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Jiangsu Hengrui Pharmaceuticals Receives NMPA Approval for SHR-9803 and SHR-A2102 Clinical Trials
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced receiving separate clinical trial approvals from the National Medical Products Administration (NMPA) for its anti-tumor drugs SHR-9803 and SHR-A2102. This marks a significant step forward in the development of these promising therapies. SHR-9803: Targeting Regulatory T CellsSHR-9803, a Category 1 biologic…
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Basilea Pharmaceutica Marks Milestone as Cresemba Sales Soar in Asia Pacific
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Switzerland-based Basilea Pharmaceutica Ltd (SWX: BSLN) announced that its antifungal Cresemba (isavuconazole), commercialized by Pfizer Inc. (NYSE: PFE), has achieved significant sales milestones in the Asia Pacific region and China. This performance has triggered a milestone payment of USD2.5 million to Basilea. Drug Profile and CommercializationCresemba, co-developed with Japan’s Astellas…
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Astellas Pharma and YASKAWA Establish JV for Cell Therapy Product Manufacturing Platform
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Japan-based Astellas Pharma Inc. (TYO: 4503) is set to establish a joint venture (JV) with compatriot firm YASKAWA Electric Corporation (TYO: 6506). The collaboration aims to develop a cell therapy product manufacturing platform utilizing Maholo, a cutting-edge dual-arm robot developed by YASKAWA’s subsidiary, the Robotic Biology Institute. This innovative platform…
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Astellas Pharma’s Xospata Wins Regular NMPA Approval for FLT3-Mutated AML
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Japan-based Astellas Pharma Inc. (TYO: 4503, OTCMKTS: ALPMY ) announced that the National Medical Products Administration (NMPA) has converted the conditional approval for its Xospata (gilteritinib) into regular approval. The decision is based on data from the COMMODORE study, a Phase III trial comparing gilteritinib to salvage chemotherapy in patients…
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Astellas Pharma’s Izervay Gets FDA Approval for GA Treatment Without Dosing Limit
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Japan-based Astellas Pharma Inc. (TYO: 4503) has announced that the US Food and Drug Administration (FDA) has approved its label extension application for Izervay (avacincaptad pegol intravitreal solution). The approval allows the drug to treat geographic atrophy (GA) secondary to age-related macular degeneration (AMD) without any limitation on the duration…
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Astellas Pharma Submits NDA for Avacincaptad Pegol in Japan for Geographic Atrophy
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Japan-based major Astellas Pharma (TYO: 4503) announced that it has submitted a New Drug Application (NDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) seeking conditional approval for its avacincaptad pegol intravitreal solution (ACP). The drug is a synthetic aptamer that inhibits the complement C5 protein and is intended…
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Astellas’ Padcev and Keytruda Combo Cleared by NMPA for Urothelial Cancer
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Japan-based Astellas Pharma Inc. (TYO: 4503) has announced marketing clearance by China’s National Medical Products Administration (NMPA) for its Padcev (enfortumab vedotin) in combination with Keytruda (pembrolizumab) to treat adult patients with locally advanced or metastatic urothelial cancer (la/mUC). This combination offers a new therapeutic option to patients in China,…
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Astellas Pharma’s Vyloy Approved by NMPA for CLDN18.2 Positive Gastric Cancer
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China’s National Medical Products Administration (NMPA) has indicated on its website that Japan-based Astellas Pharma Inc. (TYO: 4503) has received approval for its drug Vyloy (zolbetuximab-clzb). The drug is approved for use in combination with fluoropyrimidine- and platinum-containing chemotherapy for first-line locally advanced unresectable or metastatic claudin (CLDN) 18.2 positive,…
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Astellas Pharma Partners with Axcelead DDP for Targeted Protein Degraders Discovery
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Japan-based Astellas Pharma Inc. (TYO: 4503) has struck an accord with compatriot firm Axcelead Drug Discovery Partners, Inc. (Axcelead DDP) to collaborate on the discovery of new candidate compounds for targeted protein degraders (TPD). Axcelead DDP’s DegLead Platform to Support Astellas’ TPD DiscoveryAxcelead DDP, a company focused on targeted protein…
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Astellas Pharma Inks Licensing Deal with Sangamo Therapeutics for Neurological AV Capsid STAC-BBB
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Japan-based Astellas Pharma Inc. (TYO: 4503) has revealed a strategic licensing agreement with US-based Sangamo Therapeutics, Inc. (NASDAQ: SGMO). This collaboration will enable Astellas to utilize Sangamo’s novel proprietary neurotropic adeno-associated virus (AAV) capsid, STAC-BBB, targeting an undisclosed neurological condition. Financial Terms and Potential Impact on Astellas’ PipelineThe agreement allows…
