Shanghai Junshi Biosciences Co., Ltd.

March 26, 2025 -- Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that the New Drug Application (the “NDA”) for toripalimab (Singapore trade name: LOQTORZI®) 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”) has been approved by the Singapore Health Sciences Authority (the HSA). Toripalimab has become the first and only approved immuno-oncology treatment for NPC in Singapore. 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 is primarily based on the results from JUPITER-02 (NCT03581786), the first international multi-center, double-blind, randomized Phase 3 clinical study in NPC immunotherapy with the largest sample size. JUPITER-02 is also the world’s first Phase 3 clinical study with preset statistical verification (Type I error control) demonstrating a significant overall survival (“OS”) benefit for first-line immunotherapy combined with chemotherapy compared to chemotherapy alone in NPC. JUPITER-02’s results were presented in an oral report during a Plenary Session at the 2021 American Society of Clinical Oncology (ASCO) annual meeting (#LBA2). These results were subsequently featured on the cover of Nature Medicine and published in full in the Journal of the American Medical Association (JAMA). 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 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 was presented at ASCO 2024, with a 5-year survival rate of 52%. Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences, said, “Toripalimab’s approval in Singapore represents our formal entry into the Southeast Asian market. Southeast Asia is a region with a high incidence of NPC, and we are proud to introduce this groundbreaking therapy to address unmet medical needs and transform the local treatment landscape. As of now, toripalimab has received marketing authorization in over 35 countries and regions across four continents. We remain committed to our ‘In China, For Global’ strategy, advancing innovative medicines from China to improve healthcare for patients across the globe.” The NDA was submitted under Project Orbis. Project Orbis, initiated and advocated by the Oncology Center of Excellence (OCE) of the U.S. 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 to be included in Project Orbis. Previously, the Therapeutic Goods Administration of the Australian Government Department of Health and Aged Care (the “TGA”) approved two New Chemical Entity applications for toripalimab in NPC under Project Orbis. 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: 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 the first-line treatment for patients with locally recurrent or metastatic NPC; 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); 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 (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 unresectable or metastatic 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 paclitaxel for injection (albumin-bound) for the first-line treatment of recurrent or metastatic triple-negative breast cancer (TNBC); in combination with bevacizumab for the first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC) patients. 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, Singapore and other countries and regions. In addition, toripalimab BLAs are under reviews in many countries or regions around the global. 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: http://www.junshipharma.com. The content above comes from the network. if any infringement, please contact us to modify.

SHANGHAI, March 28, 2025 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences,” HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced its financial results for the full year of 2024 and provided corporate updates. FINANCIAL HIGHLIGHTS Total revenue of Junshi Biosciences was approximately RMB1,948 million in 2024, representing an increase of approximately 30% compared to 2023, which was mainly due to the increase in revenue from pharmaceutical products, in particular: the domestic sales revenue of our core product, toripalimab, was approximately RMB1,501 million, representing an increase of approximately 66% compared to 2023.Total research and development (“R&D”) expenses of the company were approximately RMB1,275 million in 2024, representing a decrease of approximately 34% compared to 2023. The decrease in R&D expenses was mainly due to the company’s cost control policy and efforts to optimize resource allocation and focus on R&D pipelines with greater potential. In addition, a number of clinical trials of our core product, toripalimab, successively met the primary endpoints, which also contributed to the natural decline of R&D expenditure.Loss attributable to owners of the company decreased to RMB1,282 million in 2024, representing a decrease of approximately RMB999 million or approximately 44% compared to 2023.As of the end of 2024, the company’s aggregate balance of bank balances and cash and financial products was approximately RMB2,917 million, ensuring a relatively sufficient cash position to support the company’s development. BUSINESS HIGHLIGHTS During 2024, our commitment to addressing “unmet medical needs” has driven original, innovative and breakthrough progress in the discovery, R&D and commercialization of innovative therapies and drugs through accelerating international development. Here are the notable achievements and milestones: Advancements in the pipeline: Junshi Biosciences’ innovative R&D field has expanded from monoclonal antibodies to the research and development of various drug modalities, including small molecule drugs, polypeptide drugs, antibody drug conjugates (ADCs), bi-specific or multi-specific antibodies, bispecific antibody drug conjugates, fusion protein and nucleic acid drugs, as well as the exploration of next-generation