Is zolbetuximab a domestic drug or an imported drug?

Since its mechanism of action was proposed, zolbetuximab has occupied an important position in the global oncology drug research and development field due to its unique strategy of targeting Claudin18.2. As an original monoclonal antibody drug developed by an overseas pharmaceutical company, it was the first in the world to be approved by regulatory agencies in many countries, and is regarded as an important breakthrough in the precise treatment of gastric cancer and gastroesophageal junction cancer. As this type of targeted drugs gradually enter the market of many countries, China has also recently completed its marketing registration, making it a state where imported original drugs have officially entered the domestic market.

Since the drug is still within the patent protection period, no generic drugs have been approved or launched in China, so the original imported versions used on the market are all. For many patients, "Whether it is made in China" not only affects the price, but also affects whether the country can quickly form a more competitive supply system. However, currently available global information shows that the technical barriers to research and development of zotuximab are relatively high, and the antibody engineering structure is complex, making imitation significantly more difficult. In addition, since it was launched not long ago, the scope of patent protection covers production details and core target design, so Chinese pharmaceutical companies have not yet been able to carry out mature commercial generics.

As for accessibility issues that patients are concerned about, factors such as hospital access, hierarchical management, and medical insurance negotiations will affect the actual scope of use of the drug after it is launched in China. Judging from overseas experience, the popularization of new monoclonal antibodies usually needs to go through stages such as channel construction, drug standardization and price competition. As domestic hospitals continue to improve the precise treatment path for gastric cancer, the accessibility of this drug is expected to increase in the future, but in the short term, the supply will still be mainly imported from original research. Generally speaking, zotuximab is currently an "imported original drug" in China and is within the patent protection period. There are no domestic substitutes on the market.

Reference materials:https://www.astellas.com/en/news/29401