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发布日期:2021年06月24日
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Congratulations to DartsBio Pharmaceutical for Analgesic DS002 Injection Approved for Clinical Trial by NMPA

2021-01-01

Congratulations to DartsBio Pharmaceutical (Guangdong) Co., Ltd. (hereinafter referred to as "DartsBio") for their self-developed human recombinant monoclonal antibody DS002  targeting NGF has been approved by NMPA for clinical trial. The antibody is designed for pain treatment .

 

Image:NMPA website

 

Sundia has assisted DartsBio to complete the efficacy study of DS002, including chemotherapy pain model behavioral testing, which accelerats the new drug development process.DS002 is the first IND approved project among DartsBio's pipelines. Congratulates to Dartsbio’ achievements, and look forward to the success of DartsBio on bringing on more innovative and quality drug to global patients!

 

Nerve growth factor (NGF) level rises when human body suffers pain or chronic pain from inflammation or injury. The monoclonal antibody DS002 achieves a strong analgesic effect though selectively binding to NGF, which prevent NGF to bind to TrkA. This has been shown good safety in Preclinical studies. DS002 is also completely different from opioids and other analgesics, including non-steroidal anti-inflammatory drugs (NSAIDs) in the mechanism of action, and thereby there is no risk of addiction.

 

 

DS002 is currently the only known domestic monoclonal antibody drug targeting NGF, and it is the third fastest research molecule in the world. It has the potential to replace opioids and NSAIDs in indications such as chronic pain and pain caused by chemotherapeutics.

 

About DartsBio

Dartsbio Pharmaceutical (Guangdong) Co., Ltd. is located in Zhongshan Cuiheng, the hometown of the Great Sun Yat Sen. it is a drug R & D enterprise dedicated to improving the quality of human life. It has the first addiction free analgesic antibody project in China and the leading antibody engineering technology in China.

The core team members of the company include returnees from famous pharmaceutical companies such as Lilly, Amgen and smart chemical, among which are special experts from the "100 Talents Program" of CAS and the "1000 Talents Program" of Shanghai. The company has gradually formed a top new drug R & D enterprise with closed-loop capability from early drug research and development, CMC, preclinical research to clinical trials. The R & D and industrialization of antibody drugs with "orphan drug" potential or obvious competitive advantage will be promoted to clinical application and benefit patients as soon as possible.

 

About Sundia

As a leading, fully-integrated ‘one-stop-shop’ service provider, Sundia provides a variety of CRO services in drug discovery and development which includes Library Design, Parallel Synthesis, Custom Synthesis, Medicinal Chemistry, in vitro & in vivo Biology, DMPK, Process Development, Analytical Chemistry, Formulation Development, and Preclinical testing to meet clients' specific project needs. Leveraging our rich project management and IND submission expertise, Sundia can efficiently integrate all the studies that are required for NMPA/FDA IND submissions and are compliant with global GMP standards.

Sundia and Bioduro have announced their merger on September 25 this year. The combined company will operate as BioDuro-Sundia, which has a combined talent pool of over 2,000 employees across 10 global R&D sites, including two new sites in China — an R&D base in Wuxi City and a manufacturing center in Bengbu. With its large-scales and integrated operations in China and the US, Bioduro-Sundia will deepened the CRDMO, providing its biopharma customers a single end-to-end solution from early stage drug discovery to late stage manufacturing.

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