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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…
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Daiichi Sankyo Reports 24.3% YOY Revenue Growth, Driven by Enhertu and Lixiana
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Daiichi Sankyo (TYO: 4568), a leading pharmaceutical company in Japan, reported a significant year-on-year (YOY) growth of 24.3%, with revenues reaching JPY 436.18 billion (USD 3.0 billion). This Q1’24 result is notable for being the first to not include revenues from Daiichi Sankyo Espha, the company’s generics unit that was…
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NICE and AstraZeneca Fail to Reach Agreement on Enhertu Reimbursement for NHS
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The UK’s National Institute for Health and Care Excellence (NICE) has announced that negotiations with AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) for the reimbursement of the antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) within the National Health Service (NHS) have concluded without an agreement. Enhertu is approved in the…
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Daiichi Sanky’s Mirogabalin Gets Green Light from China for Diabetic Neuropathic Pain
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Daiichi Sanky (TYO: 4568), a pharmaceutical company based in Japan, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its drug Tarlige (mirogabalin) for the treatment of diabetes peripheral neuropathic pain (DPNP). Mirogabalin is a gabapentinoid drug, which belongs to the same class…
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Merck’s HER3-Targeted ADC Patritumab Deruxtecan Faces FDA Complete Response Letter
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Merck, Sharp & Dohme Inc. (NYSE: MRK), a leading U.S. pharmaceutical company, has announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) for patritumab deruxtecan, a first-in-class HER3-targeted antibody-drug conjugate (ADC) discovered by Daiichi Sankyo…
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Daiichi Sankyo Reports 25.3% Revenue Growth in FY2023, Boosted by Enhertu and Lixiana Sales
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Japanese pharmaceutical company Daiichi Sankyo has reported a remarkable fiscal year 2023, with revenues increasing by 25.3% to ¥1.602 trillion (USD 10.05 billion) for the 12-month period ended March 31, 2024. The growth was primarily driven by the success of its HER2-targeted antibody drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) and…
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Roche Secures CE Mark for Ventana HER2 Test, Enhancing Access to AstraZeneca’s Enhertu
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Roche (SWX: ROG), based in Switzerland, has received CE marking from the European Commission (EC) for a new indication of its antibody-based test, Ventana HER2 (4B5). This test serves as a companion diagnostic to identify breast cancer patients eligible for AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo’s (TYO: 4568) antibody-drug…
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AstraZeneca and Daiichi Sankyo File for FDA Approval of Datopotamab Deruxtecan in Breast Cancer
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AstraZeneca (AZ; NASDAQ: AZN), headquartered in the UK, and its Japanese partner Daiichi Sankyo (TYO: 4568) have submitted a filing to the U.S. Food and Drug Administration (FDA) for their antibody-drug conjugate (ADC) datopotamab deruxtecan, aimed at treating unresectable or metastatic HR-positive, HER2-negative breast cancer in adults who have previously…
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EMA Reviews Datopotamab Deruxtecan Filings from AstraZeneca and Daiichi Sankyo for Oncology Indications
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The European Medicines Agency (EMA) has accepted for review two oncology filings for the antibody-drug conjugate (ADC) datopotamab deruxtecan, developed jointly by UK-based AstraZeneca (AZ; NASDAQ: AZN) and Japan’s Daiichi Sankyo (TYO: 4568). The indications submitted for review are for the treatment of locally advanced or metastatic nonsquamous non-small cell…
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CDE Grants Priority Review to Jiu An’s Adrenaline and AnHeart’s Taletrectinib; Two Others Earn Breakthrough Therapy Designation
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The Center for Drug Evaluation (CDE) has announced that Jiu An Pharmaceutical’s adrenaline and AnHeart Therapeutics’ taletrectinib are set for priority review, while Biotheus Inc.’s PM8002 and Sichuan Kelun Pharmaceutical Co., Ltd. (SHE: 002422)’s SKB264 have been designated as breakthrough therapies (BTDs). Adrenaline is gaining priority status due to new…
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USPTO Invalidates Key Seagen-Held Patent in ADC Conjugation Dispute with Daiichi Sankyo
