Kindos Pharmaceuticals Co., Ltd. is one of the first sterile injectables enterprises in China to be comprehensively certified by US FDA. The company specializes in the research and commercialization of small molecule chemical drugs, antibody drugs, novel drug delivery systems, nucleic acid-based macromolecular biopharmaceuticals and novel vaccines. Kindos has self-developed products cover major therapeutic areas, including oncology, infectious diseases, cardiovascular diseases, autoimmune diseases, etc., with simultaneous market launches in US and China.
Kindos provides a comprehensive CRDMO service that meets global regulatory requirements. This includes high-standard R&D for the full chain, covering small molecule sterile injections and biopharmaceuticals, as well as global filing and commercialization. Our one-stop services support global clients in accelerating development in the innovation sector while ensuring the continuous provision of high-quality medications to support patients battling critical diseases.
We consistently adhere to the concept of "Quality by Design" (QbD) and foster a quality culture among all staff. Our quality system is constructed and maintained in alignment with the latest guidelines and standards from ICH, US FDA, NMPA, EMA, WHO, PIC/S, ISPE and PDA to ensure full compliance and efficient opera-tions. We are dedicated to providing safe, effective, and high-quality products to every patient.
Kindos R&D Platform focuses on the development of niche products, including but not limited to emulsions, liposomes, inclusion complexes, nanoparticles, microsuspensions, as well as challenging liquid and lyophilized products. Our team's capabilities cover the entire development process, from small-scale development and pilot-scale upscaling to registration and commercial-scale manufacturing, while supporting dozens of partners and helping them successfully complete product development and advance to the clinical research stage.
Kindos possesses FDA qualified, leading cGMP production capabilities, including fully enclosed isolation technology, advanced pharmaceutical production processes, and GMP-certified production capabilities for biological bulk solutions.
Kindos offers a fully integrated CRDMO service that complies with global regulatory requirements, covering high-standard research and development, global clinical research, regulatory submissions, and pilot-scale to commercial production of sterile injectables. CRDMO services for protein-based biopharmaceutical drug substances and drug products represent another key value-added area for our partners. Our one-stop services support both domestic and international clients in accelerating innovations and continue to provide high-quality medications for patients in major disease areas.