Process Performance Qualification (PPQ) validates robust manufacturing standards and is crucial for regulatory compliance Marks a key step forward for the world's first once-monthly IL-4Rα-targeting antibody therapeutic for Th2-driven diseases, with a strategic focus on entering the American and European markets SHANGHAI, Jan. 3, 2025 /PRNewswire/ -- Chime Biologics, a leading global CDMO that enables its partners' success in biologics, and Mabgeek, a clinical-stage innovative antibody drug development biotech focusing on immuno-inflammation, today announced the successful completion of Process Performance Qualification (PPQ) for MG-K10, a humanized anti-IL-4Rα monoclonal antibody. This milestone propels the Phase III clinical trials for treating Th2-mediated inflammatory diseases such as moderate-to-severe atopic dermatitis (AD), asthma, rhinosinusitis, prurigo nodularis, esophagitis and chronic obstructive pulmonary disease (COPD). Chime Biologics and Mabgeek's strategic collaboration, first unveiled in 2022, focuses on commercial manufacturing of cGMP 2000L drug substance, late-stage chemistry, manufacturing, and controls (CMC) development and biologics license application (BLA) to accelerate Best-in-Class biologics MG-K10's commercialization. Combining Mabgeek's expertise in monoclonal antibody innovation with Chime Biologics' adoption of the internationally recognized quality-by-design concept, risk management methodology, and robust CMC processes, this partnership will continue to speed up development timelines while maintaining rigorous global quality standards and regulatory compliance. MG-K10 is currently the only pipeline product in this category worldwide that has been verified in late clinical study that can be dosed once every four weeks (Q4W), meeting the two key needs of strong efficacy and excellent patient adherence, which is crucial for success in the American and European markets. Dr. Jimmy Wei, President of Chime Biologics, noted, "We are delighted with the successful completion of MG-K10's PPQ. This achievement marks a significant milestone in our partnership and signals its immense potential in the global market. Chime Biologics upholds international quality standards, reflecting our commitment to delivering top-tier biopharmaceutical solutions that are in line with global regulatory requirements. Through our partnership with Mabgeek, we are advancing therapeutic innovation to accelerate the commercialization of MG-K10, ensuring patients worldwide receive transformative care sooner." Dr. Chenghai Zhang, CEO of Mabgeek, stated, "The successful PPQ for our pioneering MG-K10 antibody is a testament to the power of collaboration between us, and we are confident in entering the American and European markets, leveraging our strong innovation capabilities and commitment to meeting unmet clinical needs in allergic inflammatory diseases and autoimmune diseases. We will continue to advance this partnership with Chime Biologics to commercial manufacturing, aiming to broaden access to groundbreaking therapies for patients worldwide." With Phase III trials underway, this collaboration remains committed to delivering Best-in-Class treatments to the market. The PPQ milestone of MG-K10 highlights Chime Biologics' strategic approach to fostering global innovation through robust partnerships, with a particular emphasis on meeting the high standards required for success in the American and European markets. About MG-K10 MG-K10, a novel and long-acting humanized IL-4Rα targeting mAb drug with half-life extended, has been confirmed to have potential in treating all Th2 related disease, including AD, asthma, rhinosinusitis, prurigo nodularis, esophagitis, COPD and so on. The Phase II clinical results of MG-K10 in both AD and asthma confirmed that it has the potential to be Best-in-Class. In the Phase II moderate-to-severe AD trial, MG-K10 highly improved patients' clinical signs and quality of life, while in the Phase II moderate-to-severe asthma trial, MG-K10 significantly improved lung function and clinical symptoms. While other launched anti-IL-4Rα therapeutics need to be dosed Q2W, MG-K10 is highly effective and well tolerated dosed Q4W. MG-K10 is in Phase III in AD, asthma and prurigo nodularis. About Mabgeek Mabgeek was founded in 2016, always adhering to the research and development concept of "innovation, efficiency and safety", focusing on the Immuno-Inflammation field. Mabgeek has a research and development team composed of top experts in the industry. With excellent research and development capabilities and deep industry accumulation, Mabgeek uses its unique TEADA hybridoma platform to develop differentiated and innovative monoclonal and bispecific antibody drugs with high biological activity and high drug yield, and is committed to bringing more safe, effective and convenient treatment to all patients globally. Other than MG-K10, Mabgeek also is studying anti-TSLP (half life more than 80 days) in Phase II clinical trial in asthma, and got IND approval for half life extended anti-MASP-2 mAb. For more information, please visit: www.mabge.com. About Chime Biologics Chime Biologics is a leading global CDMO that has introduced the first modular biopharmaceutical plant KUBio in the world to empower its partners' success in biologics in the whole process from cell line development to commercial manufacturing. Relying on cell line development and advanced technology development from our Shanghai Innovation Center and proven success in IND-enabling through BLA filing at its Wuhan plant, Chime Biologics is providing a one-stop CMC solution for biopharmaceutical customers around the world. We share a common goal to make cutting-edge biomedicines affordable and accessible to all patients globally, fulfilling its commitment to human health. For more information, please visit: www.chimebiologics.com.
