2024年7月份，九洲药业向国家药品监督管理局药品审评中心(以下简称"CDE")提交该原料药的上市申 请，并于近日取得国家药监局下发的《化学原料药上市申请批准通知书》。该原料药在CDE原辅包登记 信息平台上显示状态为"A"。截至目前，公司已在甲苯磺酸艾多沙班累计研发投入约为669万元。 公告显示，本次取得甲苯磺酸艾多沙班的《化学原料药上市申请批准通知书》，表明该原料药已符合国 家药品注册的有关规定要求，将进一步丰富公司的产品结构，提升市场竞争力。 据了解，甲苯磺酸艾多沙班是一种口服抗凝药物，主要用于预防非瓣膜性房颤患者的卒中及全身性栓 塞，以及治疗或预防深静脉血栓和肺栓塞。根据公开数据，甲苯磺酸艾多沙班片2023年在国内样本医院 和城市实体药店的销售额约为3.61亿元。 本报讯(记者邬霁霞)11月25日，浙江九洲药业（603456）股份有限公司(以下简称"九洲药业")发布公告 称，公司于近日收到国家药品监督管理局颁发的《化学原料药上市申请批准通知书》，药品名称为甲苯 磺酸艾多沙班。 ...

新华制药（000756）(000756.SZ)公告，公司收到国家药品监督管理局核准签发的富马酸伏诺拉生《化 学原料药上市申请批准通知书》。该药物主要用于反流性食管炎。 ...

Core Viewpoint - Yiling Pharmaceutical has received approval for the listing application of Memantine Hydrochloride, a drug for treating moderate to severe Alzheimer's disease, which is expected to see increasing market demand due to the aging population in China [1] Group 1: Memantine Hydrochloride Approval - Yiling Pharmaceutical's wholly-owned subsidiary, Hengshui Wanyang, has received approval from the National Medical Products Administration for the listing of Memantine Hydrochloride [1] - Memantine Hydrochloride is a non-competitive NMDA receptor antagonist that can block neuronal damage caused by elevated glutamate levels [1] - The Alzheimer's disease report indicates approximately 16.9 million dementia patients in China, with a prevalence rate of about 1.19‰, which is rapidly increasing due to population aging [1] - The anti-dementia market in China is valued at 1.56 billion yuan, with Memantine being a first-line treatment drug holding a market share of 22% [1] - The market capacity for Memantine Hydrochloride in China is expected to reach 340 million yuan by 2025, with a year-on-year growth of 11% [1] - Sales volume is projected to be 160 million tablets, reflecting a year-on-year increase of 19% [1] Group 2: Anastrozole Approval - Yiling Pharmaceutical's subsidiary, Hengshui Wanyang, has also received approval for Anastrozole, a drug widely used for treating estrogen-related tumors [2] - The global breast cancer drug market is projected to reach $37.6 billion by 2025 and $55 billion by 2030, with aromatase inhibitors holding 38% of the market share [2] - The demand for Anastrozole is expected to remain stable as the incidence of breast cancer in China continues to rise [2] - Yiling Pharmaceutical plans to enhance market competitiveness by integrating raw material and formulation production for Anastrozole [2] - The company aims to accelerate international registration and overseas sales of Anastrozole, targeting markets in Europe and the United States [2] Group 3: Financial Performance - Yiling Pharmaceutical reported total revenue of 5.868 billion yuan for the first three quarters of 2025, with a net profit of 1 billion yuan, reflecting a year-on-year increase of 80.33% [3] - In Q3 2025, the company achieved revenue of 1.827 billion yuan, a year-on-year growth of 3.78%, and a net profit of 332 million yuan, showing a significant increase of 1264.61% [3] - The company has four innovative drug candidates in clinical stages and several others in preclinical research [3] - The NDA application for the drug Benanilofen has been accepted, and XY0206 for treating acute myeloid leukemia is in phase III clinical trials [3]

Core Viewpoint - Huabei Pharmaceutical's subsidiary, Hebei Huamin Pharmaceutical Co., has received approval from the National Medical Products Administration for the marketing application of Cefotolan Pivoxil, a third-generation cephalosporin antibiotic [1] Group 1: Product Details - Cefotolan Pivoxil is a third-generation cephalosporin antibiotic that is hydrolyzed into the active form Cefotolan after absorption, exhibiting antibacterial properties [1] - The antibiotic shows significant effectiveness against five major pathogens causing community-acquired respiratory infections, particularly against penicillin-resistant Streptococcus pneumoniae and Staphylococcus aureus [1] Group 2: Indications - The product is indicated for infections caused by sensitive bacteria, including superficial and deep skin infections, lymphangitis, chronic pyoderma, and secondary infections from trauma, burns, and surgical wounds [1] - Additional indications include perianal abscess, pharyngitis, laryngitis, tonsillitis (including peritonsillar abscess), acute bronchitis, pneumonia, lung abscess, chronic respiratory infections, otitis media, sinusitis, periodontitis, jaw inflammation, cystitis, pyelonephritis, scarlet fever, and whooping cough [1]

