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Sanofi’s mRNA Chlamydia Vaccine Gains FDA Fast Track Designation
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French pharmaceutical giant Sanofi (EPA: SAN, NASDAQ: SNY) has announced receiving fast track designation from the US Food and Drug Administration (FDA) for its mRNA vaccine candidate targeting the prevention of chlamydia infection. This designation represents a significant step forward in the development of the vaccine, which is designed to…
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Merck, Sharp & Dohme’s Capvaxive Approved by European Commission for Pneumococcal Prevention
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US-based Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK) has announced the European Commission (EC) approval for Capvaxive (Pneumococcal 21-valent conjugate vaccine). The vaccine is approved to prevent invasive disease and pneumonia caused by 21 different Streptococcus pneumoniae serotypes in adults: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A,…
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CanSino Biologics Partners with Saudi SPIMACO to Boost Meningococcal Vaccine Access
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China-based CanSino Biologics Inc. (HKG: 6185) has entered into a collaboration agreement with Saudi pharmaceutical firm SPIMACO, a leader in the Middle East and North Africa (MENA) region. The partnership aims to enhance access to CanSino’s ACYW135 Meningococcal Conjugate Vaccine (CRM197) (MCV4, trade name: Menhycia) in Saudi Arabia and other…
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Clover Biopharmaceuticals Receives Termination Notice from GAVI for COVID-19 Vaccine Agreement
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China-based Clover Biopharmaceuticals Ltd., (HKG: 2197) announced receiving a one-month prior written notice dated March 21, 2025, from the Global Alliance for Vaccines and Immunisation (GAVI). The notice asserts a unilateral termination of the Advance Purchase Agreement entered into between the two parties in 2021 relating to Clover Bio’s COVID-19…
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CanSino Biologics Partners with Grand Life Sciences to Commercialize Tetanus Vaccine in Greater China
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Chinese firms CanSino Biologics Inc. (HKG: 6185) and Grand Life Sciences have entered into an agreement to commercialize CanSino’s adsorbed tetanus vaccine. Under the terms of the deal, Grand Life Sciences will exclusively promote the product in Greater China upon its marketing approval. CanSino Biologics will receive an upfront payment,…
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Clover Biopharmaceuticals Receives FDA Approval for SCB-1019 RSV Vaccine Trial
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China-based Clover Biopharmaceuticals Ltd., (HKG: 2197) has announced receiving clinical approval from the US Food and Drug Administration (FDA) for its SCB-1019, a non-adjuvanted bivalent RSV prefusion-stabilized F (PreF)-Trimer subunit vaccine candidate. The company has initiated the first subjects for the Phase I revaccination study, assessing the safety, reactogenicity, and…
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AIM Vaccine’s mRNA-based Shingles Vaccine Receives FDA Approval for Clinical Study
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China-based AIM Vaccine Co., Ltd (HKG: 6660) has announced receiving approval from the US Food and Drug Administration (FDA) to initiate a clinical study for its mRNA-based shingles vaccine. This marks a significant milestone in the company’s efforts to develop innovative vaccine solutions for global markets. Pre-Clinical Study ResultsIn pre-clinical…
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Shenzhen Kangtai Partners with AstraZeneca to Establish Vaccine JV in Beijing
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China-based Shenzhen Kangtai Biological Products Co., Ltd (SHE: 300601) has formed a vaccine-focused partnership with UK pharmaceutical giant AstraZeneca (NASDAQ: AZN). The collaboration includes the establishment of a joint venture (JV) in Beijing aimed at developing and manufacturing novel vaccines for China and emerging markets. Joint Venture DetailsThe JV marks…
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Everest Medicines’ EVM14 mRNA Cancer Vaccine Clears US FDA IND Application
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China-based Everest Medicines (HKG: 1952) has announced that its Investigational New Drug (IND) application for EVM14, a tumor-associated antigen (TAA) vaccine, has been cleared by the US Food and Drug Administration (FDA). This milestone marks a significant advancement for the company’s innovative oncology pipeline. EVM14’s Mechanism and Pre-Clinical SuccessEVM14 is…
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Livzon Pharmaceutical Receives Approval for Clinical Trials of Adjuvanted Influenza Vaccine LZSN2401
