(Health Korea News / Wonjin Park) Celltrion received an clinical trial protocol (IND) from the U.S. Food and Drug Administration (FDA) for the global phase 3 clinical trial of ‘CT-P44’, a DARZALEX (ingredient name: daratumumab) biosimilar. It was announced on the 27th that approval had been obtained.
Based on this approval, Celltrion plans to begin a global phase 3 clinical trial targeting a total of 486 patients with refractory or relapsed multiple myeloma to prove the similarity in pharmacokinetics, efficacy, and safety between the original drug Darzalex and CT-P44. am.
Darzalex is a targeted anticancer drug that blocks the growth of cancer cells by targeting and binding to a specific protein present on the surface of multiple myeloma cells. As of last year, Darzalex’s global market sales amounted to approximately $9.744 billion (KRW 12.6672 trillion), and its substance patent is scheduled to expire in 2029 and 2031 in the U.S. and Europe, respectively.
Celltrion has further strengthened its anticancer drug portfolio by adding a new targeted anticancer drug pipeline through clinical trials of CT-P44. Starting with this US IND approval, the strategy is to focus on securing Phase 3 clinical results while also speeding up clinical procedures in major global countries, including Europe, where IND applications have already been completed.
Celltrion is rapidly expanding its market share by launching three targeted anti-cancer drugs, including Truxima for blood cancer treatment, Herzuma for breast and stomach cancer, and Begzelma for metastatic colorectal cancer, in major global countries such as the United States, Europe, and Japan. Additionally, in August of last year, the FDA approved the Phase 3 clinical trial IND for Keytruda biosimilar ‘CT-P51’ and began clinical trials in earnest, accelerating its entry into the immunotherapy field.
Celltrion recently disclosed the results of non-clinical research on ‘CT-P70’ and ‘CT-P71’, an antibody-drug conjugate (ADC) pipeline targeting solid cancers such as non-small cell lung cancer (NSCLC) and bladder cancer, and is also actively developing new anti-cancer drugs. They are stepping forward.
A Celltrion official said, “Our new pipeline, CT-P44, has received clinical approval in the United States, the world’s largest anticancer market, and has entered full-scale clinical procedures to prepare to target the daratumumab market worth approximately 12.7 trillion won.” He added, “We have already proven our competitiveness in the global market.” “We will do our best to secure a portfolio of anticancer antibody treatments, including three types of targeted anticancer drugs, immunotherapies, and new ADC drugs that we will secure in the future,” he said.
Meanwhile, Celltrion has recently succeeded in proving its own drug development capabilities by quickly achieving the goal of ‘building 11 product lines by 2025’ presented at the beginning of the year through successive approvals of follow-up pipelines. Celltrion plans to build a portfolio of 22 biosimilars by 2030 and further strengthen its dominance in the global market.
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