SHANGHAI, Aug. 30, 2024 /PRNewswire/ -- On August 28, 2024, Sanyou Biopharmaceuticals (Shanghai) Co., Ltd. announced the launch of a comprehensive product line targeting monkeypox, which includes antigens, monoclonal antibodies, and overexpression cell lines. This product line features 65 items across three main categories: 26 natural epitope antigens, 28 high-affinity, high-specificity monoclonal antibodies and 11 overexpression cell lines. These products target multiple key sites on the surface of monkeypox virus, including A29L, M1R, H3L, E8L, A35R, B6R, and critical sites such as A28L, A30L, B21R, L1R and I1L, which are vital for viral infection and assembly. Developed using Sanyou Bio's proprietary "over-trillion innovative antibody discovery" platform, the monoclonal antibodies span multiple species, including fully human, nano, and mouse antibodies. These antibodies are essential for therapeutic drug development, with high-affinity nano antibodies being particularly valuable for structural analysis and bispecific research. Additionally, the entire range of antibodies, natural epitope antigens, and overexpression cell lines can be utilized in diagnostic reagents and scientific research. Dr. Lang Guojun, CEO of Sanyou Bio, emphasized the company's rapid response capabilities, citing significant contributions during the COVID-19 pandemic. During that time, Sanyou Bio played a key role in the drug discovery and preclinical development of two innovative COVID-19 antibody therapies, which were published in leading journals such as Science and Cell Research, with related therapeutics advancing to clinical trials. With this new monkeypox product line, Sanyou Bio aims to strengthen the development of vaccines, therapeutics, diagnostic tools and research initiatives, furthering its commitment to global public health. About Sanyou Biopharmaceuticals Sanyou Biopharmaceuticals Co., Ltd. is a world-leading high-tech biotechnology enterprise focusing on R&D and services of innovative biologic drugs. Sanyou has built the 4C business patterns that integrate "differentiated CRO, integrated CDO, innovative CPO and characteristic CRS", to accomplish the mission "to make the R&D easy for innovative biologics". Sanyou has established an integrated innovative biologic drug R&D laboratory with advanced facilities, and has a professional team with the majority holding a Ph.D. or master degree. Sanyou has built three industry-leading innovative technology platforms featured by "super-trillion, integration, and intelligence" , which are comprised of more than 50 sub-platforms with the core innovative super-trillion phage display platform, and supported by platforms of material preparation, biologics discovery, molecule optimization, in vitro and in vivo efficacy, production cell line construction, upstream and downstream process development, preclinical R&D, industrialization development, etc. Sanyou's business network has expanded to all parts of the world, including Asia, US and Europe, and established branches in Boston, Philadelphia, San Diego and London. Sanyou has established friendly business relationships with more than 1000 pharmaceutical companies, drug R&D institutions and diagnostics companies worldwide. Sanyou received National-level certification as a high-tech enterprise and a Specialized and Sophisticated enterprise, and passed the ISO9001 quality assurance certification and GB/T intellectual property management system certification.
