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Peijia Medical Ltd (HKG: 9996), a leading medical device company, has announced the completion of its first compassionate use case utilizing the Taurus Trio transcatheter aortic valve replacement (TAVR) system in Hong Kong. This milestone marks a significant step in the application of the company’s advanced cardiovascular technology in the…
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French pharmaceutical giant Sanofi has announced that the US Food and Drug Administration (FDA) has accepted for review the supplemental biologics license application (sBLA) for Dupixent (dupilumab). The application seeks to expand the monoclonal antibody’s (mAb) indication to treat adults and pediatric patients aged 12 years and older with chronic…
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Denmark-based healthcare giant Novo Nordisk A/S (NYSE: NVO) has announced the official market launch of semaglutide in China for long-term weight management. Globally, Novo Nordisk markets the glucagon-like peptide-1 receptor agonist (GLP-1RA) under the trade name Wegovy for weight loss, expanding access to this treatment for individuals seeking to manage…
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), a leading biopharmaceutical company based in China, has announced receiving separate Investigational New Drug (IND) approvals from the National Medical Products Administration (NMPA) for its antibody drug conjugates (ADCs), SKB535 and SKB571, which target solid tumors. This development marks a significant milestone in…
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Exegenesis Bio, a leading provider of epigenetics experimental and analytical services headquartered in Hangzhou, has announced that it has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its proprietary gene therapy, EXG110, which is indicated for the treatment of Fabry disease. This designation highlights…
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Shenzhen Weiguang Biological Products Co., Ltd. (SHE: 002880), a prominent blood products manufacturer in China, has entered into a strategic partnership with Shenzhen University of Advanced Technology (SUAT). This collaboration, focused on the life and health sector, aims to foster the integration of industry and education, enhance cooperation among industry,…
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Janssen-Cilag International NV, a subsidiary of the US pharmaceutical giant Johnson & Johnson (J&J; NYSE: JNJ), has announced that it has received positive opinions from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) regarding the combination of Lazcluze (lazertinib) and Rybrevant (amivantamab-vmjw). This combination therapy…
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), a leading biopharmaceutical company based in China, has announced that it has received marketing approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its PD-1 inhibitor, toripalimab, marketed as Loqtorzi. This approval allows the use of toripalimab in…
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C-Ray Therapeutics, a specialist in radiopharmaceuticals headquartered in Chengdu, has announced the successful completion of a Series A+ financing round, raising over USD 100 million. The funding was co-led by Shenzhen Capital Group’s Manufacturing Transformation and Upgrading New Materials Fund and Tailong Capital, with additional contributions from GL Ventures, 3SBio…
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BioNTech (NASDAQ: BNTX), the biotech giant recognized for its role in developing the COVID-19 vaccine, has acquired Biotheus for an upfront payment of $800 million, with additional milestone payments potentially reaching up to $150 million. Founded in 2018 and headquartered in Zhuhai, China, Biotheus has developed eight clinical-stage products and…
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Suzhou Ribo Life Science Co., Ltd. and its subsidiary Ribocure Pharmaceuticals AB have announced that their novel siRNA drug, RBD5044, has received approval to commence Phase II clinical trials in the European Union. This represents a significant step forward in the development of RNA interference therapies targeting lipid metabolism. RBD5044:…
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Ascentage Pharma (HKG: 6855) has announced that its proprietary oral Bcl-2 selective inhibitor, Lisaftoclax (APG-2575), has submitted its market application, which has been officially accepted by regulatory authorities. The formulation is being produced in collaboration with Xuantai Pharmaceutical. This innovative treatment targets patients suffering from refractory or relapsed chronic lymphocytic…
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C-Ray Therapeutics (Chengdu) Co., Ltd., an innovative enterprise in the field of radioactive medicines, has successfully completed over $100 million in A+ round financing. This funding round was jointly led by Shenzhen Capital Group’s New Materials Fund and Tailong Investment, with participation from notable investors including Hillhouse Ventures, SiBiono GeneTech,…
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Bliss Bio announced that its Investigational New Drug (IND) application for the innovative antibody-drug conjugate (ADC) BB-1712 has been approved by the National Medical Products Administration (NMPA) of China. BB-1712, a B7-H3 targeted ADC utilizing Eribulin as its cytotoxic agent, has been developed for the treatment of multiple solid tumors,…
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Merck KGaA (NYSE: MRK), the German multinational science and technology company, has released its financial results for the third quarter of 2024, reporting net sales of EUR 5.266 billion (USD 5.55 billion), marking an organic growth of 3.8%. The company’s performance reflects a steady increase in sales across its business…
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China-based biopharmaceutical company Impact Therapeutics has reportedly secured RMB 250 million (USD 34.5 million) in a Series D++ financing round, co-led by a globally renowned industry investment institution and a prominent insurance fund. The funds raised will be directed towards the commercialization of its core product, senaparib, a PARP1 inhibitor,…
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UK-based pharmaceutical company GSK plc (NYSE: GSK) has reported positive results from a Phase III trial for Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone (BorDex) as a second-line or later treatment for relapsed or refractory multiple myeloma (RRMM). The DREAMM-7 head-to-head study demonstrated that GSK’s BCMA-targeted antibody drug…
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Janssen-Cilag International NV, a subsidiary of Johnson & Johnson (J&J, NYSE: JNJ), has unveiled the latest analysis results from the Phase II DAHLIAS study for nipocalimab, an investigational FcRn blocker, in adult patients with moderate-to-severe Sjögren’s disease (SjD). The study has shown that the drug significantly improved key measures of…
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French pharmaceutical giant Sanofi (NASDAQ: SNY) has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the treatment of adult patients with…
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Johnson & Johnson (J&J, NYSE: JNJ) MedTech, a leading player in the US medical technology sector, has announced an exclusive commercial distribution agreement with Responsive Arthroscopy Inc., an innovative medical device company specializing in sports soft tissue repair solutions. This strategic partnership is aimed at bolstering J&J MedTech’s sports medicine…