Anxu (rovadicitinib) / Sino Biopharm, Sanofi - LARVOL DELTA

Rovadicitinib, a first-in-class JAK/ROCK inhibitor, in patients with myelofibrosis: a preclinical and phase I study. (PubMed, Blood Cancer J) - No abstract available

Journal • P1 data • Preclinical • Myelofibrosis

A Clinical Trial of TQ05105 Tablets in the Treatment of Chronic Graft-versus-host Disease (clinicaltrials.gov) - P2 | N=65 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Trial completion date: Apr 2026 ➔ May 2029 | Trial primary completion date: Oct 2025 ➔ Nov 2027

Trial completion date • Trial primary completion date • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology

QT Interval/Corrected QT Interval ?QT/QTc? Clinical Study to Evaluate the Cardiac Safety of TQ05105 Tablets in Healthy Participants (clinicaltrials.gov) - P1 | N=60 | Active, not recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Myelofibrosis

Chronic graft-versus-host disease. (PubMed, Nat Rev Dis Primers) - "Four second-line treatments have been approved by the FDA - ibrutinib, ruxolitinib, belumosudil and axatilimab - targeting B cell signalling, JAK-STAT, ROCK2 and CSF1R pathways, respectively, and emerging therapies such as rovadicitinib show promise. Multidisciplinary care, infection control and psychosocial support are critical to improving quality of life in patients with cGVHD. Future research should prioritize mechanistic insights, antifibrotic therapies and integrating organ-specific interventions to enhance outcomes in patients with cGVHD."

Journal • Review • Chronic Graft versus Host Disease • Fibrosis • Graft versus Host Disease • Immunology • Infectious Disease • Transplantation • CSF1R

Study to Evaluate the Effect of Rabeprazole Sodium Enteric-coated Tablets on the Pharmacokinetics of TQ05105 Tablets (clinicaltrials.gov) - P1 | N=17 | Active, not recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Myelofibrosis

A single-center, open-label, single-dose, fixed-dose regimen, self-controlled Phase I clinical trial to evaluate the effect of rabeprazole sodium enteric-coated tablets on the pH-dependent pharmacokinetics of TQ05105 tablets (ChiCTR) - P1 | N=16 | Not yet recruiting | Sponsor: Xiangya Third Hospital of Central South University; Xiangya Third Hospital of Central South University

New P1 trial • Acute Graft versus Host Disease • Chronic Graft versus Host Disease • Graft versus Host Disease • Hemophagocytic lymphohistiocytosis • Immunology • Myelofibrosis

QT Interval/Corrected QT Interval ?QT/QTc? Clinical Study to Evaluate the Cardiac Safety of TQ05105 Tablets in Healthy Participants (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

New P1 trial • Cardiovascular • Myelofibrosis

TQ05105-II-08: A Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of TQ05105 Tablets in Subjects With Intermediate/High-risk Myelofibrosis (clinicaltrials.gov) - P2 | N=51 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Myelofibrosis • JAK2

TQ05105-I-01: A Study of TQ05105 Tablets in Subjects With Myeloproliferative Neoplasms (clinicaltrials.gov) - P1 | N=79 | Completed | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Unknown status ➔ Completed | N=50 ➔ 79

Enrollment change • Trial completion • Essential Thrombocythemia • Myeloproliferative Neoplasm • Oncology

A Study of TQ05105 Tablets in Subjects With Glucocorticoid-Refractory Acute Graft-Versus-Host Disease (aGVHD) (clinicaltrials.gov) - P1/2 | N=13 | Terminated | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Completed ➔ Terminated; This study was closed due to business reasons. Closure was not prompted by any safety or efficacy concerns.

Trial termination • Acute Graft versus Host Disease • Graft versus Host Disease • Immunology

TQ05105-Ⅱ-01: A Clinical Trial of TQ05105 Tablets in the Treatment of Moderate and High Risk Myelofibrosis (clinicaltrials.gov) - P2 | N=107 | Completed | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Myelofibrosis • JAK2

Rovadicitinib: First Approval. (PubMed, Drugs) - "On 25 February 2026, rovadicitinib received its first approval in China as first-line treatment for adult patients with intermediate-2 or higher-risk PMF, PPV-MF or PET-MF. This article summarizes the milestones in the development of rovadicitinib leading to this first approval for myelofibrosis."

