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Henlius Biotech’s HLX13 Biosimilar Gets NMPA Approval for Liver Cancer Clinical Trial
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Shanghai Henlius Biotech, Inc (HKG: 2696) has announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its HLX13, a biosimilar of US major Bristol-Myers Squibb’s (BMS, NYSE: BMY) Yervoy (ipilimumab), for the treatment of liver cancer. HLX13: A CTLA-4 Monoclonal Antibody for Cancer TreatmentsHLX13 is a…
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Chia Tai Tianqing Launches First Batch of F-627 for Neutropenia Treatment in China
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China-based Chia Tai Tianqing has announced the first batch prescriptions in China for its efbemalenograstim alfa (F-627), an in-house developed long-acting recombinant human granulocyte colony stimulating factor (rhGCSF)-Fc fusion protein. The drug is indicated for the prevention and treatment of neutropenia during chemotherapy in cancer patients. F-627 received marketing approval…
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Jiangsu Kanion Pharmaceutical Gets FDA Approval for KYS202002A Clinical Study in Multiple Myeloma
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China-based Jiangsu Kanion Pharmaceutical Co., Ltd (SHA: 600557) has announced receiving the green light from the US Food and Drug Administration (FDA) to conduct a clinical study for its pipeline candidate KYS202002A, focusing on recurrent/refractory multiple myeloma (R/R MM). This follows the molecule’s approval for clinical trials in China in…
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Jiangsu Hengrui’s Dalpiciclib Approved for Initial Therapy in HR+, HER2- Breast Cancer
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced receiving another indication approval for its drug dalpiciclib (SHR6390). The approval is for use as an initial therapy combined with an aromatase inhibitor for patients with hormone receptor (HR) positive, human epidermal growth factor…
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Fosun Kite’s Yescarta Gains NMPA Approval for Refractory Large B-Cell Lymphoma
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China-based Fosun Kite Biotechnology Co., Ltd, a joint venture between Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196; HKG: 2196) and Gilead (NASDAQ: GILD) subsidiary Kite Pharma, has announced that its product Yescarta (axicabtagene ciloleucel) has obtained marketing approval from the National Medical Products Administration (NMPA) for a new indication…
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CANbridge Pharmaceuticals Reports Positive Phase Ib Results for Omoprubart in PNH Treatment
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China-based rare disease firm CANbridge Pharmaceuticals Inc., (HKG: 1228) has published the preliminary results of a Phase Ib clinical study for its pipeline drug candidate omoprubart (CAN106), a long-acting monoclonal antibody (mAb) targeting C5 of the complement system. The drug candidate is under development as a potential treatment for paroxysmal…
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Haisco Pharmaceutical’s HSK31679 Receives Clinical Trial Approval for NASH Treatment
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China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced that its in-house developed Category 1 drug candidate, HSK31679, has obtained clinical trial approval for the treatment of non-alcoholic steatohepatitis (NASH). HSK31679: A Selective THR-β Agonist for Lipid MetabolismHSK31679 is a highly selective thyroid hormone β receptor (THR-β) agonist that…
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NMPA Approves XZenith Biopharm’s Anaprazole for Duodenal Ulcer Treatment
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The National Medical Product Administration (NMPA) has granted marketing approval for anaprazole, a proton pump inhibitor (PPI) developed by China-based XZenith Biopharm. This home-grown Category 1 drug is now approved for use in treating duodenal ulcers. Anaprazole’s Mechanism of Action and Clinical AdvantagesAnaprazole, a benzimidazole compound, functions by inhibiting gastric…
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Sichuan Kelun’s SKB264 Earns Breakthrough Therapy Designation for Breast Cancer Treatment
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The Center for Drug Evaluation (CDE) website has indicated that China-based Sichuan Kelun Pharmaceutical Co., Ltd’s (SHE: 002422) antibody-drug conjugate (ADC) SKB264, targeting trophoblast cell-surface antigen 2 (TROP2), has obtained breakthrough therapy designation (BTD) status. This designation is for use in locally advanced or metastatic hormone receptor positive and HER2…
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Innovent Biologics and RemeGen Partner on Clinical Study for PD-1 Inhibitor and ADC Drugs
