An Open-label, Single-arm, Multi-center Study to Evaluate the Long-term Safety and Efficacy of AK101 Injection in Subjects With Moderate-to-severe Plaque Psoriasis

This is an open-label Phase III clinical study to evaluate the long-term safety and efficacy of AK101 injection in subjects with moderate-to-severe plaque psoriasis.

Start Date08 Apr 2022

Sponsor / Collaborator

Akeso Biopharma Co., Ltd.

CTR20220206

/ CompletedPhase 3

单臂、开放、多中心评价AK101注射液治疗中、重度斑块型银屑病受试者长期安全性和有效性临床研究

[Translation] A single-arm, open, multicenter clinical study to evaluate the long-term safety and efficacy of AK101 injection in the treatment of moderate to severe plaque psoriasis

主要目的：评价AK101注射液治疗中国中、重度斑块型银屑病受试者的长期安全性。次要目的：评估AK101注射液治疗中国中、重度斑块型银屑病受试者的长期有效性；评估AK101注射液治疗中国中、重度斑块型对银屑病受试者的长期生活质量的影响；评估AK101注射液治疗中国中、重度斑块型银屑病受试者的长期药代动力学（PK）和免疫原性（ADA）。

[Translation]

Primary objective: To evaluate the long-term safety of AK101 injection in the treatment of Chinese subjects with moderate to severe plaque psoriasis. Secondary objectives: To evaluate the long-term effectiveness of AK101 injection in the treatment of Chinese subjects with moderate to severe plaque psoriasis; To evaluate the effect of AK101 injection in the treatment of Chinese subjects with moderate to severe plaque psoriasis on the long-term quality of life; To evaluate the long-term pharmacokinetics (PK) and immunogenicity (ADA) of AK101 injection in the treatment of Chinese subjects with moderate to severe plaque psoriasis.

Start Date28 Mar 2022

Sponsor / Collaborator

Akeso Biopharma Co., Ltd.

NCT05120297

/ CompletedPhase 3

A Study to Evaluate the Efficacy and Safety of AK101 in Subjects With Moderate-to-severe Plaque Psoriasis

This is a randomized, double-blind, placebo-controlled, multicentered phase III clinical study to evaluate the efficacy and safety of AK101 in the treatment of subjects with moderate-to-severe plaque psoriasis.

Start Date29 Nov 2021

Sponsor / Collaborator

Akeso Biopharma Co., Ltd.

100 Clinical Results associated with Ebdarokimab

100 Translational Medicine associated with Ebdarokimab

100 Patents (Medical) associated with Ebdarokimab

Literatures (Medical) associated with Ebdarokimab

01 Sep 2024·CLINICAL RHEUMATOLOGY

Prioritizing drug targets in systemic lupus erythematosus from a genetic perspective: a druggable genome-wide Mendelian randomization study

Article

Author: Wu, Haiyang ; Lin, Zikai ; Xie, Yingying ; Gao, Yuan ; Chen, Fengzhen ; Peng, Chusheng ; Zhou, Youtao

Abstract:

Objectives:

Systemic lupus erythematosus (SLE) is a heterogeneous autoimmune disease with an unsatisfactory state of treatment. We aim to explore novel targets for SLE from a genetic standpoint.

Methods:

Cis-expression quantitative trait loci (eQTLs) for whole blood from 31,684 samples provided by the eQTLGen Consortium as well as two large SLE cohorts were utilized for screening and validating genes causally associated with SLE. Colocalization analysis was employed to further investigate whether changes in the expression of risk genes, as indicated by GWAS signals, influence the occurrence and development of SLE. Targets identified for drug development were evaluated for potential side effects using a phenome-wide association study (PheWAS). Based on the multiple databases, we explored the interactions between drugs and genes for drug prediction and the assessment of current medications.

