Why is Anamorelin not yet available in China?

Anamorelin(Anamorelin) has been widely discussed internationally for many years, but so far it has not been officially approved for marketing in mainland China. This situation has confused many patients. From the perspective of drug supervision and clinical positioning, the reason is not caused by a single factor, but the result of a combination of multiple factors.

First of all, the indications of anamorelin are somewhat specific. It is mainly used for cancer cachexia, which is clinically a complex syndrome involving multiple aspects such as the tumor itself, inflammatory response, metabolic disorder and nutrient absorption. Compared with anti-tumor drugs with clear targets, the approval process for this type of supportive care drugs requires more cautious requirements for efficacy evaluation and endpoint setting. The attitude of overseas regulatory agencies on related issues also directly affects the pace of listing in different countries.

Secondly, from a global perspective, the most important original research version of Anamorelin is currently the version marketed in Japan, and its R&D and commercialization path has not adopted a "synchronous global advancement" strategy. For the Chinese market, whether to introduce a new drug often involves a company's comprehensive assessment of market size, accessibility to medical insurance, and long-term return on investment. In the context of increasingly fierce competition in cancer treatment drugs, companies are more inclined to prioritize innovative drugs that directly affect survival outcomes, rather than supporting treatment areas.

In addition, in terms of cachexia management in China, nutritional support and comprehensive intervention have long been the main focus, and the standardized path for drug treatment is still being gradually improved. This also affects the clinical positioning and approval priority of anamorelin in China to a certain extent. At present, if domestic patients need to use anamorelin, they mainly obtain it through overseas channels, and most of them are Japanese original drugs. This current situation also suggests that the drug is still in the stage of "medical attention is greater than policy advancement" in China.

Reference materials:https://pmc.ncbi.nlm.nih.gov/articles/PMC4677053/