A Phase III Study Evaluating the Efficacy and Safety of ASKB589 Combined With CAPOX and PD-1 Inhibitor as First-Line Treatment in Claudin18.2 Positive Patients With Unresectable Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

This study is a multicenter, randomized, double-blind, standard-of-care controlled phase III clinical study conducted in China. The purpose of this study is to evaluate the efficacy of ASKB589 plus CAPOX and PD-1 inhibitor compared with placebo plus CAPOX and PD-1 inhibitor (as first-line treatment) as measured by Progression Free Survival (PFS).

Start Date25 Jan 2024

Sponsor / Collaborator

AskGene Pharma, Inc.

[+1]

CTR20233416

/ RecruitingPhase 3

评价ASKB589注射液或安慰剂联合CAPOX（奥沙利铂和卡培他滨）及PD-1抑制剂一线治疗CLDN18.2 阳性的不可切除的局部晚期、复发性或转移性胃及食管胃交界处腺癌患者的有效性和安全性的III期临床研究

[Translation] A phase III clinical study to evaluate the efficacy and safety of ASKB589 injection or placebo combined with CAPOX (oxaliplatin and capecitabine) and PD-1 inhibitors as first-line treatment for patients with CLDN18.2-positive unresectable locally advanced, recurrent or metastatic gastric and esophagogastric junction adenocarcinoma

比较ASKB589注射液或安慰剂联合CAPOX及PD-1抑制剂一线治疗CLDN18.2阳性的不可切除的局部晚期、复发性或转移性胃及食管胃交界处腺癌患者的有效性

[Translation]

To compare the efficacy of ASKB589 injection or placebo combined with CAPOX and PD-1 inhibitor as first-line treatment for patients with CLDN18.2-positive unresectable locally advanced, recurrent or metastatic gastric and esophagogastric junction adenocarcinoma

Start Date12 Jan 2024

Sponsor / Collaborator

Jiangsu Aosaikang Biomedicine Co., Ltd.

NCT05632939

/ Active, not recruitingPhase 1/2

A 1/2 Phase Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ASKB589 in Combination With CAPOX and PD-1 Inhibitors in Patients With Advanced, and Unresectable Gastric/Esophagogastric Junction Cancer.

This was an open-label, phase 1/2 study to evaluate safety, tolerability, pharmacokinetics, and antitumor activity of ASKB589 in combination with CAPOX and PD-1 inhibitors in first-line treatment of patients with locally advanced, recurrent, or metastatic gastric and esophagogastric junction adenocarcinoma.

Start Date21 Feb 2023

Sponsor / Collaborator

AskGene Pharma, Inc.

[+1]

100 Clinical Results associated with Omectatug

100 Translational Medicine associated with Omectatug

100 Patents (Medical) associated with Omectatug

Literatures (Medical) associated with Omectatug

Frontiers in oncology

Case Report: A rare case of recurrent ascites after anti-Claudin18.2 antibody therapy for metastatic gastric cancer while responding sustainingly

Author: Zhu, Qing ; Jiang, Dan ; Zhu, Hong ; Lei, Qingqiang ; Liu, Jinlu

Background:

Gastric cancer remains one of the deadliest malignancies in the world, thus urgently requiring effective and safe therapeutics. Claudin18.2 is a member of the tight junction protein family specifically expressed in gastric cancer cells. Monoclonal antibodies targeting Claudin18.2 have been receiving increasing attention recently. ASKB589 is a humanized monoclonal antibody targeting Claudin18.2.

Case presentation:

This case described a 65-year-old Chinese man diagnosed with gastric cancer metastasizing to the liver and multiple lymph nodes. The biomarker examination revealed that he had proficient mismatch repair (pMMR), human epidermal growth factor receptor 2 (HER2) was negative, and the combined proportion score (CPS) of PD-L1 (22C3) was 1. After being proven to be moderately positive for Claudin18.2 expression, he received ASKB589 and CAPOX (oxaliplatin and capecitabine) chemotherapy. After a six-cycle therapy (from 14 July 2022 to 29 November 2022), the target tumor was evaluated for partial response (PR) by the investigator based on the enhanced CT scan according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. However, this patient also suffered from intolerable ascites that gradually aggravated during the therapy, which was not controlled well by the supporting therapy. Therefore, the patient stopped receiving the combined therapy in our hospital and did not receive any other anti-tumor treatment. After 4 months of discontinuation of the drug, the patient’s ascites almost disappeared, while the tumor continued to reduce and almost achieved clinically complete relapse (cCR). His progression-free survival (PFS) reached at least 10 months.

