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WuXi Biologics Expands Sterile Filling Capabilities in Germany with New Line
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China’s Contract Research, Development, and Manufacturing Organization (CRDMO) WuXi Biologics (HKG: 2269) has announced plans to establish a new sterile filling line for prefilled syringes (PFS) at its facility in Leverkusen, Germany. This move is set to enhance the company’s drug product (DP) capabilities in the region, optimizing the facility’s…
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Jiangxi Jemincare’s JMX-2002 Liposome Injection Gets NMPA Clinical Clearance
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Jiangxi Jemincare Group, a China-based pharmaceutical company, has announced that it has received clinical clearance from the National Medical Products Administration (NMPA) for its JMX-2002 liposome injection. This innovative drug, known for its high efficiency and safety, is now set to commence clinical studies focusing on solid tumors, including non-small…
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Lion TCR Gains NMPA Approval for mRNA TCR-T Therapy GZL-016 in HCC
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Singapore-based clinical-stage biotechnology company Lion TCR, supported by Chinese investors, has secured tacit clinical approval from the National Medical Products Administration (NMPA) for its innovative therapy GZL-016. This approval marks a significant milestone in the development of mRNA T-cell receptor engineered T-cells (TCR-T) therapy aimed at treating hepatitis B virus-associated…
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Eli Lilly’s Tirzepatide Shows Sustained Weight Loss in 176-Week Study
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US pharmaceutical giant Eli Lilly and Company (NYSE: LLY) has released 176-week follow-up data from its Phase III SURMOUNT-1 study for tirzepatide, marking the longest completed study to date for the dual GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonist. This data provides significant insights into the drug’s…
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ImmuneOnco Initiates Phase II Study for IMM27M in ER+ Advanced Breast Cancer
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541), a leading biopharmaceutical company specializing in immuno-oncology, has announced the commencement of a Phase II clinical study for its investigational drug, IMM27M, targeting estrogen receptor positive (ER+) advanced breast cancer following endocrine therapy failure or recurrence. This announcement coincides with the enrollment of…
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Huadong Medicine’s Biosimilar SaiLeXin Receives First National Prescription in China
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China-based pharmaceutical company Huadong Medicine Co., Ltd (SHE: 000963) has announced a significant milestone with the issuance of the first national prescription for its biosimilar drug, SaiLeXin, at the Peking University People’s Hospital. This marks a new chapter in the treatment of autoimmune diseases in China, offering patients an alternative…
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Novartis’ Pluvicto Accepted for Review by China’s NMPA for Prostate Cancer Treatment
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The Center for Drug Evaluation (CDE) under China’s National Medical Products Administration (NMPA) has accepted a marketing approval filing from Swiss pharmaceutical giant Novartis (NYSE: NVS) for its radioligand therapy (RLT), Pluvicto (177Lu vipivotide tetraxetan). This acceptance marks a significant step towards making this innovative treatment available to patients in…
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Daiichi Sankyo and AstraZeneca File BLA for Datopotamab Deruxtecan in NSCLC
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Daiichi Sankyo (TYO: 4568) and AstraZeneca (AZ, NASDAQ: AZN), partners in the development of innovative oncology treatments, have jointly announced the submission of a Biologic License Application (BLA) to the US Food and Drug Administration (FDA) for their co-developed TROP-2-targeted antibody drug conjugate (ADC), datopotamab deruxtecan (Dato-DXd). This application seeks…
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CSPC Pharmaceutical Gains NMPA Approval for Clinical Trial of mRNA Vaccine SYS6026
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its therapeutic bivalent mRNA vaccine, SYS6026. This vaccine is indicated for the treatment of precancerous lesions caused by human papillomavirus (HPV) types 16 or 18. Vaccine…
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Gan & Lee’s GZR18 Shows Significant Weight Loss in Phase IIb Study at ObesityWeek 2024
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Gan & Lee Pharmaceuticals (SHA: 603087), a China-based pharmaceutical company, has announced the oral presentation of results from the Phase IIb study for its glucagon-like peptide-1 (GLP-1) receptor agonist, GZR18, at ObesityWeek 2024. The drug is administered once per week and targets the obese or overweight Chinese population. Study Design…
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J&J’s Nipocalimab Receives FDA Breakthrough Therapy Designation for Sjögren’s Disease
