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LaNova Medicines Gets NMPA Approval for LM-305 Clinical Study
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Shanghai-based cancer therapy developer LaNova Medicines Ltd has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its antibody drug conjugate (ADC) LM-305, targeting GPRC5D. This marks a significant milestone for LaNova as it advances its innovative ADC into clinical…
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Everest Medicines’ Nefecon NDA Accepted for IgA Nephropathy in China
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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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Innovent Biologics Initiates Phase III Trial for Mazdutide in Obesity
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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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Guangdong Zhongsheng Starts Phase III Trial for COVID-19 Drug RAY1216
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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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Yabao Receives FDA Clearance for Generic Nexavar
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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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Hengrui’s Pyrotinib Granted Priority Review for HER2-Positive Breast Cancer
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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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AstraZeneca to Launch Soliris in Hangzhou After Regulatory Approval
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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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Akeso Biopharma’s AK112 Receives Two New Breakthrough Therapy Designations
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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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HutchMed Announces Initial Results from FRUTIGA Phase III Study
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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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Henlius Biotech’s BRAF V600E Inhibitor HLX208 Approved for Clinical Study in China
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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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FDA Approves Phase Ib Study for Jiangsu Yahong’s APL1401 in Ulcerative Colitis
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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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CDE Prioritizes Review for Jiedi Pharma’s Mitotane and Other Key Drugs
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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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CanSino Biologics’ Inhalable COVID-19 Vaccine Authorized in Morocco
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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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Luye Pharma’s Biosimilar LY06006/BA6101 Approved for Osteoporosis Treatment
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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 Eptinezumab Launches in Boao Lecheng for Migraine Treatment
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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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RemeGen’s Telitacicept Set for Breakthrough Therapy Designation in Myasthenia Gravis
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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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CStone’s PD-L1 Inhibitor Sugemalimab Achieves Primary Endpoint in Gastric Cancer Study
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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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BeiGene’s Brukinsa Receives Marketing Approval in Brazil
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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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Sinocelltech’s SCTV01E Vaccine Receives NMPA Approval for Phase II Study
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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…
