Recent Articles in Trials & Approvals

Zhiyi Biotech of Guangzhou, a company developing live biotherapeutic products (LBPs), reported its heat-killed Bacteroides fragilis product for Chemotherapy-induced Diarrhea (CID) was well-tolerated in a US trial. The clinical study was a randomized, double-blind, placebo-controlled, sequential dose-escalation trial that examined the safety and tolerability of SK10 in 24 healthy adult subjects. All dose levels of SK10 were generally safe and well tolerated. Based on the results, Zhiyi will advance SK10 into a trial that tests the candidate in CID patients. Zhiyi’s lead product, SK08, is in a Phase III clinical trial to treat IBS-D, which puts it ahead of the other LBPs in China. More details....

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Chengdu Hinova Pharma received US FDA Fast Track designation for HP518, an investigational drug for Androgen-receptor positive (AR+) triple-negative breast cancer (TNBC). HP518 is a potent PROTAC AR degrader that has shown efficacy in AR+ TNBC. According to Hinova, the molecular subforms of TNBC are particularly aggressive forms of breast cancer, without targeted treatment options but accounting for approximately 15-20% of all breast cancer cases. They lack estrogen and progesterone receptors along with HER2 expression. However, up to 50% of TNBC cases express the androgen receptor, HP518’s potential target. More details....

Stock Symbol: (SHA: 688302)

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AusperBio, a Hangzhou-Boston biotech, reported its lead drug, an unconjugated antisense oligonucleotide (ASO) that targets all HBV mRNA, has now treated 193 participants in global and China clinical trials. The patient base includes 101 participants with chronic HBV. AHB-137 is designed to trigger the degradation of all HBV RN. The candidate is a novel unconjugated antisense oligonucleotide (ASO) with a dual mechanism the could become a backbone for novel therapies that aim to find a functional cure for CHB. The novel ASO is currently in a global Phase Ib trial and a Phase II trial in China. More details....

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Taiwan’s Tanvex BioPharma was approved to launch a filgrastim biosimilar in the US to treat neutropenia induced by cancer chemotherapy. The originator drug is Amgen’s neupogen (filgrastim). TX01 is a recombinant human granulocyte colony-stimulating factor biologic that stimulates white blood cell production. The candidate, marketed as Nypozi, is the first Tanvex biosimilar approved for use in the US and the first biosimilar for any Taiwan biopharma. However, Nypozi is the fourth filgrastim biosimilar approved for US use, a market estimated to total $400 million per year. Tanvex was previously approved to sell the drug in Canada. More details....

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Innovent Biologics reported positive results from the first China Phase III clinical trial of mazdutide, a GLP-1R/GCGR dual agonist, in overweight or obese adults. The company said its findings from the trial, GLORY-1, show mazdutide produced impressive weight loss effects, safety and tolerability, but it also reduced liver fat and improved multiple cardiovascular metabolic risk factors. Innovent believes these results prove the ability of new-gen GLP-1R/GCGR dual agonists to treat metabolic conditions and improve overall physical health. More details....

Stock Symbol: (HK: 01801)

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