Cyril (Nirapali) has been approved in China for first-line maintenance treatment of ovarian cancer in all populations.

On September 10, Redding Pharmaceuticals announced that the State Drug Administration (NMPA) had approved the application for the listing of a new drug for advanced epitheliotic ovarian, fallopian or primary peritoneal cancer in adult patients with full or partial remission of first-line platinum-containing chemotherapy.
is an oral PARP inhibitor once a day.
The State Drug Administration accepted an application for a new supplemental drug for the first-line maintenance treatment in March 2020 and granted the application priority review eligibility in April.
PRIMA clinical studies have shown that single-drug maintenance therapy for patients with ovarian cancer with full or partial remission of first-line platinum-containing chemotherapy significantly improved progression-free survival in patients and reduced the risk of disease progression or death by 38% in the overall population.
in patients with BRCA mutations, HRD-positive and HRD-negative, the risk of disease progressity or death was reduced by 60%, 57% and 32%, respectively.
clinical study confirms that Le (Nirapali) is the first PARP inhibitor that significantly improves progression-free survival in all patients, regardless of the patient's biomarker status.
ovarian cancer is one of the most prevalent gynaecological tumors in China, with more than 52,000 new cases and 23,000 deaths each year.
although remission after initial platinum-containing chemotherapy, most ovarian cancer patients inevitably relapse.
and options for the treatment of platinum-sensitive relapsed ovarian cancer are still very limited.
drug can prolong the remission time of platinum-containing chemotherapy treatment and delay recurrence for the benefit of ovarian cancer patients in China.
Redding Pharma's ongoing or completed Cyril (Nirapali) research project includes: In November 2019, Redding Pharma completed phase 3 clinical studies of PRIME patients for first-line platinum-containing chemotherapy to achieve full or partial remission of ovarian cancer maintenance therapy.
In May 2020, Redding Pharmaceuticals announced that NORA, a phase 3 study used in Chinese patients with relapsed epithelitis, fallopian tube cancer, or primary peritanotic cancer (collectively, ovarian cancer) with full or partial remission of platinum chemotherapy, had achieved positive results.
data from the NORA study will be presented at the 2020 European EsMO online conference on 19 September 2020.
August 2020, the first patient was given the drug in a registered bridal study for the treatment of backline ovarian cancer.
also carried out a phase 1 pharmacogenetics (PK) study of Nirapali in patients with ovarian cancer in China.
also conducted in-country clinical studies of Ib phase dose increment and expansion, in pair with tebotelimab (PD-1 x LAG-3 DART molecular dual-specific antibodies) for the treatment of patients with advanced or metastatic gastric cancer who had previously failed treatment.
reference: s1, then Le first-line adaptive disease approved! The only PARP inhibitor approved for first - line maintenance therapy in all populations of ovarian cancer. Retrieved 2020-09-10, from.