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AIM Vaccine Leverages DeepSeek AI to Optimize mRNA Shingles Vaccine Design
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China-based AIM Vaccine Co., Ltd (HKG: 6660) has filed its mRNA-based shingles vaccine with the U.S. Food and Drug Administration (FDA), marking a milestone for the company’s entry into the global vaccine market. The submission follows promising preclinical data and positions AIM as a pioneer in mRNA shingles vaccine development,…
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Likang Life Sciences Gains FDA Approval for LK101 Clinical Trials
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Beijing-based cell therapy developer Likang Life Sciences announced that it has received approval from the US Food and Drug Administration (FDA) to conduct clinical trials for its LK101, an mRNA neoantigen vaccine. This marks a significant milestone in the development of personalized cancer treatments. Innovative Vaccine TechnologyLK101 is an innovative…
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Youcare Pharmaceutical Gets FDA Clearance for Herpes Zoster mRNA Vaccine YKYY026
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China-based Youcare Pharmaceutical Group (SHA: 688658) has announced that it has received clinical clearance from the US Food and Drug Administration (FDA) for its mRNA vaccine candidate, YKYY026, aimed at preventing herpes zoster. YKYY026: An Innovative mRNA Vaccine with Proprietary Delivery SystemYKYY026 is a novel mRNA vaccine that utilizes Youcare…
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CDE Approves RinuaGene’s mRNA-Based RG002 for Clinical Study in Cervical Dysplasia
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China’s Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has indicated that the Category 1 drug RG002, developed by Suzhou-based mRNA therapeutics company RinuaGene, has been approved for clinical study in cervical intraepithelial neoplasia grade 2 or 3 (CIN2/3) associated with human papillomavirus (HPV) 16 and/or…
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Abogen Biosciences and Ruijin Hospital Launch Ruijin Abogen Nucleic Acid Drug Research Institute
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China-based nucleic acid drug developer Suzhou Abogen Biosciences and Ruijin Hospital, a comprehensive Class 3A hospital in Shanghai, have jointly announced the establishment of the Ruijin Abogen Nucleic Acid Drug Research Institute. The new institute aims to further explore the application of mRNA drugs in tumors and autoimmune diseases, with…
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OBiO Technology Partners with Hanxin Biotechnology to Advance LNP Delivery System
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China-based gene therapy Contract Research Organization (CRO) OBiO Technology (Shanghai) Co., Ltd (SHA: 688238) has announced a partnership with compatriot firm Hanxin Biotechnology (Suzhou) Co., Ltd. The collaboration is focused on the lipid nanoparticle (LNP) delivery system field, aiming to enhance the clinical application of mRNA and other nucleic acid…
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Innorna’s mRNA Drug IN015 Earns Orphan Drug Designation for PFIC Treatment
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Shenzhen-based Innorna Co., Ltd, a leading platform company specializing in mRNA technology and LNP (lipid nanoparticle) delivery technology, has announced that it has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its investigational mRNA drug, IN015. The designation is for the treatment of progressive…
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Merck and Moderna Launch Phase III Study for Individualized Neoantigen Therapy in Lung Cancer
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US pharmaceutical companies Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK) and Moderna Inc. (NASDAQ: MRNA) have initiated the Phase III INTerpath-009 study to evaluate V940 (mRNA-4157), an investigational individualized neoantigen therapy (INT), in combination with Merck’s anti-PD-1 therapy, Keytruda (pembrolizumab). The study will focus on patients with resectable Stage…
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Stemirna Therapeutics, Once a Leading mRNA Developer in China, Enters Bankruptcy Proceedings
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Stemirna Therapeutics Co., Ltd, a one-time leading mRNA developer in China, has officially commenced bankruptcy proceedings, with the case accepted by the Pudong New Area People’s Court of Shanghai. Established in 2016, Stemirna secured a war chest exceeding RMB 1.5 million through a series of financing rounds from 2020 to…
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Everest Medicines Launches Trial for Personalized mRNA Cancer Vaccine EVM16 in Solid Tumors
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Everest Medicines, a biopharmaceutical company based in China and listed on the Hong Kong Stock Exchange (HKG: 1952), has announced the commencement of an investigator-initiated trial (ITT) for its cutting-edge personalized mRNA cancer vaccine, EVM16. The trial, spearheaded by Beijing Cancer Hospital and Fudan University Shanghai Cancer Center, is a…
