細胞治療之創業計畫

Abstract

細胞治療是屬於再生醫學的範疇。再生醫學是利用細胞來修復受損的組織或器官，以治療各種疾病，而這些疾病在常規藥物和醫療程序中得不到很好的管理。細胞治療依細胞種類分成自然殺手細胞、T細胞、樹突細胞、間質幹細胞 、造血幹細胞、CD34+細胞、細胞激素激活殺手細胞及腫瘤浸潤淋巴細胞等等的免疫細胞，來治療疾病。衛生福利部於2018年9月6日公告『特定醫療技術檢查檢驗儀器施行或使用管理辦法』，將自體(autologous)的六大項安全性可確定、成效可預期的細胞治療項目，納入特定醫療技術管理，對台灣的細胞治療發展將產生顯著的影響。台灣為亞洲第二個合法使用細胞治療技術的國家。製造真正具有效性及安全性細胞醫療產品需遵守細胞製備場所人體細胞組織優良操作規範(Good tissue practices; GTP)或優良製造標準(Good manufacturing practice; GMP)。由於生技產業產品開發期長、投資通常較龐大，風險較高，不僅需要技術支持及事前良好的規劃，才能擁有高的回報率。本創業計畫重點在於不影響院所的運營的行情況下，規劃2個資本投資方案，方案一: GTP建置六間細胞操作實驗室; 方案二: GTP建置2間細胞操作實驗室，預留空間使用自行開發的UJ癌細胞培養系統設備(商品名)。依照資本預算規劃方案一及及方案二，以淨現值法、內部報酬率法及收回期限法比較兩方案。經規劃及計算後，方案一及方案二皆能投資，其中方案二更優於方案一的獲利性及未來擴充性。

Cell therapy is listed in the category of regenerative medicine. Regenerative medicine aims to repair damaged, tissues or organs, using cells for the treatment of various diseases, which have been poorly managed with conventional drugs and medical procedures. Cells used for cell therapy include but not limited to natural killer (NK) cell, T Cell, dendritic cell, mesenchymal stem cell (MSC), hematopoietic stem cells (HSC), CD34+ cell, cytokine-induced killer (CIK) cell, and tumor-infiltrating lymphocyte (TIL). September 6, 2018, Ministry of Health and Welfare has amended the “Regulations governing implementation or use of specific medical technology, examination, laboratory testing and medical devices”. Six regulatory items of autologous cellular therapy to consider with ascertain safety and expectable efficacy were listed. High expectation of this new regulation could significantly impact the cell therapies development. Taiwan is the second country passed regulations for producing cell medicinal products in Asia. Good Tissue Practices (GTP) and Good Manufacturing Practices (GMP) are the core Taiwan Food and Drug Administration (TFDA) requirements for manufacturing merchandise involving human cells, tissues and cellular and tissue-based products for cell therapies. Due to the nature of biomedical product bearing long developing period, heavy investment and high risk, it requires technical supporting and well planning to ensure its high rewarding. Two business plans are proposed aiming not causing negative impacts on hospital/clinical daily practice and to pursuit cell therapy investment. Plan I is to build six, and plan II is to build two GTP labs with reserved space for an original design manufacture, ODM, UJ cell culture equipment. The capital budget plan of these two proposes has been compared based on the net present value (NPV), internal rate of return (IRR), and the payback period. The conclusion indicates both plans are working and investment worthy. The reward and future expansion favor the plan II.