Multiple Pharmaceutical Approvals This Week: XuanTai Pharma, FuYuan Pharma Among Companies Announcing New Drug Launches and IPO Filings

　　【Pharmaceutical Network Product InformationIn the past week, multiple pharmaceutical companies, including Sinotherapeutics Inc., Beijing Front Pharmaceutical Co., Ltd., SHANGHAI MODERN PHARMACEUTICAL CO LTD, and PHARSCIN PHARMA, have announced the approval and market launch of their drugs.
 

On February 4, Sinotherapeutics Inc. announced that it had received a notification from the National Medical Products Administration (NMPA) that its mesalazine enteric-coated sustained-release tablets had been officially approved. Previously, this product had already received approval from the U.S. Food and Drug Administration (FDA) in May 2023 and was launched in the U.S. market. The indication for mesalazine enteric-coated sustained-release tablets is for inducing and maintaining remission in adult patients with mild to moderate active ulcerative colitis. In 2022, the sales revenue of mesalazine preparations in the Chinese market was approximately 1 billion RMB.
 

On February 4, Beijing Front Pharmaceutical Co., Ltd. also announced that its wholly-owned subsidiary, Front Pharmaceutical, had received the "Drug Registration Certificate" for Fusidic Acid Cream issued by the National Medical Products Administration. Data shows that this product is mainly used to treat skin infections caused by Staphylococcus, Streptococcus, Propionibacterium acnes, Corynebacterium minutissimum, and other bacteria sensitive to fusidic acid.
 

SINOPHARM MODERN announced on the evening of January 29 that recently, SHANGHAI MODERN PHARMACEUTICAL CO LTD's controlling subsidiary, China National Pharmaceutical Group Zhi Jun (Shenzhen) Pharmaceutical Co., Ltd., received the "Drug Registration Certificate" for Ambroxol Hydrochloride Oral Solution issued by the National Medical Products Administration. The product name is "Ambroxol Hydrochloride Oral Solution." Data shows that Ambroxol Hydrochloride Oral Solution is an over-the-counter expectorant drug used for thick sputum and difficulty in expectoration caused by acute and chronic bronchitis. This drug was originally developed by Germany's Boehringer Ingelheim. Up to now, China National Pharmaceutical Group Zhi Jun's R&D investment in Ambroxol Hydrochloride Oral Solution is approximately RMB 10 million (unaudited).
 

PHARSCIN PHARMA announced in the evening of January 29 that the company had received the "Drug Registration Certificate" issued by the National Medical Products Administration for its product Rasagiline Mesylate Tablets. According to available information, Rasagiline Mesylate Tablets are classified as a Class B drug under China's national medical insurance scheme and are a generic drug independently developed by the company. Currently, the company is the fourth manufacturer in China to receive approval for this generic drug. Data shows that the total market sales of Rasagiline Mesylate Tablets in 2022 amounted to 121 million yuan. This medication is indicated for the monotherapy (without levodopa) of patients with primary Parkinson's disease (PD), as well as an adjunctive therapy with levodopa for Parkinson’s patients experiencing end-of-dose fluctuations.
 

In addition, recently, Qilu Pharmaceutical's treatment for overactive bladder (OAB) drug Mirabegron Sustained-Release Tablets has been approved for marketing by the National Medical Products Administration and is deemed to have passed the consistency evaluation. Data shows that Mirabegron is a β3-adrenergic receptor agonist that inhibits involuntary contractions by acting on β3AR in the detrusor muscle during the urine storage phase, thereby mediating increased bladder compliance and delaying the micturition reflex; it can also activate the second messenger cyclic adenosine monophosphate (cAMP), which further activates PKA, leading to the phosphorylation of key intracellular target proteins, resulting in smooth muscle relaxation and ultimately alleviating OAB. This product is the first new mechanism OAB treatment drug approved both domestically and internationally in nearly 30 years, which can be used alone or in combination with existing OAB treatments, providing patients with diverse treatment options.
 

Hengrui Pharma recently announced that its subsidiary, Chengdu Shengdi Pharmaceutical Co., Ltd., has received a notification from the U.S. Food and Drug Administration (FDA) that the company’s Abbreviated New Drug Application (ANDA, or generic drug application in the U.S.) for Tacrolimus Extended-Release Capsules has been approved. This is the first generic version of the drug to be approved for marketing by the U.S. FDA.
 

Novo Nordisk's semaglutide tablets (brand name: Novo Xindi) have been approved for marketing by the National Medical Products Administration (NMPA) for the treatment of type 2 diabetes. Data shows that semaglutide is a glucagon-like peptide-1 (GLP-1) analog. GLP-1 is a peptide hormone secreted by intestinal cells, which stimulates insulin secretion and inhibits glucagon secretion by binding to GLP-1 receptors, thereby promoting glucose metabolism. Additionally, it can delay gastric emptying and suppress appetite.
 

The industry expects that with the launch of a batch of new drugs, relevant patients will also have new medication options.
 

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