Securities code: 688180 securities abbreviation: Shanghai Junshi Biosciences Co.Ltd(688180) Announcement No.: pro 2022-006 Shanghai Junshi Biosciences Co.Ltd(688180)
Voluntary disclosure of the announcement on the completion of the phase III clinical study of treprizumab combined with chemotherapy as an adjuvant treatment after radical resection of gastric or esophagogastric junction adenocarcinoma and the administration of the first patient
The board of directors and all directors of the company guarantee that there are no false records, misleading statements or major omissions in the contents of this announcement, and bear legal responsibility for the authenticity, accuracy and integrity of its contents according to law.
Important content tips:
Recently, Shanghai Junshi Biosciences Co.Ltd(688180) (hereinafter referred to as “the company”) product treprizumab (trade name: tuoyi) ®， Product Code: js001) combined with standard chemotherapy as adjuvant treatment after radical resection of gastric or esophageal gastric junction adenocarcinoma. Phase III clinical study (hereinafter referred to as “jupiter-15 study”, nct05180734) has completed the administration of the first patient. Due to the long R & D cycle and many approval links of drugs, they are vulnerable to some uncertain factors. Please make careful decisions and pay attention to preventing investment risks. The relevant information is hereby announced as follows:
1、 Basic information of drugs
Treprizumab is the first domestic monoclonal antibody drug approved for listing in China with PD-1 as the target. It has won the highest award in the national patent field “China Patent Gold Award”. So far, more than 30 clinical studies covering more than 15 indications have been carried out in China, the United States, Southeast Asia and Europe. On December 17, 2018, treprizumab was conditionally approved by the State Drug Administration (hereinafter referred to as “the State Drug Administration”) for the treatment of unresectable or metastatic melanoma that failed to receive systemic treatment in the past. In December 2020, treprizumab injection passed the national medical insurance negotiation for the first time. At present, three indications have been included in the national medical insurance catalogue. In February 2021, treprizumab was approved conditionally by the State Food and Drug Administration for the treatment of patients with recurrent / metastatic nasopharyngeal carcinoma who had previously failed to receive second-line and above systematic treatment. In April 2021, treprizumab was approved conditionally by the State Food and Drug Administration for the treatment of locally advanced or metastatic urothelial carcinoma that failed platinum containing chemotherapy, including neoadjuvant or adjuvant chemotherapy within 12 months. In November 2021, treprizumab combined with cisplatin and gemcitabine was approved by the State Food and Drug Administration for the first-line treatment of patients with locally recurrent or metastatic nasopharyngeal carcinoma. In addition, treprizumab was also recommended by the Chinese society of Clinical Oncology (CSCO) guidelines for the diagnosis and treatment of melanoma, CSCO guidelines for the diagnosis and treatment of head and neck tumors, CSCO guidelines for the diagnosis and treatment of nasopharyngeal carcinoma, CSCO guidelines for the diagnosis and treatment of urothelial carcinoma and CSCO guidelines for the clinical application of immune checkpoint inhibitors.
In March 2021, the first-line treatment of advanced mucosal melanoma with treprizumab was included in the breakthrough treatment drug program by the State Food and drug administration. In July 2021, the listing application for new indications of treprizumab combined with platinum containing chemotherapy in the first-line treatment of locally advanced or metastatic esophageal squamous cell carcinoma was accepted by the State Food and drug administration. In December 2021, the new indication listing application of treprizumab combined with standard first-line chemotherapy for untreated and driver gene negative advanced non-small cell lung cancer was accepted by the State Food and drug administration. In terms of international layout, the first biological product license application (hereinafter referred to as “BLA”) of treprizumab in FDA has been officially accepted and given priority review. Treprizumab is also the first domestic anti-PD-1 monoclonal antibody to submit BLA to FDA. As of the disclosure date of this announcement, treprizumab has been awarded two breakthrough therapy accreditation, one fast track accreditation, one priority review accreditation and four orphan drug accreditation by FDA in the field of mucosal melanoma, nasopharyngeal carcinoma, soft tissue sarcoma and esophageal cancer.
2、 Research on jupiter-15
Jupiter-15 study is a randomized, double-blind, placebo-controlled, international multicenter phase III clinical study led by Professor Ji Jiafu of Peking University Cancer Hospital, Professor Shen Lin of Peking University Cancer Hospital and Professor Li Guoxin of Nanfang Hospital of Southern Medical University, To evaluate the clinical efficacy and safety of treprizumab combined with placebo-controlled standard chemotherapy as postoperative adjuvant therapy for patients with gastric or esophagogastric junction adenocarcinoma after radical resection. 680 patients are planned to be enrolled, involving more than 60 research centers. This is the first large-scale international multicenter phase III clinical study of PD-1 inhibitor independently developed in China to carry out adjuvant therapy in the field of high-risk gastric cancer in China.
The incidence rate of China’s gastric cancer ranked fifth in 2020, and the mortality rate ranked fourth. The incidence rate and mortality rate of gastric cancer ranked third in China. In 2020, 480 thousand cases of new gastric cancer cases occurred in China and more than 370 thousand cases died in 2020. The confirmed cases in China are mainly stage II and III gastric cancer. Surgical treatment must be supplemented by other comprehensive treatment methods to improve the prognosis. Postoperative adjuvant chemotherapy is still the current standard treatment. Anti-PD-1 monoclonal antibody can kill tumor by relieving the immunosuppression of tumor cells on immune cells and reactivating the patient’s own immune cells, so as to achieve the effect of long-term control or elimination of tumor. Globally, anti-PD-1 monoclonal antibody has shown significant clinical benefits in the treatment of gastric cancer. It supports the further exploration of anti-PD-1 monoclonal antibody combined with standard chemotherapy as an adjuvant treatment after radical resection of gastric or esophagogastric adenocarcinoma, so as to eliminate small lesions, delay disease recurrence, and finally prolong the survival of patients. 3、 Risk tips
Due to the characteristics of high-tech, high-risk and high added value of pharmaceutical products, the early research and development of drugs and the long cycle and many links of products from research and development, clinical trial approval to production are vulnerable to some uncertain factors. Please make careful decisions and pay attention to preventing investment risks.
The company will actively promote the above R & D projects and fulfill the obligation of information disclosure on the follow-up progress of the project in strict accordance with relevant regulations. The information about the company shall be subject to the announcements published by the designated disclosure media of the company, such as China Securities News, Shanghai Securities News, securities times, securities daily and the website of Shanghai Stock Exchange. It is hereby announced.
Shanghai Junshi Biosciences Co.Ltd(688180) board of directors February 11, 2022
