Junshi Biosciences Announces NMPA Acceptance of New Drug Applications for Toripalimab Injection (Subcutaneous) Across 12 Indications
MWN-AI** Summary
Shanghai Junshi Biosciences Co., Ltd. announced that the National Medical Products Administration (NMPA) has accepted its New Drug Applications (NDAs) for toripalimab injection (subcutaneous) for 12 tumor treatment indications. This marks a significant milestone as JS001sc is the first domestic anti-PD-1 monoclonal antibody available in a subcutaneous formulation in China. The need for more convenient administration methods in immunotherapy is underscored by the high cancer incidence in China, with over 4.8 million new cases reported in 2022.
Currently, many immunotherapies are delivered intravenously, which can be inconvenient for patients. JS001sc aims to address this by enhancing the delivery experience while maintaining similar efficacy and safety as its intravenous counterpart, toripalimab injection (JS001). The NDA is primarily supported by data from the JS001sc-002-III-NSCLC Study, a randomized phase 3 clinical trial that demonstrated JS001sc's non-inferior drug exposure compared to IV administration when combined with chemotherapy for non-squamous non-small-cell lung cancer (NSCLC).
Professor Lin Wu, the study’s principal investigator, emphasized the significance of this achievement for cancer treatment in China, citing improvements in patient convenience and quality of life. Junshi's CEO Dr. Jianjun Zou expressed optimism regarding swift regulatory review and approval, highlighting the broader implications of this formulation in enhancing treatment accessibility and adherence for various malignancies.
Developed since 2012, Junshi Biosciences is a biopharmaceutical innovator focused on discovering and commercializing novel therapeutics, with a robust pipeline aimed at diverse therapeutic areas. The acceptance of the toripalimab subcutaneous formulation positions Junshi to further impact the landscape of cancer immunotherapy in China and beyond.
MWN-AI** Analysis
Junshi Biosciences has recently announced a significant milestone with the acceptance of their New Drug Applications (NDAs) for the subcutaneous formulation of Toripalimab injection (JS001sc) across 12 oncological indications by the National Medical Products Administration (NMPA). This marks a pivotal advancement in cancer immunotherapy, potentially transforming treatment protocols across various tumor types that include NSCLC, nasopharyngeal carcinoma, and esophageal cancer.
The introduction of a subcutaneous option for an anti-PD-1 monoclonal antibody like JS001sc addresses existing patient inconveniences linked to intravenous delivery methods, which can be time-consuming and cumbersome. By offering a more convenient administration route, Junshi is not only enhancing patient compliance but also potentially improving treatment outcomes, a critical factor in oncology.
Investors should consider the implications of this development on Junshi's market position. The successful acceptance of the NDA is a precursor to potential commercialization, which could significantly increase the company's revenue streams, especially given the high incidence of cancer cases in China. The GLOBOCAN 2022 data highlights a pressing need for effective cancer treatments, positioning JS001sc favorably in a burgeoning market.
Moreover, Junshi’s commitment to expanding its portfolio with innovative solutions can enhance its attractiveness to investors focused on biopharmaceutical growth. The broad clinical evidence supporting JS001sc's non-inferiority to its intravenous counterpart, coupled with the urgency for practical treatment solutions, adds a robust foundation for future stock appreciation.
In summary, Junshi Biosciences presents a compelling investment opportunity as they prepare for the regulatory review and potential commercialization of JS001sc. Investors should closely monitor the progression of the NMPA's review and the ensuing market response, as this could drive significant value for stakeholders invested in the biopharmaceutical sector.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
SHANGHAI, March 09, 2026 (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 that the new drug applications (the “NDAs”) for the company’s product, toripalimab injection (subcutaneous injection [code: JS001sc]), for 12 indications in the treatment of tumors has been accepted by the National Medical Products Administration (“NMPA”). JS001sc is the first domestic anti-PD-1 monoclonal antibody in a subcutaneous formulation to enter the marketing application stage.
According to data released by GLOBOCAN 2022, in 2022, there were 4.8247 million new cancer cases and 2.5742 million cancer-related deaths in China. Immunotherapy (I-O), represented by anti-PD-1 monoclonal antibodies, has become a cornerstone treatment for various malignant tumors, including lung cancer, breast cancer, liver cancer, esophageal cancer, and nasopharyngeal carcinoma. Now, immunotherapy covers nearly all stages of treatment for cancer patients, encompassing adjuvant/neoadjuvant treatment for early-stage tumors, consolidation treatment after radical chemoradiation for locally advanced tumors, and first-line to last-line treatments for advanced tumors. Currently, most immunotherapy drugs in China are administered intravenously, and this not only requires lengthy infusion times, but also imposes significant inconveniences on patients. There is an urgent clinical need for more convenient administration methods for immunotherapy.
