Which company is developing and producing Zolbetuximab and its global launch and supply status?

Zolbetuximab (Zolbetuximab) was originally developed by the German biopharmaceutical company Ganymed Pharmaceuticals and is the world's first drug targeting CLDN18.2 (tight junction protein 18.2) The target monoclonal antibody drug can specifically recognize and bind to CLDN18.2 on the surface of tumor cells, thereby exerting anti-tumor effects. Later, this innovative asset was acquired by the Japanese pharmaceutical giant Astellas Pharma in 2016, and Astellas continued to promote clinical development and global launch.

In terms of global launch, zotuximab has been approved or entered the regulatory approval process in many countries and regions. As of 2024 3 months, the drug has been officially approved in Japan for the treatment of patients with CLDN18.2 positive locally advanced or recurrent gastric cancer. It is the first CLDN18.2 approved in the world. Targeted antibody drugs. Subsequently, it also obtained marketing authorization in markets such as the United Kingdom, the European Union, and South Korea, and passed FDA approval in the U.S. market, becoming one of the targeted treatment options officially available in many countries around the world.

In China, the development and marketing process of zotuximab is also continuing to advance. 2023 8 month, the drug’s marketing application has been accepted by the State Food and Drug Administration, and will be reviewed based on key phase III clinical trial data such as SPOTLIGHT and GLOW . 2024 At the end of 2024, the State Food and Drug Administration officially approved the drug to be marketed in China for the first-line treatment of CLDN18.2 positive and HER2 negative locally advanced unresectable or metastatic gastric cancer and gastroesophageal junction adenocarcinoma. This marks the first in China. CLDN18.2 Targeted antibody drugs have officially entered the market.

Regarding the supply situation, currently zotuximab is mainly supplied in the form of original drug around the world, and there is no officially approved generic version yet. This means that drugs used clinically around the world are produced by Astellas or its authorized distributors, ensuring the consistency of drug ingredients and clinical efficacy. After being launched on the market, due to its target specificity and significant survival benefit, zotuximab has become an important treatment option in the field of CLDN18.2 positive gastric cancer. In the future, with the expansion of indications and market approval in more countries, its supply and accessibility are expected to further increase.

Keyword tag:

Zotuximab,CLDN18.2, gastric cancer, efficacy, safety, targeted therapy, indications, adverse reactions, research and development progress

Reference materials:https://pubmed.ncbi.nlm.nih.gov/39282934/