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Acotec Scientific’s Vericor-14 Microcatheter Receives NMPA Approval for Vascular Surgeries
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China-based Acotec Scientific Holdings Ltd (HKG: 6669) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its Vericor-14 microcatheter. The product is now approved for use in percutaneous intervention surgery of coronary arteries and peripheral blood vessels, providing targeted access to the lesion site of narrow…
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Janssen’s Spravato Approved by NMPA for Adult Depression and Suicidal Ideation Treatment
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Janssen’s Spravato (esketamine) has been granted approval by the National Medical Products Administration (NMPA) in China for the alleviation of depressive symptoms in adult patients with acute suicidal ideation or behavior when used in combination with an oral antidepressant. Spravato: A Novel Antidepressant with Rapid-Onset ActionSpravato marks a significant advancement…
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Jiangxi Jemincare Group Secures Clinical Trial Approvals for Four Innovative Drugs
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Jiangxi Jemincare Group, a China-based pharmaceutical company, has announced receiving clinical trial approvals for four category 1 innovative drugs. Three of these approvals were granted by the National Medical Products Administration (NMPA) in China, and one by the US FDA. The drugs are targeted towards treating kidney and cardiovascular diseases.…
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CSPC Pharmaceutical Group Gets NMPA Approval for SYS6010 ADC Clinical Trial
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its antibody-drug conjugate (ADC), SYS6010, which is intended for the treatment of advanced solid tumors. Pre-Clinical Studies and Patent Protection for SYS6010Pre-clinical studies have demonstrated that…
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Legend Biotech’s Carvykti Data Boosts Stock Price by 19.64% on Positive Phase III Results
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Shares of Legend Biotech (NASDAQ: LEGN) jumped an impressive 19.64% in a single day, attributed by industry media to the recent leak of positive data from the ongoing Phase III CARTITUDE-4 study. The study is assessing Legend’s BCMA-targeted chimeric antigen receptor (CAR) T cell therapy, Carvykti (ciltacabtagene autoleucel), as a…
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Acotec Scientific Holdings Receives NMPA Approval for Paclitaxel-Coated Balloon Dilation Catheter
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China-based Acotec Scientific Holdings Ltd (HKG: 6669) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its paclitaxel-coated arteriovenous fistula high-pressure balloon dilation catheter, ACOART AVENS. The product is intended for use in percutaneous transluminal angioplasty (PTA) for autologous arteriovenous fistula stenosis in hemodialysis patients. Product…
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CARSgen Therapeutics’ CT041 Receives NMPA Approval for Post-Operative Pancreatic Cancer Therapy
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China-based chimeric antigen receptor (CAR)-T cell specialist, CARSgen Therapeutics Holdings Ltd (HKG: 2171), has announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its pipeline candidate, CT041. The therapy will be assessed as a post-operative adjuvant treatment for Claudin18.2 (CLDN18.2)-positive pancreatic cancer. Potential First-In-Class CAR-T Therapy:…
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Zelgen Biopharmaceuticals’ ZG2001 Receives NMPA Approval for Clinical Trials
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 product candidate, ZG2001. ZG2001: An Oral Pan-KRAS Mutation InhibitorZG2001, an in-house developed oral pan-KRAS mutation inhibitor, is under development for the treatment of…
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Beijing Aosaikang’s ASKG915 Receives NMPA Approval for Clinical Trials in Advanced Solid Tumors
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Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) has announced receiving clinical trial approval for its Category 1 biologic product ASKG915 from the National Medical Products Administration (NMPA). The study will initially assess the therapy in patients with general advanced solid tumors. ASKG915: A Bifunctional Fusion Protein Targeting PD-1 and IL-15ASKG915…
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InnoCare Pharma’s Orelabrutinib Gains NMPA Approval for Recurrent/Refractory MZL Treatment
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China-based InnoCare Pharma (HKG: 9969, SHA: 688428) has announced receiving another indication approval from the National Medical Products Administration (NMPA) for its Bruton’s tyrosine kinase (BTK) inhibitor, orelabrutinib. The drug can now be used to treat recurrent/refractory marginal zone lymphoma (MZL), marking it as the first BTK inhibitor for that…
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Walvax Biotechnology’s RQ3013 mRNA Vaccine Shows Efficacy in Phase III Study
