On September 29, 2022 HanX Biopharmaceuticals reported Puyouheng (generic name: Putalimab Injection, also known as HX008) received marketing approval from the National Medical Products Administration (NMPA) for the treatment of unresectable or metastatic melanoma after failure of previous systemic therapy (Press release, HanX Biopharmaceuticals, SEP 29, 2022, View Source [SID1234655944]). This is another new indication for Puyouheng (Putalimab Injection), following its approval for MSI-H/dMMR solid tumors in July of this year, and will provide a new immunotherapy option for melanoma patients in China.

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Putalimab was developed by Hans Biopharma and conducted early clinical trials in 2018 in collaboration with Lepu Biopharma. Lepu Biopharma submitted two NDAs to the NMPA in June and October 2021, for the treatment of melanoma and MSI-H/dMMR solid tumors, respectively. Both NDAs have been approved. Dr. Zhang Faming, Chairman of Hans Biopharma, stated, "The market potential for melanoma and MSI-H/dMMR solid tumors in China is enormous. This approval by the NMPA of another NDA for this product will provide new treatment options for domestic patients. I am pleased with the effective collaboration between Hans Biopharma and Lepu Biopharma over the past few years and the approval of Putalimab for both indications."