智通财经APP讯，复星医药(600196.SH)发布公告，近日，公司控股子公司桂林南药股份有限公司就膦 甲酸钠注射液(以下简称"该药品")的药品注册申请获国家药品监督管理局批准，本次获批适应症为用于 治疗(1)艾滋病(AIDS)患者巨细胞病毒性视网膜炎、(2)免疫功能损害患者耐阿昔洛韦单纯疱疹病毒性皮 肤粘膜感染。 ...

Core Viewpoint - Kanghong Pharmaceutical has received the drug registration certificate for Mirabegron extended-release tablets from the National Medical Products Administration, indicating a significant regulatory approval for the company’s product [1] Company Summary - Kanghong Pharmaceutical (002773.SZ) has announced the approval of Mirabegron, a selective β3 adrenergic receptor agonist, which acts on bladder tissue to relax bladder smooth muscle [1]

Core Viewpoint - The company has received the drug registration certificate for Compound Polyethylene Glycol (3350) Electrolyte Powder from the National Medical Products Administration, which will enable it to accelerate the mass production and market launch of the new product [1] Group 1 - The company plans to expand its product matrix and optimize its product structure layout following the approval [1] - The company aims to leverage its brand resource advantages to enhance market competitiveness [1]

Core Insights - The company announced that its wholly-owned subsidiary, Chengdu ShuoDe Pharmaceutical Co., Ltd., received the drug registration certificate for Elamomab tablets from the National Medical Products Administration [1] - Elamomab tablets are indicated for the treatment of active rheumatoid arthritis and are classified as a Category B drug in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog for 2024 [1] - The projected sales amount for Elamomab tablets in key public hospitals in major provinces and cities for 2024 is approximately 382 million yuan, representing a year-on-year growth of 12.90% [1] - The approval of this drug is considered equivalent to passing the consistency evaluation, and it is not expected to have a significant impact on the company's recent performance [1]

Core Viewpoint - The company has obtained the drug production registration approval from the National Medical Products Administration of China for Amlodipine Besylate Tablets (5mg and 2.5mg), classified as a Category 4 chemical drug, indicating it has passed the consistency evaluation [1] Group 1 - Amlodipine Besylate Tablets are primarily used for the treatment of hypertension, chronic stable angina, and vasospastic angina, and can be used alone or in combination with other medications [1]

Core Viewpoint - Chengdu Yuandong Pharmaceutical Co., Ltd. has received the drug registration certificate for its product, Hydrochloride Ephedrine Tablets, marking a significant milestone in its product portfolio and compliance with regulatory standards [1][2]. Drug Basic Information - Drug Name: Hydrochloride Ephedrine Tablets - Dosage Form: Tablets - Specification: 50mg - Registration Category: Class 4 Chemical Drug - Validity Period: 18 months - Holder of Marketing Authorization: Chengdu Shuo De Pharmaceutical Co., Ltd. - Production Company: Chengdu Shuo De Pharmaceutical Co., Ltd. - Drug Registration Standard Number: YBH23792025 - Approval Conclusion: The product meets the requirements for drug registration and has been granted a registration certificate [1][2]. Drug Indications - Hydrochloride Ephedrine Tablets are indicated for: 1. Improving muscle tension in conditions such as cervical shoulder-arm syndrome, periarthritis of the shoulder, and low back pain 2. Spastic paralysis caused by cerebrovascular disorders, spastic myelopathy, cervical spondylosis, postoperative sequelae, traumatic sequelae, amyotrophic lateral sclerosis, infantile cerebral palsy, and other spinal cord diseases [2]. Market Performance - The sales amount for Hydrochloride Ephedrine Tablets in public hospitals in key provinces and cities is projected to be approximately 102.61 million yuan in 2024, reflecting a year-on-year growth of 14.01% [3]. Impact on the Company - The approval of Hydrochloride Ephedrine Tablets signifies that the product meets the necessary registration requirements and is considered to have passed the consistency evaluation. However, it is noted that the approval will not have a significant impact on the company's short-term performance [4].

