Celltrion disclosed that the European clinical Phase 3 trial plan for Zymfentra (CT-P13 SC) in rheumatoid arthritis was approved (Part1, Part2) on November 2, 2026.

In a disclosure dated November 2, 2026, Celltrion said the European clinical Phase 3 trial plan for Zymfentra (CT-P13 SC) in patients with rheumatoid arthritis was approved on October 30, 2026 (local time). According to the disclosure, the trial will enroll 296 patients, and the treatment period is 52 weeks. The company said it expects to offer treatment opportunities to more patients, in addition to developing the drug for adult ulcerative colitis and Crohn's disease indications. The original disclosure also notes investment risk, stating that commercialization plans may be changed or abandoned depending on the results of the clinical trial.

1. 01

   The disclosure stated that the global Phase 3 trial plan for CT-P13 SC in rheumatoid arthritis, which was filed with the European Medicines Agency (EMA), was approved on both Part1 and Part2.

2. 02

   According to the company's disclosure, the purpose of the clinical trial is to demonstrate that CT-P13 SC is superior to placebo in efficacy, as determined by clinical response at week 12 under ACR50.

3. 03

   The original disclosure states that the statistical probability of a trial drug ultimately receiving approval as a medicine is known to be about 10%, and it includes a caution that commercialization plans may be changed or abandoned depending on the results of the clinical trials and the product approval process.

4. 04

   This disclosure is a follow-up to the clinical Phase 3 trial plan application disclosed on July 24, 2026.

An AI model translated the Korean summary of this filing into English; every number is carried over from the Korean original. Reference information, not investment advice.

Key figures

Target patients

296 patients

Trial period

Treatment period of 52 weeks

Application date (local time)

July 24, 2026

Approval date (local time)

October 30, 2026

Filing facts

Filing type

Material Management Information

Report name

Material Management Information for Investment Decisions

Filed

Nov 2, 2026

Receipt number

20261102800302