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Sichuan Biokin’s BL-M08D1 and CSPC’s SYS6010 Eye Breakthrough Therapy Designations in China
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The China’s Center for Drug Evaluation (CDE) website has indicated that China-based Sichuan Biokin Pharmaceutical Co., Ltd’s (SHA: 688506) BL-M08D1 and CSPC Pharmaceutical Group Ltd’s (HKG: 1093) SYS6010 are on track to obtain Breakthrough Therapy Designations (BTDs) from the agency. These designations are for the treatment of recurrent small cell…
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CDE Indicates Priority Review for Boehringer Ingelheim’s Zongertinib and Peers
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The China’s Center for Drug Evaluation (CDE) website has indicated that several drugs, including German giant Boehringer Ingelheim’s (BI) zongertinib, Visirna Therapeutics’ plozasiran, Chia Tai Tianqing’s anlotinib, and HutchMed (China) Ltd’s (HKG: 0013, NASDAQ: HCM) Orpathys (savolitinib), are on course to obtain priority review statuses. Boehringer Ingelheim’s Zongertinib for HER2-Mutated…
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Zelgen Biopharmaceuticals’ ZG005 Gets NMPA Green Light for Solid Tumor and Lymphoma Clinical Trial
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced receiving clinical approval from the National Medical Products Administration (NMPA) to test its Category 1 biologic product, ZG005, in combination with gecaicitinib for the treatment of advanced solid tumors and recurrent refractory lymphomas in China. ZG005: A Pioneering Bispecific Antibody for…
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ProteLight Pharma’s Peceleganan (PL-5) Accepted for Review by China’s CDE
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China’s Center for Drug Evaluation (CDE) website has indicated that a market filing by local firm ProteLight Pharma for its Category 1 product peceleganan (PL-5) has been accepted for review by the bureau. This development follows a licensing deal in January 2023, through which Chia Tai Tianqing obtained the exclusive…
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Bristol-Myers Squibb’s Sotyktu Meets Primary Endpoints in POETYK PsA Studies
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US pharmaceutical major Bristol-Myers Squibb (BMS; NYSE: BMY) has announced positive results from the pivotal Phase III POETYK PsA-1 (IM011-054) and POETYK PsA-2 (IM011-055) studies for its drug Sotyktu (deucravacitinib). These studies assessed the efficacy and safety of Sotyktu in adults with active psoriatic arthritis (PsA). Achievement of Primary and…
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Nuvation Bio’s Taletrectinib NDA for ROS1+ NSCLC Receives FDA Priority Review
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US-based Nuvation Bio Inc. (NYSE: NUVB) has announced that the New Drug Application (NDA) for its investigational next-generation ROS1 tyrosine kinase inhibitor (TKI), taletrectinib, has been accepted for review by the US Food and Drug Administration (FDA) with priority review status. The filing seeks approval for taletrectinib to treat advanced…
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Shanghai Henlius Biotech Initiates Patient Dosing in Global Phase III ELAINE-3 Study for Lasofoxifene
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Shanghai Henlius Biotech Inc., (HKG: 2696), a leading biopharmaceutical company based in China, has announced the first Chinese patient dosing in the global, multi-center Phase III ELAINE-3 study for its investigational drug lasofoxifene. The study focuses on pre/post menopausal women and men with estrogen receptor positive (ER+), human epidermal growth…
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Alphamab Oncology’s JSKN033 Gets Green Light for Phase I/II Study from China’s CDE
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China-based Alphamab Oncology (HKG: 9966) has announced that it has received approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to proceed with a Phase I/II study for its investigational drug, JSKN033. Design and Objectives of the Upcoming Phase I/II StudyThe imminent open, multi-center…
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CSPC Pharmaceutical’s SYH2062 Receives NMPA Clearance for Hypertension Treatment
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China-based CSPC Pharmaceutical Group Co., Ltd. (HKG: 1093) has announced that it has received clinical clearance from China’s National Medical Products Administration (NMPA) for its Category 1 chemical drug, SYH2062. SYH2062: A Novel siRNA Therapy for HypertensionSYH2062 is an N-acetyl-galactosamine (GalNAc)-conjugated small interfering RNA (siRNA) that targets the inhibition of…
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Keymed Biosciences’ Kangyueda Approved for CRSwNP Treatment in China
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China-based Keymed Biosciences Inc., (HKG: 2162) has announced that it has received another indication approval from China’s National Medical Products Administration (NMPA) for its anti-IL-4Rα monoclonal antibody (mAb), Kangyueda (stapokibart), to treat chronic rhinosinusitis with nasal polyposis (CRSwNP). This approval follows the NMPA’s endorsement for moderate to severe atopic dermatitis…
