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Sinocelltech Group Receives NMPA Approval for SCTT11 Clinical Study in Thyroid Eye Disease
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China-based Sinocelltech Group Ltd (SHA: 688520) has announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its SCTT11 therapy in thyroid eye disease (TED). This marks a significant step forward in addressing a complex autoimmune condition closely linked to thyroid disorders. Understanding Thyroid…
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Johnson & Johnson Terminate Phase III VENTURA Program for Aticaprant in adjunctive treatment of MDD
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US giant Johnson & Johnson (J&J; NYSE: JNJ) announced the termination of the Phase III VENTURA development program assessing aticaprant as an adjunctive treatment for major depressive disorder (aMDD). The decision was influenced by the insufficient efficacy of aticaprant in the target population. Safety and Future ExplorationWhile the data confirmed…
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Gan & Lee Pharmaceuticals Joins Brazil’s PDP for Localized Insulin Production
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China-based Gan & Lee Pharmaceuticals (SHA: 603087) announced receiving a financial pledge of BRL130 million (USD23 million) from the Brazilian government as part of the Parcerias para o Desenvolvimento Produtivo (PDP). This initiative, co-promoted by domestic companies in Brazil and Brazilian Ministry of Health affiliated enterprises, aims to secure the…
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Insilico Medicine’s AI-Discovered Drug Rentosertib Approved for Clinical Trials
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China’s generative artificial intelligence (AI)-driven biotech Insilico Medicine announced approval by the United States Adopted Names (USAN) Council to name its ISM001-055 as rentosertib. This groundbreaking drug candidate for idiopathic pulmonary fibrosis (IPF) represents a milestone in AI-driven drug discovery. Rentosertib’s Development and Clinical ResultsRentosertib is the world’s first drug…
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4C Medical Lands $175M Series D to Advance AltaValve TMVR System
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US-based 4C Medical Technologies, Inc., a medical device company controlled by China-based MicroPort CardioFlow Medtech Co., Ltd (HKG: 2160), announced the completion of a $175 million Series D financing round. The funding, led by Boston Scientific Corporation, will accelerate clinical development and commercialization of 4C Medical’s AltaValve System, a next-generation…
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Merck KGaA Reports 2024 Revenue Growth Despite Challenges in Life Sciences
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German major Merck KGaA (ETR: MRK) this week released its 2024 annual report, highlighting a mixed performance across its business segments. The company reported global revenues up 2.0% year-on-year (YoY) in organic terms to EUR 21.16 billion (USD 2.3 billion). The Healthcare unit drove growth, while the Life Sciences segment…
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Astellas Pharma and YASKAWA Establish JV for Cell Therapy Product Manufacturing Platform
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Japan-based Astellas Pharma Inc. (TYO: 4503) is set to establish a joint venture (JV) with compatriot firm YASKAWA Electric Corporation (TYO: 6506). The collaboration aims to develop a cell therapy product manufacturing platform utilizing Maholo, a cutting-edge dual-arm robot developed by YASKAWA’s subsidiary, the Robotic Biology Institute. This innovative platform…
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Johnson & Johnson Officially Launches Spravato in China for Depression Treatment
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US giant Johnson & Johnson (J&J; NYSE: JNJ) officially launched Spravato (esketamine) nasal spray in China to alleviate depressive symptoms in adult depression patients. The announcement comes after a swift approval by China’s National Medical Products Administration (NMPA) in April 2023. Spravato’s novel mechanism and rapid resultsSpravato is the first…
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Abbisko Therapeutics’ ABSK131 Receives Clinical Trial Approval from China’s NMPA
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced receiving clinical trial approval from the Center for Drug Evaluation of China’s National Medical Products Administration (NMPA) for its small molecule inhibitor ABSK131. This follows a similar approval from US regulators in December of last year. ABSK131: Promising Anti-Tumor ActivityABSK131…
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Cryofocus Medtech’s Malignant Stenosis Cryoablation System Approved by NMPA for Chinese Market
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Shanghai-based cryoablation treatment specialist Cryofocus Medtech (Shanghai) Co., Ltd (HKG: 6922) has announced receiving endorsement from the National Medical Products Administration (NMPA) to market its malignant stenosis cryoablation system in China. This innovative technology represents a significant advancement in the treatment of malignant airway tumors. Innovative Cryoablation TechnologyThe malignant stenosis…
