新產(chǎn)品開發(fā)

        賽百諾公司是中國基因治療產(chǎn)業(yè)領(lǐng)域的開拓者，“今又生”上市后，公司從單純研發(fā)型企業(yè)轉(zhuǎn)變成市場導(dǎo)向型企業(yè)，公司的研發(fā)系統(tǒng)也相應(yīng)進(jìn)行了調(diào)整，產(chǎn)品和技術(shù)的研發(fā)工作由研發(fā)部(負(fù)責(zé)臨床前研究)、醫(yī)學(xué)部(負(fù)責(zé)I～I(xiàn)V期臨床試驗)、營銷部(負(fù)責(zé)產(chǎn)品上市后的學(xué)術(shù)推廣型臨床研究)共同承擔(dān)。開展的研發(fā)工作主要分為“今又生”產(chǎn)品的深度研究開發(fā)和新產(chǎn)品的研制開發(fā)兩個部分。     

        公司圍繞“今又生”產(chǎn)品進(jìn)行深度研究開發(fā)，包括“今又生”IV期臨床試驗、“今又生”O(jiān)ff-label-use臨床研究、“今又生”擴(kuò)大適應(yīng)癥臨床試驗、及“今又生”生產(chǎn)工藝優(yōu)化和質(zhì)量標(biāo)準(zhǔn)完善研究等。

        在新產(chǎn)品研制開發(fā)方面，在公司科技專家委員會的指導(dǎo)下，公司開展了自主設(shè)計的2個新產(chǎn)品項目“靜脈給藥型重組人p53腺病毒注射液”(ivAd-p53）和“雙基因重組溶瘤腺病毒注射液”(SBN-3)的研制開發(fā)，并引進(jìn)了2個外部新產(chǎn)品項目“蛋白A免疫吸附系統(tǒng)”和“腺病毒多聚陽離子包被技術(shù)”。

        “靜脈給藥型重組人p53腺病毒注射液”（ ivAd-p53）是本公司已上市的世界首個基因治療藥物“重組人p53腺病毒注射液”（今又生）的改進(jìn)型，腺病毒載體經(jīng)過基因工程技術(shù)改造，更適宜于靜脈給藥，也可局部給藥。

        “雙基因重組溶瘤腺病毒注射液”(SBN-3)是“重組人p53腺病毒注射液”(今又生)的升級換代產(chǎn)品。SBN-3具有特異高效的病毒溶瘤、腫瘤凋亡誘導(dǎo)、腫瘤免疫治療等協(xié)同作用的腫瘤殺傷能力，具有廣譜抗癌特性，單獨使用即有較理想的療效。

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.