zemprocitinib (LNK01001) / Lynk Pharmaceuticals, Simcere - LARVOL DELTA

Lynk Pharmaceuticals Completes Phase III Enrolment for Zemprocitinib in Ankylosing Spondylitis (BioPharma APAC) - "The Phase III study is a randomized, double-blind, placebo-controlled, multicenter clinical trial designed to evaluate the efficacy and safety of zemprocitinib in patients with active ankylosing spondylitis. The primary endpoint is the proportion of patients achieving an Assessment of SpondyloArthritis international Society 40% response (ASAS40) at Week 16. A total of 352 patients have now been enrolled, and the study is proceeding as planned with ongoing treatment, follow-up, and data collection."

Enrollment closed • Ankylosing Spondylitis • Immunology

A Randomized Double-Blind Placebo-controlled Phase III Clinical Trial Evaluating the Efficacy and Safety of LNK01001 (zemprocitinib) in Patient with Moderate-to-Severe Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Biologic Disease-Modifying Antirheumatic Drugs (COURAGE-RA) (EULAR 2026) - P3 | "Background csDMARD use, including methotrexate (74.4% vs 74.3%), and baseline corticosteroid use (34.0% vs 41.1%) were comparable between groups...Conclusions The COURAGE-RA study demonstrated that zemprocitinib achieved rapid efficacy as early as Week 2, with benefits sustained through Week 24 and a manageable safety profile, in patients with moderate-to-severe RA who had an inadequate response to prior bDMARDs. These results support zemprocitinib as a promising oral treatment option for this difficult-to-treat population."

Clinical • P3 data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • JAK1 • JAK3

A Phase 3 Study of LNK01001 Capsule in Subjects With Moderate to Severe Atopic Dermatitis. (clinicaltrials.gov) - P3 | N=356 | Completed | Sponsor: Lynk Pharmaceuticals Co., Ltd | Trial primary completion date: Sep 2025 ➔ Apr 2025 | Active, not recruiting ➔ Completed

Trial completion • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Lynk Pharmaceuticals…announced that the New Drug Application (NDA) for its core product, zemprocitinib capsules, for the treatment of moderate-to-severe atopic dermatitis (AD), has been formally accepted by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) (Yahoo Finance) - "The NDA submission is primarily supported by positive results from a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial (NCT06277245) conducted in China."

China filing • Atopic Dermatitis

Lynk Pharmaceuticals Announces Positive Phase III Topline Data of Zemprocitinib in Moderate-to-Severe Atopic Dermatitis (PRNewswire) - "The study met all co-primary and key secondary endpoints, with both dose groups demonstrating highly and statistically significant improvements versus placebo....Full study data are undergoing further analysis and will be published at a future date....At Week 16, both zemprocitinib dose groups demonstrated statistically significant superiority over placebo across both co-primary endpoints and the key secondary endpoint: EASI-75: Differences versus placebo were 38.1% (12 mg) and 46.4% (24 mg) (p < 0.0001). vIGA-AD 0/1 response: Improvements over placebo were 30.3% (12 mg) and 31.0% (24 mg) (p < 0.0001). WI-NRS4 response rates were 31.3% (12 mg) and 31.0% (24 mg) higher than placebo at Week 16 (p < 0.0001)."

P3 data: top line • Atopic Dermatitis

Lynk Pharmaceuticals Announces Positive Phase III Topline Data of Zemprocitinib (LNK01001) in Rheumatoid Arthritis (PRNewswire) - "The primary endpoint was the proportion of patients achieving an ACR20 response at Week 24, with key secondary endpoints including the proportion of patients achieving ACR50 and DAS28 (CRP) ≤ 3.2 at Week 24...Specifically, the ACR20 response rates at Week 12 and Week 24 vs. PBO were 74.0% versus 29.9% (P < 0.0001) and 79.1% versus 39.7% (P < 0.0001), respectively. The ACR50 response rates at Week 12 and Week 24 vs. PBO were 41.4% versus 9.3% (P < 0.0001) and 55.8% versus 22.0% (P < 0.0001), respectively....The primary results of this study are planned to be formally presented at an upcoming international scientific conference."

