Recently (February 20, 2024), Daiichi Sankyo announced that it will [take action] towards GermanyMunichThe factory invested 1 billion euros (1.07 billion US dollars) to expand the production capacity of ADC drugs.
The factory, located in Pfaffenhofen an der Ilm, saw the first part of its expansion project become operational last month. Additionally, Daiichi-Sankyo will establish a new ADC laboratory, which is expected to be completed by 2026.Two ADCs Will Enter the Commercialization StageDS8201, as AstraZeneca/Daiichi Sankyo's blockbuster drug, has experienced extremely rapid sales growth. According to Daiichi Sankyo's Q3 financial report for the fiscal year 2023 released on January 31, 2024, the global sales of Enhertu in the first three quarters (from April 1, 2023, to December 31, 2023) reached 276 billion yen (approximately 1.972 billion US dollars).It is estimated that Enhertu's global sales in 2023 will reach 343.8 billion yen, more than doubling from 2022 (161.6 billion yen). Based on Enhertu's sales growth rate over the past two years, it is now certain to surpass Kadcyla and become the top-selling ADC drug this year.Note: The Japanese fiscal year starts on April 1 of the current year and ends on March 31 of the following year.In addition to DS-8201, two other ADC candidates from Daiichi Sankyo, HER3 ADC and Trop2 ADC, are also about to enter the commercialization stage.HER3-DXd is a potential first ADC drug targeting HER3 developed by Daiichi Sankyo. On October 19, 2023, Merck and Daiichi Sankyo reached a global development and commercialization agreement for three Dxd-ADC candidate drugs, including HER3-DXd, to collaboratively develop these three ADCs worldwide, with a total transaction value of up to 22 billion US dollars.On December 22, 2023, the marketing application for HER3-DXd was accepted by the FDA and granted Priority Review for the treatment of locally recurrent or metastatic EGFR-mutated non-small cell lung cancer in patients who have previously received two or more systemic therapies.The PDUFA date is June 26, 2024.The BLA application is primarily based on the pivotal Phase II HERTHENA-Lung01 clinical data. The results showed that the ORR was 29.8% after patients received HER3-DXd treatment, with a median Duration of Response (DOR) of 6.4 months, a median Progression-Free Survival (PFS) of 5.5 months, and a median Overall Survival (OS) of 11.9 months.This product is also the first HER3-ADC to be submitted for marketing approval. If the approval process goes smoothly, HER3-DXd will become the first marketed HER3-ADC drug.On the previous day (February 19, 2024), the FDA accepted the marketing application in the U.S. for Daiichi Sankyo's Trop2 ADC drug Dato-DXd, intended for advanced non-squamous non-small cell lung cancer patients who have previously received systemic therapy. The PDUFA date is December 20, 2024.The submission for marketing approval is based on the pivotal Phase III TROPION-Lung01 trial data, which showed that, as assessed by BICR, compared with docetaxel, Dato-DXd reduced the risk of disease progression or death by 25%. The median PFS was 4.4 months for patients treated with Dato-DXd and 3.7 months for those treated with docetaxel. The cORR was 26.4% in the Dato-DXd group (vs 12.8% in the docetaxel group), and the median DoR was 7.1 months (vs 5.6 months in the docetaxel group).Reference Source:
https://endpts.com/daiichi-sankyo-invests-1b-to-bulk-out-german-site-for-cancer-adcs/
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