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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for clesrovimab (MK-1654), the company’s investigational prophylactic long-acting monoclonal antibody. This antibody is designed to protect infants from respiratory syncytial virus (RSV) disease during their first…
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US-based Photys Therapeutics, Inc. has entered into an agreement with Denmark-based Novo Nordisk A/S (NYSE: NVO) to collaborate on the development of innovative proximity-based therapeutics for a cardiometabolic disease target. This multi-year partnership aims to leverage the complementary strengths of both companies to advance new treatment options in the field…
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Merck (NYSE: MRK) has announced a definitive agreement with the intention to acquire HUB Organoids Holding B.V. (HUB), a company specializing in organoid technology. Organoids, which are cell culture models that functionally resemble organs, hold the potential to revolutionize drug development by accelerating processes, enhancing disease treatment understanding across diverse…
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US-based BioAge Labs, Inc. has announced a strategic research partnership with Swiss pharmaceutical giant Novartis (NYSE: NVS). This multi-year collaboration aims to identify and validate novel therapeutic drug targets by delving into the biological mechanisms that underpin aging-related diseases and the beneficial effects of physical exercise. The partnership is designed…
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China-based DaAn Gene Co., Ltd, (SHE: 002030) affiliated with Sun Yat-sen University, has announced that it has received a Category III medical device license from the National Medical Products Administration (NMPA) for its genetic deafness gene detection kit, which employs PCR flow cytometry fluorescence hybridization methodology. Advanced Technology for Genetic…
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Suzhou-based biotech company MediLink Therapeutics (Suzhou) Co., Ltd has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for its antibody drug conjugate (ADC) YL201 for the treatment of small-cell lung cancer (SCLC). This designation highlights the potential impact of YL201 in addressing a…
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Bristol-Myers Squibb (BMS; NYSE: BMY) has reached an agreement with China-based Ablaze Pharmaceuticals to regain exclusive development and commercialization rights for ABZ-706 in Greater China, which includes mainland China, Hong Kong, Macau, and Taiwan. ABZ-706 is a targeted therapy for liver cancer that focuses on the GPC3 biomarker. Background on…
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China-based Everest Medicines (HKG: 1952) has announced that its targeted-release budesonide, Nefecon, has been prescribed for the first time to treat primary immunoglobulin A nephropathy (IgAN) in adults who are at risk of disease progression. This development signifies a significant step forward in the management of IgAN, a condition that…
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On December 18, 2024, the Food and Drug Administration (FDA) granted approval for Betta Pharmaceutical (SHE: 300558) and its controlling subsidiary Xcovery Holdings, Inc.’s ensartinib (Ensacove), a treatment for adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received…
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Shanghai INT Medical Instruments Co., Ltd. (HKG: 1501) has announced its intention to acquire at least a 51% stake in its Chinese counterpart, Hangzhou Weiqiang Medical Technology Co.,Ltd. The acquisition will see INT Med make an initial upfront payment of RMB 30 million (USD 4.11 million), along with a substantial…
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Janssen-Cilag International NV has announced the submission seeking approval for an indication extension of IMBRUVICA (ibrutinib) in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP). The extended indication is for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are eligible for autologous stem cell…
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Xunfei Healthcare Technology Co., Ltd, a subsidiary of China-based information technology company iFlytek Co., Ltd (SHE: 002230), has officially launched its initial public offering (IPO) on the Hong Kong Stock Exchange. The company issued 7,035,550 shares at a price of HKD 82.8 per share, securing over HKD 580 million (USD…
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Chengdu Kanghua Biological Products Co., Ltd, (SHE: 300841), a leading biopharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its recombinant hexavalent norovirus vaccine (Pichia pastoris). The vaccine is designed to prevent acute gastroenteritis caused by genotype…
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Sinocare Inc (SHE: 300298), a China-based medical technology company, has announced that its continuous glucose monitoring system (CGMS), TRUE VIE CGMS, has entered the 510(k) substantive review stage at the US Food and Drug Administration (FDA). This milestone follows the successful passage of the initial acceptance review for the FDA…
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received clearance from the US Food and Drug Administration (FDA) for its Category 1 chemical drug, HDM1005. The drug will now proceed to clinical trials involving patients with heart failure with preserved ejection fraction (HFpEF) and obesity. HDM1005:…
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276), a leading China-based pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for the combination of SHR-1501 with adebrelimab (SHR-1316) for the treatment of non-muscle invasive bladder cancer. Adebrelimab: A PD-L1 Monoclonal Antibody with…
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading China-based biopharmaceutical company, has announced positive results from the Phase III study (TQB2450-Ⅲ-05) for its anti-programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb) benmelstobart (TQB2450). The study evaluated benmelstobart, with or without multi-target kinase inhibitor anlotinib, as a consolidation therapy for locally advanced/unresectable (stage…
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China’s Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has announced a significant global license deal with US pharmaceutical giant Merck, Sharp & Dohme (MSD; NYSE: MRK) concerning its investigational oral molecule, HS-10535, a GLP-1 receptor agonist. Terms of the Agreement and Financial ImplicationsAccording to the agreement, Merck will secure exclusive…
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Belgium-based biopharmaceutical company UCB (EBR: UCB) has announced the disappointing results of the ORCHESTRA proof-of-concept (POC) study for minzasolmin, an alpha-synuclein misfolding inhibitor co-developed with Swiss pharmaceutical giant Novartis (NYSE: NVS). The study was designed to assess the efficacy of minzasolmin in treating early Parkinson’s disease, but it failed to…
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China-based HealthyWay Inc. (HKG: 2587) has made a significant debut on the Hong Kong Stock Exchange with an initial public offering (IPO) of 25 million shares, priced at HKD 8.8 per share. This translates to a capital raise of HKD 220 million (USD 28.3 million), marking a significant milestone for…