中信國健 CPGJ  www.cpgj-pharm.com
上海中信國健藥業(yè)股份有限公司(CPGJ)是由中國中信集團(tuán)公司和上海蘭生國健藥業(yè) 有限公司共同投資的生物醫(yī)藥高新技術(shù)企業(yè)，專注于抗體藥物的研發(fā)、中試和產(chǎn)業(yè)化。公司自2002年創(chuàng)建以來，經(jīng)過長期的不懈努力，現(xiàn)已成為國內(nèi)抗體藥物企業(yè)的領(lǐng)軍者，提供覆蓋抗腫瘤、移植、自身免疫系統(tǒng)等重大疾病領(lǐng)域的靶向藥物,其應(yīng)用效果得到了醫(yī)師和患者的廣泛贊譽(yù)。
作為一家以研發(fā)為基礎(chǔ)的生物制藥公司，中信國健已成功建立了國內(nèi)領(lǐng)先的抗體藥物開發(fā)和產(chǎn)業(yè)化生產(chǎn)平臺，掌握了尖端的核心技術(shù)，并具備了持續(xù)開發(fā)新藥的創(chuàng)新能力。公司正在研制、臨床和銷售的抗體新藥達(dá)十多個，填補(bǔ)了國內(nèi)抗體藥物領(lǐng)域的多個空白，研發(fā)實力和生產(chǎn)能力均處于國際領(lǐng)先水平。
現(xiàn)代化的生產(chǎn)設(shè)備，領(lǐng)先的生產(chǎn)工藝，嚴(yán)格的質(zhì)量控制，確保了中信國健為患者提供優(yōu)質(zhì)的醫(yī)藥產(chǎn)品。作為亞洲規(guī)模最大的哺乳動物細(xì)胞培養(yǎng)生產(chǎn)基地之一，公司擁有國內(nèi)最先進(jìn)的3條750升、2條3000升的真核細(xì)胞培養(yǎng)生產(chǎn)線；同時，6條符合歐盟標(biāo)準(zhǔn)的5000升生產(chǎn)線正在建設(shè)中。公司還特別設(shè)計建立了涵蓋影響藥品質(zhì)量所有因素，包括物料管理、生產(chǎn)管理、質(zhì)量控制、質(zhì)量保證、設(shè)備設(shè)施和包裝標(biāo)簽的完善質(zhì)量管理體系，其3000升生產(chǎn)線采用了具有國際領(lǐng)先水平的現(xiàn)場總線控制系統(tǒng)(FCS)以及過程控制系統(tǒng)(PCS)，該系統(tǒng)運(yùn)用到的Delta VTM 數(shù)字自動化技術(shù)，對藥品的整個生產(chǎn)過程進(jìn)行嚴(yán)密地不間斷地監(jiān)測，最大程度地消除產(chǎn)品質(zhì)量隱患和潛在的質(zhì)量風(fēng)險。
展望未來，中信國健將繼續(xù)發(fā)揮其在生物技術(shù)領(lǐng)域的研發(fā)優(yōu)勢，為社會提供更多高效的靶向治療藥物。
上海浦東新區(qū)張江高科技園區(qū)李冰路399號
郵編：201203
電話：86-21-50791399
傳真：86-21-58553335

Shanghai CP Guojian Pharmaceutical Co., Ltd. (CPGJ) is a bio-pharmaceutical high-tech company which is co-invested by the CITIC Group and Shanghai Lansheng Guojian Pharmaceutical Co., Ltd. We focus on the R&D, pilot test and industrialization of antibody drugs. It has become a leader in the domestic antibody class of bio-pharmaceutical companies through long-term efforts, and providing targeted drugs covering major disease fields of Oncology, Transplantation, Systemic autoimmune diseases & etc.; its application effects have gained widespread recognition by physicians and patients.
As a bio-pharmaceutical company relying greatly on Research & Development, CPGJ has successfully built a leading domestic platform for the development of Antibody Drugs and their industrialization production, grasped sophisticated core technologies and now possesses the innovation ability to continuously develop new drugs. There are currently more than 10 new Antibody Drugs under development, clinical trials or sales, which have filled a crucial void in the domestic biomedical field, and its R&D strength and production capacity had reached international advanced levels.
The modern production equipments, leading production technology and strict quality control have ensured that CPGJ can provide high-quality medicines for patients. As one of the largest Asian production base for mammalian cells, CPGJ has obtained three 750-liters and two 3,000-liters most advanced eukaryotic cell culture production lines in China. Recently six 5000-liter lines are under construction by follow of the European Union's strict standards. The consummation quality control system included materials management, production management, QC, QA, equipment and packaging label is ensured the high volumes of quality products are produced. The 3,000-liter production lines adopted the internationally leading Field bus Control System (FCS) and the Process Control System, which used the latest DeltaVTM digital automation technology. It is continuously monitored during the whole processes in order to maximize the elimination of potential product quality risks.
Looking into the future, CPGJ will continue to make the most of the advantage in its R&D strength in the biotechnology field, and providing more effective targeted therapeutic drugs for society.