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NMPA approves China's first querceton single anti-biosimilar.

 Last Update: 2020-09-04
 Source: Internet
 Author: User

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Fuhong Hanxuan announced that its self-developed quercexal mono-biosimilar HLX02 has been approved for listing by the State Drug Administration (NMPA).
July 27, ZERX02 also received approval from the European Commission (EC), making HLX02 the first "Chinese national" mono-anti-biosimilar to be approved in Europe.
the common name of
HLX02 is curt bead monoantin (150 mg/bottle, no preservatives) and can be used to treat HER2-positive early breast cancer, HER2-positive metastatic breast cancer, and HER2-positive metastatic stomach cancer.
during the development of HLX02, Fu Honghanjun strictly followed the biosimilar guidelines of the NMPA and the European Medicines Agency (EMA) and made several head-to-head comparisons between HLX02 and Hessetin.
preclinical studies, Phase 1 clinical studies, and Global Multi-Center Phase 3 clinical studies show that HLX02 is highly similar in quality, safety and efficacy to Hersheytin.
Photo Source: Mr. Zhang Wenjie, President of Fuhong Hanxuan's official website, said: "HLX02 is the second product approved by Fuhong Hanxuan in China after Lytoxi single anti-counterfeiting drugs, and the first product to be approved by the international drug regulatory agency."
hope that HLX02 will benefit china's HER2-positive breast and stomach cancer patients.
"

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