CITIC Guojian's "Herceptin" monoclonal antibody generic cypriotin obtained clinical approval

The pace of approval of mAbs is accelerating On the morning of May 30, the State Administration of food and Drug Administration reported that the approval status of Domestic Recombinant anti HER2 humanized monoclonal antibody for injection was changed to "approved, to be certified", which means that the heavy weight variety "Herceptin" monoclonal antibody of CITIC Guojian, a joint-stock company of Lansheng, has obtained clinical approval documents and is further away from the product listing In addition, according to relevant drug review professionals, new progress has also been made in the application for production approval of CITIC Guojian's siputin The review center of the State Food and Drug Administration sent a notice of on-site review in April this year That is to say, the company can obtain the production approval document only after the final on-site review The above-mentioned approval documents for clinical application are only the four phase clinical trials required by heavy weight new drug approval, involving post marketing evaluation and detection, which is an important progress in the process of new biological drug marketing and production in recent years It is reported that the original research drug of CITIC gypsitine is "Herceptin" of Roche pharmaceutical, and the indication is breast cancer, with a cure rate of 95% The drug is expensive, with a cost of 32000 US dollars (equivalent to nearly 200000 yuan) for each treatment course In 2013, the global sales amount exceeded 6.8 billion US dollars According to the pharmaceutical researchers in the securities industry, at present, the domestic McAbs used in cancer only account for less than 5% of the total market share, so the cancer drugs in the research and development stage deserve the most attention CITIC Guojian, founded in 2002, launched its main monoclonal antibody product yisaipu in 2005, which is used for ankylosing spondylitis and psoriasis, breaking the monopoly of foreign pharmaceutical enterprises on domestic monoclonal antibody drugs, and has been included in Shanghai medical insurance Its market share has expanded year by year In addition, in 2011, the company launched genipipa to prevent rejection after organ transplantation, becoming the first target of anti rejection drugs in China At present, in addition to the research of "cyprotein", the company also has the treatment of immune rejection of "gentuxi" and the treatment of autoimmune diseases of "linine" According to reports, CITIC Guojian was jointly funded by CITIC Group and Lansheng Guojian Pharmaceutical Co., Ltd the current equity structure is: CITIC Pacific holds 43.42%, Lansheng Guojian holds 41.69% and Lansheng holds 0.73% As Lansheng shares holds 34.65% equity of Lansheng Guojian, Lansheng shares holds 15.18% equity of CITIC Guojian in total.