胚胎干细胞治疗黄斑变性症 通过中国的专利申请
美国先进生物科技公司(Advance Cell Techology；ACT)日前宣布，通过中国智慧财产局的专利申请，也就是在中国利用胚胎干细胞分化成医疗用途的视网膜上皮细胞（Retinal Pigment Epithelial；RPE)的制造过程，可受到专利的保护。
ACT公司在2010年11月22日率先通过FDA核准,利用RPE细胞治疗眼底黄斑变性症(Stargardt's Macular Degeneration);2011年1月3日又再次获得批准,进行干性老年黄斑变性症(Dry Age-Related Macular Degeneration)的临床试验.在美国针对RPE细胞的医疗用途目前有3项专利。
ACT公司于中国智慧财产专利的申请项目与内容类似于去年六月在美国申请的专利字号7736896。这项专利申请的通过，象征ACT公司迈入亚洲市场。近年来，中国成为第三大的医药市场，专利的取得将可进行技术转移或交流的合作关系。未来，ACT公司希望可在欧洲等其他国家申请专利，拓展干细胞的再生医学领域。
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.