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SHANGHAI, China, April 24, 2024 (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 Drug Workplace, Division of Well being, the Authorities of the Hong Kong Particular Administrative Area (“DO”) has lately accepted the New Drug Utility (“NDA”) for toripalimab together with cisplatin and gemcitabine for the first-line therapy of adults with metastatic or recurrent domestically superior nasopharyngeal carcinoma (“NPC”), and as a single agent for the therapy of adults with recurrent, unresectable, or metastatic NPC with illness development on or after platinum-containing chemotherapy.
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The NDA is supported by outcomes from JUPITER-02, a randomized, double-blind, placebo-controlled, multinational multi-center Section 3 scientific research (NCT03581786) that examined toripalimab together with gemcitabine-cisplatin because the first-line therapy of NPC, in addition to outcomes from POLARIS-02, a multi-center, open-label, pivotal Section 2 scientific research (NCT02915432) that evaluated toripalimab because the second-line or later therapy for recurrent or metastatic NPC.
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Outcomes from JUPITER-02, the primary worldwide, multi-center, double-blind, randomized, placebo-controlled Section 3 scientific research utilizing immunotherapy for the therapy of NPC with the most important pattern measurement, have been offered on the plenary session of the 2021 American Society of Scientific Oncology (ASCO) annual assembly (#LBA2), and printed in Nature Drugs and the Journal of the American Medical Affiliation (JAMA). The research discovered that in comparison with chemotherapy alone, toripalimab together with chemotherapy for the first-line therapy of metastatic or recurrent NPC considerably improved progression-free survival (“PFS”) and total survival (“OS”), with a median PFS of 21.4 months and a 3-year OS charge of 64.5%. Toripalimab plus chemotherapy additionally decreased the chance of illness development or loss of life by 48% and the chance of loss of life by 37%, all whereas demonstrating a manageable security profile.
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The POLARIS-02 outcomes have been printed on-line in January 2021 within the Journal of Scientific Oncology. These findings confirmed that toripalimab demonstrated sturdy antitumor exercise in sufferers with recurrent or metastatic NPC who failed earlier chemotherapy, with an goal response charge (ORR) of 20.5%, a median period of response (DoR) of 12.8 months, and a median OS of 17.4 months whereas sustaining a manageable security profile.
To date, toripalimab has been authorized for advertising within the Chinese language mainland and the US. A number of NDAs are at the moment underneath regulatory evaluation within the European Union, UK, Australia, Singapore, Malaysia and Hong Kong Particular Administrative Area (“SAR”). Moreover, NDAs for toripalimab have additionally been submitted in India, South Africa, Chile and Jordan.
About NPC
NPC is a malignant tumor that happens within the nasopharyngeal mucosal epithelium and is likely one of the commonest varieties of head and neck most cancers. In accordance with the World Well being Group, the variety of newly recognized NPC instances in 2022 exceeded 120,000 worldwide. As a result of location of the first tumor, surgical procedure isn’t an possibility, whereas radiotherapy alone or together with chemotherapy are the principle therapy choices for localized cancers.
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About Toripalimab
Toripalimab is an anti-PD-1 monoclonal antibody developed for its capacity to dam PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis operate). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system’s capacity to assault and kill tumor cells.
Greater than forty company-sponsored toripalimab scientific research protecting greater than fifteen indications have been carried out globally by Junshi Biosciences, together with in China, america, Southeast Asia, and Europe. Ongoing or accomplished pivotal scientific trials evaluating the security and efficacy of toripalimab cowl a broad vary of tumor varieties, together with cancers of the lung, nasopharynx, esophagus, abdomen, bladder, breast, liver, kidney, and pores and skin.