innovative therapies, including cancer and autoimmune diseases. Our product pipelines cover five major therapeutic areas, including malignant tumors, autoimmune diseases, chronic metabolic diseases, neurologic diseases and infectious diseases. A total of four drugs have been commercialized, around 30 assets are undergoing clinical trials, and over 20 drug candidates are at the preclinical drug development stage. In January 2024, Coherus BioSciences, a partner of Junshi Biosciences, announced that toripalimab was available for access and administration in the United States. Prior to this, toripalimab (US trade name: LOQTORZI®) was approved for marketing by the US Food and Drug Administration (the “FDA”) in October 2023, and is the first drug for the treatment of nasopharyngeal carcinoma (“NPC”) in the United States. At present, it is also the only preferred drug recommended in the National Comprehensive Cancer Network (“NCCN”) Clinical Practice Guidelines in Oncology for Head and Neck Cancers 2025.V1 for the treatment of recurrent/ metastatic NPC across all lines.In January 2024, the new drug application (the “NDA”) for toripalimab for the treatment of NPC was accepted by the Singapore Health Sciences Authority (the “HSA”). In March 2025, the NDA for toripalimab (Singapore trade name: LOQTORZI®) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with recurrent, not amenable to surgery or radiotherapy, or metastatic NPC has been approved by the HSA. Toripalimab has become the first and only approved immuno-oncology treatment for NPC in Singapore.In April 2024, the Japanese Pharmaceuticals and Medical Devices Agency (the “PMDA”) agreed that the company may proceed with a randomized, double-blind, placebo-controlled, international multi-regional phase 3 clinical study of tifcemalimab (a recombinant humanized anti-BTLA monoclonal antibody, code: TAB004/JS004) in combination with toripalimab as consolidation therapy for patients with limited-stage small cell lung cancer (“LS-SCLC”) without disease progression following chemo-radiotherapy.In April 2024, the supplemental new drug application (the “sNDA”) for toripalimab in combination with axitinib for the first-line treatment for patients with medium to high risk unresectable or metastatic renal cell carcinoma (“RCC”) was approved by the National Medical Products Administration of China (the “NMPA”). This is the first approved immunotherapy for renal carcinoma in China.In April 2024, the NDA for toripalimab in combination with cisplatin and gemcitabine for 1) the first-line treatment of adults with metastatic or recurrent locally advanced NPC and 2) toripalimab, as a single agent, for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy was accepted by the Drug Office of the Department of Health, Hong Kong Special Administration Region Government (the “DO”), and was approved by the Pharmacy and Poisons Board of Hong Kong (the “PPB”) in October 2024, making toripalimab the first and only immunotherapy drug for NPC in Hong Kong SAR, China.In June 2024, the primary endpoints of progression-free survival (“PFS”, based on independent radiographic review) and overall survival (“OS”) of a multinational multi-center, randomized, open-label, active controlled phase III clinical study (the HEPATORCH study, NCT04723004) of TUOYI® in combination with bevacizumab for the first-line treatment of advanced hepatocellular carcinoma (“HCC”) met the pre-defined efficacy boundary. The sNDA was accepted by the NMPA in July 2024 and was approved by the NMPA in March 2025.In June 2024, the sNDA for TUOYI® in combination with etoposidein plus platinum as the first-line treatment of extensive-stage small cell lung cancer (“ES-SCLC”) was approved by the NMPA.In June 2024, the sNDA for TUOYI® in combination with paclitaxel for injection (albumin-bound) for the first-line treatment of recurrent or metastatic triple-negative breast cancer (“TNBC”) with a well-validated test to evaluate PD-L1 positive (CPS ≥ 1) was approved by the NMPA.In July 2024, the investigational new drug (“IND”) application for JS125 (a targeted histone deacetylases (“HDACs”) inhibitor) was accepted by the NMPA and approved in September 2024.In July 2024, a positive opinion was obtained from the Committee for Medicinal Products for Human Use (the “CHMP”) of the European Medicines Agency (the “EMA”) for the marketing authorization application (the “MAA”) of toripalimab (European trade name: LOQTORZI®), which recommended approval for the treatment of two indications: toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with recurrent, not amenable to surgery or radiotherapy, or metastatic NPC, and 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 September 2024, this MAA was approved by the European Commission (the “EC”). The approval is applicable to all 27 member states of the European Union (the “EU”), Iceland, Norway and Liechtenstein, making toripalimab 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 in Europe.In August 2024, the sNDA for toripalimab as the first-line treatment for unresectable or metastatic melanoma was accepted by the NMPA.In September 2024 and November 2024, toripalimab was approved for marketing in India and Jordan, respectively, for the treatment of two indications: toripalimab in combination with cisplatin and gemcitabine, for the first-line treatment of adults with metastatic or recurrent, locally advanced NPC and toripalimab, as a single agent, for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy. Toripalimab officially commenced commercial sales in India in 2024.In October 2024, the NDA for ongericimab injection (a recombinant humanized anti-PCSK9 monoclonal antibody injection, trade name: JUNSHIDA) as the treatment for adult patients with primary hypercholesterolemia (non-familial) and mixed dyslipidemia was approved for marketing