Hehuang Pharmaceutical (00013) issued an announcement, and Hehuang Pharmaceutical (China) Co., Ltd. and Innovent Bi...
Zhitong Finance App News, Hehuang Pharmaceutical (00013) issued an announcement. Today, Hehuang Pharmaceutical (China) Co., Ltd. and Innovent Biologics, Inc. jointly announced that the new drug marketing application for patients with advanced mismatch repair (pMMR1) or non-microsatellite-highly unstable (non-MSI-H2) endometrial cancer patients used to treat disease progression after previous systemic anti-tumor treatment and is not suitable for radical surgery or radical radiotherapy (non-) has been accepted by the China Drug Administration It will also be reviewed on a priority basis.
Data from the FRUSICA-1 study supports this new drug marketing application. FRUSICA-1 is a multicenter, open-label, phase II clinical trial of endometrial cancer registration cohort to evaluate endometrial cancer patients with recurrent disease, disease progression, or intolerable toxicity after treatment with fruquintinib plus cindilizumab in platinum-containing dual-agent chemotherapy. The primary endpoint of the study was the objective response rate (ORR) as assessed by the Independent Review Committee (IRC), and secondary endpoints included disease control rate (DCR), duration of remission (DoR), progression-free survival (PFS), overall survival (OS), and pharmacokinetic assessment. Data from the FRUSICA-1 study will be presented at an upcoming academic conference.
Dr. Shi Ming, head of R&D and chief medical officer at Chi-Med, said, “This is the first regulatory registration application for a combination of fruquintinib and the immune checkpoint inhibitor cindilimab. It also marks another important step in China's journey to rewrite the treatment landscape for this challenging disease. Endometrial cancer remains one of the most common gynecologic malignancies. We look forward to bringing this much-anticipated treatment advance to endometrial cancer patients to improve their treatment outcomes.”
Dr. Zhou Hui, senior vice president of Cinda Biotech, said, “Dabershu (cindilizumab injection) is a cornerstone therapy in the field of immuno-oncology, and is expected to improve the prognosis of endometrial cancer patients in China when used in combination with anti-angiogenic drugs. We are excited that the new drug's marketing application has been accepted and prioritized, increasing our potential to bring new treatment options to patients with endometrial cancer, while also strengthening Daberschu's leadership position in China.”
The combination therapy of fruquintinib and cindilimab was included by the National Drug Administration as a breakthrough treatment for this potential indication in July 2023. The State Drug Administration has included this combination therapy as a breakthrough treatment as an innovative drug used to treat diseases that seriously endanger life, and there are no effective prevention methods or obvious clinical advantages compared to existing treatments.