Globally, liver cancer is a common malignant tumor of the digestive system, and the main pathological type is HCC (accounting for about 90%). According to data released by the GLOBOCAN for 2022, the annual number of new cases and deaths of liver cancer worldwide was 866,000 and 759,000, respectively. China has a high incidence of liver cancer. In 2022, the number of new liver cancer cases reached 368,000 (accounting for 42.4% of global cases), ranking fourth among domestic malignant tumors, with 317,000 deaths (accounting for 41.7% of global cases), ranking second among domestic malignant tumors. Due to its insidious onset, about 70%-80% of liver cancer patients in China are already at the intermediate or advanced stage at first diagnosis, with a median overall survival (“OS”) of only approximately 10 months and a five-year survival rate of approximately 12%.
The supplemental NDA approval is based on data from the HEPATORCH study (NCT04723004), which is a multinational multi-center, randomized, open-label, active-controlled phase 3 clinical study. Professor Jia FAN, an academician of the Chinese Academy of Sciences, from Zhongshan Hospital affiliated to Fudan University, served as the principal investigator. HEPATORCH was launched in 57 clinical centers in the Chinese mainland, China’s Taiwan and Singapore, and a total of 326 patients were enrolled. The study aimed to evaluate the efficacy and safety of toripalimab in combination with bevacizumab for the first-line treatment of unresectable or metastatic HCC compared to the standard treatment with sorafenib.
In September 2024, the results of the HEPATORCH study made its debut at the 27th National Clinical Oncology Conference and 2024 Chinese Society of Clinical Oncology (CSCO) Academic Annual Meeting. The results of the study showed that the primary endpoints, progression-free survival (“PFS,” based on independent radiographic review) and OS, both achieved positive results.
HEPATORCH demonstrated that compared with sorafenib, toripalimab in combination with bevacizumab could significantly extend the PFS and OS of patients, with a median PFS of 5.8 months vs. 4.0 months, reduce the risk of disease progression or death by 31% (hazard ratio [HR]=0.69, 95% CI: 0.525-0.913; P=0.0086), with a median OS of 20.0 months vs. 14.5 months, and reduce the risk of death by 24% (HR=0.76, 95% CI: 0.579-0.987; P=0.0394). The objective response rate (“ORR”) of the toripalimab and bevacizumab group was significantly higher than that of the sorafenib group. The ORR of the two groups were 25.3% and 6.1%, respectively. Furthermore, the combination therapy has a good safety profile in patients with advanced HCC. The toxicity spectrum is consistent with the known toxicity spectrum of the standard monotherapy, and no new safety signal was identified.
Academician Jia FAN from Zhongshan Hospital affiliated with Fudan University said, “The combination of immunotherapy and anti-angiogenic therapy has become the foundation of first-line treatment for advanced liver cancer. The HEPATORCH study has fully demonstrated the clinical efficacy of toripalimab in liver cancer patients in China, achieving an ORR of 25.3%, a median PFS of 5.8 months, and a median OS of 20.0 months. The ‘TB’ regimen combining toripalimab with bevacizumab will benefit many advanced liver cancer patients in China.”
Dr. Jianjun ZOU, Junshi Biosciences’ General Manager and CEO said, “Building on the success of our previously approved 10 indications—the ‘Perfect 10,’ toripalimab has reached another breakthrough achievement with the official approval of its 11th indication, and we are extremely elated! China has suffered the brunt of liver cancer, and Chinese patients have long faced the challenge of limited treatment options. Junshi Biosciences consistently prioritizes the clinical needs of liver cancer treatment around the world, advancing clinical research through combination strategies tailored to patients across the different stages of disease progression. Our goal is to provide more precise and diverse treatment options for liver cancer patients. Moving forward, we remain dedicated to liver cancer innovation and integrating even greater ‘Chinese Wisdom’ into the fight against this disease.”
About Toripalimab
Toripalimab 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 to induce PD-1 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.
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, Europe and Southeast Asia. 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.
In the Chinese mainland, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI®). Currently, there are eleven approved indications for toripalimab in the Chinese mainland:
The first 10 indications have been included in the National Reimbursement Drug List (NRDL) (2024 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for the treatment of melanoma, perioperative treatment of NSCLC, treatment of RCC and treatment of TNBC. In October 2024, toripalimab for the treatment of recurrent or metastatic NPC was approved in Hong Kong SAR, China.
