Core Viewpoint - Jincheng Pharmaceutical announced that its subsidiary has received a notification for the approval of the chemical raw material drug, Mirabegron, which is primarily used for treating overactive bladder (OAB) conditions such as urinary incontinence, urgency, and frequency [1] Group 1: Product Approval and Market Impact - Mirabegron is a selective β-3 adrenergic receptor agonist, and its approval indicates compliance with national technical standards for raw material drug review [1] - The approval allows for production and sales in the domestic market, enhancing the company's product line in raw materials and improving its competitiveness in the chemical raw material drug sector [1] Group 2: Market Data and Trends - Currently, there are 18 companies in China with Mirabegron approval status A on the raw material drug registration platform [1] - According to IMS data, global consumption of Mirabegron raw materials is projected to be 57.91 tons in 2022, 63.05 tons in 2023, and 69.79 tons in 2024 [1] - Global sales of Mirabegron formulations are expected to reach $3.286 billion in 2022, $3.420 billion in 2023, and $3.536 billion in 2024 [1]

Core Viewpoint - Hendi Pharmaceutical has received approval from the National Medical Products Administration for the marketing application of Methochlorpromazine Hydrochloride, a dopamine receptor antagonist used to alleviate nausea and vomiting symptoms, as well as to promote gastrointestinal motility for improving dyspepsia and delayed gastric emptying [1] Company Summary - Hendi Pharmaceutical (301211.SZ) has announced the approval of Methochlorpromazine Hydrochloride, indicating a significant milestone in its product development pipeline [1] - The drug is primarily indicated for the treatment of nausea and vomiting, which could enhance the company's portfolio in the gastrointestinal therapeutic area [1] Industry Summary - The approval of Methochlorpromazine Hydrochloride reflects ongoing regulatory support for new pharmaceutical products in the market, highlighting the importance of innovative treatments for common gastrointestinal issues [1] - The use of dopamine receptor antagonists in managing gastrointestinal symptoms underscores the growing demand for effective therapies in this segment [1]

Core Viewpoint - Huaren Pharmaceutical's subsidiary, Anhui Hengxing Pharmaceutical, has received approval from the National Medical Products Administration for the marketing application of Isoproterenol Hydrochloride, indicating a significant advancement in the company's product portfolio and potential market opportunities [1]. Group 1 - The approved drug, Isoproterenol Hydrochloride, is a non-selective β-adrenergic agonist that strongly stimulates both β1 and β2 receptors, showcasing powerful positive inotropic, positive chronotropic, and bronchodilator effects [1]. - The clinical applications of Isoproterenol Hydrochloride primarily include treatment for cardiogenic or septic shock, complete atrioventricular block, cardiac arrest, and acute bronchial asthma attacks [1].

Core Viewpoint - The company Tianyao Pharmaceutical has received approval from the National Medical Products Administration for the marketing application of Difluprednate, a topical corticosteroid drug that can inhibit inflammation caused by various irritants [1] Group 1: Product Information - Difluprednate is primarily available in the form of eye drops and is used to treat inflammation and pain associated with eye surgeries [1] - According to the IQVIA database, the global sales of Difluprednate formulations are projected to be $49 million in 2023 and $41 million in 2024 [1]

Core Viewpoint - The approval of the structural triglyceride by the National Medical Products Administration enhances the product portfolio of Guangzhou Baiyunshan Hanfang Modern Pharmaceutical Co., Ltd, improving its market competitiveness in lipid excipients, although it will not have a significant impact on current performance [1] Group 1 - Guangzhou Baiyunshan Hanfang Modern Pharmaceutical Co., Ltd received the approval notice for structural triglyceride from the National Medical Products Administration [1] - The raw material is a key ingredient for formulations such as structured fat emulsion injection (C6–24) and structured fat emulsion (20%)/amino acids (16)/glucose (13%) injection, which are used for parenteral nutrition fat supplementation [1] - The domestic sales revenue for these formulations is projected to be 1.157 billion yuan in 2024 [1] Group 2 - The company has invested approximately 4.05 million yuan in research and development for this project [1] - The approval will enrich the company's medicinal lipid excipient product offerings [1] - The impact of this approval on the company's current performance is not significant [1]

