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GeneQuantum Healthcare’s GQ1005 ADC Receives CDE Clearance for Phase III Breast Cancer Trial
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SUZHOU—GeneQuantum Healthcare (Suzhou) Co., Ltd has received clearance from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to proceed with a Phase III clinical study for its antibody drug conjugate (ADC), GQ1005, targeting HER2 in patients with non-surgical/metastatic breast cancer. Preclinical studies have shown that…
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Beijing Balance Medical Secures NMPA Nod for Renatus Transcatheter Aortic Valve System
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BEIJING—Beijing Balance Medical Technology Co., Ltd (SHA: 688198) has received market approval from the National Medical Products Administration (NMPA) for its Renatus transcatheter aortic valve system. This in-house developed product is now approved for use in patients aged 70 years or older who are diagnosed with symptomatic, calcified, and severe…
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Sinocelltech’s Anti-Angiogenic Biologic SCT520FF Gets NMPA Green Light for Neovascular AMD Clinical Study
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SHANGHAI—Sinocelltech Group Ltd (SHA: 688520), a Chinese biopharmaceutical company, has announced that it has received clearance from the National Medical Products Administration (NMPA) to proceed with a clinical study for its in-house developed anti-angiogenic biologic drug, SCT520FF, for the treatment of neovascular age-related macular degeneration (nAMD). The drug SCT520FF is…
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Zhejiang Dian Diagnostics Partners with Shanghai Mycology Lab to Advance Fungal Infection Diagnostics
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SHANGHAI—Zhejiang Dian Diagnostics Co., Ltd (SHE: 300244), a leading player in the diagnostics industry, has entered into a strategic partnership with the Shanghai Key Laboratory of Medical Mycology and Molecular Biology. The collaboration aims to delve into multi-center scientific research, product development, and the integration of artificial intelligence (AI) technology…
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Sinopharm’s InnoStar Bio-tech Becomes First Pharma Company to IPO on STAR in 2024
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SHANGHAI—Shanghai InnoStar Bio-tech Co., Ltd., a subsidiary of Sinopharm’s China State Institute of Pharmaceutical Industry Co., Ltd, has made a notable debut by initiating an initial public offering (IPO) on the Shanghai Stock Exchange’s Sci-Tech Innovation Board (STAR). This marks the first pharmaceutical company to go public on this platform…
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China’s Sinovent and UK’s GSK Eye Breakthrough Therapy Designations for Cancer Therapies
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BEIJING/LONDON—The Center for Drug Evaluation (CDE) in China has indicated that Sinovent Inc.’s EZH2 inhibitor XNW5004 and GlaxoSmithKline’s (GSK) antibody drug conjugate (ADC) belantamab mafodotin are on track to receive breakthrough therapy designations (BTDs). Sinovent’s XNW5004 is targeting the recurrent or refractory peripheral T-cell lymphoma indication and has demonstrated potential…
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Duality Biotherapeutics Eyes Hong Kong IPO, Bolstering ADC Pipeline and Global Clinical Trials
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HONG KONG—Duality Biotherapeutics, Inc., a Chinese biotechnology company specializing in antibody drug conjugates (ADCs), is planning an initial public offering (IPO) on the Hong Kong Stock Exchange. While the unit price and further details remain under wraps, the company’s ambitions are clear, with a robust pipeline of 12 innovative ADCs…
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MicuRx Pharmaceuticals Reports 44% Revenue Growth and Increased R&D Spending in 2024 H1
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SHANGHAI—MicuRx Pharmaceuticals (SHA: 688373), a Shanghai-based developer of antibacterial drugs, has released its financial report for the first half of 2024, showing a revenue increase of 44.24% year-on-year to RMB 60.7382 million. Despite an expanded net loss of RMB 201 million, the company has significantly increased its research and development…
