China’s Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) announced that the National Medical Products Administration (NMPA) has accepted a market filing from its non-wholly owned subsidiary Xuanzhu Biopharmaceutical Co., Ltd for a combination therapy of fulvestrant and piroxetine in advanced breast cancer. This marks Xuanzhu Bio’s first filing for an anti-cancer therapeutic.
Drug Profile
- Fulvestrant: A blockbuster oncology product from AstraZeneca, generating over USD 1 billion in global sales in 2018. Approved in China in 2010, it is listed as a Category B product on the 2021 National Reimbursement Drug List (NRDL).
- Piroxetine: A Category 1 cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, piroxetine is under development for breast cancer, malignant brain cancer, and other solid tumors. Pre-clinical studies showed it effectively addresses endocrine therapy resistance in ER+ breast cancer patients, demonstrating efficacy as a monotherapy after multiple treatment failures and potential for combination therapy. It can also penetrate the blood-brain barrier.
Xuanzhu Bio Pipeline
Xuanzhu Bio, with platforms for small molecule and macromolecule drug development, has over 25 drugs in its pipeline, covering oncology, metabolism, and digestion. Its duodenal ulcer therapy anaprazole is currently awaiting regulatory decisions in China.-Fineline Info & Tech
