A Phase I Clinical Study on Dose Escalation Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Subcutaneous Dose of AK139 in Healthy Subjects.

This is a phase I clinical study on dose escalation evaluating the safety, tolerability, PK and PD of a single dose of AK139 administered subcutaneously in healthy subjects.

Start Date06 May 2025

Sponsor / Collaborator

Akeso Biopharma Co., Ltd.

NCT06378697

/ RecruitingPhase 3

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of AK111 in the Treatment of Subjects With Active Ankylosing Spondylitis

This is a randomized, double-blind, placebo-controlled, multi-center phase III clinical study to evaluate the efficacy and safety of AK111 in the treatment of subjects with active ankylosing spondylitis.

Start Date10 Nov 2023

Sponsor / Collaborator

Akeso Biopharma Co., Ltd.

NCT06061471

/ CompletedPhase 2

A Randomized, Double-blind, Phase II Clinical Study to Evaluate the Efficacy and Safety of AK111 in the Treatment of Subjects With Moderate to Severe Plaque Psoriasis

This is a randomized, double-blind phase II clinical study to evaluate the efficacy and safety of AK111 in the treatment of subjects with moderate to severe plaque psoriasis.

Start Date22 Sep 2023

Sponsor / Collaborator

Akeso Biopharma Co., Ltd.

100 Clinical Results associated with Gumokimab

100 Translational Medicine associated with Gumokimab

100 Patents (Medical) associated with Gumokimab

Literatures (Medical) associated with Gumokimab

01 May 2025·AMERICAN JOURNAL OF CLINICAL DERMATOLOGY

Next-Generation Anti-IL-17 Agents for Psoriatic Disease: A Pipeline Review

Review

Author: Kim, Dahyeon ; Wu, Jashin J ; Babaei, Nickoulet ; Cervantes, Mireya ; Gill, Minka ; Yang, Seanna

Innovations in biologics are transforming the treatment of psoriatic diseases. The ability to target specific levels of immune activation provides a distinct advantage. Interleukin (IL)-17 inhibitors fall into this class of biologics, and they are effectively used to treat a spectrum of psoriatic diseases, such as psoriasis vulgaris and psoriatic arthritis. In recent years, anti-IL-17 agents have been the focus of therapeutic development, with various formulations and routes of administration. In this manuscript, we review pipeline anti-IL-17 therapies for psoriatic diseases identified through a search of ClinicalTrials.gov (January 2019-December 2024) and other databases. Key agents under investigation include netakimab, vunakizumab, xeligekimab, gumokimab, HB0017, CJM 112, JS005, 608, LZM012, ZL-1102, izokibep, sonelokimab, DC-806, DC-853, and LEO 153339. Both preclinical and clinical trial data for each agent are summarized, with an emphasis on their efficacy, adverse effects, immunogenicity, and future outlooks.

01 Feb 2023·Dermatology and therapy

Efficacy, Safety and Pharmacokinetics of IL-17 Monoclonal Antibody Injection (AK111) in Patients with Moderate-to-Severe Plaque Psoriasis: A Randomized, Double-Blinded, Placebo-Controlled Phase Ib Multidose Escalation Clinical Study

Article

Author: Xia, Yu ; Jin, Hongzhong ; Li, Baiyong ; Jiang, Congjun ; Wang, Guoqin ; He, Zhimei ; Zhang, Wenhui ; Deng, Liehua ; Ni, Xiang ; Zhang, Wanlu ; Chen, Benchao ; Zhou, Huan ; Chen, Rui ; Zhang, Min

OBJECTIVES:

To evaluate the safety, tolerability, immunogenicity, and induced expression of skin biomarkers of AK111 injection after multiple administrations in subjects with moderate-to-severe plaque psoriasis.

METHODS:

This study is a randomized, double-blinded, placebo-parallel-controlled study using a dose escalation mode of multiple doses. A total of 48 subjects were sequentially randomized to receive each AK111 dose regimen (75 mg, 150 mg, 300 mg, 450 mg) or the corresponding placebo. All subjects were treated with the study drug at weeks 0, 1, 4, and 8 and were unblinded at week 12, with the placebo group ending and the AK111 group being followed up to 20 weeks.

RESULTS:

At week 12, compared with placebo, the percentage of subjects achieving Psoriasis Area and Severity Index 75 (PASI75) and static Physician Global Assessment (sPGA) 0/1 in the AK111 75 mg-450 mg dose groups was significantly increased, and higher PASI90 was achieved in the 150 mg, 300 mg, and 450 mg dose groups than in the 75 mg group. All efficacy indicators were maintained at week 20. The incidence of treatment-emergent anti-drug antibodies (ADAs) was 0% (0/48). Neutralizing antibodies (NAbs) were not detected in any subject. The proportion of subjects who reported any treatment-emergent adverse event (TEAE) was 75.0% in the AK111 group, similar to the 66.7% in the placebo group. The most commonly reported adverse events were hyperglycemia, elevated blood pressure, and hypokalemia. The AK111 pharmacokinetics showed approximate dose proportionality with regard to the maximum observed concentration (C_max) and area under the curve from 0 to the time of the last quantifiable concentration (AUC_0-t) following subcutaneous injection doses of 150-450 mg.

