Junshi Biosciences Receives NMPA Approval of sNDA for Toripalimab in Combination with Chemotherapy as First-Line Treatment for Advanced Non-squamous Non-Small Cell Lung Cancer

--6th approved indication of toripalimab in China, bringing more treatment options to patients with advanced NSCLC

SHANGHAI, China, Sept. 20, 2022 (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 today that the China National Medical Products Administration ("NMPA”) has approved the supplemental new drug application ("sNDA”) for toripalimab in combination with pemetrexed and platinum as the first-line treatment in EGFR mutation-negative and ALK mutation-negative, unresectable, locally advanced or metastatic non-squamous non-small cell lung cancer ("NSCLC”). This is the sixth indication approved for toripalimab in China and will bring more treatment options to Chinese patients with advanced NSCLC.

"We are very pleased that toripalimab’s first indication for the treatment of lung cancer has been approved, which means we will be able to help more patients fight against malignant tumors with the highest incidence and mortality rates in China,” said Dr. Jianjun Zou, Global Research and Development President at Junshi Biosciences. "We are particularly grateful to our patients, researchers, and R&D teams that participated in the clinical trials, whose efforts and contributions allowed our study to progress during the COVID-19 pandemic. We will continue to advocate for the use of toripalimab in the treatment of lung cancer as well as other cancers, and we hope to provide many more patients with better treatment options and greater survival benefits as soon as possible!”

Professor Jie Wang from the Cancer Hospital, Chinese Academy of Medical Sciences elaborated on toripalimab’s performance in clinical trials. "In China, the number of lung cancer patients is massive and so is the demand for treatment. The CHOICE-01 study provided us with reliable and substantiating data, confirming that the addition of toripalimab to standard first-line chemotherapy can bring longer progression-free survival ("PFS”) and overall survival ("OS”) to patients with advanced NSCLC, regardless of PD-L1 expression and with a manageable safety profile. For patients with advanced non-squamous NSCLC, published data reveal that the 2-year OS rate is around 50%, and according to the CHOICE-01 study results, toripalimab in combination with chemotherapy is the only PD-(L)1 inhibitor combination in this field that can achieve a 2-year OS rate of more than 60%, not to mention a 50% decrease in risk of death, indicating that toripalimab plus standard chemotherapy can significantly increase survival benefits for patients. We are excited for toripalimab’s continuous contribution to the battle against lung cancer!”

Between April 2, 2019 to August 5, 2020, the CHOICE-01 study enrolled a total of 465 NSCLC patients in 63 centers in China, among which 245 non-squamous NSCLC patients were randomly allocated in the ratio of 2:1 to receive toripalimab/placebo in combination with pemetrexed and cisplatin/carboplatin. After disease progression, eligible control subjects could receive crossover treatment with toripalimab monotherapy. Previously, the latest research results of the CHOICE-01 study were announced at the 2022 American Society of Clinical Oncology ("ASCO”) Plenary Series March Program and the ASCO annual meeting. The study data showed that compared to chemotherapy alone, toripalimab in combination with chemotherapy in the first-line treatment of patients with advanced NSCLC without EGFR/ALK mutations can significantly improve the PFS and the OS of patients with a manageable safety profile regardless of PD-L1 expression status.

As of October 31, 2021, in 245 non-squamous NSCLC patients, the median PFS of toripalimab in combination with chemotherapy was 9.7 months, which was 4.2 months longer than placebo in combination with chemotherapy (HR = 0.48 [95% CI: 0.35-0.66], p < 0.0001); the median OS of toripalimab in combination with the chemotherapy group has yet to be reached, while OS benefits had already been observed, reducing the risk of death by 52% (HR=0.48 [95%CI: 0.32-0.71]).

About NSCLC
Lung cancer is currently the second most prevalent malignant tumor with the highest mortality rate in the world^[1], and the most prevalent with the highest mortality rate in China^[2]. According to data released by the World Health Organization, in 2020, the number of new lung cancer cases in China amounted to 816,000 and accounted for 17.9% of all new cancer cases in China^[2]. 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 in China^[2]. NSCLC is a major subtype of lung cancer, accounting for approximately 85% of all cases^[3]. Non-squamous NSCLC patients account for approximately 70% of all NSCLC patients^[4]. Existing domestic and overseas studies have shown that the use of anti-PD-(L)1 monoclonal antibodies as monotherapy or in combination with chemotherapy has already become new standard for the first-line treatment of advanced driver gene-negative NSCLC.

[1] https://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf
[2] https://gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf
[3] Rosell R, Karachaliou N. Large-scale screening for somatic mutations in lung cancer. Lancet, 2016, 387(10026): 1354-1356. doi: 10.1016/S0140-6736(15)01125-3
[4] Gridelli C, et al. Nat Rev Dis Primers. 2015;1:15009

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 promotes the immune system’s ability to attack and kill tumor cells. In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing in 2018 (approved in China as TUOYI®). Currently, there are six approved indications for toripalimab in China.

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 over 50 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 monoclonal antibody for the treatment of various cancers was the first in the world to be approved for clinical trials by the FDA and NMPA and has since entered Phase Ib/II trials in both China and the US. Its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA.

In the face of the pandemic, Junshi Biosciences’ response was strong and immediate, joining forces with Chinese and international scientific research institutions and enterprises to develop an arsenal of drug candidates to combat COVID-19, taking the initiative to shoulder the social responsibility of Chinese pharmaceutical companies by prioritizing and accelerating COVID-19 R&D. Among the many drug candidates is JS016 (etesevimab), China’s first neutralizing fully human monoclonal antibody against SARS-CoV-2 and the result of the combined efforts of Junshi Biosciences, the Institute of Microbiology of the Chinese Academy of Science and Lilly. JS016 administered with bamlanivimab has been granted Emergency Use Authorizations (EUA) in over 15 countries and regions worldwide. As of December 3 2021, over 700,000 patients have been treated with bamlanivimab or bamlanivimab and etesevimab, potentially preventing more than 35,000 hospitalizations and at least 14,000 deaths. Meanwhile, VV116, a new oral nucleoside analog anti-SARS-CoV-2 drug designed to hinder virus replication, is in global Phase III clinical trials. A Phase III clinical study (NCT05341609) comparing the efficacy and safety of VV116 versus nirmatrelvir/ritonavir ("PAXLOVID”) for patients with mild to moderate COVID-19 who are at high risk for progression to severe COVID-19, has reached its pre-specified primary endpoint and secondary efficacy endpoint. The study results show that compared to PAXLOVID, VV116 provided patients with a shorter median time to sustained clinical recovery, while achieving statistical superiority. The JS016 and VV116 programs are a part of the company’s continuous innovation for disease control and prevention of the global pandemic.

Junshi Biosciences has more than 3,100 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc). For more information, please visit: http://junshipharma.com.

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