[yaocajun] the most noteworthy domestic phase 3 clinical trial in 2018, Baiji Shenzhou, Hengrui, Fosun

According to the China clinical trial database of Yaozhi, 107 clinical trials were conducted in three phases in 2018 (as of September 14), among which some important clinical trials are worthy of attention, such as 36 clinical trials related to cancer drugs, 9 clinical trials related to chronic diseases and common diseases, and 9 clinical trials related to other drugs Let's take a look Phase 3 clinical trials of cancer-related drugs in the phase 3 clinical trials of cancer-related drugs carried out in 2018, 20 of which were sponsored by domestic enterprises and others by foreign-funded enterprises 34 in progress, 1 completed, 1 not yet started The most commonly used experimental institutions were four cancer hospitals of Chinese Academy of Medical Sciences, three of the eighth hospital of the people's Liberation Army, three of Shanghai Chest Hospital, and three cancer hospitals affiliated to Fudan University See the following figure for details: (Note: if you need a clear excel form, please add Yao Xiaozhi (17318481750) as your friend, and Xiaozhi will send it to you!) 01 seven clinical trials of Bristol Myers Squibb opdivo in 2018, Bristol Myers Squibb conducted seven clinical trials related to nivolumab in China Nivolumab is the first PD-1 tumor drug approved for marketing in China It is used to treat non-small cell lung cancer Nivolumab was jointly developed by Ono and Bristol Myers Squibb (BMS) It was approved by PMDA on July 4, 2014, FDA on December 22, 2014, and EMA on June 19, 2015 Squibb is sold in the United States, Europe and Japan Several phase 3 clinical trials carried out in China in 2018 are shown below, involving non-small cell lung cancer, urothelial cancer, esophageal cancer or gastroesophageal junction cancer, localized renal cell carcinoma, advanced esophageal squamous cell carcinoma, pleural mesothelioma 02 four clinical trials of bgb-a317 in Baiji Shenzhou in 2018, Baiji Shenzhou carried out three phase clinical trials related to bgb-a317 drugs, including four indications: squamous non-small cell lung cancer, non-squamous non-small cell lung cancer, esophageal squamous cell carcinoma and liver cell carcinoma Bgb-a317 is an important PD-1 antibody in the research of Baiji Shenzhou, which has attracted much attention It belongs to a tumor immune agent called "immune checkpoint" inhibitor The mechanism of bgb-a317 is binding to PD-1 receptor on the cell surface; bgb-a317 has high affinity and specificity for PD-1 According to Baiji Shenzhou, the difference between bgb-a317 and the currently approved PD-1 antibody lies in the specific removal of binding energy with Fcgamma receptor through bioengineering technology Bgb-a317 is currently used as a single drug and a combination of drug components, and its therapeutic effect on a series of tumor species is also explored in a number of clinical trials 03 on July 18, 2018, pyrrolidine maleate tablets, an innovative drug independently developed by Hengrui, started a three-stage clinical trial of the combination of three drugs before operation to treat breast cancer, aiming to determine the safety and effectiveness of its drugs Then in August, the State Drug Administration had the conditions to approve the listing of pyrrolidine Hengrui maleate tablets for the treatment of recurrent or metastatic breast cancer, which attracted the attention of the industry Pyrrolidine maleate is an irreversible tyrosine kinase inhibitor targeting both human epidermal growth factor receptor 2 (HER2) and epidermal growth factor receptor (EGFR) 04 new indications of apatinib mesylate tablets on January 1, 2018, Hengrui carried out a three-stage intervention clinical trial of apatinib mesylate combined with tegio in the treatment of advanced pancreatic cancer Apatinib mesylate was first synthesized by advanchen laboratories in the United States, and then developed by Jiangsu Hengrui Pharmaceutical Co., Ltd on October 17, 2014, it was approved by China food and Drug Administration (CFDA) for marketing The trade name is aitan, which is suitable for the treatment of metastatic gastric cancer Now Hengrui is still developing the therapeutic effect of this medicine in other tumors 05 bivalent and tetravalent HPV