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I-Mab’s Plonmarlimab Receives Breakthrough Therapy Designation in China for R/R MAS Treatment
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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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MSD and Daiichi Sankyo’s Patritumab Deruxtecan Achieves Milestone in Phase III Lung Cancer Trial
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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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GSK’s Blenrep-BorDex Combo Earns Breakthrough Therapy Designation in China for Multiple Myeloma
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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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AstraZeneca’s Imfinzi-Imjudo Combo Sets New Longevity Benchmark in Liver Cancer Treatment
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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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BeiGene’s Tislelizumab Receives Israeli Nod for Oesophageal Cancer Treatment
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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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Abbisko Therapeutics’ FGFR4 Inhibitor Irpagratinib Shows Positive Phase I Results at ESMO Congress
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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’s JSKN003 ADC Achieves Positive Safety and Efficacy Outcomes in Phase I Studies
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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’ Sugemalimab Shows Promising Long-Term Survival Data at ESMO 202
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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 Initiates Phase I Trials for Monthly Subcutaneous and Daily Oral Obesity Treatment ASC30 in the US
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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’s Sunvozertinib Shows Promising Results in WU-KONG Series Study at ESMO 2024
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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’s Keytruda Gains Expanded Approval for First-Line Melanoma Treatment in China
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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 and GSK’s Belrestotug/Dostarlimab Combo Shows Promising Results in NSCLC
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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 and Daiichi Sankyo’s HER3-DXd ADC Patritumab Deruxtecan Passes Phase 3 Trial After FDA Rejection
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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…
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Kangfang Biotech Presents Groundbreaking mCRC Treatment Data at ESMO Congress
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At the 2024 European Society for Medical Oncology (ESMO) Congress, Kangfang Biotech (HKG: 9926) debuted its independently developed PD-1/VEGF bispecific antibody, Yivoxi, in combination with or without the next-generation CD47 monoclonal antibody, Laifali, plus FOLFOXIRI as a first-line treatment for microsatellite stable (MSS) or proficient mismatch repair (pMMR) advanced metastatic…
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Kangfang Biotech’s Yivoxi Shows Promising Results in First-Line TNBC Treatment at ESMO Congress
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At the 2024 European Society for Medical Oncology (ESMO) Congress, Kangfang Biotech (HKG: 9926) unveiled for the first time the results of its independently developed PD-1/VEGF bispecific antibody, Yivoxi, used in combination with chemotherapy for the first-line treatment of locally advanced unresectable or metastatic triple-negative breast cancer (TNBC). Preliminary data…
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Kangfang Biotech’s Yivoxi Shows Promising Results in Treating R/M HNSCC at ESMO Congress
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At the 2024 European Society for Medical Oncology (ESMO) Congress, Kangfang Biotech (HKG: 9926) unveiled the impressive Phase II clinical study results of its self-developed PD-1/VEGF bispecific antibody, Yivoxi, used in combination or alone with the next-generation CD47 monoclonal antibody, Laifali, for the first-line treatment of PD-L1 positive (CPS≥1) recurrent…
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Shanghai Pharmaceuticals’ Dual-Targeting CAR-T Therapy Advances with IND Re-Acceptance
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Shanghai Pharmaceuticals Group Co., Ltd. (SHA: 601607)’s biotech subsidiary has announced that its investigational ‘CD19 and CD22 targeting chimeric antigen receptor T cell injection’ has received renewed acceptance for its Investigational New Drug (IND) application by the relevant authorities. Known under the development code B019, this cellular therapy candidate has…
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Novartis’ Cemiplimab Approved in China for Moderate-to-Severe Atopic Dermatitis
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Novartis (SWX: NOVN, NYSE: NVS)’s Chinese arm has announced that it has received approval from the National Medical Products Administration (NMPA) for its drug candidate, cemiplimab, to be used in the treatment of adults and children aged 12 and over with moderate-to-severe atopic dermatitis (AD). The drug, known as cemiplimab…
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Johnson & Johnson’s Tremfya Gains FDA Approval for Ulcerative Colitis Treatment
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Johnson & Johnson (NYSE: JNJ) announced today that the US Food and Drug Administration (FDA) has granted approval for Tremfya (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC). With this approval, Tremfya stands out as the sole fully-human, dual-acting monoclonal antibody that not only…
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Roche’s Tecentriq Hybreza Becomes First Subcutaneous Anti-PD-(L)1 Immunotherapy in the US
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Roche (SWX: ROG; OTCMKTS: RHHBY) , a leading Swiss pharmaceutical company, has secured US Food and Drug Administration (FDA) approval for its subcutaneous formulation of the programmed death-ligand 1 (PD-L1) inhibitor, Tecentriq Hybreza (atezolizumab, hyaluronidase). This new formulation has been approved for all 12 adult indications of intravenous Tecentriq, covering…
