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Oct. 16, 2025 -- 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 investigational new drug (“IND”) application for an open-label, two-arm, randomized, active-controlled, phase 2/3 clinical study comparing the company’s product, recombinant humanized anti-PD-1/VEGF bispecific antibody (code: JS207), to nivolumab for the neoadjuvant treatment of patients with stage Ⅱ/Ⅲ, resectable, actionable genomic aberration (AGA)-negative, non-small cell lung cancer (“NSCLC”) has been approved by the U.S. Food and Drug Administration (the “FDA”). Lung cancer is currently a malignant tumor with the highest prevalence and mortality rate in the world. According to GLOBOCAN, there were approximately 2.48 million new lung cancer cases and approximately 1.82 million lung cancer deaths worldwide in 2022. NSCLC is a major subtype of lung cancer, accounting for approximately 85% of all cases. Amongst these cases, 20%-25% are surgically resectable at first diagnosis, but even after radical surgical treatment, 30%-55% of these patients suffer from post-surgical recurrence and death. Currently, immune checkpoint inhibitors, represented by anti-PD-1 monoclonal antibodies combined with chemotherapy, have been widely used in the perioperative treatment of resectable NSCLC, and show significant improvements in event-free survival (EFS), pathological complete response (pCR), and overall survival (OS). However, patients with resectable NSCLC still face low survival and cure rates, among other unmet clinical needs. The study is an open-label, two-arm, randomized, active-controlled, international multi-center phase 2/3 clinical study comparing the efficacy and safety of JS207 to nivolumab for the neoadjuvant treatment of patients with stage Ⅱ/Ⅲ, resectable, AGA-negative NSCLC. JS207 is now the first PD-1/VEGF dual-target drug approved for conducting confirmatory study in patients eligible for surgery. Professor Yilong WU from Guangdong Provincial People’s Hospital will be the principal investigator. Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences, said, “As a high-potential candidate in Junshi Biosciences' next-generation immuno-oncology portfolio (I-O 2.0), JS207 has undergone a series of proof-of-concept (POC) studies targeting prevalent cancers in China and globally. In this ongoing Phase 2/3 clinical trial evaluating neoadjuvant therapy for resectable lung cancer, we have chosen to directly challenge first-generation PD-1 monoclonal antibodies with JS207. By harnessing cutting-edge innovative therapies, we aim to offer more patients better treatments and a better future. The international regulatory authorities have recognized our clinical demand-driven R&D plus scientifically rigorous study design, and their validation is highly encouraging. Moving forward, we will accelerate our global development efforts to make JS207 a cornerstone of the I-O 2.0 porfolio and achieve evolutionary breakthroughs in immuno-oncology.” JS207, a recombinant humanized anti-PD-1/VEGF bispecific antibody, was independently developed by Junshi Biosciences for the treatment of advanced malignant tumors. Currently, JS207 has been approved for conducting phase 2/3 clinical study, and multiple ongoing phase 2 clinical studies are exploring it in combination with chemotherapy, monoclonal antibodies, antibody-drug conjugates (ADCs) and other drugs in NSCLC, colorectal cancer, triple-negative breast cancer, liver cancer and other tumor types. JS207 can simultaneously bind to PD-1 and VEGFA with high affinity, effectively blocking the binding of PD-1 to PD-L1 and PD-L2 while also inhibiting the binding of VEGF to its receptor. JS207 has the efficacy of both immunotherapeutic drugs and anti-angiogenic drugs. Through the neutralization of VEGF, JS207 inhibits the proliferation of vascular endothelial cells, improves the tumor microenvironment, and increases the infiltration of cytotoxic T lymphocytes in the tumor microenvironment, thereby achieving better anti-neoplasm activity. JS207’s design is based on the high-affinity, clinically proven and differentiated anti-PD-1 drug, toripalimab as the backbone. The anti-PD-1 moiety of JS207 adopts a Fab structure to maintain binding affinity to PD-1, thereby attaining better enrichment in the tumor microenvironment. The anti-VEGF moiety has a binding affinity for human vascular endothelial growth factor that is comparable to that of bevacizumab. In non-clinical in vitro cytological tests, compared with the combination of an anti-PD-1/PD-L1 monoclonal antibody and a VEGF monoclonal antibody, a bispecific antibody simultaneously targeting PD-1/PD-L1 and VEGF demonstrated significantly enhanced PD-1 antigen binding and internalization, as well as synergistic enhancement of the NFAT signaling pathway, thereby better activating immune cells in the tumor microenvironment. 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. Five of the company’s products have received approvals in China and international markets, one of which is toripalimab, China’s first domestically produced and independently developed anti-PD-1 monoclonal antibody. Toripalimab has been approved in over 40 countries and regions including China, the US, and Europe. During the COVID-19 pandemic, Junshi Biosciences actively shouldered the social responsibilities of a Chinese pharmaceutical company through its involvement in developing etesevimab, MINDEWEI®, and other novel therapies for the prevention and treatment of COVID-19. With a mission of “providing patients with world-class, trustworthy, affordable, and innovative drugs,” Junshi Biosciences is “In China, For Global.” At present, the company boasts approximately 2,500 employees in the United States (Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc.). The content above comes from the network. if any infringement, please contact us to modify.

