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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…
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CStone Pharmaceuticals Initiates First-in-Human Trial for PD-1/VEGF/CTLA-4 Trispecific Antibody CS2009
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China-based CStone Pharmaceuticals (HKG: 2616) has announced the clinical filing for its CS2009, a PD-1/VEGF/CTLA-4 trispecific antibody, in Australia. This first-in-human study is registered and published on Clinicaltrials.gov with the NCT number: NCT06741644. Innovative Design and Mechanism of CS2009CS2009 boasts an innovative molecular design that simultaneously targets PD-1, VEGFA, and…
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Yifan Pharmaceutical’s Evive Biotech Receives ANVISA Approval for Ryzneuta
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China-based Yifan Pharmaceutical Co., Ltd (SHE: 002019) has announced that its subsidiary, Evive Biotech Ltd, has received marketing approval from the Brazil National Health Surveillance Agency (ANVISA) for Ryzneuta (efbemalenograstim alfa, F-627). This approval follows previous marketing nods in China, the United States, and the European Union. Ryzneuta (F-627): A…
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Changchun BCHT Biotechnology Receives NMPA Approval for HSV-2 mRNA Vaccine LVRNA101
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Changchun BCHT Biotechnology Co., Ltd (SHA: 688276), a China-based biotechnology company, has announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its mRNA vaccine, LVRNA101. The vaccine is designed to prevent genital herpes caused by herpes simplex virus type 2 (HSV-2) infection. HSV-2 and the Need…
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Shenzhen Chipscreen Biosciences Gets NMPA Approval for CS231295 Solid Tumor Study
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Shenzhen Chipscreen Biosciences Co., Ltd (SHA: 688321), a China-based biopharmaceutical company, has announced receiving the go-ahead from the National Medical Products Administration (NMPA) to conduct a clinical study for its drug candidate CS231295 in advanced solid tumors. CS231295: A Promising Multi-Target InhibitorCS231295 is a multi-target protein kinase inhibitor that has…
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Jiangsu Hengrui Pharmaceuticals Gets NMPA Approval to Test SHR-1681 in Clinical Trials
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with clinical testing of its Category 1 biologic product, SHR-1681. Novel Biologic Product SHR-1681The product, SHR-1681, is designed to specifically bind to antigens present on the surface…
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CSPC Pharmaceutical’s SYH9017 Receives NMPA Clearance for Weight Management Clinical Trial
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China-based CSPC Pharmaceutical Group Co., Ltd. (HKG: 1093) has announced clinical clearance from the National Medical Products Administration (NMPA) for its SYH9017, a biosimilar version of Denmark-based Novo Nordisk’s (NYSE: NVO) weight loss drug semaglutide (Ozempic/Wegovy). The clearance allows SYH9017 to proceed to clinical trials focused on weight management for…
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CSPC Pharmaceutical Group Receives NMPA Approval for Two Antibody-Drug Conjugates
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China-based CSPC Pharmaceutical Group Co., Ltd. (HKG: 1093) has announced that it has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for its antibody drug conjugates (ADCs), SYS6005 and SYS6043. Pre-Clinical Success and Potential ApplicationsBoth SYS6005 and SYS6043, classified as Category 1 biologic products with undisclosed…
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CanSino Biologics Initiates Phase I/II Study for CS-2036 Polio Vaccine with Gates Foundation Support
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CanSino Biologics (SHA: 688185, HKG: 6185) has announced the initiation of a Phase I/II study for its CS-2036, a recombinant polio vaccine, in Indonesia with financial support from the Bill & Melinda Gates Foundation. This development is accompanied by the first subject enrollment in the Phase I trial. Additionally, the…
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Innovent Biologics’ Taletrectinib Wins NMPA Approval for ROS1+ NSCLC Treatment
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China-based Innovent Biologics, Inc. (HKG: 1801) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its taletrectinib, a second-generation ROS1 tyrosine kinase inhibitor. The drug is now approved for use in treating adult patients with ROS1 positive locally advanced or metastatic non-small cell lung cancer (NSCLC)…
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YolTech Therapeutics’ YOLT-201 Advances in ATTR Treatment Clinical Trial
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Shanghai, China, December 21, 2024 — YolTech Therapeutics today announced that its proprietary in vivo gene-editing drug, YOLT-201, has successfully completed the dose-escalation phase in Phase I clinical trials for the treatment of transthyretin amyloidosis (ATTR) and is set to enter the dose-expansion phase. YOLT-201: A Novel Gene-Editing Therapy for…
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Roche’s Prasinezumab Shows Promise in Phase IIb PADOVA Study for Early-Stage Parkinson’s Disease
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Swiss pharmaceutical giant Roche (SWX: ROG) has published results from the Phase IIb PADOVA study for its investigational monoclonal antibody, prasinezumab, in patients with early-stage Parkinson’s disease (PD). The study aimed to assess the drug’s impact on the primary endpoint of time to confirmed motor progression, with a hazard ratio…
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Sichuan Kelun-Biotech Launches Sacituzumab Tirumotecan for Triple Negative Breast Cancer in China
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China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced the commercial launch of its sacituzumab tirumotecan (SKB264/MK-2870) in China, marking a significant milestone in the treatment of adult patients with unresectable locally advanced or metastatic triple negative breast cancer (TNBC) who have been previously treated with at least two…
