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YolTech Initiates Study for YOLT-204 in Transfusion-Dependent Beta-Thalassemia
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Shanghai-based YolTech Therapeutics, a biotech startup specializing in lipid nanoparticle delivery and gene editing, has announced the initiation of a dosage escalation study to preliminarily assess the safety and efficacy of a single-dose regimen with YOLT-204 in transfusion-dependent beta-thalassemia (TDT). This marks a significant step forward in the development of…
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Haichang Bio’s siRNA Drug HC016 Cleared for US Clinical Trials
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China-based Zhejiang Haichang Biotech Co., Ltd has announced that its siRNA drug, HC016 complex lipid, has been cleared by the US Food and Drug Administration (FDA) for clinical trials. This marks a significant milestone in the development of innovative treatments for solid tumors, leveraging Haichang Bio’s proprietary QTsome technology platform.…
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iMBIORAY Raises RMB 100 Million in Series A+ for NK Cell Therapies
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Hangzhou-based cell therapy specialist iMBIORAY has reportedly raised close to RMB 100 million (USD 13.7 million) in a Series A+ financing round. The round was led by Sinowisdom, with contributions from Tailong VC, HY Capital, and other investors. The proceeds will be used to advance the clinical development of universal…
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Abbott Labs Posts Q4 Growth, Projects Strong 2025 Outlook
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US-based Abbott Laboratories (NYSE: ABT) has released its Q4 2024 financial results, reporting an 8.8% increase in organic sales to USD 10.974 billion. Excluding COVID-19 testing-related sales, the company achieved a 10.1% growth rate. For the full year, Abbott generated USD 42.0 billion in revenues, up 7.1% on an organic…
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Shenzhen TargetRx Raises $50M in Series C Financing for Global Clinical Trials
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China-based Shenzhen TargetRx, Inc., a developer of small-molecule kinase inhibitors, has announced the completion of a Series C financing round, raising USD 50 million. The funds will be used to advance overseas clinical studies for multiple innovative drugs, positioning the company for global expansion. Company Background and PipelineFounded in 2014,…
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Haisco’s HSK44459 Approved for Clinical Trials in Behcet’s Disease
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China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its investigational product HSK44459 in Behcet’s disease. This rare disease is listed in China’s second catalogue of rare diseases, highlighting the significant unmet medical need it represents. Behcet’s…
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Fosun’s Plan to Take Henlius Private Fails After Shareholder Vote
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that its plan to take its subsidiary Shanghai Henlius Biotech Inc. (HKG: 2696) private has fallen through after the shareholder vote did not pass in accordance with the terms. As a result, the listing of Henlius’ H Shares…
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Belief BioMed’s BBM-D101 Receives FDA Approval for DMD Clinical Trial
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China-based gene therapy specialist Belief BioMed Inc. (BBM) has announced receiving clinical trial approval from the US Food and Drug Administration (FDA) for its BBM-D101. An open, single-dose clinical study is scheduled to commence, assessing the safety and efficacy of the gene therapy in boys aged 4 to 9 with…
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Roche’s cobas liat STI Assay Panels Gain FDA Approval and CLIA Waiver
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Swiss pharmaceutical giant Roche (SWX: ROG, OTCMKTS: RHHBY) has announced receiving approval from the US Food and Drug Administration (FDA) and a Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver for its cobas liat sexually transmitted infection (STI) multiplex assay panels. This marks a significant advancement in rapid diagnostic capabilities…
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United Laboratories’ UBT251 Approved for Phase II Trials in Chronic Kidney Disease
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Hong Kong-based United Laboratories International Holdings Ltd (HKG: 3933) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct Phase II clinical trials for its Category 1 drug UBT251 in chronic kidney disease (CKD). This marks a significant step forward in the development of innovative therapies for…
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Sanofi’s Sarclisa Approved in EU for Newly Diagnosed Multiple Myeloma