Results:

The analysis comprised 5427 druggable genes in total. The two-sample Mendelian randomization (MR) in the discovery phase identified 20 genes causally associated with SLE and validated 8 genes in the replication phase. Colocalization analysis ultimately identified five genes (BLK, HIST1H3H, HSPA1A, IL12A, NEU1) with PPH4 > 0.8. PheWAS further indicated that drugs acting on BLK and IL12A are less likely to have potential side effects, while HSPA1A and NEU1 were associated with other traits. Four genes (BLK, HSPA1A, IL12A, NEU1) have been targeted for drug development in autoimmune diseases and other conditions.

Conclusions:

.This study identified five genes as therapeutic targets for SLE. Repurposing and developing drugs targeting these genes is anticipated to improve the existing treatment state for SLE. Key Points• We identified five gene targets of priority for the treatment of SLE, with BLK and IL12A indicating fewer side effects.• Among the existing drugs that target these candidate genes, Ustekinumab, Ebdarokimab, and Briakinumab (targeting the IL12 gene) and CD24FC (targeting HSPA1A) may potentially be repurposed for the treatment of SLE.

News (Medical) associated with Ebdarokimab

30 Mar 2025

·www.prnewswire.com

Akeso's 2024 Results: Strengthening Global Competitiveness and Transforming the Treatment Landscape with Bispecific Antibodies

