crashgamestation| Fuhong Hanlius (02696.HK): HLX02 (trastuzumab) has been approved by the US FDA for adjuvant treatment of breast cancer, metastatic breast cancer and metastatic gastric cancer

Gronghui replied to Hong Hanlin (02696) on April 26th.Crashgamestation.HK) announceCrashgamestationRecentlyCrashgamestationAccord received a letter of approval from FDA, and 150mg/ bottle size HLX02 (Trastuzumab for injection) was approved by FDA for yu (1) adjuvant therapy for breast cancer with HER2 overexpression; (2) treatment of metastatic breast cancer with HER2 overexpression; and (3) treatment of HER2 overexpression metastatic gastric adenocarcinoma or gastroesophageal borderline adenocarcinoma. Its yu is approved under the trade name HERCESSITM in the United States. Accordingly, HLX02 (Trastuzumab for injection) became the company's first product approved by FDA to be marketed in the United States.

The FDA approval is mainly based on what is known as Hanquyou in Chinese mainland.Crashgamestation? HLX02 (trastuzumab for injection) was compared with its reference drug (Herceptin?). Review of a series of research data, including analysis of similarity studies and clinical studies, these data prove that HLX02 (trastuzumab for injection) and its reference drug (Herceptin?) Highly similar in terms of quality, safety and effectiveness. At the same time, the relevant production sites and facilities of the Group HLX02 (Trastuzumab for injection) have also undergone pre-approval inspections (Pre-License Inspection, PLI) by FDA, which can meet the cGMP of FDA.

According to the announcement, HLX02 (Trastuzumab for injection) is the company's first product approved by FDA to be listed in the United States. This approval will further promote the process of the company's international layout and enhance the international influence of the company's products.