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Genetic engineering technical platform

      Genetic engineering drugs refer to those human adapted peptide or protein drugs made by expressing function specific genes or their re-engineered forms into cells via the use of recombinant DNA technology and computer aided design technique for the purpose of disease prevention or treatment. Two technical systems have been established in this platform, one is prokaryotic cell expression system, and another is Eukaryotic cell expression system. In this platform, many kinds of technical challenge have been broken through, such as high density ferment and over expression in bacteria or in mammalian cells, protein refolding on large scale, and protein purification, and antibody-drug conjugate technology. Chinese state 863 funds for thematic subject, important subject of lymphotoxin (R&D for new type lymphotoxin 2001AA215051, clinical research for new type lymphotoxin 2002AA2Z3309/2005AA2Z3G10) and State Projects For Essential Drug Research and Development-a key technical  research work of mammalian cell industrialized culture and drug manufacture 2009ZX09503-012, and antibody-drug conjugate(CD30-DM1 preclinical study; 2014ZX09508001-001)will be studied in this platform too.

      The progresses of the projects on genetic technical platform are summarized as follows:

      The clinical trial approval for high bio-activity recombinant human TNF receptor for the treatment of arthritis has been obtained in May 2014, and the project has completed clinical trial phase I. The drug is mainly used to treat self-immunological diseases, such as arthritis. Clinical research is terminated due to the consideration of efficacy.

      The antibody-drug conjugate drugs have shown obvious advantages on tumor treatment in clinical trials, which is much better than the effect of the conventional antibody plus chemotherapy drugs. In order to follow the development trend in bio-pharmaceutical area, recombinant anti-CD30 human-mouse chimeric monoclonal anti-CD30-MCC-DM1 injection (“CD30-DM1”) for the treatment of tumors has completed pre-clinical study and obtained the clinical trial approval from State Drug Administration during the year under review. The Company will carry out relevant clinical research as soon as possible.

      Two other antibody-drug conjugate for breast cancer and gastric cancer has entered into pre-clinical conceptual validation

      Avastin bio-similar drug for the treatment of tumor has obtained clinical trial approval. According to the competitive situation of the target market and the company’s existing research strategy, the Company has transferred the technology to a suitable third party.

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