Conclusion:

This is the first case of severe ascites reported after anti-Claudin18.2 monoclonal antibody treatment for advanced gastric cancer. At the same time, the patient still benefited significantly from this incomplete treatment even after discontinuation of the drug and the PFS reached at least 10 months. The ascites might be an immune adverse effect related to the monoclonal antibody-induced antibody-dependent cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). Further mechanisms remain to be investigated.

News (Medical) associated with Omectatug

23 Jul 2025

·www.prnewswire.com

Claudin 18.2-Directed Oncology Therapeutics--A Fast-Growing Market with Blockbuster Potential | DelveInsight

Claudin 18.2-directed therapies are on track to become foundational in the treatment of gastrointestinal and select solid tumors. Fueled by innovation in antibody engineering, combination strategies, and biomarker testing, this therapeutic class is set to play a transformative role in the next generation of precision oncology. LAS VEGAS, July 23, 2025 /PRNewswire/ -- DelveInsight's Claudin 18.2 Directed Therapies Market Size, Target Population, Competitive Landscape & Market Forecast report includes a comprehensive understanding of current treatment practices, addressable patient population, which includes top indications such as gastric cancer, pancreatic cancer, gastroesophageal junction adenocarcinoma, and other solid tumors. The selected indications are based on approved therapies and ongoing pipeline activity. The report also provides insights into the emerging Claudin 18.2-directed therapies, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM. Key Takeaways from the Claudin 18.2 Directed Therapies Market Report As per DelveInsight's analysis, the total market size of Claudin 18.2-directed therapies in the 7MM is expected to surge significantly by 2034. The report provides the total potential number of patients in the indications, such as Gastric cancer, pancreatic cancer, gastroesophageal junction adenocarcinoma, and other solid tumors Leading Claudin 18.2-directed therapies companies, such as AskGene, Innovent, AstraZeneca, Antegene, Antennova, Kelun, Phanes, and others, are developing novel Claudin 18.2-directed therapies that can be available in the Claudin 18.2-directed therapies market in the coming years. Some of the key Claudin 18.2-directed therapies in the pipeline include ASKB589, IBI-343, AZD0901, ATG022/ATN022, SKB315, Spevatamig (PT886), and others. In May 2025, Astellas entered an exclusive license agreement with Evopoint Biosciences for XNW27011, a novel clinical-stage antibody-drug conjugate targeting CLDN18.2. Discover which indication is expected to grab the major Claudin 18.2-directed therapies market share @ Claudin 18.2 Directed Therapies Market Report Claudin 18.2 Directed Therapies Market Dynamics The Claudin 18.2-directed therapies market has been witnessing significant momentum driven by advancements in targeted oncology therapies. Claudin 18.2 is a tight junction protein selectively expressed in certain cancers, such as gastric cancer, gastroesophageal junction adenocarcinoma, and pancreatic cancer, making it an attractive therapeutic target. The approval of zolbetuximab (VYLOY) by Astellas has validated the clinical potential of Claudin 18.2-targeting monoclonal antibodies, positioning the pathway as a critical frontier in precision oncology. Other players, including domestic and international pharmaceutical companies, are actively developing monoclonal antibodies, antibody-drug conjugates (ADCs), and bispecific antibodies directed against Claudin 18.2, further intensifying the competitive dynamics. The market is characterized by a robust pipeline across various modalities. Monoclonal antibodies such as zolbetuximab lead the segment, but the pipeline also features novel ADCs and bispecifics, aiming to improve efficacy and overcome resistance mechanisms. Several companies are exploring combination regimens with checkpoint inhibitors and chemotherapy to enhance treatment outcomes. Additionally, there is a growing interest in expanding the therapeutic scope beyond gastric and gastroesophageal junction cancers to include pancreatic, lung, and other solid tumors where Claudin 18.2 expression is evident, potentially broadening the patient pool. Despite the growth prospects, the Claudin 18.2-directed therapies market faces