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最高研发阶段批准上市 |
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首次获批日期2018-01-01 |
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非在研适应症- |
最高研发阶段临床3期 |
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靶点- |
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非在研适应症- |
最高研发阶段临床2/3期 |
首次获批国家/地区- |
首次获批日期- |
A Phase I, Double-blind, Randomized, Placebo-controlled, Dose Escalating Study to Evaluate the Safety, Immunogenicity and Efficacy of YS-HBV-002 in the Treatment of Chronic Hepatitis B (CHB) Infection in Adults ≥ 18 Years Old
This is the first-in-human Phase I, double-blind, randomized, placebo-controlled, dose escalating study to evaluate the safety, immunogenicity and preliminary efficacy of the YSHBV-002 in the treatment of CHB in adults ≥18 years old. There will be 3 escalating doses of YS-HBV-002 to be administered intramuscularly: 0.5mL, 1.0mL, and 2.0mL.
A Phase III, Randomized, Comparator-Controlled, Double-Blind, Multicenter Study to Evaluate the Immunogenicity, Safety and Lot to Lot Consistency of Three Lots of a PIKA Rabies Vaccine(Vero Cell)for Human Use,Freeze-dried in Healthy Adults Using a Post-Exposure Prophylaxis Schedule
This is a phase III, randomized, comparator-controlled, double-blind, multicenter study to evaluate lot-to-lot consistency of three lots of a PIKA Rabies Vaccine, immunogenicity and safety in healthy adults using a post-exposure prophylaxis schedule. It is also the aim of this study to evaluate non-inferiority and superiority of the PIKA Rabies Vaccine compared to the rabies vaccine comparator ChiroRab.
A Phase II/III, Randomized, Double-blinded Study to Evaluate the Efficacy, Safety and Immunogenicity of a Booster Dose of PIKA Recombinant SARS-CoV-2 Vaccine in Adults Who Received 2 or More Doses of Inactivated Covid-19 Vaccine.
This is a Phase II/III, randomized, double-blinded study in adults ≥ 18 years old who received 2 or more doses of inactivated COVID-19 vaccine to evaluate the efficacy, safety and immunogenicity of a booster dose of PIKA COVID-19 vaccine compared to the comparator inactivated COVID-19 vaccine. Phase II/III will be a competitive enrollment process in all participating countries. Once the target number of subjects is reached, the enrollment in all participating countries in the particular phase will be stopped.
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