SHANGHAI, April 29, 2024 /PRNewswire/ -- Henlius Biotech,
Inc. (2696.HK) announced that the company's business partner,
Accord BioPharma Inc. (the U.S. specialty division of Intas
Pharmaceuticals, Ltd.), has received approval from the United
States Food and Drug Administration (FDA) for HERCESSI™ (HLX02,
trastuzumab-strf, biosimilar to Herceptin® trade name:
HANQUYOU in China and
Zercepac® in Europe), a
trastuzumab biosimilar self-developed and -manufactured by Henlius.
The product has been approved in the
United States (U.S.) for adjuvant treatment of
HER2-overexpressing breast cancer, the treatment of
HER2-overexpressing metastatic breast cancer, and the treatment of
HER2-overexpressing metastatic gastric or gastroesophageal junction
adenocarcinoma. HLX02 is a China-developed monoclonal antibody (mAb)
biosimilar approved in China, the
European Union (EU) and U.S., with previous approvals for
commercialisation by the European Commission (EC) and National
Medical Products Administration (NMPA) in July 2020 and August
2020, respectively.
Since its approval in the EU and China in July and August 2020, HLX02 (trade name: HANQUYOU in
China, HERCESSI™ in the U.S.,
Zercepac® in Europe)
has been successfully approved in more than 40 countries and
regions, including the United
Kingdom, France,
Germany, Switzerland, Australia, Finland, Spain, Argentina, Saudi
Arabia, and Thailand,
covering Asia, Europe, Latin
America, North America, and
Oceania, and it is reimbursed nationally in countries and regions
including China, the United Kingdom (UK), France and Germany. To date, HLX02 has benefited more
than 180,000 patients.
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