CAMBRIDGE, Mass., Jan. 3, 2025 /PRNewswire/ -- Nona Biosciences, a global biotechnology company providing a total solution from "Idea to IND" (I to ITM), today announced that BeiGene. Ltd. has exercised its exclusive option to acquire global development, manufacturing, and commercialization rights for an antibody-drug conjugate (ADC) from DualityBio, a collaborator of Nona Biosciences. This ADC was developed under the collaboration agreement established between Nona Biosciences and DualityBio in 2022. Under the terms of the agreement, Nona Biosciences granted DualityBio exclusive rights to certain monoclonal antibodies targeting specific tumors, enabling the development of first-in-class ADC candidates worldwide. About Nona Biosciences Nona Biosciences is a global biotechnology company committed to cutting edge technology innovation and providing a total solution from "Idea to IND" (I to ITM), ranging from target validation and antibody discovery through preclinical research. The integrated antibody and antibody-related discovery services with multiple modalities range from antigen preparation, animal immunization, single B cell screening, to antibody lead generation and engineering, developability assessment and pharmacological evaluation, leveraging advantages of Harbour Mice® platforms and the experienced therapeutic antibody discovery team. Harbour Mice® generates fully human monoclonal antibodies in classical two light and two heavy chain (H2L2) format, and heavy chain only (HCAb) format. Integrating Harbour Mice® and a single B cell cloning platform, Nona Biosciences is focused on driving global inventions of transformative next-generation drugs. For more information, please visit: www.nonabio.com.
SAN FRANCISCO and SUZHOU, China, Jan. 3, 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 oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, today announced that China's National Medical Products Administration (NMPA) has approved the second New Drug Application (NDA) of DOVBLERON® (taletrectinib adipate capsule), a next-generation ROS1 tyrosine kinase inhibitor (TKI), for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC. The approval is based on positive results from the pivotal Phase 2 TRUST-I trial (NCT04395677), a multicenter, open-label, single-arm trial that evaluated the safety, tolerability and efficiency of taletrectinib in Chinese patients with advanced ROS1-positive NSCLC. The findings, presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the Journal of Clinical Oncology (JCO), demonstrated that taletrectinib continued to show high and durable overall responses and robust activity against intracranial lesions. In ROS1 TKI-naïve (n=106) patients, confirmed objective response rate (cORR, as assessed by an independent review committee, IRC) and intracranial cORR reached as high as 91% and 88%, respectively. After median follow-up of 23.5 months in TKI-naïve patients, median duration of response (IRC-assessed) and median progression-free survival (IRC-assessed) were not reached. [Link] In December 2024, DOVBLERON® was approved by the NMPA for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have been previously treated with ROS1 TKIs. DOVBLERON® is the 13th addition to Innovent's commercial portfolio, representing an innovative precision therapy expected to benefit more lung cancer patients alongside our strong TKI franchise. Caicun Zhou, M.D., Ph.D., Director of the Department of Oncology at Shanghai East Hospital, Tongji University, commented: "We are glad to see that DOVBLERON® has been approved for ROS1-positive NSCLC across treatment lines at a fast pace. DOVBLERON® demonstrated superior efficacy compared to the first-generation TKIs. These TRUST-I results reinforce taletrectinib's