CONCLUSIONS:

After moderate-to-severe plaque psoriasis subjects received multiple subcutaneous AK111 injections of 150-450 mg, AK111 exposure increased in a roughly dose-proportional relationship. AK111 was safe and tolerable. In subjects with moderate-to-severe plaque psoriasis, AK111 demonstrated encouraging preliminary efficacy, which was sustained for a relatively long time after the last dose administration.

CLINICAL TRIAL REGISTRATION:

The clinical trial identification number is NCT05504317.

Frontiers in pharmacology

Population pharmacokinetic/pharmacodynamic analysis of AK111, an IL-17A monoclonal antibody, in subjects with moderate-to-severe plaque psoriasis

Article

Author: Ni, Xiang ; Chen, Benchao ; He, Zhimei ; Hu, Pei ; Wang, Max ; Li, Baiyong ; Qiao, Ju ; Wang, Guoqin ; Li, Qian ; Chen, Rui ; Jin, Hongzhong ; Xia, Michelle

AK111 is an innovative IL-17A antibody, presenting high affinity to IL-17A and showing similar pharmacokinetic (PK) characteristics to those of typical immunoglobulin (Ig) G1 antibodies. To optimize the dosage regimen for phase 2/3 clinical trials, PK and pharmacodynamics (PD) of AK111 were first characterized in Chinese moderate-to-severe plaque psoriasis patients in a phase 1b study. AK111 PK serum sample and Psoriasis Area and Severity Index (PASI) score data were collected from 48 moderate-to-severe psoriasis patients in this study. Non-linear mixed-effects modeling was used for the population PK/PD analysis. A one-compartment model with a first-order absorption and a first-order elimination best described the PK behavior of AK111. The apparent systemic clearance was 0.182 L/day, and the central volume was 6.65 L. The exposure–response relationship was characterized using an indirect response model. The pharmacological effect of AK111 was described in the form of inhibiting the formation of psoriatic plaque, whereas placebo was quantified in the form of promoting the degradation of psoriatic skin lesions. The maximum effect of drug effect (Imax) and placebo effect (PLBmax) was 1 and 0.429, respectively. The rate constant for psoriatic plaque production (Kin) was 0.474 PASI/day and psoriatic plaque loss (Kout) was 0.024 day−1. The body surface area (BSA) affected by psoriasis was identified as a significant covariate on Kout. The simulation results confirmed that all of the predicted PASI90 response rates at week 12 were higher than 60% at 150 and 300 mg dose levels with different regimens and could reach higher than 80% at week 24. We hope this first PK/PD study of AK111 in Chinese moderate-to-severe plaque psoriasis patients will be of help in the further clinical development of AK111 and provide a reference to the dosage optimization for similar antibodies with a long half-life.

News (Medical) associated with Gumokimab

19 Jan 2026

·www.prnewswire.com

Akeso Announces NMPA Acceptance of Second NDA for Gumokimab (IL-17A Inhibitor) in Active Ankylosing Spondylitis

