Are domestic biological products seriously pushed? Characteristic monoclonal antibody or new direction, see how these 5 biological products enterprises innovate?

With the gradual warming of biological products in recent years, China's biological products market has also ushered in a new stage of development driven by technological progress and policies A group of enterprises with innovative R & D capabilities are constantly emerging Based on the report "overview of FDA approved new drugs in the first half of 2017" created by flint, this paper combs five domestic biological product R & D enterprises for readers Sansheng Guojian Pharmaceutical (Shanghai) Co., Ltd in 2002, China CITIC Group and Lansheng Guojian Pharmaceutical Co., Ltd initiated the investment to establish a high-tech biomedical enterprise, named "Shanghai CITIC Guojian Pharmaceutical Co., Ltd." In 2015, Sansheng Pharmaceutical Co., Ltd., a Hong Kong listed companies, became the largest shareholder in its equity investment, so the company changed its name to "Sansheng Guojian Pharmaceutical (Shanghai) Limited by Share Ltd Sansheng Guojian has always been focusing on the research and development, pilot test and industrialization of antibody drugs, providing targeted drugs covering major disease fields such as autoimmunity, tumor, anti organ transplant rejection, etc., and has successfully established an antibody drug research and development platform with independent intellectual property rights, with the ability to continuously develop new drugs At present, Sansheng Guojian's products on the market include yisaipu for autoimmune diseases and genipipa for organ transplant rejection Among them, ISEP, as the company's flagship product, is the first biologics independently developed and successfully listed in the field of Rheumatology treatment in China, and it is also listed and sold in many overseas countries In addition, the company has three products about to be launched, namely, cyprotein (recombinant anti HER2 humanized monoclonal antibody for injection), gentuxi (recombinant anti CD20 mouse chimeric monoclonal antibody injection) and yilairui (recombinant human CTLA4 for injection - antibody fusion protein) Suzhou Kangning Jierui Biotechnology Co., Ltd was established in April 2009 Through the establishment and improvement of the macromolecular drug development platform, so far, it has the ability of early screening and engineering of antibody / protein drugs, cell line construction and small-scale test technology, pilot scale-up and preparation of clinical research arch test products Over the years, Kangning Jierui has completed its industrial layout in the form of subsidiaries and branches Dingfu target Biotechnology Co., Ltd was established together with internationally renowned scholars in the field of tumor immunity to focus on tumor immunotherapy At present, it has obtained more than ten drug candidates for PD-L1, CD137, OX40 and other targets, and is gradually entering the CMC development stage Form strategic cooperation with Shi Huida pharmaceutical industry, build the macromolecular drug production base of Corning Jerry (Jilin) Co., Ltd in Changchun, Jilin, and build cGMP plant meeting the requirements of CFDA, EMA and FDA, with an estimated annual output value of 10 billion yuan In 2015, Jiangsu Kangning Jierui biopharmaceutical Co., Ltd., a wholly-owned subsidiary, was established It plans to build a new macromolecular drug production base in Suzhou, which will integrate R & D, production and sales After the completion of the project, the annual output value will be 12 billion yuan Biological innovative drugs developed by Corning Jerry According to Corning Jerry's website, there are 12 biological innovative drugs and 19 biological similar drugs currently under development Xinda biopharmaceutical (Suzhou) Co., Ltd., a biological analogue developed by Corning Jerry, was founded in August 2011 Xinda biopharmaceutical is committed to being the best domestic and world-class high-end biopharmaceutical pharmaceutical company The company has obtained a global well-known venture capital of up to $490 million After five years of development, Cinda biology has established a product chain including 13 new drug varieties, covering four major disease areas, including tumor, fundus disease, autoimmune disease, cardiovascular disease, etc The company's candidate drug ibi301 is an anti-CD20 monoclonal antibody, which can be used in non Hodgkin's lymphoma, chronic lymphoblastic leukemia, rheumatoid arthritis In August 2016, the drug has entered clinical phase III In addition, other candidate drugs, ibi303 and ibi305, also entered clinical phase III in 2016 Among them, ibi303 is an anti TNF - α monoclonal antibody injection, which can be used in rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, inflammatory enteritis and other 17 autoimmune related diseases Ibi305 is an anti VEGF monoclonal antibody injection, which can be used to treat colorectal cancer, lung cancer and other malignant tumors Jiahe biopharmaceutical Co., Ltd., founded in December 2007, is an innovation driven international biopharmaceutical company The company is mainly engaged in the research, development and industrialization of monoclonal antibodies such as therapeutic monoclonal antibodies and Fc fusion protein drugs In December 2013, the company was acquired and controlled by Yunna Watson Biotechnology Co., Ltd., a listed company of gem The company's products under research include two categories: biological similar monoclonal antibody and innovative monoclonal antibody The main indications of concern include tumor, autoimmune diseases and metabolic diseases At present, there are more than 10 kinds of products under research, many of which are in the stage of clinical trial or application for trial license at home and abroad The first therapeutic monoclonal antibody product has completed the international phase I clinical trial in Australia, and its domestic clinical trial is in smooth implementation The development progress of R & D product line of Jiahe biopharmaceutical industry was closely followed by two monoclonal antibody products which submitted Chinese clinical application in 2012 and 2013 respectively, one of which also submitted Korean clinical application and obtained permission to enter clinical trial Other monoclonal antibody products are in different stages of preclinical research or new drug discovery / cell line development Shanghai Fuhong Hanlin Biotechnology Co., Ltd Fuhong Hanlin is a joint venture established by Shanghai Fuxing Pharmaceutical and the US scientists team in December 2009 The company is committed to the research, development and industrialization of monoclonal antibody bioequivalent drugs, biological improvement drugs and innovative monoclonal antibodies by applying cutting-edge technologies Fuhong Hanlin is developing products mainly covering tumor, autoimmune diseases and other fields Up to now, the team of the company has completed the efficient R & D of 8 products and 13 indications of ind declaration, of which 6 products have all obtained the clinical approval of 11 indications of CFDA Fuhong Hanlin's biological modified monoclonal antibody, hlx07, which has completely independent intellectual property rights, is worth noting that the first innovative biological modified monoclonal antibody of Fuhong Hanlin, hlx07, has obtained clinical approval in three places, namely mainland China, Taiwan and the United States, and has carried out phase I clinical research in Taiwan This is a kind of humanized monoclonal antibody drug targeting epidermal growth factor receptor (EGFR) on the surface of malignant tumor cells, which can be used to treat colorectal cancer, head and neck cancer and other diseases In addition, the company has four innovative monoclonal antibodies under research, namely hlx06, hlx08, hlx10, hlx09 and hlx20 Hlx10 has submitted its ind application to CDE in July this year Fuhong Hanlin's innovative McAb products