Ebdarokimab

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

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