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Abbisko Therapeutics Presents Positive Phase II Results for HCC Treatment at ESMO-GI
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Abbisko Therapeutics Co., Ltd (HKG: 2256), a Shanghai-based biotech company, has announced the presentation of Phase II study results for its irpagratinib in combination with atezolizumab for the treatment of advanced hepatocellular carcinoma (HCC) at the 2024 ESMO-GI annual meeting. Irpagratinib, a novel FGFR4 inhibitor discovered and developed by Abbisko,…
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Dizal Pharmaceutical’s Golidocitinib Breaks Record with Rapid Market Launch in China
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Dizal Pharmaceutical Co., Ltd (SHA: 688192), a biopharmaceutical company based in China, has seen its drug golidocitinib go from marketing approval to first prescriptions in a record time of just two days in China. This marks a significant milestone, as golidocitinib is the first and only approved Janus kinase 1…
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HighTide Therapeutics Completes Enrollment for Two Phase III Trials of T2DM Drug Candidate HTD1801
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HighTide Therapeutics Inc., (HKG: 2511), a biopharmaceutical company based in China, has announced the completion of patient enrollment for two Phase III clinical studies of its drug candidate HTD1801 (berberine ursodeoxycholate, BUDCA) for the treatment of type 2 diabetes (T2DM). The studies include the multi-center, randomized, double-blind, placebo-controlled SYMPHONY-1, which…
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Shanghai Junshi Biosciences’ Toripalimab Gains NMPA Nod for First-Line TNBC Treatment
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that it has received an additional indication approval from China’s National Medical Products Administration (NMPA) for its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab). The drug can now be used in combination with Paclitaxel (Albumin bound) for the first-line treatment…
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Harbour BioMed Resubmits Biological License Application for Batoclimab in China
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Harbour BioMed (HKG: 2142), a biopharmaceutical company with operations in the United States, the Netherlands, and Suzhou, China, has announced the resubmission of a biological license application (BLA) to China’s National Medical Products Administration (NMPA) for its drug candidate batoclimab (HBM9161) for the treatment of generalized myasthenia gravis (gMG). Batoclimab…
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Antengene’s Xpovio Included in South Korea’s NHIS Reimbursement Drug List
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Antengene Corp., Ltd (HKG: 6996), a biopharmaceutical company based in China, has announced that South Korea’s National Health Insurance Service (NHIS) has included its drug Xpovio (selinexor) in the medical insurance reimbursement drug list, effective from July 1, 2024. The drug is indicated for the treatment of adult patients with…
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Bio-Thera Solutions’ BAT1806 Biosimilar Receives European Commission Approval
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Bio-Thera Solutions Ltd (SHA: 688177), a biopharmaceutical company based in China, has announced that it has received market approval from the European Commission (EC) for BAT1806, a biosimilar version of Roche Holding AG’s (OTCM: RHHBY) Actemra/RoActemra (tocilizumab). BAT1806 is indicated for the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis,…
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Novartis’s Scemblix STAMP Inhibitor for CML Accepted for Review by China’s NMPA
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Novartis (NYSE: NVS), the Swiss pharmaceutical giant, has had its market filing for Scemblix (asciminib) accepted for review by China’s National Medical Products Administration (NMPA). Scemblix is a Specifically Targeting the ABL Myristoyl Pocket (STAMP) inhibitor, which is filed for the treatment of chronic myeloid leukemia (CML). As the world’s…
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Novo Nordisk’s Ocedurenone Misses Primary Endpoint in Chronic Kidney Disease Trial
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Novo Nordisk (NYSE: NVO; CPH: NOVO-B), a Danish pharmaceutical company, has announced that its pipeline candidate ocedurenone has failed in a Phase III trial for chronic kidney disease (CKD). The drug did not meet the primary endpoint in the CLARION-CKD study, leading to the cancellation of its development for CKD.…
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Merck’s HER3-Targeted ADC Patritumab Deruxtecan Faces FDA Complete Response Letter
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Merck, Sharp & Dohme Inc. (NYSE: MRK), a leading U.S. pharmaceutical company, has announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) for patritumab deruxtecan, a first-in-class HER3-targeted antibody-drug conjugate (ADC) discovered by Daiichi Sankyo…