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Suzhou GenAssist’s GEN6050X Receives FDA Clearance for Duchenne Muscular Dystrophy Treatment
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China-based Suzhou GenAssist Therapeutic Co., Ltd has announced receiving clearance from the US Food and Drug Administration (FDA) to initiate clinical trials for its base editing drug, GEN6050X, as a treatment for Duchenne muscular dystrophy (DMD). This groundbreaking therapy represents a significant advancement in gene editing technologies for rare diseases.…
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BioRay Biopharmaceutical’s BR111 Receives NMPA Clearance for Clinical Trials in ROR1-Positive Malignancies
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Zhejiang-based BioRay Biopharmaceutical has announced receiving clearance from the National Medical Products Administration (NMPA) to initiate clinical trials for its Category 1 biologic product, BR111. The drug, an antibody-drug conjugate (ADC) targeting dual epitopes of ROR1, is being developed to treat ROR1-positive hematological malignancies and solid tumors, marking a significant…
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CStone Pharmaceuticals’ CS5001 Enters Phase Ib Trial for Diffuse Large B-Cell Lymphoma
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China-based CStone Pharmaceuticals (HKG: 2616) has announced a Phase Ib clinical filing in Australia for its ROR1-targeted antibody-drug conjugate (ADC), CS5001, in combination with first-line standard-of-care (SoC) for diffuse large B-cell lymphoma (DLBCL). The move underscores the company’s commitment to expanding the therapeutic potential of CS5001 across hematologic and solid…
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Roche’s Gazyva Receives FDA Review Acceptance for Lupus Nephritis Treatment
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Swiss pharmaceutical giant Roche (SWX: ROG, OTCMKTS: RHHBY) has announced that the US Food and Drug Administration ()FDA has accepted for review its supplemental Biologics License Application (sBLA) for Gazyva/Gazyvaro (obinutuzumab) for the treatment of lupus nephritis. The FDA is expected to make its decision by October 2025. The filing…
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Ascentage Pharma’s Olverembatinib Receives Third BTD in China for Ph+ ALL Treatment
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China-based Ascentage Pharma (HKG: 6855) has announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has awarded Breakthrough Therapy Designation (BTD) to its olverembatinib, a novel BCR-ABL1 tyrosine kinase inhibitor (TKI). The designation is for the drug’s use in combination with low-intensity chemotherapy as…
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ImmuneOnco’s Timdarpacept (IMM01) and IMM2510 Receive NMPA Approval for Clinical Study in Advanced Malignant Tumors
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China-based ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (HKG: 1541) has received approval from the National Medical Products Administration (NMPA) to commence a clinical study for its novel therapeutic combination. The study will evaluate timdarpacept (IMM01), an SIRPαFc fusion protein, in combination with IMM2510, a PD-L1/VEGF bispecific antibody (BsAb), with or without chemotherapy,…
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CSPC Pharma’s JMT108 Receives NMPA Clinical Approval for Advanced Malignant Tumors
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced clinical approval from the National Medical Products Administration (NMPA) for JMT108, an anti-PD-1/IL-15 bi-functional fusion protein. The targeted indication for this novel therapy is advanced malignant tumors, marking a significant step forward in the development of innovative cancer treatments in China.…
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Sandoz’s Q4 2024 Results Show Strong Biosimilar Growth
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Switzerland-headquartered Sandoz (SWX: SDZ) has released its Q4 2024 financial results. The firm’s global revenues rose 9% year-on-year (YOY) in constant currencies to USD 10.7 billion during the year. The firm’s performance improved during the year, with Q4 revenues up 9% YOY to USD 2.7 billion. Sales BreakdownGeneric drugs generated…
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Peijia Medical Completes First Two Implants of Trilogy THV System in Taiwan
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China’s Peijia Medical Ltd (HKG: 9996) announced the completion of the first two implant surgeries using its Trilogy transcatheter heart valve (THV) System for the treatment of severe aortic valve regurgitation in Taiwan. Product DetailsThe Trilogy THV System, a proprietary transcatheter aortic valve replacement product with CE mark, is designed…
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Huadong Medicine’s V30 Optical Radiofrequency Device Receives NMPA Review Approval
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China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that the National Medical Products Administration (NMPA) has accepted a market filing for it’s subsidiary Viora Ltd.’s V30 optical radiofrequency therapy device. The Category III medical device is used for various medical aesthetics procedures, including skin tightening, hair removal, and treating vascular…