high overall response and prolonged PFS. The efficacy and safety profile of DOVBLERON® offers a more effective first-line treatment option and I look forward to its benefit in the ROS1-positive NSCLC patients in China." Dr. Hui Zhou, Senior Vice President of Innovent, stated: "The two NDAs approval of DOVBLERON® is a reflection of its potential best-in-class efficacy to fulfill the urgent need of patients with ROS1-positive NSCLC. We recently just launched the first batch of DOVBLERON® to market, rapidly bringing this precision therapy to NSCLC patients who need novel treatment options. Innovent's robust TKI product pipeline—including RETSEMOV®, PEMAZYRE®, DUPERT® and DOVBLERON®—showcases our leadership and synergistic strengths in precision oncology. We endeavor to advance more innovative medicines to enhance patients' quality of life." About ROS1-positive Non-small Cell Lung Cancer Lung cancer continues to have one of the highest global incidences and mortality rates, with NSCLC accounting for about 85% of all cases. In China, it is estimated that approximately 2.6% of patients living with NSCLC are ROS1-positive[i]. Despite recent progress for patients with ROS1-positive NSCLC, there remains a need for more effective and tolerable treatment options. In patients with metastatic ROS1-positive NSCLC that progressed following initial treatment, many have tumors spread to their brain (up to 55%) or acquired resistance mutations, including G2032R. Next-generation ROS1 TKIs demonstrated robust intracranial and G2032R activity. In the clinical management of ROS1-positive NSCLC patients, the first-line application of the new generation ROS1 TKIs can bring a prolonged progression-free survival and provide patients with greater survival benefits. About DOVBLERON ® (Taletrectinib Adipate Capsule) DOVBLERON® is an oral, potent, central nervous system-active, selective, next-generation ROS1inhibitor. Taletrectinib, the active ingredient in DOVBLERON® is being evaluated for the treatment of patients with advanced ROS1-positive NSCLC in two Phase 2 single-arm pivotal studies: TRUST-I (NCT04395677) in China, and TRUST-II (NCT04919811), a global study. DOVBLERON® was approved by China's National Medical Products Administration (NMPA): 1) for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC who have previously been treated with ROS1 TKIs; 2) for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC. Taletrectinib has been granted Orphan Drug Designation by the U.S. FDA for the treatment of patients with ROS1-positive NSCLC and other NSCLC indications, and Breakthrough Therapy Designations by both the U.S. FDA and China's NMPA for the treatment of patients with locally advanced or metastatic ROS1-positive NSCLC. Based on pooled results of the TRUST-I and TRUST-II clinical studies, Nuvation Bio Inc. (NYSE: NUVB) submitted an NDA for taletrectinib to the U.S. FDA for the treatment of patients with advanced ROS1-positive NSCLC (line agnostic, full approval). This NDA was accepted by the U.S. FDA for priority review in December 2024. In June 2021, Innovent and AnHeart Therapeutics (Hangzhou) Co. Ltd., a Nuvation Bio Inc. company, entered into an exclusive license agreement for the co-development and commercialization of taletrectinib in Greater China, including mainland China, Hong Kong, Macau and Taiwan. 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 13 products in the market. It has 4 new drug applications 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 www.innoventbio.com, or follow Innovent on Facebook and LinkedIn. 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. References [i] Zhang et al. Prevalence of ROS1 fusion in Chinese patients with non-small cell lung cancer. Thorac Cancer. 2019 Jan;10(1):47-53.