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Moderna’s RSV Vaccine Efficacy Wanes to 50% After 18 Months, Shares Slide
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Moderna Inc. (NASDAQ: MRNA), a U.S.-based biopharmaceutical company, has announced long-term efficacy data for its recently approved respiratory syncytial virus (RSV) vaccine, mResvia, showing a decline in effectiveness to approximately 50% after 18 months. This is notably lower than the efficacy rates of RSV vaccines from competitors GSK and Pfizer,…
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J&J Halts Mid-Stage Trial for Tremfya in Giant Cell Arteritis Due to Efficacy Concerns
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Johnson & Johnson (J&J; NYSE: JNJ), a leading U.S.-based healthcare company, has reportedly discontinued a mid-stage trial for its autoimmune drug Tremfya (guselkumab) in the treatment of giant cell arteritis, according to a report from BioSpace. An emailed statement from J&J cited “insufficient efficacy findings” as the reason for this…
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AstraZeneca’s Tagrisso Wins NMPA Approval for First-Line EGFR-mutated NSCLC Treatment
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AstraZeneca (AZ; NASDAQ: AZN), a UK-based pharmaceutical company, has announced that it has received another indication approval from China’s National Medical Products Administration (NMPA) for its drug Tagrisso (osimertinib), an EGFR-tyrosine kinase inhibitor (EGFR-TKI). The drug is now approved for use in combination with chemotherapy as a first-line treatment for…
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Sino Biopharmaceutical Gains NMPA Approval for Liraglutide Biosimilar for Type 2 Diabetes
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Sino Biopharmaceutical Ltd (HKG: 1177), a major player in China’s pharmaceutical industry, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its biosimilar version of Novo Nordisk’s Victoza (liraglutide), a treatment designed to control blood sugar levels in patients with type 2 diabetes…
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CSPC Pharmaceutical’s BCMA-Targeted CAR-T Therapy SYS6020 Receives NMPA Clinical Trial Approval
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for SYS6020, a BCMA-targeted chimeric antigen receptor (CAR)-T cell therapy. This marks a significant milestone for the company as SYS6020 is…
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Novo Nordisk’s Semaglutide for Long-Term Weight Management Receives NMPA Approval
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Novo Nordisk (NYSE: NVO, CPH: NOVO-B), a leading healthcare company from Denmark, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for semaglutide, indicated for long-term weight management. Globally, Novo Nordisk markets semaglutide under the trade name Wegovy for weight loss. The STEP series…
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Jiangsu Simcere Pharmaceutical Wins NMPA Nod for Biosimilar Version of Erbitux
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Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096), a Chinese pharmaceutical company, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for CMAB009, a biosimilar of Merck KGaA/Bristol-Myers Squibb’s (BMS) cetuximab, which is marketed under the trade name Erbitux. The EGFR-targeted monoclonal antibody (mAb) was…
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Merck KGaA’s Xevinapant Misses Primary Endpoint in Phase III Head and Neck Cancer Trial
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Merck KGaA (NYSE: MRK), a leading German pharmaceutical company, has encountered a setback in the Phase III clinical trial for xevinapant, a drug licensed from Debiopharm in a deal valued at over USD 1 billion in 2021. The drug, which combines with chemoradiotherapy (CRT), was being investigated in the TrilynX…
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J&J’s Tecvayli Earns NMPA Approval for Relapsed or Refractory Multiple Myeloma
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Johnson & Johnson (J&J; NYSE: JNJ), a leading U.S. healthcare company, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its bispecific antibody (BsAb) Tecvayli (teclistamab) for the treatment of relapsed or refractory multiple myeloma (r/rMM) in patients who have received three or…
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Alebund Pharmaceuticals’ AP306 Earns Breakthrough Designation for Chronic Kidney Disease
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Alebund Pharmaceuticals, based in Shanghai, has announced that its drug candidate AP306 (EOS789), a pan-inhibitor of phosphate transporter proteins NaPi-IIb, PiT-1, and PiT-2, has been granted breakthrough therapy designation (BTD) by the Center for Drug Evaluation. The drug is intended for the treatment of chronic kidney disease hyperphosphatemia. As the…