SHANGHAI, Aug. 29, 2024 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, has announced its 2024 Interim Results. Business Highlights Zevor-cel was approved by NMPA in China. Patient enrollment for the confirmatory Phase II trial of satri-cel (CT041) in China has been completed. Multiple adjuvant studies for solid tumor CAR T-cell therapies are underway. Clinical data on satri-cel, zevor-cel, and CT071 were presented at academic conferences. Rapid development of differentiated allogeneic CAR T-cell product pipelines. Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics, said, "In the past six months, we have made significant progresses in technological innovation, product development, and business operations. Zevor-cel was successfully launched in China and has been included in nearly 20 provincial and municipal healthcare plans. The pivotal Phase II trial of satri-cel in China has completed patient enrollment. We are also actively exploring the potential of satri-cel in adjuvant therapy, aiming for greater clinical benefit for patients. Additionally, we are rapidly advancing CT071, which is manufactured with our CARcelerate® platform, while continuing to develop multiple allogeneic CAR T-cell products based on the THANK-uCAR® platform." CARsgen product pipeline 1. Zevor-cel Market Launch and Commercialization Progress in China Zevor-cel (zevorcabtagene autoleucel, CT053) is a fully human autologous CAR T-cell product targeting B-cell maturation antigen (BCMA). It was approved by the National Medical Products Administration (NMPA) on February 23, 2024 for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have progressed after at least three lines of therapy, (including a proteasome inhibitor and an immunomodulatory agent). CARsgen has been collaborating with Huadong Medicine for the commercialization of zevor-cel in mainland China. As of July 31, 2024, zevor-cel had been included in nearly 20 provincial or municipal government-subsidized insurance programs and private health insurance products; certification and regulatory filings had been completed in over 100 healthcare institutions across 19 provinces or cities nationwide; we had received a total of 52 orders from Huadong Medicine. The Group's revenue was over RMB6 million for the six months ended June 30, 2024 mainly from zevor-cel in which the primary revenue of zevor-cel was calculated on the basis of ex-works price, rather than on the basis of end-of-market prices. Our revenue is recognized upon completion of ex-works delivery of products. Besides, the Company received a milestone payment of RMB75 million from Huadong Medicine for zevor-cel for the six months ended June 30, 2024. Due to the inherent time cycle of CAR-T manufacturing, this results in a discrepancy between the number of orders obtained from Huadong Medicine and number of ex-works deliveries. 2. Progresses in Development of Differentiated CAR T Pipeline Satricabtagene autoleucel (CT041) is an autologous humanized CAR T-cell product targeting Claudin18.2. Patient enrollment for the confirmatory Phase II trial (NCT04581473) in China for the treatment of gastric cancer/gastroesophageal junction cancer (GC/GEJ) has been completed. Our collaboration with Moderna, Inc. is ongoing to investigate Moderna's investigational Claudin18.2 mRNA product in combination with satri-cel in preclinical studies. CARsgen is actively expanding the application of CAR T-cell therapies in post-surgery treatments for solid tumors, including an ongoing Phase I clinical trial for pancreatic cancer (CT041-ST-05, NCT05911217), an investigator-initiated trial that is currently in the start-up phase for GC/GEJ, and a Phase I clinical trial for hepatocellular carcinoma (CT011-HCC-03, NCT06560827). In the hematological malignancies field, the focus of the pipeline includes CT071, a fully human autologous CAR T-cell product targeting GPRC5D. CT071 was developed using CARsgen's CARcelerate® platform for the treatment of MM and primary plasma cell leukemia (pPCL). CARcelerate® is a proprietary platform developed by CARsgen that shortens the manufacturing time to approximately 30 hours, resulting in younger and potentially more potent CAR T cells compared to conventional manufacturing processes. An investigator-initiated trial (NCT05838131) for R/R MM and R/R PCL and another investigator-initiated trial (NCT06407947) for the treatment of newly diagnosed multiple myeloma (NDMM) are currently underway in China. An IND was cleared by the FDA in November 2023 for the treatment of patients with R/R MM and R/R pPCL. In addition to autologous products, CARsgen is also advancing differentiated allogeneic CAR T-cell products based on the THANK-uCAR® platform. These include: CT0590, for the treatment of R/R MM and PCL; KJ-C2320, for the treatment of acute myeloid leukemia (AML); KJ-C2219, targeting CD19 and CD20, for the treatment of B-cell-related hematologic malignancies and autoimmune diseases; and KJ-C2114, for the treatment of solid tumors. 