When is Tarlatamab expected to be launched in the country?

As of2025 June, tarlatamab (Tarlatamab, trade name Imdelltra) has not yet been officially launched in China, but its launch in China is in an active stage of advancement. The drug was developed by Amgen (Amgen) and BeiGene (BeiGene) has the commercialization rights in the Chinese market. Currently, talatumumab has entered Phase III clinical trials in China, mainly targeting patients with limited-stage small cell lung cancer (LS-SCLC). According to information from the China Clinical Trial Registration Center, the relevant Phase III clinical trial (DeLLphi-306) has been completed in 2024 It will be launched on April 28. It plans to recruit 77 patients domestically and 400 patients internationally.

Talatumumab is a bispecific T cell engager (BiT) targeting DLL3 and CD3 E), its mechanism is to guide T cells to tumor cells expressing DLL3 and activate T cells to kill tumor cells. In the United States, the drug has received accelerated approval from the FDA in May 2024 for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has progressed during or after platinum-based chemotherapy. This approval provides a new treatment option for patients with advanced small cell lung cancer.

In China, phase III clinical trials of talatumumab are ongoing and expected to be completed within the next few years. According to the progress and approval process of clinical trials in China, if the results of Phase III trials are good, the time to submit a marketing application and obtain approval may be in 2026 or 2027 year. However, the specific launch time still needs to be comprehensively considered based on clinical trial results, regulatory approval progress, market factors and other factors.

In short, the launch of talatumumab in China is progressing in an orderly manner and is expected to provide new treatment options for Chinese patients with small cell lung cancer in the next few years. Patients and healthcare professionals should monitor the latest developments in relevant clinical trial results and regulatory approvals to obtain the most accurate information.

Reference materials:https://www.drugs.com/donanemab.html