药品注册
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恩华药业:获得右酮洛芬氨丁三醇注射液《药品注册证书》
Xin Lang Cai Jing· 2026-01-22 07:51
恩华药业公告称,近日获国家药监局核准签发的化学药品右酮洛芬氨丁三醇注射液《药品注册证书》, 规格为2ml:50mg,剂型为注射剂,有效期24个月,批准文号有效期至2031年1月13日。该药品是一种非 甾体抗炎镇痛药,用于成人不适合口服给药的急性中度至重度术后疼痛。这是公司首个围手术期注射用 非甾体抗炎药,丰富了产品管线,将提升市场竞争力和业绩。不过,生产销售可能受不确定因素影响。 ...
复星医药:注射用乳糖酸红霉素药品注册申请获受理
Xin Lang Cai Jing· 2026-01-14 09:42
Core Viewpoint - Fosun Pharma's subsidiary, Suzhou Erye Pharmaceutical Co., Ltd., has recently had its drug registration application for injectable lactulose erythromycin accepted by the National Medical Products Administration [1] Group 1: Company Developments - The cumulative R&D investment for the injectable lactulose erythromycin by the group is approximately RMB 6.33 million (unaudited) as of December 2025 [1] - The sales revenue for injectable lactulose erythromycin in mainland China (excluding Hong Kong, Macau, and Taiwan) is projected to be around RMB 170 million in 2024 according to IQVIA CHPA data [1]
美诺华:全资子公司获得利奥西呱片药品注册证书
Xin Lang Cai Jing· 2026-01-12 08:37
Core Viewpoint - Meheco's wholly-owned subsidiary, Meheco Tiankang, has received the drug registration certificate for Liosiguat tablets from the National Medical Products Administration, enhancing the company's market competitiveness in the treatment of chronic thromboembolic pulmonary hypertension and arterial pulmonary hypertension [1] Group 1: Company Developments - The drug Liosiguat acts as a soluble guanylate cyclase (sGC) agonist, expanding blood vessels through the NO-sGC-cGMP pathway [1] - Meheco Tiankang is now qualified to produce and sell Liosiguat tablets in the domestic market following the approval [1] - The approval marks a significant milestone for Meheco Tiankang, as it joins two other approved companies, Qilu Pharmaceutical and Jiangsu Huayang Pharmaceutical, in the domestic market [1] Group 2: Market Potential - The global sales forecast for Liosiguat tablets in 2024 is approximately $494.16 million, with expected sales in China around $10.38 million [1] - The approval of Liosiguat tablets is expected to enhance the company's product competitiveness in a growing market [1] Group 3: Future Considerations - Future sales of Liosiguat tablets may be influenced by various uncertainties, including policy changes, market demand, and competition from similar drugs [1]
立方制药:全资子公司诚志生物取得洛索洛芬钠口服溶液药品注册证书
Xin Lang Cai Jing· 2026-01-09 09:05
Group 1 - The core point of the article is that Lifan Pharmaceutical's subsidiary, Chengzhi Biological, has received approval from the National Medical Products Administration for the drug registration certificate of Loxoprofen Sodium Oral Solution, marking a significant milestone for the company [1] - Loxoprofen Sodium is a non-steroidal anti-inflammatory drug (NSAID) with effective analgesic, anti-inflammatory, and antipyretic properties [1] - As of the announcement date, there are no imported products approved for sale in the domestic market, making Chengzhi Biological the eighth company in China to hold the drug registration for this product [1] Group 2 - The acquisition of the drug registration certificate will further enrich Lifan Pharmaceutical's product pipeline and enhance its market competitiveness [1] - However, the production and sales of the drug remain subject to policy and market factors, indicating potential uncertainties [1]
爱美客:公司独家经销进口注射用 A 型肉毒毒素产品获得药品注册证书
Cai Jing Wang· 2026-01-09 07:21
Core Viewpoint - The company has received approval from the National Medical Products Administration for its exclusive distribution of injectable type A botulinum toxin produced by Huons BioPharma Co., Ltd, marking a significant milestone in its strategic layout [1] Group 1 - The approval of the injectable type A botulinum toxin product is a key milestone in the company's strategic planning [1] - The product will enhance the company's core competitiveness by providing a more comprehensive solution to customers when combined with existing products [1]
爱美客(300896.SZ):公司独家经销进口产品获得药品注册证书
Ge Long Hui A P P· 2026-01-08 12:40
