Oral versus intravenous antimicrobial prophylaxis for the prevention of surgical site infection for elective cesarean section and gynacological procedures

开始日期2023-10-01

申办/合作机构

Sohag University

[+1]

CTR20222308

/ CompletedN/A

头孢拉定胶囊在中国健康受试者中单中心、随机、开放、单剂量、两周期交叉空腹及餐后状态下的生物等效性试验

主要目的：比较空腹和餐后给药条件下单次口服悦康药业集团股份有限公司生产的头孢拉定胶囊（0.25 g）与中美上海施贵宝制药有限公司持证的头孢拉定胶囊（0.25 g，商品名：泛捷复®）在健康人群中吸收程度和速度的差异，评价空腹和餐后状态下口服两种制剂的生物等效性。次要目的：评价空腹和餐后条件下，悦康药业集团股份有限公司生产的头孢拉定胶囊（0.25 g）的安全性。

开始日期2022-10-08

申办/合作机构

悦康药业集团股份有限公司

CTR20212453

/ CompletedN/A

头孢拉定胶囊（0.25g/粒）在中国健康受试者中空腹和餐后给药条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效性试验

按有关生物等效性试验的规定，选择中美上海施贵宝制药有限公司生产的头孢拉定胶囊（商品名：泛捷复，规格：0.25g/粒）为参比制剂，对华北制药河北华民药业有限责任公司生产的受试制剂头孢拉定胶囊（规格：0.25g/粒）进行空腹和餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，比较两种制剂在空腹和餐后给药条件下的生物等效性；并观察在健康受试者中的安全性。

开始日期2021-10-28

申办/合作机构

华北制药河北华民药业有限责任公司

100 项与头孢拉定相关的临床结果

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100 项与头孢拉定相关的转化医学

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100 项与头孢拉定相关的专利（医药）

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项与头孢拉定相关的文献（医药）

2025-10-01·JOURNAL OF CONTROLLED RELEASE

Hierarchically structured hydrogel exhibiting spatiotemporal release profiles: Enabling digital remote diagnosis and personalized therapeutics

Article

作者: Zhang, Lei ; Liu, Ailing ; Ji, Xiongtao ; Yu, Lu ; Wang, Jingkang ; Huang, Xin ; Jin, Shuo ; Wang, Na ; Wang, Ting ; Hao, Hongxun ; Yang, Yingying

Wound therapy has long been a complex challenge within the medical field. The parameters at the wound area change constantly, presenting a significant challenge in monitoring wound conditions for guiding drug release and enabling real-time therapy. Herein, a hierarchically structured hydrogel, composed of a supramolecular hydrogel with bactericidal activity and a polymer hydrogel promoting wound healing, was designed and fabricated using physical crosslinking method. This hierarchically structured hydrogel could serve as wound dressing. Specifically, physicochemical properties testing indicates that the hierarchically structured hydrogel exhibits tunable rheological property, high swelling and similar mechanical properties to human skin. The drug release in vitro proved that cephradine would be released quickly at pH 5.0 and hyaluronic acid would be dissociated easily at pH 7.5, aligning perfectly with the processes of wound disinfection and healing. Moreover, clinical animal experiments showed that the hierarchically structured hydrogel significantly enhances the granulation tissue thickness, improves vascularization and collagen deposition, thereby promoting wound healing more effectively than the commercial films. Notably, the hierarchically structured hydrogel's excellent conductivity and multiple stimulus response behaviors allow for real-time monitoring physiological environment of wounds and drug release, thereby promoting digital remote diagnosis and personalized treatment.

2025-08-01·CURRENT MICROBIOLOGY

Oryzobacter faecalis sp. nov., an Antibiotics-Resistant Actinobacterium of the Family Intrasporangiaceae Isolated from Pig Faeces