Journal • Graft versus Host Disease • Hematological Disorders • Hemophagocytic lymphohistiocytosis • Immunology • Myelofibrosis • Myeloproliferative Neoplasm • Rare Diseases • Thrombocytosis

Study to Evaluate the Effect of Rabeprazole Sodium Enteric-coated Tablets on the Pharmacokinetics of TQ05105 Tablets (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

New P1 trial • Myelofibrosis

A Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of TQ05105 Tablets in Subjects With Intermediate/High-risk Myelofibrosis (clinicaltrials.gov) - P2 | N=51 | Not yet recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

New P2 trial • Myelofibrosis • JAK2

To Evaluate the Pharmacokinetics and Safety of TQ05105 Tablet in Hepatic Impairment Subjects (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatology • Myelofibrosis

To Evaluate the Pharmacokinetics and Safety of TQ05105 Tablet in Hepatic Impairment Subjects (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

New P1 trial • Hepatology • Myelofibrosis

Experimental JAK inhibitors: the current, present and future in graft-versus-host disease management? (PubMed, Expert Opin Investig Drugs) - "We evaluate the efficacy and safety of selective and nonselective agents, including ruxolitinib, baricitinib, itacitinib, pacritinib, and rovadicitinib. We anticipate a transition from the current 'steroid-first' paradigm to risk-stratified algorithms utilizing biomarker profiling and novel combination strategies. While ruxolitinib is the current cornerstone, the development of highly selective inhibitors and the resolution of financial access barriers will be crucial for establishing JAK inhibitors as the frontline standard of care over the next decade."

Journal • Review • Acute Graft versus Host Disease • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology • Transplantation

Sino Biopharmaceutical…announces that the rovadicitinib tablet…has been approved by the National Medical Products Administration (NMPA) of China for marketing (HKEXnews) - "It is indicated for the first-line treatment of adult patients with intermediate-2 or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF) or post-essential thrombocythemia myelofibrosis (PET-MF)....In a multicenter, randomized, double-blind, double-simulation, positive drug-parallel controlled Phase II clinical study (TQ05105-II-01), rovadicitinib demonstrated superior efficacy and showed a favorable safety profile compared to hydroxyurea in treating patients with intermediate-2 or high-risk myelofibrosis."

China approval • Myelofibrosis

Sanofi strikes $1.5B global licensing deal for Sino Biopharm's first-in-class JAK/ROCK asset (Fierce Pharma) - "Sanofi will pay $135 million upfront to Sino Biopharm’s subsidiary Chia Tai Tianqing Pharmaceutical to bag exclusive rights to the Chinese company’s rovadicitinib...Beyond the initial payment, Sanofi has pledged up to $1.395 billion in potential development, regulatory and sales milestones as well as up to double-digit tiered royalties based on net sales of rovadicitinib."

Licensing / partnership • Chronic Graft versus Host Disease • Myelofibrosis

Optimal Treatment of Steroid-refractory Chronic Graft-versus-host Disease (cGvHD) in the Era of Novel drugs - a Systematic Review and Meta-analysis. (PubMed, Stem Cell Rev Rep) - "The analyzed treatment options included: axatilimab, belumosudil, extracorporeal photopheresis (ECP), ibrutinib, imatinib, rovadicitinib, and ruxolitinib. The analysis of imatinib yielded inconsistent results. As cGvHD is a disease with a heterogeneous clinical image, clinical experience remains an important factor that affects treatment choice for patients with certain disease manifestations."

Journal • Retrospective data • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology

A Clinical Trial of TQ05105 Tablets Combined With TQB3909 Tablets in the Treatment of Myelofibrosis (MF) (clinicaltrials.gov) - P1/2 | N=21 | Terminated | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | N=93 ➔ 21 | Trial completion date: May 2027 ➔ Dec 2025 | Recruiting ➔ Terminated | Trial primary completion date: Jun 2026 ➔ Dec 2025; Per sponsor request. Premature closure was not prompted by any safety or efficacy concerns.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Myelofibrosis

A Clinical Trial of Mass Balance of [14C] TQ05105 in Healthy Chinese Subjects (clinicaltrials.gov) - P1 | N=6 | Completed | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

New P1 trial

TQ05105-Ⅱ-01: A Clinical Trial of TQ05105 Tablets in the Treatment of Moderate and High Risk Myelofibrosis (clinicaltrials.gov) - P2 | N=107 | Active, not recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Recruiting ➔ Active, not recruiting | Trial completion date: Sep 2023 ➔ Feb 2026

Enrollment closed • Trial completion date • Myelofibrosis • JAK2

A Study to Evaluate Drug-Drug Interaction of TQ05105 Tablets (clinicaltrials.gov) - P1 | N=40 | Completed | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Not yet recruiting ➔ Completed

Trial completion • Myelofibrosis

Safety and efficacy of the JAK/rock inhibitor rovadicitinib in combination with the bromodomain and extra-terminal inhibitor TQB3617 in patients with myelofibrosis: A phase ib/II study (ASH 2025) - P1, P1/2, P2 | "Rovadicitinib in combination with TQB3617 was generally safe, well-tolerated, and showed clinical activityin pts with MF who were either JAKi-naïve or had a suboptimal response to JAKi treatment. This regimenmay represent a new treatment option for such patients with MF. A phase III study is currently beingplanned in pts with MF who had a suboptimal response to JAKi treatment."

Clinical • Combination therapy • P1/2 data • Hematological Disorders • Hematological Malignancies • Lymphoma • Myelofibrosis • CALR • HEY1 • JAK2