Independently developed by Junshi Biosciences, JS001sc injection is a subcutaneous injection based on the marketed product toripalimab injection (code: JS001) that is expected to enhance convenience for patients. The 12 indications in the JS001sc NDAs cover all currently approved indications of toripalimab injection in the Chinese Mainland.
The NDA is mainly based on the JS001sc-002-III-NSCLC Study (NCT06505837), a multi-center, open-label, randomized phase 3 clinical study led by principal investigator Professor Lin WU from Hunan Cancer Hospital. The study aimed to compare the exposure, efficacy and safety of JS001sc plus chemotherapy versus JS001 plus chemotherapy for the first-line treatment of recurrent or metastatic non-squamous non-small-cell lung cancer (“NSCLC”). The results showed that JS001sc’s exposure was non-inferior to that of JS001 with comparable efficacy and safety profiles. JS001sc-002-III-NSCLC was the first phase 3 clinical study of domestic anti-PD-1 monoclonal antibody in a subcutaneous formulation. Further details will be presented at an upcoming international academic conference.
Professor Lin WU said, “The JS001sc-002-III-NSCLC study, as China’s first Phase 3 clinical trial of a domestically developed PD-1 monoclonal antibody in a subcutaneous formulation, confirmed that the subcutaneous administration method achieved statistical non-inferiority in drug exposure compared with intravenous administration, while demonstrating comparable efficacy and safety. This milestone not only validates the scientific rationale behind the pharmaceutical development of the subcutaneous formulation, but also provides a novel administration pathway for cancer immunotherapy at the clinical level. In the current era of holistic cancer management, treatment convenience and improved quality of life have become critical clinical priorities. The development and application of subcutaneous injection formulations are expected to significantly reduce dosing time, optimize healthcare resource allocation, and offer new technical support for advancing hierarchical medical systems and home-based treatment management. We anticipate the early approval of the subcutaneous formulation of toripalimab, which will further enrich China’s cancer immunotherapy landscape and ultimately benefit a broader population of cancer patients.”
Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences, said, “We are excited that the NMPA has formally accepted the NDA for JS001sc covering all approved indications of TUOYI® (toripalimab). This signifies JS001sc's potential to address multiple tumor types, including NSCLC, nasopharyngeal carcinoma, esophageal cancer, renal cancer, and liver cancer. It also marks another critical milestone in expanding toripalimab's innovative and clinical value. As a subcutaneous formulation, JS001sc will substantially enhance dosing convenience, optimize patient treatment experiences, and improve long-term therapy adherence. Moving forward, we will actively advance the regulatory review process, consistently centering patient needs. Using our clinical evidence, we hope to leverage evidence-based medicine to advance high-quality development of China's cancer therapies, ultimately delivering more accessible, convenient, and high-quality treatment options to patients."
About JS001sc
JS001sc is a subcutaneous injection formulation developed by Junshi Biosciences based on the marketed product toripalimab injection (code: JS001). It is the first domestic anti-PD-1 monoclonal antibody in a subcutaneous formulation to enter the marketing application stage and is expected to bring convenient administration to patients. The 12 indications in the NDAs of JS001sc covers all currently approved indications of toripalimab injection in the Chinese Mainland.
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. 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.). For more information, please visit: http://www.junshipharma.com.
Junshi Biosciences Contact Information
IR Team:
Junshi Biosciences
info@junshipharma.com
+ 86 021-6105 8800
PR Team:
Junshi Biosciences
Zhi Li
zhi_li@junshipharma.com
+ 86 021-6105 8800
FAQ**
How will the acceptance of the NDAs for toripalimab injection by the NMPA impact Shanghai Junshi SHJBF’s market position compared to competitors in the biopharmaceutical sector?
What are the expected timelines for the approval process of JS001sc, and how might this affect Shanghai Junshi SHJBF’s revenue projections for the next fiscal year?
Can you elaborate on the clinical trial data supporting JS001sc's efficacy and safety, and how this positions Shanghai Junshi SHJBF in the evolving immunotherapy market?
What strategies does Shanghai Junshi SHJBF plan to implement to maximize patient accessibility to the new subcutaneous formulation of toripalimab?
**MWN-AI FAQ is based on asking OpenAI questions about Shanghai Junshi (OTC: SHJBF).
NASDAQ: SHJBF
SHJBF Trading
-82.07% G/L:
$3 Last:
1,000 Volume:
$3 Open:
