醣聯攜手三菱瓦斯化學 啟動骨鬆生物相似藥臨床試驗 MoneyDJ新聞 2021-07-12台灣醣聯(4168)宣布，醣聯與日本三菱瓦斯化學(MITSUBISHI GAS CHEMICAL CO., INC.)已於近日簽訂骨質疏鬆症生物相似藥SPD合作協議，將共同進行該項藥物之臨床試驗。醣聯指出，生物相似藥SPD是醣聯運用其獨特的技術平台，從基因定序、生產細胞株製備及產程開發、分析技術開發，一路到50公升試量產全程自行開發之生物相似藥。SPD與原廠藥具有極高的相似度，並已由日本三菱瓦斯化學確認1000公升之量產，其品質與醣聯製造之50公升產品一致，但由於去(2020)年以來，COVID-19疫情影響，醣聯在風險考量之下，決定委由台康生技(6589)生產臨床試驗用藥，以加速進入臨床試驗之時程，日本三菱瓦斯化學將來則將承接日本市場的藥品生產。醣聯表示，台康不僅是國內專業經驗非常值得信賴之CDMO，而且在生物相似藥開發的領域也有相當優異的成績，相信此次合作也能為這項產品帶來加分的作用。此產品不僅與原廠藥相似度極佳，醣聯所優化的精簡生產流程更能有效節省成本，使產品更具市場競爭力。醣聯並指出，醣聯與三菱瓦斯化學的合作，將由雙方共同出資，進行SPD後續之臨床試驗，以最快速度啟動該藥物於日本及全球主要市場之臨床試驗工作。醣聯與三菱瓦斯化學自2011年開始在抗體藥物製造上有長期的合作關係，這次的合作是十多年以來雙方規模最大的一次合作投資，這也象徵兩家公司的專業合作及信賴關係更趨穩固。醣聯也表示，調研機構GII研究報告指出，受人口老化影響，全球骨質疏鬆症治療藥市場2020～2025年的年複合成長率將達5.3%，預估超過2億人受骨質疏鬆症所苦，市場規模超過70億美金。有鑒於此龐大商機，雙方除積極推動SPD的臨床試驗進程，也同步持續拓展與其他國際大藥廠之合作商機，積極與具全球行銷通路之生技藥廠洽商SPD的共同開發及對外授權事宜，希望盡早以高品質的低價藥物，幫助到無法負擔高額藥物的病患。
Prolia (Denosumab) : 對人類RANKL(細胞核因子kappa-B配糖接受體活化因子)具有親和力及專一性的人類IgG2單株抗體，會與RANKL結合，RANKL是一種對蝕骨細胞(會產生骨蝕作用的細胞)之形成、功能與存活極為重要的穿膜蛋白或可溶性蛋白。Prolia可阻止RANKL活化其接受體，亦即蝕骨細胞及其前驅物表面上的RANK。遏阻RANKL/RANK間的交互作用可抑制蝕骨細胞的形成、功能與存活，因此可降低骨蝕作用（bone resorption），並提高皮質骨及小梁骨的骨量與強度。
Successful Mass-culture of Cells Producing Denosumab Biosimilar candidate March 07, 2019 Mitsubishi Gas Chemical Company, Inc. (MGC; Head Office: Chiyoda-ku, Tokyo; President: Toshikiyo Kurai) has established the conditions that enable the mass-culture of cells producing a denosumab biosimilar candidate (referred to as "denosumab-producing cells" below), which is the antibody drug used to treat diseases such as osteoporosis and multiple myeloma. In order to mass-produce an antibody drug, it is necessary not only to improve the productivity of the cells that produce the antibody used as a drug substance, but also to mass-culture these cells. Maintaining antibody quality while mass-culturing the antibody-producing cells is a key requirement for successful commercial production. Using the denosumab-producing cells and the relevant manufacturing technology transferred from GlycoNex, an MGC partner, MGC had Cultivecs develop technology for mass-culturing those cells. The MGC subsidiary has now successfully identified the conditions for mass-culturing. With the establishment of the technology for mass-culturing denosumab-producing cells, MGC expects to be able to supply large quantities of a high-quality denosumab drug substance at a low cost. For possible joint development in the future, MGC will discuss this with a pharmaceutical company interested in commercializing the denosumab biosimilar. Leveraging the findings gained through developing the mass-culture technology, MGC will continue to develop various antibody drugs.
About denosumab Used for the treatment of diseases such as osteoporosis, multiple myelitis and giant cell tumor of bone, denosumab is the world's first antibody drug to target the RANK ligand, which is the protein required for developing and activating osteoclasts. Denosumab inhibits osteoclast activity.