Medicilon helps Sungening Biological's first innovative drug SG1001 oral tablet obtain IND approval in China

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 accumulation and improvement of Medicilon's professional knowledge and skills, and it also lays a solid foundation for Medicilon to provide more efficient services in the future. Sungening's SG1001 has obtained clinical trial approval, which is undoubtedly another affirmation of the professional strength and excellent service of Medicilon's preclinical research service platform, and also adds another important success story to the platform.

Currently, Medicilon's preclinical research service platform has a laboratory of 29,000 square meters, has obtained the NMPA GLP laboratory certification qualification, and has established a research operation process and quality system that complies with international standards. Medicilon complies with the GLP laboratory standards of the US FDA, Australian TGA, and EU EMA; the animal experimental facilities have passed the International Laboratory Animal Assessment and Accreditation (AAALAC) and the non-human primates, dogs, mice, rabbits, guinea pigs, mini pigs and other experimental animals can be raised at the same time. Complete and professional facilities provide Medicilon with strong support for pharmacological efficacy, pharmacokinetic research and safety evaluation services, ensuring the accuracy and reliability of experimental results.

About Sungening Biological

Founded in 2021, Sungening Biological is an innovative drug company focusing on innovative antifungal infection drugs and oral cyclic peptides. Sungening Biological also has a complete independently developed drug pipeline and mature commercialization capabilities. With the vision of "focusing on the research and development of new drugs to solve clinical needs and protecting human health", Sungening Biological strives to develop innovative drugs that can fulfill clinical needs.

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