JUNSHI BIO - Shanghai Haijunjunshi Biopharmaceutical Technology Co., Ltd. voluntarily discloses the acceptance of the supplementary application for the treatment of perioperative treatment of patients with resectable non-small cell lung cancer II-III for the combination of tetracycline, prilumab and chemotherapy.
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SHANGHAI JUNSHI BIOSCIENCES CO., LTD.*
Shanghai Junshi Biomedical Technology Co., Ltd. (a joint stock limited company incorporated in the People's Republic of China) (Stock code: 1877)
Overseas regulatory announcement
This announcement is made in accordance with Rule 13.10B of the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited.
This is to set forth the "Shanghai Junshi Biomedical Technology Co., Ltd. voluntarily discloses information about toripalimab combined with chemotherapy for resectable patients
Announcement that the supplementary application for perioperative treatment of patients with stage II-III non-small cell lung cancer has been accepted” is for reference only.
By order of the board of directors Shanghai Junshi Biomedical Technology Co., Ltd. Mr. Xiong Jun
Chairman
China, Shanghai, July 21, 2026
As of the date of this announcement, the Company’s Board of Directors includes Executive Directors Mr. Xiong Jun, Dr. Li Ning, Dr. Zou Jianjun,
Mr. Li Cong, Mr. Zhang Zhuobing, Dr. Wang Gang and Dr. Li Xin; non-executive directors Dr. Yao Sheng and Tang Yixian students; and independent non-executive directors Dr. Feng Xiaoyuan, Mr. Li Zhongxian, Ms. Lu Kun, Dr. Yang Jin and Chen Liang Sir.
*For identification purposes only
Securities code: 688180 Securities abbreviation: Junshi Biotechnology Announcement number: Lin 2026-040
Shanghai Haijunjunshi Biomedical Pharmaceutical Technology Co., Ltd.
Voluntary Disclosure Regarding Triterygium, Prilimumab and Combination Chemotherapy for Use in
Can be resected, perioperative treatment of patients with non-small cell lung cancer II-III Announcement that the supplementary application has been accepted
The board of directors and all directors of the company guarantee that the contents of this announcement do not contain any false records or misleading statements.
or major omissions, and shall bear legal responsibility for the authenticity, accuracy and completeness of its content in accordance with the law.
Recently, Shanghai Junshi Biomedical Technology Co., Ltd. (hereinafter referred to as the "Company") received a national
The "Notice of Acceptance" approved and issued by the Food and Drug Administration, toripalimab (trade name: Tuoyi®, produced Product code: JS001) combined with platinum-containing chemotherapy for perioperative treatment, followed by this product alone as adjuvant therapy, with
Revision of indications for adult patients with resectable stage II-III non-small cell lung cancer (hereinafter referred to as "NSCLC")
The supplemental application was accepted. The indications for this application include resectable stage IIIA-IIIB non-small cell lung cancer.
of adult patients expanded to adult patients with resectable stage II-III non-small cell lung cancer. Due to drug development week
It has a long period and many approval steps, and is easily affected by some uncertain factors. Can this supplementary application be obtained? There is uncertainty in the approval. Investors are advised to make prudent decisions and pay attention to guarding against investment risks. Now the relevant information
The announcement is as follows:
- Basic information on pharmaceuticals and drugs
Drug name: Toripalimab injection
Application matters: Supplementary application for domestically produced drugs Acceptance number: CYSB2600212, CYSB2600213
Applicant: Shanghai Junshi Biomedical Technology Co., Ltd.
Approval conclusion: According to the provisions of Article 32 of the "Administrative Licensing Law of the People's Republic of China", after review,
decided to accept it.
- Other related situations of pharmaceuticals and drugs Lung cancer is currently the malignant tumor with the highest morbidity and mortality in the world. According to the National Cancer Clinical Research Institute
Data released by the Research Center shows that the number of new cases of lung cancer in China in 2024 will be approximately 1.18 million, accounting for 10% of all new cases of lung cancer in China.
