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泽璟制药(688266.SH):注射用ZG005与盐酸吉卡昔替尼片联合用药获得药物临床试验批准

Zhejiang Jiankang Pharmaceutical (688266.SH): The clinical trial for the injection ZG005 combined with hydrochloride gilteritinib tablets has been approved.

Zhitong Finance ·  Dec 25, 2024 16:37

Zejing Pharmaceutical (688266.SH) announced that the company recently received a notice from the National Medical Products Administration (hereinafter referred to as...

According to the Zhizhong Finance APP, Zejing Pharmaceutical (688266.SH) announced that it recently received the "Notice of Approval for Clinical Trial of Drugs" issued by the National Medical Products Administration (hereinafter referred to as the "National Drug Administration"). The clinical trial for the injection of ZG005 combined with Jakaratin HCl tablets for advanced solid tumors and refractory relapsed lymphoma has been approved.

It is understood that ZG005 is a recombinant humanized anti-PD-1/TIGIT bispecific antibody powder injection, which is an innovative tumor immunotherapy Biological Product, classified as a category 1 drug, and is expected to be used in the treatment of various solid tumors. According to public inquiries, ZG005 is one of the first drugs targeting the same site to enter clinical research globally, and there are currently no drugs with the same mechanism approved for marketing worldwide.

ZG005 has the dual-targeted action of blocking PD-1 and TIGIT, which can effectively block the signaling pathways of PD-1 and its ligand PD-L1, thus promoting T cell activation and proliferation; it can also effectively block the signaling pathways of TIGIT and its ligands like PVR, promoting PVR binding with CD226 to produce co-stimulation activation signals, thereby enhancing the activation and proliferation of T cells and NK cells, and generating a synergistic enhancement of the immune system's ability to kill tumor cells with both targets being blocked simultaneously.

Jakaratin HCl (formerly known as JAK1/2 Inhibitor) is a new type of JAK and ACVR1 dual inhibitor developed independently by the company, belonging to category 1 new drugs, with independent intellectual property rights for the product. Jakaratin HCl tablets are currently undergoing clinical studies for multiple immune inflammatory diseases and fibrotic diseases. The NDA application for the treatment of intermediate and high-risk myelofibrosis with Jakaratin HCl tablets is currently under review by the National Medical Products Administration. The phase III clinical trial for the treatment of severe alopecia areata and the phase II clinical trial for the treatment of idiopathic pulmonary fibrosis have been successful.

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