Key Highlights: Global first "immuno + anti-vascular" bispecific antibody approved: ivonescimab for EGFR-TKI resistant nsq-NSCLC. Phase III HARMONi study topline data expected mid-2025 (FDA FTD). ivonescimab outperforms pembrolizumab in Phase III study for first-line PD-L1+ NSCLC: mPFS HR=0.51; sNDA under priority review. Cadonilimab approved for first-line gastric cancer: Fills immunotherapy gap for patients with low or negative PD-L1 expression. Cadonilimab's sNDA for first-line cervical cancer accepted by NMPA. New commercial milestones: cadonilimab and ivonescimab added to the National Reimbursement Drug List (NRDL). AK117 (CD47) enters Phase III trials: ivonescimab combined with AK117 for first-line HNSCC treatment, compared with pembrolizumab. Cadonilimab and ivonescimab: Over 20 Phase III and 40+ Phase II trials ongoing, covering 40+ indications. "IO+ADC" 2.0 strategy gaining momentum: First self-developed ADC and bispecific ADC enter clinical trials. Non-oncology expansion: ebronucimab (PCSK9) approved, NDAs for ebdarokimab (IL-12/IL-23) and gumokimab (IL-17) under review. 3 drugs approved, 5 new drugs with 5 indications under regulatory review. HONG KONG, March 30, 2025 /PRNewswire/ -- Akeso Inc. (9926.HK) ("Akeso", "the Company") released its 2024 annual report, emphasizing the company's key achievements in drug research, clinical development, and commercialization. In 2024, Akeso achieved key success in antibody therapy research and development. The approval of new indications for cadonilimab and the launch of first-in-class drugs like ivonescimab expanded the company's footprint in major solid tumors, including lung and gastric cancers. Akeso continues to challenge current standard of care with head-to-head trials against pembrolizumab and other therapies, while advancing novel treatments such as anti-CD47 monoclonal antibody, antibody drug conjugates ("ADCs") and bispecific ADCs. The company also achieved major milestones in commercialization and patient access, with products included in national insurance directories. Currently, over 25 registrational and Phase III clinical trials are actively progressing. On the commercial front, Akeso's adjustments in drug pricing and optimization of its commercial systems led to new drug sales revenue surpassing RMB 2 billion in 2024, a 25% year-on-year increase. The company continues to reduce operating losses, with an EBITDA loss of 225 million RMB in 2024. Dr. Xia Yu, Founder, Chairwoman, President, and CEO of Akeso Biopharma: "We are thrilled to have reached historic milestones in our innovative drug development in 2024. The approval of several globally competitive products and breakthroughs in advanced therapies have strengthened our global competitiveness in biopharmaceutical innovation. Notably, our first-in-class bispecific antibodies, cadonilimab and ivonescimab, have been approved for commercial sales and included in China's NRDL. This significantly improves drug accessibility, reduces patient burdens, and fulfills a key strategic goal in our domestic commercialization efforts. In clinical development, cadonilimab and ivonescimab are currently in over 20 registrational/Phase III clinical trials globally, establishing a strong presence in first-line treatments for a wide range of high-incidence cancers. Additionally, more than 40 Phase II trials are ongoing, further strengthening our leadership in global cancer immunotherapy. We've also made key advances in novel therapies, with ligufalimab (anti-CD47 mAb) moving to Phase III for solid tumors, and progress in next-gen ADCs, bispecific ADCs, and autoimmune bispecific antibodies. These achievements have expanded our oncology pipeline and strengthened our global expansion strategy with a comprehensive 'IO 2.0+' combination therapy platform." Akeso's Bispecific Antibody Clinical Portfolio Continues to Expand, Demonstrating Global Leadership in Next-Generation Tumor Immunotherapy In 2024, Akeso continued to focus and make progress on research and clinical development. The accomplishments from these efforts include : 3 novel drugs approved for market 5 NDAs under review for 5 indications 24 drug candidates in global clinical development Over 25 registrational/Phase III trials actively progressing Notably, Akeso has focused on redefining global treatment paradigms through the development of breakthrough therapies that provide additional survival and safety benefit to current standard of care. Centered around its internally developed first-in-class bispecific antibodies—cadonilimab (PD-1/CTLA-4) and ivonescimab (PD-1/VEGF)—the company has conducted over 40 clinical trials across a number of indications. Cadonilimab After its approval for recurrent/metastatic cervical cancer, cadonilimab reached a major milestone in 2024 with the approval for a new indication in first-line gastric cancer, addressing unmet needs in PD-L1 low/negative populations. The sNDA for first-line cervical cancer is currently under review. Cadonilimab is also currently in 8 Phase III trials and nearly 20 Phase II studies, exploring treatments for major cancers in both first- and later-line settings. Ivonescimab In 2024, ivonescimab was approved for the treatment of EGFR-TKI-resistant, locally advanced or metastatic non-squamous non-small cell lung cancer (nsq-NSCLC). A major milestone was reached in May 2024 when the Phase III HARMONi-2 trial, comparing ivonescimab to pembrolizumab in first-line PD-L1-positive NSCLC, showed positive results. Data presented at the 2024 World Conference on Lung Cancer (WCLC) revealed a median Progression-Free Survival (mPFS) of 11.14 months for ivonescimab, compared to 5.82 months for pembrolizumab. This breakthrough highlights ivonescimab's potential as a key therapy in next-gen immuno-oncology and boosts its global commercialization prospects. Currently, ivonescimab is in 12 registrational/Phase III clinical trials, including 6 head-to-head studies against PD-1/L1 therapies, as well as in over 20 Phase II trials. Key Phase III Trials in NSCLC : Ivonescimab monotherapy vs. pembrolizumab as first-line (1L) treatment for PD-L1+ NSCLC Ivonescimab + chemotherapy vs. pembrolizumab + chemotherapy (global multicenter trial) as 1L treatment for NSCLC Ivonescimab + chemotherapy vs. tislelizumab + chemotherapy as 1L treatment for squamous NSCLC (sq-NSCLC) Phase III Trials in Other Major IO Indications: Ivonescimab + chemotherapy vs. durvalumab + chemotherapy as 1L treatment for biliary tract cancer Ivonescimab + AK117 (CD47 mAb) vs. pembrolizumab as 1L treatment for PD-L1+ head and neck squamous cell carcinoma (HNSCC) Ivonescimab combination as 1L treatment for triple-negative breast cancer (TNBC) Ivonescimab in PD-(L)1-resistant NSCLC, and ivonescimab combination as 1L treatment for pancreatic cancer (preparation/initiation underway) These trials reflect ivonescimab's development strategy that is based on a fundamental understanding of tumor immunobiology and designing clinical studies that compares it with standard of care, encompassing both first-line and later-line treatments for high-incidence, high-mortality cancers. This positions Akeso as a key innovator in next-generation cancer immunotherapy, improving and contributing to the global IO cancer treatment landscape. Breakthrough Bispecifics Enter NRDL, Paving the Way for the Next Stage of Commercial Growth In 2024, Akeso Biopharma achieved commercial sales of RMB 2 billion, representing a 25% year-over-year growth. As China's innovative drug market transforms, clinically innovative medicines face historic development opportunities. Both cadonilimab and ivonescimab, recognized for their innovation and clinical value, were successfully included in the National Reimbursement Drug List (NRDL) during the 2024 negotiations, marking a major milestone in Akeso's commercial franchise. The inclusion of both cadonilimab and ivonescimab in the NRDL represents the next stage in Akeso's market strategy, with a clear focus on hospital-based markets as the core growth area. It greatly improves the therapy accessibility, reduces patient treatment burdens, and evolves the innovative value of the company's first-in-class bispecific antibodies into tangible social and commercial benefits. Following the NRDL inclusion, Akeso has made key upgrades to its commercial infrastructure, aligning with its strategic priorities for accelerated growth: Rapid Hospital Access: Prioritizing swift hospital access for cadonilimab and ivonescimab through data-driven tiering of key accounts. Commercial Team Expansion: Enhancing coverage of core hospitals and regional hubs to ensure maximum reach and impact. Scientific Leadership: Strengthening engagement with KOLs and generating real-world evidence to highlight the differentiated efficacy and safety profiles of its bispecifics, driving physician adoption. These initiatives set the stage for Akeso's growth in 2025 and beyond, while building a strong foundation for long-term, sustainable commercial growth. Akeso's non-oncology portfolio is also advancing with the launch of PCSK9 inhibitor ebronucimab and the potential approvals for assets like ebdarokimab and gumokimab. The company is building a dedicated commercial team to tap into the multi-billion RMB metabolic and autoimmune markets. Akeso's strong pipeline in non-oncology indications will provide additional drivers for sales growth. Potential Disclosure of Ivonescimab's Topline HARMONi Clinical Data Mid-Year International Expansion of Novel Drug Development Accelerates Akeso's global partner on ivonescimab, Summit Therapeutics, is advancing three international multicenter Phase III clinical trials: The HARMONi study, a Phase III clinical trial that evaluates ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib). Summit has announced plans to disclose topline data in mid-2025. Summit expanded the HARMONi-3 study cohort in 2024 to include both squamous NSCLC (sq-NSCLC) and non-squamous NSCLC (nsq-NSCLC), expanding first-line coverage for all NSCLC populations. The HARMONi-7 study, a global Phase III trial comparing ivonescimab monotherapy with pembrolizumab monotherapy as a first-line treatment for PD-L1-high NSCLC, is expected to begin in 2025. In February 2025, Summit has entered into a clinical collaboration with Pfizer to evaluate ivonescimab in combination with Pfizer's antibody-drug conjugates (ADCs) across solid tumors. Pfizer will be responsible for conducting the operations of the studies. The studies will be overseen by both Summit and Pfizer. Both parties retain their respective rights to their products. Akeso is responsible for the production of ivonescimab used in the clinical trial conducted globally. Beyond bispecific antibodies Akeso is advancing a pipeline of promising candidates beyond bispecific antibodies. The company's first self-developed ADC, AK138D1, with the first patient enrolled in Australia for Phase I. Clinical trials for the Company's first bispecific ADC have also begun. Additionally, the IND application for AK139, the first IL-4Rα/ST2-targeting bispecific, has been accepted. Ligufalimab (CD47 mAb), considered a key target in immuno-oncology, advanced to Phase III in 2024. A randomized, double-blind, controlled Phase III trial (vs. pembrolizumab) is ongoing for first-line PD-L1(+) head and neck squamous cell carcinoma (HNSCC), making ligufalimab the first CD47 mAb to reach Phase III for solid tumors. A global Phase II trial combining ligufalimab with azacitidine for first-line myelodysplastic syndromes (MDS) is actively progressing across multiple countries, including the U.S. In parallel with the accelerated global expansion of its novel drug development, Akeso's therapies and clinical studies have also received recognition in top-tier academic journals and conferences. In 2024, the company revealed nearly 80 groundbreaking research findings in prestigious journals and academic conferences, including JAMA, Nature Medicine, and The Lancet. 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, 24 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 6 new drugs are commercially available, and 5 new drugs with 5 new indications are under regulatory review for approval. 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. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Phase 2Drug ApprovalImmunotherapyClinical Result

