Recent Articles in Trials & Approvals

South Korea’s Samsung Bioepis announced that its Soliris biosimilar, Epysqli, is approved in the US to treat paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). Samsung acquired Epysqli as part of its $39 billion takeover of Alexion in 2020. In 2023, Soliris produced $3.15 billion in 2023 global revenues for AstraZeneca, which was 14% lower than the previous year because Soliris had gone off-patent in Europe. Samsung’s Epysqli is the lead biosimilar in Europe to replace Soliris, where it is also approved for the same two rare diseases, PNH and aHUS. More details....

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Gan & Lee Pharma posted impressive weight loss results in a China Phase IIb trial of its long-acting GLP-1 receptor agonist (GLP-1 RA). Overweight and obese patients were treated at one of four dosing levels. After 30 weeks, the results varied from 11.15% average weight loss in the lowest dose to 17.79% at the highest doses. Patients were treated every two weeks. Gan & Lee, a Beijing company that focuses on diabetes therapies, was the first Chinese company to develop a domestic insulin analog drug. More details....

Stock Symbol: (SHA: 603087)

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Suzhou Innovent announced positive data from another Phase III clinical trial of mazdutide, its dual agonist for type 2 diabetes. This trial showed mazdutide met its endpoint of lowering glycated hemoglobin (HbA1c) at week 24 while also producing an average weight loss of 9.6% at week 48. Innovent has already filed for mazdutide approval in China as a weight loss drug based on an earlier trial. Mazdutide combines a glucagon-like peptide-1 receptor (GLP-1R) with a glucagon receptor (GCGR). Innovent acquired China rights to the candidate from its long-time US partner, Lilly. More details....

Stock Symbol: (HK: 01801)

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Shanghai’s Everest Medicines reported China's NMPA accepted the filing of a supplemental New Drug Application for full approval of Nefecon®, a first-in-disease IgA nephropathy (IgAN) therapy. Immunoglobulin A (IgA) nephropathy (IgAN) occurs when IgAN builds up in the kidneys. It can lead to renal failure and end-stage renal disease. Previously, Everest was approved to market Nefecon® in China to patients at risk of disease progression, and it is now seeking approval for all patients with IgAN. Nefecon® is an oral, delayed release formulation of the corticosteroid budesonide. More details...

Stock Symbol: (HK: 1952)

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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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