Yahoo Finance

SHANGHAI, China, Aug. 30, 2023 (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 2023 interim financial results and provided corporate updates.

FINANCIAL HIGHLIGHTS

• As of 30 June 2023, the company’s total revenue was approximately RMB670 million, representing a decrease of approximately 29% compared to the corresponding period in 2022, which was mainly due to the decrease in income related to out-licensing from overseas. During the Reporting Period, the company’s revenue from pharmaceutical products increased significantly. In particular, the sales revenue of TUOYI® (toripalimab) was approximately RMB447 million, representing an increase of approximately 50% compared to the corresponding period in 2022; the sales revenue of MINDEWEI, a newly launched product, was approximately RMB110 million during the Reporting Period.

• The company’s total R&D expenses were approximately RMB949 million during the first half of 2023, representing a decrease of approximately 11% compared to the corresponding period in 2022. The decrease in R&D expenses was mainly due to the company’s strategic management of R&D investments in certain early-stage pipelines, choosing to optimize resource allocation and focus on R&D pipelines with greater potential.

BUSINESS HIGHLIGHTS

During the first half of 2023, we focused on “unmet medical needs”. We have made original, innovative and breakthrough progress in the discovery, R&D and commercialization of innovative therapies and novel drugs. The following achievements and milestones were attained:

• Advancements in the pipeline: the company’s innovative R&D field has expanded from monoclonal antibodies to the research and development of more drug modalities, including small molecules drugs, polypeptide drugs, antibody-drug conjugates (ADCs), bi-specific or multi-specific antibodies and nucleic acid drugs, as well as the exploration of 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. As of the date of this announcement, a total of three drugs (TUOYI®, JUNMAIKANG and MINDEWEI) are being commercialized, around 30 assets are undergoing clinical trials, and over 20 drug candidates are at the pre-clinical drug development stage.
  
  

  • In January 2023, the marketing of MINDEWEI (Deuremidevir Hydrobromide Tablets, code: JT001/VV116), an oral nucleoside analog anti-SARS-CoV-2 Category 1 innovative drug, for the treatment of adult patients with mild to moderate COVID-19 was conditionally approved by the National Medical Products Administration of China (the “NMPA”).
    

  • In February 2023, the marketing authorization application (the “MAA”) for toripalimab combined with cisplatin and gemcitabine for the first-line treatment of patients with locally recurrent or metastatic nasopharyngeal carcinoma (“NPC”), toripalimab combined with paclitaxel and cisplatin for the first-line treatment of patients with unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma (“ESCC”) was accepted by the United Kingdom’s Medicines and Healthcare products Regulatory Agency (the “MHRA”).

  • In March 2023, the investigational new drug (“IND”) application for JS010 (a recombinant humanized anti-CGRP monoclonal antibody injection) was approved by the NMPA.

  • In April 2023, the supplemental new drug application (“sNDA”) for TUOYI® in combination with chemotherapy as perioperative treatment and monotherapy as consolidation therapy after adjuvant therapy for the treatment of resectable stage III non-small cell lung cancer (“NSCLC”) was accepted by the NMPA.

  • In April 2023, the new drug application (“NDA”) for ongericimab (a recombinant humanized anti-PCSK9 monoclonal antibody, code: JS002) was accepted by the NMPA.

  • In April 2023, the IND application for JS401 (a small interfering RNA (“siRNA”) drug targeting angiopoietin-like protein 3 (“ANGPTL3”) messenger RNA (“mRNA”)) was approved by the NMPA.

  • In May 2023, the sNDA for TUOYI® in combination with paclitaxel for injection (albumin-bound) for the treatment of PD-L1 positive (CPS ≥ 1) untreated metastatic or recurrent metastatic triple-negative breast cancer was accepted by the NMPA.

  • In June 2023 and August 2023, the IND application for a randomized, double-blind, placebo-controlled, international multi-center 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 was approved by the U.S. Food and Drug Administration (the “FDA”) and the NMPA, respectively.

  • In June 2023, the IND application for JS207 (a recombinant humanized anti-PD-1/VEGF bispecific antibody) was accepted by the NMPA.

  • In July 2023, the sNDA for TUOYI® in combination with axitinib for the first-line treatment of patients with unresectable or metastatic renal cell carcinoma (“RCC”) was accepted by the NMPA.

  • In July 2023, the sNDA for TUOYI® in combination with etoposide plus platinum as the first-line treatment of extensive-stage small cell lung cancer (“ES-SCLC”) was accepted by the NMPA, which is the tenth marketing application submitted for TUOYI® in China.