Core Viewpoint - Jinling Pharmaceutical announced that its subsidiary Chizhou Dongsheng Pharmaceutical has received approval from the National Medical Products Administration for the registration of potassium sulfate, which is a raw material for oral solutions used for bowel cleansing before medical procedures. This approval indicates that the raw material meets domestic drug registration requirements and can be produced and sold in the domestic market, enhancing the company's product line in raw materials. However, production and sales will take time, and it will not have a significant impact on the company's current performance [1]. Summary by Relevant Categories - **Regulatory Approval**: The approval for potassium sulfate registration has been granted by the National Medical Products Administration, allowing for its production and sale in the domestic market [1]. - **Product Line Expansion**: This approval will enrich the company's raw material product line, providing more options for its offerings [1]. - **Impact on Performance**: The company indicates that the production and sales of potassium sulfate will take time, and therefore, it will not significantly affect the company's current financial performance [1].

Core Viewpoint - Rundu Co., Ltd. has received approval from the National Medical Products Administration for the listing application of hydrochlorothiazide, which is expected to enhance the company's product portfolio and market competitiveness, positively impacting future operating performance [1]. Group 1 - The approval of hydrochlorothiazide is applicable for treating edema-related diseases, hypertension, central or renal diabetes insipidus, and nephrolithiasis [1]. - This approval enriches the company's product categories and improves its full industry chain layout [1]. - The development is anticipated to strengthen the company's market competitiveness [1].

Core Viewpoint - The announcement indicates that Jianfeng Group's subsidiary, Anhui Jianfeng Beika Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the chemical raw material drug Vonoprazan Fumarate, which is a potassium ion competitive acid blocker used for treating gastroesophageal reflux disease [1] Company Summary - Jianfeng Group's subsidiary, Anhui Jianfeng Beika, has obtained the "Chemical Raw Material Drug Listing Application Approval Notice" for Vonoprazan Fumarate, with the notice number 2025YS00694 [1] - The approval signifies that the raw material drug meets the national technical standards for raw material drug review, allowing it to be sold in the domestic market [1] - The company has the necessary production line in place for Vonoprazan Fumarate, which will help expand the subsidiary's business scope [1] Industry Summary - Vonoprazan Fumarate is developed by Takeda Pharmaceutical Company Limited and is used for the treatment of reflux esophagitis [1] - The approval of this drug aligns with the growing demand for effective treatments in the gastroenterology sector, indicating potential market opportunities [1]

Core Viewpoint - Jincheng Pharmaceutical's subsidiary, Beijing Jincheng Taier Pharmaceutical Co., has received approval from the National Medical Products Administration for the marketing application of Lactobionic Acid Erythromycin, indicating a significant development in the company's product portfolio and potential market opportunities [1] Company Summary - Jincheng Pharmaceutical's approval for Lactobionic Acid Erythromycin marks a milestone as it is currently the only company in China with this approval for the injectable form of the antibiotic [1] - The company is positioned in a competitive landscape with 17 enterprises holding marketing approvals for injectable Lactobionic Acid Erythromycin, but no original research products are available in the domestic market [1] Industry Summary - Lactobionic Acid Erythromycin is classified as a macrolide antibiotic, primarily used for treating severe infectious diseases, and was first approved in the U.S. in 1964 [1] - Global sales for Lactobionic Acid Erythromycin formulations are projected to grow from $44.75 million in 2022 to $72.45 million in 2024, indicating a positive market trend for this antibiotic [1]

Core Viewpoint - The company, Rundu Pharmaceutical, has received approval from the National Medical Products Administration for the marketing application of its drug, Benzylsuccinate Atracurium, which is intended for use in surgical procedures and intensive care treatments [1] Group 1: Product Approval - Rundu Pharmaceutical's subsidiary, Rundu Pharmaceutical (Jingmen) Co., Ltd., has been granted a marketing approval notice for Benzylsuccinate Atracurium [1] - The drug is suitable for adults and children aged one month and older, specifically for surgical operations and other therapeutic procedures [1] - It can be used as an adjunct to general anesthesia or for sedation in the ICU to facilitate tracheal intubation and mechanical ventilation [1]