several challenges. These include the need for reliable diagnostic tools to identify Claudin 18.2 expression, patient heterogeneity in expression levels, and potential off-target effects leading to safety concerns. Moreover, market penetration may be impacted by the high cost of biologics and the evolving reimbursement landscape, particularly in emerging markets. Nonetheless, the strong clinical efficacy signals, favorable regulatory momentum, and increasing physician awareness position Claudin 18.2 therapies for substantial growth over the next decade. Looking ahead, the Claudin 18.2-directed therapy landscape is expected to diversify with the introduction of next-generation modalities such as CAR-T therapies and vaccines targeting the protein. The competitive intensity is likely to increase as additional players enter late-stage development and as combination regimens redefine the treatment paradigm. Continued biomarker-driven patient selection and companion diagnostic development will be critical to optimizing outcomes and driving adoption. Overall, the Claudin 18.2 market represents a dynamic and evolving segment of the oncology therapeutics space, poised for continued innovation and expansion. Claudin 18.2 Directed Therapies Treatment Market Therapies targeting Claudin 18.2 have shown activity across several cancers, such as gastric cancer, pancreatic cancer, gastroesophageal junction adenocarcinoma, and other solid tumors. Astellas' VYLOY (zolbetuximab) is currently the first and only approved therapy directed against Claudin 18.2 for advanced gastric and gastroesophageal junction adenocarcinoma. It was first approved in Japan in March 2024, followed by regulatory clearance in the UK in August 2024, and later by the US FDA in October 2024. VYLOY is a cytolytic monoclonal antibody that targets claudin 18.2 and is approved for use alongside fluoropyrimidine- and platinum-based chemotherapy as a first-line treatment for adults with locally advanced, unresectable, or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma. This treatment is specifically intended for patients whose tumors express claudin 18.2, as confirmed by an FDA-approved diagnostic test. As a claudin 18.2-targeting cytolytic antibody, VYLOY destroys CLDN18.2-positive cells through mechanisms such as antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). Preclinical models have shown that combining VYLOY with chemotherapy enhances antitumor activity in CLDN18.2-positive tumors compared to the use of either treatment alone. Learn more about the Claudin 18.2-directed therapies @ Claudin 18.2 Directed Therapies Analysis Key Emerging Claudin 18.2 Directed Therapies and Companies Several companies, including AskGene (ASKB589), Innovent (IBI-343), Antegene (ATG022/ATN022), Kelun (SKB315), AstraZeneca (AZD0901), Phanes (Spevatamig), and others, are currently engaged in the development and production of CLDN 18.2 therapies, which have the potential to significantly impact and enhance the MCR therapies market. ASKB589 is a humanized IgG1 monoclonal antibody targeting CLDN1, specifically designed to enhance antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). In combination with CAPOX chemotherapy and a PD-1 inhibitor as a first-line therapy for patients with gastric/gastroesophageal junction (G/GEJ) cancer, ASKB589 showed a favorable safety and tolerability profile. The addition of a PD-1 inhibitor to the ASKB589 plus CAPOX regimen in patients expressing moderate to high levels of CLDN18.2 led to promising anti-tumor effects, characterized by strong and lasting responses. IBI-343 is a recombinant human monoclonal antibody targeting Claudin 18.2, linked to a topoisomerase I inhibitor payload (Exatecan). Engineered with an Fc-silenced backbone to reduce unwanted immune activation, it features a cleavable linker for targeted drug release within tumor cells, enabling a bystander killing effect that affects neighboring tumor cells with low antigen expression. IBI-343 has been granted Fast Track Designation by the U.S. FDA and is currently being investigated in the Phase III G-HOPE trial (NCT06238843). The anticipated launch of these emerging therapies are poised to transform the Claudin 18.2-directed therapies market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the Claudin 18.2-directed therapies market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. To know more about Claudin 