3. Clinical Data Disclosure Updated results of the pivotal Phase II registrational trial of zevor-cel in China were reported as an oral presentation at the European Hematology Association (EHA) 2024 annual meeting. Updated data from the investigator-initiated trial (CT041-CG4006, NCT03874897) of satri-cel were published in Nature Medicine in June and presented orally at the 2024 American Society of Clinical Oncology (ASCO) annual meeting. A summary of safety and efficacy in patients with refractory metastatic pancreatic cancer (PC) (CT041-CG4006 & CT041-ST-01 Ib) was published in Journal of Clinical Oncology. The results from the satri-cel phase 1b clinical trial (CT041-ST-02, NCT04404595) in the U.S. were presented at the 2024 ASCO GI meeting. Results from the investigator-initiated trial (NCT05838131) of CT071 for the treatment of R/R MM were presented as a poster at the EHA 2024 annual meeting. Data updates for CT071 and CT0590 are to be disclosed in the second half of 2024. About CARsgen Therapeutics Holdings Limited CARsgen is a biopharmaceutical company with operations in China and the U.S., focusing on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors. CARsgen has established a comprehensive CAR T-cell research and development platform that covers target discovery, innovative CAR T-cell development, clinical trials, and commercial-scale production. Internally, CARsgen has developed novel technologies and a product pipeline with global rights to address significant challenges faced by existing CAR T-cell therapies. Efforts include improving safety profile, enhancing the efficacy in treating solid tumors, and reducing treatment costs. CARsgen's mission is to become a global biopharmaceutical leader that provides innovative and differentiated cell therapies for cancer patients worldwide and makes cancer curable. Forward-looking Statements All statements in this press release that are not historical fact or that do not relate to present facts or current conditions are forward-looking statements. Such forward-looking statements express the Group's current views, projections, beliefs and expectations with respect to future events as of the date of this press release. Such forward-looking statements are based on a number of assumptions and factors beyond the Group's control. As a result, they are subject to significant risks and uncertainties, and actual events or results may differ materially from these forward-looking statements and the forward-looking events discussed in this press release might not occur. Such risks and uncertainties include, but are not limited to, those detailed under the heading "Principal Risks and Uncertainties" in our most recent annual report and interim report and other announcements and reports made available on our corporate website, https://www.carsgen.com. No representation or warranty is given as to the achievement or reasonableness of, and no reliance should be placed on, any projections, targets, estimates or forecasts contained in this press release.
SAN FRANCISCO and SUZHOU, China, Aug. 29, 2024 /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, announces that nearly 20 accepted clinical data of its novel oncology molecules, including six oral presentations, will be released at World Conference on Lung Cancer (WCLC) from Sept 7-10, 2024, in San Diego, U.S., and the European Society of Medical Oncology (ESMO) from Sept 13-17, 2024, in Barcelona, Spain. Key data showcase includes: an oral presentation of updated Phase 1 result of its first-in-class PD-1/IL-2α-bias (IBI363) in NSCLC (up to 3mg/kg dosage) at WCLC, updated Phase 1 results of IBI363 (PD-1/IL-2α-bias) combination therapy in colorectal cancer at ESMO, an oral presentation of updated pivotal Phase 2 results of Dupert® (fulzerasib, KRAS G12C inhibitor) in NSCLC at WCLC, an oral presentation of Phase 1 results of IBI354 (HER2 ADC) in HER2+ solid tumors at ESMO, and multiple clinical results of TYVYT® (sintilimab injection). Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are very pleased to present a robust set of clinical data for our next-generation innovative bispecific antibodies and ADC molecules across renowned medical conferences of 2024 including ASCO, ESMO Plenary and ESMO GI in June, and WCLC and ESMO in September. We observed the preliminary efficacy and safety signals for those innovative candidates, underscoring their potential for further development and clinical value. As one of the few biopharmaceutical companies with both the technology platforms and robust pipeline in "IO+ADC" areas, Innovent remains dedicated to advancing cancer treatment and is committed to offering doctors and patients more innovative, effective, and safe therapeutic options." Details on the abstracts are listed below: WCLC: Oral Sessions Abstract Title: First-in-Class PD-1/IL-2 Bispecific Antibody IBI363 In Patients with Advanced Non-Small Cell Lung Cancer in a Phase 1 StudyAbstract No: MA11.04Session Type and Title: WCLC 2024-MA11. Building on the Foundations of Current ImmunotherapiesPresentation Time: Tuesday, September 10, 2024, 13:37-13:42 PDTPresenter: Jianya Zhou,The First Affiliated Hospital of Zhejiang University School of Medicine Abstract Title: KRAS G12C Inhibitor IBI351 In Patients (pts) with Advanced Non-Small Cell Lung Cancer (NSCLC): Updated Results from a Pivotal Phase 2 StudyAbstract No: OA14.05Session Type and Title: WCLC 2024-OA14. New Horizons in Targeting KRAS G12CPresentation Time: Monday, September 9, 2024, 15:52-16:02 PDTPresenter: Qing Zhou, Guangdong People's Hospital Abstract Title: Neoadjuvant Sintilimab plus Chemotherapy in EGFR-mutant NSCLC Followed by adjuvant Osimertinib or Observation: A Phase 2 CTONG2104 TrialAbstract No: MA15.11Session Type and Title: Mini OralPresentation Time: Tuesday, September 10, 2024 at 3:48-3:53 PM PDTPresenter: Guangdong Lung Cancer Institute, C. Zhang Abstract Title: First-Line Treatment of Locally Advanced or Metastatic Pulmonary Lymphoepithelioma-like carcinoma: A Multicenter, Single-Arm, Phase 2 TrialAbstract No: MA11.03Session Type and Title: Mini OralPresentation Time: Tuesday, September 10, 2024 at 1:32-1:37 PM PDTPresenter: The First Affiliated Hospital of Medical University, C. Zhou ESMO: Oral Sessions Abstract Title: IBI354 (anti-HER2 antibody-drug conjugate [ADC]) in patients (pts) with advanced solid tumors and breast cancer (BC): results from a Phase 1 studyAbstract No: 345MOSession Type and Title: ESMO 2024-Mini oral session 1: Breast cancer, metastaticPresentation Time: Sunday, September 15, 2024, 9:15-9:20 AM CESTPresenter: Christina Teng, Scientia Clinical Research, Australia Abstract Title: IBI354 (anti-HER2 antibody-drug conjugate [ADC]) in patients (pts) with advanced gynecological cancers (Gynecol C): results from a phase 1 studyAbstract No: 720MOSession Type and Title: ESMO 2024-Mini oral session 2: Gynecological cancersPresentation Time: Sunday, September 15, 2024, 15:45-15:50 CESTPresenter: Jin Shu, Chongqing University Affiliated Cancer Hospital WCLC: Posters Abstract Title: Neoadjuvant Chemoimmunotherapy for Potentially Resectable IIIA/IIIB NSCLC: Survival Updates and Predictive Effect of MRDAbstract No: EP.08D.01Session Type and Title: E-PosterPresentation Time: Saturday, September 7, 2024 at 11:58-11:59 AM PDTPresenter: First Hospital of Jilin University, K. Ma Abstract Title: Safety and Efficacy of Sintilimab Combined with Anlotinib in Patients with KRAS-Mutant Advanced Non-Small Cell Lung CancerAbstract No.: P4.11E.10Session Type and Title: E-PosterPresentation Time: Monday, September 9, 2024 at 6:30 PM PDTPresenter: Peking University Shenzhen Hospital, F. Wang ESMO: Posters Abstract Title: First-in-class PD-1/IL-2 bispecific antibody fusion protein IBI363 + bevacizumab (beva) in patients (pts) with advanced colorectal cancer (CRC): A phase I studyAbstract No: 574PSession Type and Title: ESMO 2024-PosterPresentation Time: Monday, September 16, 2024 CESTPresenter: Zhen Yu Lin, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Abstract Title: Safety and efficacy of IBI354 (anti-HER2 ADC) in patients (pts) with advanced gastrointestinal (GI) cancers: results from a Phase 1 studyAbstract No: 576PSession Type and Title: ESMO 2024-PosterPresentation Time: Monday, September 16, 2024 CESTPresenter: Jifang Gong, Peking University Cancer Hospital Abstract Title: Hepatic Artery Infusion Chemotherapy (HAIC) Plus Sintilimab and Bevacizumab Biosimilar (IBI305) for Initial Unresectable Hepatocellular Carcinoma (HCC) in Patients with Child-Pugh B Liver Function: A prospective studyAbstract No.: 980PSession Type and Title: Hepatocellular carcinoma (HCC) - PosterPresentation Time: Monday, September 16, 2024Presenter: Tianjin Medical University Cancer Institute & Hospital, Huikai Li Abstract Title: Hepatic arterial infusion chemotherapy combined with Sintilimab and regorafenib as adjuvant therapy for colorectal liver metastasis patients with high risk of recurrent: a