China-based CSPC Pharmaceutical Group Co., Ltd. (HKG: 1093) has announced that the National Medical Products Administration (NMPA) of China has accepted a marketing filing for its Category 2.2 chemical drug, SYHX2011. The drug is indicated for the treatment of metastatic breast cancer that has failed combined chemotherapy or has relapsed within six months after adjuvant chemotherapy. The filing marks a significant step towards expanding treatment options for breast cancer patients in China.
SYHX2011: An Innovative Nano-Preparation for Breast Cancer
SYHX2011 is an innovative nano-preparation based on paclitaxel (albumin bound). The marketing filing was supported by data from a multi-center, randomized, double-blinded pivotal Phase III study, which enrolled breast cancer patients suitable for paclitaxel (albumin bound) as a standalone anti-tumor treatment. The study’s results demonstrated that SYHX2011 provided more significant therapeutic benefits compared to paclitaxel (albumin bound) in patients with advanced breast cancer.
Implications for Breast Cancer Treatment in China
The acceptance of the marketing filing for SYHX2011 by the NMPA highlights the potential for CSPC Pharmaceutical Group to contribute to the treatment landscape for metastatic breast cancer in China. If approved, SYHX2011 could offer a new therapeutic option for patients who have exhausted other treatment avenues or experienced relapse post-chemotherapy.-Fineline Info & Tech