18.2-directed therapies clinical trials, visit @ Claudin 18.2 Directed Therapies Treatment Claudin 18.2 Directed Therapies Overview Claudin 18.2 is a tight junction protein essential for preserving the integrity of the stomach lining. It is one of the two isoforms produced by the CLDN18 gene and is normally found only in differentiated epithelial cells of the gastric mucosa. In healthy tissues, Claudin 18.2 is hidden within tight junctions, making it inaccessible to drugs. However, during the development of cancers like gastric, gastroesophageal junction (GEJ), and pancreatic cancer, Claudin 18.2 becomes abnormally exposed on the surface of tumor cells, while its expression in normal tissues remains limited. This distinct expression profile makes Claudin 18.2 a promising and highly specific therapeutic target. The most advanced treatment targeting this protein is VYLOY, a monoclonal antibody that binds to Claudin 18.2 and induces immune-mediated killing of tumor cells. VYLOY has demonstrated encouraging results in late-stage clinical trials and is now approved for treating CLDN18.2-positive gastric and GEJ cancers. Additional therapies under investigation include CAR-T cell therapies, bispecific antibodies, and antibody-drug conjugates. Testing for CLDN18.2 expression using immunohistochemistry (IHC) helps identify patients who may benefit from these targeted treatments, highlighting the dual role of CLDN18.2 as both a biomarker and a therapeutic target in precision cancer therapy. Claudin 18.2 Directed Therapies Epidemiology Segmentation The Claudin 18.2-directed therapies market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Cases of Selected Indications for Claudin 18.2-directed Therapies Total Eligible Patients of the Selected Indications of Claudin 18.2-directed Therapies Total Treated Cases in Selected Indications for Claudin 18.2-directed Therapies Scope of the Claudin 18.2 Directed Therapies Market Report Claudin 18.2 Directed Therapies Therapeutic Assessment: Claudin 18.2 Directed Therapies current marketed and emerging therapies Claudin 18.2 Directed Therapies Market Dynamics: Conjoint Analysis of Emerging Claudin 18.2 Directed Therapies Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Claudin 18.2 Directed Therapies Market Access and Reimbursement Discover more about Claudin 18.2-directed therapies in development @ Claudin 18.2 Directed Therapies Clinical Trials Table of Contents Related Reports Gastric Cancer Market Gastric Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key gastric cancer companies, including BeiGene, Linton Pharm Co. Ltd., RAPT Therapeutics, Leap Therapeutics, Idience, Bolt Biotherapeutics, Hubro Therapeutics, Immunocore, Ambrx, Hangzhou DAC Biotech, Beijing Immunoah Pharma Tech, Nanjing KAEDI Biotech, HiberCell, Transcenta Holding, Suzhou Zelgen Biopharmaceuticals, Daiichi Sankyo, Ipsen, Alligator Bioscience, Bristol Myers Squibb, Jiangsu Hengrui Medicine, Shanghai Junshi Biosciences, ImmunoACT, among others. Pancreatic Cancer Market Pancreatic Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key pancreatic cancer companies, including AstraZeneca, Merck Sharp & Dohme LLC, Bayer, Roche, Celgene, Bristol Myers Squibb, BioLineRx, Alligator Bioscience, Bellicum Pharmaceuticals, OSE Immunotherapeutics, Actuate Therapeutics, FibroGen, NeoImmuneTech, NOXXON Pharma, Silenseed Ltd., Amgen, NGM Biopharmaceuticals, Merus, Mirati Therapeutics, Rexahn Pharmaceuticals, Ocuphire Pharma, Processa Pharmaceuticals, ImmunityBio, Berg, Panbela Therapeutics, GlaxoSmithKline, Eleison Pharmaceuticals, Molecular Templates, Lokon Pharma AB, Cantargia AB, Bristol-Myers Squibb, among others. Gastroesophageal Junction Adenocarcinoma Market Gastroesophageal Junction Adenocarcinoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key gastroesophageal junction adenocarcinoma companies, including Astellas Pharmaceuticals, AstraZeneca, Bayer, Beigene, Bristol-Myers Squibb, Daichii Sankyo, Elevar Therapeutics, Eli Lilly, FivePrime Therapeutics, Incyte Corporation, Macrogenics, Merck Co., Ono Pharmaceuticals, Roche, Taiho Pharmaceuticals, Zai Labs, ZymeWorks, among others. Pancreatic Ductal Adenocarcinoma Market Pancreatic Ductal Adenocarcinoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key PDAC companies, including Cardiff Oncology, Cantargia, RenovoRx, Jeil Pharmaceutical, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

License out/inImmunotherapyPhase 3Phase 1

26 Apr 2025

·www.prnewswire.com

Innovent Announces NMPA Approval of Limertinib, a Third-generation EGFR TKI Collaborated with ASK Pharma, for the First-line Treatment of Lung Cancer

SAN FRANCISCO and SUZHOU,China, April 25, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major diseases, announces that China's National Medical Products Administration (NMPA) has approved the New Drug Application (NDA) for limertinib as the first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 19 deletions or exon 21 L858R mutations. Innovent and ASK Pharm entered into a commercial collaboration agreement for limertinib in Mainland China in 2024. The approval of this new indication is supported by positive results from a randomized, double-blind, positive-controlled Phase 3 clinical trial. A total of 337 treatment-naïve patients with EGFR-sensitive mutation-positive locally advanced or metastatic NSCLC were enrolled and randomized 1:1 to receive either limertinib or gefitinib. The primary endpoint was progression-free survival (PFS), as assed by an independent review committee (IRC). The data showed that limertinib significantly prolonged median PFS compared to gefitinib (20.7 months vs. 9.7 months), representing a 56% risk reduction in disease progression or death (hazard ratio [HR] 0.44; 95% CI: 0.34–0.58; p < 0.0001). In patients with central nervous system (CNS) lesions at baseline, median CNS PFS was also significantly longer with limertinib (20.7 months vs. 7.1 months), corresponding to a 72% risk reduction for CNS progression or death (HR 0.28; 95% CI: 0.10–0.82; p = 0.0136), underscoring its robust intracranial activity and clinical utility in such population with high-unmet-needs. The safety profile of limertinib was consistent with that of known EGFR-targeted therapies. Adverse events were predominantly mild to moderate and well-tolerated, with no new safety signals identified during the clinical trial. Full data and analysis from this pivotal Phase 3 study will be published in academic journals. "Limertinib has demonstrated exceptional efficacy and safety as first-line therapy in patients with EGFR-muted locally advanced or metastatic NSCLC, including notable efficacy in those with brain metastases. The approval of this first-line indication introduces a new treatment option for Chinese patients, addressing a critical clinical need in this population." said Professor Shi Yuankai, MD, Department of Medical Oncology at Chinese Academy of Medical Sciences and Principal Investigator of the Phase 3 Clinical Study. Dr. Hui Zhou, Senior Vice President of Innovent, stated："We are delighted that both the first-line and second-line indications for limertinib have been successively approved. As a next-generation EGFR TKI, limertinib is poised to significantly improve survival outcomes for mutation-positive patients. Innovent has built a rich portfolio of precision therapies for lung cancer—including limertinib, Retsevmo®(selpercatinib), Dupert®(fulzerasib) and DOVBLERON® (taletrectinib)—with ongoing efforts to enhance their synergistic value. We will continue to work closely with Ask Pharm to ensure that limertinib brings a new hope to the broad population of patients with EGFR-mutated NSCLC." Mr. Jingfei Ma, CEO of ASK Pharm, stated: "Within a few months, limertinib has obtained approvals for both second-line and first-line indications. The approval of the first-line indication further expands its clinical applicability. Meanwhile, ASK Pharm is advancing a clinical trial of limertinib in combination with the cMET inhibitor ASKC202 for patients with NSCLC resistant to third-generation EGFR-TKIs. We look forward to working with our partner Innovent to accelerate the accessibility of limertinib for more patients in need." About EGFR mutation-positive non-small-cell lung cancer (NSCLC) Lung cancer remains one of the deadliest and most common cancers globally[1], with NSCLC accounting for approximately 85% of cases. Around 70% of NSCLC patients are diagnosed at locally advanced or metastatic stages that are not amenable to surgical resection. EGFR mutations are particularly prevalent among Asian NSCLC patients, affecting 30% to 50% of cases. EGFR-TKIs are the recommended standard of care in the first-line setting, with third-generation EGFR-TKIs offering the broadest treatment applicability. About Limertinib Limertinib is an orally-administrated, third-generation EGFR TKI with proprietary rights. It has been approved by the China's NMPA for: 1) the treatment of adult patients with locally advanced or metastatic EGFR T790M-mutated non-small cell lung cancer (NSCLC), who have previously experienced disease progression during or after treatment with EGFR TKI; and 2) the first-line treatment of adult patients with locally advanced or metastatic NSCLC carrying EGFR exon 19 deletions or exon 21 L858R mutations. In October 2024, Innovent and ASK Pharm entered into a strategic collaboration and license agreement for limertinib in Mainland China. About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 15 products in the market. It has 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Statement: （1）Innovent does not recommend the use of any unapproved drug (s)/indication (s). （2）Ramucirumab (Cyramza®) and Selpercatinib (Retsevmo®) and Pirtobrutinib (Jaypirca®) were developed by Eli Lilly and Company. About Jiangsu Aosaikang Pharmaceutical Co. Ltd. (ASK Pharm) Founded in January 2003, Jiangsu Aosaikang Pharmaceutical Co. Ltd. (ASK Pharm) is a research-based pharmaceutical enterprise that integrates and streamlines innovative research and development with manufacture, marketing promotion and sales of proprietary pharmaceuticals, fine chemicals and health-care products. ASK Pharm specializes in digestive disease, multidrug resistant infection, oncology and chronic disease areas. ASK Pharm focuses on the R&D of small-molecule targeted innovative drugs and immuno-oncology biologic drugs. Currently, there are 48 major research projects, including 11 disclosed key projects focused on innovative chemical and biologic drugs. Among these, ASKC109 (maltol iron capsules) and ASKB589 (Claudin18.2 monoclonal antibody) are in Phase III clinical trials. ASK Pharm has Ranked among the top 20 best industrial enterprises in China's pharmaceutical R&D pipeline for 14 consecutive years and it has also received numerous honors such as "Top Ten National R&D Innovators", "Best National Enterprise for Investment", and "National Torch Program High-Tech Enterprises". For more information, visit . Innovent's Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. Reference [1] Bray F, et al. Global cancer statistics 2022. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4. PMID: 38572751. SOURCE Innovent Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3License out/inDrug ApprovalClinical ResultNDA