ALL-RISE Study Included Over 1,924 Patients in 59 Sites Across North America, Asia, Europe and the Middle East NEWPORT BEACH, Calif., Jan. 3, 2025 /PRNewswire/ -- CathWorks, a global leader in medical device digital health innovations, announced today the successful completion of enrollment of the Advancing Cath Lab Results with FFRangio Coronary Physiology Assessment (ALL-RISE) randomized controlled trial (RCT). This landmark study represents a significant milestone in the field of interventional cardiology, evaluating the clinical and economic benefits of the CathWorks FFRangio® System in diagnosing and treating coronary artery disease (CAD), offering potentially groundbreaking evidence that could redefine the standard of care. The ALL-RISE Study included over 1,924 patients across 59 sites in North America, Asia, Europe and the Middle East. Participants presenting with coronary stenoses of intermediate significance and requiring physiology assessment were randomized to receive either FFRangio-guided treatment or invasive pressure wire-guided treatment. Notably, this was the first-ever randomized controlled trial in the United States to assess clinical outcomes using an angiography-based tool for physiologic lesion assessment. In a joint statement, the ALL-RISE Study Chair, Dr. Ajay J. Kirtane (NewYork-Presbyterian/Columbia University Irving Medical Center) and Principal Investigators, Dr. William Fearon (Stanford University) and Dr. Allen Jeremias (St. Francis Hospital & Heart Center), stated, "On behalf of the study executive committee, we would like to congratulate and thank all the global investigators, study coordinators and patients who collectively enabled this incredible accomplishment. The high level of engagement and record speed of enrollment parallel the growing adoption of FFRangio globally. We look forward to sharing the results of this landmark study after clinical follow-up is completed." CathWorks Sr. Director of Clinical Affairs, Alex Froimovich M.D., added, "The completion of ALL-RISE enrollment marks a significant milestone for our company and team's mission to transform how cardiovascular disease is diagnosed and treated. We believe this study, adding to FFRangio's growing body of clinical evidence, has the potential to significantly advance the field of coronary physiology and close the gap between its current adoption and the appropriate use guidelines recommendations. FFRangio has already demonstrated higher diagnostic accuracy over all other angio-based technologies, highlighting the fact that not all angio-based technologies are created equal, and therefore technology-specific clinical data are needed." Cardiovascular disease (CVD) remains the leading cause of death in the United States. According to the American Heart Association's (AHA) 2024 Heart Disease and Stroke Statistics Update, CVD accounted for 931,578 deaths in the U.S. in 2021, and close to 18 million deaths globally. Coronary artery disease (CAD) is the single largest contributor, responsible for over 40% of CV deaths. CathWorks believes the results from the ALL-RISE study will build on what the company refers to as a new era in physiology, underscoring FFRangio as the new standard of care with the potential to drive better patient outcomes while delivering tangible economic and resource utilization benefits to healthcare systems. ABOUT CATHWORKS CathWorks is the leader in digital health innovations that can improve the lives of patients globally. The CathWorks FFRangio® System combines artificial intelligence and advanced computational science, transforming how cardiovascular disease is diagnosed and treated. The FFRangio System obtains physiologic information from routine angiograms, eliminating the need for drug stimulation and invasive pressure wires. It provides physicians with quick and reliable intraprocedural FFRangio values for the entire coronary tree. For more information on CathWorks, visit www.cath.works and follow @CathWorks on LinkedIn. Investors:Mike Fehermike.feher@cath.works Media:Sarita Monicosarita.monico@cath.works
