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

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

BCL-2 inhibitor TQB3909 combined with JAK inhibitors in patients with intermediate- or high-risk myelofibrosis: A two-cohort, open-label, Phase ib/II, multicenter study (ASH 2025) - P1/2 | "Previous studies of BCL-2 inhibitor plus ruxolitinib (RUX) have shown improved efficacycompared to JAKi monotherapy...Palpable splenomegaly (≥5 cm below LCM) or spleen volume ≥450 cm³ (MRI/CT) was required.Pts received either RUX or rovadicitinib (ROV) combined with TQB3909 based on investigator discretion.Dose escalation of TQB3909 (100 mg, 200 mg, 300 mg QD) was first explored in the RUX cohort, followedby a 3+3 dose-escalation design in the ROV cohort (10mg, 15 mg bid)... TQB3909 combined with JAKi demonstrated meaningful clinical activity in MF pts,particularly in combination with ROV, showing spleen reduction, symptom improvement, and potentialanemia benefit. However, TQB3909+ROV is associated with hematologic toxicities, and dose optimizationis ongoing to balance efficacy and tolerability. Acknowledgement: This research was funded by the Zhejiang Provincial Health High-level InnovativeTalent Project (2022-2026)."

Clinical • IO biomarker • P1/2 data • Infectious Disease • Myelofibrosis • Thrombocytopenia • BCL2L1 • MCL1

A Study of TQ05105 Tablets in Subjects With Glucocorticoid-Refractory Acute Graft-Versus-Host Disease (aGVHD) (clinicaltrials.gov) - P1/2 | N=13 | Completed | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Active, not recruiting ➔ Completed

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

A Study of TQ05105 in Patients With Chronic Graft Versus Host Disease (clinicaltrials.gov) - P1/2 | N=45 | Active, not recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Trial completion date: Dec 2024 ➔ Dec 2026

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

JAK/Rock Inhibitor Rovadicitinib for Glucocorticoid-Refractory or -Dependent Chronic Graft-Versus-Host Disease:Updated Results of Multicenter, Phase 1b/2a Trial (ASH 2024) - P1/2 | "The BOR was 83.3% in patients prior to ruxolitinib therapy. Conclusion : Rovadicitinib was well tolerated in patients with cGVHD, eliciting a high rate of clinical response, improved quality of life, and CS dose reduction. Rovadicitinib may be effective in patients with glucocorticoid-refractory or -dependent cGVHD, and a phase 3 randomized study for registration will be launched soon."

Clinical • P1/2 data • Anemia • Chronic Graft versus Host Disease • Epstein-Barr Virus Infections • Fibrosis • Gastrointestinal Disorder • Graft versus Host Disease • Hematological Disorders • Immunology • Infectious Disease • Leukopenia • Neutropenia • Pneumonia • Respiratory Diseases • Thrombocytosis • JAK1 • JAK2

First-in-Class JAK/Rock Inhibitor Rovadicitinib in Myeloproliferative Neoplasms: A Single Arm, Multicenter, Open-Label, Phase I/Ib Study (ASH 2023) - P1, P2 | "Rovadicitinib was generally safe, well-tolerated and showed meaningful clinical activity in patients with MF, especially with palpable splenomegaly. Rovadicitinib may be a new treatment option for myelofibrosis patients. Furthermore, a randomized double-blind phase 2 study is ongoing, aiming to assess the efficacy and safety of rovadicitinib compared to hydroxyurea in patients with intermediate-2 or high-risk myelofibrosis in China (NCT05020652)."

Clinical • P1 data • Anemia • Myelofibrosis • Myeloproliferative Neoplasm • CALR • JAK2

Rovadicitinib in Patients with Hemophagocytic Lymphohistiocytosis: A Single Arm, Open-Label, Phase I Study (ASH 2024) - P1, P2 | "Rovadicitinib combined with glucocorticoid may be a new treatment option for patients with HLH unresponsive to glucocorticoid therapy. Meanwhile, a phase Ib/II study is ongoing, aiming to assess the efficacy and safety of rovadicitinib in patients with MAS unresponsive to glucocorticoid therapy."

Clinical • P1 data • Anemia • Hematological Disorders • Hematological Malignancies • Hemophagocytic lymphohistiocytosis • Immunology • Lymphoma • Myelofibrosis • Oncology • Rare Diseases • IL2RA

Rovadicitinib in Patients with Myelofibrosis Who Were Refractory or Relapsed or Intolerant to Ruxolitinib: A Single Arm, Multicenter, Open-Label, Phase Ib Study (ASH 2024) - P1, P1/2, P2 | "Rovadicitinib may be a new treatment option for those patients who failed ruxolitinib. Meanwhile, a phase Ib/II study is ongoing, aiming to assess the efficacy and safety of Rovadicitinib combined with TQB3617 (a novel oral BET inhibitor) in patients with myelofibrosis (NCT06122831)."

Clinical • P1 data • Anemia • Hematological Disorders • Infectious Disease • Myelofibrosis • Respiratory Diseases • CALR • JAK2

New molecules in the therapy of chronic graft-versus-host disease. (PubMed, Curr Opin Hematol) - "Expanding therapeutic options in cGvHD require decision-making based on organ involvement, prior therapy, and tolerability. Emerging compounds offer the potential to modulate chronic inflammation and fibrosis more precisely, supporting a move toward personalized and combinatorial approaches in advanced-line settings."