single-arm, Phase 2 studyAbstract No.: 539PSession Type and Title: Colorectal cancer - PosterPresentation Time: Monday, September 16, 2024Presenter: Fudan University Shanghai Cancer Center, Lu Wang Abstract Title: Fruquintinib combined with sintilimab and chemotherapy as the first-line treatment in advanced naïve EGFR- and ALK-negative non-squamous non-small cell lung cancer (nsq-NSCLC): Updated resultsAbstract No: 1329PSession Type and Title: NSCLC, metastatic - PosterPresentation Time: Saturday, September 14, 2024Presenter: Jiangsu Province Hospital, Pei Ma Abstract Title: Sintilimab plus anlotinib in patients with advanced sarcomas (SINANLOSARC): a single-center, single-arm, Phase 2 trialAbstract No.: 1735PSession Type and Title: Sarcoma - PosterPresentation Time: Saturday, September 14, 2024Presenter: Shandong Cancer Institute, Shandong Cancer Hospital, Zengjun Liu Abstract Title: Efficacy and safety of sintilimab in combination with anlotinib plus metronomic chemotherapy in advanced triple negative breast cancer (SPACE): preliminary results of a single-arm, multicenter Phase 2 trialAbstract No.: 389PSession Type and Title: Breast cancer, metastatic - PosterPresentation Time: Monday, September 16, 2024Presenter: Shandong Cancer Institute, Shandong Cancer Hospital, Huihui Li Trial in Progress Abstract Title: Fruquintinib in combination with sintilimab and CAPEOX as first-line treatment for advanced G/GEJ cancer: A phase 1b/2 clinical trial (FUNCTION)Abstract No.: 1475TiPSession Type and Title: Oesophagogastric cancer, PosterPresentation Time: Monday, September 16, 2024Presenter: Henan Cancer Hospital, Bei-Bei Chen About InnoventInnovent 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 treat some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has 11 products in the market, 3 new drug applications under the NMPA review, 4 assets in Phase III or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare leaders, including Eli Lilly, Roche, Sanofi, Adimab, Incyte 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. Statement: Innovent does not recommend the use of any unapproved drug (s)/indication (s). Forward-looking statementThis 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 Biologics ("Innovent"), are intended to identify certain of such forward-looking statements. The Company 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 the Company 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 the Company'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, the Company's competitive environment and political, economic, legal and social conditions. The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialise or turn out to be incorrect.
BEIJING, Aug. 28, 2024 /PRNewswire/ -- Jenscare Scientific Co., Ltd. ("Jenscare" or the "Company") (HKEX: 9877), an innovative medical device company dedicated to interventional treatment for structural heart diseases with TTVR breakthroughs, released interim results for 2024H1 ended June 30, 2024. Financial Highlights: Net Loss Narrowed Significantly with Solid Cash Balance Net Loss attributable to common shareholders was RMB 102 million[1] (US$ 14 million), narrowed down by 41.8% compared to the same period of last year. Cash and cash equivalents, term deposits and financial assets was RMB 922 million (US$ 129 million), which is sufficient for the future development of the Company to achieve its business strategy by advancing the global application of its Core Products, including carrying forward the clinical trial, the registration process, and market launch of the products. [1] Conversions from RMB to US$ is made at an exchange rate of RMB7.1644 to US$1.00, set forth in the H.10 statistical release of the Federal Reserve Board on Aug 19, 2024. Business Highlights: Remarkable Clinical Results of LuX-Valve Plus were Published, Which Gained Worldwide Recognition and High Attention LuX-Valve Plus, the proprietary TTVR system, is designed for patients with severe tricuspid regurgitation (TR) and high surgical risk. LuX-Valve Plus breaks through multiple technical difficulties in tricuspid valve interventional therapy. With the design of innovative "interventricular septum anchoring" and "leakproof self-adaptive braided ring", which avoid traditional radial-force fixation and tend to effectively prevent AV Block. LuX-Valve series product is designated by the FDA as a breakthrough device, is enrolled in the Total Product Life Cycle Advisory Program (TAP) pilot of the FDA and was selected for the Expert Panel Scientific Advice Pilot by the EMA. The six-month clinical follow-up results of multicenter clinical trial TRAVEL II study of the LuX-Valve