创新是信诺维的战略支柱,围绕成熟靶点新一代Best-in-Class产品和全新靶点First-in-Class产品两个战略维度进行了一系列布局。目前已有五个产品进入国内外临床阶段,另有多款产品处于临床前研究阶段。
凭借独特的研发模式,信诺维极大的加速了药品的开发及上市进程,使更多患者尽早获益于信诺维的创新治疗方案。
产品 适应症 PCC IND-Enabing IND申报 临床
XNW3009
代谢
XNW4107

Expanded Access Policy

Sinovent’s Expanded Access Policy to XNW4107

January 2020

Sinovent is to develop XNW4107 in combination with imipenem/cilastatin for the treatment of patients with infection caused by resistant  pathogens including carbapenem-resistant Enterobacteriaceae (CRE), carbapenem-resistant A. baumannii (CRAB) and multidrug resistant (MDR) P. aeruginosa.  XNW4107 has been granted the fast-track designation by the U.S. Food and Drug Administration (FDA).

An expanded access policy, also known as compassionate use, allows investigational medical products that have not yet been approved or cleared by the U.S. Food and Drug Administration to be provided to patients with immediately life-threatening conditions or serious diseases when treatment within a clinical trial or comparable or satisfactory alternative therapy options are not available.

We understand that expanded access to our investigational product XNW4107 may be needed in certain patients prior to FDA approval.  With a careful review to expanded access, Sinovent has determined that it cannot offer XNW4107 for expanded access at this time, since XNW4107 itself has no antimicrobial activities, and more clinical data of  safety and efficacy for XNW4107 in combination with imipenem/cilastatin need to be generated to determine whether XNW4107 will benefit to patients with serious infections.

If you or a family member would like to learn more about Sinovent’s clinical trials, we encourage you to work with your physician to see if you are a candidate for  our clinical trials. You may also find helpful information regarding Sinovent’s clinical trials by visiting www.clinicaltrials.gov.

If you have questions about Sinovent’s expanded access policy, please email us at info@sinvovent.com.

 

抗感染
XNW1011
肿瘤
XNW7201
肿瘤
XNW5004
肿瘤
XNW8011
抗感染
XNW10016
肿瘤
地址 · 苏州工业园区桑田街218号生物产业园二期22号楼
电话 · +0512-89162086
邮箱 · info@sinovent.com
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