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Daiichi Sankyo Reports 16.6% Revenue Growth in First Three Quarters of FY2024
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Japan-based Daiichi Sankyo (TYO: 4568) has reported revenues of JPY 1.37 trillion ($8.927 billion) for the first three quarters of the fiscal year 2024 (April 1, 2024, to March 31, 2025), representing a 16.6% year-on-year (YOY) growth. Core operating revenue stood at JPY 248.311 billion ($1.621 billion), up 27.6% YOY.…
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Enhertu Approved by FDA for HR-Positive, HER2-Low Breast Cancer
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Daiichi Sankyo (TYO: 4568) and AstraZeneca (AZ, NASDAQ: AZN) jointly announced that their co-developed antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) has received FDA approval for the treatment of unresectable or metastatic hormone receptor (HR) positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2 ultra-low (IHC 0 with membrane staining) breast…
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FDA Approves Datroway for HR+/HER2- Breast Cancer Treatment
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Datroway (datopotamab deruxtecan-dlnk, Dato-Dxd), a Trop-2-directed antibody and topoisomerase inhibitor conjugate co-developed by Japan-based Daiichi Sankyo (TYO: 4568) and UK major AstraZeneca (AZ, NASDAQ: AZN), last week received approval from the US FDA for the treatment of adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor…
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Daiichi Sankyo Acquires Gatipotuzumab IP Rights for $132.5M
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Japan-based Daiichi Sankyo Company, Ltd (TYO: 4568) has announced an investment of USD 132.5 million to acquire the intellectual property (IP) rights of gatipotuzumab, an antitumor-associated mucin-1 (TA-MUC1) antibody, from Germany-headquartered Glycotope GmbH. This strategic acquisition strengthens Daiichi Sankyo’s portfolio in cancer therapy. Acquisition Details and BackgroundDaiichi Sankyo obtained global…
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Hengrui’s HER2-Targeted ADC and Antibody Drug Combo Approved for Trials
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its SHR-A1811 combined with SHR-9839 in advanced solid tumors. This approval is a significant step forward in the development of innovative treatments for patients with advanced cancer. SHR-A1811:…
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Daiichi Sankyo’s Datroway Approved in Japan for HR+, HER2- Breast Cancer
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Japan-based pharmaceutical company Daiichi Sankyo (TYO: 4568) has announced that it has received marketing approval in Japan for its datopotamab deruxtecan, to be sold under the commercial name Datroway. Datroway is indicated for the treatment of adult patients with hormone receptor (HR) positive, HER2 negative unresectable or recurrent breast cancer,…
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Daiichi Sankyo and AstraZeneca Withdraw EU Application for Datopotamab Deruxtecan in Lung Cancer
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Partners Daiichi Sankyo (TYO: 4568) and AstraZeneca (AZ, NASDAQ: AZN) have jointly announced the voluntary withdrawal of the marketing authorization application (MAA) in the European Union for their co-developed drug, datopotamab deruxtecan (Dato-DXd). This decision pertains to the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell…
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Jiangsu Hengrui’s Trastuzumab Rezetecan on Track for NMPA’s Breakthrough Therapy Designation
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276), a leading pharmaceutical company based in China, has announced that its trastuzumab rezetecan (SHR-A1811), an HER2 targeted antibody-drug conjugate (ADC), is on course to receive Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation of the National Medical Products Administration (NMPA). The…
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Daiichi Sankyo and AstraZeneca’s Datopotamab Deruxtecan Earns FDA Breakthrough Therapy Designation
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Partners Daiichi Sankyo (TYO: 4568) and AstraZeneca (AZ, NASDAQ: AZN) have jointly announced that their co-developed TROP-2-targeted antibody drug conjugate (ADC), datopotamab deruxtecan (Dato-DXd), has received Breakthrough Therapy Designation (BTD) from the US Food and Drug Administration (FDA). The designation is based on the positive results from the Phase II…
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Daiichi Sankyo Invests RMB 1.1 Billion in New ADC Manufacturing Plant in Shanghai
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Japanese pharmaceutical company Daiichi Sankyo (TYO: 4568) is significantly increasing its investment in China with a RMB 1.1 billion outlay to establish a new antibody drug conjugate (ADC) manufacturing plant in Zhangjiang, located in Shanghai’s Pudong New Area. This strategic move by the firm is aimed at addressing the escalating…
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Daiichi Sankyo and AstraZeneca File BLA for Datopotamab Deruxtecan in NSCLC