Plus were officially published at New York Valves 2024. According to the results, the device success rate was about 97%, and the average device operation time was around 35.56 minutes. The efficacy results showed that all patients had their TR grade improved and 97.62% of the patients had no moderate or above TR. In terms of New York Heart Association (NYHA) cardiac function improvement, 91.86% of patients improved from pre-procedure class III/IV to class I/II. In terms of quality of life, patients increased their Kansas City Cardiomyopathy Questionnaire (KCCQ) averaging score by 20 points. The safety results showed that the incidence of composite events is 8.33%. The TRAVEL II study results indicated that LuX-Valve Plus demonstrated promising mid-term clinical performance with no noticeable increase in safety events and continued improvement in efficacy over a longer clinical observation period, enabling the patients to further improve their cardiac function and quality of life, and sustained clinical benefits. The global compassionate use outcomes of LuX-Valve Plus were released at EuroPCR 2024. In-hospital outcomes indicated that TR grade reduced instantly and 92.2% of patients recovered to moderate and below. The percentage of incidence of new pacemaker implantation was only 3.9%. Subsequently, 30-day outcomes showed TR grade reduced significantly, 95% of patients recovered to moderate and below. NYHA cardiac function improved continuously, 85.4% of patients improved to post-operative class I/II. The echocardiographic findings showed that the right heart/ventricle benefits as well. The study outcomes demonstrate that the LuX-Valve Plus system for TTVR is safe and results in an efficacious TR reduction, and it is applicable to patients with advanced tricuspid disease characterized by large right ventricle dimensions. The compassionate use experience outcomes of LuX-Valve Plus in Hong Kong were shared at CHINA VALVE (HANGZHOU) 2024. According to the published data, the procedure success rate was 100%. The procedural and 30-day outcomes showed that the incidence rates of all-cause mortality, cardiovascular mortality, malposition/migration, emergency surgery/reintervention, vascular access complication, cerebrovascular accident and myocardial infarction were all 0%, and 100% of the patients had their TR grade improved to none/trace. The study concluded that LuX-Valve Plus is a promising TTVR device, which can cover a wide range of tricuspid annulus dimensions with low pacemaker rate, and demonstrated good procedural and post-procedural results. Future Expectations: Positive Progress of Clinical Trial and Business Operations Has Made Worldwide, Important Milestones Will be Achieved Started from 2024H2 LuX-Valve Series Products, the TTVR system In Europe, the subject enrollment for LuX-Valve Plus clinical trial aiming for obtaining CE Certificate is expected to complete in 2024Q3. Various clinical institutions from seven countries worldwide are actively participating in the clinical trial. LuX-Valve Plus has won unanimous acclaim from those participating clinical institutions. In the U.S., the IDE for EFS of LuX-Valve Plus has been approved by FDA, and the EFS has already been initiated. It is expected the subject enrollment for the EFS clinical trial to complete in 2024Q4. In mainland China, the one-year follow-up for registration clinical trial of LuX-Valve Plus has been completed. It is expected the application for registration to the NMPA for approval to be submitted in 2024Q3, and is expected to be approved in 2025H2. LuX-Valve Plus has completed a number of pre-commercial activities in multi-regions worldwide. In order to meet the substantial and urgent demand from tricuspid regurgitation patients around the world, the Company will continue to promote the application of the products around the world, which helps to lay a solid foundation for the Company's globalization strategy. Other Products Ken-Valve, the proprietary TAVR system designed for the treatment of aortic regurgitation or combined with aortic stenosis, is under registration review process by the NMPA. The application was admitted to enter the priority approval process of the NMPA (the "Priority Approval Process") for medical devices, making Ken-Valve the first valve product to enter this process. JensClip, the proprietary clip-based TMVr system designed for treatment of severe mitral regurgitation, has completed the subject enrollment for the confirmatory clinical trial and the one-month follow-up with encouraging clinical results. The one-year follow-up results is expected to be submitted for the NMPA approval in 2025H1.
