Core Insights - WuXi Biologics congratulates CANbridge Pharmaceuticals on the approval of velaglucerase-beta for injection, marking it as China's first locally developed enzyme replacement therapy for Gaucher disease [1][5] Company Overview - WuXi Biologics is a leading global Contract Research, Development and Manufacturing Organization (CRDMO) that provides end-to-end solutions for biologics [10][11] - The company has over 12,000 employees across multiple countries and supports 817 integrated client projects, including 21 in commercial manufacturing [11] Product Development - Velaglucerase-beta for injection is the first collaboration project between CANbridge and WuXi Biologics, utilizing WuXi's integrated technology platform to enhance yield and quality [3][5] - The project achieved over 110 times increase in overall yield and over 50% increase in specific enzyme activity, ensuring affordability for patients [3] Clinical Significance - The pivotal clinical trial for velaglucerase-beta demonstrated significant efficacy, with a statistically significant reduction in spleen volume for Gaucher disease patients [8] - Gaucher disease affects approximately 0.7 to 1.75 per 100,000 people globally, with around 3,000 patients reported in China as of 2020 [2][9] Market Impact - The approval of velaglucerase-beta represents a significant milestone in rare disease drug innovation in China, reflecting CANbridge's commitment to addressing unmet clinical needs [4][5] - CANbridge has a differentiated drug portfolio with three approved drugs and a pipeline of eight assets targeting rare diseases [15]
WuXi Biologics Congratulates Partner CANbridge Pharmaceuticals on the Approval of Innovative Velaglucerase-beta for Injection (Gaurunning) for Gaucher Disease by China NMPA