Shanghai Medicilon Inc.

Recently, Sungening Biological's (Sungening) first innovative drug SG1001 successfully obtained the implicit clinical trial approval from the National Medical Products Administration (Acceptance Number: CXHL2400203).  The approved indication is invasive fungal disease (IFD), and clinical trials are about to begin.  This milestone progress not only marks Sungening’s official entry into the ranks of clinical-stage innovative drug companies, but also promotes China’s drug innovation process in the field of antifungal infections. Shanghai Medicilon Inc. (Medicilon), as a partner of Sungening Biological, relies on its technical strength and rich experience in the field of biopharmaceutical preclinical research and development to provide pharmacokinetics and  GLP safety evaluation research services  for the research and development of SG1001, and fully ensures its efficient and high-quality research and development. The success of every R&D collaboration is the accumul...

  Medicilon’s   IND application service platform   has an in-depth understanding of the regulatory and policy environment of China and the United States and its technical requirements for chemical drugs. It can provide domestic customers with CFDA IND declaration and USFDA IND/ANDA declaration services; it can provide foreign customers with CFDA IND /ANDA declaration service. The service targets of Medicilon’s  IND  application platform include not only clients who do a complete set of preclinical research on Medicilon, but also pharmaceutical industry counterparts who require separate registration and declaration. The details are as follows: Medicilon IND Application Service: ◇ Preparation and submission of CFDA IND documents for domestic customers; ◇ Submission of USFDA IND/ANDA documents as an agent for domestic customers; ◇ Submission of CFDA IND/ANDA documents as an agent for foreign clients; ◇ Provide project management services (limited to clients who pro...