Haizheng pharmaceutical adamumumab injection included in the priority review

On March 4, Haizheng pharmaceutical released a notice that adamumumab injection of the company was included in the publicity list of the proposed priority review varieties by the national drug review center, with the publicity period of 5 days; on March 1, 2019, according to the information on the official website of the national drug review center, the drug was officially included in the priority review process after the approval of the objection demonstration process within the publicity period Basic information of drugs according to the data, on September 14, 2018, the drug review center of the State Drug Administration accepted the application for registration of adamumumab injection drugs submitted by Haizheng pharmaceutical This product belongs to the biological preparation of anti-tumor necrosis factor (TNF) It can neutralize the biological activity of TNF - α in vivo and play the function of treating corresponding diseases The indications were ankylosing spondylitis, rheumatoid arthritis and plaque psoriasis This product is developed in strict accordance with the guiding principles of biological similar drugs and based on the completed comprehensive comparable research, including pharmacy, preclinical and clinical trials (pharmacokinetic, efficacy, safety and immunogenicity, etc.), which are highly similar to the original drug Humira Global sales of adalimumab (sumac) (unit: US $100 million) sumac was developed by Aberdeen It was listed in the United States in 2003 and entered the Chinese market in 2010 Currently, it has been listed in more than 90 countries around the world Its efficacy and safety have been widely verified The indications approved by sumil in China are ankylosing spondylitis, rheumatoid arthritis and plaque psoriasis The dosage for adults is subcutaneous injection, once every two weeks, 40mg each time In 2013, the global sales volume has exceeded 10 billion yuan, and in 2018, it reached 19.936 billion US dollars At present, there is no adalimumab bio similar drug on the market in China Up to now, about 166 million yuan has been invested in the R & D project of adamumumab injection of Haizheng pharmaceutical.