Sept. 07, 2025 -- 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 company’s product, recombinant humanized anti-IL-17A monoclonal antibody (code: JS005) has achieved positive results in a multi-center, randomized, double-blind, parallel, placebo-controlled pivotal registrational Phase 3 clinical study (study number: JS005-005-III-PsO) for the treatment of moderate to severe plaque psoriasis. Both the co-primary endpoints and key secondary endpoints showed statistically significant and clinically meaningful improvements. Junshi Biosciences plans to submit the new drug application of this product to the regulatory authorities in the near future. Psoriasis is a common chronic, recurrent, inflammatory, and systemic disease mediated by the immune system. Its prevalence varies significantly across different regions: the overall global prevalence of psoriasis ranges from 2.0% to 3.0%, while in China it is 0.47%. According to data released by the World Psoriasis Day Consortium, the total number of patients with psoriasis worldwide is approximately 125 million, and shows a year-on-year increasing trend. Psoriasis can be accompanied by other systemic abnormalities, patients with moderate-to-severe psoriasis have an increased risk of developing metabolic syndrome and atherosclerotic cardiovascular disease. Mental health conditions such as depression, anxiety, and suicidal tendencies caused by physical and psychological distress are also relatively common among the patients with psoriasis. Therefore, psoriasis is a disease that seriously affects the physical and mental health of patients, and is also a global disease that urgently needs to be addressed. So far, the multi-center, randomized, double-blind, parallel, placebo-controlled pivotal registrational Phase 3 study (study number: JS005-005-III-PsO) of JS005 has been successfully completed and met the co-primary endpoints and key secondary endpoints. Led by Professor Jianzhong ZHANG from the Peking University People’s Hospital, the study was conducted in 60 clinical sites across China, and its primary objective is to determine whether the proportion of participants achieving at least a 90% improvement in Psoriasis Area and Severity Index (PASI 90) and a static Physician Global Assessment (the “sPGA”) score of 0 or 1 at Week 12 in JS005 group are both superior to that of the placebo group. The study results showed that, compared to the placebo, JS005 significantly improved the area and severity of psoriasis lesion in participants, and the proportion of participants achieving a sPGA score of 0 or 1 was also significantly higher, and JS005 demonstrated good safety in participants with moderate to severe plaque psoriasis. The relevant study results will be announced at future international academic conferences. Prof. Jianzhong ZHANG from the Peking University People’s Hospital said, “Patients with moderate-to-severe psoriasis suffer from long-term recurrent skin lesions and pruritus, imposing significant physical and mental burdens. Traditional treatments remain limited, making the success of this Phase 3 study for JS005 a significant milestone. Results demonstrate JS005’s superior efficacy in achieving deep symptom remission, sustained therapeutic effects, and improved quality of life. We hope this therapy will soon benefit millions of patients, further advancing China’s psoriasis treatment landscape.” Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences, said, “We sincerely thank patients, investigators, and the R&D team for their exceptional contributions in achieving the primary endpoints of JS005’s Phase 3 study. This milestone not only brings new hope to patients with moderate-to-severe psoriasis but also marks our innovation breakthrough in the autoimmune field. Moving forward, we will actively collaborate with regulators to accelerate the availability of this innovative therapy, ensuring earlier patient access.” JS005 is an anti-IL-17A monoclonal antibody independently developed by Junshi Biosciences. IL (interleukin)-17A is a pleiotropic cytokine, and the disordered secretion of which is closely related to the occurrence and progression of autoimmune diseases such as psoriasis, rheumatoid arthritis and ankylosing spondylitis. By binding to IL-17A with high affinity and selectively blocking the binding of IL-17A with its receptor IL-17RA/IL-17RC, JS005 blocks the activation of downstream signaling pathways and the release of inflammatory factors, thereby effectively alleviating the symptoms of autoimmune diseases. So far, the phase 3 clinical study of JS005 for the treatment of moderate to severe plaque psoriasis has met the co-primary endpoints and key secondary endpoints. All subjects in the phase 2 clinical study of JS005 for the treatment of active ankylosing spondylitis have completed the primary endpoint visit and entered the extension treatment period. 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. Five of the company’s products have received approvals in China and international markets, one of which is toripalimab, China’s first domestically produced and independently developed anti-PD-1 monoclonal antibody. Toripalimab has been approved in 40 countries and regions including China, the US, and Europe. During the COVID-19 pandemic, Junshi Biosciences actively shouldered the social responsibilities of a Chinese pharmaceutical company through its involvement in developing etesevimab, MINDEWEI®, and other novel therapies for the prevention and treatment of COVID-19. With a mission of “providing patients with world-class, trustworthy, affordable, and innovative drugs,” Junshi Biosciences is “In China, For Global.” At present, the company boasts approximately 2,500 employees in the United States (Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc.). The content above comes from the network. if any infringement, please contact us to modify.