Beijing InnoCare Pharma (HKG: 9969) announced that as of June 30, its manufacturing plant in Guangzhou has been approved for the commercial manufacturing of its Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib. The plant, located in Sino-Singapore Guangzhou Knowledge City, is compliant with Good Manufacturing Practice (GMP) standards in China, Japan, the US, and the European Union (EU). The facilities passed the EU’s Qualified Person audit in April this year.
Drug Profile
Orelabrutinib is an in-house drug from InnoCare targeted toward both cancers and autoimmune diseases. The drug’s first indication approval was won in December 2020, for relapsed / refractory (R / R) chronic lymphocytic leukemia / small lymphocytic lymphoma (CLL / SLL) and R / R mantle cell lymphoma (MCL). It went on to be included in the National Reimbursement Drug List (NRDL) for those indications at the end of 2021.-Fineline Info & Tech
