices of medical product for unmet medical needs.