List of important clinical trials in China in 2018 (3)

Source: Sina Pharma 2018-03-15 CFDA issued relevant policies on encouraging innovation and reform of clinical trial management of pharmaceutical and medical devices, which will further promote the development of new drugs and clinical trials in China in the future Support researchers and clinical trial institutions to carry out clinical trials; improve ethics committee and review mechanism; optimize clinical trial review procedures; accept overseas clinical trial data, etc As can be seen below, some important clinical trials in China in 2018, including some key clinical trials (3) [list of important clinical trials in China in 2018 (2)] It is also expected that more and more clinical trial data will be disclosed, and the phenomenon of "happy but not worried" will be reduced 1 The full name of bat8001 bat8001 is recombinant humanized anti erbB2 / neu / HER2 antibody drug conjugate, which is the first ADC (anti drug conjugates) developed by baiaotai It is the coupling of recombinant humanized anti erbB2 / neu / HER2 monoclonal antibody and meddensone drug derivative through linker At present, we are preparing to carry out phase III clinical Baiaotai's products under research mainly include innovative antibody drugs and biological similar drugs Among them, batifiban and bat1406 have entered phase III clinical practice Batifeban and its analogues are antiplatelet IIb / IIIa (integrin receptor α IIb / β 3) and vascular wall cell α V / β 3 receptors Bat1406 is a biological analogue of adalimumab 2 The product is from Zejing biology This product is intended to develop bone marrow fibrosis, autoimmune disease, a deuterium Jak1 / 2 selective inhibitor The company adopts the research and development strategy of PSO (proven, short cut, overseas), selects the high-quality new drugs that have been successful in Europe and the United States and are urgently needed in Chinese clinical practice, uses the core technology of Zejing to optimize precisely, breaks through the bottleneck of production technology, and rapidly advances to clinical research 3 Ct-1530 is a Btk inhibitor from Beijing celestine The first indication of the drug in clinical practice was recurrent / refractory B-cell-derived non-Hodgkin's lymphoma (B-NHL) In the future, ct-1530 is expected to be developed as a first-line treatment for chronic lymphoblastic leukemia (CLL) and small Lymphoid Lymphoma (SLL) In the future, it can also expand the indications to mantle cell lymphoma, diffuse large B-lymphoma, Fahrenheit megaglobulinemia, etc Related patent: cn 104837825 a Sailintai is one of the early new drug development and follow-up enterprises, and has cooperation with Zhengda Tianqing, Shiyao group, etc 4 Insulin glargine injection (rd10044) this product is from dongyangyao and is in the third phase of clinical practice In addition to the original research of Sanofi, glargine insulin has been listed in the domestic varieties of Ganli pharmaceutical industry and UL (for relevant market information, please refer to the IPO prospectus of Ganli Pharmaceutical Co., Ltd.) three phases of clinical work are under way or later: Haizheng pharmaceutical hs004; Shandong new era Pharmaceutical Co., Ltd.; Jiangsu Wanbang Biochemical Co., Ltd.; Tonghua Dongbao Pharmaceutical Co., Ltd 5 Fluzoparil is a PARP inhibitor from hausen Pharmaceutical Co., Ltd., which is recruiting patients with recurrent ovarian cancer A phase I clinical study on the treatment of ovarian cancer or triple negative breast cancer with fluzopali and apatinib has been carried out before In the clinical trial of a phase I trial of shr3162 in subjects with advanced solid tumors, the author compares the previously disclosed shr3162 of xiahengrui, and indicates that the drug: shr3162, other name: fluzoparib (https://clinicaltrials.gov/ct2/show/nct02759666? Term = shr3162 & rank = 1) 6 Domestic enterprises carrying out clinical trials of adalimumab biological analogues include: baiaotai, bat1406, phase III; Xinda biology, phase III; Fuhong Hanlin, phase III; Junshi biology, ubp1211, Phase III: Tonghua Dongbao, Zhengda Tianqing, Dongfang Baitai, Corning Jerry, Huahai pharmaceutical, Qilu pharmaceutical, etc are in phase I This is only one of Adamu The domestic TNF α inhibitor market is highly competitive Other important clinical references are as follows: