Jiebeian (azvudine) / Genuine Biotech - LARVOL DELTA

Azvudine (FNC), a next-generation cytidine analog with broad inhibitory activity against drug-resistant HIV-1 strains via stabilization of the reverse transcriptase catalytic complex. (PubMed, Bioorg Chem) - "FNC exhibited sub-nanomolar potency (EC50 = 0.0812-0.1596 nM) across diverse HIV-1 subtypes, achieving up to 3000-fold higher antiviral activity than lamivudine (3TC) and emtricitabine (FTC). These interactions provide a plausible structural basis for the retained potency against resistant mutants by stabilizing the catalytic complex, reducing excision, and impeding strand translocation. Collectively, these findings identify FNC as a structurally optimized cytidine analogue with broad activity against clinically relevant resistance variants, highlighting its potential as a promising candidate for next-generation HIV-1 therapy."

Journal • Human Immunodeficiency Virus • Infectious Disease

The efficacy and safety of azvudine (FNC) in phase 1 investigator-initiated study in patients with advanced solid tumors. (ASCO 2026) - P=N/A | "All CRC subjects received the triple-combination regimen of FNC, penpulimab, and fruquintinib. Overall, the combination of FNC with PD-1 and VEGFR inhibitors was safe and well-tolerated, with encouraging clinical activity in advanced/metastatic pMMR/MSS CRC."

Clinical • Metastases • P1 data • CNS Disorders • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Insomnia • Liver Failure • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Sleep Disorder • Solid Tumor

Azvudine combined with Doxitinib, a potential therapy for EGFRm+ NSCLC (AACR 2026) - P1/2 | "In vivo, the combination achieved superior tumor growth inhibition compared to either monotherapy in the NCI-H1975 (EGFR L858R/T790M) xenograft model.Collectively, these findings suggest that the combination of FNC and Doxitinib represents a promising therapeutic strategy to enhance efficacy and overcome acquired resistance in EGFRm⁺ NSCLC. Based on these preclinical and clinical findings, a phase 1/2 clinical trial will be initiated to evaluate the safety and efficacy of this combination therapy in EGFR-mutant NSCLC patients."

Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD8

Azvudine : An emerging immunomodulator in the treatment of cancer and viral infections (AACR 2024) - "Typically, nucleoside analog drugs function by integrating into DNA and impeding DNA synthesis, evident in drugs like 5-FU, Capecitabine, Ara-C, and Gemcitabine...Given these revelations, there's a compelling argument that FNC monotherapy possesses immense potential as an anti-tumor agent. The potent anticancer effects of FNC in vitro and in vivo warrants further investigation of its anticancer potential as immunomodulator."

Immunomodulating • IO biomarker • Oncology • Solid Tumor • ANXA1 • CALR • CD4 • CD8 • CDC37 • DCK • HMGB1 • HSP90AA1

A Phase Ⅰ/Ⅱa Clinical Study of GEN-725 in Combination With Dositinib (clinicaltrials.gov) - P1/2 | N=110 | Recruiting | Sponsor: Henan Genuine Biotech Co., Ltd.

New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Azvudine remodels the local immunosuppressive microenvironment and exhibits sustained anti-tumor effects in combination with anti-PD-1 therapies. (PubMed, Front Med) - "FNC remodels the TME by mitigating immunosuppression and amplifying anti-tumor immunity, offering a promising strategy to augment existing immunotherapies. Further clinical evaluation is warranted to ascertain the translational potential of FNC in diverse oncologic settings."

Journal • Oncology • CALR • CD8 • HMGB1

A Phase Ⅰ Clinical Study of GEN-725 Tablets in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Henan Genuine Biotech Co., Ltd.

New P1 trial • Solid Tumor