Congratulations! Qilu Pharmaceutical's Pomalidomide Capsules (Youboan®) Approved for Market Launch with Efficient IRC Services from Taimei Medical Technologies

On June 3, according to the official website of the National Medical Products Administration, Qilu Pharmaceutical's anti-tumor drug Pomalidomide Capsules (Youboan®) officially received marketing approval. The approval of this drug will provide a new treatment strategy for the long-term clinical control of multiple myeloma.

As a collaborative service provider, the Independent Review Center (IRC) of Taimei Medical Technology undertook the clinical efficacy assessment work for its pivotal confirmatory clinical study. Relying on extensive experience in independent efficacy evaluations of imaging and oncology data, a robust quality management system, an efficient digital collaboration platform, and high-quality services with rapid response, the project outcomes were delivered on time with high quality, facilitating product approval and earning acclaim from the sponsor.

Previously, the two parties have cooperated in several key clinical studies, leading to the smooth approval of multiple innovative drugs and indications.

Multiple Myeloma: A Malignant Disease of Clonal Plasma Cell ProliferationMultiple myeloma is a malignant disease characterized by the abnormal proliferation of clonal plasma cells and is one of the most common malignant tumors of the hematological system. Currently, the incidence of multiple myeloma in China has surpassed that of acute leukemia, making it the second most common hematological malignancy. As a third-generation immunomodulatory agent, pomalidomide exhibits unique effects such as anti-infection, immunomodulation, anti-tumor proliferation, and anti-tumor angiogenesis. Clinical trials targeting refractory and relapsed multiple myeloma have demonstrated its good efficacy and lower toxicity.

Clinical data shows that pomalidomide has a high remission rate in the treatment of newly diagnosed relapsed/refractory multiple myeloma, and can significantly prolong progression-free survival and overall survival in subsequent maintenance and consolidation therapy. Pomalidomide also demonstrates convincing efficacy in patients refractory to both lenalidomide and bortezomib.

The newly approved pomalidomide capsules cover four clinical specifications. Compared with the existing pomalidomide capsules in China, two new specifications, 2mg and 3mg, have been added, making it more suitable for patients with mild to severe hepatic and renal impairment, allowing for more convenient dose adjustment. Qilu Pharmaceutical's Youboan® will provide multiple myeloma patients with high-quality yet affordable medication options and greater benefits.

The Independent Review Center (IRC) of Taimei Medical Technology, relying on its self-developed eImage system, supports remote image evaluation and full online operational project management. Equipped with a professional medical and project operations team, as well as extensive resources of senior radiology/reading experts both domestically and internationally, it ensures efficient, compliant, and accurate blinded independent central reading, reduces reading bias, improves the accuracy and reliability of reading results, accelerates trial progress and approval, and lowers costs. To date, the company has provided IRC services to over 150 sponsors, accumulated experience in more than 300 projects, of which nearly 50 projects have passed inspections, and 27 projects have been approved for marketing.