Global Pharma Pipeline Cuts Surge: Major Companies Halt Multiple Clinical Programs Amid Strategic Restructuring

Oct 17, 2024 19:11 CST Updated 19:12

Johnson & Johnson

Medical Device R&D and Manufacturer

Gilead Sciences

Innovative Drug Developer, Distributor

SPH

Pharmaceutical R&D and Manufacturing

Source: Ouryao, organized by Wuyou

Multiple pharmaceutical companies halt R&D projects in 2024:

Multinational pharmaceutical companies:

Johnson & Johnson:On October 15, Johnson & Johnson updated its Q3 R&D pipeline. Johnson & Johnson terminated three clinical research programs in the field of neuroscience, including: a Phase II clinical study of seltorexant for the treatment of Alzheimer's disease, a Phase II clinical study of a P2X7 antagonist for the treatment of bipolar depression, and a Phase I clinical study of JNJ-0376 for the treatment of Parkinson's disease.

Gilead Sciences:On February 15, Gilead Sciences announced that it had paused patient enrollment for part of the ongoing magrolimab (a CD47 antibody drug) solid tumor studies, and the FDA has placed partial clinical holds on these trials.Previously, magrolimab had halted all CD47 hematological malignancy indication programs, and on July 21, 2023, the drug announced failure in the Phase III clinical trial for myelodysplastic syndromes.

Pfizer:In 2024, Pfizer announced a voluntary withdrawal of its sickle cell disease drug Oxbryta from the global market and the cessation of all ongoing clinical trials and global expanded access programs related to Oxbryta.The reason is that existing clinical trial data show that the clinical benefit of Oxbryta in the SCD patient population no longer outweighs the risks, with an imbalance in vaso-occlusive crises and fatal events, requiring further evaluation.

Domestic pharmaceutical enterprises:

SPH, 12

Three projects terminated on May 1:

Project i010: An epidermal growth factor receptor tyrosine kinase inhibitor intended for the treatment of malignant tumors such as non-small cell lung cancer, currently in Phase I clinical trials, with cumulative R&D investment of approximately several billion yuan.

Project B002: A novel recombinant monoclonal antibody product for human use, intended for the treatment of HER2-positive metastatic breast cancer and neoadjuvant therapy for HER2-positive breast cancer. It is currently in Phase I clinical trials, with an investment of approximately 130 million yuan.

Project B003: A conjugate product of human recombinant monoclonal antibodies and small molecule drugs, intended for the treatment of HER2-positive locally advanced or metastatic breast cancer, is currently in Phase II clinical trials, with an investment of approximately 140 million yuan.

Four projects terminated on June 8:

Project b001: A novel recombinant human monoclonal antibody product for the treatment of CD20-positive B-cell non-Hodgkin lymphoma, currently at the end of Phase I clinical trials, with cumulative R&D investment of approximately 64.6668 million yuan.

Project B001-A: Identical to B001, intended for the treatment of multiple sclerosis. It has received clinical trial approval but has not yet commenced clinical trials. The cumulative R&D investment is approximately 5.9346 million yuan.

Project i022: A Class 1 chemical small-molecule innovative drug, currently at the end of Phase II clinical trials. The clinical development for its first-line treatment of breast cancer indication has been terminated, while clinical trials and subsequent development for other indications are proceeding normally, involving R&D investment of approximately 6.9937 million yuan.

i022-k Project: A Class 1 chemical small-molecule innovative drug intended for the treatment of advanced solid tumors, currently at the end of Phase I clinical trials, with cumulative R&D investment of approximately 36.999 million yuan.

Five Pipelines Terminated in October:

i020 Project: A selective inhibitor with anti-tumor effects, intended for the treatment of malignant tumors such as non-small cell lung cancer. It is currently in Phase I clinical trials, with cumulative R&D investment amounting to approximately RMB 41.4507 million.

Project B006: A novel recombinant human monoclonal antibody product intended for the treatment of anaplastic large cell lymphoma, Hodgkin's lymphoma, and cutaneous T-cell lymphoma. It is currently in Phase I clinical trials, with cumulative R&D investments amounting to approximately RMB 44.2253 million.

