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706,366 Results for "shanghai henlius biotech inc".
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European Medicines Agency (EMA) Validates Henlius and Organon Filings for Prolia® and Xgeva® (denosumab) Biosimilar Candidate HLX14
Shanghai Henlius Biotech, Inc. and Organon announced that the European Medicines Agency has validated the marketing authorization applications for HLX14, an investigational Prolia® and Xgeva® biosimilar.
May 24, 2024
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7 min read
Business
Henlius and Sermonix Announce Strategic Collaboration and Exclusive License Agreements for Novel Endocrine Therapy Lasofoxifene
Sermonix Pharmaceuticals Inc. and Shanghai Henlius Biotech, Inc. (2696.HK), today announced a strategic collaboration agreement in which Henlius will receive exclusive rights to develop, manufacture and commercialize Sermonix’s lead investigational drug, lasofoxifene, in China.
January 10, 2024
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9 min read
Business
Henlius Deepens Collaboration with Intas to bring Henlius’ Novel anti-PD-1 mAb Serplulimab to Europe and India
Shanghai Henlius Biotech, Inc. (2696.HK) has entered into an exclusive license agreement with Intas Pharmaceuticals Limited (“Intas”) for the development and commercialisation in Europe and India for several indications including ES-SCLC, and specific formulation of HANSIZHUANG (serplulimab injection), Henlius’ novel anti-PD-1 mAb.
October 27, 2023
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10 min read
BioMidwest
Sermonix Pharmaceuticals Announces Chinese Approval of Investigational New Drug Application for Lasofoxifene
Sermonix Pharmaceuticals Inc. today announced that China’s National Medical Products Administration (NMPA) approved the investigational new drug application (IND) for oral lasofoxifene (HLX78 in China) submitted with the assistance of Chinese development partner Shanghai Henlius Biotech, Inc. (2696.HK).
June 6, 2024
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6 min read
Drug Development
Phase 3 Comparative Clinical Study of Prolia® and Xgeva® (denosumab) Biosimilar Candidate HLX14 Met Primary Endpoints
Shanghai Henlius Biotech, Inc. and Organon announced that the phase 3 comparative clinical trial for the investigational Prolia® and Xgeva® biosimilar HLX14 met the primary endpoints.
April 8, 2024
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7 min read
Drug Development
OncoHost’s PROphet® Platform to Support Henlius US-Based Phase III Trial for Patients with Extensive-Stage Small Cell Lung Cancer
OncoHost today announced a collaboration with Hengenix Biotech, Inc. (Henlius USA), affiliated with Shanghai Henlius Biotech, Inc., a global biopharmaceutical company with the vision to offer high-quality, affordable, and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases, and ophthalmic diseases.
October 3, 2023
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5 min read
Business
HanchorBio and Henlius Announce Strategic Collaboration to Develop Innovative Immunotherapies
HanchorBio Inc. and Shanghai Henlius Biotech, Inc. today announced that the two companies have entered into a strategic framework agreement for collaboration to combine HanchorBio’s protein engineering expertise and proprietary Fc-based designer biologics (FBDB™) technology platform with Henlius’ integrated product development and commercialization capabilities.
August 28, 2023
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5 min read
Business
Henlius Expands Collaboration with KGbio to Develop, Commercialize and Supply Henlius’ novel anti-PD-1 mAb HANSIZHUANG in MENA
Shanghai Henlius Biotech, Inc. has entered into an exclusive license agreement with PT Kalbe Genexine Biologics, an Indonesian pharmaceutical company and a holding subsidiary to PT Kalbe Farma, Tbk, for the development and commercialisation of HANSIZHUANG as a treatment for two indications including ES-SCLC, Henlius’ novel anti-PD-1 mAb, in 12 Middle East and North African countries including Saudi Arabia, the United Arab Emirates, Egypt, Qatar, Jordan, Morocco, etc.
September 12, 2023
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9 min read
The NDA for New Indication of Henlius Anti-PD-1 mAb Serplulimab in Combination with Chemotherapy for the First-line Treatment of non-squamous NSCLC Accepted by the NMPA
Shanghai Henlius Biotech, Inc. announced that the NDA for new indication of HANSIZHUANG, serplulimab, an innovative anti-PD-1 mAb independently developed by the company, in combination with chemotherapy as a first-line treatment for patients with locally advanced or metastatic non-squamous non-small cell lung cancer has been accepted by the National Medical Products Administration, which is the fifth indication for HANSIZHUANG accepted by the NMPA.
December 12, 2023
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7 min read
Henlius’ Novel Anti-PD-1 mAb HANSIZHUANG (Serplulimab) Approved for the Treatment of ESCC
Shanghai Henlius Biotech, Inc. announced that the new drug application for new indication of HANSIZHUANG in combination with drugs containing fluorouracil and platinum for the first-line treatment of patients with PD-L1 positive unresectable locally advanced/recurrent or metastatic ESCC, has been approved by the NMPA, providing a new treatment option for patients with ESCC.
September 22, 2023
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11 min read
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