商业世界网

SHANGHAI, Aug. 30, 2024 (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 2024 interim financial results and provided corporate updates.

FINANCIAL HIGHLIGHTS

• As of June 30, 2024, the total revenue of Junshi Biosciences was approximately RMB786 million during the first half of 2024, representing an increase of approximately 17% compared to 2023. The growth was mainly due to the approximately 11% increase in revenue from pharmaceutical products compared to 2023. In particular, the domestic sales revenue of our core product, TUOYI® (toripalimab), reached approximately RMB671 million, representing an increase of approximately 50% compared to 2023.
• Total research and development (“R&D”) expenses were approximately RMB546 million for the first half of 2024, representing a decrease of approximately 42% compared to 2023. The decrease in R&D expenses was mainly due to the company's cost control policy, efforts to optimize resource allocation and focus on R&D pipelines with greater potential. In addition, several clinical trials for our core product, TUOYI®, successively met their primary endpoints, contributing to the natural decline of R&D expenditure.
• Loss attributable to owners of the company decreased to RMB646 million for the first half of 2024, representing a decrease of approximately RMB351 million or approximately 35% compared to 2023.
• As of June 30, 2024, the company's aggregate balance of bank balances, cash and financial products was approximately RMB3,311 million, a slight decrease of RMB467 million compared to the balance at the end of 2023, which ensured our relatively sufficient cash position to support the company's development.

BUSINESS HIGHLIGHTS

During the first half of 2024, we focused on addressing “unmet medical needs”. We have made original, innovative and breakthrough progress in the discovery, R&D and commercialization of innovative therapies and novel drugs with accelerating international development. The following achievements and milestones were reached:

• Advancements in the pipeline: the company's innovative R&D field has expanded beyond monoclonal antibodies to a wider range of drug modalities, including small molecules drugs, polypeptide drugs, antibody-drug conjugates (ADCs), bi-specific or multi-specific antibodies and nucleic acid drugs. The company is also exploring next-generation innovative therapies including cancer and autoimmune diseases. The product pipelines cover five major therapeutic areas, including malignant tumors, autoimmune diseases, chronic Metabolic diseases, neurologic diseases and infectious diseases. A total of three drugs (TUOYI®, JUNMAIKANG and MINDEWEI) are currently on the market, around 30 assets are undergoing clinical trials, and over 20 drug candidates are at the pre-clinical drug development stage.
   
  • In January 2024, the National Drug List for Basic Medical Insurance, Work-Related Injury Insurance and Maternity Insurance (Year 2023) (the “NRDL”) was officially implemented. Junshi Biosciences has three drugs included in the newest edition of the NRDL. Notably, 3 new TUOYI® indications have been included: first-line treatment of nasopharyngeal carcinoma (“NPC”), first-line treatment of esophageal squamous cell carcinoma (“ESCC”) and first-line treatment of non-squamous non-small cell lung cancer (“NSCLC”), bringing the current number of indications in the NRDL to a total of 6. MINDEWEI's indication for adult patients with mild to moderate coronavirus disease 2019 (“COVID-19”) was officially included in the NRDL for the first time. All eight approved indications of JUNMAIKANG remain in the NRDL.
  • In January 2024, Coherus BioSciences, Inc. (“Coherus”), a partner of the company, announced that toripalimab was available for access and administration in the United States. Prior to that, toripalimab (U.S. trade name: LOQTORZI®) was approved for marketing by the U.S. Food and Drug Administration (the “FDA”) in October 2023, and became the first innovative biological drug from China included as a preferred treatment option in the NPC guidelines of the National Comprehensive Cancer Network (“NCCN”) in December 2023.
  • In January 2024, the Singapore Health Sciences Authority (the “HSA”) accepted the new drug application (the “NDA”) for toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adults with Metastatic 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 on or after platinum-containing chemotherapy.
  • In April 2024, the Japanese Pharmaceuticals and Medical Devices Agency (the “PMDA”) approved the company's initiation of a randomized, double-blind, placebo-controlled, international multi-regional phase III clinical study of tifcemalimab (a recombinant humanized anti-BTLA monoclonal antibody, code: TAB004/JS004) in combination with toripalimab as consolidation therapy in patients with limited-stage small cell lung cancer (“LS-SCLC”) without disease progression following chemo-radiotherapy.
  • In April 2024, two supplemental new drug applications (the “sNDA”) for ongericimab (a recombinant humanized anti-PCSK9 monoclonal antibody, code: JS002) were accepted by the National Medical Products Administration of China (the “NMPA”).
  • In April 2024, the NMPA approved the sNDA for TUOYI® in combination with axitinib for the first-line treatment of patients with medium to high risk unresectable or Metastatic renal cell carcinoma (“RCC”). This was the first approved immunotherapy for renal carcinoma in China.
  • In April 2024, the NDA for toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adults with Metastatic 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 on or after platinum-containing chemotherapy was accepted by the Drug Office, Department of Health, the Government of the Hong Kong Special Administration Region (the “DO”).
  • In June 2024, the primary endpoints of progression-free survival (“PFS”, based on independent radiographic review) and overall survival (“OS”) of a 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, and the sNDA was accepted by the NMPA in July 2024.
  • In June 2024, the NMPA approved the sNDA for TUOYI® in combination with etoposidein plus platinum as the first-line treatment of extensive-stage small cell lung cancer (“ES-SCLC”).
  • In June 2024, the NMPA approved 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). This was the 10th indication of toripalimab approved in the Chinese mainland.

• Business operations
   
  • As of the end of the first half of 2024, Junshi Biosciences completed the Good Manufacturing Practice (“GMP”) and Good Clinical Practice inspections of the European Union (the “EU”). Currently, the European Commission (the “EC”) is reviewing the marketing authorization applications (the “MAA”) for toripalimab for the first-line treatment of NPC and ESCC.
  • In June 2024, the company 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 for the fourth session of the Board of Directors and the Board of Supervisors.

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. Four of the company's innovations have already reached the Chinese or international markets, one of which is toripalimab, China's first domestically produced and independently developed anti-PD-1 monoclonal antibody, approved in China and the US. Additionally, more than 30 drugs are currently in clinical development. 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://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