R & D Daily: Kelen pharmaceutical amoxicillin granules passed the conformity evaluation of generic drugs

The first domestic trastuzumab bioequivalent hlx02 reached the main clinical end point in the third phase of the world The tablet of metformin hydrochloride of lingyao pharmaceutical passed the consistency evaluation The DPP-4 inhibitor "agliptin" was first imitated We focus on the latest development of pharmaceutical research and development, and provide timely and accurate information reference for R & D personnel Recently, Fuhong Hanlin announced the latest research progress of the biological analogue hlx02 (trastuzumab for injection) at the 2019 European Society of Oncology annual meeting in Singapore Hlx02 is a humanized monoclonal antibody against HER2, which is a biological analogue of trastuzumab Today, pixel SA announced that imeglimin, an innovative oral type 2 diabetes treatment developed by the company, has achieved positive top line results in the open label extension of time 3, a phase 3 clinical trial So far, imeglimin has reached the main clinical end point in two key phase 3 clinical trials On November 27, Yiling pharmaceutical announced that recently, the company received the approval document for supplementary application of metformin hydrochloride tablets approved and issued by the State Drug Administration, which passed the consistency evaluation of quality and efficacy of generic drugs On November 26, Kelun pharmaceutical announced that its subsidiary Hunan Kelun Pharmaceutical Co., Ltd had recently obtained the approval document for supplementary application of the chemical "amoxicillin granules" approved and issued by the State Drug Administration On November 26, Huabei pharmaceutical released a notice that Huabei pharmaceutical Hebei Huamin Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Huabei pharmaceutical, received the approval document for supplementary application of Cefalexin capsule (0.25g) approved and issued by the State Drug Administration, which passed the consistency evaluation of quality and efficacy of generic drugs On November 26, Taiji Group announced that its holding subsidiary, Taiji Group Chongqing Fuling Pharmaceutical Factory Co., Ltd., had recently received the access approval issued by the health and non prescription drug Department of Pakistan drug administration, which approved that the company's products Huoxiang Zhengqi oral liquid and Jizhi syrup could be sold and used in the Islamic Republic of Pakistan On November 26th, green leaf Pharmaceutical Group announced that the new drug application of its independently developed innovative preparation, risperidone sustained-release microspheres for injection (LY03004), had been accepted by the drug evaluation center of the State Drug Administration of China Prior to that, the drug has entered the NDA stage in the United States, and its production base has passed the pre-approval inspection of FDA On November 25, intercept announced that FDA has accepted the listing application of obecholate in the treatment of liver fibrosis caused by nonalcoholic steatohepatitis, and awarded the priority review qualification Recently, according to the nmpa website, the listing application (acceptance No.: cyhs1600193) of the three generic drugs of bendamostine hydrochloride declared by Zhengda Tianqing has been in the state of approval and is expected to be approved for listing in the near future The drug is used in the treatment of non-Hodgkin's lymphoma Recently, the review of listing application of 4 generic drugs of Yabao Pharmaceutical Co., Ltd., "agagliptin benzoate tablets" (acceptance No.: cyhs1700049) in China has been completed Nmpa official website shows that the approval document has been sent on November 25 After three rounds of supplementary information and on-site verification of clinical trials, Yabao Pharmaceutical Co., Ltd will eventually win the first domestic imitation of the product Recently, intercept pharmaceuticals announced that the FDA accepted the company's application for the listing of new drugs for obacholic acid, and granted it priority review qualification The application seeks accelerated approval to market for the treatment of liver fibrosis due to nonalcoholic steatohepatitis Recently, the usona Institute announced that the U.S FDA has granted psilocybin breakthrough therapy certification to treat patients with depression This recognition will promote the development of psilocybin in the treatment of depression Today, Zaixin biotechnology announced a R & D cooperation with AstraZeneca to jointly develop the world's first humanized model of HFPEF, providing a unique solution for future evaluation of new therapies.