Junshi Biosciences Pronounces Toripalimab’s Approval in Singapore

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SHANGHAI, March 26, 2025 (GLOBE NEWSWIRE) — Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a number one innovation-driven biopharmaceutical firm devoted to the invention, growth, and commercialization of novel therapies, introduced that the New Drug Utility (the “NDA”) for toripalimab (Singapore commerce title: LOQTORZI®) together with cisplatin and gemcitabine for the first-line therapy of grownup sufferers with recurrent, not amenable to surgical procedure or radiotherapy, or metastatic nasopharyngeal carcinoma (“NPC”) has been authorized by the Singapore Well being Sciences Authority (the HSA). Toripalimab has turn into the primary and solely authorized immuno-oncology therapy for NPC in Singapore.

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NPC is a malignant tumor that happens within the epithelium mucosae of the nasopharynx and is among the commonest forms of head and neck cancers. In response to GLOBOCAN 2022 statistics, the variety of newly identified NPC instances in 2022 exceeded 120,000 worldwide. Toripalimab is the one most well-liked routine really useful for the great therapy of recurrent or metastatic NPC within the Nationwide Complete Most cancers Community (NCCN) Pointers (Model 1.2025) for head and neck cancers.

The approval is based on the outcomes from JUPITER-02 (NCT03581786), the primary worldwide multi-center, double-blind, randomized Part 3 scientific examine in NPC immunotherapy with the most important pattern dimension. JUPITER-02 can also be the world’s first Part 3 scientific examine with preset statistical verification (Kind I error management) demonstrating a big general survival (“OS”) profit for first-line immunotherapy mixed with chemotherapy in comparison with chemotherapy alone in NPC. JUPITER-02’s outcomes have been introduced in an oral report throughout a Plenary Session on the 2021 American Society of Scientific Oncology (ASCO) annual assembly (#LBA2). These outcomes have been subsequently featured on the duvet of Nature Medication and revealed in full within the Journal of the American Medical Affiliation (JAMA). The outcomes of the examine confirmed that, in comparison with chemotherapy alone, toripalimab together with chemotherapy decreased the danger of illness development by 48% and the danger of dying by 37%. The median progression-free survival (“PFS”) within the toripalimab plus chemotherapy group was extended by 13.2 months in comparison with chemotherapy alone, from 8.2 months to 21.4 months. As well as, sufferers handled with this mixed remedy achieved the next goal response charge (“ORR”) and longer period of response (“DoR”), with a whole response (CR) charge of 26.7%, and no new security sign was recognized. Lengthy-term survival follow-up information was introduced at ASCO 2024, with a 5-year survival charge of 52%.

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Dr. Jianjun ZOU, Basic Supervisor and CEO of Junshi Biosciences, stated, “Toripalimab’s approval in Singapore represents our formal entry into the Southeast Asian market. Southeast Asia is a area with a excessive incidence of NPC, and we’re proud to introduce this groundbreaking remedy to handle unmet medical wants and rework the native therapy panorama. As of now, toripalimab has acquired advertising and marketing authorization in over 35 nations and areas throughout 4 continents. We stay dedicated to our ‘In China, For World’ technique, advancing revolutionary medicines from China to enhance healthcare for sufferers throughout the globe.”

The NDA was submitted below Mission Orbis. Mission Orbis, initiated and advocated by the Oncology Middle of Excellence (OCE) of the U.S. Meals and Drug Administration (the “FDA”), gives a collaborative mechanism and framework among the many FDA and regulatory authorities in different nations and areas, permitting totally different regulatory authorities to collectively evaluation the purposes for registration of oncology medicine. Toripalimab was the primary home oncology drug to be included in Mission Orbis. Beforehand, the Therapeutic Items Administration of the Australian Authorities Division of Well being and Aged Care (the “TGA”) authorized two New Chemical Entity purposes for toripalimab in NPC below Mission Orbis.

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About Toripalimab

Toripalimab is an anti-PD-1 monoclonal antibody developed for its capability to dam PD-1 interactions with its ligands, PD-L1 and PD-L2, and to induce PD-1 receptor internalization (endocytosis perform). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system’s capability to assault and kill tumor cells.

