Jiabao Yaoyin Announces NMPA Approval for Phase I Clinical Trials of Two Novel Class 1 Drugs: JDB175 for DLBCL and JDB153 for Advanced Solid Tumors

On December 23, 2021, and December 28, 2021, JDB175 tablets and JDB153, two Class I novel small-molecule drugs independently developed by Shanghai Jiabao Yaoyin Pharmaceutical Technology Co., Ltd., a wholly-owned subsidiary of Chengdu Jiabao Yaoyin, respectively received the Notice of Approval for Drug Clinical Trials issued by the National Medical Products Administration (NMPA). The approved indications are diffuse large B-cell lymphoma (DLBCL) and advanced solid tumors, respectively.

JDB175 is a highly selective, second-generation oral Bruton’s tyrosine kinase (BTK) inhibitor. BTK is a key protein molecule in the B-cell receptor pathway, involved in B-cell proliferation, trafficking, chemotaxis, and adhesion. It is widely expressed in various types of hematologic malignancies, and inhibiting its activity can produce significant anti-tumor effects. Preclinical studies have demonstrated that JDB175 exhibits superior BTK selectivity compared to similar drugs, with a favorable safety and tolerability profile, as well as robust anti-cancer activity in diffuse large B-cell lymphoma (DLBCL). Currently, there is a lack of effective and safe treatment options for DLBCL, particularly for high-grade cases. The standard R-CHOP regimen yields a 5-year survival rate of less than 50%, with relatively poor prognosis. JDB175 has the potential to improve patient survival rates and extend overall survival.

JDB153 is the world’s first dual inhibitor targeting MNK and VEGFR. By downregulating MYC, it effectively suppresses the phosphorylation level of eukaryotic initiation factor 4E (eIF4E), enhances T-cell activity, and acts synergistically with PD-(L)1 monoclonal antibodies. In preclinical studies, JDB153 demonstrated excellent safety and tolerability, exhibited anticancer activity across multiple solid tumor types, and achieved superior tumor inhibition compared to benchmark drugs in the same class. Currently, there are no highly effective treatment options for advanced solid tumors that have become refractory to PD-(L)1 therapy. JDB153 holds promise as a novel, effective, and safe therapeutic option with a new mechanism of action, offering significant clinical value and social impact.

Jiabao Yaoyin was established in 2019 and is dedicated to developing Class I innovative drugs urgently needed in clinical practice. Its current primary R&D pipeline includes: the drug-resistant tuberculosis medication with the highest global clinical safety profile; a first-in-class combination therapy targeting tumor immunity and anti-tumor angiogenesis, capable of rescuing patients who have failed PD-1 inhibitor treatment; a highly selective BTK inhibitor with excellent blood-brain barrier penetration; and the world’s only colony-stimulating factor inhibitor validated through PDX models. Jiabao Yaoyin understands patients’ real needs, adopts a clinical-oriented approach to address practical clinical challenges, and continues to deepen its expertise across numerous therapeutic areas.