华纳药厂12月10日公告，公司近日收到国家药品监督管理局核准签发的硫酸镁钠钾口服用浓溶液《药品 注册证书》。硫酸镁钠钾口服用浓溶液适用于成人，用于任何需要清洁肠道的操作前的肠道清洁（如需 要肠道可视化的操作包括内镜、放射性检查、外科手术）。本品不用于治疗便秘。公司硫酸镁钠钾口服 用浓溶液按新注册分类化学药品4类获得药品注册证书，视同通过一致性评价。 ...

福安药业12月10日公告，公司全资子公司福安药业集团湖北人民制药有限公司收到国家药品监督管理局 签发的药品注册证书，药品名称为注射用硫酸艾沙康唑，注册分类为化药4类，规格为0.2g。该药品适 用于治疗成人患者侵袭性曲霉病和侵袭性毛霉病。截至目前，共有11家企业（含人民制药）通过一致性 评价或视同通过一致性评价。药品注册证书的获得将进一步丰富子公司产品线，提升市场竞争力，但受 行业政策、市场环境变化等因素影响，产品的生产、销售情况以及对公司业绩的具体影响存在不确定 性。 ...

Core Viewpoint - The company announced that its wholly-owned subsidiary, Jiangsu Shenhua Pharmaceutical Co., Ltd., has received the acceptance notice for the registration application of Lactulose Oral Solution from the National Medical Products Administration, indicating the product has entered the registration review stage [1] Group 1: Product Details - Lactulose Oral Solution is a laxative characterized by its quick, gentle, and effective action, with high safety, making it suitable for individuals with chronic or habitual constipation [1] Group 2: Regulatory Process - The acceptance of the drug registration application signifies that the product is now in the registration review phase, with completion time, approval results, and post-approval sales conditions remaining uncertain [1] Group 3: Financial Impact - The company stated that the registration application will not have a significant impact on its short-term performance [1]

Core Viewpoint - Shanghai Modern Pharmaceutical Co., Ltd.'s wholly-owned subsidiary, China National Pharmaceutical Group Industrial Co., Ltd., has received a drug registration certificate for Hydromorphone Hydrochloride Injection, marking a significant step in expanding its product line in the analgesic sector [1][3]. Group 1: Drug Information - The drug is named Hydromorphone Hydrochloride Injection, with a specification of 1ml:2mg and classified as a Class 3 chemical drug [1]. - The drug registration certificate number is 2025S03532, and the approval number is 国药准字H20256055, with a validity period of 18 months [1]. - The production facility is located in Langfang Economic and Technological Development Zone, and the drug is intended for patients requiring opioid analgesia [2]. Group 2: Market and R&D Situation - Sales figures for Hydromorphone Hydrochloride Injection in public medical institutions over the past three years were RMB 41.34 million in 2022, RMB 74.84 million in 2023, and RMB 71.68 million in 2024 [2]. - The cumulative R&D investment for the Hydromorphone Hydrochloride Injection project is approximately RMB 4.728 million [2]. - Other companies, such as Yichang Renfu Pharmaceutical Co., Ltd., have also obtained registration certificates for the same drug [2]. Group 3: Impact on the Company - The approval of the drug registration certificate allows the company to produce and sell the product in the domestic market, enhancing its competitive position in the analgesic market [3][4]. - This development is expected to positively influence the company's future growth, although it will not have a significant immediate impact on current operating performance [4].

Core Viewpoint - The company has received approval from the National Medical Products Administration for the drug registration certificate of Esomeprazole Magnesium Enteric-coated Suspension, indicating a significant advancement in its product portfolio [1] Group 1: Company Developments - The company's wholly-owned subsidiary, Guangzhou Yipinhong Pharmaceutical Co., Ltd., has recently obtained the drug registration certificate for Esomeprazole Magnesium Enteric-coated Suspension [1] - Esomeprazole is a proton pump inhibitor and the S-isomer of Omeprazole, which specifically inhibits the H+-K+ ATPase in gastric parietal cells, blocking the final step of gastric acid secretion [1] Group 2: Product Information - Esomeprazole is converted into its active form in the acidic environment of gastric parietal cells, providing inhibition of both basal gastric acid secretion and stimulated gastric acid secretion [1]