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China-based Livzon Pharmaceutical Group Inc. (HKG: 1513) announced receiving clinical trial approval for its investigational adjuvanted quadrivalent influenza vaccine LZSN2401 in China. This marks a significant step forward in the development of more effective influenza prevention solutions. Vaccine InnovationLZSN2401 is positioned as the world’s first adjuvanted quadrivalent influenza vaccine to…
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AIM Vaccine Co. Ltd Announces Market Filing for Innovative Serum-Free Rabies Vaccine
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China-based AIM Vaccine Co., Ltd (HKG: 6660) announced plans to file for market approval for its serum-free iterative rabies vaccine following the acquisition of the Drug Manufacturing License. The unblinded Phase III study results have demonstrated that the product meets the predetermined evaluation criteria for safety, immunogenicity, and immune persistence.…
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AIM Vaccine Co. Ltd Receives NMPA Approval for Human Diploid Rabies Vaccine Trial
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China-based AIM Vaccine Co., Ltd (HKG: 6660) has announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its human diploid rabies vaccine. This marks a significant step forward in the development of more effective rabies prevention measures. Vaccine Features and AdvantagesThe updated human…
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Everest Medicines Begins Clinical Trial for Personalized mRNA Cancer Vaccine EVM16
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China-based Everest Medicines (HKG: 1952) has announced the first patient dosing of an investigator-initiated clinical trial (IIT) for its personalized mRNA cancer vaccine, EVM16. The trial is designed to assess the safety, tolerability, immunogenicity, and preliminary efficacy of EVM16 alone or combined with a PD-1 inhibitor in advanced or recurrent…
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RongCan Biotech’s mRNA HPV Vaccine Receives FDA Clinical Approval
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China-based mRNA specialist RongCan (Shanghai) Biotech Co., Ltd announced that it has received clinical approval from the US Food and Drug Administration (FDA) for its mRNA-based human papillomavirus (HPV) therapeutic vaccine. Clinical Approval and SignificanceThis approval marks a significant step forward in the development of therapeutic options for HPV-related conditions.…
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Fosun Pharma’s 24-Valent Pneumococcal Vaccine Receives NMPA Approval for Phase I Trial
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China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd’s (SHA: 600196, HKG: 2196) subsidiary Fosun Adgenvax (Chengdu) Biopharmaceutical Co.,Ltd. is set to commence a Phase I clinical study for its 24-valent pneumococcal polysaccharide conjugate vaccine in China, following clearance from the National Medical Products Administration (NMPA). Vaccine ProfileThe preventative biologic product is…
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Suzhou Abogen’s RSV mRNA Vaccine IND Approved by China’s CDE
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China-based nucleic acid drug developer Suzhou Abogen Biosciences announced that the Investigational New Drug (IND) filing for its freeze-dried respiratory syncytial virus (RSV) mRNA vaccine has been approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). RSV and Vaccine TechnologyRSV is a common viral…
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Precigen’s RRP Therapy PRGN-2012 Gets FDA Review
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US-based cell and gene therapy (CGT) specialist Precigen, Inc. (NASDAQ: PGEN) announced that the US Food and Drug Administration (FDA) has accepted a biologics license application (BLA) for its zopapogene imadenovec (PRGN-2012) for the treatment of adults with recurrent respiratory papillomatosis (RRP). The agency is expected to act on the…
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CanSino Biologics Receives NMPA Approval for DTcP Hib MCV4 Combined Vaccine
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China-based vaccine specialist CanSino Biologics Inc. (HKG: 6185) announced that its absorbed diphtheria, tetanus, acellular pertussis (DTcP), Haemophilus influenzae type b (Hib), and Group ACYW135 meningococcal (MCV4) combined vaccine has received clinical trial approval from the National Medical Products Administration (NMPA). The single-dose vaccine aims to provide comprehensive immune protection…
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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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GSK’s Penmenvy Meningococcal Vaccine Approved by FDA for Ages 10-25
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UK-based multinational GSK plc (LON: GSK) announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its Penmenvy (meningococcal groups A, B, C, W, and Y vaccine) for use in individuals aged 10 through 25 years. The vaccine targets the five major serogroups of…