Article

作者: Xiong, Miaohuan ; Liu, Bin ; Yan, Qiuxiang ; He, Xinyan

A Gram-stain-positive, aerobic, rod-shaped, and non-motile bacterium, designated strain R7^T, was isolated from pig faeces. Strain R7^T grew at 15-37 °C (optimum 30 °C), pH 6-8 (optimum pH 7), and salinity of 0-5.0% (w/v; optimum 1.0%). Strain R7^T was resistant to cefradine, ampicillin, gentamicin, and spectinomycin. Phylogenetic analysis based on 16S rRNA gene sequences indicated that strain R7^T belonged to genus Oryzobacter, and showed 98.9% similarity with Oryzobacter terrae PSGM2-16^T. The average nucleotide identity and digital DNA-DNA hybridization values between strain R7^T and O. terrae PSGM2-16^T were 84.5% and 27.6%, respectively. The predominant fatty acids of strain R7^T were iso-C_16:0, C_17:1ω8c, iso-C_14:0, C_17:0, and iso-C_15:0. The predominant ubiquinone was MK-8(H₄). The major polar lipids of strain R7^T were phosphatidylethanolamine, diphosphatidylglycerol, phosphatidylinositol, aminophosphoglycolipid, one unidentified phospholipid, and two unidentified polar lipids. The diagnostic diamino acid of the cell-wall peptidoglycan was meso-diaminopimelic acid. Based on the phenotypic, genotypic and phylogenetic evidence, strain R7^T represents a novel species in the genus Oryzobacter, for which the name Oryzobacter faecalis sp. nov. is proposed. The type strain is R7^T (=GDMCC 1.4961^T = KCTC 59403^T = KACC 23902^T).

2025-07-01·European Journal of Obstetrics & Gynecology and Reproductive Biology

Oral versus intravenous antibiotic prophylaxis before obstetric and gynecological surgical interventions: A randomized clinical trial

Article

作者: Abdelkareem, Amr Othman ; Anwar, Yasmeen Tharwat ; Elftooh Awaga, Hatem Abo ; Ait-Allah, Abdou Saeed

OBJECTIVE:

The current study was conducted to compare the efficacy of prophylactic intravenous versus oral (Cephradin) for the prevention of surgical site infections (SSI) in Obstetric and Gynecological interventions.

METHODS:

A randomized clinical trial was carried out on 230 patients fulfilling the eligibility criteria between 1st October 2023 and 31st July 2024, including pregnant women who were approached prior to their delivery and non-pregnant women who were approached prior to their intended interventions. (group A) 116 patients received oral antimicrobial prophylaxis, while (group B) 114 patients received intravenous antimicrobial prophylaxis. Furthermore, all included patients received oral antibiotics postoperatively (oral cephradine 500 mg/ 12 h for 7 days). Patients were evaluated twice; the 1st assessment was done 1 week, while the 2nd assessment was done a month after the intervention.

RESULTS:

SSI rate was 14 % CI (0.07-0.20) in the oral group compared to 13 % CI (0.07-0.20) in the intravenous group after one week with no significant difference in between (p = 0.84). However, the SSI rate was 5.5 % CI (0.02-0.11) in the oral group compared to 6.3 % CI (0.02-0.12) in the intravenous group after one month of the intervention, with no significant difference in between (p = 0.78).

CONCLUSION:

The current study showed that oral antibiotic prophylaxis before obstetric and gynecological interventions seems to be safe, easy, practical, cheap, and as effective as parenteral antibiotic prophylaxis in the prevention of SSI. However, more randomized trials with larger sample sizes are needed to pave the way for replacing parenteral with oral antibiotic chemoprophylaxis.

TRIAL REGISTRATION:

The study was approved by the Sohag Ethical Committee, Faculty of Medicine, with IRB number (Soh-Med-23-09-05MS) and was registered on clinical trial.gov with T.R.N (NCT06255652).