WUHAN, China, Jan. 3, 2025 /PRNewswire/ -- Hanx Biopharmaceuticals, CO. Ltd, an innovative biotechnology company developing next-generation immunotherapies to address the challenges of unmet medical need diseases, today announced the first patient dosing in Australia on Dec 30, 2024 for Phase 1 clinical trial of HX044 in patients with advanced solid tumors (HX044-I-01, A Phase I/IIa, First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of HX044 in Patients with Advanced Solid Tumor Malignancies, NCT06649708). HX044 is an innovative bispecific antibody independently developed by Hanx Biopharmaceuticals. It is a first-in-class and considered to be a next generation immune-checkpoint inhibitor designed to treat a wide range of malignant tumors, including PD-1-resistant solid tumors such as non-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma, and gastrointestinal cancers. HX044 represents a new generation CTLA-4 immunotherapy by expanding the therapeutic window, optimizing safety, and enhancing antitumor immune responses, showcasing a breakthrough in CTLA-4 immunotherapy. "We are thrilled to see the first patient entered into clinical study, which marks a significant development milestone for this therapeutic candidate in our pipeline. This achievement demonstrated our strong R&D and clinical development capacity, and it reflects our commitment to addressing unmet medical needs for the patients. We will be working diligently to move this project forward", said Dr. Faming Zhang, Chairman of Hanx Biopharmaceuticals. "HX044 is a next generation CTLA-4 bispecific antibody fully developed in-house by the company, starting from molecule design. It enhances Treg-depletion function within tumor microenvironment through its effective cis-binding mechanism. It shows strong efficacy even against PD-1-resistant "cold" tumors in preclinical models, demonstrating superior therapeutic potential", commended by Dr. Henry Li, CEO/CSO of Hanx Biopharmaceuticals. About HANX BIOPHARMACEUTICALS Hanx Biopharmaceutical Co., Ltd. is an innovative biotechnology company dedicated to structural biology, translational medicine, and clinical development. The company strives to develop next-generation immunotherapies to provide global patients with affordable, safe, and effective medical solutions, addressing the challenges of major diseases. Guided by a mission and vision driven by innovation, Hanx Biopharmaceuticals focuses on discovering, developing, and commercializing First-in-Class and Best-in-Class therapies for cancer and autoimmune diseases. The company is committed to meeting unmet medical needs worldwide, advancing disease prevention, control, and ultimately elimination, and contributing to global health initiatives.
SHANGHAI, Jan. 2, 2025 /PRNewswire/ -- Shanghai MicuRx Pharmaceutical Co., Ltd. ("MicuRx"，688373.SH) announced that MRX-5, its self-developed anti-infection drug, has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of non-tuberculous mycobacteria (NTM) infections. This designation marks a significant milestone for MicuRx in the field of NTM infection treatment. MRX-5 is a novel benzoxazole antibiotic developed for the treatment of mycobacteria infections, particularly infections caused by non-tuberculous Mycobacteria (NTM). In recent years, NTM diseases have been increasing rapidly and have become one of the major public health threats worldwide[1]. However, current treatment options for NTM infections are limited, and traditional drugs face common challenges such as drug resistance, poor efficacy, and numerous adverse effects[1,2]. MRX-5 is a new drug specifically aimed at treating drug-resistant NTM infections, demonstrating good antibacterial activity against common NTM strains. It has also shown potent antibacterial activity against NTM pathogens in both animal studies and human trial, along with favorable safety and pharmacokinetic profiles. Additionally, MRX -5 features minimal interactions, low potential for resistance, and high oral bioavailability, making it suitable for long-term use in treating chronic infections. The granting of ODD is not only an important milestone in the development of MRX-5, but also a recognition of research and development capabilities of MicuRx. ODD applies to drugs used to prevent, treat, or diagnose rare diseases that affect fewer than 200,000 people in the U.S., including biologics. According to the Orphan Drug Act, applicants who receive ODD are eligible for various benefits, including tax credits, waivers for certain clinical trial costs, exemption from New Drug Application (NDA)/Biologics License Application (BLA) fees, and seven years of market exclusivity after approval. This designation will help accelerate the clinical development and commercialization process of MRX-5. Moving forward, MicuRx will continue to advance the clinical development and commercialization of MRX-5, actively exploring oral treatment strategies that include MRX-5, with the goal of providing safer and more effective treatment options for patients with NTM infections. Reference: [1] Chinese Thoracic Society, The Diagnosis and Treatment Guidelines for Non-tuberculous Mycobacterial Disease (2020 Edition), Chinese Journal of Tuberculosis and Respiratory Diseases, 2020, 43(11): 918-946. DOI: 10.3760/cma.j.cn112147-20200508-00570. [2] Zhiming Ma. Treatment of Non-Tuberculous Mycobacteria: Challenges and Prospects. https://mp.weixin.qq.com/s/m14Jj8v2gs8zs8bt8YKClA
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