Core Viewpoint - Shandong Xinhua Pharmaceutical's subsidiary, Shandong Zibo Xinda Pharmaceutical, has received approval for Ursodeoxycholic Acid Capsules from the National Medical Products Administration, enhancing the company's product offerings in the digestive system medication sector [1] Group 1: Regulatory Approval - The company submitted the application for Ursodeoxycholic Acid Capsules to the Center for Drug Evaluation in January 2024, which was accepted [1] - The product received its registration certificate in September 2025, with the evaluation conclusion being approval for registration [1] Group 2: Product Indications - Ursodeoxycholic Acid Capsules are indicated for the treatment of cholesterol gallstones, cholestatic liver diseases, and bile reflux gastritis [1] Group 3: Market Potential - The product is classified as a Category A drug in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog for 2024 [1] - The estimated sales revenue for Ursodeoxycholic Acid in Chinese public medical institutions is approximately RMB 2.155 billion in 2024 [1] Group 4: Strategic Impact - The approval of Ursodeoxycholic Acid Capsules is expected to enrich the company's product variety in digestive system medications and enhance its overall competitiveness [1]

Core Viewpoint - The company Yipinhong (300723.SZ) has received approval from the National Medical Products Administration for its drug, Escitalopram Oxalate Drops, which is indicated for the treatment of depression and panic disorder with or without agoraphobia [1] Group 1: Product Approval - Yipinhong's wholly-owned subsidiary, Guangzhou Yipinhong Pharmaceutical Co., Ltd., has recently obtained the drug registration certificate for Escitalopram Oxalate Drops [1] - The approved indication for the drug includes treatment for depression and panic disorder, with or without agoraphobia [1] Group 2: Mechanism of Action - Escitalopram is the S-enantiomer of racemic citalopram, and its antidepressant effect is believed to be related to the inhibition of serotonin (5-HT) reuptake in the central nervous system, thereby enhancing serotonergic activity [1] Group 3: Market Potential - The drug was registered as a Class 3 chemical drug, which is considered equivalent to passing the consistency evaluation [1] - According to data from Minet, the sales scale of Escitalopram in urban and county-level public hospitals in China is projected to be approximately 1,879.76 million RMB in 2024 [1]

Core Viewpoint - Jiangsu Nuotai Aosaino Biopharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the registration of two drugs: Acetate Cetrorelix Injection and Agomelatine Tablets, marking a significant expansion into reproductive and mental health sectors [1][2][4]. Drug Registration Details - **Acetate Cetrorelix Injection**: - Formulation: Injection - Specification: 0.25mg - Registration Category: Class 4 chemical drug - Validity: 18 months - Approval Number: H20254895, valid until July 21, 2030 [1][3]. - **Agomelatine Tablets**: - Formulation: Tablet - Specification: 25mg - Registration Category: Class 4 chemical drug - Validity: 18 months - Approval Number: H20255026, valid until July 28, 2030 [2][3]. Clinical Advantages - Acetate Cetrorelix is a third-generation GnRH antagonist with clinical advantages over other similar drugs, including faster onset, better safety profile (prevention of OHSS), shorter treatment cycles, and improved patient tolerance [4]. - Agomelatine is a novel antidepressant with a unique dual mechanism of action, offering rapid sleep improvement without daytime functional impairment, low risk of sexual dysfunction, minimal weight impact, and good tolerance [4]. Strategic Impact - The approval of these drugs represents a strategic expansion for the company into reproductive and mental health, aligning with national policies on child-rearing subsidies and the inclusion of assisted reproduction in health insurance, thereby supporting high-quality population development [4].

Core Viewpoint - The company XinTiandi has received approval from the National Medical Products Administration for its drug "Vildagliptin Tablets," which is classified as a Category 4 chemical drug and is effective for the treatment of type 2 diabetes [1] Group 1: Drug Approval and Details - The drug Vildagliptin Tablets has been granted a registration certificate with a validity period of 24 months, expiring on July 21, 2030 [1] - The original developer of Vildagliptin is Novartis Pharmaceuticals, and it is marketed in China under the name "Jiaweile" [1] - Vildagliptin works by increasing the levels of incretin hormones, which helps to reduce blood glucose levels by decreasing liver glucose production [1] Group 2: Company Impact - The approval of Vildagliptin Tablets signifies that the product meets the necessary registration requirements, allowing the company to produce and sell the drug in the domestic market [1] - This approval will enhance the company's product portfolio and improve its market competitiveness [1]