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Genmab A/S (NASDAQ: GMAB), a Danish biotechnology company, and its co-development partner AbbVie (NYSE: ABBV), have announced that the U.S. Food and Drug Administration (FDA) has granted the first approval for Tepkinly/Epkinly (epcoritamab), an off-the-shelf T-cell engaging CD3xCD20-targeted bispecific antibody (BsAb). The molecule has received accelerated approval for the treatment…
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Novo Nordisk (NYSE: NVO; CPH: NOVO-B), a leading healthcare company, has reportedly planned a cautious market launch for the anti-obesity drug Wegovy (semaglutide) in China following its recent approval. The strategy is aimed at preserving manufacturing capacity and maintaining the stability of global supply chains, according to Maziar Mike Doustdar,…
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Hybio Pharmaceutical Co., Ltd (SHE: 300199), a Chinese pharmaceutical company, has announced that it has received a Drug Master File (DMF) First Adequate Letter from the U.S. Food and Drug Administration (FDA) for its tirzepatide raw materials. Tirzepatide, a first-to-market dual GIP/GLP-1 receptor agonist, has been approved in the U.S.…
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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 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 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 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 (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 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 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 (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 (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, 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 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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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 (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 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 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 (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 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…