It accounts for 22.83% of the number of cancer cases. The number of lung cancer deaths in China is about 740,000, accounting for 10% of all cancer deaths in China.
28.79% of the cases. Among them, 20-25% of patients can be surgically removed at first diagnosis, but even if they undergo radical surgery,
Despite surgical treatment, 30-55% of patients will still experience recurrence and death after surgery. Radical surgery combined with chemotherapy is One of the means to prevent disease recurrence, but the clinical benefits of chemotherapy as preoperative neoadjuvant or postoperative adjuvant treatment are
It is limited and can only increase the patient's 5-year survival rate by about 5%.
In recent years, immunotherapy represented by PD-(L)1 inhibitors is changing the landscape of tumor treatment. It can
By removing the immunosuppression of immune cells by tumor cells and reactivating the patient's own immune cells to kill
tumors, to achieve long-term control or elimination of tumors. PD-1/PD-L1 inhibitors have been approved by domestic and foreign authorities Cancer treatment guidelines recommend it as one of the perioperative standard treatments for resectable stage II-III non-small cell lung cancer.
This supplemental application is primarily based on the NEOTORCH study (NCT04158440), a
A randomized, double-blind, placebo-controlled phase III clinical study designed to compare toripalimab or placebo combined with
The efficacy and safety of chemotherapy in the perioperative treatment of patients with stage II/III resectable non-small cell lung cancer. The research
The study was led by Professor Lu Shun from the Chest Hospital Affiliated to Shanghai Jiao Tong University School of Medicine as the principal investigator, and a total of
501 patients with stage II-III resectable non-small cell lung cancer. The primary endpoint was investigator-assessed phase III and II-III
Event-free survival (hereinafter referred to as "EFS"), blinded independent center pathology (hereinafter referred to as "BIPR") of stage 1 patients
Major pathological response rate ("MPR rate") was evaluated in patients with stage III and stage II-III disease. times
Primary endpoints include overall survival (hereinafter referred to as "OS"), EFS assessed by the Independent Review Committee (IRC), Complete pathological response rate (hereinafter referred to as "pCR rate"), disease-free survival (DFS) and safety, etc.
In January 2023, the EFS stage of patients with stage III resectable non-small cell lung cancer in the NEOTORCH study
The mid-stage analysis has met the primary study endpoint and will be presented at the 2023 American Society of Clinical Oncology (ASCO) General Meeting.
The latest research results were announced in the form of oral reports at the April meeting and the ASCO annual meeting, and will be released in 2024.
In January of this year, it was listed in the main issue of the top international authoritative journal "Journal of the American Medical Association" (Journal of the American Medical Association). Medical Association, JAMA), the world's first anti-PD-1 monoclonal antibody for perioperative use in non-small cell lung cancer
Phase III clinical studies (covering both neoadjuvant and adjuvant therapy) with positive EFS results. The result shows
showed that perioperative treatment with tripril combined with chemotherapy significantly prolonged EFS compared with perioperative chemotherapy alone.
(Median EFS: not reached vs. 15.1 months, P<0.001), reducing the risk of disease recurrence, progression or death
Reached 60% (HR=0.40, 95%CI: 0.28-0.57). At the same time, the OS of the toripalimab combined with chemotherapy group was also
showed a clear benefit trend (HR=0.62, 95%CI: 0.38-1.00). In addition, toripalimab combined with
Perioperative chemotherapy treatment increased the pCR rate to nearly 25 times (pCR rate: 24.8% vs. 1.0%), and the MPR rate
Improved to nearly 6 times (MPR rate: 48.5% vs. 8.4%).
In December 2023, based on the interim analysis results of the NEOTORCH study, toripalimab combined with New indications of platinum-based doublet chemotherapy for perioperative treatment of patients with resectable stage IIIA-IIIB non-small cell lung cancer
The disease marketing application was approved. It is the first perioperative therapy for lung cancer approved in China and the second in the world.