Project B007 (Non-Hodgkin Lymphoma Indication): A novel recombinant human monoclonal antibody product originally intended for the treatment of CD20-positive B-cell non-Hodgkin lymphoma, pemphigus, and myasthenia gravis. The clinical trial and subsequent development for the non-Hodgkin lymphoma indication have been terminated, with cumulative R&D investment in this indication amounting to approximately RMB 50.4003 million.

Project i008: A compound obtained through purification, processing, and chemical structural modification of triptolide, the main active component of the traditional Chinese medicine Tripterygium wilfordii, intended for the treatment of rheumatoid arthritis. It is currently in Phase II clinical trials, with cumulative R&D investment amounting to approximately RMB 62.1875 million.

BCD-100 Project (Cervical Cancer Indication): Recombinant human anti-PD-1 monoclonal antibody, intended for the treatment of cervical cancer and non-small cell lung cancer. It is currently in Phase III clinical trials. The cumulative R&D investment for the cervical cancer indication is approximately RMB 59.008 million.

BeiGene:On February 26, BeiGeneAnnouncement of the Termination of Collaboration with Shoreline Biosciences on an Allogeneic NK Cell Therapy Project, Effective Q1 2024A spokesperson for BeiGene stated that after an internal strategic portfolio review, the company decided to terminate its partnership with Shoreline Biosciences. This decision is the result of BeiGene's internal priority adjustments and does not imply any shortcomings in Shoreline’s platform technology.

Huadong Medicine:On August 15, Huadong Medicine announced the termination of further development of the oral small molecule GLP-1 drug TTP273 project.

Asia Pioneer Pharmaceuticals:On February 4, Asieris Pharmaceuticals announced that the pivotal clinical trial of APL1202 in combination with chemotherapy instillation for the treatment of intermediate- and high-risk non-muscle invasive bladder cancer recurring after chemotherapy instillation has been completed but did not meet the primary endpoint. The company decided to terminate further development of this indication. As of December 31, 2023, this clinical trial had accumulated an investment of approximately 130 million yuan. However, Asieris Pharmaceuticals is still advancing clinical trials of APL1202 for other indications.

Tiantan Bio:On January 31, Tiantan Biological decided to terminate the Phase III clinical trial and subsequent development of its holding subsidiary Rongsheng Pharmaceutical's "Intravenous Cytomegalovirus Human Immunoglobulin (pH4)."The reason is based on a comprehensive and prudent analysis of the current situation of prevention and treatment of cytomegalovirus infection after allogeneic hematopoietic stem cell transplantation in China, considering the market conditions and the company's strategic planning.The company has invested RMB 70.6909 million in the development of this drug.

Yabao Pharmaceutical:On January 3, Yabao Pharmaceutical announced that after prudent consideration of the investment risks and future market value associated with the continued development of the SY-004 project, and in order to allocate R&D resources reasonably and focus on advantageous projects in the R&D pipeline, it has decided to suspend the clinical research and development work for the SY-004 project.SY-004, or the Alagatratin Hydrochloride Capsules and Active Pharmaceutical Ingredient Development Project, is applicable to Type II Diabetes, but the clinical research did not meet favorable expectations.

Zai Lab:Starting from the fourth quarter of 2023, Zai Lab made adjustments to some of its pipelines. Its 2023 financial report showed that three drugs—margetuximab, odronextamab, and blu-945—are no longer on the list of candidate drugs. In the fourth quarter of 2023, Zai Lab decided to halt the development of margetuximab and odronextamab and issued notices to terminate cooperation with the relevant companies, effective on May 14, 2024, and December 20, 2024, respectively. Regarding the reasons for terminating the development, Zai Lab stated that it was based on considerations of the competitive landscape.

Staidson:On March 25, Staidson announced that, based on the current situation of the COVID-19 pandemic and in conjunction with the progress of the annual audit work, the company conducted a review of its R&D projects. After careful consideration, it was decided to terminate the research work on the COVID-19 indication for BDB-001 Injection, STSA-1002 Injection, STSA-1005 Injection, as well as the combination therapy of STSA-1002 and STSA-1005. As of the announcement date, the total R&D investment in these projects for this indication amounted to 383 million yuan.

Reasons for the suspension of drug development includePoor Clinical Trial Results, lack of market competitiveness;Shortage of funds and adjustment of resource allocation;Technical difficulties are hard to overcome;Market FactorsChanges have led to fierce competition and a decline in drug demand;Increased regulatory requirements andImpact of policy adjustments, etc.

Reference:Corporate Announcement