新产品开发

        赛百诺公司是中国基因治疗产业领域的开拓者，“今又生”上市后，公司从单纯研发型企业转变成市场导向型企业，公司的研发系统也相应进行了调整，产品和技术的研发工作由研发部(负责临床前研究)、医学部(负责I～IV期临床试验)、营销部(负责产品上市后的学术推广型临床研究)共同承担。开展的研发工作主要分为“今又生”产品的深度研究开发和新产品的研制开发两个部分。     

        公司围绕“今又生”产品进行深度研究开发，包括“今又生”IV期临床试验、“今又生”Off-label-use临床研究、“今又生”扩大适应症临床试验、及“今又生”生产工艺优化和质量标准完善研究等。

        在新产品研制开发方面，在公司科技专家委员会的指导下，公司开展了自主设计的2个新产品项目“静脉给药型重组人p53腺病毒注射液”(ivAd-p53）和“双基因重组溶瘤腺病毒注射液”(SBN-3)的研制开发，并引进了2个外部新产品项目“蛋白A免疫吸附系统”和“腺病毒多聚阳离子包被技术”。

        “静脉给药型重组人p53腺病毒注射液”（ ivAd-p53）是本公司已上市的世界首个基因治疗药物“重组人p53腺病毒注射液”（今又生）的改进型，腺病毒载体经过基因工程技术改造，更适宜于静脉给药，也可局部给药。

        “双基因重组溶瘤腺病毒注射液”(SBN-3)是“重组人p53腺病毒注射液”(今又生)的升级换代产品。SBN-3具有特异高效的病毒溶瘤、肿瘤凋亡诱导、肿瘤免疫治疗等协同作用的肿瘤杀伤能力，具有广谱抗癌特性，单独使用即有较理想的疗效。

New Product Development

Sibiono is a pioneer gene therapy in China. Since Gendicine^® is in market, we have made the transition from solely a research enterprise to a market-directed one. The R&D is subdivided into R&D dept. for basic sciences, medical dept. for Phase I&II studies, the sales dept. for the promotion of products with academic activity support on clinical research.The R&D activities centered around further in-depth study of Gendicine^® while others work on new product research.

The Gendicine^® in-depth research covers the Phase IV clinical trial, ‘off-label-use’ research, and extended clinical use of the drug, while the upgrading of production efficiency and quality improvement research are also included.

As for the new product development, the Co. has started 2 new products under the ‘Expert Committee of S&T’. They are the ‘ivAdp53’ for iv infusion and ‘dual gene recombinant oncolytic adenovirus for injection’ (SBN-3), in addition to 2 invited product: ‘protein A immunoadsorption system and polycation encapsulation of adenovirus’. 

The upgraded product ‘ivAdp53,’ is an improved form of Gendicine^®‘rAd-p53,Inj’. The genetically modified adenovirus vector will be more suitable for iv infusion or even used locally.

’Dual gene oncolytic adenovirus for injection’ (SBN-3) is the upgraded product of Gendicine^®. SNB-3 is highly specific for lysing tumor, induces apoptosis and immune response, and synergistic in tumor killing. It has a wide spectrum anti-tumor activity and can be used well by itself.