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Ascletis Pharma’s ASC40 Meets Acne Treatment Goals in Phase II Trial
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China-based Ascletis Pharma Inc. (HKG: 1672) has announced that its first-in-class, once-daily oral fatty acid synthase (FASN) inhibitor, ASC40 (senifanstat), has successfully met primary and key secondary endpoints in a Phase II clinical trial for acne vulgaris. ASC40’s Mechanism of Action and Trial DesignASC40 is an oral, selective small-molecule inhibitor…
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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…