In China, toripalimab was the primary home anti-PD-1 monoclonal antibody authorized for advertising (authorized in China as TUOYI®). At present, there are eight authorized indications for toripalimab within the Chinese language mainland:
- unresectable or metastatic melanoma after failure of normal systemic remedy;
- recurrent or metastatic NPC after failure of a minimum of two traces of prior systemic remedy;
- domestically superior or metastatic urothelial carcinoma that failed platinum-containing chemotherapy or progressed inside 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy;
- together with cisplatin and gemcitabine because the first-line therapy for sufferers with domestically recurrent or metastatic NPC;
- together with paclitaxel and cisplatin in first-line therapy of sufferers with unresectable domestically superior/recurrent or distant metastatic esophageal squamous cell carcinoma (ESCC);
- together with pemetrexed and platinum because the first-line therapy in EGFR mutation-negative and ALK mutation-negative, unresectable, domestically superior or metastatic non-squamous non-small cell lung most cancers (NSCLC);
- 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;
- together with axitinib for the first-line therapy of sufferers with medium to excessive threat unresectable or metastatic renal cell carcinoma (RCC).
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The primary six indications have been included within the Nationwide Reimbursement Drug Checklist (NRDL) (2023 Version). Toripalimab is the one anti-PD-1 monoclonal antibody included within the NRDL for the therapy of melanoma. In April 2024, the Hong Kong DO accepted the NDA for toripalimab, together with cisplatin and gemcitabine for the first-line therapy of adults with metastatic or recurrent domestically superior NPC, and as a single agent for the therapy of adults with recurrent, unresectable, or metastatic NPC with illness development on or after platinum-containing chemotherapy.
In america, the FDA has authorized the Biologics License Utility for toripalimab together with cisplatin and gemcitabine for the first-line therapy of adults with metastatic or recurrent domestically superior NPC, and for toripalimab, as a single agent, for the therapy of adults with recurrent, unresectable, or metastatic NPC with illness development on or after platinum-containing chemotherapy in October 2023. The FDA has granted toripalimab 2 Breakthrough Remedy designations for the therapy of NPC, 1 Quick Monitor designation for the therapy of mucosal melanoma, and 5 Orphan Drug designations for the therapy of esophageal most cancers, NPC, mucosal melanoma, delicate tissue sarcoma, and small cell lung most cancers (SCLC).
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In Europe, advertising authorization purposes (MAA) have been accepted by the European Medicines Company (EMA) and the MHRA for 1) toripalimab mixed with cisplatin and gemcitabine for the first-line therapy of sufferers with domestically recurrent or metastatic NPC and a couple of) toripalimab mixed with paclitaxel and cisplatin for the first-line therapy of sufferers with unresectable domestically superior/recurrent or metastatic ESCC, in December 2022 and February 2023.
In Australia, Singapore and Hong Kong SAR, NDAs have been accepted by the Australia Therapeutic Items Administration (TGA), the Singapore Well being Sciences Authority (HSA) and DO for toripalimab, each together with cisplatin and gemcitabine for the first-line therapy of adults with metastatic or recurrent domestically superior NPC, and as a single agent for the therapy of adults with recurrent, unresectable, or metastatic NPC with illness development on or after platinum-containing chemotherapy. Toripalimab obtained an Orphan Drug designation from the TGA and a Precedence Evaluate designation from the HSA.
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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 progressive therapeutics. The corporate has established a diversified R&D pipeline comprising over 50 drug candidates, with 5 therapeutic focus areas protecting most cancers, autoimmune, metabolic, neurological, and infectious illnesses. 4 of the corporate’s improvements have already reached the Chinese language or worldwide markets, one among which is toripalimab, China’s first domestically produced and independently developed anti-PD-1 monoclonal antibody, authorized in China and the US. Moreover, greater than 30 medication are at the moment in scientific growth. Through the COVID-19 pandemic, Junshi Biosciences actively shouldered the social tasks of a Chinese language pharmaceutical firm by its involvement in creating 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 progressive medication,” Junshi Biosciences is “In China, For International.” At current, the corporate boasts roughly 3,000 staff in america (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, and so on.). For extra info, please go to: http://junshipharma.com.
Junshi Biosciences Contact Info
IR Group:
Junshi Biosciences
information@junshipharma.com
+ 86 021-6105 8800
PR Group:
Junshi Biosciences
Zhi Li
zhi_li@junshipharma.com
+ 86 021-6105 8800
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