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Ocumension Therapeutics’ Zerviate NDA Accepted for Review by China’s NMPA
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Ocumension Therapeutics (HKG: 1477), a leading Chinese ophthalmology specialist, has announced that the National Medical Products Administration (NMPA) has accepted for review the New Drug Application (NDA) for Zerviate (OT-1001), a histamine H1 receptor-targeted therapy. This development marks a significant step forward for the company in bringing this innovative treatment…
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Fosun Pharmaceutical’s FCN-159 Earns Breakthrough Therapy Designation for Histiocyte Tumors
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The Center for Drug Evaluation (CDE) website has announced that Shanghai Fosun Pharmaceutical (Group) Co., Ltd’s (SHA: 600196, HKG: 2196) novel small-molecule chemical drug FCN-159 has been granted breakthrough therapy designation (BTD) status for the treatment of histiocyte tumors. FCN-159’s Mechanism and ImpactFCN-159 is a highly selective MEK1/2 inhibitor with…
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Aosaikang Pharmaceutical Receives NMPA Review for ASKC200 Liniment from Propella Therapeutics
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Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) has announced that the National Medical Products Administration (NMPA) has accepted for review its clinical trial approval filing for ASKC200, a liniment product in-licensed from US-based Propella Therapeutics, Inc. The primary indication for the product is the treatment of osteoarthritis pain. Product Rights…
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Convalife Pharmaceuticals’ Mefuparib Earns Orphan Drug Designation for Cholangiocarcinoma
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Shanghai-based Convalife Pharmaceuticals has announced that it has received orphan drug designation (ODD) status from the US FDA for its second-generation PARP inhibitor, mefuparib (CVL218). The designation is in recognition of the drug’s potential as a treatment for cholangiocarcinoma, a rare and aggressive form of cancer. Advantages of CVL218 Over…
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Overland ADCT BioPharma Achieves Primary Endpoint in Zynlonta Phase II Study for R/R DLBCL
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Joint venture Overland ADCT BioPharma (CY) Ltd, a partnership between China’s Overland Pharmaceuticals and Swiss firm ADC Therapeutics SA (NYSE: ADCT), announced that the primary endpoint has been reached in a Phase II regulatory study. The study assessed the efficacy and safety of Zynlonta (loncastuximab tesirine), an antibody-drug conjugate (ADC)…
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Novartis’ Jakavi Secures NMPA Approval for Acute GVHD Treatment in China
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced that it has received a new indication approval from the National Medical Products Administration (NMPA) for its Janus kinase (JAK) 1/2 inhibitor, Jakavi (ruxolitinib), as a treatment for patients with acute graft versus host disease (acute GVHD). This marks the first approval…
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Chengdu Hyperway Pharmaceuticals’ HBW-004285 Gets NMPA Tacit Approval for Pain Treatment
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China-based Chengdu Hyperway Pharmaceuticals has announced receiving tacit clinical trial approval from the National Medical Products Administration (NMPA) for its Nav1.8 inhibitor, HBW-004285, which is intended for the treatment of acute and chronic pain. Understanding the Role of Nav1.8 in Pain SignalingNav1.8 is a tetrodotoxin-insensitive voltage-gated sodium ion channel that…
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Grand Pharmaceutical’s APP13007 Achieves Clinical Endpoints in US Trials for Post-Operative Treatment
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China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that a Phase II clinical study and two Phase III clinical studies for its APP13007, a modified hormone nano suspension eye drop, have successfully reached their clinical endpoints in the United States. The clinical results demonstrate that APP13007 exhibits significant efficacy…
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Sirnaomics Commences Phase I Clinical Trial for Factor Xl RNAi Drug STP122G
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Sirnaomics Ltd (HKG: 2257) has announced the commencement of a single-center, randomized, double-blind, placebo-controlled, sequence grouping Phase I clinical study for its factor Xl-targeted RNAi drug, STP122G. The US-based trial is designed to assess the safety, tolerability, and pharmacokinetics of the drug in healthy subjects initially, before expanding to its…
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Shanghai Fosun Pharmaceutical Submits Market Approval Filing for Daxibotulinumtoxin A in China
