Shanghai Pharmaceuticals: Termination of Five R&D Projects

Recently, Shanghai Pharmaceuticals announced that in order to allocate R&D resources more rationally and focus on advantageous R&D projects, it has decided to terminate the clinical trials and subsequent development of five R&D projects: I020, B006, B007 (non-Hodgkin lymphoma indications), I008, and BCD-100 (cervical cancer indications), based on a comprehensive assessment of factors such as the future market value of the R&D projects, business synergy, and subsequent development investments.

Among these, I020, B006, and B007 (non-Hodgkin lymphoma indications) are in the Phase I clinical trial stage, I008 is in the Phase II clinical trial stage, and BCD-100 (cervical cancer indications) is in the Phase III clinical trial stage.

According to the semi-annual report for 2024, from January to June, Shanghai Pharmaceuticals achieved an operating revenue of 139.413 billion yuan, a year-on-year increase of 5.14%; the net profit attributable to shareholders was 2.942 billion yuan, a year-on-year increase of 12.72%. It is understood that Shanghai Pharmaceuticals attaches great importance to the development of innovative drugs, with continuous increases in R&D investment. During the reporting period, the company’s R&D investment reached 1.404 billion yuan, a year-on-year increase of 15.26%, accounting for 11.03% of industrial sales, of which R&D expenses were 1.105 billion yuan, a year-on-year increase of 7.67%. As of the end of the reporting period, Shanghai Pharmaceuticals had 64 new drug pipelines that had received clinical application acceptance and entered subsequent clinical research phases, including 50 innovative drugs (three of which are in Phase II clinical trials in the United States). Among the innovative drug pipelines, several have submitted pre-NDA applications, marketing applications, or are in critical research or Phase III clinical trial stages, approaching harvest time.

About I020

I020 is a selective inhibitor with antitumor effects intended for the treatment of malignant tumors such as non-small cell lung cancer (NSCLC). In May 2018, this project was approved by the National Medical Products Administration to conduct clinical trials and is currently in the final phase of Phase I clinical trials. To date, the project has accumulated R&D investments totaling approximately 41.4507 million yuan.

About B006

B006 is a novel human recombinant monoclonal antibody product intended for the treatment of anaplastic large cell lymphoma, Hodgkin lymphoma, and cutaneous T-cell lymphoma. In July 2018, this project was approved by the National Medical Products Administration to conduct clinical trials and is currently in the final phase of Phase I clinical trials. To date, the project has accumulated R&D investments totaling approximately 44.2253 million yuan.

About B007

B007 is a novel human recombinant monoclonal antibody product intended for the treatment of CD20-positive B-cell non-Hodgkin lymphoma, pemphigus, and myasthenia gravis. The clinical trials and subsequent development for the non-Hodgkin lymphoma indications have been terminated, but the trials and subsequent development for pemphigus and myasthenia gravis indications are still proceeding normally. The clinical trials and subsequent development for the membrane nephropathy indications of the B007-A project are also proceeding normally. In January 2021, B007 (non-Hodgkin lymphoma indications) was approved by the National Medical Products Administration to conduct clinical trials and is currently in the final phase of Phase I clinical trials. To date, this indication has accumulated R&D investments totaling approximately 50.4003 million yuan.

About I008

I008 is a patented compound obtained by purifying, processing, and chemically modifying the main active ingredient of the traditional Chinese medicine Tripterygium wilfordii. It is intended for the treatment of rheumatoid arthritis. The clinical trials and subsequent development for the I008-A project, which addresses chronic immune activation in AIDS, are still proceeding normally. In May 2019, I008 was approved by the National Medical Products Administration to conduct further exploratory clinical trials and is currently in the final phase of Phase II clinical trials. To date, the project has accumulated R&D investments totaling approximately 62.1875 million yuan.

About BCD-100

BCD-100 is a recombinant human anti-PD-1 monoclonal antibody intended for the treatment of cervical cancer and non-small cell lung cancer. BCD-100 is an R&D project introduced by the company, which was approved to conduct Phase III clinical trials domestically in February 2021. The cervical cancer indication for BCD-100 is currently in the final phase of Phase III clinical trials, and the clinical trials and subsequent development for this indication are proposed to be terminated; however, the clinical trials and subsequent development for the non-small cell cancer indication are still proceeding normally. To date, the cervical cancer indication has accumulated R&D investments totaling approximately 59.0080 million yuan.