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Dizal Pharmaceutical’s Sunvozertinib Earns Breakthrough Designation for NSCLC from China’s NMPA
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Dizal Pharmaceutical Co., Ltd (SHA: 688192), a biopharmaceutical company based in China, has announced that it has received Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) for its next-generation epidermal growth factor receptor (EGFR) inhibitor, sunvozertinib. This designation is in relation to the drug’s potential use as…
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NMPA Sets Forthcoming Guidelines for Domestic Drug Refiling Procedures
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The National Medical Products Administration (NMPA) has issued a notification outlining the requirements for the refiling procedures and materials for domestically produced drugs, which will come into effect on January 1, 2025. The document mandates that marketing authorization holders (MAHs) of these drugs and registrants of chemical raw materials must…
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Huawei Partners with Medical University Hospital to Boost Healthcare Innovation
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The Affiliated Hospital of Xuzhou Medical University has entered into a comprehensive partnership with Huawei Technologies Co., Ltd., a leading global provider of information and communications technology (ICT) solutions. Under this alliance, Huawei will offer a suite of advanced technologies, including network connectivity, transportation support, diverse computing power products, intelligent…
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Reforgene Medicine’s Gene Editing Therapy RM-101 Clears IND Hurdle for Usher Syndrome Treatment
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Reforgene Medicine, a pioneer in gene editing therapy based in Guangzhou, has secured Investigational New Drug (IND) approval from China’s National Medical Products Administration (NMPA) for its flagship candidate, RM-101. This AAV-based gene editing drug is aimed at treating Usher syndrome, a genetic condition that leads to significant vision impairment…
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Akeso Biopharma Secures USD 250 Million in Share Placement, Bolstering Drug Development War chest
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Akeso Biopharma (HKG: 9926), a biopharmaceutical company based in China, has declared the successful completion of a share placement that has raised USD 250 million. This capital raise has garnered significant attention from international investment firms, with a majority of the final subscribers being long-term and healthcare funds. With this…
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Jiangsu Hengrui’s RGL-193 Receives NMPA Greenlight for Parkinson’s Disease Clinical Study
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Jiangsu Hengrui Medicine Co., Ltd, a leading pharmaceutical company based in China and listed as (SHA: 600276), has received approval from the National Medical Products Administration (NMPA) for its Category 1 drug, RGL-193. This marks a significant step forward as the drug advances into clinical studies focused on Parkinson’s disease…
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Novartis’s Brolucizumab Accepted for Review by China’s CDE for Potential DME Treatment
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The Center for Drug Evaluation (CDE) has indicated that Novartis (NYSE: NVS), the Swiss pharmaceutical giant, has had its second market filing for brolucizumab accepted for review. The filing is anticipated to be for the treatment of visual impairment resulting from macular edema associated with diabetes (DME). Brolucizumab, recognized as…
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Pfizer’s Talzenna Combo Shows Improved Survival in mCRPC Patients, According to TALAPRO-2 Study
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Pfizer Inc. (NYSE: PFE) has announced positive topline results regarding overall survival (OS) in the Phase III TALAPRO-2 study for Talzenna (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, when combined with Xtandi (enzalutamide), an androgen receptor pathway inhibitor (ARPI). This combination is used for the treatment of patients with…
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