P3 data: top line • Rheumatoid Arthritis

AS: A Study to Evaluate Efficacy and Safety of LNK01001 in Adults With Ankylosing Spondylitis (clinicaltrials.gov) - P3 | N=352 | Recruiting | Sponsor: Lynk Pharmaceuticals Co., Ltd

New P3 trial • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies

A Phase 3 Study of LNK01001 Capsule in Subjects With Moderate to Severe Atopic Dermatitis. (clinicaltrials.gov) - P3 | N=354 | Active, not recruiting | Sponsor: Lynk Pharmaceuticals Co., Ltd | Recruiting ➔ Active, not recruiting

Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study of LNK01001 Capsule in Subjects With Active Rheumatoid Arthritis (clinicaltrials.gov) - P3 | N=430 | Active, not recruiting | Sponsor: Lynk Pharmaceuticals Co., Ltd | Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Efficacy and Safety of LNK01001, a Highly Selective Janus Kinase 1 Inhibitor, in Chinese Patients with Moderate to Severe Atopic Dermatitis: Results from a, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study (EADV 2024) - "LNK01001 at doses of 12 mg bid and 24 mg bid resulted in greater improvements of AD than placebo and was generally safe and well-tolerated in Chinese adult patients with moderate to severe atopic dermatitis. Larger and longer-duration trials are required to determine the durability of its effects and longer-term safety in AD patients. Figure."

Clinical • P2 data • Atopic Dermatitis • Cardiovascular • Dermatitis • Dermatology • Hematological Disorders • Immunology • Oncology • Thrombosis • JAK2 • JAK3 • TYK2

A Phase 3 Study of LNK01001 Capsule in Subjects With Moderate to Severe Atopic Dermatitis. (clinicaltrials.gov) - P3 | N=354 | Recruiting | Sponsor: Lynk Pharmaceuticals Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Lynk Pharmaceuticals Announces First Atopic Dermatitis Patient Dosed in Phase III Clinical Study of LNK01001 (PRNewswire-Asia) - "Lynk Pharmaceuticals...announced that it has dosed the first patient with Atopic Dermatitis (AD) in a Phase III clinical trial of its highly selective JAK1 inhibitor LNK01001. This clinical study is a randomized, double-blind, placebo-controlled Phase III clinical trial evaluating the efficacy and safety of LNK01001 in adult patients with moderate to severe Atopic Dermatitis (AD) in China."

Trial status • Atopic Dermatitis

A Phase 3 Study of LNK01001 Capsule in Subjects With Moderate to Severe Atopic Dermatitis. (clinicaltrials.gov) - P3 | N=354 | Not yet recruiting | Sponsor: Lynk Pharmaceuticals Co., Ltd

New P3 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Phase 3 Study of LNK01001 Capsule in Moderately to Severely Active Rheumatoid Arthritis (clinicaltrials.gov) - P3 | N=430 | Recruiting | Sponsor: Lynk Pharmaceuticals Co., Ltd

New P3 trial • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CRP

Lynk Pharmaceuticals Announced First Rheumatoid Arthritis Patient Dosed in Phase III Clinical Study of LNK01001 (PRNewswire-Asia) - "Lynk Pharmaceuticals...announced that it has dosed the first patient with Rheumatoid Arthritis (RA) in a Phase Ⅲ clinical trial of its highly selective JAK1 inhibitor LNK01001. The clinical study is a randomized, double-blind, placebo-controlled Phase III trial evaluating the efficacy and safety of LNK01001 in the treatment of moderate to severe active rheumatoid arthritis with inadequate response or intolerant to bDMARDs. The trial is led by Professor Xiaofeng Zeng from Peking Union Medical College Hospital and Chinese Academy of Medical Sciences."

Trial status • Rheumatoid Arthritis

Efficacy and Safety of LNK01001 in Chinese Patients with Moderate to Severe Active Rheumatoid Arthritis with an Inadequate Response to Conventional Synthetic DMARDs: 24-week Results from a Phase 2 Trial (ACR Convergence 2023) - "Treatment with LNK01001 12 mg or 24 mg BID up to 24 weeks in patients with moderate to severe active RA and an inadequate response to csDMARDs were generally safe, and well tolerated with most TEAEs being mild to moderate. Both doses were superior to placebo in reducing the severity of rheumatoid arthritis over a period of 12 weeks across multiple efficacy end points."

Clinical • Late-breaking abstract • P2 data • Cardiovascular • Dyslipidemia • Immunology • Infectious Disease • Inflammatory Arthritis • Oncology • Rheumatoid Arthritis • Rheumatology • Venous Thromboembolism

A Study of LNK01001 Capsule in Moderately to Severely Active Rheumatoid Arthritis (clinicaltrials.gov) - P2 | N=156 | Completed | Sponsor: Lynk Pharmaceuticals Co., Ltd

New P2 trial • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CRP

A Study of LNK01001 Capsule in Patients With Ankylosing Spondylitis (clinicaltrials.gov) - P2 | N=177 | Completed | Sponsor: Lynk Pharmaceuticals Co., Ltd