Core Viewpoint - Wanbangde Pharmaceutical has obtained exclusive import and sales rights for Sildenafil Citrate Oral Suspension in mainland China for 10 years, marking a significant opportunity in the erectile dysfunction (ED) treatment market [1] Group 1: Company Developments - Wanbangde's wholly-owned subsidiary, Wanbangde Pharmaceutical Group Zhejiang Medical Sales Co., Ltd., has secured exclusive rights from Farmalider, S.A. for the product in China [1] - The product has received the Drug Registration Certificate from the National Medical Products Administration, allowing for its import and sale [1] Group 2: Product Information - Sildenafil Citrate Oral Suspension is a selective inhibitor of phosphodiesterase type 5 (PDE5), specifically targeting cyclic guanosine monophosphate (cGMP) [1] - The product is clinically used for treating male erectile dysfunction, indicating its relevance in addressing a significant health issue [1] Group 3: Market Implications - The exclusive rights for the next decade enable the company to better meet the medication needs of different patient groups in the ED market [1]

Core Viewpoint - Aorite Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the registration of a combined packaging of estradiol tablets and estradiol/dydrogesterone tablets, which is expected to enhance the company's market competitiveness and positively impact its operating performance [1][5][6]. Group 1: Drug Registration Information - The drug is named estradiol tablets/estradiol/dydrogesterone tablets combined packaging, with a registration number of 2025S03486 [1]. - The formulation includes estradiol 2mg and dydrogesterone 10mg [1]. - The drug is classified as a Class 4 chemical drug and is produced by Aorite's subsidiary, Yangzhou Aorite Pharmaceutical Co., Ltd. [1][2]. Group 2: Market Situation - The drug is indicated for the treatment of menopausal syndrome caused by natural or surgical menopause [2]. - The drug was originally developed by Abbott B.V. and was approved for domestic sale in 2015 under the brand name "Fentam." [3]. - As of now, there are two companies, Abbott and Yangzhou Aorite, that have passed the consistency evaluation for this drug in China [3]. Group 3: Financial Investment - As of October 31, 2025, the company has invested approximately 12.64 million RMB in the research and development of this drug [4]. - The hospital sales revenue for "Fentam" is projected to be 564 million RMB in 2024 [4]. Group 4: Impact on Company - The approval of the drug registration is expected to enhance the company's competitiveness in the pharmaceutical market [5]. - The new product's market entry is anticipated to have a positive effect on the company's financial performance [5].

山东新华制药股份(00719)发布公告，近日，山东新华制药股份有限公司(以下简称"... 利丙双卡因乳膏是利多卡因和丙胺卡因的复方制剂，用于下列情况的皮肤局部麻醉：1.针穿刺，例如： 置入导管或采血;2.浅层外科手术，例如：粘膜，在浅层外科手术或浸润麻醉之前;腿部溃疡清洁/清创 术。 根据相关统计数据，2024年中国公立医疗机构利丙双卡因乳膏销售额约为人民币6.15亿元。追加内容 本文作者可以追加内容哦 ! 山东新华制药股份(00719)发布公告，近日，山东新华制药股份有限公司(以下简称"新华制药"或"本公 司")收到国家药品监督管理局核准签发的利丙双卡因乳膏(以下简称"本品")《药品注册证书》。 2024年2月，新华制药向国家药品监督管理局药品审评中心(CDE)递交利丙双卡因乳膏境内生产药品上 市许可注册申报资料并获受理，2025年11月获得《药品注册证书》，审评结论为批准注册。 ...

Core Viewpoint - Xinhua Pharmaceutical (000756.SZ) has received approval from the National Medical Products Administration for the registration certificate of Lidocaine and Prilocaine Cream, indicating a significant advancement in its product offerings [1] Group 1: Product Approval - The approved product, Lidocaine and Prilocaine Cream, is a compound formulation used for local anesthesia in various medical procedures [1] - Indications for use include skin local anesthesia for needle punctures, such as catheter insertion or blood sampling, and superficial surgical procedures [1] - The cream is also indicated for cleaning and debridement of leg ulcers, showcasing its versatility in clinical applications [1]

Core Viewpoint - Pro Pharmaceutical Co., Ltd. has received a drug registration certificate for Cefdinir capsules from the National Medical Products Administration, indicating a significant development in its product portfolio [1] Group 1: Company Developments - The company’s subsidiary, Zhejiang Pro Pharmaceutical Co., Ltd., is the entity that received the drug registration certificate for Cefdinir capsules [1] - Cefdinir capsules are indicated for infections caused by various bacteria, including Staphylococcus, Streptococcus, and Escherichia coli, among others [1] Group 2: Product Indications - The indications for Cefdinir capsules include infections such as pharyngitis, tonsillitis, acute bronchitis, pneumonia, otitis media, sinusitis, pyelonephritis, cystitis, and gonococcal urethritis [1] - Additional indications cover conditions like pelvic inflammatory disease, intrauterine infections, and various skin and soft tissue infections [1]