Doripenem

近日，正大天晴注射用多黏菌素E甲磺酸钠（天韵）上市申请获得国家药监局批准，成为国内首个获批的注射用多黏菌素E甲磺酸钠。目前，该品种进口药尚未在国内上市，天韵的获批为我国耐药革兰阴性菌感染患者带来福音。 正大天晴多黏菌素E甲磺酸钠获批适应症： 适用于革兰阴性杆菌敏感菌株引起的急性或慢性感染，特别是由铜绿假单胞菌敏感株所致者。本品对于产气肠杆菌、大肠埃希菌、肺炎克雷伯菌和铜绿假单胞菌所致感染临床有效性已经获得证实； 本品亦可用于疑为革兰阴性菌所致严重感染的初始治疗和敏感革兰氏阴性杆菌感染的治疗； 为减少耐药细菌的产生并保持本品及其它抗菌性的有效性，本品应仅用于治疗确诊或高度怀疑由敏感细菌引起的感染。 多黏菌素是由多黏类芽孢杆菌产生的一组环肽类抗菌药物，其中多黏菌素E抗菌谱广，可全面覆盖革兰氏阴性菌。它主要通过破坏细胞外膜结构使其通透性增加，导致细胞膜不稳定，最终渗透压失衡，细胞溶胀，内容物外流，导致菌体死亡，最终导致细胞快速死亡。 多黏菌素E甲磺酸钠是治疗多重耐药铜绿假单胞菌等革兰氏阴性菌引起感染的首选药物，且与其他种类抗生素不产生交叉耐药，并获得美国感染病协会《成人医院获得性肺炎和呼吸机相关性肺炎临床实践指南》、欧洲外科感染学会《腹腔感染管理指南》、中华医学会《中性粒细胞缺乏伴发热患者抗菌药物临床应用指南》的一致推荐。 正大天晴多黏菌素E甲磺酸钠在2015年获得国家“重大新药创制”科技重大专项课题支持，于2017年12月在国内递交上市申请。该申请被国家药监局药品审评中心（CDE）纳入优先审评程序。天韵上市后，将让更多患者获益。 同时，该产品原料药为正大天晴自主研发，已经获得欧洲药品质量管理局（EDQM）签发的CEP（欧洲药典适用性认证）证书，并陆续销往西班牙等欧洲国家。这标志着该原料药符合欧洲药典的质量要求，工艺技术已达到国际先进水平。该产品在中国获准上市将会加速产品的国际化步伐，促进海外市场布局。 在抗感染领域，正大天晴时刻保持国际视野，在抗阴性菌、抗阳性菌、抗耐药菌及抗真菌等多个方向着眼布局，紧随国际前沿。目前，正大天晴已经形成完善的抗感染产品线，上市了天册（比阿培南）、天解（替加环素）、天礼（利奈唑胺）、天铭（卡泊芬净）等产品，在研的抗感染产品还有多立培南、泊沙康唑和碳青霉烯复方制剂等重磅产品，持续为临床一线输送抗感染利器，造福广大患者，为国人健康保驾护航。

Summary Shionogi Inc Shionogi, formerly Sciele Pharma, Inc., is a pharmaceutical company. It undertakes the development and commercialization of pharmaceutical products to address the unmet medical needs. The company offers a wide range of branded prescription products to treat chronic diseases. It markets products for various therapeutic areas such as pain, antiinfectives, women's health, pediatrics, cardiovascular, diabetes and others. Shionogi offers its products in various formulations such as tablets, oral suspensions solutions, lotions, capsules, chewable tablets and injections. Some of the company's key branded products include Doribax, Fortamet, Triglide, Altoprev, Fexmid, Methylin, Osphena and Furadantin, among others. The company is a subsidiary of Shionogi Co Ltd Shionogi is headquartered in Florham Park, New Jersey, the US. Shionogi Inc 4507 Pharmaceuticals Healthcare Deals and Alliances Profile provides you comprehensive data and trend analysis of the company's Mergers and Acquisitions MAs, partnerships and financings. The report provides detailed information on Mergers and Acquisitions, Equity/Debt Offerings, Private Equity, Venture Financing and Partnership transactions recorded by the company over a five year period. The report offers detailed comparative data on the number of deals and their value categorized into deal types, subsector and regions. GlobalData derived the data presented in this report from proprietary inhouse Pharma eTrack deals database, and primary and secondary research. Scope Financial Deals Analysis of the company's financial deals including Mergers and Acquisitions, Equity/Debt Offerings, Private Equity, Venture Financing and Partnerships. Deals by Year Chart and table displaying information encompassing the number of deals and value reported by the company by year, for a five year period. Deals by Type Chart and table depicting information including the number of deals and value reported by the company by type such as Mergers and Acquisitions, Equity/Debt Offering etc. Deals by Region Chart and table presenting information on the number of deals and value reported by the company by region, which includes North America, Europe, Asia Pacific, the Middle East and Africa and South and Central America. Deals by Subsector Chart and table showing information on the number of deals and value reported by the company, by subsector. Major Deals Information on the company's major financial deals. Each such deal has a brief summary, deal type, deal rationale; and deal financials and target Company's major public companies key financial metrics and ratios. Business Description A brief description of the company's operations. Key Employees A list of the key executives of the company. Important Locations and Subsidiaries A list and contact details of key centers of operation and subsidiaries of the company. Key Competitors A list of the key competitors of the company. Key Recent Developments A brief on recent news about the company. Reasons to Buy Get detailed information on the company's financial deals that enable you to understand the company's expansion/divestiture and fund requirements The profile enables you to analyze the company's financial deals by region, by year, by business segments and by type, for a five year period. Understand the company's business segments' expansion / divestiture strategy The profile presents deals from the company's core business segments' perspective to help you understand its corporate strategy. Access elaborate information on the company's recent financial deals that enable you to understand the key deals which have shaped the company Detailed information on major recent deals includes a summary of each deal, deal type, deal rationale, deal financials and Target Company's key financial metrics and ratios. Equip yourself with detailed information about the company's operations to identify potential customers and suppliers. The profile analyzes the company's business structure, locations and subsidiaries, key executives and key competitors. Stay uptodate on the major developments affecting the company Recent developments concerning the company presented in the profile help you track important events. Gain key insights into the company for academic or business research Key elements such as break up of deals into categories and information on detailed major deals are incorporated into the profile to assist your academic or business research needs. Note*: Some sections may be missing if data is unavailable for the company.