| Product | Indications | Target population | Country/Region | Preclinical | IND | Phase I | Phase II | Phase III | BLA | |
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| FRSW107 | Hemophilia A | Adults and adolescents | China |
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| Children aged ≤12 years old | China |
FRSW107 is the first double chain coagulation factor VIII-Fc fusion protein of“homodimeric” structure with coagulation activity using an innovative rigid linker technology, which not only extends the half-life of coagulation factor VIII but also improves the product's stability and capacity. FRSW107 is the first domestic long-acting factor Ⅷ product，enabling a "twice-a-week" dosing frequency in adults and adolescents .The product’s core technology has been patented in many countries including China, the United States, and Japan, establishing a high technological barrier. |
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| FRSW117 | Hemophilia A | Adults and adolescents | China |
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| US |
FRSW117 is the world’s innovative, latest-generation ultra-long-acting recombinant coagulation factor VIII product that incorporates two technologies (Fc fusion and PEG technologies), enabling a "once-a-week" dosing frequency. The preventive treatment strategy with a "once-a-week" dosing frequency enables hemophilia A patients to return to normal life and achieve "functional cure". The product possesses independent intellectual property rights, and its core patents have entered substantive examination phase in over 10 countries and regions in the world, with multiple authorizations obtained. |
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| SS109 | Hemophilia inhibitor | Adults and adolescents | China |
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| Children aged ≤12 years old | China |
Based on Gensciences's mature Fc fusion protein technology platform, SS109 is the only long-acting recombination seven-factor product under research in China. It is characterized by extended half-life and superior hemostasis efficacy, which can compensate for the extremely short half-life limitation of existing recombinant human coagulation factor VII products on the market. The core technology of the product has been patented in China, making it likely to become the first domestic long acting coagulation factor VII product with independent intellectual property rights in China. |
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| SS327 | Hemophilia B | Adults and adolescents | China |
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| Children aged ≤12 years old | China |
SS327 is the world's innovative long-acting recombinant factor IX product that combines the Fc fusion and PEG technologies. It is expected to become the first domestic long-acting factor IX product with a dosing frequency of "10-14 days" in China.The product is expected to significantly reduce the number of puncture and the risk of hemorrhage, thus alleviating their disease and economic burdens. The product possesses independent intellectual property rights and has obtained patents in multiple countries. |
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| SS315 | Routine prevention and treatment of hemophilia A | Adults and adolescents | China |
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| Children aged ≤12 years old | China |
SS315 is a bispecific antibody with independent intellectual property, mimicking the function of activated coagulation factor VIII for coagulation promotion; compared with coagulation factor, it offers a more convenient route of administration (subcutaneous injection) and a longer half-life. It is mainly used for the prophylactic treatment of hemophilia A. SS315 can significantly lower treatment costs and is expected to become an affordable domestic bispecific antibody product for Chinese patients. |
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