by the NMPA.In November 2024, toripalimab (UK trade name: LOQTORZI®) obtained the marketing authorisation from the United Kingdom’s (the “UK”) Medicines and Healthcare products Regulatory Agency (the “MHRA”) for the treatment of two indications: toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with recurrent, not amenable to surgery or radiotherapy, or metastatic NPC, and toripalimab in combination with cisplatin and paclitaxel for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic ESCC. Toripalimab has become 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 in the UK.In November 2024, four new indications of toripalimab were successfully included in Category B of the National Drug List for Basic Medical Insurance, Work-Related Injury Insurance and Maternity Insurance (Year 2024) (the “NRDL”). The ten approved indications of toripalimab in the Chinese mainland were all included in the NRDL, and TUOYI® is the only anti-PD-1 monoclonal antibody included in the NRDL for the treatment of melanoma, perioperative treatment of non-small cell lung cancer (“NSCLC”), treatment of renal carcinoma and treatment of TNBC. Update on business operations In June 2024, Junshi Biosciences convened the 2023 annual general meeting, the 2024 first class meeting of A shareholders and the 2024 first class meeting of H shareholders, and completed the election of the fourth session of the Board of Directors and the board of supervisors of the company and other matters.In July 2024, Suzhou Union Biopharm Co., Ltd., a wholly-owned subsidiary of Junshi Biosciences, received the CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER issued by The Ireland Health Products Regulatory Authority (the “HPRA”) in accordance with the relevant regulations of the EMA. This is the first time that the relevant production facilities of toripalimab obtained the GMP certificate of a member state of the EU. According to the GMP mutual recognition system among the EU member states, obtaining the GMP certificate indicates that the production facilities with the certificate have met the GMP standards of the EU.In August 2024, the A shares of Junshi Biosciences (“A Shares”) were included in the SSE STAR Brand Name Drug Index. The index selects 30 securities of companies listed on the STAR Market with the largest market capitalization and engaged in innovative drugs as constituents, reflecting the overall performance of the securities of the companies listed on the STAR Market and engaged in innovative drugs.As of September 2024, the company completed the implementation of the A-Share repurchase plan, with a total of 815,871 A Shares repurchased, accounting for 0.0828% of the total share capital of the company, which will be used for the purpose of share incentives and/or employee stock ownership plan(s) at an appropriate time in the future.In December 2024, the company’s A Shares were included in the CSI A500 Index. The index selects 500 securities with the largest market capitalization and strong liquidity from various sectors as constituents, reflecting the overall performance of the most representative listed companies across different sectors. About Junshi BiosciencesFounded 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: http://www.junshipharma.com. Junshi Biosciences Contact InformationIR Team:Junshi Biosciencesinfo@junshipharma.com+ 86 021-6105 8800 PR Team:Junshi BiosciencesZhi Lizhi_li@junshipharma.com+ 86 021-6105 8800

LEO Pharma will be gaining the rights to commercialise Junshi Biosciences’ toripalimab in Europe under a new distribution and marketing partnership. The collaboration is aimed at increasing the accessibility of the PD-1 inhibitor, which is designed to help the immune system fight cancer. The drug, sold under the brand name Loqtorz, was approved by the European Commission (EC) and Medicines and Healthcare Products Regulatory Agency (MHRA) last year as part of a first-line combination treatment for certain adults with recurrent or metastatic nasopharyngeal carcinoma. More than 120,434 new cases of the rare form of cancer, which affects the part of the throat connecting the back of the nose to the back of the mouth, were reported globally in 2022. Toripalimab was also approved by both regulators in 2024 as part of a first-line combination treatment for adults with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma. LEO will now be responsible for toripalimab’s distribution, promotion and sales in all EU and European Economic Area member states, as well the UK and Switzerland. TopAlliance Biosciences Europe will remain the marketing authorisation holder for toripalimab in Europe and will receive an upfront fee from LEO. The Junshi subsidiary will also be eligible for milestone payments if LEO wants to pursue any subsequently approved indications for the drug. Jean Monin, executive vice president of LEO’s thrombosis business unit at LEO, said: “The distribution and marketing partnership for [toripalimab] 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.” Sheng YAO, senior vice president of Junshi Biosciences and chief executive officer of TopAlliance Biosciences, added: “By leveraging both parties’ strengths in research and development, manufacturing and commercialisation, we believe toripalimab will be efficiently integrated into the Europe markets benefitting local patients-in-need.” The agreement comes less than two weeks after LEO partnered with Gilead Sciences to advance its small molecule oral STAT6 programme for inflammatory diseases. The deal, worth $1.7bn, gave Gilead global rights to develop, manufacture and commercialise the oral STAT6 programme. Meanwhile, LEO will hold exclusive global rights to STAT6 topical formulations in dermatology, and will have the option to co-commercialise oral programmes for dermatology indications outside the US.