项与头孢拉定相关的新闻（医药）

2025-09-16

·医药代表

确认了！BMS出售合资药企，不是退出…

这个消息在业界流传几天了，不断有小伙伴们留言问询此事。前两天，一封在业界流传的内部邮件显示，百时美施贵宝已和高瓴投资（Hillhouse Capital）关联公司签署协议，转让其持有的中美合资上海施贵宝制药有限公司持有的 60% 股权，以及仅为中国大陆市场生产的相关产品博路定（Baraclude）、百服宁（Bufferin）、施尔康（Theragran）、蒙诺（Monopril）、泛捷复（Velosef）。预计交易将于 2026 年初完成。现在有实锤的消息出来了，据 fiercepharma 报道，百时美施贵宝已通过邮件向其确认了这个消息，并表示，这个交易主要涉及在中国生产的老药和消费类产品，不会影响百时美施贵宝在华核心业务。百时美施贵宝发言人表示：“作为长期战略的一部分，我们持续优化资源配置，以支持全球网络不断变化的业务需求。出售我们在 SASS 的股权，体现了公司持续实施制造战略的决心——通过在内部能力与外部伙伴之间取得平衡，BMS 希望进一步聚焦区域市场，保障中国以及全球患者的长期供应安全。交易的财务细节依然没有得到公布，其发言人补充称，百时美施贵宝将为受交易影响的员工提供支持，并优先确保在股权变更过程中实现“平稳而尊重的过渡”。所以，现在最关键的地方可以确定了——百时美施贵宝出售 SASS，并不意味着其在华核心创新药业务将退出。大家都知道，百时美施贵宝简称 BMS。在业界，中美上海施贵宝制药有限公司又称 SASS，是其英文公司名字 Sino-American Shanghai Squibb Pharmaceuticals 的简称。趁此机会，大咪给新人小伙伴们介绍一下这家公司的前世今生。中美上海施贵宝制药成立于 1982 年 10 月 14 日，是我国实行改革开放政策后，于上海最早建立的中外合资企业之一，也是中美第一家制药合资企业。大家知道，在早期，跨国药企进入中国市场只能通过与国有本地企业的合资方式。 1978 年我国实行改革开放政策后，美国施贵宝公司开始积极谋求合作，当年年底，施贵宝公司高级总裁费尔就来华洽谈合资筹建制药公司等事宜。 1980 年 7 月，当时的国家医药管理总局将这个合资项目定在上海，经过多次谈判，最终于 1982 年 5 月在上海签约，并于 10 月 14 日获颁营业执照。当时，中方投资方原为上海医药工业公司，1986 年 6 月因上海经济体制改革，上海医药工业公司作为行政性公司被撤销后，经双方协定，改由上海医药进出口公司和中国医药贸易总公司为中方投资方。创立初期，中美双方对等投资，其后经过几次增资，中外方投资比例变为 4:6，目前持股比例为：百时美施贵宝持股 60%，上海医药集团股份有限公司持股 30%，国药集团资产管理公司持股 10%。成立以来，中美上海施贵宝制药给中国医药产业带来了很多先进理念和创新成果，比如早在 1989 年，就通过美国 FDA 的 GMP 审查，成为中国第一家西药制剂可以出口美国的制药企业，以及之前大咪曾提到的，在 1993 年创建中国第一支 OTC 营销团队，等等。而发展至今，中国已是百时美施贵宝公司全球重要的研发、生产、营销和创新中心之一，目前，百时美施贵宝在中国拥有四个法人单位, 除了中美上海施贵宝制药有限公司，还包括： • 百时美施贵宝（上海）贸易有限公司：成立于 1997 年，进出口各类医药产品、原材料和设备。 • 百时美施贵宝（中国）投资有限公司：成立于 1998 年。 • 百时美施贵宝（中国）医药有限公司：成立于 2013 年。这次出售的即是 BMS 目前持有的中美上海施贵宝制药 60% 股权。这二十多年，随着中国市场逐步向外资开放，许多跨国药企当年建立的合资公司，更多承载着老品牌药物、专利到期产品以及消费类药品的产销功能，有的仅仅保留生产功能了，与这些跨国药企的创新药业务已逐渐分离。此前大咪分享过多家跨国药企类似的举措了，这里就不一一列举了，感兴趣的直接查询 MRCLUB 历史消息即可。总的来说，BMS 这个举措，不应该像一些媒体解读为“退出”，而是老资产的剥离与新局面的启动，运营重心转向创新与高价值领域。对 BMS 及一众跨国药企来说，中国药品市场的核心战场，依旧是创新药。医药代表伴您成长！

