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China-based biotech Everest Medicines (HKG: 1952) announced that the National Medical Products Administration (NMPA) has accepted a New Drug Application (NDA) for its Nefecon, an oral budesonide-targeted release preparation. The drug is intended for the treatment of primary IgA nephropathy (IgAN) with a risk of progression. This marks a significant…
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China-based Innovent Biologics, Inc. (HKG: 1801) has announced the first patient dosing in the randomized, double-blind, placebo-controlled Phase III GLORY-1 study for its mazdutide (IBI362), a glucagon-like peptide-1 (GLP-1) and glucagon receptor dual agonist. The drug is being evaluated for the treatment of overweight or obese Chinese patients, marking a…
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China-based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) has announced the enrollment of the first subject in a randomized, double-blind, placebo-controlled Phase III study for its drug candidate RAY1216, which is being evaluated as a treatment for mild SARS-CoV-2 infection. The study is expected to enroll 1,070 patients with mild…
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China-based Yabao Pharmaceutical Group Co., Ltd (SHA: 600351) has announced that it has received Abbreviated New Drug Application (ANDA) clearance from the US FDA for its generic version of Nexavar (sorafenib), originally developed by German pharmaceutical giant Bayer. This approval marks a significant milestone for Yabao in expanding its presence…
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The Center for Drug Evaluation (CDE) website has announced that China-based Hengrui Pharmaceuticals’ (SHA: 600276) pyrotinib has been granted priority review status. The drug is being evaluated for use in combination with trastuzumab and docetaxel for the treatment of recurrent or metastatic breast cancer that is human epidermal growth factor…
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UK-based pharmaceutical giant AstraZeneca Plc (AZ, NASDAQ: AZN) has revealed plans to sell Soliris (eculizumab) in Hangzhou for the first time. The drug, originally developed by Alexion Pharmaceuticals, received conditional approval in 2018 for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) in adults and…
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The Center for Drug Evaluation (CDE) website indicates that China-based Akeso Biopharma (HKG: 9926) has obtained two additional Breakthrough Therapy Designations (BTDs) for its AK112, a bispecific antibody (BsAb) targeting programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF). These designations follow last month’s BTD for AK112 in combination with…
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China-based Hutchison China Meditech (HutchMed; NASDAQ: HCM, HKG: 0013) has announced the initial results from the FRUTIGA Phase III study, which evaluated Elunate (fruquintinib) combined with paclitaxel in 703 Chinese patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJ). The study aimed to assess the efficacy and safety of…
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China-based Shanghai Henlius Biotech (HKG: 2696) has announced that the National Medical Products Administration (NMPA) has approved a Phase Ib/II clinical study for its BRAF V600E inhibitor HLX208. The study will evaluate the combination of HLX208 with HaiSiZhuang (serplulimab) plus standard therapies (cetuximab or trametinib) for the treatment of advanced…
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China-based urogenital cancer specialist Jiangsu Yahong Meditech Co., Ltd (Asieris, SHA: 688176) has announced that it has received approval from the US FDA to conduct a Phase Ib clinical study for its drug candidate APL1401. The trial will evaluate APL1401 as a treatment for moderate to severe active ulcerative colitis…
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The Center for Drug Evaluation (CDE) website indicates that market filings for several key drugs, including Jiedi Pharma’s mitotane, Pfizer’s ritlecitinib, Northrop Grumman’s trientine, and Ark Bio’s ziresovir, have been prioritized for review. This move highlights the CDE’s efforts to expedite the approval process for drugs with significant therapeutic potential.…
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China-based CanSino Biologics (SHA: 688185, HKG: 6185) has announced that it has received emergency use authorization (EUA) for its inhalable recombinant novel coronavirus vaccine (adenovirus type 5 vector) in Morocco. This marks a significant milestone in the global deployment of innovative COVID-19 vaccines. Convidecia ProfileConvidecia, the recombinant novel coronavirus vaccine…
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China-based Luye Pharma Group (HKG: 2186) has announced that it has received market approval from the National Medical Products Administration (NMPA) in China for its pipeline drug LY06006/BA6101, a biosimilar version of Amgen’s Xgeva (denosumab). The approval is for the treatment of osteoporosis in postmenopausal women at high risk of…
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Lundbeck’s (FRA: LDBB) Eptinezumab has been launched in the Boao Lecheng International Medical Tourism Zone, marking it as the first innovative drug available in the region for migraine treatment. This milestone was announced on November 10, 2022, at a joint press conference held by the Hainan Boao Lecheng International Medical…
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The Center for Drug Evaluation (CDE) website indicates that China-based RemeGen Co., Ltd’s (HKG: 9995, SHA: 688331) novel fusion protein telitacicept is set to receive breakthrough therapy designation (BTD) status for the treatment of myasthenia gravis (MG). This marks a significant step forward in addressing a rare and challenging autoimmune…
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China-based CStone Pharmaceuticals (HKG: 2616) has announced that its GEMSTONE-303 study for the programmed death-ligand 1 (PD-L1) inhibitor sugemalimab, combined with chemotherapy as a first-line treatment for locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma (GC/GEJC) with PD-L1 expression ≥ 5%, has reached the primary endpoint of progression-free survival (PFS). This…
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China-based biotech BeiGene Inc. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has announced that it has received marketing approval in Brazil for its Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib). The in-house developed drug is now approved for the treatment of Waldenström’s macroglobulinemia (WM) and relapsed/refractory (r/r) marginal zone lymphoma (MZL)…
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China-based Sinocelltech Group Ltd (SHA: 688520) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a bridging Phase II clinical study assessing the safety and immunogenicity of its SCTV01E vaccine. The quadrivalent (Alpha + Beta + Delta + Omicron variants) S trimer protein…
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China-based 3SBio Inc. (HKG: 1530) has announced that its multi-center, randomized, double-blind, placebo-controlled study assessing the safety, efficacy, and pharmacokinetics of thrombopoietin in chronic primary immune thrombocytopenia (ITP) in children or adolescents has reached its pre-set primary endpoint. The results of the statistical analysis showed that the study group’s superiority…