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In a surprising turn of events in the ongoing intellectual property dispute, the US Patent and Trademark Office (PTO) has invalidated a 2020 patent for conjugation compounds used in antibody-drug conjugates (ADCs), which was held by Pfizer’s (NYSE: PFE) subsidiary Seagen and contested by Japan’s Daiichi Sankyo (TYO: 4568). The…
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Daiichi Sankyo and Esperion Therapeutics Amend Collaboration on Antilipidemic Drugs
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Daiichi Sankyo (TYO: 4568)’s European subsidiary, a Japanese pharmaceutical company, has entered into a collaboration amendment agreement with US-based Esperion Therapeutics (NASDAQ: ESPR) concerning Esperion’s antilipidemic drugs Nilemdo (bempedoic acid) and Nustendi (bempedoic acid + ezetimibe). The revised agreement stipulates that Esperion will receive an immediate payment of USD 100…
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FDA Grants Priority Review to MSD and Daiichi Sankyo’s ADC for Lung Cancer
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The US Food and Drug Administration (FDA) has accepted under priority review a filing from Merck, Sharp & Dohme (MSD; NYSE: MRK) and Daiichi Sankyo (TYO: 4568) for their jointly developed antibody-drug conjugate (ADC) patritumab deruxtecan. The treatment is intended for patients with locally advanced or metastatic EGFR-mutated non-small cell…
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Jiangsu Hengrui Pharmaceuticals Wins NMPA Approvals for SLE and Lymphoma Drug Candidates
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading Chinese pharmaceutical company, has announced that it has received separate clinical trial approvals from China’s National Medical Products Administration (NMPA) for two of its drug candidates, SHR0302 and SHR2554. SHR0302 is anticipated to treat systemic lupus erythematosus (SLE), while SHR2554 is…
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Enhertu Receives Priority Review Status for HER2-Positive Gastric Cancer Treatment in China
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The Center for Drug Evaluation (CDE) website has indicated that Enhertu (trastuzumab deruxtecan), a HER2-targeted antibody drug conjugate (ADC) co-developed by AstraZeneca (AZ, NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568), is set for priority review status in China. This priority review is specifically for the ADC’s potential use as a…
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Daiichi Sankyo Reports 19.5% YOY Revenue Growth in First Half of Fiscal 2023
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Japan’s Daiichi Sankyo (TYO: 4568) reported a robust 19.5% year-on-year (YOY) increase in revenue for the six months ended September 30, 2023, reaching JPY 726.3 billion (USD 4.8 billion), according to the company’s financial report published this week. This growth was driven by a combination of factors, including the depreciation…
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EMA’s CHMP Backs Enhertu for Advanced NSCLC with HER2 Mutations
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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the use of Enhertu (trastuzumab deruxtecan), an antibody-drug conjugate (ADC) developed by AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568), in the treatment of advanced non-small cell lung…
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AstraZeneca and Daiichi Sankyo Report Positive Results for Datopotamab Deruxtecan Combo in NSCLC
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UK-based pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) has announced positive data from a Phase Ib study for the antibody-drug conjugate (ADC) datopotamab deruxtecan in combination with checkpoint inhibitor Imfinzi (durvalumab). The study, conducted in partnership with Daiichi Sankyo (TYO: 4568), focused on first-line advanced or metastatic non-small cell lung cancer…
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AstraZeneca and Daiichi Sankyo’s Enhertu Earns Two BTDs for HER2+ Malignancies
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The US Food and Drug Administration (FDA) has granted AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) two breakthrough therapy designations (BTDs) for their co-developed antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan). This recognition is for its potential as a therapy for HER2-positive malignancies, including unresectable or metastatic solid tumors…
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FDA Approves Daiichi Sankyo’s Vanflyta for FLT3-ITD Positive AML Maintenance Treatment
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The US Food and Drug Administration (FDA) has granted clearance to Japan-based Daiichi Sankyo (TYO: 4568) for its type II FLT3 inhibitor, Vanflyta (quizartinib), as a maintenance treatment following consolidation chemotherapy for newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive in adult patients. Phase III Study Results and…