Internationally, toripalimab has been approved for marketing in the United States, the European Union, India, the UK, Jordan, Australia and other countries and regions. In addition, toripalimab BLAs are under reviews in many countries or regions around the global.
]]>Toripalimab, independently developed by Junshi Biosciences, is a monoclonal antibody targeting PD-1 for the treatment of multiple malignant tumors. To date, toripalimab has been approved for marketing in over 35 countries and regions around the world. In 2024, toripalimab received approvals from both the European Commission (EC) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for the following indications: 1) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with recurrent, not amenable to surgery or radiotherapy, or metastatic nasopharyngeal carcinoma (NPC); 2) 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). Toripalimab is the first and only drug in Europe for the treatment of NPC, and the only first-line treatment for advanced or metastatic ESCC, regardless of tumor PD-L1 expression status.
Under the agreement, LEO Pharma will be responsible for toripalimab’s distribution, promotion, sales, etc., in up to 32 countries, including all member states of the European Union (EU) and the European Economic Area (EEA), as well as Switzerland and the United Kingdom. TopAlliance Biosciences Europe will remain the Marketing Authorization Holder (MAH) for toripalimab in Europe, retaining responsibility for product development, manufacturing, registration, pharmacovigilance, quality management, etc. LEO Pharma will make payments, including an upfront payment, milestone payments if LEO Pharma wishes to pursue any subsequently approved indications, and a revenue share of a double-digit percentage on the net sales of toripalimab throughout the collaboration territory.
Dr. Sheng YAO, Senior Vice President of Junshi Biosciences and CEO of TopAlliance Biosciences, said, “The partnership with LEO Pharma has established a significant milestone for Junshi Biosciences in the European market and is closely aligned with the company’s global expansion strategy. Europe has been identified as a pivotal strategic region for the corporate business growth. As the Marketing Authorization Holder (MAH) of the product in Europe, the company has already established a local operational center and is actively collaborating with local health authorities to prepare for the successful commercial launch of toripalimab in Europe. As a century-old multinational pharmaceutical company headquartered in Europe, LEO Pharma has established a mature distribution network and rich marketing expertise in the local markets. By leveraging both parties’ strengths in R&D, manufacturing, and commercialization, we believe toripalimab will be efficiently integrated into the Europe markets benefitting local patients-in-need. Moving forward, we will continue to implement our ‘In China, For Global’ strategy and work with partners to provide high-quality, innovative therapies from China to patients worldwide.”
Jean Monin, Executive Vice President of Thrombosis Business Unit, LEO Pharma, commented, “We are excited to partner with Junshi Biosciences, supplementing LEO Pharma’s Thrombosis business, which already serves patients with cancer-associated thrombosis. The distribution and marketing partnership for LOQTORZI® brings an important new treatment option to areas of high unmet medical need and focuses on a specialty hospital product that complement our existing heparin-based anti-coagulation treatments for cancer-associated thrombosis and other specialty patients. Leveraging our commercial platform, LOQTORZI® will create valuable synergies and drive continued growth.”
About Toripalimab
Toripalimab 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 to induce PD-1 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.
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, Europe, and Southeast Asia. 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.
In the Chinese mainland, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI®). Currently, there are ten approved indications for toripalimab in the Chinese mainland:
The ten indications have been included in the National Reimbursement Drug List (NRDL) (2024 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for the treatment of melanoma, perioperative treatment of NSCLC, treatment of RCC and treatment of TNBC. In October 2024, toripalimab for the treatment of recurrent or metastatic NPC was approved in Hong Kong SAR, China.
Internationally, toripalimab has been approved for marketing in the United States, the European Union, India, the UK, Jordan, Australia and other countries and regions. In addition, toripalimab BLAs are under reviews in many countries around the global, including the Singapore Health Sciences Authority (HSA).
About LEO Pharma
LEO Pharma is a global company dedicated to advancing the standard of care through innovation for the benefit of people with skin conditions. LEO Pharma also provides anti-coagulant therapy for cancer patients and other specialty patients. LEO Pharma is co-owned by majority shareholder the LEO Foundation and, since 2021, Nordic Capital. LEO Pharma offers a broad portfolio of treatments, serving 100 million patients annually. Headquartered in Denmark, LEO Pharma has a global team of 4,000 people. In 2023, the company generated net sales of $1.6 billion. For more information, please visit: https://www.leo-pharma.com.
