Junshi Biological re -submits Tripley monoclonal anti -resistance to treat nasopharyngeal carcinoma biological products permits for FDA acceptance

On July 7, Capital State learned that the Science and Technology Board Corporation (688180.SH) voluntarily disclosed the announcement on re -submission of the biological product license application for the treatment of nasopharynx cancer for the treatment of nasophagal cancer.

Recently, the U.S. Food and Drug Administration (hereinafter referred to as "FDA") accepted the Tripley Midgrot submitted by Shanghai Junshi Biomedical Technology Co., Ltd. (hereinafter referred to as "Company") The first -line therapy and single drugs for patients with advanced Jesitabin/cisplatin as advanced recurrence or metastatic nasopharyngeal carcinoma for recurrence or metastatic nasopharyngeal carcinoma -based biological product license (Biology BLA ").

The FDA has set the target review date of the Prescription Pharmaceutical Pharmaceutical Paid Act (PDUFA) to December 23, 2022. FDA said earlier that because it needs to conduct on -site inspections in China, the review time limit for BLA will be submitted to BLA for six months. Earlier, the restrictions on travel related to the new coronary virus pneumonia have hindered the FDA to complete the necessary on -site verification work. If it is approved, the company's partner Coherusbiosciences, Inc. Tumor immunotherapy for nasopharyngeal cancer treatment.

The BLA of Tripley monoclonal anti-anti-resistance is based on the Jupiter-02 (a random, double-blind, placebo control, international multi-center III clinical study) and Polaris-02 (a multi-center, open label, Phase II key registration Research results of clinical research). Jupiter-02 research results were first published for the first time at the overall conference (#LBA2) of the American Clinical Oncology Society (ASCO) Annual Conference in June 2021, and subsequently published as the cover article of NatureMedicine in September 2021. Polaris-02 research results were published online in January 2021 in "JournalofclinicalonCology".

Nasopharyngeal cancer is a malignant tumor that occurs in the mucosal epitidium of the nasopharynx. It is one of the common malignant tumors in the head and neck. According to statistics from the World Health Organization, the number of new developments diagnosed in the world in 2020 exceeded 130,000. Due to the location of primary tumors, surgical treatment is rarely used, and patients with local diseases mainly use chemotherapy and radiotherapy. In the United States, no immunotherapy has been approved to treat nasopharyngeal cancer.

Tripley monoclonal anti-anti-resistance is China's first domestic monoclonal anti-resistant drug with PD-1 as its target. It has won the highest award "China Patent Gold Award" in the national patent field. And Europe and other places) carried out more than 30 clinical research initiated by the company that covered more than 15 indications. The key registered clinical research that is undergoing or completed will evaluate the safety and efficacy of Treepley monoclonal anti -resistance within the scope of multiple tumors, including lung cancer, nasopharyngeal cancer, esophageal cancer, gastric cancer, bladder cancer, breast cancer, liver cancer, and liver cancer Kidney cancer and skin cancer.

As of the disclosure date of this announcement, the five indications of Tripley monoclonal anti -resistance have been approved in China: the treatment of irrevised or metastatic melanoma for the failure of systemic system treatment (December 2018); for In the past, the treatment of recurrence/metastatic nasopharyngeal cancer patients (February 2021), which failed to fail in the treatment of second -tier and above systems; for local advanced or metastasis for complaint chemotherapy failure including neo -assisted or auxiliary chemotherapy for 12 months Treatment of urinary tract cancer (April 2021); first -line treatment of local recurrence or metastatic nasopharyngeal cancer patients (November 2021); combined with paclitaxel and cisplatin for non -removal local advanced stages /The first -line treatment of patients with recurrence or distant metastatic esophageal squamous carcinoma (May 2022).

The first three adaptive diseases have been included in the national medical insurance directory (2021 edition). Tripley monoclonal antibody is the only anti-PD-1 monoclonal drug for treating melanoma and nasopharyngeal cancer in the national medical insurance catalog. In addition, Tripley Micometer Anti -combined chemotherapy is currently under the review of new indications for patients with non -EGFR or ALK mutations without EGFR or ALK mutations.

As of the disclosure date of this announcement, Tripley Mipide has obtained 2 breakthrough therapy identification in the field of mucosa melanoma, nasopharyngeal cancer, soft tissue sarcoma, esophageal cancer and small cell lung cancer. Priority review identification and 5 orphan drug qualifications.

- END -