J&J Halts Two Drug Development Programs Within a Week

　　【Pharmaceutical Network Enterprise NewsIn recent years, many pharmaceutical companies have halted their R&D pipelines, with some stopping up to 12 pipelines within a year. Since 2025, the development of several blockbuster drugs has been terminated. Among them, Johnson & Johnson stopped the Phase 3 project of the investigational drug aticaprant for treating Major Depressive Disorder (MDD) due to insufficient efficacy and, within a week, announced the abandonment of the option for a new generation CD38 antibody.
 

News on March 10: Johnson & Johnson (J&J) announced that it has abandoned the option for the global licensing, development, manufacturing, and commercialization of the next-generation CD38 monoclonal antibody HexaBody-CD38 (GEN3014).
 

It is reported that in 2019, Genmab reached an exclusive global research and development licensing agreement for HexaBody-CD38 with Johnson & Johnson. According to the agreement signed by both parties, Genmab provided Johnson & Johnson with proof-of-concept study data of HexaBody-CD38 for multiple myeloma, including a head-to-head comparison with Darzalex (daratumumab).
 

Based on this, Johnson & Johnson will exercise its option to continue the development, manufacturing, and promotion of HexaBody-CD38. If it chooses to proceed, it will pay Genmab $150 million and potentially up to $125 million in milestone payments, as well as future sales royalties.
 

It is reported that the two companies have been cooperating since 2012, when Janssen acquired the rights to Genmab's anti-CD38 drug DARZALEX® for more than 1 billion US dollars. DARZALEX® is one of the most successful new drugs in recent years, with sales reaching 2 billion US dollars in 2018. Industry analysts believe that in the long term, the drug could achieve sales of 10 billion US dollars.
 

In fact, Darzalex does have significant development potential. Recently, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended expanding the indications for the subcutaneous formulation of Darzalex – using subcutaneous Darzalex in combination with bortezomib, lenalidomide, and dexamethasone for the first-line treatment of adult patients with newly diagnosed multiple myeloma.
 

Darzalex Subcutaneous Injection is the first anti-CD38 antibody that can be administered via subcutaneous injection. It has been approved for eight indications for multiple myeloma, four of which are for frontline treatment.
 

Including the aforementioned drugs, there are currently over a hundred CD38-targeted drugs under development globally, including monoclonal antibodies, bispecific/multispecific antibodies, ADCs, cell therapies, fusion proteins, and more. With continuous advancements in research and development, the field is frequently bringing good news. For example, on January 9, 2025, Sanofi announced that its CD38 monoclonal antibody Isatuximab Injection (Sarclisa®) was approved for marketing by China’s National Medical Products Administration (NMPA); on January 10, I-Mab announced that the marketing application for its previously introduced CD38 monoclonal antibody Fizatumab Injection had been accepted by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration. On the same day, Convelo Therapeutics announced that its CD38 monoclonal antibody CM313 achieved an overseas deal through Newco with a potential total transaction value of $367.5 million.
 

Notably, against the backdrop of increasingly fierce competition surrounding the CD38 target, most drugs are still in the clinical stage, with only a few having reached the market. In response, industry experts believe that while the CD38 target market holds promising prospects, research and development is challenging. For pharmaceutical companies to stand out in drug R&D and application in the future, they must achieve breakthroughs in efficacy, data, safety, and other aspects.
 

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