Fuhong Hanxuan Beval bead single anti-listing registration application was accepted by NMPA.

Recently, Fu Hong Hanxuan submitted on the Beval Pearl single anti-injection HLX04 (recombinant anti-VEGF humanized monoclonal antibody injection) listing application was officially accepted by the State Drug Administration (NMPA).
HLX04 is expected to be used in the treatment of patients with advanced, metastatic or relapsed non-small cell lung cancer and metastatic colorectal cancer.
HLX04 is a biosynthic drug developed by Fuhong Hanxuan, with the original research drug Beval bead monoantin as a reference drug.
the listing application is mainly based on a series of research data, including pharmaceutical ratio study, non-clinical ratio study, clinical ratio study.
HLX04 chose metastatic colorectal cancer adaptation in the design of clinical safety effectiveness III. Phase III. Phase ratio study, becoming the only bevaju single anti-biological similar drug with clinical data on metastatic colorectal cancer in China, and accumulated more clinical evidence and experience for the application of bevazhu monoantigen resistance in Chinese colorectal cancer patients.
colorectal cancer as the second highest incidence of malignant tumors in China, the incidence rate is second only to lung cancer.
522,000 new cases of colorectal cancer in China in 2018.
study shows that combining beva bead monoantigen on the basis of traditional chemotherapy program can significantly delay the progress of disease in patients with advanced colorectal cancer and prolong their survival, which is one of the main treatment options for advanced colorectal cancer.
because of drug access and other reasons, the clinical drug demand of beva bead monoantial has not been satisfied.
it is learned that the domestic beva bead single anti-resistance market in 2018 reached 3.2 billion yuan, with the listing of bio-similar drugs and the application of beval pearl single anti-innovation combination therapy, it is expected that by 2030, the domestic beval bead single anti-resistance market is expected to reach 17.7 billion yuan.
Fuhong Hanxuan based on its own rich product pipeline, give full play to HLX04 in the field of broad-spectrum anti-tumor advantages, and actively explore the HLX04 and the company's core immunotherapy mono-anti-HLX10 (recombinant anti-PD-1 humanized monoclonal antibody injection) composed of tumor immunotherapy in a number of solid tumor efficacy.
As of the date of this announcement, beva pearl monoantigens listed in China (excluding Hong Kong, Macao and Taiwan, the same between 2nd) include Roch Pharma (Schweiz) Ltd.'s Avetin, Qilu Pharmaceutical Co., Ltd.'s Anda, Zinda Biopharmaceuticals (Suzhou) Co., Ltd.
, according to the latest IQVIA CHPA data, sales in China in 2019 were about RMB2,883 million.
as of August 2020, Fuhong Hanxuan's cumulative research and development investment for the new drug at this stage is about RMB00,047 million (unaudited).
, Fu Hong Hanxuan has submitted Lytosi single anti-Hanlikang to the NMPA? , Curto Pearl single anti-Han song excellent? As well as Adamo single anti-HLX03 listing registration application, which Hanley Kang? With Han Quyou? Successfully approved for listing.
beabel bead single anti-injection HLX04 is the fourth product to be accepted by the NMPA listing application.
It is worth mentioning that the HLX10 and HLX04 combination therapy program is the first domestic monoantigen combination therapy to obtain FDA clinical trial approval (IND) for new drugs, and clinical trials for first-line non-squamous non-small cell lung cancer have entered critical clinical phase III.
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