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Sichuan Biokin’s GNC-038 Tetra-Specific Antibody Clears for Clinical Trials in Autoimmune Diseases
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a China-based pharmaceutical company, has announced that it has received approval from China’s National Medical Products Administration (NMPA) to proceed with clinical trials for its innovative tetra-specific antibody, GNC-038. The trials will focus on the treatment of systemic lupus erythematosus and rheumatoid arthritis.…
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Changchun High & New Technology Industries Receives FDA Approval for Menopausal VMS Drug Trial
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China-based Changchun High & New Technology Industries (Group) Inc., (SHE: 000661) has received the green light from the US Food and Drug Administration (FDA) to initiate a Phase II clinical study for its Category 1 chemical drug, GS1-144, in treating menopausal vasomotor symptoms (VMS). Understanding Menopausal Vasomotor Symptoms and the…
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AstraZeneca’s Tagrisso Secures EU Approval for EGFR-Mutated Locally Advanced NSCLC
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UK pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN) has announced that the European Commission (EU) has granted another indication approval for its drug Tagrisso (osimertinib). The approval is for the treatment of adult patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) whose tumors exhibit epidermal growth factor receptor (EGFR)…
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ETERN Therapeutics’ YAP/TEAD Inhibitor ETS-006 Wins FDA Clinical Approval for Advanced Solid Tumors
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China-based biopharmaceutical company ETERN Therapeutics has announced that it has received clinical approval from the US Food and Drug Administration (FDA) for its YAP/TEAD inhibitor, ETS-006, which targets multiple advanced solid tumors. ETS-006: A Promising Oral YAP/TEAD PPI InhibitorETS-006 is an oral YAP/TEAD protein-protein interaction (PPI) inhibitor that has shown…
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Bristol-Myers Squibb’s Opdivo-Yervoy Combo Approved by EC for MSI-H/mCRC
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Global biopharmaceutical company Bristol-Myers Squibb (BMS, NYSE: BMY) has announced that it has received marketing approval from the European Commission (EC) for its combination therapy of Opdivo (nivolumab) and Yervoy (ipilimumab). This treatment is indicated for the first-line treatment of adult patients with microsatellite instability–high (MSI-H) or mismatch repair deficient…
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Roche’s Lunsumio Receives NMPA Approval for R/R Follicular Lymphoma Treatment
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Swiss pharmaceutical giant Roche (SWX: ROG) has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its bispecific antibody (BsAb), Lunsumio (mosunetuzumab). This therapy targets CD20 and CD3 and is designed to treat adult patients with recurrent or refractory follicular lymphoma (R/R FL) who…
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GSK’s Jemperli Combo Shows Improved PFS in Phase III Ovarian Cancer Trial
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UK-based GSK plc (NYSE: GSK) has announced a positive readout from the Phase III FIRST-ENGOT-OV44 trial for Jemperli (dostarlimab), a programmed death-1 (PD-1) inhibitor, when combined with Zejula (niraparib) for the first-line treatment of advanced ovarian cancer. The trial evaluated the addition of Jemperli to the standard of care carboplatin-paclitaxel…
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Pfizer’s Braftovi Receives FDA Approval for Metastatic Colorectal Cancer Treatment
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US-based Pfizer (NYSE: PFE) has announced receiving an indication extension approval from the US Food and Drug Administration (U.S. FDA) for Braftovi (encorafenib) in combination with cetuximab and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation. Braftovi’s Existing…
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Eli Lilly’s Zepbound Receives FDA Approval for Moderate-to-Severe OSA and Obesity
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US pharmaceutical giant Eli Lilly & Co. (NYSE: LLY) has revealed that the US Food and Drug Administration (FDA) has granted another indication approval for its drug Zepbound (tirzepatide), marking it as the first and only prescription medicine for adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity. Zepbound can…
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Novo Nordisk’s Alhemo Receives FDA Approval for Hemophilia A and B Prophylaxis
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Denmark-based Novo Nordisk A/S (NYSE: NVO) has announced that the US Food and Drug Administration (FDA) has granted marketing approval for its Alhemo (concizumab-mtci) injection. The drug is indicated as a once-daily prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients aged 12 years…