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France-based Sanofi (EPA: SAN, NASDAQ: SNY) has announced receiving marketing approval in the European Union (EU) for its CD38 monoclonal antibody (mAb) Sarclisa (isatuximab) in combination with the standard-of-care regimen of bortezomib, lenalidomide, and dexamethasone (VRd). The approval is for the treatment of adult patients with newly diagnosed multiple myeloma…
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Eli Lilly and Merck Launch Consortium for Innovative Drug Manufacturing
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US-based Eli Lilly and Company (NYSE: LLY) and Merck & Co. Inc. (NYSE: MRK) have announced the launch of the Young Institute Pharmaceutical Manufacturing Consortium in collaboration with Purdue University. The initiative aims to develop new methods of drug manufacturing, driving technological innovation in the pharmaceutical industry. Consortium Focus and…
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Akeso Biopharma Receives Development Payment for PD-L1 Monoclonal Antibody
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China-based Akeso Biopharma (HKG: 9926) has announced receiving a drug collaboration development payment from compatriot firm Kelun Pharmaceutical Research Institute, following the National Medical Products Administration’s (NMPA) approval of its programmed death ligand 1 (PD-L1) monoclonal antibody (mAb) tagitanlimab last month. Collaboration BackgroundAkeso entered into a collaboration agreement with Kelun…
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Shanghai Bao Pharmaceuticals Launches IPO to Advance Biopharmaceutical Pipeline
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China-based Shanghai Bao Pharmaceuticals Co., Ltd., a high-end biopharmaceuticals developer, has announced its initial public offering (IPO). Specific details regarding the unit price and other IPO particulars have not been disclosed at this stage. Company Background and PipelineSince its inception in 2019, Bao Pharma has focused on improving treatment standards…
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Degron Therapeutics Secures $20M Series A+ for Molecular Glue Drug Development
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China-based Degron Therapeutics, a specialist in molecular glue-based drugs, has reportedly raised over USD 20 million in a Series A+ financing round last month. The round was supported by investors including the Zhejiang Province “4+1” Biomedical and High-End Equipment Industry Fund, Takeda Ventures, Fontus Capital, Longmen Capital, HaoYue China Healthcare…
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FDA Lifts Clinical Hold on Sanofi’s Cialis Over-the-Counter Trial
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France-based Sanofi’s (NASDAQ: SNY, EPA: SAN) Consumer Healthcare unit Opella has announced that the US FDA has lifted a clinical hold on its planned Actual Use Trial (AUT) for Cialis (tadalafil). This move allows Sanofi to initiate the AUT and potentially switch the PDE5 inhibitor from a prescription to an…
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Johnson & Johnson’s Spravato Approved as Monotherapy for Major Depressive Disorder
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US-based Johnson & Johnson (J&J; NYSE: JNJ) has announced that its Spravato (esketamine) CIII nasal spray has received clearance from the US Food and Drug Administration (FDA) as the first and only monotherapy for adults with major depressive disorder (MDD) who have had an inadequate response to at least two…
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CD Biopharma Initiates Phase I Trial for CD-001 in Advanced Solid Tumors
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Suzhou-based tumor immunotherapy specialist CD Biopharma has announced the first subject dosing of a Phase I study for its novel anti-tumor drug CD-001 in patients with advanced solid tumors. The patient is reported to be stable with all indicators being normal. This milestone marks the beginning of clinical evaluation for…
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Kehua Bioengineering Gains NMPA Approval for Gene Polymorphism Detection Kits
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China-based Shanghai Kehua Bioengineering Co., Ltd (SHE: 002022) has announced receiving marketing approvals from the National Medical Products Administration (NMPA) for its human CYP2C9 gene polymorphism detection kit and human VKORC1 gene polymorphism detection kit, both utilizing the fluorescence PCR method. These approvals mark a significant advancement in personalized medicine,…
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Humanwell’s HWH340 Receives Clinical Approval for Prostate Cancer Treatment
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Humanwell Healthcare (Group) Co., Ltd (SHA: 600079) has announced that its Class 1 chemical drug HWH340 has received clinical approval from the National Medical Products Administration (NMPA). The drug is indicated for use in combination with abiraterone acetate for the treatment of advanced prostate cancer. This approval marks a significant…
