Pharma Companies Streamline R&D Pipelines Amid Strategic Refocus: 3,895 Drug Candidates Withdrawn in 2023

　　【Pharmaceutical Network Industry Dynamics】In recent years, due to factors such as changes in the capital market environment and intensified market competition, pharmaceutical companies have been cutting back on related pipelines. According to the "2024 Pharmaceutical R&D Trends Annual Review White Paper" (hereinafter referred to as the White Paper) recently released by Citeline, in 2023, 5,428 new drugs were added to the global R&D pipeline, while 3,895 candidate drugs exited the pipeline under research.
 

Since entering 2024, based on the needs for cost control, strategic adjustments, and improving R&D efficiency, many pharmaceutical companies have announced the termination of development for their candidate drugs.
 

For example, in April this year, BMS closed its Cancer Immunology and Cell Therapy Research Center located in Redwood City, California. BMS currently has approximately 12 projects that have been halted or designated for outsourced development, including the follow-up version of its immunotherapy Yervoy, SIRPα and BET-targeted drugs, and will continue to review its product pipeline for the remainder of the year.
 

On May 9, Takeda Pharmaceutical Company Limited mentioned in its fiscal year 2023 earnings report. To alleviate operational pressure, Takeda plans to simplify its employee organizational structure, allocate approximately $900 million for restructuring, and streamline its drug pipeline by explicitly discontinuing the development of TAK573, TAK981, and the CAR-NK therapy TAK007 for hematological tumor indications. Takeda also disclosed that it will soon close its San Diego research center, potentially affecting 340 employees.
 

Gilead Sciences announced this year that it will remove six trials of the CD47 monoclonal antibody magrolimab from its pipeline, including multiple solid tumor studies such as magrolimab combination therapy for squamous cell carcinoma of the head and neck, triple-negative breast cancer, colorectal cancer, and hematological malignancy trials. In addition, the Phase II basket trial (ZUMA-25) of its CD19 CAR-T cell therapy Tecartus (Brexucabtagene autoleucel) for rare B-cell malignancies, as well as the Phase I trial of the CLL-1-targeted CAR-T cell therapy KITE-222 for relapsed/refractory acute myeloid leukemia (R/R AML), have also been removed. Additionally, in the Q1 pipeline update, Novartis announced the removal of the CD73 monoclonal antibody NZV930 and the CSF-1R inhibitor sotuletinib from its pipeline. Among them, NZV930 is in Phase I, and sotuletinib has reached Phase II.
 

In addition to the products in the early clinical stage being abandoned, those in Phase III clinical pipelines are no exception. For instance, Roche discontinued the development of RG6168 (Satralizumab) for the treatment of myasthenia gravis due to its failure to demonstrate expected clinical efficacy in Phase III trials. Sanofi also terminated the Phase III trial of Venglustat for the treatment of GM2 gangliosidosis.
 

Currently, not only multinational pharmaceutical companies but also local pharmaceutical enterprises are accelerating their efforts to "streamline." For instance, Shanghai Pharmaceuticals recently announced that, in order to allocate R&D resources reasonably and focus on advantageous R&D projects, it has decided to terminate the subsequent development of three R&D projects with cumulative investments exceeding 300 million yuan. These projects are I010, B002, and B003. Two of the projects are in Phase I clinical trials, while one is in Phase II clinical trials.
 

Asieris announced in February that the pivotal, randomized, double-blind, controlled, multicenter clinical trial of APL-1202 in combination with chemotherapy instillation for the treatment of recurrent intermediate- and high-risk non-muscle invasive bladder cancer (NMIBC) after chemotherapy instillation has been completed. Statistical analysis showed that although a certain trend of superiority was observed in some patients, the primary endpoint was not met. Asieris has decided to terminate further development of APL-1202 in combination with chemotherapy instillation for this indication. As of December 31, 2023, Asieris has cumulatively invested approximately 130 million yuan in this pivotal clinical trial.
 

The industry believes that as major pharmaceutical companies actively do "subtraction," it may be more conducive to focusing on key product pipelines. It is expected that leading companies will continue to make efforts on blockbuster products, and the concentration of the pharmaceutical industry will further increase in the future.
 

Disclaimer: Under no circumstances shall the information or opinions expressed in this article constitute investment advice to any person.