17 Jan 2025

·www.prnewswire.com

Innovent and ASK Pharm Jointly Announce NMPA Approval of Limertinib, a Third-generation EGFR TKI for the Treatment of Lung Cancer

SAN FRANCISCO and SUZHOU, China, Jan. 16, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major diseases, and Jiangsu Aosaikang Pharmaceutical Co. Ltd. (ASK Pharm, 002755.SZ), jointly announce that China's National Medical Products Administration (NMPA) has approved the New Drug Application (NDA) of limertinib for the treatment of adult patients with locally advanced or metastatic EGFR T790M-mutated non-small cell lung cancer (NSCLC). Limertinib is the 14th product in Innovent's commercial portfolio and represents a cutting-edge addition to its strong TKI franchise, offering an innovative precision therapy option to lung cancer patients. A Phase 2b pivotal study evaluating 301 patients with locally advanced or metastatic EGFR T790M-mutated NSCLC demonstrated limertinib's robust efficacy and safety profile. Independent review committee（IRC） assessment showed an overall response rate (ORR) of 68.8% and a disease control rate (DCR) of 92.4%. The median progression-free survival (PFS) reached 11.0 months, with a median duration of response (DoR) of 11.1 months. For patients with assessable central nervous system (CNS) lesions (N=99), the CNS best-ORR was 65.9% with a median PFS of 10.6 months. The safety profile aligned with other EGFR-targeting agents in its class. Additionally, limertinib met its primary endpoint in a Phase 3 clinical trial comparing it to gefitinib for first-line treatment of locally advanced or metastatic NSCLC harboring EGFR mutations. A separate NDA for the first-line treatment in adult patients with locally advanced or metastatic NSCLC carrying EGFR exon 19 deletions or exon 21 L858R mutations is currently under NMPA review. "Limertinib has demonstrated significant efficacy and safety in NSCLC patients with EGFR T790M mutation and EGFR-sensitive mutations. Patients treated with limertinib showed a reduced risk of CNS progression or death. This approval brings new hope and options to patients with advanced EGFR-mutated NSCLC in China," said Professor Shi Yuankai, MD, Department of Medical Oncology at Chinese Academy of Medical Sciences and Principal Investigator of the Phase 2b and Phase 3 clinical studies. Dr. Hui Zhou, Senior Vice President of Innovent, stated："The approval of limertinib's first indication marks a significant milestone, providing new treatment options for T790 mutation-positive lung cancer patients who have progressed after previous EGFR-TKI treatments. We anticipate the first-line treatment indication will benefit even more patients in the near future. As our 14th commercial product, limertinib represents an important advancement in precision medicine for lung cancer. We look forward to working with ASK Pharm to bring limertinib to market and benefit Chinese patients with EGFR-mutated NSCLC." Mr. Jingfei Ma, CEO and Executive Director of ASK Pharm, stated: "Beyond the approval for EGFR T790M+ NSCLC, limertinib is also under regulatory review for first-line treatment of EGFR 19DEL+ or L858R+ NSCLC in China. ASKC202, a new highly selective c-Met inhibitor, is currently undergoing clinical study in combination with limertinib to treat patients with third-generation EGFR-TKI resistance. Together with Innovent, we look forward to limertinib benefiting more Chinese lung cancer