Is the time for the domestic launch of elastran determined?

Elacestrant is an innovative oral selective estrogen receptor degrader (SERD) specifically used to treat patients with advanced or metastatic ER+, HER2- and ESR1-mutated breast cancer. The drug was approved for marketing by the US FDA in January 2023, and was subsequently approved by the European Union in September of the same year. However, for the Chinese market, although ilastrast has received an exclusive license signed by Menarini and SciClone Pharmaceuticals in November 2023 for development and commercialization in China, as of June 2025, the drug is still in the application and clinical trial stages, has not been officially launched in the country, and has not been included in the medical insurance directory.

Elagrastrant is taken orally once a day and directly degrades estrogen receptors. It breaks through the limitations of traditional anti-estrogen therapy from a mechanism, and especially shows higher efficacy for patients who are drug-resistant due toESR1 mutations. This innovative treatment modality leads to its clinical application as the only oral drug targeting this specific mutation. However, drugs still need to go through a series of complex processes before being marketed in China, including clinical trial approval from the China Food and Drug Administration, new drug registration application and marketing authorization approval. Therefore, although elastran has become one of the new standards of treatment internationally, domestic patients still need to wait for the completion of the regulatory approval process before they can obtain the drug.

Currently, in mainland China, elastran is not on the market, which means that it cannot be obtained in regular hospitals and pharmacies, and it cannot be reimbursed through medical insurance. If patients have urgent medication needs, they can only obtain them through "overseas drug purchase"; they can also complete steps such as ordering overseas prescriptions from pharmacies, cold chain transportation, and customs clearance through the assistance of qualified cross-border medical platforms or third-party service intermediaries. However, this path involves regulatory, legal and logistics risks, is costly and time-consuming, and domestic itinerary monitoring also needs to be conducted under the guidance of the attending physician.

References:https://www.drugs.com/mtm/elacestrant.html