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Novartis AG (NYSE: NVS), a leading Swiss pharmaceutical company, last week announced positive preliminary data from a late-stage study for its complement inhibitor Fabhalta (iptacopan) in patients with the ultra-rare kidney disease C3 glomerulopathy (C3G). The study showed that compared to placebo, iptacopan achieved a 35.1% reduction in proteinuria and…
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Kexing Pharmaceutical (SHA: 688136), based in China, has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study targeting childhood growth hormone deficiency. The clinical trial will investigate a Category I innovative product candidate, an Fc fusion protein designed as a long-acting growth hormone. This molecule…
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Shanghai Henlius Biotech Inc. (HKG: 2696), a biopharmaceutical company based in China, has announced that the European Medicine Agency (EMA) has accepted two marketing approval filings for its drug candidate HLX14, a biosimilar version of Amgen’s Prolia/Xgeva (denosumab). Denosumab, a recombinant anti-RANKL human monoclonal antibody injection, is utilized for various…
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Bio-Thera Solutions Ltd (SHA: 688177), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its drug candidates BAT6005 in combination with BAT1308 for the treatment of locally advanced or metastatic solid tumors. BAT6005…
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Novartis AG (NYSE: NVS), a Swiss pharmaceutical company, last week presented interim results for the primary endpoint of a Phase III trial for atrasentan in patients with IgA nephropathy (IgAN). The trial indicated that the endothelin A (ETA) receptor antagonist demonstrated a 36.1% reduction in proteinuria at 36 weeks compared…
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AccurEdit Therapeutics (Suzhou) Co., Ltd., a leading gene editing therapy specialist based in China, has published the efficacy and safety data for its drug candidate ART001, which is being investigated as a treatment for transthyroxine protein amyloidosis. ART001, the first non-viral vector in vivo gene-edited drug in China to enter…
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that the National Medical Products Administration (NMPA) has accepted its market approval filing for the novel small-molecule drug FCN-159 for review. The drug is being considered for the treatment of dendritic and histiocytic tumors, indications that have previously…
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Akeso Biopharma (HKG: 9926), a biopharmaceutical company based in China, has announced that its bispecific antibody (BsAb) ivonescimab (AK112), which targets programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF), has been approved for use in combination with chemotherapy to treat locally advanced or metastatic non-squamous non-small cell lung cancer…
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The 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from May 31 to June 4 in Chicago, will feature updates from Chinese pharmaceutical companies Ascentage Pharma (HKG: 6855), Lepu Biotechnology Co., Ltd (HKG: 2157), Transcenta Holding Ltd, and Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) on their…
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Johnson & Johnson (J&J; NYSE: JNJ) has announced that a Phase III trial for its dual-acting biologic Tremfya (guselkumab) has successfully met its composite co-primary endpoints in patients with moderately to severely active Crohn’s disease (CD) when compared to placebo. The study also demonstrated that the IL-23-focused subcutaneous maintenance therapy…
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The European Commission (EC) has granted registration approval to Sandoz, a Switzerland-headquartered pharmaceutical company (SWX: SDZ), for its biosimilars Wyost and Jubbonti. These products are reference treatments for Amgen’s (NASDAQ: AMGN) bone treatments Xgeva (denosumab) and Prolia (denosumab), respectively. Sandoz anticipates launching the biosimilars in November 2025. Wyost is indicated…
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Roche (SWX: ROG)’s Genentech, a leading biotechnology company based in Switzerland, has received approval to initiate a clinical study in China for its Category 1 drug vixarelimab. The drug will be evaluated as a potential treatment for ulcerative colitis (UC). Vixarelimab is a selective, fully human monoclonal antibody that targets…
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RemeGen Ltd (HKG: 9995), a biopharmaceutical company based in China, has announced that its antibody-drug conjugate (ADC) candidate, disitamab vedotin (RC48), is poised to receive breakthrough therapy designation (BTD) in China. This designation underscores the molecule’s potential in treating perioperative treatment of muscle invasive bladder cancer (MIBC) with HER2 expression,…
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Gan & Lee Pharmaceuticals (SHA: 603087), a Chinese pharmaceutical company, has announced that it has received marketing approval for its insulin glargine pre-filled pen in Mexico. This marks the company’s first marketing authorization as a holder (MAH) in the Mexican market. Insulin glargine, a long-acting insulin analogue that requires daily…
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Keymed Biosciences Inc., (HKG: 2162), a biopharmaceutical company based in China, has announced that its drug candidate stapokibart (CM310) has been granted priority review status by China’s Center for Drug Evaluation (CDE) for its potential as a treatment for chronic sinusitis with nasal polyps (CRSwNP). The IL-4Rα monoclonal antibody (mAb)…
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company based in China, has announced positive interim analysis results from a Phase III clinical study for its anti-programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb) benmelstobart (TQB2450) in combination with anlotinib for the treatment of advanced unresectable or metastatic renal cell carcinoma…
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that its biosimilar drug HanDaYuan has received additional indication approvals from China’s National Medical Products Administration (NMPA). HanDaYuan, a biosimilar version of AbbVie’s Humira (adalimumab), an autoimmune disease therapy, is now approved to treat a wider range of…
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Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096) has announced that it has received marketing approval from the Hong Kong health authorities for Quviviq (daridorexant), an anti-insomnia drug co-developed with Idorsia Pharmaceuticals Ltd. The dual orexin receptor antagonist (DORA) will now be available in 50mg and 20mg dosages in the region,…
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NK CellTech, a Shanghai-based developer of natural killer (NK) cell therapies, has announced that it has received clinical clearance from China’s National Medical Products Administration (NMPA) for its proprietary genetically modified NK-cell therapy. This marks a significant milestone as the company’s molecule is set to be assessed as a treatment…
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Laekna Therapeutics Shanghai Co., Ltd, a biopharmaceutical company based in China, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase III clinical study for its drug combination LAE001 and LAE002 (afuresertib) in patients with metastatic castration-resistant prostate cancer (mCRPC) who…