Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), a Chinese pharmaceutical company, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its generic version of AstraZeneca (AZ, NASDAQ: AZN)’s PARP inhibitor Lynparza (olaparib). This marks the second approval for a Lynparza generic in China, following Qilu Pharma’s approval in May 2023.
Olaparib, initially approved in the United States in 2017, was granted approval in China for the treatment of epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer in 2018. The drug is included in the National Reimbursement Drug List (NRDL), making it accessible to a broader patient population. Olaparib’s compound, preparation, and usage patents are not set to expire until March 2024, October 2029, and November 2024, respectively. Qilu Pharma made a Category 4.2 patent declaration in 2021, asserting that their molecule did not infringe on any existing Lynparza patents, leading to their approval. Kelun followed suit with a similar declaration in September 2022. Other companies, including Sinotherapeutics, CSPC, Huadong Medicine, Fangshenghe Medicine, Shanxiang Pharm, and India’s NATCO Pharma, are also developing generics of this important drug.- Flcube.com
