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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.

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.

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.

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).

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.

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.

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.

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.

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.