New P2 trial • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies

A Study of LNK01001 Capsule in Patients With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=150 | Completed | Sponsor: Lynk Pharmaceuticals Co., Ltd

New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Lynk Pharmaceuticals Announces Positive Topline Data from Phase II Clinical Trial of LNK01001 in the Treatment of Ankylosing Spondylitis (PRNewswire) - P2 | N=NA | "Lynk Pharmaceuticals Co., Ltd...announced positive topline data from a Phase II clinical trial of LNK01001 for the treatment of ankylosing spondylitis (AS)....Preliminary efficacy data indicates that after 12 weeks of treatment, both the high and low dose groups of LNK01001 showed a statistically significant difference in the proportion of patients achieving an ASAS40 response compared to the placebo group, reaching the primary endpoint. The improvement in other efficacy indicators is consistent with the primary endpoint. Moreover, LNK01001 demonstrated a rapid onset of action, with response rates for various efficacy endpoints in both the high and low dose groups of LNK01001 showing varying degrees of improvement starting from the second week."

P2 data • Ankylosing Spondylitis • Immunology

Lynk Pharmaceuticals Announced Positive Topline Data from Phase II Clinical Trial of LNK01001 in the Treatment of Atopic Dermatitis (PRNewswire) - P2 | "Lynk Pharmaceuticals Co., Ltd...announced positive topline data from a Phase II clinical trial of LNK01001 for the treatment of atopic dermatitis....Preliminary data showed that after 12 weeks of treatment, patients in both the high and low dose groups showed significant improvement, with a statistically significant difference in the percentage change from baseline in EASI score compared to the placebo group, achieving the primary endpoint. Additionally, the proportion of responders achieving EASI-75 (≥75% improvement from baseline in EASI score) and Investigator's Global Assessment (IGA) response were significantly higher in both high and low dose groups of LNK01001 compared to the placebo group."

P2 data • Atopic Dermatitis • Dermatitis • Immunology

LYNK's LNK01001 Achieved Exciting Phase II Results in Rheumatoid Arthritis (PRNewswire) - P2 | N=156 | "Lynk Pharmaceuticals Co., Ltd...announced that the Phase II clinical trial of LNK01001 in the treatment of rheumatoid arthritis (RA) showed statistically significant differences in efficacy compared with placebo in both primary and key secondary efficacy endpoints, and demonstrated good safety and tolerability. The company has applied for the pre-Phase III meeting with Center for Drug Evaluation (CDE)....The study showed that both low dose and high dose groups of LNK01001 exceeded all projected primary and key secondary endpoints at week 12, showing statistically significant differences in efficacy compared with placebo; ACR20 rates of both low dose and high dose groups reached over 90% at week 24. Additionally, the overall safety and tolerability of the study drug was very good. The majority of TEAE were mild, there was no SAE reported in the active drug treatment groups."

Non-US regulatory • P2 data • Immunology • Rheumatoid Arthritis

EQRx Resets to Focus on Clinically Differentiated Medicines, Leveraging $1.3 Billion Cash Position; Reports First Quarter 2023 Financial Results (Yahoo News) - "EQRx is seeking commercialization partnerships for aumolertinib outside Greater China....EQRx has provided notice to Lynk Pharmaceuticals (Lynk) of its termination of the license agreement for EQ121. Lynk will regain rights for the research, development and commercialization of EQ121 outside Greater China."

Licensing / partnership • Ankylosing Spondylitis • Atopic Dermatitis • Dermatitis • Immunology • Inflammation • Inflammatory Arthritis • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Rheumatoid Arthritis • Rheumatology • Solid Tumor • Thoracic Cancer

"#LynkPharmaceuticals and #Simcere announced Strategic Commercialization Partnership upon novel #JAK1 #Inhibitor #LNK01001 https://t.co/FhA0BsdiWQ" (,@1stOncology)

Licensing / partnership • JAK1

Lynk Pharmaceuticals and Simcere announced Strategic Commercialization Partnership upon novel JAK1 inhibitor LNK01001 (PRNewswire) - "On March 18, 2022, Lynk Pharmaceuticals Co., Ltd...and Simcere...announced a strategic partnership to develop and commercialize a highly selective JAK1 inhibitor LNK01001 in China....Under the terms of the agreement, Lynk Pharmaceuticals is responsible for the development of the product. Simcere will obtain the exclusive rights to market LNK01001 for the indications of rheumatoid arthritis and ankylosing spondylitis in China, after completing the payment of all commercialization rights and interests."

Licensing / partnership • Ankylosing Spondylitis • Immunology • Rheumatoid Arthritis