Recently, Hangzhou Sino-US Huadong Pharmaceutical Co., Ltd. (hereinafter referred to as "Sino-US Huadong"), a wholly-owned subsidiary of Huadong Medicine Co., Ltd. (hereinafter referred to as "the Company"), has obtained the approval of the National Medical Products Administration (NMPA) for the exclusive marketing product Cenaparib Capsules (trade name: Paisuning®, research and development code: IMP4297) for marketing, which is used for maintenance treatment of adult patients with advanced epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer after achieving complete remission or partial remission of first-line platinum-containing chemotherapy.

About Cenaparib
On December 19, 2023, Sino-US Huadong and Shanghai Yingpai Pharmaceutical Co., Ltd. (hereinafter referred to as "Yingpai Pharmaceutical"), a wholly-owned subsidiary of Nanjing Yingpai Pharmaceutical Co., Ltd., signed an exclusive marketing service agreement. Sino-US Huadong obtained Yingpai Pharmaceutical's exclusive marketing rights for Cenaparib in mainland China.

Cenaparib is a novel, highly effective PARP1/2 inhibitor independently developed by Impa Pharmaceuticals. It has a unique molecular structure that enables it to have high in vitro and in vivo activity, as well as high target selectivity and a wide safety window. In August 2022, Cenaparib combined with temozolomide (TMZ) was granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with small cell lung cancer (SCLC). In August 2023, the National Medical Products Administration (NMPA) accepted the new drug application for Cenaparib capsules, which was applied for maintenance treatment of adult patients with advanced epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer after complete remission or partial remission of first-line platinum-containing chemotherapy, and was recently approved.

The approval of Cenaparib Capsules is based on the FLAMES study (NCT04169997), a randomized, double-blind, placebo-controlled, multicenter Phase III clinical study designed to evaluate the efficacy and safety of Cenaparib monotherapy as a maintenance therapy for patients with advanced ovarian cancer after achieving complete remission (CR) or partial remission (PR) with first-line platinum-containing chemotherapy. In the form of oral reports at important academic conferences such as the 2023 European Society for Medical Oncology (ESMO) Congress and the 2024 Chinese Society of Clinical Oncology (CSCO) Congress, Inpai Pharmaceuticals announced the FLAMES study data on the use of PARP inhibitor Cenaparib (IMP4297) as a first-line maintenance therapy for patients with advanced ovarian cancer, and the study data were published in the top international medical journal Nature Medicine on May 15, 2024. The results of the FLAMES study showed that maintenance therapy with Cenaparib can significantly prolong the progression-free survival (PFS) of patients with advanced ovarian cancer, and patients can benefit from Cenaparib treatment regardless of their BRCA gene expression. At the same time, Senapari is well tolerated and has controllable safety.

Impact on listed companies
Ovarian cancer is one of the most common lethal female reproductive system malignancies. According to GLOBOCAN 2020 data, the number of new cases of ovarian cancer worldwide reached 310,000 per year, and the number of deaths reached 210,000. According to the latest national cancer statistics released by the National Cancer Center in 2024, there were 61,100 new cases of ovarian cancer and 32,600 deaths in my country in 2022, making it the most lethal gynecological tumor. The early symptoms of ovarian cancer are hidden and non-specific. Studies have shown that about 70% of patients are already in the advanced stage when diagnosed, and the 5-year survival rate is only 41.8%. Although ovarian cancer can be relieved after initial platinum-containing chemotherapy, most patients will inevitably face recurrence, and there is still a significant unmet clinical treatment demand in the ovarian cancer patient population.

In recent years, PARP inhibitors are changing the treatment landscape of ovarian cancer. Their maintenance treatment can prolong the duration of sustained remission after platinum-containing chemotherapy and delay disease recurrence. The results of the key Phase III registration study of Cenaparib, FLAMES, confirmed that newly diagnosed ovarian cancer patients, regardless of whether they carry BRCA gene mutations, can benefit from Cenaparib monotherapy as a first-line maintenance treatment with good overall safety. This study result will strongly support Cenaparib monotherapy as a standard regimen for first-line maintenance treatment of all newly diagnosed ovarian cancer patients. The approval of Cenaparib capsules in China will bring new treatment options to ovarian cancer patients. The company's marketing team is ready and will actively promote the commercialization of this product after approval.

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