27 Jan 2025

·www.prnewswire.com

Akeso's Gumokimab Monoclonal Antibody (IL-17) New Drug Application for the Treatment of Moderate to Severe Psoriasis Accepted by NMPA

HONG KONG, Jan. 26, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is pleased to announce that the New Drug Application (NDA) of its internally-developed IL-17-targeting monoclonal antibody gumokimab (AK111) has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the treatment of moderate to severe plaque psoriasis. The strategic combination of drugs such as gumokimab and ebronucimab (PCSK9) to address the differentiated treatment needs of psoriasis has further enhanced the company's overall product synergy in the autoimmune disease field. Gumokimab is the eighth successfully approved drug developed independently by Akeso (with six already approved for market), and it is also the third non-oncology innovative drug, following ebronucimab (PCSK9) and ebdarokimab (IL-12/IL-23), to progress to the commercialization stage. Gumokimab has been evaluated in four clinical studies involving patients with moderate to severe plaque psoriasis, including one pivotal Phase III clinical trial (AK111-301) and three supportive studies. Efficacy data show that gumokimab acts quickly, with significant therapeutic improvement observed after just 2 weeks of treatment. S hort-term Efficacy: At week 12, the PASI 75 response rate approached 96%, with an sPGA 0/1 response rate nearing 90%. The PASI 90 response rate was close to 80%, and the PASI 100 response rate exceeded 40%, all efficacy measures significantly superior to the placebo group. Over 80% of patients achieved a PASI 90 response, and approximately 50% achieved a PASI 100 response. Long-term Efficacy: Gumokimab monotherapy demonstrated sustained efficacy over 52 weeks, with continuous improvement and long-lasting maintenance. By week 52, the PASI 75 response rate approached 100%, with stable sPGA 0/1 response rates. The PASI 90 and PASI 100 response rates further improved to nearly 90% and 65%, respectively. Safety: During both the placebo-controlled phase and the overall treatment phase, the incidence of adverse events was comparable between the gumokimab and placebo groups, with the gumokimab group showing slightly lower values across all metrics. Professor Xu Jinhua, the principal investigator of the pivotal registration study of gumokimab, professor at Huashan Hospital, Fudan University, stated: "There is an increasing demand for medications that offer rapid onset, short-term efficacy, long-term stability, and good tolerability. Gumokimab, an IL-17A IgG1 monoclonal antibody, directly targets the IL-17RA pathway, a key driver of psoriasis, providing faster and more effective results. Data from four studies demonstrate its potential to better meet patient needs, particularly in achieving near-clearance of lesions and maintaining disease stability. Moreover, the incidence of adverse events with gumokimab is comparable to that of the placebo, indicating good safety and tolerability. We eagerly anticipate the early availability of Gumokimab as a more efficient treatment option for psoriasis patients in China." Dr. Yu Xia, Founder, Chairwoman, and CEO of Akeso, stated: "We are excited about the outstanding results of gumokimab in clinical trials and the successful submission of its new drug application for market approval. I would like to express my sincere gratitude to all the participants in the project and to all the patients who took part in the clinical trials for their hard work and trust. Psoriasis patients are in urgent need of better treatment options, and Akeso is addressing this with ebdarokimab and gumokimab, which target different disease pathways and complement each other in treatment, allowing us to meet a wide range of patient needs. With the successful launch of products such as ebronucimab (PCSK9), ebdarokimab (IL-12/IL-23) and gumokimab (IL-17), as well as the efficient advancement of innovative non-oncology drugs targeting multiple indications, including manfidokimab (IL-4R), IL-4R/ST2 bispecific antibody, and therapies for neurodegenerative diseases, the vitality and synergy of our product portfolio are growing stronger. This progress significantly enhances Akeso's global competitiveness in the non-oncology business segment. At the same time, with the development and optimization of a more systematic, refined, and efficient commercialization team, we have formulated a comprehensive and scientific commercialization strategy for our non-oncology products. This strategy is designed to accelerate market expansion, positioning our non-oncology business as a powerful driver of the company's high-quality growth." About gumokimab Gumokimab is an innovative, humanized IL-17 (interleukin-17) monoclonal antibody developed by Akeso for the treatment of autoimmune diseases such as psoriasis and ankylosing spondylitis. IL-17 is a pro-inflammatory cytokine primarily secreted by activated Th17 cells, which binds to its receptor (IL-17R) on cell surfaces, mediating immune-inflammatory responses and playing a critical role in the pathogenesis of psoriasis and ankylosing spondylitis. Gumokimab specifically targets IL-17, blocking the IL-17/IL-17R signaling pathway to inhibit the onset and progression of related immune-inflammatory responses. Currently, the NDA for gumokimab in moderate-to-severe plaque psoriasis has been accepted by the NMPA, and a phase III clinical trial for ankylosing spondylitis is ongoing. 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, 22 candidates have entered clinical trials (including 11 bispecific/multispecific antibodies and bispecific antibody-drug conjugates). Additionally, 5 new drugs are commercially available, and 5 new drugs across 7 indications are currently under regulatory review for approval. 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, and X . SOURCE Akeso, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3NDADrug ApprovalClinical ResultPhase 2

