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A batch of drugs has been approved for market in China, involving anti insomnia drugs and kidney dis


Time:2025-06-23 10:20:50  Source:  Author:

 

According to the new announcement on the website of China National Drug Administration (NMPA) on June 20, a batch of drug marketing applications have been approved, including Xiansheng Pharmaceutical's Dalileisheng Hydrochloride Tablets, Zhendong Pharmaceutical's Vonorasome Fumarate Tablets, Yabao Pharmaceutical's Propranolol Hydrochloride Tablets, Kelun Pharmaceutical's Penehyclidine Hydrochloride Injection, Jiudian Pharmaceutical's Choline Fenofibrate Sustained Release Capsules, Otsuka Pharmaceutical's Spellin Monoclonal Antibody Injection (VIS649), and Centrita's Fogliptin Benzoate Tablets, covering insomnia, kidney disease, diabetes, dyslipidemia and other disease fields.

 
 
 
Among them, Xiansheng Pharmaceutical's Dalilei Hydrochloride Tablets are a dual orexin receptor antagonist (DORA), belonging to the new generation of anti insomnia drugs. Previously, the product has been approved for market in countries such as the United States, the United Kingdom, Switzerland, and Canada. In November 2022, Simcere Pharmaceutical entered into an exclusive licensing agreement with Idorsia, obtaining the exclusive rights to clinical development and commercialization of Dalyrex in China.
 
 
 
It is reported that insomnia is a serious sleep disorder, characterized by difficulty falling asleep (sleep latency exceeding 30 minutes), sleep maintenance disorders (≥ 2 awakenings throughout the night), going to bed early, decreased sleep quality, and reduced total sleep time (usually less than 6.5 hours), accompanied by daytime dysfunction. Dali Leisheng reduces overactive central arousal by blocking the binding of orexin neuropeptides to their receptors. Due to its ability to only block the activation of orexin receptors, it can reduce arousal drive, induce sleep without altering the proportion of sleep stages, and has no residual effects the next day.
 
 
 
Otsuka Pharmaceuticals' VIS649 is a monoclonal antibody developed by the company that targets the inhibitor of proliferation inducing ligand (APRIL). APRIL is a cytokine in the tumor necrosis factor (TNF) family that plays a key role in the "four hit" pathogenesis of IgAN. It delays kidney damage and the progression of IgAN to end-stage kidney disease (ESKD) by promoting the production of pathogenic galactose deficient IgA1 (Gd IgA1) antibodies and the formation of immune complexes.
 
 
 
It is reported that IgAN is a progressive, autoimmune chronic kidney disease, usually occurring between the ages of 20-40, which can lead to progressive loss of kidney function in patients and ultimately result in ESKD. The characteristic of IgAN is the accumulation of Gd-IgA1 complex in the kidney.
 
 
 
Xinglitai's phenytoin tablets belong to the DPP-4 inhibitor class of oral hypoglycemic drugs. By inhibiting DPP-4, endogenous GLP-1 levels increase, and GLP-1 increases insulin secretion in a glucose concentration dependent manner, inhibiting glucagon secretion and thereby lowering blood sugar. DPP-4 inhibitors, due to their unique hypoglycemic mechanism, accurately control blood sugar without increasing the risk of hypoglycemia, have almost no impact on weight, and have relatively few gastrointestinal reactions, making them more suitable for elderly patients. In recent years, DPP-4 inhibitors have been recommended as the primary hypoglycemic drug for elderly T2DM patients in both domestic and international guidelines and consensus. It is reported that Fugliptin benzoate tablets were approved for market by the National Medical Products Administration on June 28, 2024. It is a Class 1 innovative drug independently developed by Xinlitai Pharmaceutical.
 
 
 
Fenofibrate choline sustained-release capsules are mainly used clinically to reduce triglyceride (TG) levels in patients with severe hypertriglyceridemia, as well as to treat patients with primary hypercholesterolemia or mixed dyslipidemia, on the basis of adult controlled diet. Data shows that fenofibrate is a pharmacological active ingredient in the bloodstream after oral administration of fenofibrate choline sustained-release capsules. It modifies lipids by activating peroxisome proliferator activated receptor alpha (PPAR alpha). Through this mechanism, fenofibrate activates lipoprotein lipase and reduces the production of Apo CIII (lipoprotein lipase inhibitor), thereby increasing fat breakdown and eliminating triglyceride rich particles in plasma. The activation of PPAR α also induces an increase in the synthesis of high-density lipoprotein cholesterol, Apo AI, and AII. Fumarate Fumarate Fumarate Fumarate Fumarate Fumarate Fumarate Fumarate Fumarate Fumarate Fumarate Fumarate Fumarate Fumarate Fumarate Fumarate Fumarate Fumarate Fumarate Fumarate Fumarate Fumarate Fumarate Fumarate Fumarate Fumarate Fumarate Fumarate Fumarate Fumarate Fumarate Fum.
 
 
 
The approval of these new drugs is the result of the continuous improvement of China's pharmaceutical innovation system. Their listing not only brings more effective treatment options for patients, but also promotes the development of related disease treatment fields, helping China's pharmaceutical industry move towards a higher level.

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