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 therapeutics. The company has established a diversified R&D pipeline comprising over 50 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Five of the company’s products have received approvals in China and international markets, one of which is toripalimab, China’s first domestically produced and independently developed anti-PD-1 monoclonal antibody. Toripalimab has been approved in over 35 countries and regions including China, the US, and Europe. During the COVID-19 pandemic, Junshi Biosciences actively shouldered the social responsibilities of a Chinese pharmaceutical company through its involvement in developing etesevimab, MINDEWEI®, and other novel therapies for the prevention and treatment of COVID-19.
With a mission of “providing patients with world-class, trustworthy, affordable, and innovative drugs,” Junshi Biosciences is “In China, For Global.” At present, the company boasts approximately 2,500 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc.). For more information, please visit: //www.yitiaoweiba.com.
]]>This NCE application was submitted under Project Orbis. Project Orbis, initiated and advocated by the Oncology Center of Excellence (OCE) of the US Food and Drug Administration (the “FDA”), provides a collaborative mechanism and framework among the FDA and regulatory authorities in other countries and regions allowing different regulatory authorities to jointly review the applications for registration of oncology drugs. Toripalimab was the first domestic oncology drug included in Project Orbis. Additionally, the TGA also granted an orphan drug designation to toripalimab for the treatment of NPC, which has accelerated the review and registration process to a certain extent.
General Manager and CEO of Junshi Biosciences, Dr. Jianjun ZOU, said, “Toripalimab has made significant strides in its internationalization. As of today, toripalimab has been approved in 35 countries across four continents and offers hope to patients worldwide. This recent approval in Australia is not only extremely meaningful to the nasopharyngeal carcinoma patients there, but it also represents our company’s continued efforts toward globalization. In the following days, we will closely collaborate with our partner Dr. Reddy’s Laboratory to expedite toripalimab’s availability in Australia, ensuring that local patients can benefit from this treatment as soon as possible.”
M.V. Ramana, CEO of Branded Markets, Dr. Reddy’s, said: “This approval is a significant milestone in our collaborative efforts with Junshi Biosciences to make their novel treatment available to patients around the world. Toripalimab is the first and only immuno-onocology treatment for nasopharyngeal carcinoma in Australia, and meets a significant unmet need for patients. In oncology, our offerings aim to build an end-to-end ecosystem of care – access to current standard of care cancer medicines across multiple countries globally, innovation in formulations, strategic collaborations for novel innovative molecules, beyond-the-pill support such as nutrition and digital tools. Following our successful launch of toripalimab in India, we are looking forward to bringing it to patients in Australia and other markets in the coming days.”
NPC is a malignant tumor that occurs in the epithelium mucosae of the nasopharynx and is one of the most common types of head and neck cancers. According to GLOBOCAN 2022 statistics, the number of newly diagnosed NPC cases in 2022 exceeded 120,000 worldwide. Toripalimab is the only preferred regimen recommended for the comprehensive treatment of recurrent or metastatic NPC in the National Comprehensive Cancer Network (NCCN) Guidelines (Version 1.2025) for head and neck cancers.
The approval of the NPC indications is primarily based on the results from JUPITER-02 (a randomized, double-blind, placebo-controlled, multinational multi-center Phase 3 clinical study for the first-line treatment of NPC, NCT03581786), and the results from POLARIS-02 (a multi-center, open-label, pivotal Phase 2 clinical study for second-line or later treatment of recurrent or metastatic NPC, NCT02915432).
The JUPITER-02 study is the first international multi-center, double-blind, randomized Phase 3 clinical study in NPC immunotherapy with the largest sample size, and is the world’s first Phase 3 clinical study in which there is preset statistical verification (Type I error control) for Overall Survival (“OS”) in first-line immunotherapy combined with chemotherapy for NPC compared to chemotherapy alone that demonstrated a survival benefit. The results of the study were presented in an oral report during the Plenary Session of the 2021 annual meeting of the American Society of Clinical Oncology (ASCO) (#LBA2), and were subsequently featured on the cover of Nature Medicine (IF: 58.7). The results were also published in full in the Journal of the American Medical Association (JAMA, IF: 63.1). The results of the study showed that, compared to chemotherapy alone, toripalimab in combination with chemotherapy reduced the risk of disease progression by 48% and the risk of death by 37%. The median progression-free survival (“PFS”) in the toripalimab in combination with chemotherapy group was prolonged by 13.2 months compared to chemotherapy alone, from 8.2 months to 21.4 months. In addition, patients treated with this combined 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 new safety signal was identified. Long-term survival follow-up data was presented at ASCO 2024, with a 5-year survival rate of 52%.
