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GlycoNex, Inc. (4168, hereinafter referred to as GNX), today announced that the Phase III clinical trial for SPD8, a Denosumab biosimilar co-developed with Mitsubishi Gas Chemical, has successfully met its primary endpoint. Statistical analysis confirms that SPD8 demonstrated therapeutic equivalence to the reference drug, Prolia® (marketed as Pralia® in Japan). The company expects to finalize the clinical study report by the end of September, followed by a drug approval application in Japan. Jap
GlycoNex, Inc. (4168, hereinafter referred to as GNX), clinical stage biotechnology company focused on the development of glycan-directed cancer immunotherapies, today announced that Japan's Pharmaceuticals and Medical Devices Agency (PMDA) has approved the initiation of a first-in-human (FIH) Phase 1 clinical trial of GNX1021, the company's lead antibody-drug conjugate (ADC) candidate, in patients with advanced gastrointestinal cancers.
GlycoNex, Inc. (4168, hereinafter referred to as GNX), a clinical-stage biotechnology company focused on the development of glycan-directed cancer immunotherapies, today announced that it has entered into a collaboration agreement with Nippon Kayaku Co., Ltd. ("Nippon Kayaku") to advance GNX201-ADC, a next-generation antibody-drug conjugate (ADC) candidate for the treatment of solid tumors. Under the agreement, the two companies will jointly support preclinical development activities for GNX201-
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