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Mabwell Bioscience Receives NMPA Approval for 9MW2821 Clinical Trials
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a China-based biopharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate clinical studies for its antibody drug conjugate (ADC), 9MW2821. This drug targets Nectin-4 and will be evaluated in combination with programmed-death 1 (PD-1)…
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Mabwell Bioscience Initiates Phase III Trial for 9MW2821 Combo in Urothelial Carcinoma Following NMPA Clearance
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Mabwell (Shanghai) Bioscience Co., Ltd, a biopharmaceutical company listed in China (SHA: 688062), has announced the commencement of patient enrollment for a pivotal Phase III clinical trial. The study will evaluate the efficacy and safety of 9MW2821 in combination with toripalimab for the first-line treatment of patients with locally advanced…
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Mabwell Bioscience Receives Approval for Phase III Trial of 9MW2821 in Cervical Cancer from China’s CDE
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Mabwell (Shanghai) Bioscience Co., Ltd, a biopharmaceutical company listed in China (SHA: 688062), has received approval from the Center for Drug Evaluation (CDE) in China to proceed with a Phase III clinical trial for its pipeline candidate, 9MW2821. The study is designed as a randomized, open, controlled, multi-center trial, comparing…
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Mabwell’s Nectin-4 Targeting ADC 9MW2821 on Path to Breakthrough Designation in China for Urothelial Carcinoma
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced that its antibody drug conjugate (ADC), 9MW2821, which targets Nectin-4, is on track to receive breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the…
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Mabwell Bioscience Partners with Cristália for Biosimilar Denosumab in Brazil
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has entered into a licensing agreement with Cristália Produtos Químicos Farmacêuticos LTDA, a Brazil-headquartered pharmaceutical company. Cristália will take on the responsibility for the regulatory submission and commercialization of Mabwell’s biosimilars MAILISHU (9MW0311) and MAIWEIJIAN (9MW0321) in…
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Mabwell Bioscience Secures Rights to Risen Pharmaceutical’s OA Treatment in Greater China
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a leading biopharmaceutical company in China, has entered into a licensing agreement with Suzhou Risen Pharmaceutical, securing comprehensive rights for the latter’s osteoarthritis treatment, RP901, and its companion diagnostics in Greater China. This includes rights for research and development, regulatory filing, commercialization, and…
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Mabwell Bioscience Lands Orphan Drug Status for B7-H3 Targeting ADC in Small Cell Lung Cancer
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has been granted Orphan Drug Designation (ODD) by the National Medical Products Administration (NMPA) for its antibody drug conjugate (ADC), 7MW3711. The drug targets B7-H3, a receptor overexpressed in various cancers, and is specifically indicated for the treatment of small cell lung cancer…
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Mabwell Bioscience Receives NMPA Approval for Phase II TNBC Clinical Trial of 9MW2821
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced that China’s National Medical Products Administration (NMPA) has granted approval for a Phase II clinical study of its antibody drug conjugate (ADC) 9MW2821, which targets Nectin-4, in patients with triple negative breast cancer (TNBC). The study will evaluate the efficacy and…
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Mabwell Bioscience’s 9MW2821 Earns FDA Fast Track Designation for Triple Negative Breast Cancer
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced that it has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for its investigational antibody-drug conjugate (ADC), 9MW2821. This candidate is designed to target Nectin-4 and is currently in development…
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Fosun Pharmaceutical’s Humira Biosimilar Gains New Indications with NMPA Approval
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that its biosimilar drug HanDaYuan has received additional indication approvals from China’s National Medical Products Administration (NMPA). HanDaYuan, a biosimilar version of AbbVie’s Humira (adalimumab), an autoimmune disease therapy, is now approved to treat a wider range of…
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Mabwell’s 9MW2821 ADC for Triple Negative Breast Cancer Accepted for Review by NMPA
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has accepted for review a clinical trial filing for its pipeline candidate, 9MW2821. This antibody drug conjugate (ADC) targets Nectin-4 and is planned to be assessed in combination…
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Mabwell Bioscience’s 9MW2821 Earns Orphan Drug Status from FDA for Esophageal Cancer
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced that it has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its pipeline candidate, the antibody-drug conjugate (ADC) 9MW2821. This designation is for the drug’s potential in treating esophageal…
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Mabwell Bioscience Receives NMPA Approval for Biosimilar Version of Amgen’s Xgeva
