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A Phase II, Randomized, Double -blind, Placebo -controlled ...

Date: 16 May 2017 Supersedes: Page 1 of 97 TJ301 Protocol No.: CTJ301UC201 Solution for Injection Clinical Trial Protocol Leading Biopharm Limited CONFIDENTIAL CLINICAL TRIAL PROTOCOL A Phase II, Randomized, Double -blind, Placebo -controlled Study to Evaluate the Safety and Efficacy of TJ301 (FE 999301) Administered Intravenously in Patients with Active Ulcerative Colitis Protocol Number: CTJ301UC201 Investigational Medicinal Product: TJ301 (solution for injection), also referred to as FE 999301 and Olamkicept Indication: Active Ulcerative Colitis Phase : 2 Investigators: Multicenter, international, across Mainland China, Taiwan, Republic of Korea and Australia Coordinating Investigator Prof. Dr. Minhu Chen Chair, Department of Gastroenterology and Hepatology Vice President The First Affiliated Hospital, Sun Yat-sen University 58 Zhongshan Road, Guangzhou, China Expert committee Prof. Dr. Stefan Schreiber Institute for Clinical Molecular Biology University Hospital Schleswig-Holstein Schittenhelmstrasse 12, 24105 Kiel, Germany Name and Address of Sponsor: Leading Biopharm Limited Sponsor Contact: Yin Liu Suite 802, OmniVision Park West Tower 88 Shangke Road, Pudong, Shanghai 201210, China Tel: + 86 135 0178 1723 GCP Statement: This trial will be performed in compliance with GCP.

Visit 7 (Week 10), and Visit 8 (Week 12). During Screening and at Visit 8 (Week 12), assessments of disease activity will also include endoscopy (colonoscopy or sigmoidoscopy); mucosal biopsies for assessment of mucosal healing, histology, immunohistochemistry will be collected during endoscopy at these time points.

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