SHANGHAI, Nov. 16, 2024 (GLOBE NEWSWIRE) — Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE (LON:): 688180), a leading innovation-driven biopharmaceutical company dedicated to discovery, development and commercialization of new therapies, and its wholly owned subsidiary, TopAlliance Biosciences Inc. (TopAlliance Biosciences), announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved toripalimab (UK trade name: LOQTORZI ®) for treatment. of two indications:
- Toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with recurrent metastatic nasopharyngeal carcinoma (NPC), not amenable to surgery or radiotherapy;
- Toripalimab in combination with cisplatin and paclitaxel for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC).
In the UK, toripalimab is the first and only drug for the treatment of NPC and the only first-line treatment for advanced or metastatic ESCC, regardless of PD-L1 status.
NPC is a malignant tumor that occurs in the epithelium of the nasopharyngeal mucosa and is one of the most common types of head and neck cancers worldwide. According to GLOBOCAN 2022 statistics, the number of newly diagnosed NPC cases in 2022 exceeded 120,000 worldwide. Due to the location of the primary tumor, surgery is rarely an option. The last European Society of Doctor (TASE:) Oncology (ESMO) guidelines recommend immunotherapy combined with chemotherapy as first-line treatment for recurrent or metastatic NPC.
The approval of the NPC indication is primarily based on the results of the JUPITER-02 study (a phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled clinical study, NCT03581786). JUPITER-02 is the first international, multicenter, double-blind, randomized Phase 3 clinical study on NPC immunotherapy with the largest sample size, and the world’s first Phase 3 clinical study with pre-established statistical verification (type I error control). for overall survival. (OS) in first-line immunotherapy combined with chemotherapy for NPC compared with chemotherapy alone demonstrated a survival benefit. The study results were presented in an oral report during the plenary session of the 2021 American Society of Clinical Oncology (ASCO) annual meeting (#LBA2) and subsequently appeared on the cover of Nature Medicine. The results were also published in full in the Journal of the American Medical Association (JAMA). The results showed that, compared with chemotherapy alone, toripalimab in combination with chemotherapy reduced the risk of disease progression by 48% and the risk of death by 37%. Median progression-free survival (PFS) in the toripalimab plus chemotherapy group was prolonged by 13.2 months compared with chemotherapy alone, from 8.2 months to 21.4 months. Additionally, patients treated with this combination therapy achieved a higher objective response rate (ORR) and longer duration of response (DoR), with a complete response (CR) rate of 26.7%, and no identified no new security sign. Long-term survival follow-up data, presented at ASCO 2024, reported a 5-year survival rate of 52.0%.
EC is one of the most common malignant tumors in the alimentary tract. According to GLOBOCAN 2022 statistics, esophageal cancer is the 11th most commonly diagnosed cancer and the 7th leading cause of cancer death worldwide, with more than 511,000 new cases and more than 445,000 deaths in 2022. The ESCC and Esophageal adenocarcinoma are the two main histological subtypes of esophageal cancer. .
The approval of the ESCC indication is primarily based on the results of the JUPITER-06 study (a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical study, NCT03829969). The study aimed to evaluate the efficacy and safety of toripalimab in combination with paclitaxel/cisplatin (TP) for the first-line treatment of advanced ESCC compared to placebo in combination with chemotherapy. The results were first presented in an oral session during the ESMO 2021 Congress and then published in Cancer Cell and Journal of Clinical Oncology, two leading international oncology journals. Study findings showed that toripalimab in combination with chemotherapy resulted in superior PFS and OS in patients with advanced or metastatic ESCC, median OS was prolonged from 6 to 17 months, and the risk of disease progression or death in patients was significantly reduced by 42%. . Furthermore, there was a significant improvement in survival benefits regardless of PD-L1 status.
