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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 Therapeutics Earns FDA Approval for Phase I/II Clinical Trial of Self-Replicating RNA Cancer Therapy
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Immorna Therapeutics, 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 drug…
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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…
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AIM Vaccine Advances Pneumococcal Vaccine and Initiates Phase II Meningococcal Study
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AIM Vaccine Co., Ltd (HKG: 6660) has delivered a series of updates on the development progress of its vaccine candidates. The company has submitted a preliminary market filing for its 13-valent pneumococcal conjugate vaccine, designed to prevent invasive diseases caused by 13 pneumococcal serotypes, including bacteremic pneumonia, meningitis, sepsis, and…
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GSK In-Licenses Elegen’s Cell-Free DNA Tech to Advance Next-Gen Gene Therapies and Vaccines
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GlaxoSmithKline (GSK; NYSE: GSK), a UK-based pharmaceutical giant, has this week in-licensed US partner Elegen’s cell-free DNA manufacturing technology to bolster the potential development of next-generation mRNA, cell, and viral gene therapies, as well as RNA-based vaccines. Elegen will receive upfront fees, purchase commitments, potential equity investment, and milestone payments…
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China Grand Pharmaceutical Gets NMPA Green Light for mRNA Cancer Vaccine ARC01 Phase I Study
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China Grand Pharmaceutical and Healthcare Holdings Ltd (HKG: 0512; CGP) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct an open-label, dosage escalation Phase I study for its therapeutic cancer vaccine ARC01 (A002). The study will assess the safety, tolerability, immunogenicity, pharmacokinetics, and…
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Lion TCR Partners with MaxCyte to Develop mRNA-Based TCR-T Therapies for Solid Tumors and Viral Diseases
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Lion TCR, a Singapore-based clinical-stage biotechnology company with backing from Chinese investors, has entered into a partnership with U.S. firm MaxCyte Inc. to harness mRNA technology for the development of TCR-T therapies. These therapies are aimed at treating solid tumors and virus-related diseases. The collaboration will enable Lion to utilize…
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CATUG Biotechnology Partners with PersonGen to Advance Global CAR-T Cell Therapies
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China-based CATUG Biotechnology (Suzhou) Co., Ltd. has entered into a partnership with fellow Suzhou firm PersonGen BioTherapeutics (Suzhou) Co., Ltd. to collaboratively develop in vivo chimeric antigen receptor (CAR)-T cell therapies utilizing CATUG’s mRNA-lipid nanoparticle (LNP) technology for global markets. As of November 2023, a total of ten CAR-T therapies…
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Jiangsu Synthgene and Starna Therapeutics Join Forces in mRNA Technology Advancement
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China’s Jiangsu Synthgene Biotechnology Co., Ltd has announced a strategic partnership with Suzhou-based Starna Therapeutics, an RNA drug developer. The collaboration will focus on mRNA raw materials, lipid chemistry, lipid nanoparticle (LNP) technology, and complex preparations, among other areas. Financial details of the agreement have not been disclosed. Synthgene and…
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CATUG Biotechnology Partners with Carcell Biopharma to Advance Nucleic Acid Drug Development
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CATUG Biotechnology (Suzhou) Co., Ltd, a Chinese biotechnology company, has entered into a partnership with domestic firm Carcell Biopharma, a developer of medical technology service platforms. The collaboration will focus on technical cooperation in the global development of Lipid Nanoparticle (LNP) delivered mRNA and other nucleic acid drugs, aiming to…
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Beijing-Based Immupeutics Medicine Secures Tens of Millions in Pre-Series A+ Financing
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Immupeutics Medicine, a Beijing-based developer in the field of tumor immunotherapy, has reportedly secured tens of millions of renminbi in a pre-Series A+ financing round. The funding round was led by Beijing state-owned Capital Operation and Management Center, with additional investments from Junshi Bio, Alwin Capital, and the company’s founder.…
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SciClone Pharmaceuticals Gains FDA Nod for Thymalfasin COVID-19 Vaccine Booster Study
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SciClone Pharmaceuticals Inc. (HKG: 6600), formerly a US-based and Nasdaq-listed company, has announced that it has received approval from the US FDA to conduct a clinical study for its drug thymalfasin as a booster for COVID-19 mRNA vaccines. This marks a significant step in exploring new ways to enhance the…
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Suzhou Novoprotein and Shanghai Model Organisms Center Ink Global Partnership
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Suzhou Novoprotein Scientific Co., Ltd, (SHA: 688137) a leading provider of protein technology and application solutions in China, has entered into a strategic partnership with Shanghai Model Organisms Center, Inc. (SHA: 688265). The collaboration aims to combine the companies’ expertise on a global scale, focusing on technology and commerce. Novoprotein…
