"HLB's Global Clinical Options for Rivoceranib Continue to Expand"
Hansoh Pharmaceutical, which holds the Chinese rights to HLB's rivoceranib, is rapidly expanding the indications for rivoceranib. Expectations for HLB's global clinical expansion beyond liver cancer continue to grow.
Hansoh Pharmaceutical, which has obtained approval for the anticancer drug rivoceranib in combination with camrelizumab, has also received consecutive new drug approvals for the combination of rivoceranib and fluzoparib, increasing expectations for the excellence and versatility of rivoceranib.
HLB's partner, Hansoh Pharmaceutical, announced on the 3rd that it has received approval from the National Medical Products Administration (NMPA) of China for rivoceranib + fluzoparib (Hansoh-developed PARP inhibitor) combination therapy or fluzoparib monotherapy as a treatment for gBRCA-mutated HER2-negative breast cancer.
The rivoceranib combination therapy, which was approved as a treatment for ovarian cancer last April, has now also received new drug approval for breast cancer.
According to the results presented at the European Society for Medical Oncology (ESMO) in May, a phase 3 clinical trial involving 203 patients with metastatic breast cancer showed that the progression-free survival (mPFS) for the rivoceranib + fluzoparib combination therapy (11.0 months) was significantly higher compared to fluzoparib monotherapy (6.7 months) or conventional chemotherapy (3.0 months). It also demonstrated superior benefits in overall survival (mOS) and objective response rate (ORR).
The combination of the two drugs was found to reduce the risk of severe disease progression in patients by approximately 73%, further proving the outstanding efficacy and broad applicability of rivoceranib.
Following the excellent data in ovarian cancer, the positive results in breast cancer have also turned on a green light for further collaboration discussions between HLB and Hansoh Pharmaceutical. Expanding this combination therapy to global markets such as the United States and Europe outside China requires cooperation between HLB, which holds the global patent rights for rivoceranib, and Hansoh Pharmaceutical, the developer of fluzoparib.
With mutual cooperation, having already entered the threshold of global new drug development in the first-line treatment of liver cancer (rivoceranib + camrelizumab), another successful collaboration case can be created. This is because global phase 3 trials can be conducted immediately in countries like the United States based on clinical data conducted in China.
A bio industry official said, "As the domestic bio market continues to experience a cold wave, many biotech companies are facing great difficulties in securing research and development funds amid market indifference," adding, "HLB's liver cancer drug approval and indication expansion can instantly overturn this skeptical view, drawing attention and support not only for the company but for the entire Korean bio industry."
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