Group 1 - The core viewpoint of the article is that Aimeike (300896.SZ) has received approval from the National Medical Products Administration for the drug registration certificate of its exclusive distribution of injectable type A botulinum toxin products produced by Huons BioPharma Co., Ltd. in China, including Macau and Hong Kong [1] - The acquisition of the drug registration certificate for the injectable type A botulinum toxin product is a key milestone in the company's strategic layout [1] - This product, combined with existing offerings, will provide customers with a more comprehensive solution, enhancing the company's core competitiveness [1]
中国医药(600056.SH):尼麦角林片获得药品注册证书
Ge Long Hui A P P· 2026-01-08 09:00
Core Viewpoint - China Medical (600056.SH) announced that its wholly-owned subsidiary, Hainan Tongyong Sanyang Pharmaceutical Co., Ltd. (referred to as "Sanyang Pharmaceutical"), has received the drug registration certificate for Nicergoline Tablets from the National Medical Products Administration, which is expected to enhance the company's product line and strengthen its position in the neurological medication sector [1]. Group 1 - Sanyang Pharmaceutical's Nicergoline Tablets are primarily used to improve motivation deficits caused by sequelae of cerebral infarction and are also applicable for vascular dementia, particularly in early treatment to enhance cognitive and memory functions, as well as to alleviate disease severity [1]. - The approval of the drug registration certificate is beneficial for enriching the company's product portfolio and further developing its presence in the neurological medication field [1]. - This development will accumulate valuable experience for the company's future generic drug development [1].
中国医药子公司获得尼麦角林片药品注册证书
Zhi Tong Cai Jing· 2026-01-08 08:59
Core Viewpoint - China Medical (600056.SH) announced that its wholly-owned subsidiary, Hainan General Sanyou Pharmaceutical Co., Ltd. (referred to as "Sanyou Pharmaceutical"), has received the drug registration certificate for Nicergoline Tablets from the National Medical Products Administration [1] Group 1 - Nicergoline Tablets are primarily used to improve motivation deficits caused by sequelae of cerebral infarction [1] - The drug is also applicable for vascular dementia, particularly in early treatment, where it can enhance cognitive and memory functions and reduce the severity of the disease [1]
新华制药:缬沙坦胶囊获得药品注册证书
Xin Lang Cai Jing· 2025-12-29 09:09
Core Viewpoint - The company has received approval from the National Medical Products Administration for the registration of Valsartan capsules, which will enhance its cardiovascular product portfolio and overall competitiveness [1] Group 1: Product Approval - The company announced that it has obtained the drug registration certificate for Valsartan capsules, a prescription medication classified as a chemical drug of category 4, with a specification of 80mg [1] - The approval is significant as it allows the company to offer a treatment for mild to moderate primary hypertension [1] Group 2: Market Impact - The registration certificate for Valsartan capsules was granted in December 2025, indicating a future opportunity for the company to expand its product offerings [1] - The sales of the drug may be influenced by various factors such as domestic pharmaceutical policy changes, tender procurement, and market environment fluctuations, which introduces a level of uncertainty [1]
华海药业获得盐酸纳洛酮注射液药品注册证书
Zhi Tong Cai Jing· 2025-12-26 10:04
Core Viewpoint - Huahai Pharmaceutical (600521.SH) has received the drug registration certificate for Naloxone Hydrochloride Injection from the National Medical Products Administration, indicating a significant regulatory approval for the company’s product line [1] Group 1: Product Approval - The approval is for Naloxone Hydrochloride Injection, which is indicated for multiple uses including reversing respiratory depression caused by opioid drugs during anesthesia recovery [1] - The product can also be used to partially or completely reverse respiratory depression due to opioid overdose, rescue acute ethanol poisoning, and diagnose acute opioid overdose [1]