Junshi Biosciences Announces NMPA Accepted supplemental New Drug Application for Toripalimab in Combination with Chemotherapy as First-Line Treatment of Advanced NSCLC

6th indication for toripalimab submitted in China

SHANGHAI, China, Dec. 10, 2021 (GLOBE NEWSWIRE) -- Junshi Biosciences (HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced today that the National Medical Products Administration (the "NMPA”) has accepted the company’s supplemental New Drug Application ("sNDA”) for toripalimab in combination with chemotherapy as the first-line treatment of patients with treatment-naive advanced or metastatic non-small cell lung cancer ("NSCLC”) with no EGFR or ALK tumor aberrations.

The sNDA is based on the CHOICE-01 study (NCT03856411), which is the first domestic randomized, double-blind, placebo parallel-controlled, multi-center, Phase III study of an anti-PD-1 monoclonal antibody in combination with chemotherapy as first-line treatment that recruits both histological types of advanced squamous and non-squamous NSCLC. Professor Jie Wang from Cancer Hospital, Chinese Academy of Medical Sciences is the leading principal investigator for the study. The study enrolled 465 NSCLC patients in 63 centers in China, among which 220 were squamous NSCLC patients and 245 were non-squamous NSCLC patients. Based on the interim analysis results of the CHOICE-01 study, the Independent Data Monitoring Committee (IDMC) determined that the primary endpoint of progression-free survival ("PFS”) has crossed the pre-defined efficacy boundary. The result of the study was presented during the Oral Session (abstract number MA13.08) at the 2021 World Conference on Lung Cancer (WCLC), showing that compared with chemotherapy alone, toripalimab in combination with chemotherapy as the first-line treatment for advanced NSCLC significantly prolonged the PFS of patients, reduced the risk of disease progression, and showed a positive trend in terms of overall survival ("OS”).

Junshi will submit further analysis of the results of OS of the CHOICE-01 study to the NMPA subsequently on a rolling basis and communicate with the US Food and Drug Administration (the "FDA”) on the same matter.

About NSCLC
Lung cancer is currently the second most prevalent malignant tumor with the highest mortality rate in the world, and the most prevalent with the highest mortality rate in China. According to data released by the World Health Organization, in 2020, the number of new lung cancer cases in China was estimated to be 816,000 and accounted for 17.9% of all new cancer cases in China. In the same year, the number of lung cancer deaths in China amounted to 715,000 and accounted for 23.8% of all cancer deaths. NSCLC is a major subtype of lung cancer, accounting for approximately 85% of all cases. Existing domestic and overseas studies have shown that monotherapy or combination chemotherapy of anti-PD-(L)1 monoclonal antibody has already become new standard for the first-line treatment of NSCLC.

About Toripalimab
Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 is thought to recharge the immune system’s ability to attack and kill tumor cells. More than thirty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally, including in China, the United States, Southeast Asia, and European countries. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.

In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI^®). On December 17, 2018, toripalimab was granted a conditional approval by the National Medical Products Administration (NMPA) for the second-line treatment of unresectable or metastatic melanoma. In February 2021, the NMPA granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma ("NPC") after failure of at least two lines of prior systemic therapy. In April, the NMPA granted a conditional approval to toripalimab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. In November 2021, the NMPA approved toripalimab in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic nasopharyngeal carcinoma. In addition, the supplemental NDA for the first-line treatment of patients with advanced or metastatic esophageal squamous cell carcinoma was accepted by the NMPA for review in July 2021.

In December 2020, toripalimab was successfully included in the updated National Reimbursement Drug List for the indication of the second-line treatment of unresectable or metastatic melanoma. In December 2021, two additional indications were included on the list: recurrent or metastatic nasopharyngeal carcinoma after failure of at least two lines of prior systemic therapy and locally advanced or metastatic urothelial carcinoma after failure of platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.

In the United States, the FDA has granted priority review for the toripalimab BLA for the treatment of recurrent or metastatic NPC, an aggressive head and neck tumor which currently has no FDA-approved immuno-oncology treatment options. Earlier, the FDA granted Breakthrough Therapy designation for toripalimab in combination with chemotherapy for the 1st line treatment of recurrent or metastatic NPC as well as for toripalimab monotherapy in the second or third-line treatment of recurrent or metastatic NPC. Additionally, the FDA has granted Fast Track designation for toripalimab for the treatment of mucosal melanoma and orphan drug designation for esophageal cancer, NPC, mucosal melanoma and soft tissue sarcoma. Earlier in 2021, Coherus in-licensed rights to develop and commercialize toripalimab in the United States and Canada. Coherus and Junshi Biosciences plan to file additional toripalimab BLAs with the FDA over the next three years for multiple other cancer types.

About Junshi Biosciences
Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R & D pipeline comprising 45 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA antibody for solid tumors was the first in the world to be approved for clinical trials by the FDA and NMPA and its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA. In early 2020, Junshi Biosciences joined forces with the Institute of Microbiology of Chinese Academy of Science and Eli Lilly to co-develop JS016 (etesevimab), China’s first neutralizing fully human monoclonal antibody against SARS-CoV-2. JS016 administered with bamlanivimab has been granted Emergency Use Authorizations (EUA) in more than 15 countries and regions worldwide. The JS016 program is a part of our continuous innovation for disease control and prevention of the global pandemic. Junshi Biosciences has over 2,500 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou). For more information, please visit: http://junshipharma.com.

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