HONG KONG, Jan. 19, 2026 /PRNewswire/ -- Akeso, Inc. (9926.HK) announced that its supplemental New Drug Application (sNDA) for gumokimab (AK111), a novel humanized anti-IL-17A monoclonal antibody for the treatment of active ankylosing spondylitis (AS), has been accepted for review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). There are approximately 4 million AS patients in China, and gumokimab represents a potentially promising new therapeutic option for this disease. Active ankylosing spondylitis (AS) is the second indication for which gumokimab has gained acceptance for NDA review. The application for its use in treating moderate-to-severe psoriasis was previously accepted by the CDE in January 2025. Gumokimab is Akeso's third non-oncology drug candidate to enter the regulatory review phase, following ebronucimab (PCSK9 monoclonal antibody) and ebdarokimab (IL-12/lL-23 monoclonal antibody). Recent notable progress from Akeso's non-oncology franchise includes the market launch and NRDL inclusion of both ebronucimab and ebdarokimab, and the steady advancement of gumokimab and manfidokimab (IL-4R monoclonal antibody) towards commercialization. These commercial and late stage developments are coupled with world-class innovation highlighted by the entry into clinical studies by AK139, Akeso's first-in-class IL-4Rα/ST2 bispecific antibody for immunological indications, and by AK152, Akeso's potential best-in-class bispecific candidate for neurodegeneration. The NDA acceptance for gumokimab is based on the positive results from its pivotal Phase III clinical trial in the treatment of AS, AK111-303. This study demonstrated that gumokimab offers effective and swift alleviation of AS symptoms, significantly improves patients's activity, physical function, and quality of life. In the study, gumokimab successfully met all pre-specified efficacy endpoints in individuals with active ankylosing spondylitis. The primary endpoint (ASAS20 response rate) showed consistent improvements across all subgroup analyses. The key secondary endpoint (ASAS40 response rate), and several other predefined secondary endpoints all reflected statistically significant and clinically meaningful outcomes. Forward-Looking Statement of Akeso, Inc. This announcement by Akeso, Inc. (9926.HK, "Akeso") contains "forward-looking statements". These statements reflect the current beliefs and expectations of Akeso's management and are subject to significant risks and uncertainties. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso. There can be no assurance that the drug candidate(s) indicated in this announcement or Akeso's other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in P.R.China, the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Akeso's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law. About Akeso Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 26 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new drugs are commercially available. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise. For more information, please visit and follow us on Linkedin. SOURCE Akeso, Inc. 21% more press release views with Request a Demo

Phase 3NDAClinical ResultDrug Approval

08 Sep 2025

·www.fiercebiotech.com

Junshi heralds phase 3 psoriasis win for IL-17 drug, prepares push to Chinese regulators

Professor Jianzhong Zhang, M.D., from the Peking University People’s Hospital—who led the study—claimed that “traditional treatments” for psoriasis “remain limited.”\n Junshi Biosciences has announced that its IL-17 antibody hit the goals of a phase 3 psoriasis trial in China, setting up the biopharma to seek national approval.The Shanghai-headquartered company evaluated the anti-IL-17A monoclonal antibody, dubbed JS005, in a placebo-controlled study of patients with moderate to severe plaque psoriasis across 60 sites in China. IL-17A plays a major role in driving excess skin cell proliferation and activation in psoriasis.The trial showed that JS005 resulted in a statistically significant and clinically meaningful improvement in the proportion of patients who achieved at least a 90% improvement in their Psoriasis Area and Severity Index (PASI 90) score compared to placebo, while the proportion of patients whose skin was deemed “clear” or “almost clear” was “significantly higher” in the JS005 group than in the placebo cohort, Junshi said in a Sept. 7 release. It means the study hit its co-primary as well as secondary endpoints, according to the biopharma. The drug also showed a good safety profile, the company added.With Junshi holding back any detailed data for a future medical conference, it’s not clear how JS005 performed in comparison to FDA-approved anti-IL-17 antibodies for psoriasis such as Novartis’ Cosentyx, UCB’s Bimzelx and Eli Lilly’s Taltz.Professor Jianzhong Zhang, M.D., from the Peking University People’s Hospital—who led the study—claimed that “traditional treatments” for psoriasis “remain limited.”“Results demonstrate JS005’s superior efficacy in achieving deep symptom remission, sustained therapeutic effects, and improved quality of life,” he added. “We hope this therapy will soon benefit millions of patients, further advancing China’s psoriasis treatment landscape.” Junshi CEO Jianjun Zou, M.D., Ph.D., said hitting the primary endpoints “not only brings new hope to patients with moderate-to-severe psoriasis but also marks our innovation breakthrough in the autoimmune field.”“Moving forward, we will actively collaborate with regulators to accelerate the availability of this innovative therapy, ensuring earlier patient access,” the CEO added.The company—with approved drugs including the PD-1 checkpoint inhibitor Loqtorzi—is also evaluating JS005 in a phase 2 study for another inflammatory disease called ankylosing spondylitis.Chinese regulators are currently mulling a psoriasis approval application for another IL-17A monoclonal antibody in the form of Akeso Biopharma’s gumokimab. The Hong Kong-based company said its phase 3 data last year demonstrated “superior outcomes” in a phase 3 psoriasis trial.

