Telitacicept

Overview

No overview information available.

Indication

用于治疗系统性红斑狼疮（SLE）、类风湿性关节炎等多种自身免疫疾病。小知识：SLE症状表现多样，如面部出现红斑、关节肿痛、对光过敏、口腔溃疡等，随着病情的进展可导致肾脏、心血管等全身多系统、多器官的不可逆损害，严重威胁生命。目前，我国SLE患病人数超过100万，居全球之首，且多发于15-45岁的年轻女性，女性患病率为男性的10.1倍。

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Clinical Study on the Efficacy and Safety of Telitacicept in the Treatment of Pediatric IgA Nephropathy or IgA Vasculitis Nephritis	2025/07/08	NCT07052981	Not Applicable	Not yet recruiting	Guixia Ding
Telitacicept for the Treatment of Refractory RA	2025/06/06	NCT07008196	Phase 4	Not yet recruiting	Chinese SLE Treatment And Research Group
Telitacicept and Low-dose Steroids in Refractory Myasthenia Gravis	2024/12/09	NCT06723548	Phase 4	Not yet recruiting	First Affiliated Hospital of Wenzhou Medical University
Immune Cell Subsets in SLE Patients Treated with Telitacicept	2024/11/07	NCT06677801	Phase 4	Active, not recruiting	Second Affiliated Hospital, School of Medicine, Zhejiang University
The Efficacy and Safety of Treatment with Telitacicept in Antineutrophil Cytoplasmic Antibody-associated Nephritis (AAGN)	2024/10/24	NCT06656962	Phase 1	Active, not recruiting	Renmin Hospital of Wuhan University
Efficacy and Safety of Telitacicept in IgAN	2024/10/23	NCT06654596	Not Applicable	Recruiting	Ruijin Hospital
The Efficacy and Safety of Treatment With Telitacicept in Primary Membranous Nephropathy	2024/09/26	NCT06614985	Phase 2	Not yet recruiting	Renmin Hospital of Wuhan University
A Single Dose Study to Investigate the Pharmacokinetics (PK) of Telitacicept Pre-filled Injection and Freeze-dried Powder Injection in Chinese Healthy Subjects	2024/08/12	NCT06549959	Phase 1	Recruiting	RemeGen Co., Ltd.
The Safety and Efficacy of Telitacicept in the Treatment of Systemic Sclerosis	2024/08/09	NCT06546540	Phase 4	Recruiting	Peking University Third Hospital
A Study of Telitacicept for the Treatment of Generalized Myasthenia Gravis	2024/11/11	2024-512126-29-00	Phase 3	Recruiting	Remegen Co. Ltd.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Telitacicept for Injection	荣昌生物制药（烟台）股份有限公司	国药准字S20210008	生物制品	注射剂	3/9/2021

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Related News

Vor Bio Secures Global Rights to Telitacicept in $4+ Billion Deal with RemeGen

18 days ago

Vor Bio acquired exclusive global rights (excluding Greater China) to develop and commercialize telitacicept, a dual-target fusion protein approved in China for multiple autoimmune diseases including generalized myasthenia gravis.

RemeGen's Telitacicept Receives Approval in China for Generalized Myasthenia Gravis Treatment

a month ago

RemeGen announced that Telitacicept has officially been approved for marketing in China by the National Medical Products Administration for treating generalized myasthenia gravis.

Pfizer Strikes $6 Billion Deal with 3SBio as RemeGen Raises HK$796 Million in Premium Placement

2 months ago

• Pfizer has completed a record-breaking $6 billion acquisition deal with Chinese biopharmaceutical company 3SBio, energizing China's innovative drug industry and potentially driving further valuations upward. • RemeGen successfully raised HK$796 million through a premium placement, demonstrating strong investor confidence following the successful out-licensing of its RC18 asset. • The transactions highlight the growing momentum in China's biotech sector, with 3SBio's valuation expected to continue rising while competitor Akeso may face downward pressure. • China's 11th batch of national Volume-Based Procurement (VBP) rules are expected to include optimizations balancing competitive bidding prices with drug quality standards.

IgA Nephropathy Pipeline Shows Robust Growth with 30+ Therapies in Development

3 months ago

DelveInsight's 2025 pipeline analysis reveals over 30 companies developing 30+ therapies for IgA nephropathy treatment, representing a robust therapeutic landscape.

RemeGen's Telitacicept Shows Remarkable 98% Response Rate in Phase 3 Trial for Generalized Myasthenia Gravis

4 months ago

Telitacicept demonstrated a 98.1% response rate in reducing MG-ADL scores by ≥3 points at Week 24, potentially positioning it as best-in-class among treatments for generalized myasthenia gravis.

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