The board of directors of Shanghai Junshi Biosciences Co., Ltd. announced that the Company has received a notice from the Singapore Health Sciences Authority that the New Drug Application for toripalimab (product code: TAB001/JS001) 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 has been accepted by the HSA. Due to the location of the primary tumor, surgery is rarely an option, while radiotherapy alone or in combination with chemotherapy are the main treatment options for localized cancers. This NDA is supported by the results from JUPITER-02, a randomized, double blind, placebo-controlled, multinational multi-center Phase III clinical study (NCT03581786), for the first-line treatment the NPC and the results from POLARIS-02, a multi-center, open-label, pivotal Phase II clinical study (NCT02915432), for second-line or more prior treatments for recurrent or metastatic NPC.

The results of JUPITer-02, the first multinational multi-center, double blind and randomized controlled Phase III clinical study with the largest sample size, were published at the plenary session of the 2021 American Society of Clinical Oncology (ASCO) annual meeting (#LBA2), and in Nature Medicine (IF: 82.9) and the Journal of the American Medical Association (IF: 120.7). The results showed that as compared to chemotherapy alone, toripalimab in combination with chemotherapy for the first-line treatmentof recurrent or metastatic NPC significantly improved progression-free survival ("PFS") and overall survival ("OS"), with a median PFS of 21.4 months, and a 3-year OS rate of 64.5%, reduced the risks of disease progression or death by 48%, and the risk of death by 37% and demonstrated a manageable safety profile. The POLARIS-02 results were published online in January 2021 in the Journal of Clinical Oncology (IF: 45.3).

The results showed that toripalimab demonstrated durable antitumor activity in patients with recurrent or metastatic NPC who failed previous chemotherapy, with an objective response rate (ORR) of 20.5%, a median duration of response (DoR) of 12.8 months, and a median OS of 17.4 months with a manageable safety profile. Toripalimab injection is the first domestic anti-PD-1 monoclonal antibody approved for marketing in China, and has won the Chinese Patent Gold Award Over forty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally, including in China, the United States, Southeast Asia, and Europe. Ongoing or completed pivotal clinical studies evaluating the safety and efficacy of toripalimab cover a broad range of tumor types.

As of the date of this announcement, there are seven approved indications for toripalimab in China. (the " MHRA") accepted the marketing authorization application (MAA) for toripalimab in combination With cisplatin and gemcitibine for the first-line treatment. The Australia Therapeutic Goods Administration (the "TGA") accepted the new chemical entity application for tor principalimab in combination with cisplatin, for the first-linetreatment of adults with metastatic or metastatic NPC, and for toripalimab.