Knobbe Martens
Nov 29, 2023

The First FDA Approved, Chinese Developed, PD-1 Inhibitor For Nasopharyngeal Carcinoma

ANDA Litigation

Written by: Jason J. Jardine

On October 27th, 2023, the U.S. Food and Drug Administration (FDA) approved LOQTORZITM (toripalimab-tpzi), developed by Coherus BioSciences, Inc., and Shanghai Junshi Biosciences Co., Ltd., for two indications: 1) in combination with cisplatin and gemcitabine as treatment of metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC), and 2) as a single agent treatment in adults with recurrent, unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy. [1]

NPC is a metastasis-prone head and neck cancer arising in the epithelial tissue of the nasopharynx. [2] While the exact cause of NPC is unknown, the cancer is closely associated with Epstein-Barr virus. [3]  A variety of other factors including genetics and the environment are also known to play a role. [4] NPC is rare in the United States, affecting fewer than 1 in 100,000 people, but is more prevalent in central, south and southeast Asia, the Arctic, Middle East, and North Africa. [5]

LOQTORZITM is a programmed death receptor-1 (PD-1) monoclonal antibody that blocks PD-1 ligands PD-L1 and PD-L2 on the PD-1 receptor.  [6] The approval was based on results of the JUPITER-02 Phase 3 study and the POLARIS-02 Phase 2 study. [7] In the JUPITER-02 Phase 3 clinical trial, LOQTORZITM reduced the risk of cancer progression or death by 48% compared to using chemotherapy alone, and LOQTORZITM also improved overall survival, with a 37% reduction in the risk of death as compared to chemotherapy alone. LOQTORZITM approval includes treatment irrespective of a patient’s PD-L1 status. [8]  In the POLARIS-02 clinical study LOQTORZITM showed antitumor activity in patients with recurrent or metastatic NPC who had failed previous chemotherapy, with an objective response rate (ORR) of 20.5%, and a disease control rate (DCR) of 40.0%. [9]

LOQTORZITM is the first FDA approved treatment for NPC as well as the first FDA approved, Chinese developed, PD-1 inhibitor. [10] The global PD-1/PD-L1 inhibitor market is estimated to be approximately USD $50 billion in 2023 and is predicted to increase to approximately USD $123 billion by 2033. [11]. Unlike the approach Coherus took when pricing its Humira® biosimilar YUSIMRYTM at about an 85% discount from the originator, Coherus CEO Denny Lanfear has indicated that Coherus will not engage in heavily discounted pricing with LOQTORZITM. [12]

Editor: Brenden G. Gingrich, Ph.D.

*Phillip J. Minnick California Bar Admission Pending


[1] See

[2] See Shah AB, Nagalli S. Nasopharyngeal Carcinoma. [Updated 2022 Oct 1]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from:

[3] Id.

[4] Id.

[5] Id.

[6] See

[7] See

[8] Id.

[9] Id.

[10] See

[11] See

[12] See