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The clinical trial of Haichuang Pharmaceutical HP515 tablets for the treatment of non-alcoholic fatty liver disease has been approved by the Drug Evaluation Center (CDE) of the National Medical Products Administration. According to the data, HP515 is an oral highly selective THR - β agonist independently developed by Haichuang Pharmaceutical, which can directly act on the transcription of downstream genes activated by THR - β, and improve non-alcoholic steatohepatitis by enhancing liver cell lipid metabolism activity, improving liver fat metabolism, and reducing lipid toxicity.

 

 

 

Kangfang Biological AK135 obtained implied approval for clinical trials last week and is intended to be developed for the treatment of chemotherapy induced peripheral neuropathy. According to publicly available information from Kangfang Biotechnology, AK135 is a biopharmaceutical targeting IL-1RAP. Research has shown that IL-1RAP is highly involved in the inflammatory process through the interleukin-1, IL-33, and IL-36 (IL-1, IL-33, IL-36) signaling pathways, and has been found to be overexpressed in various hematological and solid cancer tumor cells.

 

 

 

Kangyuan Pharmaceutical's injection drug "KYS202004A" was also approved for clinical trials last week, and its indication is psoriasis. It is reported that psoriasis is a chronic and recurrent autoimmune skin disease that poses great challenges to the quality of life of patients. KYS202004A is a novel bispecific fusion protein targeting TNF - α and IL-17A, aimed at antagonizing TNF - α and IL-17A, playing a key role in the pathophysiology of autoimmune and inflammatory diseases. In preclinical studies of psoriasis, this product has been shown to be equally effective when used in combination with other approved products.

 

 

 

Eli Lilly and Company's application for LY3540378 injection was also approved for clinical use last week, with plans to develop it for the treatment of patients with chronic kidney disease (CKD). Public information shows that LY3540378 (volenrelaxin) is an effective agonist of the long-acting relaxin family peptide receptor 1 (RXFP1) currently under development by Lilly.

 

 

 

In addition, according to the review, the Class 1 new drug VV261 tablets jointly declared by Wangshan Wangshui, the Chinese Academy of Sciences Wuhan Institute of Virology, and the Chinese Academy of Sciences Shanghai Institute of Materia Medica were approved for clinical use, and were intended to be developed for the treatment of fever with thrombocytopenia syndrome. According to the data, VV261 is a nucleoside based candidate new drug for anti novel Bunyavirus (SFTSV).

 

 

 

The 177Lu-TR0471 injection declared by Tongrui Biotechnology has been approved for clinical use, intended for the treatment of adult patients with prostate specific membrane antigen (PSMA) positive metastatic castration resistant prostate cancer (mCRPC) who have received androgen receptor inhibitors but have not received paclitaxel chemotherapy. The human GLP-1 and FGF21 double factor high expression adipose stem cell injection declared by Jiyuan Biology was approved for clinical trial, and it is planned to develop and treat type 2 diabetes. The BN-1001 ophthalmic injection applied by Beisio Biotechnology has been approved for clinical use and is intended to be developed for the treatment of neovascular (wet) age-related macular degeneration (wAMD). The LH-1901 inhalation drug jointly applied by Lianhuan Pharmaceutical and China Pharmaceutical University has been approved for clinical use and is intended to be developed for the treatment of chronic obstructive pulmonary disease (COPD). The PG-033 tablets submitted by Puqi Pharmaceutical have been approved for clinical use and are intended to be developed for the treatment of moderate to severe itching associated with neurodermatitis. The RG002C0106 injection applied by Xuanjing Biotechnology has been approved for clinical use, intended for the treatment of complement mediated primary or secondary glomerular diseases.

 

 

 

Industry insiders say that clinical trials are not only an important step in drug development, but also a critical link in testing its safety and efficacy. With more innovative drugs approved for clinical trials, patients are also expected to have more and better treatment options.