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Daiichi Sankyo (TYO: 4568) and AstraZeneca (AZ, NASDAQ: AZN), partners in the development of innovative oncology treatments, have jointly announced the submission of a Biologic License Application (BLA) to the US Food and Drug Administration (FDA) for their co-developed TROP-2-targeted antibody drug conjugate (ADC), datopotamab deruxtecan (Dato-DXd). This application seeks…
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Alteogen Secures Exclusive Licensing Deal with Daiichi Sankyo for Subcutaneous Enhertu
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Alteogen Inc. (KOSDAQ: 196170), a South Korea-based biotechnology company, has announced an exclusive licensing agreement with Japan-headquartered Daiichi Sankyo (TYO: 4568). This strategic partnership grants Daiichi Sankyo worldwide rights to utilize Alteogen’s ALT-B4, a novel hyaluronidase based on Hybrozyme Technology, in the development and commercialization of a subcutaneous version of…
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Daiichi Sankyo and Alteogen Sign $300 Million Deal to Develop Subcutaneous Enhertu
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Daiichi Sankyo (TYO: 4568), a leading Japanese pharmaceutical company, has entered into a potentially $300 million agreement with South Korean biotechnology firm Alteogen to develop a subcutaneous injection version of its cancer drug Enhertu, which is also in collaboration with AstraZeneca. This innovative step aims to enhance patient accessibility and…
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Daiichi Sankyo’s Pexidartinib Poised for Priority Review in China for TGCT Treatment
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The official website of the Center for Drug Evaluation (CDE) under China’s National Medical Products Administration (NMPA) has indicated that Daiichi Sankyo (TYO: 4568)’s pexidartinib (PLX3397) is on track to receive priority review status for the treatment of symptomatic giant cell tumor of the tendon sheath (TGCT) in adult patients…
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MSD and Daiichi Sankyo’s Patritumab Deruxtecan Achieves Milestone in Phase III Lung Cancer Trial
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Global healthcare leaders Merck, Sharp & Dohme Inc.(MSD; NYSE: MRK), known as MSD outside the US and Canada, and Daiichi Sankyo (TYO: 4568) have announced that their jointly developed anti-HER3 antibody drug conjugate (ADC), patritumab deruxtecan, has demonstrated a significant progression-free survival (PFS) benefit in the Phase III HERTHENA-Lung02 trial.…
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Merck and Daiichi Sankyo’s HER3-DXd ADC Patritumab Deruxtecan Passes Phase 3 Trial After FDA Rejection
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Merck (NYSE: MRK) and Daiichi Sankyo (TYO: 4568) announced that their antibody-drug conjugate (ADC) patritumab deruxtecan (HER3-DXd) has passed Phase 3 HERTHENA-Lung 02 study, months after the drug was rejected by the U.S. FDA due to manufacturing issues following its presentation at this year’s ESMO conference. The companies will discuss…
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Merck and Daiichi Sankyo’s Ifinatamab Deruxtecan Shows Promising Results in Phase II ES-SCLC Trial
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Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK), a leading U.S. pharmaceutical company, and its co-development partner Daiichi Sankyo (TYO: 4568), have announced preliminary data from a Phase II clinical trial for the investigational B7-H3-directed antibody-drug conjugate (ADC) ifinatamab deruxtecan. The trial has identified a recommended dosage of 12mg/kg for…
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Daiichi Sankyo Launches Tarlige for Diabetes Peripheral Neuropathic Pain in China
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Daiichi Sankyo (TYO: 4568), a leading Japanese pharmaceutical company, has announced the official market launch of its medication Tarlige (mirogabalin) in China, targeting the treatment of diabetes peripheral neuropathic pain (DPNP). This third-generation calcium channel regulator received marketing approval in China in July of this year and holds the potential…
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Enhertu Gains Conditional Approval in China for Advanced HER2-Positive Gastric Cancer
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Enhertu (trastuzumab deruxtecan), an HER2-targeted antibody-drug conjugate co-developed by AstraZeneca (NASDAQ: AZN, LON: AZN) and Daiichi Sankyo (TYO: 4568), has received conditional approval in China for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJ) who have undergone two or more…
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Daiichi Sankyo and MSD Broaden Partnership to Co-Develop T-Cell Engager MK-6079
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Daiichi Sankyo (TYO: 4568), a Japanese pharmaceutical company, has announced an expansion of its strategic partnership with U.S.-based Merck, Sharp & Dohme (MSD; NYSE: MRK) to include global co-development of an antibody drug conjugate (ADC). This extension incorporates a new T-cell engager, MK-6079, which MSD acquired as part of its…
