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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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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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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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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 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 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 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 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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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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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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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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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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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…
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China-based Keymed Biosciences Inc. (HKG: 2162) and InnoCare Pharma (HKG: 9969, SHA: 688428) have jointly announced a licensing agreement with Prolium, a US-based biotech backed by RTW Investments. Under the terms of the agreement, Prolium will obtain development, regulatory filing, manufacturing, and commercialization rights to ICP-B02 (CM355), a CD20xCD3 bispecific…
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UK-based GSK plc (NYSE: GSK, LON: GSK) has announced receiving approval from the European Commission for a new indication for its PD-1-blocking antibody Jemperli (dostarlimab). The drug is now approved for use in combination with chemotherapy (carboplatin and paclitaxel) as a first-line treatment for adult patients with primary advanced or…
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China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced receiving another clearance from the National Medical Products Administration (NMPA) for its PD-L1 monoclonal antibody (mAb) Ketailai (tagitanlimab). The latest approval indicates the drug for first-line treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC) when combined with chemotherapy. This follows…
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China-based Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced a licensing agreement with Denmark-based LEO Pharma A/S, granting the dermatology specialist exclusive rights to store, distribute, promote, market, and sell its PD-1 inhibitor, toripalimab, in the European Union (EU), the European Economic Area (EEA), Switzerland, and the…
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China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced the first subject dosing in an investigator-initiated trial (ITT) for its KJ-C2320, a universal chimeric antigen receptor (CAR)-T cell therapy targeting recurrent/refractory acute myeloid leukemia (R/R AML). This milestone marks a significant step forward in the development of innovative treatments for…
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US-based science and tech services giant Danaher Corporation (NYSE: DHR) has announced a partnership between its subsidiary Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. and Huashan Hospital. The collaboration aims to develop innovative solutions for the early diagnosis and differential diagnosis of Alzheimer’s disease (AD). No financial details were disclosed.…
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China-based Chongqing Genrix Bio Pharmaceutical Co., Ltd (SHA: 688443) has announced receiving approval from the National Medical Products Administration (NMPA) for an additional indication of its in-house developed Category 1 biologic product, xeligekimab. The anti-IL-17 antibody is now approved to treat ankylosing spondylitis (radiologically positive axial spondyloarthritis), following its initial…