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Astellas Pharma’s Izervay sNDA for Geographic Atrophy Receives FDA Complete Response Letter
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Japan-based Astellas Pharma Inc. (TYO: 4568) has announced that its supplemental New Drug Application (sNDA) for Izervay (avacincaptad pegol), indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD), has received a Complete Response Letter (CRL) from the US FDA. The CRL addresses a statistical matter…
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LaNova Medicines Regains Rights to Claudin 18.2 Targeting ADC LM-302 from BMS
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LaNova Medicines Ltd, a Shanghai-based developer of cancer therapies, has announced the reclamation of control over LM-302, an antibody drug conjugate (ADC) targeting Claudin 18.2, from US pharmaceutical giant Bristol-Myers Squibb (BMS; NYSE: BMY). LaNova had previously signed an agreement with Turning Point Therapeutics, Inc. (TPTX.US) in May 2022 to…
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Astellas Pharma’s Vyloy Receives FDA Approval for Gastric Cancer Treatment in CLDN18.2 Positive Tumors
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Astellas Pharma Inc. (TYO: 4503), a Japanese pharmaceutical company, has announced that it has received market approval from the US Food and Drug Administration (FDA) for its drug Vyloy (zolbetuximab-clzb). The approval is for use in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally…
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Astellas Pharma Employee in China Formally Indicted on Espionage Suspicion
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Astellas Pharma Inc., a Japanese pharmaceutical company listed on the Tokyo Stock Exchange (TYO: 4503), is facing a challenging situation as one of its employees, detained in China since March 2023 on suspicion of espionage, has reportedly been formally indicted by Chinese authorities. The news was reported by Reuters, citing…
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Astellas Pharma’s Padcev Receives NMPA Approval for Urothelial Cancer Treatment
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TOKYO—Astellas Pharma Inc. (TYO: 4503) has announced that its anti-HER3 antibody-drug conjugate (ADC), Padcev (enfortumab vedotin), in partnership with Pfizer, has been granted approval by China’s National Medical Products Administration (NMPA) for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) who have received prior platinum-containing…
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Astellas Pharma Secures UK Approval for First-in-Class Gastric Cancer Therapy Vyloy
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Astellas Pharma (TYO: 4503), a leading Japanese pharmaceutical company, has secured market approval in the UK for its first-in-class gastric cancer therapy, Vyloy (zolbetuximab), targeting Claudin18.2 (CLDN18.2). According to a press release from the Medicines and Healthcare products Regulatory Agency (MHRA), the approval allows Vyloy to be used as a…
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Pfizer, Astellas, and University of California Sue Qilu Pharma Over Xtandi Patent Infringement
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Pfizer Inc. (NYSE: PFE), through its subsidiary Medivation, and co-development partner Astellas Pharma Inc. (TYO: 4503), are stepping up their efforts to safeguard the intellectual property of their blockbuster prostate cancer drug, Xtandi (enzalutamide). In a joint legal action with the University of California, the companies have filed a lawsuit…
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Astellas Pharma Reports Robust Q1 FY2024 Results, Highlighting Growth in Core Therapies
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Japan-based Astellas Pharma Inc. (TYO: 4503) has announced its financial results for the first quarter of the fiscal year 2024, ending June 30, 2024. The company reported a robust performance with a 26.2% increase in global sales, reaching JPY 473,124 million (USD 3.16 billion) compared to the same period last…
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Astellas Pharma’s Xtandi Secures Third Market Approval in China for Prostate Cancer Treatment
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Astellas Pharma Inc. (TYO: 4503), a leading Japanese pharmaceutical company, has announced that it has secured market approval in China for a new indication of its drug Xtandi (enzalutamide), marking its third such approval in the country. The drug is now approved for the treatment of metastatic hormone-sensitive prostate cancer…
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Astellas Resubmits FDA Application for Vyloy as Treatment for CLDN18.2-Positive Cancer
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Astellas Pharma Inc. (TYO: 4503), a Japanese pharmaceutical company, has resubmitted its first-in-class anti-CLDN18.2 biologic Vyloy (zolbetuximab) to the US Food and Drug Administration (FDA) for the treatment of locally advanced unresectable or metastatic HER2-negative CLDN18.2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. This resubmission follows an earlier rejection and comes…