patients in the near future. The first approval of limertinib, a Class I innovative product, represents significant progress in the company's transformation toward innovative drug research and development. " About EGFR mutation-positive non-small-cell lung cancer (NSCLC) Lung cancer remains one of the deadliest and most common cancers globally[i], with NSCLC accounting for about 85% of cases. Around 70% of NSCLC patients are diagnosed at locally advanced or metastatic disease stages that cannot be surgically resected. EGFR mutations are particularly prevalent in Asian NSCLC patients, affecting 30% to 50% of cases. EGFR-TKIs are the recommended first-line standard of care for this group, with third-generation EGFR inhibitors offering the broadest applicability. About Limertinib Limertinib is an orally-administrated, third-generation EGFR TKI with proprietary rights, approved by the China's NMPA for the treatment of adult patients with locally advanced or metastatic EGFR T790M-mutated non-small cell lung cancer (NSCLC). A second NDA is under NMPA review for first-line treatment of adult patients with locally advanced or metastatic NSCLC carrying EGFR exon 19 deletions or exon 21 L858R mutations. The drug demonstrated success in a multi-center, randomized, double-blind, controlled Phase 3 clinical trial comparing its efficacy and safety of to gefitinib in first-line treatment of patients with locally advanced or metastatic NSCLC harboring EGFR mutations. With the primary endpoint met, results will be presented at upcoming academic conferences or published in academic journals. In October 2024, Innovent and ASK Pharm entered into a strategic collaboration and license agreement for limertinib in Mainland China. About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 14 products in the market. It has 3 new drug applications (NDA) under regulatory review, 3 assets in Phase III or pivotal clinical trials and 17 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. About Jiangsu Aosaikang Pharmaceutical Co. Ltd. (ASK Pharm) Founded in January 2003, Jiangsu Aosaikang Pharmaceutical Co. Ltd. (ASK Pharm) is a research-based pharmaceutical enterprise that integrates and streamlines innovative research and development with manufacture, marketing promotion and sales of proprietary pharmaceuticals, fine chemicals and health-care products. ASK Pharm specializes in digestive disease, multidrug resistant infection, oncology and chronic disease areas. ASK Pharm focuses on the R&D of small-molecule targeted innovative drugs and immuno-oncology biologic drugs. Currently, there are 48 major research projects, including 11 disclosed key projects focused on innovative chemical and biologic drugs. Among these, the innovative anti-tumor drug Limertinib are in the NDA stage, while ASKC109 (maltol iron capsules) and ASKB589 (Claudin18.2 monoclonal antibody) are in Phase III clinical trials. ASK Pharm has Ranked among the top 20 best industrial enterprises in China's pharmaceutical R&D pipeline for 14 consecutive years and it has also received numerous honors such as "Top Ten National R&D Innovators", "Best National Enterprise for Investment", and "National Torch Program High-Tech Enterprises". For more information, visit . Innovent's Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. Reference SOURCE Innovent Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 2Phase 3License out/inDrug Approval

