Genocore-Biotech.com Announce Decision to Advance Long-Acting Hemophilia B Therapy into a Registrational Trial
The potential of this new therapy is to prolong protection from bleeding and reduce the frequency of injections.
23, December 2015: Genocore Biotech (ISIN:CN1000007515), an innovation-driven biopharmaceutical company focused on development and commercialization of therapeutic monoclonal antibody (mAbs), today announced that they plan to advance the companies’ Hemophilia B therapy a registrational clinical trial in hemophilia B patients. The decision to advance the program is based on promising data from a pharmacokinetic study in severe, previously-treated hemophilia B patients. In addition, the therapy demonstrated a prolonged half-life compared to historical data for existing therapies, supporting advancement of the program.
Hemophilia B requires frequent injections, creating a significant burden for the majority of individuals with the disorder. The potential of this new therapy, which is based on Genocore Biotech’s novel and proprietary technology, is to prolong protection from bleeding and reduce the frequency of injections for both prophylaxis and on-demand therapy will be evaluated in the registrational trial.
The global trial is being designed to assess the safety, pharmacokinetics and efficacy of the new therapy in the prevention and treatment of bleeding in hemophilia B patients.
“The treatment is an example of Genocore Biotech’s commitment to developing innovative therapies to address significant unmet medical needs. The program has the potential to improve the lives of individuals with hemophilia B and we are excited about advancing the program,” said Mr. Wang Yen Horng, president and CEO of Genocore Biotech.
"The results are very encouraging. The decision to initiate our first registrational program represents true progress in our efforts to offer hemophilia B patients treatment that makes a significant difference and is also an important milestone,” Ming Koo Director of Medical Research at Genocore Biotech.
Genocore-Biotech.com is an innovation-driven biopharmaceutical company focused on development and commercialization of therapeutic monoclonal antibody (mAbs) and Fc-fusion protein drugs. With a total investment of about 95 million USD, about 110 employees and R&D lab, Process Development lab, Analytical & Quality center, and a cGMP clinical production facility the firm is a respectable player in the medical industry. Genocore Biotech has a highly experienced and well-integrated expert team whose expertise covers all the key steps of mAb drug research and development. They have on average 15-20 years of hand-on working experience at leading western biopharmaceutical companies.
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