Junshi Biosciences Announces 2024 Full Year Financial Results and Provides Corporate Updates

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$(R)$) 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(R)) 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(R) 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(R) 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(R) 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(R)), 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(R)) 
             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(R) 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 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(R) , 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 Information

IR Team:

Junshi Biosciences

info@junshipharma.com

+ 86 021-6105 8800

PR Team:

Junshi Biosciences

Zhi Li

zhi_li@junshipharma.com

+ 86 021-6105 8800

(END) Dow Jones Newswires

March 28, 2025 21:35 ET (01:35 GMT)