Junshi Biosciences Announces Approval of the Supplemental New Drug Application for Toripalimab as Perioperative Treatment for Resectable NSCLC Patients

>The supplemental new drug application for toripalimab in combination with chemotherapy as perioperative treatment and subsequently, monotherapy as adjuvant therapy for the treatment of adult patients with resectable stage IIIA-IIIB non-small cell lung cancer has been approved by the National Medical Products Administration

Junshi Biosciences Announces New Chemical Entity Application for Toripalimab Accepted by Australia’s TGA

>Therapeutic Goods Administration of the Australian Government Department of Health and Aged Care (TGA) has accepted the New Chemical Entity (NCE) application for toripalimab in combination with cisplatin and gemcitabine, for the first-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC), and for toripalimab, as a single agent, for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy

Junshi Biosciences Announces FDA Approval of LOQTORZI™ (toripalimab-tpzi) in All Lines of Treatment for Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)

>The U.S. FDA approved LOQTORZI (toripalimab-tpzi) in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced NPC, and as monotherapy for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy

Junshi Biosciences Announces Initiation of Phase 3 Study of Tifcemalimab plus Toripalimab for Treatment of Limited-stage Small Cell Lung Cancer

>SHANGHAI, China, June 28, 2023 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences,” HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that the U.S. Food and Drug Administration (“FDA”) has recently agreed a randomized, double-blind, placebo-controlled, multi-regional phase 3 clinical study of tifcemalimab (product code: TAB004/JS004), an anti-BTLA monoclonal antibody used in combination with toripalimab, an anti-PD-1 monoclonal antibody, as consolidation therapy for patients with limited-stage small cell lung cancer without disease progression following chemoradiotherapy may proceed. Junshi Biosciences will officially initiate the phase 3 clinical study in the near future.