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WestGene Biopharma’s EB Virus-Targeting mRNA Vaccine WGc-043 Clears for Clinical Trials in China
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WestGene Biopharma Co., Ltd., a biotechnology company based in Chengdu, has received approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to proceed with clinical trials for its candidate drug, WGc-043. This marks a significant milestone as WGc-043 is the world’s first mRNA therapeutic…
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BioNTech’s mRNA Cancer Immunotherapy BNT111 Achieves Primary Endpoint in Phase II Trial
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Germany-based BioNTech SE (NASDAQ: BNTX) has announced that its mRNA cancer immunotherapy BNT111, in combination with the programmed death-1 (PD-1) inhibitor Libtayo (cemiplimab), has achieved the primary endpoint in a Phase II clinical trial. The study, part of a collaboration with Regeneron, is assessing the combination and monotherapies in treating…
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CanSino Biologics Partners with Malaysia’s NIBM to Develop mRNA Influenza Vaccine
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CanSino Biologics Inc. (HKG: 6185), a leading Chinese biotechnology company, has entered into a strategic partnership with the National Institute of Biotechnology Malaysia (NIBM). The collaboration aims to enhance the development, manufacturing, technology transfer, and talent exchange between the two entities, focusing on mRNA multivalent influenza vaccines and the exploration…
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Anhui Anke Biotechnology Receives NMPA Clearance for Clinical Trial of mRNA Drug AFN0328 for HPV-Related Cancers
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Anhui Anke Biotechnology (Group) Co., Ltd (SHE: 300009), a biopharmaceutical company based in China, has announced that it has received clinical clearance from the National Medical Products Administration (NMPA) for its drug candidate AFN0328. The drug is intended for the treatment of malignant tumors associated with HPV16/18 infection, including cervical…
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CSPC Pharmaceutical’s RSV mRNA Vaccine SYS6016 Receives Clinical Trial Approval from NMPA
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its candidate mRNA vaccine, SYS6016, targeting the respiratory syncytial virus (RSV). The vaccine, SYS6016, is designed using mRNA molecules that…
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Immorna Earns FDA Approval for Phase I/II Clinical Trial of Self-Replicating RNA Cancer Therapy
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Immorna (Hangzhou) Biotechnology, a biotech company specializing in mRNA-based vaccines and located in Hangzhou, has announced that it has received approval from the U.S. Food and Drug Administration (FDA) to conduct a Phase I/II clinical study for its self-replicating RNA cancer therapy, JCXH-211-IV (intravenous injection). JCXH-211-IV is a potential first-in-class…
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Walvax Biotechnology Halts COVID-19 mRNA Vaccine Trials Co-Developed with Abogen Biosciences
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Walvax Biotechnology Co., Ltd (SHE: 300142), a biopharmaceutical company based in China, has announced the termination of clinical trials for a COVID-19 mRNA vaccine that was co-developed with Abogen Biosciences Co., Ltd, a specialized developer of messenger ribonucleic acid (mRNA) drugs. This decision also affects the technology development cooperation between…
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Macera Therapeutics and Innorna Co., Ltd Collaborate on CAR-M mRNA-LNP Technology
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Macera Therapeutics, a company based in Nanjing specializing in the development of macrophage immunotherapies, has entered into a partnership with Shenzhen-based Innorna Co., Ltd, a platform company focused on delivery platforms for nucleic acid therapeutics. Under the agreement, Macera will leverage Innorna’s mRNA-LNP technology to advance the development of in…
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WestGene Biopharma’s Groundbreaking mRNA Vaccine for EB Virus Tumors Gets FDA Green Light
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WestGene Biopharma Co., Ltd., a biopharmaceutical company based in Chengdu, has announced that its drug candidate WGc-043 has been approved for clinical trials by the US Food and Drug Administration (FDA). WGc-043 is recognized as the world’s first clinically approved mRNA therapeutic vaccine targeting Epstein-Barr (EB) virus-related tumors. The vaccine…
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Sirnaomics Partners with Hualan Biological to Develop and Commercialize RSV mRNA Vaccine in China
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Sirnaomics Ltd (HKG: 2257) has entered into a strategic partnership with China’s Hualan Biological Engineering Inc., (SHE: 002007), to enhance the clinical development and commercialization of Sirnaomics’ respiratory syncytial virus (RSV) mRNA vaccine, RV-1770, in China. Under the agreement, Hualan will oversee clinical development, industrialization, and commercialization of the vaccine…