Dr Jianjun ZOU, Chairman and CEO of Junshi Biosciences, said: The approval of toripalimab by the MHRA marks another important milestone for toripalimab in Europe, not only making toripalimab the first and only drug in the UK for the treatment of NPC, but also as only the first-line treatment for ESCC, regardless of PD-L1 status. We are very proud to introduce innovative Chinese biopharmaceuticals to Europe that can address the long-unmet medical needs of patients there. Going forward, we will remain committed to our globalization strategy: “In China, for global.” We will continue to work towards the commercialization of toripalimab and offer innovative, high-quality, domestically developed medicines to benefit more patients around the world.
About toripalimab
Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block interactions of PD-1 with its ligands, PD-L1 and PD-L2, and to enhance receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system’s ability to attack and kill tumor cells.
Junshi Biosciences has conducted more than forty company-sponsored clinical studies of toripalimab covering more than fifteen indications worldwide, including in China, the United States, Southeast Asia and Europe. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a wide range of tumor types, including lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney, and skin cancers.
In mainland China, toripalimab was the first anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI ®). Currently, there are ten approved indications for toripalimab in mainland China:
- unresectable or metastatic melanoma after failure of standard systemic therapy;
- recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy;
- locally advanced or metastatic urothelial carcinoma that failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy;
- in combination with cisplatin and gemcitabine as first-line treatment for patients with locally recurrent or metastatic NPC;
- in combination with paclitaxel and cisplatin in the first-line treatment of patients with distantly metastatic, locally advanced/recurrent or unresectable esophageal squamous cell carcinoma (ESCC);
- in combination with pemetrexed and platinum as first-line treatment in EGFR mutation-negative and ALK mutation-negative non-squamous, metastatic, locally advanced or unresectable non-small cell lung cancer (NSCLC);
- in combination with chemotherapy as perioperative treatment and subsequently with monotherapy as adjuvant therapy for the treatment of adult patients with resectable stage IIIA-IIIB NSCLC;
- in combination with axitinib for the first-line treatment of patients with medium- to high-risk metastatic or unresectable renal cell carcinoma (RCC);
- in combination with etoposide plus platinum for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC);
- in combination with injectable paclitaxel (albumin-bound) for the first-line treatment of recurrent or metastatic triple negative breast cancer (TNBC).
The first six indications have been included in the National Reimbursement Drug List (NRDL) (2023 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for the treatment of melanoma. In October 2024, toripalimab was approved for the treatment of recurrent or metastatic NPC in Hong Kong SAR, China.
In terms of international distribution, toripalimab has been approved for marketing in the United States, the European Union, India, the United Kingdom, Jordan and other countries and regions. In addition, the Australian Therapeutic Goods Administration (TGA) and the Health Sciences Authority of Singapore (HSA) accepted the new chemical entity application and the new drug application for toripalimab in combination with cisplatin and gemcitabine, for the treatment first-line treatment for adults with metastatic disease. or recurrent locally advanced NPC, and for toripalimab, as a single agent, for the treatment of adults with recurrent, unresectable or metastatic NPC with disease progression during or after platinum-containing chemotherapy, respectively.
About Junshi Biosciences
Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies. The company has established a diversified R&D portfolio comprising more than 50 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological and infectious diseases. Five of the company’s innovations have already reached the Chinese or international markets, one of which is toripalimab, the first anti-PD-1 monoclonal antibody produced in China and independently developed, approved in more than 35 countries and regions , including China, the US and Europe. . Additionally, there are currently more than 30 drugs in clinical development. During the COVID-19 pandemic, Junshi Biosciences actively assumed the social responsibilities of a Chinese pharmaceutical company through its participation in the development of etesevimab, MINDEWEI ® and other novel therapies for the prevention and treatment of COVID-19.
With a mission to provide patients with innovative, reliable, affordable and world-class medicines, Junshi Biosciences is in China, for the world. Currently, the company has approximately 2,500 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc.). For more information, please visit: http://junshipharma.com.
Junshi Biosciences Contact Information
IR Equipment:
Junshi Biosciences
info@junshipharma.com
+86 021-6105 8800
Public relations team:
Junshi Biosciences
zhili
zhi_li@junshipharma.com
+86 021-6105 8800
Source: Junshi Biosciences