2025-09-15

·FiercePharma

BMS sells controlling stake in historic US-China pharmaceutical joint venture

Bristol Myers Squibb originally linked up with China’s Sinopharm Foreign Trade to establish Sino-American Shanghai Squibb Pharmaceuticals as the first U.S.-China pharmaceutical joint venture back in 1982. More than 40 years after establishing the first U.S. pharmaceutical joint venture in China, Bristol Myers Squibb is handing over its controlling stake in the business.BMS has inked an agreement to sell a 60% ownership stake in its China-based joint venture Sino-American Shanghai Squibb Pharmaceuticals (SASS), a BMS spokesperson told Fierce Pharma in an emailed statement. The move is primarily related to manufacturing of older medicines and consumer products in China and doesn't affect Bristol's core business in the country.An internal email circulating online suggests Hillhouse Capital is on the other end of the transaction. Hillhouse is one of Asia’s biggest investment firms, having invested in such biopharma outfits as BeOne Medicines (formerly BeiGene) and Jiangsu Hengrui Pharmaceuticals. The BMS spokesperson didn’t address the buyer’s identity. “As part of our long-term strategy, we continue to align our resources to support evolving business needs across our global network,” the BMS spokesperson said. “The planned sale of our interest in the SASS joint venture reflects the continued implementation of our manufacturing strategy—one that balances internal capabilities with strong external partnerships to enhance regional focus and ensure long-term supply reliability for patients in China and around the world.”BMS will work to assist any employees impacted by the deal and is prioritizing a “smooth and respectful transition” during the ownership change, the spokesperson added. BMS did not elaborate on the financial terms of the agreement.Crucially, the news does not mean that BMS’ core innovative drugs business will cease operation in China. BMS originally linked up with China’s Sinopharm Foreign Trade to establish SASS as the first U.S.-China pharmaceutical joint venture back in 1982. When China opened its economy to foreign entities in the 1980s, multinational corporations were only allowed to enter the country through joint ventures with state-owned, local companies such as Sinopharm.BMS’ China joint venture operates a 58,000-square-meter (roughly 624,307-square-foot) manufacturing facility in Shanghai responsible for production of antibiotics, cardiovascular drugs, analgesics and metabolic medicines, according to the company’s website.BMS’ stake sale isn’t expected to disrupt facility operations or product supply in China. The transaction includes both the sale of the joint venture itself and products that SASS makes exclusively for the mainland China market, including the hepatitis antiviral Baraclude, the buffered aspirin product Bufferin, the vitamin deficiency supplement Theragran, Monopril for high blood pressure and heart failure, and Velosef, which is an antibiotic used to treat bacterial infections. Several other prescription or over-the-counter medicines are listed under the joint venture, according to a database managed by China’s National Medical Products Administration.These days, as China has become more amenable to foreign entities’ participation in the domestic market, legacy joint ventures established by Western drugmakers often maintain a mix of older drug brands, off-patent medicines and consumer products separate from the companies’ innovative therapeutics businesses.Meanwhile, BMS isn’t the only ex-China drugmaker to dispense with certain legacy brands in the country. Last August, Belgium’s UCB said it was selling its mature neurology and allergy business in mainland China to local healthcare asset manager CBC Group and the Abu Dhabi-based investment organization Mubadala in a deal worth $680 million.The deal covered the divestment of seizure drugs Keppra and Vimpat, Neupro for Parkinson’s disease and restless leg syndrome, and the allergy meds Zyrtec and Xyzal, as well as a manufacturing facility in the city of Zhuhai, located in China’s Guangdong Province.The deal was designed, in part, to free up UCB’s focus on potential innovative medicine launches across immunology, neurology and rare diseases in China, the company’s CEO, Jean-Christophe Tellier, said at the time.

