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UK-based pharmaceutical company GlaxoSmithKline (GSK; NYSE: GSK) has announced that the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for Blenrep (belantamab mafodotin). GSK is seeking approval for the drug in combination with bortezomib plus dexamethasone (BorDex [BVd]) and pomalidomide plus dexamethasone (PomDex…
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China’s generative artificial intelligence (AI)-driven biotech company, Insilico Medicine, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study for its potential best-in-class ENPP1 inhibitor, ISM5939, in solid tumors. ISM5939: A Promising ENPP1 InhibitorISM5939 targets ENPP1, an external nucleotide pyrophosphatase…
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China-based Shenzhen Kangtai Biological Products Co., Ltd (SHE: 300601) has announced the enrollment of the first patient in the Phase I study for its 20-valent pneumococcal polysaccharide conjugate vaccine. This vaccine is designed to prevent infectious diseases caused by 20 pneumococcal serotypes, targeting infants and children aged between 2 months…
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced that it has received clearance from the National Medical Products Administration (NMPA) in China for a clinical trial filing of its pipeline candidate, SKB501. The novel antibody drug conjugate (ADC) is now set to be assessed in the treatment of advanced…
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China-based Lepu Medical Technology (Beijing) Co., Ltd (SHE: 300003), a leading provider of cardiovascular disease solutions, has announced that it has received clinical approvals from the National Medical Products Administration (NMPA) for its innovative therapies, MWN109 and MWN105. Both treatments are indicated for overweight or obesity and type 2 diabetes,…
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China-based 3SBio Inc. (HKG: 1530) has announced a licensing deal with fellow Chinese firm Sunshine Lake Pharma Co., Ltd., a member of HEC Group (SHA: 600673), concerning the commercialization of clifutinib in mainland China. Under the terms of the agreement, 3SBio will handle the commercialization efforts for the drug, paying…
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US-based pharmaceutical giant Merck & Co., Inc. (NYSE: MRK) has announced favorable interim analysis results from the pivotal Phase III ZENITH study for its drug Winrevair (sotatercept-csrk), an activin signaling inhibitor. The study’s success marks a significant milestone in the treatment of pulmonary arterial hypertension (PAH). ZENITH Study Design and…
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China-based Hubei Guangji Pharmaceutical Co., Ltd. (SHE: 000952) is poised to establish a strong presence in the ex-hospital market, which encompasses drug sales and health services beyond public medical institutions. The company has secured separate partnerships with Qingdao Guoxin Pharmaceutical Co., Ltd and Pingguang Pharmaceutical Limited by Share Ltd to…
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China-based GeneQuantum Healthcare, a leading developer of antibody drug conjugates (ADCs), has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study for GQ1011 (AMB302). This FGFR3-targeted ADC was co-developed with South Korea-based biotech Aimed Bio under an agreement established in…
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China-based E-nitiate Biopharmaceuticals (Hangzhou) Co., Ltd, a joint venture between VivaVision Biotech and Betta Pharmaceuticals (SHE: 300558) focusing on autoimmune disease drug development, has entered into a licensing deal with compatriot firm Joincare Pharmaceutical Group Industry Co., Ltd (SHA: 600380). Under the agreement, Joincare will acquire development and commercialization rights…
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China-based Luye Pharma Group’s (HKG: 2186) controlling subsidiary, Shandong Boan Biotechnology Co., Ltd (HKG: 6955), has announced a licensing agreement with an unnamed Brazilian partner. The agreement grants the Brazilian company the rights to commercialize Boan Bio’s BA6101 and BA1102 in the local market as their Marketing Authorization Holder (MAH).…
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced revisions to its private placement plan, downsizing the initially disclosed proceeds from RMB 2.608 billion (USD 360 million) in April to RMB 1.848 billion (USD 255.1 million). The adjusted funds will be allocated towards new drug research and development, a global-aligned…
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Denmark-based pharmaceutical company H. Lundbeck A/S (OTCMKTS: HLBBF) has revealed its financial results for the third quarter and the first three quarters of 2024. For the three-month period, revenues increased by 18% year-on-year (YOY) in constant currency terms to DKK 5.722 billion (USD 805 million). Over the nine-month period, sales…
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China-based Acotec Scientific Holdings Ltd (HKG: 6669) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its thrombus aspiration catheter special support tube. This product is designed to assist in the delivery and placement of interventional instruments during peripheral vascular intervention surgery. Enhancing…
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Shanghai Henlius Biotech Co., Ltd (HKG: 2696) has announced the dosing of the first patient in a global, multi-center Phase III study for its drug candidate HLX22. The study will compare the combination of HLX22 with trastuzumab and chemotherapy against the same regimen with or without pembrolizumab in the first-line…
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Shanghai-based medical device giant MicroPort Scientific Corp. (HKG: 0853) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its whole-body magnetic resonance imaging (MRI) condition safety pacing electrode lead, BonaFire. This marks a significant milestone, as BonaFire becomes the first product of its…
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Shanghai-based cell therapy specialist Base Therapeutics has achieved clearance from the US Food and Drug Administration (FDA) to study its NK510 in advanced solid tumors, following clinical approval in China last month. This development marks a significant step forward for the company’s base-edited universal NK cell therapy. NK510: A Leap…
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Merck KGaA (NYSE: MRK) has entered into a Memorandum of Understanding with the Digital Trust Centre (DTC) at Nanyang Technological University, Singapore (NTU Singapore), to implement and deploy innovative trust technology solutions. This partnership aims to drive the digital transformation of Singapore-based companies by focusing on secure, automated, traceable, and…
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UK-based pharmaceutical company GlaxoSmithKline (GSK; NYSE: GSK) has announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved an expansion of the indication for Arexvy to include adults aged 50-59 who are at an increased risk of respiratory syncytial virus (RSV) infection. This marks a significant step in…