▎WuXi AppTec Content Team Report

The official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration recently announced the latest information, Roche's submitted Class 1 new drug.RO7790121 Injection Granted Two Clinical Trial Implied Approvals for DevelopmentModerate to Severe Ulcerative Colitis. Public information shows that this isATargetedTumor Necrosis Factor-Like Cytokine 1A (TL1A) Monoclonal Antibody, for Roche to acquire at over 71 billion US dollarsTelavant's product has recently been launched in the United States.Initiate Phase 3 Clinical Trial, TargetingModerate to Severe Ulcerative Colitis Indication。

Screenshot source: CDE official website

The full Chinese name of TL1A is Tumor Necrosis Factor (TNF)-Like Ligand 1A, which has gained widespread attention in the industry in recent years. Studies have found that TL1A is abnormally expressed in autoimmune diseases.From the perspective of mechanism of action, TL1A plays a key role in intestinal inflammation cascade and fibrosis through its DR3 receptor. Therefore, drugs targeting TL1A have the potential to treat various autoimmune diseases such as ulcerative colitis and Crohn's disease.。

RO7790121 InjectionIt is an anti-TL1A monoclonal antibody. The product was initially developed byTelavant (Developed by Roivant and Pfizer(Previous R&D code name:RVT-3101/PF-06480605）。In December 2023, Roche completed the acquisition of Telavant.TherebyAcquire the rights to develop, manufacture, and commercialize the product in the United States and Japan for the treatment of inflammatory bowel disease and potentially various other conditions.。At the same time, Roche will also obtain from PfizerNext-Generation P40/TL1A-Directed Bispecific AntibodyThe option for global collaboration, this antibody is currently in Phase 1 of research. In this collaboration,Roche to Pay $7.1 Billion Upfront and $150 Million in Near-Term Milestone Payments.

According to the researchers' previous announcementTheClinical Data, inRO7790121 InjectionIn a Phase 2b clinical trial for the treatment of patients with ulcerative colitis,Patients receiving the expected dose in Phase 3 clinical trialsThe clinical remission rate reached 36% at 56 weeks., further increased from 14 weeks (29%);The proportion of patients achieving endoscopic improvement reached 50% at 56 weeks., significantly higher than at 14 weeks (36%).

According toClinicalTrialsOfficial website, Roche has recently launched twoThe Phase 3 clinical study of RO7790121 injection, respectivelyEvaluation of RO7790121 InductionGuidance and Maintenance Treatment for Moderate to Severe Active Ulcerative ColitisEfficacy and Safety (Ametrine-1 Study); Evaluation of RO7790121Induction Treatment for Moderate to Severe Active Ulcerative ColitisEfficacy and Safety (Ametrine-2 Study).

In China, Pfizer has previously completed a Phase 2 clinical study of this product in adult subjects with moderate to severe ulcerative colitis. The recent approval for another clinical trial in China indicates that the product is about to enter a new stage of clinical development.

TL1A blockers have now become a potential new therapy for treating inflammatory and fibrotic diseases. In addition to Roche, several other large pharmaceutical companies are collaborating to develop such products, demonstrating recognition of their clinical application potential. For example:

• In June 2023, Merck & Co., Inc. (MSD) completed a deal worth a total of $10.8 billion.For Prometheus CorporationAcquisition，The latter's core product is precisely aTargetedTL1A Monoclonal Antibody；

• In October 2023, Sanofi announced that it had reached an agreement with Teva Company for approximately$1 billionAgreement，Thereby jointly developing the latter'sTL1A Antibody TherapyTEV’574；

• June 2024,Mingji Biologics Announces a Deal with AbbVie Worth Approximately $1.71 BillionCooperation, thereby jointly developingAt the preclinical stageNext-Generation TL1A AntibodyFG-M701, for the treatment of inflammatory bowel disease.
  

It is hoped that with the progress of research, more breakthroughs can be made in the development of new drugs targeting this site, bringing more treatment options to patients.