Johnson & Johnson Secures Global First Approvals for Tremfya in IBD and Acquires Proteologix for $6.5B to Lead Autoimmune Therapeutics

Just last week, Johnson & Johnson dropped two major bombshells: its IL-23 inhibitor Tremfya (guselkumab) secured the world's first Crohn's disease (CD) indication in China, and soon after, it was swiftly approved in the ulcerative colitis (UC) field, becoming the first IL-23 inhibitor in China for treating UC. On another front, Johnson & Johnson spent $6.5 billion (approximately 46.7 billion RMB) to acquire the bispecific antibody platform company Proteologix, aiming to gain an early advantage in inflammatory pathways such as IL-13/IL-17 and IL-13/TSLP.

From this series of actions, Johnson & Johnson's strategic intent is self-evident: to use Tremfya as a follow-up to the soon-to-expire Simponi and Stelara, while doubling down on the next generation of "bispecific antibodies" to solidify its leading position in the autoimmune market. However, behind this "defense of the autoimmune throne," the competition is fiercer than ever, and Johnson & Johnson is not without its concerns.

Tremfya (guselkumab) is a fully human IL-23p19 monoclonal antibody that initially gained prominence in psoriasis, subsequently expanding rapidly to plaque psoriasis and psoriatic arthritis. In the two core IBD indications, UC and CD, Tremfya's approval pace in the Chinese market may lead in some global markets.

Taking the recently approved UC as an example, Tremfya demonstrated excellent data in the Phase IIb/III QUASAR study: Subcutaneous injection for maintenance treatment over one year achieved a clinical remission rate of 45%-50% and an endoscopic remission rate exceeding 34%, both significantly higher than the placebo group. Most importantly—The patient is inThe First WeekThat is, symptom improvement occurs much earlier than with most IL-23 counterparts.

In the CD field, Tremfya achieved global approval for the first time in China this February. This means Johnson & Johnson has completed a closed loop in China across the three major immunology areas: "psoriasis—arthritis—IBD." As a leading player in the IL-23 class, Tremfya is not just a drug but also the anchor point for Johnson & Johnson’s "reconstruction of the autoimmune landscape."

Why is Johnson & Johnson so eager?

The answer is straightforward,StelaraPatent Expiration ImminentThis IL-12/23 dual-target drug boasts annual sales exceeding $10 billion and serves as a key revenue pillar for Johnson & Johnson's immunology business. However, its U.S. patent is set to expire in 2025, with a wave of biosimilars already poised to enter the market. Meanwhile, the veteran drug Simponi (a TNF-α monoclonal antibody) has already faced marginalization in the market.

Johnson & Johnson is clearly unwilling to repeat the覆辙of Pfizer and Amgen's "cliff-like decline" of blockbuster products. It needs sufficient replacements that not only cover the gaps in indications but also match Stelara's commercial performance — this also explains Tremfya’s multi-indication "succession" and the accelerated advancement of new pathways.

The reason why Proteologix triggered a $6.5 billion acquisition frenzy by Johnson & Johnson (an early-stage platform with almost no revenue and no products on the market) actually lies behind...Path PressureTechnical Signals:Bispecific Antibodies Will Be the New Battleground for the Next Generation of Autoimmune Drugs。

This acquisition includes two core preclinical projects:

PX128: IL-13/TSLP bispecific antibody, targeting atopic dermatitis (AD) and asthma, to soon commence Phase I clinical trial.

PX130: IL-13/IL-22 bispecific antibody, also targeting atopic dermatitis, is in the preclinical development stage.

PX128 and PX130, two bispecific antibodies, precisely target the core of the Th2 pathway, covering atopic dermatitis and asthma. The former blocks the upstream activator TSLP and the core inflammatory cytokine IL-13, while the latter focuses on skin barrier repair and local immune regulation. The combination of targets is not a simple叠加, but a synergistic path closure, aiming to突破the efficacy ceiling of existing monoclonal antibodies, especially for难治性populations.

For Johnson & Johnson, this is not only a pipeline enhancement but also a pathway defense following the full implementation of popular targets such as IL-13, IL-22, and TSLP — to win the future, it is essential to integrate the pathways first.

The battle for Tremfya is far from over. On the crowded track of IL-23 monoclonal antibodies, Johnson & Johnson is facing a head-on confrontation with old rivals such as Eli Lilly, AbbVie, and Novartis:

Skyrizi(AbbVie): The strongest competitor in IL-23, with sales exceeding $11.7 billion in 2024, has been approved for psoriasis, arthritis, and Crohn's disease (CD);

Mirikizumab(Eli Lilly): Approved by the FDA for UC in 2023, priced slightly lower, with a focus on rapid onset of action;

Netakimab（UCB）：IL-17A/F Dual Targeting Shows Strong Performance in Psoriasis, Indirectly Challenging the IL-23 Market.

Especially Skyrizi, which has shown extremely strong performance in CD. Studies show that after 52 weeks of maintenance therapy, the clinical remission rate is close to 50%, with excellent mucosal healing capabilities. This is almost on par with Tremfya's GALAXI data (56% remission rate), foreshadowing intense competition in the IBD market.

The field of dual antibodies is no longer a "vacant land." Sanofi's IL-13/TSLP dual antibody SAR443765 has entered Phase II clinical trials, and AbbVie also has an IL-17/IL-23 fusion protein under development. This means that even if Johnson & Johnson secures the platform, to stand out in the future will still depend on real product strength and commercial transformation capabilities.

In addition to mergers and acquisitions and the accelerated expansion of listed drugs, Johnson & Johnson is also quietly building a more long-term ecological layout in the autoimmune field: withBenevolentAICollaborate with AI platforms to advance the screening and optimization of inflammatory targets; support multiple emerging companies focusing on oral biologics, microbiome therapies, and delivery systems through JLABS; within Janssen’s R&D, more than 10 early-stage autoimmune drugs are still in IND or Phase I clinical trials, including novel IL pathways, small molecules, and cell therapies.

In other words, Johnson & Johnson is not content with using Tremfya or bispecific antibodies as a "relay" for Stelara but is instead building the ecosystem for the next "blockbuster drug."

From the global launch of Tremfya and its dual success in UC/CD, to acquiring the highly promising bispecific antibody at a premium price, Johnson & Johnson's immunology division has indeed played several "trump cards." However, these moves seem more like proactive transformations: with Stelara’s patent ceiling approaching, IL-23 competition intensifying, and the next-generation pathway still unclear, Johnson & Johnson chose to act early rather than wait until options dwindled.

The key to stabilizing this transformation lies in two points: whether Tremfya can compete against Skyrizi in the IBD market, and whether Proteologix's bispecific antibody pipeline can successfully enter clinical trials and realize its technology premium.

Johnson & Johnson's game has just begun, and the outcome remains uncertain.

Disclaimer:

The content of the article is for reference only and does not constitute investment advice. Investors who take actions based on this information bear their own risks. The article maintains a neutral stance on the statements and viewpoints presented, and does not provide any explicit or implicit guarantees regarding the accuracy, reliability, or completeness of the content. Readers are advised to use it solely as a reference and assume full responsibility for their actions.