08 Jan 2024

·www.biospace.com

Akeso to Present at the 42nd Annual J.P. Morgan Healthcare Conference and Share Its Corporate & Innovative Clinical Development Roadmap

HONG KONG, Jan. 8, 2024 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso," "we," or the "Company") today announced that Michelle Xia, Ph.D, the founder, chairwoman, president, and CEO of Akeso, will deliver a keynote speech focusing on the Company's achievements in the development of new bispecific antibody drug therapeutics and the Company's 2024 key milestones at the 42nd Annual J.P. Morgan Healthcare Conference, to be held January 8-11, 2024 in San Francisco, California. The presentation will take place on Tuesday, January 9, at 4:30 PM PST. Thanks to clear strategic vision and efficient execution by our leadership and team,we delivered yet another exceptional performance, surpassing expectations and successfully achieving all of our stated goals in 2023. We are seeking to achieve the followings potential milestones that may take place in 2024 and into early 2025: Approval of four NDAs/sNDAs across five indications NDAs/sNDAs filing across four indications for three drugs Topline data readout from up to five registrational trials Completing enrollment for up to four registrational trials Initiating up to five new Phase III trials In addition, Akeso continues to plan for first-in-human clinical trials for a range of products currently in preclinical evaluation, including, for the first time, an antibody-drug conjugate (ADC). Updated Clinical Data and Milestone Outlook for Ivonescimab (PD-1/VEGF Bispecific) We currently have three Phase III clinical trials for ivonescimab at varying stages of progress: AK112-301, for which the NDA has been submitted for approval to the CDE, AK112-303, for which enrollment has completed AK112-306, for which we are currently enrolling. We are presenting updated data from our Phase II clinical trials, supporting our rapid development of ivonescimab across multiple indications. Updated Data for AK112-201 (NCT04736823) AK112-201 is an open-label, Phase II study evaluating ivonescimab plus chemotherapy across three cohorts. The patients with tumors of squamous histology in Cohort 1 help support our decision to initiate the AK112-306 Phase III clinical trial comparing ivonescimab against tislelizumab plus chemotherapy; the patients in Cohort 2 supported our earlier decision to enter into AK112-301 comparing ivonescimab plus chemotherapy against chemotherapy alone. * Confirmed responses for patients with at least one post-baseline scan; SQ-NSCLC n=60; EGFR-TKI n=19 ** NE – Not Established For Cohort 1, the frequency of treatment-emergent adverse events (TEAEs) leading to discontinuation of ivonescimab was 11%; there were no treatment-related adverse events (TRAEs) leading to the death of a patient. The most frequent treatment-emergent adverse events were anemia, decreased neutrophil counts, and decreased white-blood cell counts. In Cohort 2, ivonescimab had an acceptable safety profile. There were no TRAEs leading to permanent discontinuation of therapy or patient death. Key Near-Term Milestones of Ivonescimab: For the NDA for ivonescimab based on AK112-301, a decision from the Chinese Center for Drug Evaluation (CDE) is expected in Q2 2024, along with a read-out of topline data from the study. Ivonescimab is expected to become the world's first bispecific drug combining immunotherapy and anti-angiogenesis. Phase III data readout of ivonescimab monotherapy versus pembrolizumab monotherapy as first-line treatment for NSCLC patients with positive PD-L1 expression is expected in Q2 2024. Based on this data, the Company will submit an NDA for this indication as appropriate. Phase III enrollment completion of ivonescimab in combination with chemotherapy versus tislelizumab in combination with chemotherapy for first-line treatment of advanced or metastatic squamous NSCLC is expected in the second half of 2024. Phase III completion by Summit of the global enrollment of ivonescimab (AK112/SMT112) combined with chemotherapy in patients with EGFR-mutated, locally advanced or metastatic nsq-NSCLC who have progressed after treatment with a third-generation EGFR -TKI is expected in the second half of 2024. Potential initiation of Phase III clinical trials for ivonescimab in additional tumor types in 2024. Milestone Outlook for Cadonilimab (PD-1/CTLA-4 Bispecific) Following the