SUZHOU – October 29, 2024— CANbridge Pharmaceuticals Inc. (1228.HK), a global biopharmaceutical company, with a foundation in China, committed to the research, development and commercialization of transformative therapies to treat rare disease, announced today that it has successfully passed the Manufacturing Authorization Holder (MAH) production and quality management system audit and on-site inspection, obtaining the Drug Manufacturing License Type B certificate issued by the Shanghai Municipal Drug Administration.

Receiving the Drug Manufacturing License Type B certificate signifies CANbridge’s transformation into an integrated biopharmaceutical company with the capabilities of drug research and development, manufacturing, and sales. 

This Type B Certificate is a significant milestone, providing essential prerequisites for subsequent drugs, such as CAN103 (velaglucerase-beta for injection) for the treatment of Type I and Type III Gaucher disease in adult and pediatric patients, in terms of NDA filing and post-approval commercial production. It is a crucial step for CAN103 to become the first enzyme replacement therapy developed and produced locally in China, which will create expansive opportunities for CANbridge to further unleash its innovative capabilities and potential.

“Receiving the Drug Manufacturing License Type B Certificate demonstrates that CANbridge fully complies with national laws and regulations in terms of corporate structure, personnel qualifications, drug production, and quality management systems, ensuring stable and continuous quality in drug production.” said James Xue, Ph.D., CANbridge Founder, Chairman and CEO, “With this license, we now have the qualification to submit a New Drug Application (NDA) for CAN103, which is poised to be the third rare disease treatment and the first in-house developed product CANbridge to commercialize in China.”

About CANbridge Pharmaceuticals Inc.

CANbridge Pharmaceuticals Inc. (HKEX:1228) is a global biopharmaceutical company, with a foundation in China, committed to the research, development and commercialization of transformative therapies for rare disease. CANbridge has a differentiated drug portfolio, with 3 approved drugs and a pipeline of 9 assets, targeting prevalent rare disease indications that have unmet needs and significant market potential. These include Hunter syndrome and other lysosomal storage disorders, paroxysmal nocturnal hemoglobinuria and other complement-mediated disorders, hemophilia A, metabolic disorders, rare cholestatic liver diseases and neuromuscular diseases. The CANbridge Next-Generation Innovation and Process Development Facility is developing novel, potentially curative, gene therapies for rare genetic diseases, including Pompe disease, Fabry disease, spinal muscular atrophy (SMA), Duchenne muscular dystrophy (DMD) and other neuromuscular conditions, and collaborates with world-leading researchers and biotech companies. CANbridge global partners include: Apogenix, GC Pharma, Mirum, Wuxi Biologics, Privus, UMass Chan Medical School, the University of Washington School of Medicine and Scriptr Global.

For more on CANbridge Pharmaceuticals Inc., please go to: www.canbridgepharma.com.

China Investor Relations

CANbridge Pharmaceuticals Inc.

ir@canbridgepharma.com