Included in the "National Medical Insurance Catalog (2025)". This therapy also received the 2024 edition of CSCO Non-Small Cell Lung
The highest level of recommendation in the Cancer Diagnosis and Treatment Guidelines.
In May 2026, the NEOTORCH study completed the final analysis, with the primary endpoint of the Phase II-III population The EFS, MPR rate and MPR rate of the phase III population all reached the preset superiority margins of the plan.
In July 2026, toripalimab combined with chemotherapy in the NEOTORCH study for resectable NSCLC
The results of post hoc analysis of surgical outcomes in stage III patients treated perioperatively were officially published in the International Journal of Surgery in full.
The top journal "JAMA Surgery". This analysis focuses on NEOTORCH
In patients with stage III NSCLC who underwent surgery in the study, perioperative toripalimab combined with chemotherapy was systematically evaluated.
The impact of treatment on surgical performance, complications, survival and other outcomes. The results showed that toripalimab combined with chemotherapy Significantly reduced the surgery cancellation rate (17.8% vs. 26.7%, p=0.03), allowing more patients to obtain surgical resection
opportunity without increasing perioperative risks or new safety signals. Among 314 patients who completed surgery,
Compared with placebo combined with chemotherapy, toripalimab combined with chemotherapy effectively achieves tumor downstaging and lymph node downstaging rates
Improved (tumor downstaging rate: 80.7% vs. 50.7%, lymph node downstaging rate: 67.5% vs. 48.6%), improved
Patients benefited from EFS (HR=0.50, 95%CI: 0.33-0.74; p<0.001). also achieved tumor downstaging In patients with lymph node downstaging, toripalimab combined with chemotherapy significantly improved EFS compared with placebo combined with chemotherapy.
(HRs are both 0.45, p=0.002 and p=0.009).
Toripalimab injection is the first domestically produced monoclonal antibody drug targeting PD-1 approved for marketing in China.
Once won the "China Patent Gold Award", the highest award in the national patent field, it has been awarded worldwide (including China, the United States).
(China, Europe, Southeast Asia and other places), more than 40 clinical trials initiated by the company covering more than 15 indications have been carried out. Clinical studies, ongoing or completed pivotal registration clinical studies evaluating tripril across multiple tumor types
Safety and efficacy of monoclonal antibodies. As of the disclosure date of this announcement, 13 indications of toripalimab have been approved in China.
Approved domestically. In December 2020, toripalimab injection passed the national medical insurance negotiation for the first time.
12 approved indications have been included in the national medical insurance directory, and it is the only indication in the national medical insurance directory for kidney cancer,
Anti-PD-1 monoclonal antibody for the treatment of negative breast cancer and melanoma. Toripalimab for advanced nasopharyngeal cancer and food
Three indications for the treatment of ductal squamous cell carcinoma have been approved in Hong Kong, China.
In terms of international layout, as of the disclosure date of this announcement, toripalimab is currently available in the United States, the European Union,
Nearly 50 countries and regions including India, the United Kingdom, Australia, Singapore, Malaysia and South Africa have obtained approval It is quasi-listed and is undergoing listing review in many countries and regions around the world.
- Risk reminders
Since pharmaceutical products are high-tech, high-risk, and high-value-added, will this supplementary application be approved?
There are uncertainties in obtaining approval, and the commercialization of drugs after they are approved for marketing is also susceptible to some uncertainties.
Due to the influence of factors, investors are advised to make prudent decisions and pay attention to guarding against investment risks. The company will actively promote the above projects and promptly monitor the subsequent progress of the projects in strict accordance with relevant regulations.
Perform information disclosure obligations. Relevant company information shall be disclosed in the company's designated media, "China Securities Journal" and "Shanghai Securities".
The announcements published in "Newspaper", "Securities Times" and the website of Shanghai Stock Exchange shall prevail.
Announcement is hereby made.
Shanghai Junshi Biomedical Technology Co., Ltd.
board of directors
July 22, 2026