化学原料药

Search documents
金城医药:米拉贝隆原料药获批上市,治疗包括尿失禁、尿急和尿频在内的膀胱过度活动症
Cai Jing Wang· 2025-09-24 07:12
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]
亨迪药业:盐酸甲氧氯普胺获化学原料药上市申请批准
Zhi Tong Cai Jing· 2025-09-16 08:04
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]
华仁药业:盐酸异丙肾上腺素化学原料药上市申请获批准
Zhi Tong Cai Jing· 2025-09-02 08:21
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].
津药药业:收到化学原料药上市申请批准通知书
Xin Lang Cai Jing· 2025-08-29 09:02
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]
白云山:子公司获化学原料药上市申请批准
Xin Lang Cai Jing· 2025-08-29 08:21
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]
金陵药业:控股子公司获硫酸钾上市批准
Xin Lang Cai Jing· 2025-08-25 10:28
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].
润都股份(002923.SZ):公司氢氯噻嗪获得上市批准通知,适用于水肿性疾病等症状
Xin Lang Cai Jing· 2025-08-19 10:07
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].
尖峰集团子公司获得富马酸伏诺拉生化学原料药上市申请批准通知书
Zhi Tong Cai Jing· 2025-08-13 07:40
尖峰集团(600668)(600668.SH)发布公告,近日,公司的下属子公司安徽尖峰北卡药业有限公司(简 称"尖峰北卡")收到国家药品监督管理局关于化学原料药富马酸伏诺拉生的《化学原料药上市申请批准 通知书》(通知书编号:2025YS00694)。 富马酸伏诺拉生(Vonoprazan Fumarate)是由日本武田药品工业株式会社研发的用于治疗反流性食管炎的 钾离子竞争性酸阻滞剂。尖峰北卡已具备相应的生产线,本次获得化学原料药富马酸伏诺拉生的《化学 原料药上市申请批准通知书》,表明该原料药已符合国家相关原料药审评技术标准,可在国内市场进行 销售,有助于拓展子公司的业务领域。 ...
金城医药(300233.SZ):乳糖酸红霉素获得化学原料药上市申请批准通知书
Ge Long Hui A P P· 2025-08-05 08:55
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]
润都股份:苯磺顺阿曲库铵获化学原料药上市申请批准
Zhi Tong Cai Jing· 2025-08-04 08:02
润都股份(002923)(002923.SZ)公告,公司全资子公司润都制药(荆门)有限公司(简称"润都荆门公司") 近日收到国家药品监督管理局签发的关于苯磺顺阿曲库铵《化学原料药上市申请批准通知书》。该药品 适用于成人及1个月及以上儿童的外科手术和其他操作治疗,亦可用于成人的重症监护治疗。可用作全 麻辅助,或者用作ICU中镇静以松弛骨骼肌,利于气管插管和机械通气。 ...