vaccine in 2018, the 9valent cervical cancer vaccine has the conditions to be approved for marketing in China, so that many people in need can have new prevention opportunities At the same time, bivalent and tetravalent vaccines are also being studied in China In 2018, a three-phase clinical trial on the effectiveness of bivalent human papillomavirus adsorbed vaccine was conducted, entitled "the persistence of immune response of HPV vaccine in healthy Chinese female subjects in the hpv-058 study", which started on February 28 and ended on June 29, lasting for four months In addition, a three-stage intervention clinical trial of recombinant human papillomavirus vaccine was carried out The title of the trial was "a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial to evaluate the protective effect, safety and immunogenicity of recombinant human papillomavirus vaccine (6,11,16,18) (Hanson yeast) in Chinese women aged 18-45 years old" It is currently in progress and is expected to end on March 25, 2023 In addition to phase 3 clinical trials of drugs related to chronic diseases and common diseases, phase 3 clinical trials of some drugs related to chronic diseases and common diseases were carried out in 2018, among which four were applied by domestic enterprises and the rest by foreign enterprises There are 4 diabetes drug trials, 4 arthritis drug trials and 1 Alzheimer's disease trial 06 Roche AD drug crenezumab injection in May 2018, Roche carried out a three-phase clinical trial of crenezumab injection for prodromal to mild Alzheimer's disease to evaluate the efficacy, safety and pharmacokinetics of crenezumab compared with placebo in prodromal to mild Alzheimer's disease (AD) patients The clinical trial institution is Peking Union Hospital of Chinese Academy of Medical Sciences In the past 18 years, Lilai and Shandong new era respectively carried out three clinical trials on insulin glargine ly2963016 injection and recombinant insulin glargine injection Lilly mainly evaluates the safety and effectiveness of ly2963016 and Laishi in the study of type 1 diabetes and type 2 diabetes Shandong new era is to study the safety and effectiveness of recombinant insulin glargine injection in the treatment of type 2 diabetes mellitus Insulin glargine was developed by Sanofi and approved by FDA on April 20, 2000, EMA on June 9, 2000, CFDA on November 7, 2003, and PMDA on January 30, 2008 Novi is sold in the US, Europe, Japan and China under the trade names Lantus and toujeo Insulin glargine is a long-acting human insulin analogue, which can stimulate the uptake of glucose by skeletal muscle and adipose tissue and inhibit the production of glucose in liver, thus reducing blood glucose The drug is approved for blood glucose control in adults and children with type 1 diabetes and adults with type 2 diabetes 08 Fuhong Hanlin recombinant human mouse chimeric anti-CD20 monoclonal antibody injection on June 11, 2018, Fuhong Hanlin carried out a three-phase clinical trial of recombinant human mouse chimeric anti-CD20 monoclonal antibody injection for rheumatoid arthritis, aiming to study the safety and effectiveness of HLX01 combined with MTX in the treatment of moderate and severe active RA subjects At present, 10 domestic enterprises have also applied for the clinical application of recombinant human mouse chimeric anti-CD20 monoclonal antibody injection, and all of them have been approved However, only Fuhong Hanlin has a fast speed and has carried out three clinical trials Other phase 3 clinical trials In addition to the above, there are other types of drug clinical trials that are also worthy of attention, such as the safety and effectiveness of ixekizumab for the rare and moderate to severe plaque psoriasis, as well as drug-related clinical trials such as dexmedetomidine hydrochloride injection, dizosin injection, concentrated solution of pranabulin for injection, recombinant plasmid hepatocyte growth factor injection See the following figure for details: data source: statement of the Chinese clinical trial database of Yaozhi: the viewpoint of this article only represents the author, not the position of yaozhi.com, welcome to exchange and supplement in the message area; if you need to reprint, please be sure to indicate the author and source of the article.