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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…
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Sichuan Biokin Re-submits IPO Application to Hong Kong Stock Exchange
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) has announced that it has resubmitted its application for an initial public offering (IPO) to the Hong Kong Stock Exchange. The company also published the application documents on the exchange’s website on the same day. This move follows the expiration of its previous…
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Acotec’s Vericor-S2 Coronary Microcatheter Approved by NMPA
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Acotec Scientific Holdings Ltd (HKG: 6669) has announced that its Vericor-S2 coronary microcatheter has received registration approval from the National Medical Products Administration (NMPA). The product is designed for use in percutaneous coronary interventions, specifically for guiding guidewires through narrow vessel lesions and providing a channel for saline or contrast…
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Lepu Biopharma Licenses Potential Best-in-Class ADC MRG007 to ArriVent
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Lepu Biopharma Co., Ltd (HKG: 2157) has announced an exclusive licensing agreement with ArriVent BioPharma, Inc. (NASDAQ: AVBP) for MRG007, a potential best-in-class antibody-drug conjugate (ADC) targeting gastrointestinal (GI) cancers. This partnership aims to advance the development and commercialization of MRG007 globally, excluding Greater China. Agreement DetailsUnder the terms of…
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NMPA Approves Synaptic Medical’s Cryoablation Device and Gene Methylation Detection Kit
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China’s National Medical Products Administration (NMPA) has granted marketing approval for two new medical devices: Synaptic Medical’s cryoablation device and Wuhan Kadwise Biotechnology Co., Ltd’s human CDO1/AJAP1/GALR1 gene methylation detection kit (fluorescence PCR method). These approvals highlight advancements in treating atrial fibrillation and diagnosing endometrial cancer. Cryoablation Device for Atrial…
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Huadong Medicine’s MediBeacon TGFR System Receives FDA Marketing Clearance
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced receiving marketing clearance from the US Food and Drug Administration (FDA) for its MediBeacon Transdermal GFR System (TGFR), a medical device co-developed with US partner MediBeacon Inc. The system is designed to evaluate renal function in adult patients with both impaired…
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MediLink’s YL201 Receives Breakthrough Therapy Designation for Nasopharyngeal Carcinoma
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Suzhou-based biotech MediLink Therapeutics (Suzhou) Co., Ltd has announced receiving another breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for its antibody drug conjugate (ADC) YL201. The designation is for the treatment of recurrent/metastatic nasopharyngeal carcinoma (R/M NPC), following the…
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Jiangsu Lianhuan Completes Enrollment for Phase III Study of LH-1801 in Type 2 Diabetes
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China-based Jiangsu Lianhuan Pharmaceutical Co., Ltd (SHA: 600513) has announced the completion of subject enrollment for the Phase III clinical study of its Category 1 drug LH-1801, in combination with metformin. The study aims to evaluate the efficacy and safety of LH-1801 in treating type 2 diabetes, building on its…
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Arrowhead’s Plozasiran Accepted for FDA Review in Familial Chylomicronemia Syndrome
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US-based Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) has announced that the New Drug Application (NDA) for its plozasiran, targeting familial chylomicronemia syndrome (FCS), has been accepted for review by the US Food and Drug Administration (FDA). The Prescription Drug User Fee Act (PDUFA) target date for the review is set for…