The POLARIS-02 results were published online in January 2021 in the Journal of Clinical Oncology. The results showed that toripalimab demonstrated durable antitumor activity and a manageable safety profile in patients with recurrent or metastatic NPC who had failed prior chemotherapy, with an ORR of 20.5%, a DoR of 12.8 months, and a median OS of 17.4 months.
As of today, toripalimab has been approved for marketing in over 35 countries and regions in 4 continents, including China, Hong Kong SAR, the United States, the European Union, the UK, Australia, India, Jordan, etc.
About Toripalimab
Toripalimab 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 to induce PD-1 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.
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, Europe and Southeast Asia. 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.
In the Chinese mainland, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI®). Currently, there are ten approved indications for toripalimab in the Chinese mainland:
The 10 indications have been included in the National Reimbursement Drug List (NRDL) (2024 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for the treatment of melanoma, perioperative treatment of NSCLC, treatment of RCC and treatment of TNBC. In October 2024, toripalimab for the treatment of recurrent or metastatic NPC was approved in Hong Kong SAR, China.
Internationally, toripalimab has been approved for marketing in the United States, the European Union, India, the UK, Jordan, Australia and other countries and regions. In addition, toripalimab BLAs are under reviews in many countries around the global, including the Singapore Health Sciences Authority (HSA).
]]>In 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 nasopharyngeal mucosal epithelium and is one of the most common types of head and neck cancers globally. 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 latest European Society of Medical Oncology (ESMO) Guidelines recommend immunotherapy combined with chemotherapy as the first-line treatment for recurrent or metastatic NPC.
The approval of the NPC indication is primarily based on the results from the JUPITER-02 study (a randomized, double-blind, placebo-controlled, multinational multi-center Phase 3 clinical study, NCT03581786). JUPITER-02 is the first international multi-center, double-blind, randomized Phase 3 clinical study in NPC immunotherapy with the largest sample size, and the world’s first Phase 3 clinical study with preset statistical verification (Type I error control) for overall survival (“OS”) in first-line immunotherapy combined with chemotherapy for NPC compared to chemotherapy alone that demonstrated a survival benefit. The study results were presented in an oral report during the Plenary Session of the 2021 annual meeting of the American Society of Clinical Oncology (ASCO) (#LBA2) and were subsequently featured on the cover of Nature Medicine. The results were also published in full in the Journal of the American Medical Association (JAMA). Results showed that, compared to chemotherapy alone, toripalimab in combination with chemotherapy reduced the risk of disease progression by 48% and the risk of death by 37%. The median progression-free survival (“PFS”) in the toripalimab plus chemotherapy group was prolonged by 13.2 months compared to chemotherapy alone, from 8.2 months to 21.4 months. In addition, patients treated with this combined 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 new safety signal was identified. 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 seventh leading cause of cancer death worldwide, with over 511,000 new cases and over 445,000 deaths in 2022. 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 from the JUPITER-06 study (a randomized, double-blind, placebo-controlled, multi-center 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 with placebo in combination with chemotherapy. The results were first presented in an oral session during the ESMO Congress 2021 and later 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, the median OS was prolonged by 6 months to 17 months and the risk of disease progression or death in patients was significantly reduced by 42%. Futhermore, there was a significant improvement in survival benefits regardless of PD-L1 status.
Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences, said, “The approval of toripalimab by MHRA marks another significant milestone for toripalimab in Europe, not only making toripalimab the first and only drug in UK for the treatment of NPC, but also the only first-line treatment for ESCC, regardless of PD-L1 status. We are extremely proud to introduce innovative Chinese biopharmaceuticals to Europe that can address longstanding unmet medical needs of the patients there. Moving forward, we will remain committed to our globalization strategy, ‘In China, For Global.’ We will continue working towards the commercialization of toripalimab, and offer high-quality, innovative, domestically developed medicines to benefit more patients around the world.”
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