Clinical ResultPhase 3Phase 2

29 Aug 2025

·www.fiercepharma.com

Fierce Pharma Asia—Ivonescimab's survival win; Fosun, Sitala's $670M deal; HutchMed's acting CEO

The first overall survival win for a PD-1xVEGF drug, Fosun Pharma's immune disease deal with Sitala Bio and Hutchmed's acting CEO appointment made our news this week. Akeso and Summit Therapeutics' PD-1xVEGF drug has delivered its first overall survival win in a phase 3 trial. Fosun Pharma out-licensed another immune disease candidate. Hutchmed's CEO took medical leave. And more.1. Akeso, Summit's PD-1xVEGF drug meets overall survival goal for the first time in a lung cancer trialFor the first time, Akeso and Summit Therapeutics’ ivonescimab has hit the overall survival goal in a phase 3 trial. The study, HARMONi-A, tested the PD-1xVEGF drug alongside chemo in patients with previously treated EGFR-mutated nonsquamous non-small cell lung cancer in China. The success of the trial increases the chances that its global version, HARMONi, could meet its overall survival goal, too, Evercore ISI analysts said.2. Sitala, backed by Forbion and OrbiMed, seals $670M deal for Fosun immune disease drugFosun Pharma has signed its second immune-related disease deal in about two weeks. For up to $670 million, the Chinese biopharma is granting Britain’s Sitala Bio ex-China rights to its drug coded FXS6837. Existing therapies for the candidate’s targeted indications generated $3.8 billion in global revenue last year, Fosun said, citing IQVIA data.3. Hutchmed names interim chief as CEO Weiguo Su takes medical leaveHutchmed CEO Weiguo Su, Ph.D., is taking a leave of absence due to health reasons, the company said Monday. The firm’s chief financial officer Johnny Cheng has been named acting CEO to oversee day-to-day operations and management of the company. “This has been a very difficult decision to make, but at this time my focus must be on my health,” Su said in a statement.4. Akeso scores twice in pair of phase 3 trials, teeing up regulatory submission in ChinaAkeso is more than just an oncology company. The company just recorded two positive phase 3 readouts for two of its inflammatory disease candidates. The two drugs, the anti-IL-17A agent gumokimab and the anti-IL-4Rα med manfidokimab, were successful in their respective Chinese trials in active ankylosing spondylitis and atopic dermatitis. Akeso is now planning regulatory submissions in China.5. RemeGen and Vor score again with telitacicept, this time in IgA nephropathyRemeGen’s telitacicept has pulled off another China phase 3 win. The IgA nephropathy study met its primary endpoint, linking the BLyS/APRIL dual-target agent to a 55% reduction in 24-hour urine protein-to-creatinine ratio at 39 weeks compared with placebo. RemeGen recently partnered with Vor Bio on the drug outside of China.Other News of Note:6. Nippon Kayaku, Formiica, CBC form Singapore JV to license drugs in Asia (release)7. Nasdaq-listed LakeShore receives buyout offer from investment consortium (release)8. Chinese CRO ChemPartner gets ready to debut new Boston research facility

Phase 3Executive ChangeAcquisitionClinical ResultBiosimilar

100 Deals associated with Gumokimab

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Ankylosing Spondylitis	NDA/BLA	China	Akeso Pharmaceuticals, Inc.	16 Jan 2026
Psoriasis	NDA/BLA	China	Akeso Biopharma Co., Ltd.	27 Jan 2025
Plaque psoriasis	Phase 3	China	Akeso Biopharma Co., Ltd.	31 Mar 2023
Axial Spondyloarthritis	Phase 2	China	Akeso Biopharma Co., Ltd.	07 Jun 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06378697 (NEWS) Manual	Phase 3	Ankylosing Spondylitis	-	AK111	htjpgigaiv(cweqrjlldm) = 具有统计学显著性和临床意义的改善。 fdtpdowari (bqqapofqud ) Met View more	Positive	21 Aug 2025
				Placebo + AK111
NCT06066125 (AK111-301, NEWS) Manual	Phase 3	Plaque psoriasis	-	古莫奇单抗	czfbrzntno(pioezgllrh) = kfoktrqhfk klnynohuij (swyiztkidd ) View more	Positive	28 Oct 2024
				Placebo	-
NCT05096364 (NEWS) Manual	Phase 2	Plaque psoriasis	250	古莫奇 300mg (W0/1/3/4 + 第1组)	tspenojpcu(zrnzcvvlvl) = vmaleundnw ifvnkhpsee (vnopodvjir ) View more	Positive	02 Oct 2024
				古莫奇 300mg (W0/2/4/6/8 + 第2组)	tspenojpcu(zrnzcvvlvl) = sxipvcfxfo ifvnkhpsee (vnopodvjir ) View more
NEWS Manual	Phase 3	Psoriasis	-	AK111	hsatcsxplo(hjkwkstbuv) = 与对照组相比,显著提高达到PASI 75的患者比例 rytvvsgcuw (ydudegzdcy ) View more	Positive	02 Dec 2023
				placebo
AAI2023	Phase 2	Ankylosing Spondylitis IL-17A	120	AK111 75mg	kwlceckmos(qrycjoroov) = yknzedpyro zugknjijva (nyamsehmug ) View more	Positive	01 May 2023
				AK111 150mg	kwlceckmos(qrycjoroov) = fdgdtomggj zugknjijva (nyamsehmug ) View more

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