On March 17, Hengrui Medicine issued an announcement stating that its subsidiary Chengdu Shengdi Medicine had recently received the "Drug Clinical Trial Approval Notice" for fluzoparil capsules and abiraterone acetate tablets (I) approved and issued by NMPA.
And will carry out clinical trials in the near future
Hengrui Medicine's fluzoparib capsules have been approved by the National Medical Products Administration on December 11, 2020 for platinum-sensitive recurrent ovarian cancer and germline BRCA mutations (gBRCAm) that have undergone second-line and above chemotherapy.
Treatment of patients with fallopian tube cancer or primary peritoneal cancer
In January 2021, this product was used for maintenance treatment of platinum-sensitive recurrent epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer after platinum-containing chemotherapy has achieved complete remission or partial remission.
It has been approved by the National Medical Products Administration.
The evaluation center is included in the priority evaluation
In addition to the treatment of platinum-sensitive recurrent ovarian cancer, fallopian tube cancer or primary peritoneal cancer, the development of multiple indications of fluzoparil capsules alone or in combination with apatinib mesylate tablets is in phase III In the clinical research phase, there are also a variety of combination treatment options, including combination with abiraterone, combination with anti-PD-L1 antibody SHR-1316, and combination with temozolomide to treat a variety of solid tumors, which are already in the clinical development stage
Fluzoparil is a poly(ADP-ribose) polymerase (PARP) inhibitor that can specifically kill BRCA-mutated tumor cells
After inquiry, fluzoparib currently has similar products Olaparib (trade name Lynparza), Rucaparib (trade name Rubraca), Niraparib (trade name Zejula) and Talazoparib (trade name Talzenna) have been approved for sale in the United States.
Olaparib (trade name Lynparza) was approved for listing in China in August 2018, under the trade name Lipzo
Domestic Zai Lab's Nirapali Tosylate Capsules (trade name Zile) was approved for marketing in China in December 2019 for platinum-sensitive recurrent epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer Maintenance treatment for adult patients after platinum-containing chemotherapy has achieved complete or partial remission
Upon inquiry, the global sales of Olaparib (trade name Lynparza), Rucaparib (trade name Rubraca) and Niraparib (trade name Zejula) in 2020 are approximately US$2.
Up to now, the total R&D expenses of fluzoparil-related projects have been approximately 321.
24 million yuan
Abiraterone tablets were first developed by Janssen-Cilag International NV under the trade name Zytiga®.
They were approved for listing in the United States in April 2011 and are currently on the market in Canada, the European Union, Japan and other countries
2015, Janssen-Cilag International NV developed abiraterone tablets in China approved the trade name Zeke?
After querying EvaluatePharma's data, the sales of abiraterone acetate tablets in 2019 were US$2.
Up to now, a total of RMB 14.
29 million has been invested in research and development expenses related to abiraterone acetate tablets (I)