Company's benchmark sales of cadonilimab, the world's first PD-1/CTLA-4 bispecific antibody, in 2023, the Company is poised to achieve additional important breakthroughs in 2024 that will significantly enhance clinical and commercial value. In January 2024, the NMPA accepted the sNDA for cadonilimab in combination with chemotherapy as first-line treatment for recurrent or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. NDA submission of cadonilimab + chemotherapy ± bevacizumab for first-line treatment for advanced cervical cancer is expected in Q1 2024. Phase III enrollment completion of cadonilimab for adjuvant treatment of hepatocellular carcinoma (HCC) is expected in Q4 2024. Phase III data readouts for first-line GC/GEJ cancer and first-line cervical cancer in 2024. Potential initiation of Phase III clinical trials for cadonilimab in additional tumor types in 2024. Other Potential Milestones for Oncology Products In terms of other significant oncology drug milestones, the Company is expected to reach several important milestones in 2024 to early 2025. Two bispecific antibodies, AK129 (PD-1/LAG3) and AK130 (TIGIT/TGFβ), are anticipated to enter Phase II, while ADC and neurodegenerative diseases candidates will undergo human clinical trials for the first time. Additionally, the CDE will also make a decision on the NDA for penpulimab for first-line treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC). Finally, additional combination therapy data is anticipated to be announced. Key Near-Term Milestones of Non-Oncology Products NDA decision expected in 2024 on ebronucimab (PCSK9) for the treatment of hypercholesterolemia and heterozygous familial hypercholesterolemia. NDA decision expected in 2024 on ebdarokimab (IL-12/IL-23) for the treatment of moderate-to-severe psoriasis. Phase III enrollment completion of gumokimab (IL-17) for ankylosing spondylitis. Phase III data readout of gumokimab (IL-17) for Moderate-to-severe psoriasis. Based on this data, an NDA submission for gumokimab (IL-17) for the treatment of moderate-to-severe psoriasis. Potential initiation of a Phase III clinical trial for manfidokimab (IL-4R) for the treatment of moderate atopic dermatitis. Over the next five years, Akeso has high expectations of launching around 10 internally developed blockbuster drugs, both in China and worldwide, thereby achieving successful commercialization. Akeso has established and continuously advances its integrated and efficient system of discovery, development, production, and sales of its innovative drugs and pipeline candidates. About Akeso, Inc. Akeso (HKEX: 09926) is a commercial-stage biopharmaceutical company committed to discovering, developing, manufacturing, and commercializing innovative medicines that address significant medical needs globally. Since our inception, we have established a distinctive and 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 fundamental components, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode. Akeso is actively developing a diverse pipeline of over 30 innovative assets in areas such as cancer, autoimmune disease, inflammation, metabolic disease, and other therapeutic fields. Among these, 19 assets have entered the clinical stage, with 3 innovative drugs already approved, 13 Phase III studies ongoing. Utilizing its proprietary Tetrabody technology, Akeso has successfully developed the first-in-class PD-1/CTLA-4 bispecific antibody drug for the market. Additionally, the company has five other innovative bispecific antibody drugs in the clinical stage, including ivonescimab (PD-1/VEGF), PD-1/LAG-3, TIGIT/TGF-Beta, PD-1/CD73, and claudin18.2/CD47 bispecific antibodies. In June 2022, cadonilimab was approved by the NMPA and became the first commercialized bispecific IO drug globally. Another Akeso internally discovered and developed oncology product, penpulimab (a PD-1 antibody), was granted marketing approval in China in August 2021. In December 2022, Akeso entered into a collaboration and license agreement for up to US$5 billion with Summit Therapeutics to accelerate global development and commercialization of ivonescimab. In August, the NDA submission of ivonescimab was accepted by China's NMPA with priority review. Akeso is listed on the Main Board of the Stock Exchange of Hong Kong Limited. For more information, please visit and follow us on X (formerly Twitter) @AkesoInc Company Codes: HongKong:9926

