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白云山分公司获得药品补充申请批件
Zhi Tong Cai Jing· 2025-12-29 11:06
白云山(00874)公布,近日,公司分公司广州白云山医药集团股份有限公司白云山制药总厂收到国家药 品监督管理局签发的《药品补充申请批准通知书》。 白云山制药总厂注射用头孢呋辛钠于2006年5月在国内正式上市,并于2025年4月3日向国家药品监督管 理局递交一致性评价申请,于2025年4月11日获得受理。 头孢呋辛钠为第二代头孢菌素,对大多数革兰氏阴性菌、革兰氏阳性菌敏感,具有抗菌谱广、肾脏毒性 较低、对β内酰胺酶稳定的优势,临床广泛用于治疗唿吸道感染、泌尿系统感染及外科感染。注射用头 孢呋辛钠被列入国家基本药物目录(2018),属于国家医保乙类品种(2025)。 白云山制药总厂的注射用头孢呋辛钠通过仿制药一致性评价,有利于提升该药品的市场竞争力。 ...
Adlai Nortye Enters Exclusive License Agreement with ASK Pharm for Pan-RAS (ON) Inhibitor AN9025 in Greater China
Globenewswire· 2025-12-29 11:00
SINGAPORE and NORTH BRUNSWICK, N.J. and HANGZHOU, China, Dec. 29, 2025 (GLOBE NEWSWIRE) -- Adlai Nortye Ltd. (NASDAQ: ANL) (the “Company” or “Adlai Nortye”), a clinical-stage biotechnology company focused on the development of innovative cancer therapies, today announced that it has entered into an exclusive licensing agreement with ASK Pharm for its proprietary pan-RAS (ON) inhibitor AN9025. Under the terms of the agreement, ASK Pharm will obtain exclusive rights to develop, manufacture, and commercialize ...
新华制药磷酸奥司他韦干混悬剂获批上市
Qi Lu Wan Bao· 2025-12-29 10:59
近日,新华制药(000756)磷酸奥司他韦干混悬剂获国家药品监督管理局批准正式上市,并视同过评。 新华制药方面表示,该产品为该公司首个成功获批上市的口服型抗流感仿制药物,这一成果标志着公司 在口服抗流感治疗领域达成了产品线"从无到有"的实质性突破,填补了企业在该细分市场自主产品的空 白,为公司整体治疗领域的战略布局补上了关键的一环。 同时,对于新华制药的另一层意义在于,伴随集中采购的推进以及基层医疗需求的增长,磷酸奥司他韦 干混悬剂有望成为儿童流感防治的主力剂型。该产品需配制成混悬液使用,故而消化道反应相对较少, 其配备的给药器可通过液体抽取方式精准控制给药剂量,对于低龄儿童而言,用药更为灵活便捷,是儿 童流感预防与治疗的优选方案。 磷酸奥司他韦作为一种选择性的流感病毒神经氨酸酶抑制剂,能够有效抑制甲型和乙型流感病毒的传 播,适用于成人和2周龄及以上儿童的甲型和乙型流感治疗,以及适用于1岁及1岁以上人群的甲型和乙 型流感的预防。 据了解,磷酸奥司他韦是世界上第一种获批的抗流感病毒药物,由美国生物制药公司吉利德科学的科研 团队研制,后与瑞士罗氏制药合作完成临床开发及商业化,于1999年获得美国FDA批准上市,商 ...
The Weight Loss Drug Competition Is Heating Up: These 2 Industry Leaders Just Filed Competing Drugs with the FDA.
The Motley Fool· 2025-12-29 09:23
Other drugmakers seem to be too far behind to disrupt this duopoly, at least for now.The weight loss market has garnered plenty of headlines over the past two years. Yet, to date, and despite plenty of pipeline candidates, only two brands dominate this field. One of them is Wegovy, a medication marketed by Novo Nordisk (NVO 0.30%), and the other is Zepbound, which was developed by Eli Lilly (LLY +0.07%). These two are the undisputed leaders in this therapeutic area, and they could soon solidify their lead w ...
华润双鹤(600062.SH):子公司低钙腹膜透析液(碳酸氢盐)、腹膜透析液(碳酸氢盐)系列药品获得药品注册证书
Ge Long Hui A P P· 2025-12-29 09:04
低钙腹膜透析液(碳酸氢盐)、腹膜透析液(碳酸氢盐)系列药品获得《药品注册证书》,将进一步丰富公 司产品线,有助于提升公司产品的市场竞争力,并为后续其他产品研发积累了宝贵的经验。 格隆汇12月29日丨华润双鹤(600062.SH)公布,近日,华润双鹤药业股份有限公司全资子公司上海长征 富民金山制药有限公司(以下简称"上海长富")收到了国家药品监督管理局颁发的低钙腹膜透析液(碳酸氢 盐-G1.5%)、低钙腹膜透析液(碳酸氢盐-G2.5%)[以下简称"低钙腹膜透析液(碳酸氢盐)系列药品"],腹膜 透析液(碳酸氢盐-G1.5%)、腹膜透析液(碳酸氢盐-G2.5%)[以下简称"腹膜透析液(碳酸氢盐)系列药品"] 《药品注册证书》。 ...
