Securities code: Shanghai Junshi Biosciences Co.Ltd(688180) securities abbreviation: Shanghai Junshi Biosciences Co.Ltd(688180) Announcement No.: pro 2022040 Shanghai Junshi Biosciences Co.Ltd(688180)
Voluntary disclosure on the submission of treprizumab to FDA
Announcement on the progress of biological product license application for the treatment of nasopharyngeal carcinoma
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.
1、 Overview of relevant situations
Recently, The United States Food and Drug Administration for the treatment of recurrent nasopharyngeal carcinoma (hereinafter referred to as “gemcitabine I / 001”) and gemcitabine II line (hereinafter referred to as “gemcitabine I / 001”) received the application of gemcitabine plus platinum for the treatment of recurrent nasopharyngeal carcinoma (biology licenseapplication, hereinafter referred to as “BLA”) (hereinafter referred to as “reply letter”). The reply letter requires a change in the quality control process that the company considers easier to complete. The company plans to meet directly with the FDA and expects to resubmit the BLA by midsummer 2022. The reply letter mentioned that the on-site verification to be completed was hindered by travel restrictions related to the outbreak of novel coronavirus pneumonia. The specific time of on-site verification will be notified separately.
2、 Drug related information
Nasopharyngeal carcinoma (NPC) is a malignant tumor occurring in the mucous epithelium of the nasopharynx. It is one of the common head and neck malignancies. According to the statistics of the World Health Organization, more than 130000 new cases of nasopharyngeal carcinoma were diagnosed worldwide in 2020. Due to the location of the primary tumor, surgery is rarely used. Patients with local diseases are mainly treated with chemotherapy and radiotherapy. In the United States, no immunotherapy has been approved for the treatment of nasopharyngeal carcinoma.
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 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 five orphan drug accreditation by FDA in the field of mucosal melanoma, nasopharyngeal carcinoma, soft tissue sarcoma, esophageal cancer and small cell lung cancer.
3、 Impact on the company
Since there is no tumor immunotherapy approved for the treatment of nasopharyngeal carcinoma in the United States, the BLA of treprizumab in the treatment of nasopharyngeal carcinoma meets the “unmet clinical needs”. The FDA said it has flexibility in the regulation of this indication in terms of the adequacy of clinical data in a single country. FDA also pointed out that the existing clinical data of treprizumab can support the declaration of BLA. The company has successfully completed the online part of FDA’s on-site inspection of production base. The company will maintain close communication with regulators and actively make preparations for FDA on-site verification, so as to accept on-site verification at any time and promote the commercialization of treprizumab in the United States as soon as possible.
4、 Risk tips
Due to the uncertainty of the time and results of FDA on-site verification, there is uncertainty about whether this BLA can be approved. The company will actively promote the above R & D projects and timely perform the obligation of information disclosure on the follow-up progress of the project in strict accordance with relevant regulations. Please make careful decisions and pay attention to preventing investment risks. 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 may 5, 2022
