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Accutar terminated the clinical trials of AC176 for prostate cancer

 Accutar Biotech has terminated the clinical trials of AC176, an AR PROTAC therapy, for the treatment of prostate cancer. These decisions came after the termination of a clinical trial of AC682, an ER PROTAC treatment in the phase 1 stage. Homepage of Accutar The clinical trials AC176 is an AR-targeting PROTAC drug candidate discovered by Accutar Biotech. The IND application was cleared by both the China NMPA and the US FDA. The clinical trial (NCT05673109/CTR20223355) was started in China, with the first patient receiving the dose in February 2023. Currently, the study has enrolled eight patients as reported on the clinical trial disclosure website. However, the trial was terminated due to changes in the benefit-risk ratio for the subjects at the end of 2023. No further statements were reported regarding this matter. The phase 1 trial (NCT05241613) in the US has enrolled 28 patients and has been terminated for the same reason as above. The trial stopped enrolling new patients in Octob

Cascade Submits IND Application for CS060304, a THR-β agonist

 Cascade submitted the IND application for a THR-β agonist, CS060304, as a treatment for NASH. The US FDA approved the application in February 2024. This is the second drug candidate for NASH patients, following the first clinical-stage FXR agonist, CS0159. FDA letter CS060304 The CS060304 target is the same as MGL-3196, a novel THR-β agonist developed by Cascade, with highly specific enrichment in liver tissue. Compared to Resmetirom, CS060304 demonstrates significantly positive preclinical data, particularly in improving NAS scores and fibrosis in NASH mouse models. It exhibits characteristics of low effective dosage, significant efficacy, and good tolerability. Its clinical trial approval is expected to provide NASH patients with a safe and effective potential treatment option, making it a potential best-in-class potent selective THR-β agonist. The clinical trial in China will  begin at the Peking Union Medical College Hospital  led by Professor Zhang Shuyang. From 2021, Cascade ha

CSPC has started a phase 2 clinical trial for non-segmental vitiligo using SYHX1901

 CSPC Pharmaceutical is conducting a phase 2 study (CTR20241075) for nonsegmental vitiligo of SYHX1901, an oral JAK/SYK inhibitor. The first phase 2 study for psoriasis began in March 2023.  The first-in-human study, initiated in healthy participants in 2021, has been completed in 2022. The study was aimed at patients with SLE and RA. SYHX1901 SYHX1901 is a dual inhibitor of JAK and SYK, expected to be effective in treating autoimmune diseases such as psoriasis, lupus, and vitiligo. In 2023, CSPC filed a patent (WO2022188796) covering the use of a compound containing a tricyclic heteroaryl group for the treatment of autoimmune disease.  2021 Patent The IC 50 values for the compound I were measured against JAK1, JAK2, JAK3, TYK2, and SYK, yielding values of 20.04 nM, 3.92 nM, 1.43 nM, 0.82 nM, and 7.25 nM, respectively. Efficacies for psoriasis, atopic dermatitis, and SLE were tested in the IMQ-induced model, OXA-induced model, and SLE model mice.  Efficacy results in SLE model Accordi

Hansoh initiates the trial of anti-B7H4 ADC plus anti-PD-L1 or anti-VEGF mAbs in solid tumors

Hansoh conducted a new clinical study to evaluate the efficacy of anti-B7H4 ADC in combination with anti-PD-L1 or anti-VEGF mAbs for treating solid tumors. This marks the 3rd clinical trial for HS-20089 in China. HS-20089 is a novel B7-H4 targeted ADC with a TOPOi payload (DAR=6) , developed by Hansoh and licensed to GSK with an $85 million upfront payment. Factors controlling B7-H4 and B7-H4 receptor expression The clinical study This study contains four combination therapy cohorts, each consisting of a dose exploration part and a dose expansion part. The combination includes Adebrelimab, an anti-PD-L1 monoclonal antibody, either with or without platinum, or Bevacizumab with or without platinum. Adebrelimab was an anti-PD-L1 monoclonal antibody discovered and launched by Hengrui in China as their second anti-PD-(L)1 therapy. The clinical trial identified as NCT06336707 is expected to enroll a total of 1,048 participants, while the trial registered in China (CTR20241023) showed an e

Hengrui has submitted an IND application for HRS5931 in China

 Hengrui is seeking IND approval for HRS9531, an orally administered GLP-1/GIP dual receptor agonist, in China. The subcutaneous formulation is being evaluated in phase 2 trials for patients with type 2 diabetes and for patients who are overweight. Metabolic actions of GLP-1 and GIP on key target tissues. In 2021, Hengrui filed a patent (WO/2023/098777) for the subcutaneous injection and oral tablet of GLP-1/GIP dual receptor agonist. The oral version contains 2.5-30 mg API of 18#. 18# in the patent Results of clinical study of subcutaneous  HRS9531 In June 2023, Hengrui reported the PK and PD results of the phase 1 study of subcutaneous HRS9531:  Sixty and 30 subjects were recruited into SAD and MAD respectively. The most common adverse events were abdominal distension and nausea in SAD, and urine ketone body present and nausea in MAD. Drug exposure were proportional to dose from 0.9-8.1 mg. The median Tmax and mean t1/2 were 48-72 h and 156-182 h in SAD, and 48-72 h and 169-192 h aft