Recently, Sapu003, an innovative drug developed by SAPU Bioscience, has officially obtained clinical trial approval in Australia. This is the first successfully approved IND since Medicilon and SAPU entered into a strategic agreement for 20 IND projects in February this year. The quality and speed of this approval serve as a strong testament to the high standard of Medicilon ‘s services.
As a strategic partner of SAPU, Medicilon has leveraged its one-stop preclinical R&D service platform for pharmaceuticals to provide efficient preclinical R&D services for Sapu003, including CMC release validation (in progress), pharmacokinetics, safety evaluation, and IND submission filing. These services accelerated the IND application process for Sapu003.
Medicilon & SAPU:
Collaborating to Overcome Multiple Challenges, Accelerating IND Filing via One-Stop Services
Medicilon’s support
During the R&D of Sapu003’s innovative formulation, various teams at Medicilon worked closely with SAPU to jointly overcome multiple technical hurdles: The CMC team established a sensitive and stable analytical method using a CAD. The pharmacokinetics department significantly improved detection response and reproducibility through systematic optimization. The toxicology testing department promptly adapted to updated ICH guidelines, optimizing experimental protocols to ensure compliance. The bioanalysis team effectively enhanced data accuracy and sample stability by improving internal standard selection and optimizing matrix and solution preparation strategies.
Compared to existing oral medications, Sapu003 employs intravenous administration, which dramatically increases the drug’s bioavailability. The approval of this clinical trial is not only a testament to SAPU’s innovative R&D capabilities but also a strong validation of Medicilon’s comprehensive service capabilities in complex formulation analysis, cross-departmental collaboration, and international regulatory filing.
Medicilon congratulates SAPU on obtaining clinical trial approval for Sapu003 in Australia and looks forward to the early approval of Sapu003 in both China and the United States. Medicilon will continue to uphold the service philosophy of “Innovation Driven and Quality Focused,” deepening its cooperation with global innovative pharmaceutical companies.
About Medicilon
From its inception in 2004, Shanghai Medicilon Inc. (stock code: 688202.SH) has been committed to providing comprehensive R&D services to pharmaceutical companies, research institutions, and any organizations working in the preclinical space.Medicilon has built an integrated one-stop R&D platform covering drug discovery, CMC and preclinical studies, and has established service platforms in cutting-edge fields such as ADC, nucleic acids, peptides, CGT, PROTAC, and antibodies. Medicilon has established a quality system in compliance with international standards and has obtained GLP certifications from China’s NMPA, the US FDA, the EU OECD, and Japan’s PMDA, as well as AAALAC accreditation. Currently, Medicilon has nearly 80,000 square meters of R&D laboratories.
By the end of June 2025, Medicilon has provided drug development services to over 2,000 clients worldwide, and has been involved in the research and development of 588 new drugs and generic drug projects that have been approved for clinical trials with IND applications. For more information, please visit the company’s official website at www.medicilon.com.cn.
