High Risks in Drug Development: Genmab, Wuhan Myer and Others Recently Halt New Drug Programs

 

Recently, Genmab announced the termination of clinical development for the ADC drug GEN1160. According to available information, GEN1160 is one of three clinical-stage ADC projects that Genmab acquired through the purchase of ProfoundBio. It is an antibody-drug conjugate targeting CD70. The CD70 protein is expressed in various solid tumors and hematologic malignancies, making this target a promising option in the field of cancer treatment.
 

Notably, this is already the second clinical-stage ADC asset that Genmab has abandoned in 2024 after acquiring ProfoundBio for $1.8 billion in April. In September, Genmab discontinued GEN1107, a solid tumor candidate drug from ProfoundBio, citing that its risk-benefit profile in Phase 1/2 clinical trials did not meet expectations. Despite the consecutive abandonment of two ADC assets, Genmab remains committed to the core pipeline acquired from ProfoundBio.
 

On November 14, Bristol-Myers Squibb and Johnson & Johnson announced the decision to terminate the Phase 3 Librexia ACS trial evaluating the efficacy and safety of milvexian in combination with standard treatment (conventional antiplatelet therapy) for patients who recently experienced acute coronary syndrome (ACS). Milvexian is an investigational oral, highly selective Factor XIa (FXIa) inhibitor, part of a new class of anticoagulant drugs designed to prevent harmful blood clots (which restrict blood flow) while preserving normal clotting function (hemostasis).
 

The decision to terminate this trial was based on the pre-specified interim analysis results from the Independent Data Monitoring Committee (IDMC), which indicated that the trial was unlikely to meet its primary efficacy endpoint. Despite the setback in the ACS trial, BMS and Johnson & Johnson remain committed to advancing the phase 3 clinical trials of milvexian in atrial fibrillation (AFib) and secondary stroke prevention (SSP).
 

On November 14, WOLWOPHARMA announced that, after prudent evaluation by the management of the Aspergillus fumigatus skin prick solution research and development project, and considering factors such as the progress of the project and the risks associated with continuing development, the company decided to terminate the Aspergillus fumigatus skin prick solution R&D project in order to allocate R&D resources more reasonably and focus on advantageous projects within its R&D pipeline. No further clinical trials will be conducted.
 

Aspergillus fumigatus Prick Solution is clinically intended for use in skin prick tests to assist in diagnosing Type I hypersensitivity diseases caused by Aspergillus fumigatus sensitization. As of the date of this announcement, the cumulative development expenditure balance for the Aspergillus fumigatus Prick Solution project is 4.77 million yuan.
 

From a broad perspective, the termination of numerous R&D projects in recent years reveals profound changes occurring within the pharmaceuticals industry. The sector has shifted from the previous "high-stakes gambling era" of casting a wide net to a more calculated "actuarial model," with corporate decision-making increasingly based on rigorous cost-benefit analyses and clear assessments of commercialization pathways. Moving forward, for most companies, building diversified R&D pipelines, carefully considering rights retention (such as regional rights) in BD transactions, and engaging in capital partnerships aligned with strategic preferences will become even more crucial.
 

Disclaimer: In any case, the information or opinions expressed in this article do not constitute investment advice to any person.