Shanghai Fuxing Pharmaceutical "kafezomi" has been approved for clinical research and development, with an investment of more than 10 million yuan

1 overview recently, Chongqing pharmaceutical industry Research Institute Co., Ltd., a holding subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd (hereinafter referred to as "the company"), received the approval from the State Food and Drug Administration for the approval of clinical trials of the preparation of API kafzomi The API kafezomib and injection kafezomib are collectively referred to as "the new drug" 2 Basic information of the new drug 1 Drug name: kafzomi dosage form: API application matters: domestic drug registration classification: original chemical category 3.1 applicant: Chongqing Medical Engineering Institute acceptance No.: cxhl1502458 Chongqing approval No.: 2016l10435 approval conclusion: it is agreed to carry out clinical trial of the product 2 Drug name: non Zomi dosage form of injection card: injection specification: 60mg application items: domestic drug registration classification: original chemical class 3.1 applicant: acceptance no of Chongqing Medical Engineering Institute: cxhl1502460 Chongqing approval No.: 2016l10125 approval conclusion: agree to carry out clinical trial of the product 3 research of the new drug 2015 In, Chongqing Medical Engineering Institute submitted the clinical trial application to Chongqing food and Drug Administration for the first time and was accepted The new drug is the original class 3.1 chemical independently developed by the company and its holding subsidiary / unit (hereinafter referred to as "the group"), which is mainly applicable to the treatment of multiple myeloma patients Shanghai kaimao biomedical Co., Ltd., the holding subsidiary of the company, will accept the clinical approval documents of non Zomi injection card and carry out the follow-up clinical research according to the agreement In July 2012, the new drug was first approved by food and Drug Administration (U.S FDA) to be marketed in the United States for the treatment of relapsed or refractory myeloma, specifically including (1) combination of dexamethasone or lenalidomide plus dexamethasone in the treatment of relapsed or refractory multiple myeloma that received first-line to third-line treatment; (2) Single drug therapy has received first-line and multi line treatment of recurrent or refractory multiple myeloma The formulation of the new drug is freeze-dried powder for injection, with the specification of 60mg / bottle As of the date of this announcement, there is no listed non Zomi injection card in China According to IMS midatm, the sales volume of fizomib for injection in the global market in 2015 was about US $550 million As of November 2016, the group has invested about 12.9 million yuan in research and development of the new drug at this stage.