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China-based Innovent Biologics Inc., (HKG: 1801) has entered into a clinical study and supply cooperation agreement with compatriot firm RemeGen (HKG: 9995). The collaboration will pair Innovent’s programmed death-1 (PD-1) inhibitor Tyvyt (sintilimab injection) with RemeGen’s antibody drug conjugate (ADC) drug candidates RC88 and RC108 in a clinical study. Clinical…
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Sino-Cuban JV Biotech Pharmaceutical Receives NMPA Approval for Nimotuzumab in Pancreatic Cancer
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Sino-Cuban joint venture (JV) Biotech Pharmaceutical Limited (BPL) announced last week that it has received an indication extension from China’s National Medical Products Administration (NMPA) for its biologic drug nimotuzumab. This new approval marks an expansion of the drug’s use beyond its original authorization in nasopharyngeal carcinoma (NPC) to now…
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Sarepta Therapeutics’ Elevidys Receives FDA Accelerated Approval for Duchenne Muscular Dystrophy
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US-based Sarepta Therapeutics, Inc. (NASDAQ: SRPT) has announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Elevidys (delandistrogene moxeparvovec-rokl), an adeno-associated virus-based gene therapy co-developed by Roche. This treatment is designed for ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD)…
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S-Evans Biosciences Receives NMPA Tacit Approval for Stem Cell Therapy in ARDS
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S-Evans Biosciences, a stem cell specialist based in Hangzhou, has obtained tacit clinical trial approval from the National Medical Products Administration (NMPA) for its “human umbilical cord mesenchymal stem cell injection” in the treatment of moderate to severe acute respiratory distress syndrome (ARDS). Product Development and ARDS OverviewThe in-house developed…
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Hopstem Biotechnology’s hNPC01 Receives Tacit Approval for Stroke Sequelae Treatment from CDE
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Hopstem Biotechnology Co., Ltd, a neural stem cell specialist founded by neuroscientists and stem-cell biologists from Johns Hopkins University, has announced receiving tacit clinical trial approval from China’s Center for Drug Evaluation (CDE) for its hNPC01. This induced pluripotent stem cells (iPSC) derived cell therapy is intended for the treatment…
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CDE Releases Guidelines for Clinical Trials of Stem Cell Therapies and Derived Products
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The Center for Drug Evaluation (CDE) has released a set of “Guidelines for Clinical Trial Techniques for Human-Derived Stem Cells and Derived Cell Therapy Products,” which are now in immediate effect. These guidelines focus on clinical trials for stem cell-related products that are potential candidates for product approval, distinguishing them…
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Sciwind Biosciences Leads China’s Anti-Obesity Drug Market with GLP-1 Analog Ecnoglutide
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Sino-US biotech Sciwind Biosciences Co., Ltd has positioned itself as a frontrunner in China’s race to market anti-obesity drugs. The company made a significant impact at the American Diabetes Association (ADA) conference with three poster presentations, including a late-breaking presentation, highlighting its glucagon-like peptide-1 (GLP-1) analog, ecnoglutide (XW003). Ecnoglutide: An…
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CDE Releases Draft Guidelines for Antibody Drug Conjugate Research and Evaluation
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The Center for Drug Evaluation (CDE) has released a draft set of “Guiding Principles for Pharmaceutical Research and Evaluation of Antibody Drug Conjugates” and is soliciting public feedback until July 21, 2023. The document primarily addresses the technical requirements during the market approval filing stage for antibody drug conjugate (ADC)…
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Jiangsu Hengrui’s Camrelizumab Earns Full Approval for Advanced Hepatocellular Carcinoma in China
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China-based Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced the transition of its programmed death-1 (PD-1) monoclonal antibody (mAb) camrelizumab from conditional approval to full approval for the treatment of advanced hepatocellular carcinoma (HCC) in patients previously treated with sorafenib or chemotherapy. Camrelizumab’s Approval History and IndicationsCamrelizumab, which received first approval…
