[3]<\/a> Both \u201cDr. Reddy\u2019s Territory 1\u201d and \u201cDr. Reddy\u2019s Territory 2\u201d are collectively known as \u201cDr. Reddy\u2019s Territory\u201d, totalling 21 countries.<\/h5>\n\n\n\n\n\nAbout Toripalimab<\/strong><\/p>\n\n\n\nToripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system\u2019s ability to attack and kill tumor cells.<\/p>\n\n\n\n
More than forty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally by Junshi Biosciences, including in China, the United States, Southeast Asia, and European countries. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.<\/p>\n\n\n\n
In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI\u00ae). Currently, there are six approved indications for toripalimab in China:<\/p>\n\n\n\n
\n- unresectable or metastatic melanoma after failure of standard systemic therapy;<\/li>\n\n\n\n
- recurrent or metastatic NPC after failure of at least two lines of prior systemic therapy;<\/li>\n\n\n\n
- locally advanced or metastatic urothelial carcinoma that failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy;<\/li>\n\n\n\n
- in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic NPC;<\/li>\n\n\n\n
- in combination with paclitaxel and cisplatin in first-line treatment of patients with unresectable locally advanced\/recurrent or distant metastatic esophageal squamous cell carcinoma (“ESCC”);<\/li>\n\n\n\n
- in combination with pemetrexed and platinum as the first-line treatment in EGFR mutation-negative and ALK mutation-negative, unresectable, locally advanced or metastatic non-squamous non-small cell lung cancer (\u201cNSCLC\u201d).<\/li>\n<\/ol>\n\n\n\n
<\/p>\n\n\n\n
The first three indications have been included in the National Reimbursement Drug List (NRDL) (2022 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for treatment of melanoma.<\/p>\n\n\n\n
In the United States, the Biologics License Application (BLA) for toripalimab in combination with gemcitabine\/cisplatin, for the first-line treatment of patients with advanced recurrent or metastatic NPC and toripalimab monotherapy for the second-line or later treatment of recurrent or metastatic NPC after platinum-containing chemotherapy is under review by the U.S. Food and Drug Administration (FDA). The FDA has granted Breakthrough Therapy designations for toripalimab in combination with chemotherapy for the first-line treatment of recurrent or metastatic NPC as well as for toripalimab monotherapy in the second or third-line treatment of recurrent or metastatic NPC. Additionally, the FDA has granted Fast Track designation for toripalimab for the treatment of mucosal melanoma and Orphan Drug designations for the treatment of esophageal cancer, NPC, mucosal melanoma, soft tissue sarcoma, and small cell lung cancer (SCLC).<\/p>\n\n\n\n
In Europe, marketing authorization applications (MAA) were accepted by the European Medicines Agency (EMA) and the United Kingdom\u2019s Medicines and Healthcare products Regulatory Agency (MHRA) for 1) toripalimab combined with cisplatin and gemcitabine for the first-line treatment of patients with locally recurrent or metastatic NPC and 2) toripalimab combined with paclitaxel and cisplatin for the first-line treatment of patients with unresectable locally advanced\/recurrent or metastatic ESCC, in December 2022 and February 2023.<\/p>\n\n\n\n
<\/p>\n\n\n\n
About Dr. Reddy\u2019s <\/strong><\/p>\n\n\n\nDr. Reddy\u2019s is a global pharmaceutical company headquartered in Hyderabad, India and listed on the New York Stock Exchange (stock code: RDY), the National Stock Exchange of India (stock code: DRREDDY), and the Bombay Stock Exchange (stock code: 500124). Established in 1984, Dr. Reddy\u2019s is committed to providing access to affordable and innovative medicines. Driven by its purpose of \u2018Good Health Can\u2019t Wait\u2019, Dr. Reddy\u2019s offers a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Dr. Reddy\u2019s major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Its major markets include \u2013 the United States, India, China, Brazil and Europe. As a company with a history of deep science that has led to several industry firsts, Dr. Reddy\u2019s continues to plan ahead and invest in businesses of the future. As an early adopter of sustainability and ESG actions, Dr. Reddy\u2019s released its first Sustainability Report in 2004. Its current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance. For more information, log on to: www.drreddys.com.<\/p>\n\n\n\n
<\/p>\n\n\n","protected":false},"excerpt":{"rendered":"
SHANGHAI, China, May 7, 2023 (GLOBE NEWSWIRE) — Shanghai Junshi Biosciences Co., Ltd (\u201cJunshi Biosciences\u201d, HKEX: 1877; SSE: 688180) announced a collaboration with Dr. Reddy\u2019s Laboratories Limited (\u201cDr. Reddy\u2019s\u201d) to develop and commercialize toripalimab, the anti-PD-1 monoclonal antibody in Latin America, India , South Africa, and at the election of Dr. Reddy\u2019s, also in Australia, New Zealand and other countries.<\/p>\n","protected":false},"author":3,"featured_media":1117,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[22],"tags":[],"class_list":["post-2248","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"yoast_head":"\n
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