JUNSHI BIO (01877): Tepilumab, a second-line and above treatment for melanoma, receives regular approval from the National Medical Products Administration.

JUNSHI BIO (01877) announces that recently, the company has received the approval notice of a drug supplementary application from the National Medical Products Administration (referred to as "NMPA" below). Tislelizumab (trade name: Tuoyi, product code: JS001) has obtained NMPA's approval for the indication of treating unresectable or metastatic melanoma that has failed previous systemic therapy, with conditional approval being converted to regular approval. Melanoma is the most malignant type of skin cancer. According to data released by GLOBOCAN 2022, there are approximately 332,000 new cases of melanoma worldwide in 2022, with around 59,000 deaths. Melanoma is relatively rare in China, but with a high mortality rate (around 9,000 new cases and 5,000 deaths in 2022), and the incidence is increasing year by year. The policy of conditional approval for marketing authorization aims to encourage drug innovation based on clinical value and accelerate the market entry of urgently needed drugs with outstanding clinical value. On December 17, 2018, based on a multicenter, single-arm, open-label Phase II clinical study (POLARIS-01 study, NCT03013101), tislelizumab obtained conditional marketing approval from NMPA for the treatment of unresectable or metastatic melanoma that has failed previous systemic therapy, becoming the first domestically produced PD-1-targeted monoclonal antibody drug approved for marketing in China. This regular approval means that tislelizumab has completed the necessary confirmatory clinical trials as required by regulatory authorities and has proven its efficacy and safety in the target population. This regular approval is mainly based on the MELATORCH study (NCT03430297). The MELATORCH study is a multicenter, randomized, open-label, positive-controlled Phase III clinical study aimed at comparing the efficacy and safety of tislelizumab versus dacarbazine in patients with unresectable or metastatic melanoma who have not received systemic anti-tumor therapy in the past. The primary endpoint is progression-free survival (PFS, based on independent imaging evaluation). Professor Guo Jun from Peking University Cancer Hospital serves as the principal investigator of this study, with participation from 11 clinical centers nationwide. This study is currently the first and only key registration clinical study in China to achieve positive results for PD-(L)1 inhibitors in the first-line treatment of advanced melanoma. The results of the study show that compared to the dacarbazine group (N=128), the tislelizumab group (N=127) significantly extended PFS based on independent imaging evaluation, reducing the risk of disease progression or death by 29.2% (HR=0.708; 95%CI: 0.526-0.954; P=0.0209).Other efficacy endpoints (including PFS evaluated by investigators, objective response rate, duration of response, and overall survival) also show a beneficial trend, with good safety profile and no new safety signals identified. Based on the study, in August 2024, the application for a new indication of tislelizumab for first-line treatment of unresectable or metastatic melanoma has been accepted by NMPA. Tislelizumab injection is the first domestically produced monoclonal antibody drug targeting PD-1 approved for marketing in China. It has received the highest award in the national patent field, the "China Patent Gold Award." Up to now, the drug has conducted over 40 clinical studies covering more than 15 indications globally including China, the United States, Southeast Asia, and Europe, initiated by the company. Ongoing or completed key registration clinical studies evaluate the safety and efficacy of tislelizumab in multiple tumor types. As of the date of this announcement, tislelizumab has been approved for 10 indications in mainland China. In December 2020, tislelizumab injection was included in the National Medical Insurance Catalog (2024) through national medical insurance negotiations. It is the only anti-PD1 monoclonal antibody for the treatment of melanoma, non-small cell lung cancer perioperative period, kidney cancer, and triple-negative breast cancer in the National Medical Insurance Catalog. In October 2024, tislelizumab was approved for the treatment of recurrent/metastatic nasopharyngeal cancer in Hong Kong, China. In terms of international layout, as of the date of this announcement, tislelizumab has been approved for marketing in countries and regions such as the United States, the European Union, India, the United Kingdom, and Jordan. In addition, the Therapeutic Goods Administration (TGA) of Australia and the Health Sciences Authority (HSA) of Singapore have respectively accepted the marketing authorization applications for tislelizumab in combination with cisplatin/gemcitabine as first-line treatment for adult patients with metastatic or recurrent locally advanced nasopharyngeal cancer, and as a monotherapy for adult patients with recurrent, unresectable or metastatic nasopharyngeal cancer which has progressed after platinum-containing treatment or after treatment.