并购引进/卖出

2025-09-15

·GBIHealth

传BMS剥离中国业务

药械追踪 No.1 / 智翔金泰IL-4Rα单抗上市申请获受理，拟治疗特应性皮炎 2025年9月15日，重庆智翔金泰生物制药股份有限公司（智翔金泰，688443.SH）宣布，旗下泰利奇拜单抗注射液（GR1802注射液）治疗成人中、重度特应性皮炎的III期临床试验达到了主要终点指标，公司向国家药品监督管理局（NMPA）药品审评中心（CDE）提交了该适应证的新药上市申请并获得受理。泰利奇拜单抗注射液（GR1802注射液）是一款由智翔金泰自主研发的重组全人源抗IL-4Rα单克隆抗体，作用靶点为IL-4Rα。泰利奇拜单抗注射液能特异性结合细胞表面人IL-4Rα，阻断IL-4、IL-13与IL-4Rα的结合，抑制下游STAT6磷酸化，抑制CD23上调，从而抑制由IL-4或IL-13介导的Th2型炎症反应。泰利奇拜单抗注射液的多个适应证处于临床试验阶段，慢性鼻窦炎伴鼻息肉、慢性自发性荨麻疹、成人以及青少年季节性过敏性鼻炎适应证处于III期临床试验阶段，哮喘适应证处于II期临床试验阶段，儿童/青少年特应性皮炎适应证处于Ib/IIa期临床试验阶段。 ->点击文末阅读原文，解锁完整双语新闻企业动态 No.1 / 西门子医疗或将出售其诊断业务，估值超60亿欧元据彭博社报道，有知情人士透露，西门子医疗已与一些大型私募股权公司进行了初步洽谈，拟出售其诊断业务。上述人士称，黑石集团、CVC 资本以及KKR等公司已参与了初步洽谈。另外一些人士表示，蒙塔古公司（Montagu）也曾对这一交易表现出过兴趣。据其中一些人士称，该诊断业务在此次交易中的估值可能超过 60 亿欧元（约合 70 亿美元）。如果讨论进入正式阶段，公司可能会任命顾问团队。这些人士表示，目前尚无法确定初步洽谈是否会导致交易的最终达成，西门子医疗也有可能决定保留该业务。目前，西门子医疗公司、黑石集团、CVC资本、KKR以及蒙塔古公司的代表均未予置评。 ->点击文末阅读原文，解锁完整双语新闻 No.2 / 传BMS剥离中国业务，高瓴资本或将接手近日，百时美施贵宝（BMS）内部邮件在网络流传。根据网传邮件内容，BMS已签署协议，将其在中美上海施贵宝制药有限公司（SASS）所持有的60%股权，以及数款仅为中国大陆市场制造的关联产品出售给Hillhouse投资集团（高瓴资本）的关联公司，包括恩替卡韦（Baraclude/博路定）、对乙酰氨基酚（Bufferin/百服咛）、复合维生素（Theragran/施尔康）、福辛普利（Monopril/蒙诺）和头孢拉定（Velosef/泛捷复）。预计该交易将于2026年初完成，具体金额尚未披露。 BMS在邮件中表示，“此次计划中的资产剥离直接反映了公司不断演进的网络战略。出售给高瓴资本将使BMS能够将内部资源聚焦于最重要的增长领域。” ->点击文末阅读原文，解锁完整双语新闻 No.3 / 百洋医药与济坤医药达成JK1033授权合作 2025年9月12日，青岛百洋医药股份有限公司（SHE：301015）与天津济坤医药科技有限公司签订战略合作协议，百洋医药战略投资济坤医药，拟持有其24%股权，进而锁定济坤医药旗下用于治疗肺纤维化1类创新药的JK1033所有权益。同时，公司对济坤医药持有的所有产品的全球化合物权益享有同等条件下优先购买权。 JK1033项目是一种从中药单体及其衍生物中提取并经高通量筛选及改构优化得到的抗纤维化小分子化合物，拟用于治疗IPF和进行性肺纤维化（PPF）。目前该项目已完成药学、药理学、药效学等研究，在中国获得临床试验默示许可并在2025 年1 月启动Ⅰ期临床试验，同时已与美国FDA完成Pre-IND沟通，可根据安排提交IND申请。 ->点击文末阅读原文，解锁完整双语新闻全球医疗情报领导者解锁隐藏在数据中的商业潜力关于 G B I ” 自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。联系我们投稿 | 发稿 | 媒体合作 ▶ olivia.xu@generalbiologic.com 数据库 | 咨询服务 | 资讯追踪 ▶ 点击左下“阅读原文”完成表单填写点击阅读原文，解锁完整双语新闻

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100 项与头孢拉定相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00264	头孢拉定	J01DB09	DB01333

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适应症	国家/地区	公司	日期
细菌感染	中国	天津华津制药有限公司	1985-01-01
革兰氏阴性菌感染	美国	Bristol Myers Squibb Co.	1982-01-01
革兰氏阳性细菌感染	美国	Bristol Myers Squibb Co.	1982-01-01