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BDgene Technology’s BD111 Receives Tacit Approval for HSV-1 Keratitis Trial
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Shanghai BDgene Technology Co., Ltd has announced that it has received tacit clinical trial approval from the Center for Drug Evaluation (CDE) for its innovative therapy, BD111. This CRISPR-Cas9 in vivo-based therapy is designed for the treatment of recurrent type 1 herpes simplex virus (HSV-1)-related keratitis (HSK) and is being…
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SanReno Therapeutics Completes Dosing in Kidney Disease Trial for BION-1301
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SanReno Therapeutics, a China-based joint venture (JV) specializing in nephropathy treatments, has announced the completion of dosing in 36 patients for its new kidney disease drug, BION-1301, in a trial conducted in Shanghai. The JV is a collaboration between Chinook Therapeutics Inc., a US-based biopharmaceutical company listed on Nasdaq (KDNY),…
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Qilu Pharmaceutical Launches First Generic Iressa in the US Market
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China-based Qilu Pharmaceutical has announced the market launch of its generic version of AstraZeneca’s (AZ, NASDAQ: AZN) first-generation epidermal growth factor receptor (EGFR) inhibitor, Iressa (gefitinib), in the United States. This marks the debut of the first generic version of Iressa in the country, expanding access to this crucial medication…
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NeuExcell Therapeutics Secures Over $14.5 Million in Pre-Series A+ Funding for Neurological Treatments
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NeuExcell Therapeutics, a Sino-US biotech company specializing in treatments for neurological damage and degenerative diseases, has successfully raised over RMB 100 million (USD 14.5 million) in a pre-Series A+ financing round. The funding round saw participation from notable investors such as ZJ Leading VC, Jemincare, HX Pharma, Leader Venture Capital,…
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Transcenta’s Osemitamab Achieves Full Enrollment in Phase II Gastric Cancer Study
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Transcenta Holding Limited (HKG: 6628), a China-based biopharmaceutical company, has announced the completion of enrollment in two patient cohorts for its Phase II study of osemitamab (TST001), a CLDN18.2-targeted monoclonal antibody. The study, known as Transtar-102 (NCT04495296), focuses on patients with CLDN18.2 expressing gastric/gastro-esophageal junction (G/GEJ) adenocarcinoma in China. A…
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TYK Medicines’ TY-9591 Gains CDE Green Light for Pivotal Phase II Study in NSCLC with Brain Metastases
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Shanghai-based TYK Medicines has announced that it has received the green light from the Center for Drug Evaluation (CDE) to proceed with a pivotal Phase II clinical study for its drug candidate TY-9591, a novel therapy targeting lung cancer with brain metastases. This trial is strategically designed to support a…
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NMPA Transitions Desloratadine, Loratadine, Ambroxol, and Naproxen to OTC Status
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The National Medical Products Administration (NMPA) has indicated on its website that four products will be switched from prescription-only to over-the-counter (OTC) status. The medications in question are desloratadine, loratadine, ambroxol, and naproxen. This move is part of ongoing efforts to make certain medications more accessible to the public. Instructions…
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Skyline Therapeutics Reports Positive Preclinical Results for SKG0106 and SKG0201 Gene Therapies
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Skyline Therapeutics, a Shanghai-based cell and gene therapy (CGT) developer, has announced encouraging preclinical study results for its AAV gene therapies, SKG0106 and SKG0201, targeting neovascular age-related macular degeneration (nAMD) and spinal muscular atrophy (SMA), respectively. SKG0106: A Novel AAV Therapy for nAMDSKG0106 is a self-developed novel AAV vector carrying…
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Cellular Biomedicine Group Inc. and Janssen Biotech, Inc. Announce Global Collaboration for CAR-T Therapies
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China-based cell therapy specialist Cellular Biomedicine Group Inc. (CBMG), emerging from a merger deal in February 2021, has announced a significant global collaboration and license agreement with US firm Janssen Biotech, Inc. (Janssen). The partnership is centered on the development and commercialization of C-CAR039, an anti-CD19 and CD20 bi-specific chimeric…
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Chinese Authorities Launch Special Campaign to Combat Fraud in Medical Insurance
