SHANGHAI, China- Shanghai Juncell Therapeutics Co., Ltd. (Juncell Therapeutics), a biotechnology company focused on the research, development, and commercialization of cell therapies for the treatment of solid tumors, announced that the New Drug Application (NDA) for Nolgileucel has been accepted by China's National Medical Products Administration (NMPA), for use in combination with Sintilimab injection in patients with unresectable or metastatic melanoma who have previously failed at least two prior lines of systemic therapy (including PD-1 inhibitors).

This year, Nolgileucel has been successively featured presentations at ASCO, CSCO and ESMO, three top global oncology conferences. Previously at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, the results of the pivotal Phase II clinical study of Nolgileucel in patients with advanced melanoma were accepted as a Late-Breaking Abstract (LBA) and presented orally^[1]. This is the first clinical study of a solid tumor cell therapy in ASCO history to be selected as a LBA. Nolgileucel has been included in 2026 CSCO Guidelines for the Diagnosis and Treatment of Melanoma^[2], and the related research was awarded the First Prize of the 2026 CSCO Excellent Paper and the Innovative Research Award. The extended follow-up results of Nolgileucel have been accepted for a LBA and presented at the 2026 European Society for Medical Oncology (ESMO) Congress^[3], making it the only oncology innovative drug to date to be featured at three top global oncology conferences. This represents domestic and international recognition of the study's innovative value and urgent expectation of its clinical translation potential.

Deputy Director of Peking University Cancer Hospital, Professor Jun Guo said, "Treatment options remain very limited for patients with advanced melanoma. For those who have progressed despite prior treatment with PD-1 inhibitors and multiple lines of systemic therapy, more effective regimens are urgently needed. In the MIZAR-003 study, Nolgileucel showed encouraging antitumor activity and favorable safety profile, providing a new option for melanoma patients after immunotherapy failure."

Founder, CEO & CTO of Juncell Therapeutics, Dr. Huajun Jin said, "The acceptance of NDA for Nolgileucel by NMPA marks an important milestone in Juncell's clinical development. In China, there is a significant unmet clinical treatment need among patients with advanced refractory melanoma. As the world's first TIL therapy that does not require high-intensity lymphodepletion chemotherapy or the administration of IL-2, Nolgileucel's clinical evidence is expected to reshape the treatment landscape of advanced melanoma. "

Reference:

[1] Lu S, et al. ASCO 2026, Chicago, IL, USA. LBA 9509.

[2] CSCO Guidelines Working Committee. Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Melanoma 2026 [M]. Beijing: People's Medical Publishing House, 2026.

[3]Lu S, et al. ESMO 2026, Madrid, Spain. LBA55.