Core Viewpoint - Company Huabei Pharmaceutical has received approval from the National Medical Products Administration for the marketing application of Cefotolan Pivoxil, a third-generation cephalosporin antibiotic [1] Group 1: Product Information - Cefotolan Pivoxil is a third-generation cephalosporin antibiotic that is hydrolyzed into its active form, Cefotolan, after absorption, providing antibacterial effects [1] - The antibiotic shows significant efficacy against five major pathogens causing community-acquired respiratory infections, particularly against penicillin-resistant Streptococcus pneumoniae and Staphylococcus aureus [1] - The product is indicated for various infections caused by sensitive bacteria, including superficial and deep skin infections, lymphangitis, chronic pyoderma, and respiratory tract infections [1]

Core Viewpoint - The company, Jibeier (688566.SH), has received the approval notice for the marketing application of its chemical raw material, gatifloxacin, from the National Medical Products Administration, indicating a significant advancement in its product pipeline [1]. Group 1: Product Information - Gatifloxacin is a quinolone antibiotic effective against various bacteria, including Gram-positive and Gram-negative bacteria, as well as Chlamydia trachomatis [1]. - The product gatifloxacin eye drops, which utilize gatifloxacin as the main raw material, are primarily used for treating acute bacterial conjunctivitis caused by sensitive bacteria [1]. - The antibacterial action of gatifloxacin is achieved by inhibiting bacterial DNA gyrase and topoisomerase IV, thereby blocking the processes of DNA replication, transcription, and repair [1].

Core Viewpoint - The company Kyushu Tong (600998.SH) announced that its subsidiary Beijing Jingfeng Pharmaceutical (Shandong) Co., Ltd. received approval from the National Medical Products Administration for the marketing application of Glycopyrrolate, a quaternary ammonium anticholinergic drug [1] Group 1: Product Approval - The approval notification for Glycopyrrolate was issued on October 16, 2025 [1] - Glycopyrrolate is indicated for conditions such as gastric and duodenal ulcers, chronic gastritis, and for maintenance treatment in adults with chronic obstructive pulmonary disease (COPD) [1] Group 2: Drug Mechanism and Applications - Glycopyrrolate selectively acts on the gastrointestinal tract, inhibiting gastric secretion and adjusting gastrointestinal motility [1] - The drug specifically binds to and inhibits the M3 acetylcholine receptors in bronchial smooth muscle, leading to airway dilation [1]

Core Viewpoint - The approval of the listing application for Glycopyrrolate by the National Medical Products Administration is expected to positively impact the future development of the company's pharmaceutical industrial business and enhance its competitiveness in the active pharmaceutical ingredient market [1] Group 1: Company Developments - The company's subsidiary, Beijing Jingfeng Pharmaceutical (Shandong) Co., Ltd., received the approval notice for the listing application of Glycopyrrolate on October 16, 2025 [1] - Glycopyrrolate is a quaternary ammonium anticholinergic drug used for treating gastric and duodenal ulcers, chronic gastritis, and for maintaining bronchial dilation in adult patients with chronic obstructive pulmonary disease [1] - The approval will enrich the company's product line and strengthen its market position in the active pharmaceutical ingredient sector [1]

Core Viewpoint - Sichuan Shuangma (000935) announced that its subsidiary, Hubei Jianxiang Biopharmaceutical Co., Ltd., has recently received the approval notice for the listing application of Acetate Leuprolide from the National Medical Products Administration [1] Group 1: Company Developments - The approval pertains to Acetate Leuprolide, a Gonadotropin-Releasing Hormone (GnRH) agonist, which effectively suppresses the secretion of gonadotropins when administered at therapeutic doses [1] - The drug is currently approved in China for the treatment of endometriosis, uterine fibroids, prostate cancer, estrogen receptor-positive premenopausal breast cancer, and central precocious puberty [1]

Core Viewpoint - Sichuan Shuangma (000935.SZ) announced that its subsidiary Hubei Jianxiang Biopharmaceutical Co., Ltd. has received the approval notice for the listing application of Acetate Leuprolide from the National Medical Products Administration [1] Group 1: Company Developments - Hubei Jianxiang has obtained the approval for Acetate Leuprolide, which is a Gonadotropin-Releasing Hormone (GnRH) agonist [1] - The drug is effective in suppressing the secretion of gonadotropins when administered at therapeutic doses [1] Group 2: Market Applications - Acetate Leuprolide is currently approved in China for the treatment of endometriosis, uterine fibroids, prostate cancer, estrogen receptor-positive premenopausal breast cancer, and central precocious puberty [1]