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Ocumension Therapeutics (HKG: 1477), a leading ophthalmology specialist in China, has announced that its histamine H1 receptor-targeted drug Zerviate (OT-1001) has been granted marketing approval in China with priority review status. The drug is indicated for the treatment of itching symptoms associated with allergic conjunctivitis. Zerviate, originally developed by the…
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Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK) has announced that the US Food and Drug Administration (FDA) has approved a new indication for its programmed death-1 (PD-1) inhibitor, Keytruda (pembrolizumab). The approval allows for the use of Keytruda in combination with pemetrexed and platinum chemotherapy as a first-line treatment…
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UK pharmaceutical giant AstraZeneca (NASDAQ: AZN, LON: AZN) has announced that the US Food and Drug Administration (FDA) has approved a new indication for its interleukin-5 (IL-5)-targeted antibody, Fasenra (benralizumab), for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA), a rare and potentially fatal disease. The approval comes on the…
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Global pharmaceutical company AstraZeneca (AZ, NASDAQ: AZN, LON: AZN) has reported updated results from the Phase III LAURA study on its EGFR-tyrosine kinase inhibitor (EGFR-TKI), Tagrisso (osimertinib), at the 2024 European Society of Medical Oncology (ESMO) Congress. The study included data from the Chinese cohort, highlighting the drug’s efficacy in…
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China-based biotech company Keymed Biosciences Inc. (HKG: 2162) has reached a significant milestone with its drug candidate stapokibart, as it receives its first prescription in the country. This marks a pivotal step for the IL-4Rα monoclonal antibody (mAb), which is the first drug developed by a Chinese biotech to target…
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Adagene Inc. (NASDAQ: ADAG), a biopharmaceutical company dedicated to the discovery and development of innovative antibody-based therapies, has announced updated results from the Phase Ib/II study of its anti-CTLA-4 SAFEbody, ADG126 (Muzastotug), in combination with pembrolizumab for the treatment of advanced/metastatic microsatellite stable colorectal cancer (MSS CRC) at the 2024…
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Transcenta Holdings Ltd (HKG: 6628), a leading biopharmaceutical company, has announced updated positive results from the cohort-G data of its drug candidate osemitamab (TST001) in combination with nivolumab and CAPOX for the first-line treatment of advanced gastric or gastroesophageal junction (G/GEJ) cancer at the 2024 European Society of Medical Oncology…
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China-based biopharmaceutical company I-Mab (NASDAQ: IMAB) has announced that its proprietary human granulocyte-macrophage colony-stimulating factor (GM-CSF) neutralizing antibody, plonmarlimab, is poised to receive breakthrough therapy designation (BTD) from the National Medical Products Administration (NMPA) for the treatment of recurrent/refractory hemophagocytic lymphohistiocytosis (R/R MAS), a severe and life-threatening condition. Plonmarlimab is…
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Global healthcare leaders Merck, Sharp & Dohme Inc.(MSD; NYSE: MRK), known as MSD outside the US and Canada, and Daiichi Sankyo (TYO: 4568) have announced that their jointly developed anti-HER3 antibody drug conjugate (ADC), patritumab deruxtecan, has demonstrated a significant progression-free survival (PFS) benefit in the Phase III HERTHENA-Lung02 trial.…
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The UK-based pharmaceutical colossus, GSK (LON: GSK, NYSE: GSK), has secured a Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) for its antibody-drug conjugate, Blenrep (belantamab mafodotin), used in combination with bortezomib and dexamethasone (BorDex). This regulatory milestone for the treatment of relapsed or refractory multiple myeloma…
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UK pharmaceutical giant AstraZeneca (NASDAQ: AZN, LON: AZN) has achieved a significant milestone with its drug combination of Imfinzi (durvalumab) and Imjudo (tremelimumab), used in the treatment of patients with unresectable or metastatic oesophageal squamous cell carcinoma (ESCC). Data from the Phase III HIMALAYA trial, showcased at the 2024 European…
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China-based biotech firm BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has been granted market approval in Israel for its programmed death-1 (PD-1) inhibitor, Tevimbra (tislelizumab). The Israeli Ministry of Health has approved Tevimbra for use as a monotherapy second-line treatment for adult patients with unresectable or metastatic oesophageal squamous…
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Shanghai-based biotech firm Abbisko Therapeutics Co., Ltd (HKG: 2256) has presented updates on its innovative cancer treatments at the 2024 European Society of Medical Oncology (ESMO) Congress. The company highlighted the Phase I study results for irpagratinib, a novel small-molecule FGFR4 inhibitor, in patients with FGF19 over-expressing advanced hepatocellular carcinoma…
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Alphamab Oncology (HKG: 9966), a leading player in the oncology space, has reported encouraging results from its Phase I clinical studies of JSKN003, a HER2-targeted antibody-drug conjugate (ADC), at the 2024 European Society of Medical Oncology (ESMO) Congress. The studies, conducted in Australia and China, targeted advanced and metastatic solid…
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CStone Pharmaceuticals (HKG: 2616), a biopharmaceutical company based in China, has presented long-term treatment and survival data for sugemalimab at the 2024 European Society for Medical Oncology (ESMO) Annual Meeting. The data comes from the GEMSTONE-302 study, which combines sugemalimab with platinum-based chemotherapy. The Phase III trial, a multicenter, randomized,…
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Ascletis Pharma Inc. (HKG: 1672), a biopharmaceutical company based in China, has announced the dosing of the first batch of patients in two Phase I clinical studies for its investigational drug ASC30 in the United States. ASC30 is positioned as the world’s first and only small molecule glucagon-like peptide-1 receptor…
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Dizal Pharmaceutical Co., Ltd (SHA: 688192), a biopharmaceutical company based in China, has presented updates on the WU-KONG series study for its next-generation epidermal growth factor receptor (EGFR) inhibitor, sunvozertinib (DZD9008), at the 2024 European Society of Medical Oncology (ESMO) Congress. Sunvozertinib received approval in China in August of the…
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Merck & Co., Inc. (NYSE: MRK), a leading US pharmaceutical company, has announced that its programmed death-1 (PD-1) inhibitor, Keytruda (pembrolizumab), has received expanded approval in China. The updated approval allows the drug’s package insert to be revised to include “pembrolizumab is suitable for the treatment of unresectable or metastatic…
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iTeos Therapeutics has announced the latest data from the Phase 2 platform study GALAXIES Lung-201, led by its development partner GSK. The study evaluates the efficacy of the combination therapy consisting of the anti-TIGIT monoclonal antibody belrestotug and the anti-PD-1 monoclonal antibody dostarlimab in patients with untreated, unresectable, locally advanced,…
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Merck (NYSE: MRK) and Daiichi Sankyo (TYO: 4568) announced that their antibody-drug conjugate (ADC) patritumab deruxtecan (HER3-DXd) has passed Phase 3 HERTHENA-Lung 02 study, months after the drug was rejected by the U.S. FDA due to manufacturing issues following its presentation at this year’s ESMO conference. The companies will discuss…