新华制药:获得缬沙坦胶囊药品注册证书
Xin Lang Cai Jing· 2025-12-29 08:59
新华制药公告称,近日收到国家药监局核准签发的缬沙坦胶囊《药品注册证书》。该药品规格为 80mg,属处方药、化学药品4类,用于治疗轻、中度原发性高血压,为医保甲类品种。2024年9月公司 递交上市许可申报资料并获受理,2025年12月获批。2024年中国公立医疗机构缬沙坦胶囊销售额约18.2 亿元。获批有利于丰富公司心血管疾病产品线,提升竞争力,但药品销售受政策、市场等因素影响,存 在不确定性。 ...
华润双鹤:子公司低钙腹膜透析液(碳酸氢盐)、腹膜透析液(碳酸氢盐)系列药品获得药品注册证书
Ge Long Hui· 2025-12-29 08:56
格隆汇12月29日丨华润双鹤(600062.SH)公布,近日,华润双鹤药业股份有限公司全资子公司上海长征 富民金山制药有限公司(以下简称"上海长富")收到了国家药品监督管理局颁发的低钙腹膜透析液(碳酸氢 盐-G1.5%)、低钙腹膜透析液(碳酸氢盐-G2.5%)[以下简称"低钙腹膜透析液(碳酸氢盐)系列药品"],腹膜 透析液(碳酸氢盐-G1.5%)、腹膜透析液(碳酸氢盐-G2.5%)[以下简称"腹膜透析液(碳酸氢盐)系列药品"] 《药品注册证书》。 低钙腹膜透析液(碳酸氢盐)、腹膜透析液(碳酸氢盐)系列药品获得《药品注册证书》,将进一步丰富公 司产品线,有助于提升公司产品的市场竞争力,并为后续其他产品研发积累了宝贵的经验。 ...
所谓的天然GLP-1补充剂,真的能当自然版司美格鲁肽吗?
GLP1减重宝典· 2025-12-29 08:46
Core Viewpoint - GLP-1 class weight loss drugs are reshaping global perceptions of weight management, demonstrating weight loss of 10% or more in clinical and real-world studies, while natural GLP-1 supplements are gaining popularity as milder alternatives [4][10] Mechanism of Action - GLP-1 is a hormone secreted by the intestines after eating, which stimulates insulin release, delays gastric emptying, and acts on the brain's appetite center to reduce hunger [4][10] - True GLP-1 receptor agonists are structurally modified to provide sustained, stable, and high-intensity activation of GLP-1 receptors, which is crucial for their significant weight loss effects [4][10] Natural GLP-1 Supplements - Natural GLP-1 supplements are not true GLP-1 or receptor agonists; they attempt to influence metabolic environments through indirect pathways, such as stimulating small amounts of GLP-1 release and improving gut microbiota [6][9] - Common ingredients in these supplements include psyllium husk, green tea extract, saffron extract, polyphenols from lemon or blood orange, various probiotics or prebiotics, and amino acids [7][9] Efficacy and Evidence - There is currently no convincing evidence that natural GLP-1 supplements can achieve weight loss effects comparable to pharmaceutical-grade GLP-1 receptor agonists; their impact is often limited to mild appetite reduction or improved eating control [9][10] - Increasing protein intake is emphasized as a more reliable strategy for stimulating endogenous GLP-1, with recommendations of 1.2 to 1.5 grams of protein per kilogram of body weight per day [9][10] Safety and Regulation - The supplement industry is loosely regulated, leading to issues such as inconsistent ingredient labeling, potential liver function abnormalities from plant extracts, and interactions with existing medications [9][10] - Some products may contain stimulants like caffeine, which could increase cardiovascular or neurological burdens, especially for individuals with chronic diseases or metabolic disorders [9][10] Conclusion - Natural GLP-1 supplements are not entirely ineffective but are better positioned as auxiliary tools in health management rather than core weight loss treatments; the most effective and evidence-backed option remains the regulated use of GLP-1 class drugs [10]
HSBC Sees Pharma Poised to Outperform in 2026, Lifts GSK Target
Yahoo Finance· 2025-12-29 08:28
Core Insights - GSK plc is recognized as one of the 15 Global Dividend Stocks, indicating its potential for portfolio diversification [1] - HSBC has raised its price target for GSK to 1,500 GBp from 1,200 GBp, maintaining a Reduce rating, reflecting a positive outlook for the pharmaceutical sector in 2026 [2] - GSK is preparing for a leadership transition with Luke Miels set to become CEO, amidst challenges such as US tariffs and the need to replenish its pipeline due to expiring patents [3] Regulatory Updates - The FDA approved GSK's Exdensur as an add-on treatment for severe eosinophilic asthma, marking it as the first biologic with a twice-yearly dosing schedule [4] - In the UK, Exdensur has been approved for use in patients aged 12 and older for asthma and for chronic rhinosinusitis with nasal polyps, showcasing a broader label than the FDA's approval [5] Market Position - GSK operates as a global biopharmaceutical company with a focus on developing medicines and vaccines, particularly in respiratory disease, immunology, and infectious diseases [5]
Delayed MS Decision and Trial Miss Add to Sanofi’s R&D Challenges
Yahoo Finance· 2025-12-29 08:13
Sanofi (NASDAQ:SNY) is included among the 15 Global Dividend Stocks to Diversify Your Portfolio. Delayed MS Decision and Trial Miss Add to Sanofi’s R&D Challenges Sanofi (NASDAQ:SNY) said on December 15 that a US regulatory decision for its experimental multiple sclerosis drug will be delayed again. On the same day, the company also disclosed weaker-than-expected results from a late-stage clinical study, adding to a difficult stretch for its research pipeline. Analysts said the latest setbacks could we ...