SEOUL, South Korea, Aug. 28, 2024 /PRNewswire/ -- Yunovia, a drug R&D subsidiary of Ildong Pharmaceutical Group, announced on the 26th that the Ministry of Food and Drug Safety (MFDS) of Korea has cleared the IND application of Phase 1 Multiple Ascending Dose (MAD) study for ID110521156, an orally available small molecule GLP-1 agonist being developed for obesity and diabetes following the successful completion of the Phase 1 Single Ascending Dose (SAD) study. Phase 1 MAD study will be conducted to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) characteristics of ID110521156 following repeated administration and stepwise increase in dose. Previously, Yunovia not only confirmed the drug's effectiveness related to insulin secretion and blood glucose control, but also, its superior tolerability compared to other drugs in the same class through preclinical efficacy and toxicity evaluations in the recently completed Phase 1 SAD study. ID110521156 is a GLP-1 (glucagon-like peptide-1) receptor agonist that plays the same role as the GLP-1 hormone which is involved in the synthesis and secretion of insulin in the body, reduction of blood glucose level, regulation of gastrointestinal tract movements, and appetite suppression. Since ID110521156 is a small molecule compound, the Company's strategy is to develop it as an orally administrable drug for diabetes and obesity with differentiated attributes such as superior manufacturability and ease of use compared to peptide injections, the current standard of care. A Yunovia representative emphasized, "ID110521156 is the only small molecule based new drug in the clinical stage among all GLP-1 receptor agonists in Korea, and even by the global market standards, it falls within the group of GLP-1 receptor agonists whose development status is relatively advanced." The Company representative further stated, "We had been communicating with potential partner companies from the early development stage where their feedback from the perspective of the needs of the 'GLP-1 market', had been reflected in the designing of the SAD and MAD studies" Based on our continuing dialogue with them, we will proceed with further development of ID110521156 and, pursue global out-licensing. About ID110521156 ID110521156 is an orally available small molecule agonist of the GLP-1 receptor. Yunovia completed its Phase I SAD, including food effect study, in July 2024. ID110521156 was well tolerated and demonstrated potential as a once-daily drug with a sustained PK profile. The company plans to collect PD data, including continuous glucose monitoring and body weight changes, as exploratory endpoints from a 4-week MAD study. About Yunovia Yunovia was established in 2023 as a split-off from Ildong pharmaceutical to release the full potential value of global, innovative drug pipeline and to maximize the R&D productivity for accelerated drug development. Yunovia's R&D pipeline includes more than 20 innovative programs at various development stages for various therapeutic areas. With its small molecule R&D expertise and pipeline, including 3+ clinical programs, Yunovia will strive to grow as a leading innovator for life changing therapeutics. For more information, please visit https://www.yunovia.com/eng/main/. CONTACT: Hyang Choi, Business Development Team 2, Deputy General Manager, +82-2-526-3288, hyang.choi@ildong.com
BEIJING, Aug. 28, 2024 /PRNewswire/ -- Jenscare Scientific Co., Ltd. ("Jenscare" or the "Company") (HKEX: 9877), an innovative medical device company dedicated to interventional treatment for structural heart diseases with TTVR breakthroughs, released interim results for 2024H1 ended June 30, 2024. Financial Highlights Net Loss attributable to common shareholders was RMB 102 million[1] (US$ 14 million), narrowed down by 41.8% compared to the same period of last year. Cash and cash equivalents, term deposits and financial assets was RMB 922 million (US$ 129 million), which is sufficient for the future development of the Company to achieve its business strategy by advancing the global application of its Core Products, including carrying forward the clinical trial, the registration process, and market launch of the products. [1] Conversions from RMB to US$ is made at an exchange rate of RMB7.1644 to US$1.00, set forth in the H.10 statistical release of the Federal Reserve Board on Aug 19, 2024. Business Highlights and Future Expectations LuX-Valve Series Products, the TTVR system The six-month follow-up results of confirmatory clinical trial of LuX-Valve Plus has been published. The average device operation time was 35.56 minutes. The efficacy and safety results showed encouraging trends with respect to improvement in tricuspid regurgitation (97.62% of patients had no moderate or above TR), NYHA cardiac function (91.86% improved to post-procedure class I/II), and quality of life (KCCQ score averagely increased by 20 points), with low incidences of composite adverse events (8.33%). Innovative design concept allows wide applicability to large anatomies. In Europe, the subject enrollment for LuX-Valve Plus clinical trial aiming for obtaining CE Certificate is expected to complete in 2024Q3. In the U.S., the IDE for EFS of LuX-Valve Plus has been approved by the FDA, and the EFS has been initiated. It is expected subject enrollment for the EFS clinical trial to complete in 2024Q4. In mainland China, the one-year follow-up for registration clinical trial of LuX-Valve Plus has been completed. It is expected the application for the NMPA approval to be submitted in 2024Q3, and to be approved in 2025H2. Other Products Ken-Valve, the TAVR system designed for treatment of severe aortic regurgitation or combined with aortic stenosis, is under registration review process by the NMPA. JensClip, the TMVr system, has completed the subject enrollment for the registration clinical trial and the one-month follow-up with encouraging clinical results.
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