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196) has announced a market approval filing to the National Medical Products Administration (NMPA) in China for its in-licensed daxibotulinumtoxin A for injection (RT002). The drug is intended for use in the temporary improvement of moderate to severe frown lines in adults, attributed…
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Junshi Biosciences’ Senaparib Meets Primary Endpoint in Phase III Ovarian Cancer Study
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China’s Junshi Biosciences (HKG: 1877, SHA: 688180) has declared that the Phase III FLAMES study for senaparib (JS109/IMP4297), a PARP inhibitor co-developed with Impact Therapeutics Inc., has achieved the pre-set optimal efficiency threshold, marking the trial’s primary endpoint. The study targets the first-line maintenance treatment for stage III/IV ovarian cancer,…
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Luye Pharma’s Bevacizumab Biosimilar Accepted for Review in Brazil by ANVISA
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China-based Luye Pharma Group (HKG: 2186) has announced that the market approval filing for its biosimilar version of Roche’s Avastin (bevacizumab) has been accepted for review by Brazil’s National Health Surveillance Agency (ANVISA). Luye’s Biosimilar Approval and Global OutlookLuye’s biosimilar bevacizumab was approved in China in 2021 to treat indications…
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Bristol-Myers Squibb Launches Zeposia in China for Multiple Sclerosis Treatment
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Global pharmaceutical company Bristol-Myers Squibb (BMS, NYSE: BMY) has announced the market launch in China of Zeposia (ozanimod), the world’s first selective sphingosine-1-phosphate (S1P) receptor modulator indicated for the treatment of recurrent multiple sclerosis (MS). This includes clinically isolated syndrome, relapsing-remitting multiple sclerosis, and active secondary progressive multiple sclerosis. Mode…
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Zelgen Biopharmaceuticals’ ZG006 Earns FDA Approval for Small-Cell Lung Cancer Trial
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China-based Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced receiving clinical trial approval from the US FDA for its investigational drug ZG006, intended to treat small-cell lung cancer and other solid tumors. ZG006: A Tri-Specific Antibody Targeting CD3 and DLL3 EpitopesZG006 is a tri-specific antibody developed through the company’s…
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JW Therapeutics’ Carteyva Receives NMPA Approval for Moderate-to-Severe SLE Clinical Trial
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China-based JW Therapeutics (HKG: 2126) has announced receiving tacit clinical trial approval from the National Medical Products Administration (NMPA) for its product Carteyva (relmacabtagene autoleucel injection; relma-cel). The treatment will be assessed for its efficacy in managing moderate-to-severe refractory systemic lupus erythematosus (SLE). Understanding Systemic Lupus Erythematosus (SLE)SLE is a…
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Takeda Pharma’s Iclusig Poised for Priority Review by CDE for Leukemia Treatments
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The Center for Drug Evaluation (CDE) website has indicated that Takeda Pharma’s (TYO: 4502) Iclusig (ponatinib) is on track to obtain priority review status for the treatment of specific leukemia conditions in China. These include chronic myeloid leukemia (CML) that is resistant or intolerant to previous medications, recurrent or refractory…
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FDA Issues Complete Response Letters to Six Novel Drugs in Q1 2023
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According to an analysis, the US FDA issued complete response letters (CRLs) to six novel drugs seeking first approval approvals during the first quarter of 2023. These CRLs highlight the stringent requirements for efficacy and safety data that the FDA demands before granting market access to new pharmaceuticals. Eli Lilly’s…
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Yiling Pharmaceutical’s XY0206 Advances to Phase III Trial for FLT3-ITD AML
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China-based Yiling Pharmaceutical Co., Ltd (SHE: 002603) has announced its plans to initiate a Phase III clinical study for its Category 1 chemical drug XY0206, which targets recurrent/refractory acute myeloid leukemia (AML) patients with FLT3-ITD mutation (FMS-like tyrosine kinase 3 internal tandem duplication). XY0206: A Promising Multi-Target Tyrosine Kinase InhibitorXY0206…
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MicuRx Pharmaceuticals Initiates Phase III Study for MRX-4 in Diabetic Foot Infection Treatment
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Sino-US firm MicuRx Pharmaceuticals Inc. has announced the initiation of a Phase III clinical study for its novel anti-microbial agent MRX-4, used in combination with contezolid (MRX-I), as a sequential treatment for diabetic foot infection in China. Global Multi-Center Phase III Study Design and ApprovalThe global multi-center, randomized, double-blind Phase…
