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Beijing’s Apollobio Receives NMPA Approval for HPV Therapeutic Vaccine VGX-3100
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Beijing’s Apollobio, has announced that the National Medical Products Administration (NMPA) has granted market approval for its innovative therapeutic vaccine VGX-3100. This vaccine, which targets HPV-16/18 related anal precancerous lesions, is a significant advancement in the treatment landscape for conditions associated with Human Papillomavirus (HPV). The vaccine’s approval follows a…
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Insilico Medicine’s AI-Generated Drug Candidate ISM001-055 Shows Positive Phase II Results in IPF Study
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China-based artificial intelligence (AI) drug developer Insilico Medicine has reported initial positive data from its Phase IIa study for ISM001-055, an in-house generative AI-generated drug candidate for idiopathic pulmonary fibrosis (IPF). The molecule, which targets TNIK (Traf2- and NCK- interacting kinase), has shown a positive safety profile and dose-dependent lung…
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Lee’s Pharmaceutical’s Zhaoke Ophthalmology Receives NMPA Approval for Generic Lumigan
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Lee’s Pharmaceutical Holdings Ltd (HKG: 0950), through its subsidiary Zhaoke Ophthalmology Ltd (HKG: 6622), has announced that it has received market approval from China’s National Medical Products Administration (NMPA) for its generic version of Allergan’s (NYSE: AGN) Lumigan (bimatoprost), a treatment for glaucoma. The product, marketed under the Chinese trade…
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Jiangsu Hengrui Pharmaceuticals’ SHR-1701 Combo Therapy for Gastric Cancer Accepted for Review by China’s NMPA
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that the National Medical Products Administration (NMPA) has accepted for review its market filing for SHR-1701 in combination with fluorouracil and platinum for the first-line treatment of locally advanced unresectable, recurrent, or metastatic adenocarcinoma of…
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Ocumension Therapeutics’ Zerviate Receives Marketing Approval in China for Allergic Conjunctivitis Treatment
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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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MSD’s Keytruda Secures FDA Approval for First-Line Mesothelioma Treatment in Combination with Chemotherapy
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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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AstraZeneca’s Fasenra Secures FDA Nod for EGPA Treatment, Strengthening Rare Disease Portfolio
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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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AstraZeneca’s Tagrisso Achieves Milestones in Phase III LAURA Study for EGFR-mutated NSCLC at ESMO 2024
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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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Keymed Biosciences’ Stapokibart Receives First Prescription in China for IL-4Rα Targeting Therapy
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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’s ADG126 Shows Promising Results in Phase Ib/II Study for MSS CRC at ESMO 2024
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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’s Osemitamab Combo Therapy Shows Promising Results in G/GEJ Cancer Treatment at ESMO 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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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…
