胚胎幹細胞治療黃斑變性症 通過中國的專利申請
美國先進生物科技公司(Advance Cell Techology；ACT)日前宣佈，通過中國智慧財產局的專利申請，也就是在中國利用胚胎幹細胞分化成醫療用途的視網膜上皮細胞（Retinal Pigment Epithelial；RPE)的製造過程，可受到專利的保護。
ACT公司在2010年11月22日率先通過FDA核准,利用RPE細胞治療眼底黃斑變性症(Stargardt's Macular Degeneration);2011年1月3日又再次獲得批准,進行乾性老年黃斑變性症(Dry Age-Related Macular Degeneration)的臨床試驗.在美國針對RPE細胞的醫療用途目前有3項專利。
ACT公司於中國智慧財產專利的申請項目與內容類似於去年六月在美國申請的專利字號7736896。這項專利申請的通過，象徵ACT公司邁入亞洲市場。近年來，中國成為第三大的醫藥市場，專利的取得將可進行技術轉移或交流的合作關係。未來，ACT公司希望可在歐洲等其他國家申請專利，拓展幹細胞的再生醫學領域。
ACT receives Chinese patent for human ES cell-derived RPE cells
Advanced Cell Technology, Inc. (ACT) a leader in the field of regenerative medicine, announced that China’s State Intellectual Property Office (SIPO) has allowed the company’s patent application to provide broad intellectual property protection in China for the manufacturing and pharmaceutical preparations of Retinal Pigment Epithelial (RPE) cells from human Embryonic Stem Cells (hESCs).
“The fact that we are being awarded a set of broad claims in China, following the issuance of the three far-reaching RPE patents in the US last year, gives us greater confidence that we are in a position to create a dominant patent position around our stem cell-derived RPE programme in leading markets around the world,” said Gary Rabin, ACT’s interim chairman and CEO. “Our progress in obtaining patent protection in China for our RPE programme is a testament to the continued recognition of the inventions and innovations resulting from our scientific team’s ongoing research, and further protects the platform technology underlying one of our key therapeutic programmes.”
The efficient production of highly pure RPE cell preparations derived from human embryonic stem cells represents the first critical step in the creation of a renewable source of transplantable cells that can be used to target macular degenerative diseases such as Stargardt’s Macular Dystrophy (SMD) and Dry Age-related Macular Degeneration (Dry AMD). The company has already demonstrated that its hESC-derived RPE cells can rescue visual function in animal models of macular degeneration. At the end of 2010, ACT received clearance from the United States Food and Drug Administration (FDA) for two of its Investigational New Drug (IND) applications to initiate multi-centre clinical trials using hESC-derived RPE cells to treat patients with SMD in one case (a common form of juvenile macular degeneration) and to treat Dry AMD in the other. The claims allowed by SIPO are similar to those the company received as part of US Patent Number 7736896, issued last June.
“This IP issuance is a particularly valuable step forward for us in Asia, as it could facilitate partnering and licensing arrangements,” added Rabin. “China is predicted to become the third-largest pharmaceutical market in the world later this year, and is an essential part of our global strategy. This patent allowance is an indicator of what we hope to achieve in the IP realm in Europe and elsewhere.”
Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the field of regenerative medicine.