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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 Pharmaceuticals 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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Teva Pharmaceutical Reaches Settlement with DOJ Over Alleged Kickbacks and Price-Fixing
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Teva Pharmaceutical Industries Ltd (NYSE: TEVA), headquartered in Israel, has entered into a settlement agreement with the U.S. Department of Justice (DOJ) to resolve allegations of misconduct related to its multiple sclerosis (MS) therapy, Copaxone. The DOJ had filed a lawsuit in August 2020, accusing Teva of violating the Anti-Kickback…
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CSPC Pharma Initiates Phase III Trial for JMT101 in First-Line EGFR-Positive NSCLC Treatment
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has initiated a Phase III clinical study for its Category 1 drug JMT101. This study combines JMT101 with osimertinib (Tagrisso) and compares it against osimertinib alone in the first-line treatment of locally advanced or metastatic epidermal growth…
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KangaBio’s KGX101 Receives NMPA Approval for Clinical Trial in China
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KangaBio, a biopharmaceutical company based in Shanghai, has announced that its investigational new drug (IND) application for KGX101 has received clinical trial approval from the China National Medical Products Administration (NMPA). This Class 1 new drug, an IL-12 Fc fusion protein injection, is expected to be used for the treatment…
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Johnson & Johnson’s KLK2-CD3 Bispecific Antibody JNJ-78278343 Advances in Prostate Cancer Clinical Trials
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JNJ-78278343, a KLK2-CD3 bispecific antibody, is currently in Phase I clinical trials globally. According to data released by Johnson & Johnson (J&J, NYSE: JNJ), this drug targets kallikrein-related peptidase 2 (KLK2), an antigen highly expressed in prostate cancer, and binds to CD3 on T cells to activate them, inducing an…
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Merck KGaA’s Pergoveris Treatment Expands Access to Advanced Reproductive Care in Greater Bay Area
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Merck KGaA (MRK, NYSE: MRK) , a leading science and technology company based in Germany, has announced the availability of its ovulation-stimulating treatment Pergoveris in the Guangdong–Hong Kong–Macao Greater Bay Area. The treatment, which combines recombinant human follicle stimulating hormone (r-hFSH) and recombinant human luteinizing hormone (r-hLH), has been approved…
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Junshi Biosciences’ Ongericimab Wins NMPA Nod for Hypercholesterolemia Treatment
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Junshi Biosciences (HKG: 1877; SHA: 688180), a leading biopharmaceutical company in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its PCSK9 monoclonal antibody, ongericimab (JS002). This therapy is now approved for use in combination with statins or statins plus ezetimibe for…
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WuXi AppTec Addresses Media Speculation on Potential Sale of WuXi ATU
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WuXi AppTec Co., Ltd (SHA: 603259, HKG: 2359, OTCMKTS: WUXAY), a leading China-based Contract Development and Manufacturing Organization (CDMO), has issued a statement addressing media speculations about the potential sale of its cell and gene therapy segment, WuXi Advanced Therapies (WuXi ATU). The company clarified that no decision has been…
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Juventas Cell Therapy’s CAR-T Therapy Clears for SLE-ITP Study in China
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The China Center for Drug Evaluation (CDE) has given the green light for a study on inaticabtagene autoleucel (CNCT 19), a chimeric antigen receptor (CAR)-T cell therapy developed by Juventas Cell Therapy Ltd, a Chinese firm. This therapy is now approved for research in refractory systemic lupus erythematosus-associated immune thrombocytopenia…
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Sanofi Commences Negotiations with CD&R for Potential Sale of Opella Stake
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Sanofi (EPA: SAN; NASDAQ: SNY) has initiated negotiations with private equity firm CD&R for the potential sale of a 50% controlling stake in Opella, its consumer healthcare business, marking a significant milestone in the French pharmaceutical giant’s strategic realignment. While no decision has been finalized, Sanofi will provide further updates…
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SAMR Proposes Guidelines to Curb Commercial Bribery in Pharmaceutical Industry
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The State Administration for Market Regulation (SAMR) has unveiled the “Guidelines for Compliance of Pharmaceutical Enterprises in Preventing Commercial Bribery Risks (draft proposal),” marking a significant step towards transparency and ethical business practices within the pharmaceutical industry. The public is invited to provide feedback on the draft until October 20.…
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JD Healthcare and Genrix Bio Join Forces to Revolutionize Patient Care and Pharmacy Services
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JD Healthcare, a subsidiary of China’s e-commerce juggernaut JD.com (NASDAQ: JD), has formed a strategic partnership with Chongqing Genrix Biopharmaceutical Co., Ltd. This alliance combines Genrix Biopharmaceutical’s prowess in drug research and development with JD Healthcare’s extensive resource and ecological advantages in medical treatment, medication, health management, and insurance. Together,…
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Guangdong Province Aims for RMB One Trillion in Biopharma Industry Growth by 2027
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The People’s Government of Guangdong Province has unveiled an ambitious “Action Plan for Further Promoting the High Quality Development of the Biomedical Industry in Guangdong,” with the aim of expanding the province’s biopharmaceutical and health industry cluster to a scale exceeding RMB one trillion (USD 141.43 billion) by 2027. The…