Journal • Chronic Graft versus Host Disease • Fibrosis • Graft versus Host Disease • Immunology • Inflammation • Transplantation

TQ05105 Tablet for Myelofibrosis Treatment in Ruxolitinib-Resistant or Intolerant Patients (clinicaltrials.gov) - P1 | N=9 | Terminated | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Trial completion date: Dec 2024 ➔ Aug 2025 | Active, not recruiting ➔ Terminated | Trial primary completion date: Dec 2024 ➔ Aug 2025; This study was closed due to business reasons. Closure was not prompted by any safety or efficacy concerns.

Trial completion date • Trial primary completion date • Trial termination • Myelofibrosis

To Evaluate the Pharmacokinetics and Safety of TQ05105 Tablet in Renal Impairment Subjects (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Not yet recruiting ➔ Completed | Trial primary completion date: Jul 2025 ➔ Mar 2025

Trial completion • Trial primary completion date • Myelofibrosis • Renal Disease

ROVADICITINIB TABLET “JAK/ROCK INHIBITOR” INCLUDED IN THE BREAKTHROUGH THERAPEUTIC DESIGNATION PROCESS (HKEXnews) - "The board of directors (the 'Board') of Sino Biopharmaceutical Limited (the 'Company', together with its subsidiaries, the 'Group') announces that Rovadicitinib Tablet 'TQ05105 (JAK/ROCK inhibitor)' independently developed by the Group has been included in the Breakthrough Therapeutic Designation (BTD) process by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China for the treatment of chronic graft-versus-host disease (cGVHD)....Currently, the Phase III clinical trial of rovadicitinib for the treatment of moderate to severe cGVHD is in the process of subject recruitment. The Group will accelerate the R&D of rovadicitinib globally to bring a better treatment solution to patients worldwide as soon as possible."

Breakthrough therapy • Trial status • Chronic Graft versus Host Disease

A First-in-Class JAK/ROCK Inhibitor, Rovadicitinib in Patients with Myelofibrosis who were Refractory or Relapsed or Intolerant to Ruxolitinib: A Single-Arm, Multicenter, Open-Label, Phase Ib Study. (PubMed, Eur J Pharmacol) - P1 | "This study suggests that patients with MF who are intolerant or resistant to Ruxolitinib or other JAK inhibitors might achieve significant clinical benefit after treatment with Rovadicitinib. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT06388759."

Journal • P1 data • Hematological Disorders • Myelofibrosis • Thrombocytopenia

PRECLINICAL…DATA ON ROVADICITINIB PRESENTED AT EHA 2025 (HKEXnews) - "The board of directors (the 'Board') of Sino Biopharmaceutical Limited...announces that the Group presented orally the results of preclinical...study of rovadicitinib for the treatment of acute graft-versus-host disease (aGVHD) at the 2025 European Hematology Association (EHA) Congress....Immunomodulatory mechanism of rovadicitinib: (i) Regulation of T cell subsets: It reduced the infiltration of pro-inflammatory Th1 and Tc1 cells in the small intestine of aGVHD mouse models while increasing the number of anti-inflammatory Treg cells, thereby improving the intestinal immune microenvironment; (ii) Inhibition of dendritic cell (DC) function: It downregulated the secretion of co-stimulatory molecules (CD80, CD86, CD40), chemokines (Cxcl9, Cxcl10), and IL-12, thereby weakening DC mediated T cell activation and differentiation."

Preclinical • Acute Graft versus Host Disease

EHA 2025 | Rovaxin Phase Ib data is amazing, which may rewrite the treatment pattern of hormone-resistant aGVHD [Google translation] (Sino Biopharm Press Release) - P1b | N=13 | NCT04941404 | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | "Recently, at the 30th European Hematology (EHA 2025) Congress, Sino Biopharmaceutical...announced the results of a Phase Ib clinical study of rovacitinib (JAK/ROCK dual pathway inhibitor, TQ05105) for acute graft-versus-host disease (aGVHD) in the form of an oral presentation....The single-arm, open, multicenter Phase Ib clinical trial of rovacitinib for the treatment of glucocorticoid-resistant aGVHD showed that for patients with hormone-resistant aGVHD, the overall remission rate reached 84% within 28 days, and the intestinal remission rate was as high as 80%, showing the characteristics of high response rate, rapid onset of action, and lasting remission. 38.5% of aGVHD patients completely stopped using glucocorticoids within 56 days , greatly reducing the side effects of long-term immunosuppression, and the 1-year survival rate was as high as 92.3%."

P1 data • Acute Graft versus Host Disease

JAK/ROCK INHIBITION WITH ROVADICITINIB SUPPRESSES MURINE AND HUMAN ACUTE GRAFT-VERSUS-HOST DISEASE: THE RESULTS OF PRECLINICAL AND PHASE 1B STUDY (EHA 2025) - P1/2 | "These data provide further evidence that rovadicitinib represents a new and potentially clinically approach to aGVHD in mice and humans."

P1 data • Preclinical • Acute Graft versus Host Disease • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Disorders • Immunology • Oncology • Pneumonia • Thrombocytopenia • CD80 • CD86 • IFNG • JAK1 • TNFA