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US-based pharmaceutical giant Johnson & Johnson (J&J, NYSE: JNJ) has announced that it has received Breakthrough Therapy Designation (BTD) from the US Food and Drug Administration (FDA) for its investigational drug nipocalimab. The designation is for the treatment of moderate-to-severe Sjögren’s disease (SjD), a chronic autoantibody disease with a high…
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Zai Lab and argenx Receive NMPA Approval for Vygart Hytrulo in Chronic Inflammatory Demyelinating Polyneuropathy
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China-based biotech Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688) and its US partner argenx SE (NASDAQ: ARGX) have announced the receipt of supplementary Biologic License Application (sBLA) approval from the National Medical Products Administration (NMPA) for Vygart Hytrulo (efgartigimod alfa subcutaneous injection; SC). This approval allows Vygart Hytrulo to be…
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Cutia Therapeutics’ CU-10201 Receives NMPA Approval for Acne Vulgaris Treatment
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Cutia Therapeutics (HKG: 2487), a developer of dermatology therapies, has announced that its CU-10201, a 4% minocycline foam agent for external use, has received market approval from the National Medical Products Administration (NMPA) in China. The approval is for the treatment of non-nodular moderate to severe acne vulgaris in individuals…
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BeyondSpring Presents Positive Phase II Data for Plinabulin Combination Therapy in NSCLC at SITC
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BeyondSpring Inc. (NASDAQ: BYSI), a US-based biotech company, has announced the presentation of the latest results from the Phase II KeyPelms-004 study at the 39th Society for Immunotherapy of Cancer’s (SITC) Annual Meeting. The study evaluated the efficacy and safety of plinabulin combined with pembrolizumab plus docetaxel in patients with…
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Abbisko Therapeutics’ Pimicotinib Meets Primary Endpoint in Phase III MANEUVER Study for TGCT
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hanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has revealed positive top-line results from the pivotal Phase III MANEUVER study for its drug candidate ABSK021 (pimicotinib) in tendon sheath giant cell tumor (TGCT). The study, designed to assess the efficacy and safety of pimicotinib in TGCT patients suitable for systemic…
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ETERN Therapeutics’ ETS-006 Receives FDA Orphan Drug Designation for Pleural Mesothelioma
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ETERN Therapeutics, a Shanghai-based developer of small-molecule anti-tumor drugs, has announced that it has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its compound ETS-006. The designation is for the treatment of pleural mesothelioma (PM), a rare and aggressive form of cancer. Development and…
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Frontera Therapeutics Receives FDA Approval for Phase II Study of FT-003 in nAMD
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Frontera Therapeutics, Inc., a Sino-US biopharmaceutical company, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase II clinical study for its investigational drug FT-003. This recombinant adeno-associated virus (rAAV) gene therapy is designed for the treatment of neovascular age-related macular…
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Alteogen Secures Exclusive Licensing Deal with Daiichi Sankyo for Subcutaneous Enhertu
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Alteogen Inc. (KOSDAQ: 196170), a South Korea-based biotechnology company, has announced an exclusive licensing agreement with Japan-headquartered Daiichi Sankyo (TYO: 4568). This strategic partnership grants Daiichi Sankyo worldwide rights to utilize Alteogen’s ALT-B4, a novel hyaluronidase based on Hybrozyme Technology, in the development and commercialization of a subcutaneous version of…
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AstraZeneca’s Tezspire Meets Phase III Co-Primary Endpoints in CRSwNP Study
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AstraZeneca Inc., (AZ, NASDAQ: AZN), a leading UK pharmaceutical company, has announced positive high-level results from the Phase III WAYPOINT study for Tezspire (tezepelumab) in patients with chronic rhinosinusitis with nasal polyps (CRSwNP). The drug, a thymic stromal lymphopoietin (TSLP)-targeted monoclonal antibody (mAb) co-developed with US firm Amgen (NASDAQ: AMGN),…
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Jiangsu Kanion Pharmaceutical Gets FDA Approval to Test KYS202004A for Psoriasis
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Jiangsu Kanion Pharmaceutical Co., Ltd (SHA: 600557), a Chinese pharmaceutical company, has announced that it has received approval from the US Food and Drug Administration (FDA) to initiate a clinical study for its pipeline candidate, KYS202004A, in the treatment of psoriasis. KYS202004A: A Dual-Targeted Fusion Protein for PsoriasisKYS202004A is an…