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China’s Walvax Biotechnology Co., Ltd (SHE: 300142) has announced the efficacy interim results of a Phase III clinical study for its RQ3013, a bivalent mRNA vaccine based on the S protein chimera of Alpha/Beta SARS-CoV-2 variants. The study provides crucial data on the vaccine’s performance as a sequential booster in…
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Alcon Laboratories’ Innovative Intraocular Lens Approved by China’s NMPA
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The National Medical Products Administration (NMPA) has granted import approval to US firm Alcon Laboratories, Inc. for its innovative intraocular lens, marking it as the 197th innovative medical device to be approved by the bureau. Product Features and BenefitsThe product in question is a one-piece posterior chamber intraocular lens that…
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Biosyngen Receives US FDA IND Approval for T-Cell Redirection Therapy for EBV-Positive Lymphoma
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Biosyngen Pte Ltd, a cell and gene therapy (CGT) biotech with operations in Singapore and Guangzhou, China, has announced receiving Investigational New Drug (IND) approval from the US FDA for its second pipeline product, a T-cell redirection therapy designed for the treatment of EBV-positive lymphoma. This approval follows closely on…
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EOC Pharma Group Partners with China National Accord Medicines for Distribution Rights
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China-based EOC Pharma Group has announced a strategic partnership with compatriot firm China National Accord Medicines Corporation Ltd, granting the latter distribution and importing rights to its Vascepa (ethyl Icosapentate) and Mulpleta (lusutrombopag). The collaboration aims to enhance the commercialization of both products within the Chinese market. Vascepa: A FDA-Approved…
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Ubrigene Secures RMB 150 Million in Series C+ Financing to Expand Global CGT CDMO Platform
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Yiming Cell Biotechnology Co., Ltd, known as Ubrigene Biosciences Inc., a leading gene and cell therapy contract development and manufacturing organization (CDMO) based in Beijing, has reportedly raised RMB 150 million (USD 21.8 million) in a Series C+ financing round. The funding was led by Guotai Junan Innovation Investment and…
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Shanghai Huikai Medical Technology Secures Series A+ Funding for Prostate Stent System
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Shanghai Huikai Medical Technology Co., Ltd, a China-based urology device manufacturer, has reportedly raised tens of millions of renminbi in a Series A+ financing round, led exclusively by Beijing NatonTechnology Group Co., Ltd. The funds raised will be directed towards clinical studies and market promotion efforts. HuiKai Medtech’s Core Product…
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Shandong Jincheng Pharmaceutical Initiates Phase II Study for LT-01 Antibacterial Drug
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Shandong Jincheng Pharmaceutical Group Co., Ltd. (SHE: 300233), China’s largest cephalosporin manufacturer, has announced receiving ethical approval to initiate a Phase II clinical study for its LT-01 (litazolid dry suspension). This development marks a significant step in the advancement of the company’s pipeline. LT-01: A Promising Oxazolidone Antibacterial DrugThe Category…
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RemeGen Ltd Partners with Shandong Cancer Hospital for ADC Development and Integrated System
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RemeGen Ltd (HKG: 9995) has announced a strategic partnership with Shandong Cancer Hospital to establish a clinics-centered integrated system that spans the pharmaceutical industry, academia, and research fields, with a focus on antibody-drug conjugate (ADC) development. RemeGen’s ADC Achievements and PipelineRemeGen’s disitamab vedotin marked a significant milestone as the first…
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Nona Biosciences Partners with Dr. Michael S. Diamond for Viral Disease Monoclonal Antibody Research
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Nona Biosciences, a wholly owned subsidiary of Harbour BioMed (HKG: 2142), which operates in the Netherlands, the United States, and China, has struck a partnership with Dr. Michael S. Diamond from Washington University School of Medicine in St. Louis. This collaboration aims to explore viral disease fields that are currently…
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Everest Medicines and SPH Keyuan Ink MoU to Expand Xerava Distribution in China
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China-based Everest Medicines (HKG: 1952) has announced a Memorandum of Understanding (MoU) with a subsidiary of Shanghai Pharma, SPH Keyuan Xinhua Pharmaceutical Co., Ltd (SPH Kyuan), for a strategic partnership. According to the MoU, Everest and SPH Keyuan will collaborate to promote the import and channel distribution of Xerava (eravacycline)…
