Recent Articles in Trials & Approvals

Innovent Biologics reported Phase III results for mazdutide, its GLP-1/GCGR dual therapy for type 2 diabetes and weight loss, showing the candidate showed better efficacy for glycemic control than dulaglutide, Lilly’s Trulicity, a single GLP-1 agonist. Mazdutide also showed multiple cardiometabolic benefits in T2D patients including weight loss. The trial was designed to test non-inferiority, but once non-inferiority was achieved, further testing for superiority was conducted.  Innovent acquired China rights to mazdutide from Lilly in 2019. More details....

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Seoul’s HanAll Biopharma has started a US Phase III trial to evaluate the efficacy of tanfanercept, a novel topical anti-inflammatory therapy for moderate to severe dry eye disease (DED). HanAll says tanfanercept has the potential to be a first-in-class topical anti-inflammatory treatment that targets tumor necrosis factor (TNF). TNF, a major cytokine, mediates DED inflammation. Tanfanercept is a molecularly engineered tumor necrosis factor receptor 1 (TNFR1) fragment with strong affinity for TNF and resistance to degradation by proteinases. More details....

Stock Symbol: (KRX: 009420)

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Shanghai NeuShen Therapeutics has dosed the first healthy patient in an Australian Phase I trial of its novel selective M4 receptor positive allosteric modulator (M4 PAM), a proposed therapy for schizophrenia. NeuShen believes M4 PAM offers a novel approach to treating schizophrenia, with potential benefits in alleviating symptoms and cognitive impairment. In addition, the candidate may be able to treat psychosis in late-stage Alzheimer's disease or Parkinson's disease. NeuShen developed NS-136 from its proprietary small molecule R&D platform. In preclinical animal tests, the molecule showed efficacy against both positive and negative symptoms of schizophrenia. More details....

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Guangzhou Bio-gene Technologies has started a China Phase I trial for an autologous CAR-T cell therapy that targets CLL-1, a member of the C-type lectin-like receptor family, in patients with relapsed/refractory acute myeloid leukemia (AML). BG1805 has already been studied in Investigator Initiated Studies, where it showed efficacy in both adults and children with blood malignancies and solid tumors. The BG1805 trial is the first of Bio-Gene’s CAR-T candidates to start formal clinical studies, although several have been tested in Investigator Initiated Trials. More details....
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Nanjing Leads Biolabs has been approved to begin a China Phase III trial of LBL-024, an anti-PD-L1/4-1BB bispecific antibody developed by Leads that will be tested in solid tumor cancers. The single-arm pivotal study will examine the candidate for registration and market authorization by China’s CDE. LBL-024 is a bispecific antibody containing anti-programmed death ligand-1 and anti-4-1BB antibodies. Leads said the candidate binds to PD-L1 with high affinity, blocking the PD-L1/PD-1 immunosuppressive pathway while activating the 4-1BB costimulatory pathway in the tumor microenvironment. More details....

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