Shanghai, December 21,2020 – Congratulations to GenFleet Therapeutics Inc. for their selective CDK9 inhibitor GFH009 Injection have been approved by the CDE (Center for Drug Evaluation), NMPA for clinical trials. It has received US FDA approval first half of this year for clinical trials. The potential indications of GFH009 are mainly for the treatment of Recurrent/refractory hematological malignancies.

Sundia assists GenFleet GFH009 Injection CMC part and accelerated the new drug development process. Sundia contributes to complete the developability assessment, formulation process development, release testing, stability study, toxicology batch and application batch sample preparation, and GMP batch production support. Regulatory services include preclinical IND document preparation for both NMPA & FDA.

About Highly Selective CDK9 Inhibitor

CYCLIN-DEPENDENT PROTEIN (CDK) is a large class of serine/threonine kinase family proteins that play an important role in cell cycle regulation and transcription. At present, dozens of selective CDK inhibitor pipelines have been listed and are not under research worldwide. Among more than 10 CDK subtypes, CDK9, as a subunit of POSITIVE TRANSCRIPTION ELONGATION FACTOR B (P-TEFB), participates in the transcriptional regulation of a variety of cancer cell anti-apoptotic protein genes, and is the one of the most potential pan-cancer targets in CDK family. Compared with non-selective CDK inhibitors, highly selective CDK9 inhibitors can minimize off-target toxicity for other CDK subtypes and may reduce the risk of dose-limiting toxicity.

GFH009 is a potent and highly selective small molecule CDK9 inhibitor. It is the first new drug under development for GenFleet to obtain FDA clinical trial approval. Preclinical experimental data show that the selective inhibition rate of CDK9 protein is more than 100 times higher than that of other CDK subtypes. Up to now, there is no highly selective CDK9 inhibitor approved for commercial globally. GFH009 is the first in China and the third in the world to enter clinical trials, with broad application prospects. We are looking forward to the success of GenFleet on bringing more innovative and quality drug to global patients.

About GenFleet

Founded in 2017, GenFleet Therapeutics Inc. is a China-based R&D biotech company pursuing innovative therapeutic molecules – small and large. We focus on developing cutting-edge products, which potentially serve as globe-wise front runners among “first-in-class” therapeutics with novel mechanism of actions. To achieve this goal, we are leveraging China’s local advantages with a global prospective for new drug.

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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