Greater than forty company-sponsored toripalimab scientific research masking greater than fifteen indications have been performed globally by Junshi Biosciences, together with in China, the US, Europe and Southeast Asia. Ongoing or accomplished pivotal scientific trials evaluating the protection and efficacy of toripalimab cowl a broad vary of tumor sorts, together with cancers of the lung, nasopharynx, esophagus, abdomen, bladder, breast, liver, kidney, and pores and skin.

Within the Chinese language mainland, toripalimab was the primary home anti-PD-1 monoclonal antibody authorized for advertising and marketing (authorized in China as TUOYI®). At the moment, there are eleven authorized indications for toripalimab within the Chinese language mainland:

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1. unresectable or metastatic melanoma after failure of normal systemic remedy;
2. recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of not less than two traces of prior systemic remedy;
3. regionally superior or metastatic urothelial carcinoma that failed platinum-containing chemotherapy or progressed inside 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy;
4. together with cisplatin and gemcitabine because the first-line therapy for sufferers with regionally recurrent or metastatic NPC;
5. together with paclitaxel and cisplatin in first-line therapy of sufferers with unresectable regionally superior/recurrent or distant metastatic esophageal squamous cell carcinoma (ESCC);
6. together with pemetrexed and platinum because the first-line therapy in EGFR mutation-negative and ALK mutation-negative, unresectable, regionally superior or metastatic non-squamous non-small cell lung most cancers (NSCLC);
7. together with chemotherapy as perioperative therapy and subsequently with monotherapy as adjuvant remedy for the therapy of grownup sufferers with resectable stage IIIA-IIIB NSCLC;
8. together with axitinib for the first-line therapy of sufferers with medium to excessive danger unresectable or metastatic renal cell carcinoma (RCC);
9. together with etoposide plus platinum for the first-line therapy of extensive-stage small cell lung most cancers (ES-SCLC);
10. together with paclitaxel for injection (albumin-bound) for the first-line therapy of recurrent or metastatic triple-negative breast most cancers (TNBC);
11. together with bevacizumab for the first-line therapy of unresectable or metastatic hepatocellular carcinoma (HCC) sufferers.

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The primary 10 indications have been included within the Nationwide Reimbursement Drug Checklist (NRDL) (2024 Version). Toripalimab is the one anti-PD-1 monoclonal antibody included within the NRDL for the therapy of melanoma, perioperative therapy of NSCLC, therapy of RCC and therapy of TNBC. In October 2024, toripalimab for the therapy of recurrent or metastatic NPC was authorized in Hong Kong SAR, China.

Internationally, toripalimab has been authorized for advertising and marketing in the US, the European Union, India, the UK, Jordan, Australia, Singapore and different nations and areas. As well as, toripalimab BLAs are below evaluations in lots of nations or areas across the world.

About Junshi Biosciences

Based in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical firm devoted to the invention, growth and commercialization of revolutionary therapeutics. The corporate has established a diversified R&D pipeline comprising over 50 drug candidates, with 5 therapeutic focus areas masking most cancers, autoimmune, metabolic, neurological, and infectious ailments. 5 of the corporate’s merchandise have acquired approvals in China and worldwide markets, certainly one of which is toripalimab, China’s first domestically produced and independently developed anti-PD-1 monoclonal antibody. Toripalimab has been authorized in over 35 nations and areas together with China, the US, and Europe. In the course of the COVID-19 pandemic, Junshi Biosciences actively shouldered the social obligations of a Chinese language pharmaceutical firm by its involvement in growing etesevimab, MINDEWEI®, and different novel therapies for the prevention and therapy of COVID-19.

With a mission of “offering sufferers with world-class, reliable, reasonably priced, and revolutionary medicine,” Junshi Biosciences is “In China, For World.” At current, the corporate boasts roughly 2,500 workers in the US (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, and so on.). For extra info, please go to: http://www.junshipharma.com.

Junshi Biosciences Contact Data

IR Staff:
Junshi Biosciences 
data@junshipharma.com 
+ 86 021-6105 8800

PR Staff:
Junshi Biosciences
Zhi Li 
zhi_li@junshipharma.com 
+ 86 021-6105 8800

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