CSPC Pharmaceutical Group has achieved two significant milestones with its Leuprorelin Extended-Release Injection and Regorafenib Tablets, both receiving approvals from the National Medical Products Administration (NMPA) of China. The Leuprorelin injection is set for clinical trials, while Regorafenib Tablets have been approved for treatment, enhancing CSPC's oncology portfolio.
Leuprorelin Extended-Release Injection: Clinical Trial Approval
The NMPA has granted approval for clinical trials of CSPC's Leuprorelin Extended-Release Injection, a GnRH receptor agonist, for the treatment of solid tumors. This approval marks a significant step for CSPC in the field of long-acting GnRH agonists. The product utilizes CSPC's long-acting delivery technology, forming a gel depot upon subcutaneous injection for sustained drug release.
Compared to existing leuprorelin microsphere products, CSPC's injection offers potential advantages. Administered once a month, it simplifies preparation, reduces dosing volume, and uses a thinner needle, potentially minimizing injection site pain and improving patient compliance. Preclinical studies have demonstrated favorable safety and efficacy profiles.
Beyond solid tumors, the Leuprorelin injection holds promise for treating endometriosis and central precocious puberty, expanding its clinical development value. This approval establishes a strong foundation for CSPC's future development of other GnRH agonist products.
Regorafenib Tablets: Drug Registration Approval
CSPC's Regorafenib Tablets (40mg) have received drug registration approval from the NMPA and have passed the consistency evaluation of quality and efficacy of generic drugs. Regorafenib is an oral small-molecule multi-target kinase inhibitor with several indications.
It is approved for treating patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, and those who have been previously treated with or are not suitable for anti-VEGF and anti-EGFR therapy (RAS wild-type). Additionally, it is indicated for patients with locally advanced, unresectable, or metastatic gastrointestinal stromal tumor (GIST) previously treated with imatinib mesylate and sunitinib malate, and for patients with hepatocellular carcinoma (HCC) previously treated with sorafenib.
The approval of Regorafenib Tablets significantly enriches CSPC's product offerings in the oncology therapeutic area, providing a new treatment option for patients with these cancers.
