Junshi biosks announce the approval of Toripalimab’s Singapore

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Shanghai, March 26, 2025 (Globe Newswire) – Shanghai Junshi Biosciyences Co., Ltd (Singapore Shopping Name: Logtorzi ®) with Casplatin and Gemcitabine or Metastatic NasofaryGeal Carcinoma (“NPC) First Line of First Line (Approved by the NPC) (approved by NPC). Toripalimab became the first and only approved immuno-oncological treatment for the NPC in Singapore.

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The NPC is a malignant tumor, which forms Nasofarynx’s epithelium mucosa and is one of the head and neck cancers. According to Globocan 2022 statistics, in 2022, the number of newly diagnosed NPC work has exceeded 120,000 world. The National Comprehensive Cancer Network (NCCN) instructions (NCCN) instructions (NCCN) instructions (NCCN) instructions (NCCN) instructions (NCCN) instructions (NCCN) instructions (NCCN) instructions (NCCN) instructions (NCCN) instructions (NCCN) instructions (NCCN) instructions (NCCN) instructions (NCCN) instructions (NCCN) instructions (NCCN) instructions (NCCN) instructions (NCCN) instructions (NCCN) instructions.

Approved, primarily based on the results of Jupiter-02 (NCT035811786), the first international, double-blind, two blind, randomized Phase 3 immunotherapy in clinical research. Jupiter-02 is also a first-stage clinical research to demonstrate first-class inspection (“OS”) in advance of a pre-combined statistical inspection (OS “), the annual meeting of Jupiter-02, 2021 Annual Meeting (# LBA2) was presented in a verbal report during a plenary meeting. The magazine of the American Medical Association (Jama) was fully released. The results of the study were 48% and the risk of death in the Toripalimab, the media in the Group of Chemotherapy (PFS “) in 13.2 months in 13.2 months Until 21.4 months, 13.2 months were extended compared to chemotherapy. In addition, these combined therapy treated with a higher objective response rate (“Orr”) and a longer response period (“Dor”), 26.7% and new security signal with full response (CR). Long-term survival information Information on ASCO 2024, 52% of the 52-year survival rate was presented.

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Dr. Junyjun Zou, the CEO of Junshi Biosciens, “We are proud to solve our official entry to the Southeast Asian market. Four continents. We remain loyal to the strategy, global strategy for the development of innovative drugs from China.”

It was presented in the Project Orb. The United States has a joint mechanism and a framework for the initiative and lawyer (“FDA”) on the initiative and regulatory and regulatory registration between the FDA and regulatory and regulatory and regulatory registration of the Ministry of Food and Drug and the FDA). The Department of Therapeutic Goods of the Department (TGA) has approved the application of two new chemical organizations for Toripalimab in the NPC in the Project Orb.

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About Toripalimab

Toripalimab is an anti-PD-1 monoclonal antibody designed for Ligands, PD-L1 and PD-L2, PD-L1 and PD-L2, and a anti-PD-1 monoclonal antibody designed for the ability to close the internal use of the PD-1 receptor (endocitive function). Blocking interactions with PD-L1 and PD-L2 promotes the ability to attack and kill the tumor system of the immune system.

Toripalimab clinical research sponsored by forty companies, clinical studies covering more than fifteen tips, China, the United States, Europe and Southeast Asia, including Junshi biosque global scale. Sustainable or filled Pivotal clinical trials cover a wide range of types of tumors, including a wide range, lung, nasofarynx, Özofagus, stomach, liver, kidneys and skin.

In the Chinese mainland, Toripalimab was the first local Anti-PD-1 monoclonal antibody approved for marketing (confirmed as Tuoyi® in China). Currently there are eleven instructions for China Matipalimab:

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1. silent or metastatic melanoma after standard systemic therapy fails;
2. repeated or metastatic nasofarygeal carsinoma (NPC) after the failure of at least two lines of previous systemic therapy;
3. Chemotherapy in chemotherapy containing chemotherapy within 12 months of the Neoadjuvant or Adjuvant Platinum, local or metastatic ulotel carcinoma;
4. Local repetitive or metastatic NPC together with Cisplatin and Gemcitabine as the first line treatment;
5. Local developed or distant metastatically developed or distant metastatic Özoflitachel and Cisplatin with Paclitakhel and Cisplatin
6. EGFR mutation-negative and alk mutation-negative, unusual, unusual or non-usable non-unusual cell with pemetrected and platinum with platinum
7. With chemotherapy with periopperative treatment and monotherapy with monotherapy, tedious stage as a helper for the treatment of adult patients with IIIA-IIB NSCLC;
8. Along with axitinib for the treatment of first string patients with medium or high risk-free and metastatic kidney cell carcinoma (RCC);
9. Wide-stage small cell lung cancer (ES-SCLC) together with the Etoposide Plus Platinum for first-line treatment;
10. Injection (albumin-link) for treatment in the first line of repeated or metastatic triple breast cancer (Albumin-connection) with Paclitaxel (TNBC);
11. Including or metastatic hepatosellulural language (HCC) with Bevacizumab for the first line of patients.

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The first 10 instruction was included in the National Payment Drugs (NRDL) (NRDL) (2024 edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in NRDL for NSCLC’s Melanoma, Peri-PERIAL TREATMENT, RCC treatment and TNBC treatment and treatment. In October 2024, Toripalimab was approved in the city of Hong Kong, China for repetitive or treating metastatic NPC.

International, Toripalimab, in the United States, the European Union, India, Iordania, Australia, Singapore and Toripalimab were approved for marketing in Singapore and other countries and regions. In addition, the Torpalimab Blas is under reviews in many countries or in the global areas.

About Junshi Bioscons

In December 2012, Cunshi Bioscenses (HKEX: 1877; SSE: 688180) is an innovative controlled biofarmautic company dedicated to the discovery, development and trade of innovative therapeutics. The company, a diversified R & D pipeline, cancer, autoimmune, metabolic, nevelic and infectious diseases, consisting of more than 50 drug candidates, five therapeutic focus area. The company’s products are an anti-PD-1 monoclonal antibody designed and independent of Toripalimab, China and International Markets, China and Independently developed and independent of China. Toripalimab has been approved in more than 35 countries and regions, including China, USA and Europe. During the CovID-19 pandemic, Junshi bioskas are active in the social responsibilities of a Chinese pharmaceutical company with the participation of Eteesevimab, Mindewei ® and other novel therapies for the prevention and treatment of Covid-19.

“Providing patients with world-class, reliable, affordable and innovative drugs,” Global Biosciens “in China, Global” Global “in China. http://www.junshipharma.com.

Junshi Bioccions Contact Information

IR Team:
Junshi Bioccions
info@junshipharma.com
+ 86 021-6105 8800

Proters:
Junshi Bioccions
未分类
zhi_li@junshipharma.com
+ 86 021-6105 8800

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