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced that it has received market approval from China’s National Medical Products Administration (NMPA) for its biosimilar product 9MW0321, a version of Amgen’s Xgeva (denosumab). This makes Mabwell the first company to gain approval for a biosimilar version of the drug in…
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Mabwell’s Nectin-4 Targeting ADC 9MW2821 Shows Promise in Cervical Cancer Clinical Study
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced positive results from a clinical study of its pipeline candidate, the antibody drug conjugate (ADC) 9MW2821, which targets Nectin-4. The data, highlighting the potential of 9MW2821 in treating cervical cancer, is set to be presented…
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Mabwell Bioscience Cancels Licensing Agreements with Yangtze River Pharma for Two Drug Candidates
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced the cancellation of licensing agreements with Yangtze River Pharmaceutical Group for two of its drug candidates: 8MW0511, a recombinant (yeast secreted) human serum albumin human granulocyte colony-stimulating factor (I) fusion protein for injection, and 9MW1111,…
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Mabwell Bioscience’s Nectin-4 Targeting ADC Earns FDA Fast-Track Designation for Esophageal Cancer
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced that it has received fast-track designation from the US Food and Drug Administration (FDA) for its antibody drug conjugate (ADC) 9MW2821. This candidate targets Nectin-4 and is under investigation for the treatment of advanced, recurrent,…
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Mabwell Bioscience Receives FDA Green Light for B7-H3 Targeting ADC 7MW3711
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study for its antibody drug conjugate (ADC) 7MW3711, which targets B7-H3. The molecule is intended to be assessed…
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Mabwell Bioscience Extends Research Partnership with Fudan University Cancer Center
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Mabwell (Shanghai) Bioscience Co., Ltd., (SHA: 688062) has announced the renewal of its strategic research partnership with Fudan University Shanghai Cancer Center. The collaboration, initiated in July 2021, focuses on advancing research cooperation, nurturing talent, enhancing hospital management, and constructing robust platforms for scientific exchange. The partnership has seen significant…
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Mabwell Secures NMPA Approval for Phase III Study of ADC 9MW2821 in Urothelial Carcinoma
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Mabwell (Shanghai) Bioscience Co., Ltd. (SHA: 688062) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase III clinical study for its antibody-drug conjugate (ADC), 9MW2821, which targets Nectin-4. The randomized, open-label, controlled, multi-center Phase III trial aims to evaluate the efficacy…
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Mabwell Bioscience Enters Thai Market with Licensing Deal with Innobic
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a Chinese biopharmaceutical company, has announced the signing of a licensing and supply agreement with Thailand-based Innobic. Under the terms of the deal, Innobic will support the registration and commercialization of Mabwell’s products in Thailand, a member country of the Pharmaceutical Inspection Co-operation…
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Mabwell to Present Promising Clinical Data at 2023 ESMO Congress
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China-based Mabwell (Shanghai) Bioscience Co., Ltd. (SHA: 688062) has announced that it will present the latest clinical data for its investigational drugs 9MW2821 and 8MW0511 at the upcoming 2023 European Society for Medical Oncology (ESMO) Congress. This presentation underscores the company’s commitment to advancing innovative therapies in oncology. 9MW2821: Promising…
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Mabwell Bioscience Enters Licensing Agreement with Laboratorios Legrand for Biosimilars in Colombia and Ecuador
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China-based Mabwell (Shanghai) Bioscience Co., Ltd. (SHA: 688062) has announced a strategic licensing agreement with Colombia-headquartered Laboratorios Legrand S.A. Under this agreement, Laboratorios Legrand will manage the regulatory filing and commercialization of Mabwell’s biosimilars, MAILISHU and 9MW0321, which are both biosimilars of denosumab. This deal specifically covers the territories of…
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Mabwell Bioscience Initiates Phase Ib/II Study for Nectin-4 Targeting ADC 9MW2821
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a China-based biopharmaceutical company, has announced the first patient dosing in a Phase Ib/II clinical study for its antibody-drug conjugate (ADC) 9MW2821, which targets Nectin-4. The study is designed to evaluate the safety, tolerability, preliminary efficacy, and pharmacokinetics of 9MW2821 in combination with…
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Mabwell Bioscience’s 9MW3011 Earns US FDA Fast Track Designation for Polycythemia Vera Treatment
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a China-based biopharmaceutical company, has announced that it has received Fast Track Designation (FTD) from the US Food and Drug Administration (FDA) for its drug candidate 9MW3011 (MWTX-003/DISC-3405) for the treatment of patients with polycythemia vera (PV). This designation underscores the potential impact…