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The National Healthcare Security Administration, Supreme People’s Procurator, Ministry of Public Security, Ministry of Finance, and National Health Commission have collaboratively released a special rectification work plan aimed at combating fraud and deception in the medical insurance field in China. This initiative underscores the government’s commitment to safeguarding the integrity…
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Johnson & Johnson’s Kenvue IPO Raises USD 3.8 Billion, Marking Year’s Largest US IPO
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US healthcare giant Johnson & Johnson (J&J, NYSE: JNJ) has announced the initial public offering (IPO) of 173 million shares by its consumer health spin-off company Kenvue to the New York Stock Exchange (NYSE), raising a staggering USD 3.8 billion. This transaction has secured its place as the biggest IPO…
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Full-Life Technologies Ltd to Establish GMP-Compliant Radiopharmaceutical Plant in Belgium’s Wallonie Region
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Shanghai-headquartered Full-Life Technologies Ltd has announced a significant land acquisition deal in the Wallonie region of Belgium, with the aim of establishing a Good Manufacturing Practice (GMP)-compliant advanced radiopharmaceutical plant. This strategic move is set to bolster the company’s position in the radiation therapy sector. Addressing Manufacturing Challenges in Radiation…
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Q1 2023 financial report: AstraZeneca leads innovation in China, Sanofi’s sales in China decline
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Several multinational companies (MNCs) have released their Q1 2023 financials, showing a varied performance over the quarter. AstraZeneca’s China Innovation BoomAstraZeneca (AZ, NASDAQ: AZN) CEO Pascal Soriot warned that Europe is lagging behind China in fostering innovation and access to medicines. This statement came during the company’s Q1 2023 earnings…
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CMS Receives NMPA Approval for Clinical Study of Tetravalent BsAb for nAMD
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China Medical System Holdings (CMS; HKG: 0867) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for its tetravalent bispecific antibody (BsAb) targeting vascular endothelial growth factor A (VEGFA) and angiopoietin 2 (ANG2) for intravitreal injection in the treatment…
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Sirnaomics’ RV-1730 Receives FDA Clearance for Phase I COVID-19 Vaccine Booster Trial
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Sirnaomics Ltd (HKG: 2257) has announced that it has received clearance from the United States Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for a Phase I clinical trial of RV-1730, a SARS-CoV-2 vaccine booster candidate. Design of the Phase I Study for RV-1730The Phase I…
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Reforgene Medicine Secures Pre-Series B Funding to Advance Thalassemia Gene Therapy
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Reforgene Medicine, a Guangzhou-based gene editing therapy company, has reportedly secured hundreds of millions of renminbi in a Pre-Series B financing round. The round was led by Yuexiu Industrial Fund, with participation from other notable investors including Yuanying Venture Capital, Shanfeng Venture Capital, Emerging Fund, Ganyue Investment, Guoju Venture Capital,…
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Zai Lab Partners with MediLink Therapeutics to Develop YL212 DLL3 ADC
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Zai Lab Limited (NASDAQ: ZLAB, HKG: 9688), a China-based biopharmaceutical company, has announced a strategic partnership and exclusive worldwide license agreement with MediLink Therapeutics, a specialist in antibody drug conjugates (ADCs) founded in 2020. The agreement pertains to MediLink’s YL212, a novel DLL3 ADC program, highlighting Zai Lab’s commitment to…
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Jiangsu Hengrui’s Vunakizumab for Plaque Psoriasis Accepted for Review by NMPA
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Jiangsu Hengrui Pharmaceutials Co., Ltd (SHA: 600276), a leading China-based pharmaceutical company, announced that the National Medical Products Administration (NMPA) has accepted its market filing for vunakizumab, an IL-17A monoclonal antibody (mAb), for the treatment of moderate to severe plaque psoriasis suitable for systemic therapy or phototherapy. Global IL-17A Products…
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OBiO Technology and ImmVira Partner on Oncolytic Virus Project for BLA Filing and Commercialization
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OBiO Technology (Shanghai) Co., Ltd (SHA: 688238), a leading gene therapy specialist based in China, has entered into a partnership with fellow Chinese firm ImmVira. The collaboration pertains to the Biologics License Application (BLA) filing and the commercial industrialization of an oncolytic virus project. ImmVira, which is responsible for the…