Phase 3Phase 2NDALicense out/inClinical Result

100 Deals associated with Ebdarokimab

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Plaque psoriasis	NDA/BLA	China	Akeso Biopharma Co., Ltd.	23 Aug 2023
Psoriasis vulgaris	Phase 3	China	Akeso Biopharma Co., Ltd.	29 Nov 2021
Colitis, Ulcerative	Phase 2	China	Akeso Biopharma Co., Ltd.	30 Jan 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05509361 (AK101-303, Company_Website) Manual	Phase 3	Psoriasis	950	依若奇（AK101） (第1组)	nrcbqcrlya(ogeoktfihn) = fmpacugykx eontiuvoxl (shzozfbyul ) View more	Positive	02 Oct 2024
				依若奇（AK101） (对照药16周治疗后，第16周切换到依若奇治疗)	nrcbqcrlya(ogeoktfihn) = glfovpipmd eontiuvoxl (shzozfbyul ) View more
EADV2023	Phase 3	Plaque psoriasis IL-12 \| IL-23	450	AK101 135mg	gixxfgdewh(jsqtowofkm) = No adverse events with special interest ( AESI ) and no AEs leading to death of subjects in this study shymtkfdjo (rwkckmwhgu ) View more	Positive	11 Oct 2023
				Placebo
FOCIS2023	Phase 1	IL-12 \| IL-23	34	Ebdarokimab 270mg SC	yufktbxeof(ifvacvueiz) = smdkrzxqkh mrwdyuxrvq (vimbyhdouc ) View more	Positive	20 Jun 2023
				Placebo	vndkvhkvmy(etrzuxtaoo) = otfubeyvhw prcqomoyxh (tjvymoswat )

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