100 Deals associated with Omectatug

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Gastroesophageal Junction Adenocarcinoma	Phase 3	China	AskGene Pharma, Inc.	25 Jan 2024
Metastatic Gastroesophageal Junction Adenocarcinoma	Phase 3	China	Jiangsu Aosaikang Pharmaceutical Co. Ltd.	25 Jan 2024
stomach adenocarcinoma	Phase 3	China	Jiangsu Aosaikang Pharmaceutical Co. Ltd.	25 Jan 2024
stomach adenocarcinoma	Phase 3	China	AskGene Pharma, Inc.	25 Jan 2024
CLDN18.2 positive Gastroesophageal junction adenocarcinoma	Phase 3	China	Jiangsu Aosaikang Biomedicine Co., Ltd.	12 Jan 2024
CLDN18.2 positive Stomach Cancer	Phase 3	China	Jiangsu Aosaikang Biomedicine Co., Ltd.	23 Nov 2023
Gastrooesophageal junction cancer	Phase 2	China	AskGene Pharma, Inc.	21 Feb 2023
Malignant neoplasm of gastro-oesophageal junction	Phase 2	China	AskGene Pharma, Inc.	21 Feb 2023
Malignant Solid Neoplasm	Phase 2	China	Jiangsu Aosaikang Pharmaceutical Co. Ltd.	28 Jan 2021
Gastroesophageal junction adenocarcinoma	Phase 2	China	Jiangsu Aosaikang Pharmaceutical Co. Ltd.	22 Jan 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05632939 (ESMO2025) Manual	Phase 1/2	CLDN18.2 positive Gastrooesophageal junction cancer \| CLDN18.2 positive Stomach Cancer First line CLDN18.2 Positive	47	ASKB589 + Capecitabine/Oxaliplatin + PD-1 inhibitor (CLDN18.2 expression-M/H)	okufxaudpx(ogezfdfttn) = yfmykmyvlm jisnpqlkmy (fntiwunlhm ) View more	Positive	17 Oct 2025
				ASKB589 + Capecitabine/Oxaliplatin + PD-1 inhibitor (CLDN18.2 expression-H)	okufxaudpx(ogezfdfttn) = ubsvmkyxux jisnpqlkmy (fntiwunlhm ) View more
ASCO2025	Not Applicable	Malignant neoplasm of gastro-oesophageal junction \| Stomach Cancer	-	ASKB589 6mg/kg plus chemotherapy	dcnlsduugp(xzlwymecus) = Treatment related adverse events (TRAEs) occurred in all pts including 26 (55.3%) pts with grade ≥3 TRAEs ibwwvnqpvz (crlkgrblwv ) View more	-	30 May 2025
				Paclitaxel
NCT05632939 (ASCO_GI2025) Manual	Phase 1/2	Metastatic Gastroesophageal Junction Adenocarcinoma \| Metastatic Gastric Carcinoma First line PD-L1 Expression \| CLDN18.2 Positive	50	ASKB589 6 mg/kgASKB589 6 mg/kg + CAPOX + PD-1 inhibitor	kzrqqwkduz(bxcvpipaqr) = gbwxpqcaqh smcyoyunzt (lwhcaojlol, 58.9 - 85.1) View more	Positive	23 Jan 2025
				ASKB589 6 mg/kgASKB589 6 mg/kg + CAPOX + PD-1 inhibitor (PD-L1 CPS <1)	kzrqqwkduz(bxcvpipaqr) = nzaoeejhgd smcyoyunzt (lwhcaojlol )
NCT05632939 (ASCO_GI2024) Manual	Phase 1/2	stomach adenocarcinoma \| Gastroesophageal junction adenocarcinoma First line CLDN18.2 Positive	9	ASKB589 (in escalation)	satqsfvzan(jfhorulajl) = rotajfoqmv bismuxrysi (vtzwfucttp ) View more	Positive	18 Jan 2024
				ASKB589ASKB589 10mg/kg (in expansion)	satqsfvzan(jfhorulajl) = itmkzmxlpj bismuxrysi (vtzwfucttp ) View more
NEWS Manual	Phase 1/2	Stomach Cancer \| Gastroesophageal junction adenocarcinoma First line	-	ASKB589+奥沙利铂+卡培他滨	mhpavvqckz(lvazfvzjtf) = kvultzjuwj jzrkbmesoj (swilporkks ) View more	Positive	28 Nov 2023
NCT04632108 (ASCO_GI2023) Manual	Phase 1/2	HR-positive/HER2-low Solid Tumors	51	ASKB589 (solid tumors + Part A)	nhmbawlfcf(qthhhsutoc) = dsarjqxxzv ytwpegyexv (vbbfwjnnsw ) View more	Positive	24 Jan 2023
				ASKB589+capecitabine+oxaliplatin (gastric/gastro-esophageal junction cancers + Part B)	nhmbawlfcf(qthhhsutoc) = zhebqodpqx ytwpegyexv (vbbfwjnnsw ) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis