Novotech Acquires US-based Drug Development Consulting Firm, CBR International ACN Newswire

Novotech Acquires US-based Drug Development Consulting Firm, CBR International

January 12, 2023
SINGAPORE, Jan 12, 2023 - (ACN Newswire via SEAPRWire.com) - Novotech, the leading Asia Pacific-centered biotech CRO today announced the acquisition of CBR International, a global product development, clinical oversight and strategic regulatory operations group.CBR was founded in 2002 as a consultancy company focused on assisting biotechnology and pharma companies navigate FDA requirements from early-stage development through to approval. CBR adds a group of experts to Novotech to provide US and global regulatory, scientific, quality, and clinical development services. CBR's specific regulatory expertise and services include long-range Regulatory Strategy and Writing, FDA Representation, eSubmissions, and Scientific Affairs to support requirements for cGMP commercial product development.The acquisition will further strengthen Novotech's capabilities in regulatory strategy and US FDA interactions and submissions including IND, IDE, NDA, BLA, Fast-Track, Break-through, and Orphan Drug Applications.Novotech CEO Dr. John Moller said: "CBR will provide decades of FDA regulatory experience for our biotech clients. They have experience across all product types and are highly regarded for their IND expertise having managed approximately 80 INDs through all phases of development. This acquisition, together with Novotech's existing regulatory affairs capability, creates a large global group of experts in toxicology, drug development, and global regulatory submissions support. This regulatory expertise benefits our US, European, and Asia Pacific biotech clients as they progress through the US clinical environment and navigate often complex FDA requirements."CEO and Founder of CBR, Dr. Jeanne Novak said: "We are extremely pleased to be joining a company the size and calibre of Novotech which brings global demand for our regulatory expertise. The US is an important region for global biotech and pharma companies as part of their clinical program development. We have the experience and track-record of directly supporting US approvals for over 10 programs. Navigating novel product development and achieving multiple approvals has built our expertise to support the complex development needs of clients worldwide which will now support Novotech clients. We look forward to working with Novotech clients to support their drug development programs in the US and globally. We are excited to continue working with our clients and bringing Novotech expanded services to our colleagues."Novotech has decades of biotech drug development experience, exceptional site and investigator relationships, access to vast patient populations, and a project management approach focused on problem-solving, ownership and flexibility. Consistent investment in advanced training and technology combines to deliver a specialist full-service biotech CRO solution.Novotech has recently been recognised with significant CRO awards including the Asia-Pacific Biotech CRO of the Year by Frost & Sullivan, benchmarked as a top 10 CRO among the world's leading CROs, a finalist in the prestigious Scrip awards, and has just been awarded the Gene & Cell Therapy Excellence Award. In Asia Pacific Novotech has more than 50 Leading Site Partnership agreements with major medical research institutions which delivers exclusive benefits for sponsors.About NovotechNovotech is the leading Asia-Pacific centered biotech CRO. Novotech has integrated labs and phase I facilities and provides drug development consulting and clinical development services across all phases. Novotech is well-positioned to serve biotech clients conducting clinical trials in Asia-Pacific the US, and Europe. For more information visit https://novotech-cro.com/contactMedia ContactDavid JamesE: communications@novotech-cro.comAU: +61 2 8218 2144USA: +1 415 951 3228Asia: +65 3159 3427 Copyright 2023 ACN Newswire. All rights reserved. (via SEAPRWire)
More
Preventing Strokes and Heart Attacks Doesn't Have to Come with the Risk of Life-threatening Bleeding ACN Newswire

Preventing Strokes and Heart Attacks Doesn't Have to Come with the Risk of Life-threatening Bleeding

December 15, 2022
FREMONT, CA, Dec 14, 2022 - (ACN Newswire via SEAPRWire.com) - Verseon is delighted to announce that the European Journal of Medicinal Chemistry has published a paper (www.sciencedirect.com/science/article/abs/pii/S0223523422007577) describing the company's groundbreaking research that led to promising novel drug candidates for cardiovascular disease. Cardiovascular disease is the leading cause of death and disability in the world. Hundreds of millions of patients worldwide need anticoagulants to prevent clots that lead to life-threatening events like strokes, heart attacks, and pulmonary embolisms. However, currently prescribed so-called novel oral anticoagulants (NOACs) carry well-documented risks of major bleeds, which in many cases require hospitalization and can be life threatening. Developing drugs that prevent unwanted clots while preserving the body's ability to stop excessive bleeding is the "Holy Grail" of anticoagulant drug programs. Verseon is developing a new generation of anticoagulants called PROACs (Precision Oral Anticoagulants) that address this significant unmet medical need.The peer-reviewed paper documents how Verseon's medicinal chemistry team optimized various physicochemical properties -- including potency, selectivity, and in vivo stability -- of compounds from a novel class called N-acylpyrazoles. The resulting reversible covalent thrombin inhibitors are highly effective at preventing clots in vivo. Yet unlike NOACs, they do not inhibit thrombin-mediated activation of platelets, a critical step to stop injury-induced bleeding. Because of their unique mechanism of action, Verseon's drug candidates have demonstrated comparable efficacy to NOACs but with far lower bleeding risks in animal tests. The first lead candidate from this program is currently in clinical trials. "We are pleased to publish the discovery of this novel class of direct thrombin inhibitors with unique pharmacology," commented Dr. David Kita, Verseon's Chief Scientific Officer. "We look forward to describing further work behind the development of our first PROAC clinical candidate (VE-1902), which we expect will address a significant unmet medical need affecting a very large number of cardiovascular patients worldwide."The scientific paper, entitled "Discovery of novel N-acylpyrazoles as potent and selective thrombin inhibitors," is available at https://doi.org/10.1016/j.ejmech.2022.114855.About VerseonVerseon International Corporation (www.verseon.com) is redefining delay, prevention, and treatment of disease. Using its unique physics- and AI-based molecule-engineering platform, Verseon is rolling out a steady stream of life-changing medicines. Each of the company's drug programs features multiple novel candidates with unique therapeutic properties. Verseon's pipeline currently includes seven drug programs spanning major cardiometabolic diseases and cancers.Verseon's precision oral anticoagulants (PROACs) are potent, highly selective, reversible covalent inhibitors of thrombin. PROACs have shown excellent efficacy in multiple preclinical studies. The fact that PROACs do not disrupt platelet function and demonstrate correspondingly low bleeding risk makes them excellent candidates for use in long-term combination anticoagulant-antiplatelet therapy. The first development candidate, VE-1902, is currently in clinical trials. Among other unique properties of PROACs, VE-1902 has very low renal clearance, a highly desirable feature for patients with impaired kidney function. Verseon also has a second anticoagulant development candidate, VE-2851, which is expected to enter clinical trials at a later date.Contact:Walter Jonesmediarelations@verseon.com Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)
More
Novotech Awarded the Asia Pacific CRO of the Year 2022 for Best Practices in Clinical Trials ACN Newswire

Novotech Awarded the Asia Pacific CRO of the Year 2022 for Best Practices in Clinical Trials

December 6, 2022
SYDNEY, AU, Dec 6, 2022 - (ACN Newswire via SEAPRWire.com) - Novotech, the leading Asia Pacific biotech specialist CRO, has been awarded the Frost & Sullivan Company of the Year Award 2022 for Best Practices in the Asia-Pacific contract research organization industry. Novotech has been a recipient of the Frost & Sullivan Asia Pacific Best Practices awards since 2006.Frost & Sullivan identifies companies that consistently develop growth strategies based on a visionary understanding of the future, and effectively address new challenges and opportunities.Frost & Sullivan said: "Our approach involves the deployment of best practices and strategic analytics across a value chain. Against this backdrop, Frost & Sullivan recognizes Novotech for its valuable achievement. Novotech addresses the global drug development market's unmet needs with a strong leadership focus that incorporates client-centric strategies with best-practice implementation. From feasibility assessments to regulatory submission support, data management, medical monitoring, and project management, the company provides a 360-degree approach to drug development for its biotech clients."In response to the Company of the Year Award announcement, Novotech CEO Dr. John Moller said this award is a credit to our entire global team which has decades of biotech drug development experience."Every day our team supports biotech companies in their drug development programs with unparalleled regulatory knowledge, vast site and investigator networks, technology-driven clinical data management, and a project management approach focused on problem-solving, ownership, and flexibility. Our global clients benefit from access to our expert teams in Asia Pacific, which is the fastest-growing clinical trial region, due to its vast patient populations and sophisticated medical research infrastructure. Our consistent investment in advanced training and technology systems combine to deliver a specialist full-service biotech CRO solution."Novotech regularly produces expert reports on East-West strategies. A new publication is now available for international biotechs considering China for their clinical research, as well as China biotechs conducting research in China, and the relevant processes required for global regulatory approvals. The report details regulatory requirements for biotechs including NDA and IND processes as well as ex-US research guidance for a successful US FDA approval pathway. Novotech can provide the relevant regulatory knowledge and drug development pathways specifically designed to support the US FDA approval process, avoiding delays and additional costs.Download whitepaper here https://novotech-cro.com/whitepapers/china-biotech-landscape-opportunities-china-and-path-usfda-approvalNovotech has also recently been benchmarked as a top 10 CRO among the world's leading CROs, is a finalist in the prestigious Scrip awards, and has just been awarded the Gene & Cell Therapy Excellence Award. In Asia Pacific Novotech has more than 50 Leading Site Partnership agreements with major medical research institutions delivering exclusive benefits for sponsors.About Novotech Novotech is the leading Asia Pacific biotech specialist CRO. Novotech has integrated labs and phase I facilities and provides drug development consulting and clinical development services across all phases. It has been instrumental in the success of approximately 4,000 clinical trials across a broad range of therapeutic areas. Novotech is well-positioned to serve biopharma clients conducting clinical trials in Asia-Pacific and the US. For more information visit https://novotech-cro.com/contactMedia ContactDavid JamesE: communications@novotech-cro.comAU: +61 2 8218 2144 USA: +1 415 951 3228Asia: +65 3159 3427 Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)
More

巨生医MPB-1734抗癌药物新剂型取得成分专利

November 15, 2022
EQS 新闻 via SEAPRWire.com / 2022-11-15 / 10:41 UTC+8 【巨生生医(6827)巨生医MPB-1734取得成分专利新闻稿】 发布日期：2022年11月15日 巨生医MPB-1734抗癌药物新剂型取得成分专利 巨生生医股份有限公司（以下简称”巨生医”，台湾柜买中心股票代码：6827）宣布奈米微胞技术平台下产品MPB-1734抗癌药物新剂型正式获得美国成分专利，MPB-1734且已获得美国及台湾FDA核准临床1/2期试验，目前已完成收治2位受试者。 巨生医执行副总许源宏博士表示，奈米微胞技术平台应用于药物传输系统 (drug delivery systems，DDS) 开发，利用本公司独家高分子奈米微胞技术，可将难溶于水的疏水性药物，利用奈米微胞技术改良后，可稳定分散于水中并提高溶解度1,000倍以上，且能直接注射至人体中，大幅改善目前市售剂型注射时，需要使用有致敏性疑虑的乳化剂溶解并以类固醇预先治疗的缺点；另外由于奈米化的特性，改变了药物在体内的分布，大幅降低了化疗药物的副作用。同时因为具有避开 P-Glycoprotein drug efflux pump的特性，让MPB-1734 药物有机会用在已产生化疗抗药性的病人。 另外巨生医指出，在头颈癌的动物实验中发现，MPB-1734的治疗可大幅增加免疫细胞在肿瘤的浸润能力(例如:CD8+ T细胞等免疫细胞指标)，此肿瘤微环境的变化也反应在治疗效果上，MPB-1734并用免疫疗法的组别其肿瘤抑制效果显著优于单用免疫疗法及单用MPB-1734组别，具有加成性。MPB-1734未来有机会结合免疫疗法，除了本身的治疗效果，也可藉由改变肿瘤的微环境，让原本认为对免疫治疗无效的冷肿瘤(cold tumor)改变为热肿瘤(hot tumor)，达到最佳的合并治疗效果。 巨生医进一步表示，MPB-1734目前针对晚期的实体肿瘤病患进行临床试验，公司未来将针对高复发率的卵巢癌及病人数众多的头颈癌为目标，尤其对那些因为产生严重的白血球低落副作用，而无法继续接受治疗的病患，有一个新的可以使用的药物。日后也将以向美国FDA申请505(b)(2)新剂型新药与孤儿药等快速审查方式加速取得药证时程，希望能加惠病患，得到新的治疗机会。 关于巨生医： 巨生医（股票代号：6827）成立于2014年，由工研院分割成立，主要从事利基型奈米药物开发的新药技术公司。拥有两个奈米技术平台-「奈米微粒」及「奈米微胞」，并开发出奈米氧化铁产品。目前进度最快是应用于缺铁性贫血之注射型铁剂补充剂与肝癌显影剂。目前巨生医已发展出三大产品，分别为MPB-1514缺铁性贫血铁剂，MPB-1523磁振造影诊断用显影剂肝细胞癌，及MPB-1734新剂型抗癌药物。 更多公司介绍详见官网：https://www.megaprobio.com/ 声明： 本文件及同时发布之相关信息内含有预测性叙述。除针对已发生事实，所有对巨生医(以下简称本公司)未来经营业务、可能发生之事件及展望（包括但不限于预测、目标、估算和营运计划）之叙述皆属预测性叙述。预测性叙述会受不同因素及不确定性的影响，造成与实际情况有相当差异，这些因素包括但不限于价格波动、实际需求、汇率变动、市占率、市场竞争情况，法律、金融及法规架构的改变、国际经济暨金融市场情势、政治风险、成本估计等，及其他本公司控制范围以外的风险与变量。这些预测性叙述是基于现况的预测和评估，本公司不负日后更新之责。 文件: 巨生医MPB-1734抗癌药物新剂型取得成分专利 2022-11-15 此新闻稿由EQS Group via SEAPRWire.com转载。本公告内容由发行人全权负责。原文链接: http://www.todayir.com/sc/index.php
More
Eisai Announces Plans to Submit Application for Partial Change to Label for Dosage and Administration of Aricept for Treatment of Dementia with Lewy Bodies Based on Results of Drug Reexamination JCN Newswire

Eisai Announces Plans to Submit Application for Partial Change to Label for Dosage and Administration of Aricept for Treatment of Dementia with Lewy Bodies Based on Results of Drug Reexamination

November 2, 2022
TOKYO, Nov 2, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. announced today that it has received notification that Aricept (donepezil hydrochloride), a treatment for Alzheimer's disease and dementia with Lewy bodies that was discovered and developed in-house, has been granted Category 2* status based on the results of a reexamination of its efficacy, dosage and administration for the treatment of dementia with Lewy bodies (DLB) in Japan. In conjunction with this, Eisai plans to promptly submit an application for a partial change to label regarding dosage and administration. The indication for DLB remains unchanged. The indication of "suppression of progression of dementia symptoms in DLB" was approved in September 2014, primarily based on a Phase II study (Study 431) and Phase III study (Study 341) conducted by Eisai on people living with DLB in Japan. In accordance with the condition for the approval of this indication, "a clinical trial to verify the efficacy and safety of the drug in patients with DLB should be conducted and the results of the trials and analyses should be submitted promptly after completion," Eisai conducted a post-marketing clinical study (Study 419) to evaluate the efficacy and safety of the drug in patients with DLB. The results of Study 419 did not show a statistically significant difference between the placebo group and the Aricept group in the primary endpoint of global function (CIBIC-plus** comprehensive assessment), but the re-examination based on post-marketing studies, including the results of Study 419, stated that "at present, the evaluation of clinical function in DLB using CIBIC-Plus is not always sufficiently established as an evaluation method, and it is difficult to comprehensively evaluate the efficacy of this drug for DLB, although efficacy was seen in some patients. On the other hand, treatment with this drug showed a trend toward improvement in cognitive function (MMSE***), and this result is consistent with the results of the clinical trial at the time of approval of the drug. Since there are a certain number of patients who can be expected to benefit from the administration of this drug, it was concluded that the efficacy should be evaluated after the start of administration, and administration should only continue if efficacy is confirmed."Therefore, it was concluded that the approved label (dose and administration) and package insert should be appropriately revised (Category 2).The condition of the approval was lifted as of the date of receipt of the reexamination results. Along with this prompt application for a partial change to label regarding dosage and administration for the DLB indication, Eisai will place the highest priority on the provision of proper use and safety information for this drug, and will make continued contributions to address the diversified needs of, and increase the benefits provided to people living with DLB and their families. For more information, visit www.eisai.com/news/2022/news202274.html. Media Inquiries:Public Relations Department,Eisai Co., Ltd.+81-(0)3-3817-5120 Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)
More

Hua Medicine’s Innovative First-In-Class Glucokinase Activator (GKA) HuaTangNing Is Approved, New Type 2 Diabetes Treatment Paradigm to Begin in China

October 10, 2022
SHANGHAI, CHINA, Oct 10, 2022 - (ACN Newswire via SEAPRWire.com) - Hua Medicine (the "Company", HKEx Stock Code: 2552.HK) today announces that the New Drug Application (NDA) of HuaTangNing (dorzagliatin tablets, HMS5552), a first-in-class glucokinase activator (GKA) developed by the Company has been approved by the National Medical Products Administration (NMPA) of China on October 8th for two indications, both to improve blood glucose control for Type 2 diabetes (T2D) patients, as monotherapy for drug-naive T2D patients, or in combination with metformin in metformin tolerated T2D patients to control blood glucose level. For those patients with chronic kidney disease (CKD) and Type 2 diabetes (i.e., diabetes kidney disease), no dose adjustment is required. At the same time, clinical trials have shown that HuaTangNing in combination with empagliflozin (SGLT-2 inhibitor) and sitagliptin (DPP-IV inhibitor) is expected to better improve blood glucose control and pancreatic islet functions in T2D patients than either empagliflozin or sitagliptin taken alone.HuaTangNing is the first approved glucokinase activator (GKA) worldwide. Accordingly, the commercialization of HuaTangNing represents the first time globally in almost ten years that a new mechanism of action to treat Type 2 diabetes is introduced, and the first time in history that a global first-in-class drug for Type 2 diabetes is introduced first in China. This milestone represents unprecedented progress in the application of innovative scientific concepts in the Chinese biopharmaceutical industry to meet the clinical needs of Chinese patients. HuaTangNing is the first innovative first-in-class drug developed using the operation model of "Integration of global pharmaceutical research and development resources, to achieve joint innovation," and whereby China has led pharmaceutical innovation into a new historical stage.With the mission of "For Patients, Global Innovation, Effective Medicines", Hua Medicine has independently developed HuaTangNing, a first-in-class drug based on the characteristics of Chinese diabetic patients. Since the beginning of its scientific development, the research and development project of HuaTangNing has been highly valued by the new drug R&D community and national drug regulators. The project was selected as a national key scientific and technological project during the "12th Five-Year Plan" and the "13th Five-Year Plan" periods. HuaTangNing is a drug with new concept, new mechanism, new efficacy, new structure and new technology. It is led by a Chinese R&D team and Chinese clinical researchers from pre-clinical to Phase I, II, and III clinical trials. Therefore, it is not only a major R&D breakthrough in translating innovative concepts into innovative products, but also a pioneering path for China in developing first-in-class drugs independently. The approval of HuaTangNing also represents the first approved GKA drug, after many large and small pharmaceutical companies globally have spent over 2 decades of R&D resources on the glucokinase activator class, thereby achieving a breakthrough from zero. Going forward, Hua Medicine will partner with Bayer, a leading global pharmaceutical company, to commercialize HuaTangNing in China, benefiting diabetic patients and their families.Globally, the incidence of diabetes has been on the rise. According to the International Diabetes Federation (IDF), the number of adult diabetes patients worldwide reached 537 million in 2021, which was an increase of 74 million or 16% from 2019. Global health spending due to diabetes and its complications stood at USD 966 billion in 2021. China is no exception. There were over 140 million diabetic patients in 2021, 51.7% of which (around 72.83 million) have not been diagnosed or treated. In addition, fluctuating blood glucose levels lead to a series of diabetic complications such as cardiovascular and cerebrovascular, kidney, eye diseases, and diabetic feet, etc., which greatly affect the survival and life quality of diabetic patients, and exert a heavy pressure on their families. Therefore, stabilizing the T2D patient's blood glucose level at a good TIR (Time in Range) is an important goal in diabetes treatment and management. According to the 14th Five-Year National Health Planning issued by the General Office of the State Council, improving the prevention and treatment capacity of diabetes and other major chronic diseases is a key health-care topic for the country. It is estimated that over 65% of T2D patients will be covered by the health management service of community-level medical institutions during the 14th Five Year Plan period. The NDA approval and HuaTangNing adheres closely to the national strategy of developing the pharmaceutical industry and improving citizens' health.A rapidly growing population of diabetic patients and a huge market for diabetes drugs clearly establish strong unmet medical needs. With the original concept of "repairing the sensor, restoring homeostasis, and treating the underlying cause of diabetes", Hua Medicine boldly aims at directly addressing the root cause of the failure of blood glucose sensors in T2D patients. Clinical studies have shown that HuaTangNing can restore the impaired glucokinase sensor function and improve the ability of T2D patients to regulate blood glucose autonomously, thus potentially control the progression and complications of Type 2 diabetes from its source.As a new class of T2D treatment drug, the R&D of HuaTangNing has received continuous attention from the academic community worldwide. In 2018, the results of its Phase II clinical trial were published in The Lancet Diabetes and Endocrinology, a top international medical journal, which was the first time for the journal to publish the clinical research results of a T2D original innovative drug from China. In May 2022, Nature Medicine, a top international medical journal, simultaneously published two peer-reviewed papers on the results of our two Phase III clinical trials, describing the results of our monotherapy trial (the SEED study), and in combination with metformin trial (the DAWN study), respectively. It fully recognized HuaTangNing as a first-in-class diabetic drug with significant safety advantages and the characteristics of improving pancreatic islet functions in T2D patients. The unique advantages of HuaTangNing in T2D patients with nephropathy suggested by the clinical trials was also highlighted. Other clinical research also showed that HuaTangNing safely creates clear synergies in combination therapy with DPP-4 inhibitors and SGLT-2 inhibitors in blood glucose control, suggesting its broader potential in T2D patients with different needs in glycemic control and at different stages of disease progression. By potentially restoring early-phase insulin secretion and improving beta-cell function, HuaTangNing is expected to be a key path in diabetes remission. In the future, Hua Medicine will continue to explore HuaTangNing's potential in the remission of T2D drug discontinuation and the combination therapies with the other nine existing types of diabetes drugs. Hua Medicine is committed to addressing the needs of diabetic prevention, remission and complication control, and bringing Chinese innovation to the world.Xiaolan Zhou, Executive Vice President, Pharmaceuticals Division, Bayer AG and President of Bayer Pharmaceuticals China, said, "Bayer has been working on diabetes treatment and contributing to the development of diabetes prevention and treatment in China for years. HuaTangNing and Glucobay, the first oral hypoglycemic drug with impaired glucose tolerance (IGT), together with continuous glucose monitoring systems (CGMs), establish end-to-end course management from prevention to treatment for Chinese T2D patients. Real-time blood glucose monitoring helps achieve the goal of 'steady blood glucose control'. At the same time, Bayer proactively explores digital solutions to help hundreds of millions of Chinese patients to achieve the vision of diabetes-free."Dr. Li Chen, the founder, CEO and Chief Scientific Officer of Hua Medicine, said, "the NDA approval of HuaTangNing is a major milestone for Hua Medicine, as it also marks that the innovative drug industry in China has entered a new stage of new development. Diabetes chronic disease management is strategically important for China's economy and people's livelihood. Hua Medicine adheres to our original intention of 'China leading pharmaceutical innovation'. Amid fierce international competition, researchers and partners of Hua Medicine have spent 10 years of hard work to develop the first-in-class new diabetes drug - first in the world and start from China, achieving a breakthrough from zero. This achievement is attributed to all Chinese scientists, clinicians and partners participated in the R&D of HuaTangNing. We are proud of HuaTangNing and grateful to everyone for their hard work and wholehearted dedication. At the same time, Hua Medicine looks forward to in-depth integration and full vitality with Bayer in the commercialization of HuaTangNing, which will bring new hope of diabetes prevention, treatment and relief to up to one hundred million Chinese T2D patients, establish standards for diabetes prevention and treatment, and contribute to the national strategy of achieving Healthy China 2030."About HuaTangNingHuaTangNing (dorzagliatin tablets) is a first-in-class glucokinase allosteric activator (GKA) with a brand-new mechanism. It can be used alone or in combination with metformin hydrochloride (when using metformin hydrochloride alone is ineffective in controlling blood glucose), to improve blood glucose control for T2D adult patients with diet and exercise. HuaTangNing targets at restoring the impaired glucose sensor glucokinase (GK) in pancreas, intestine and liver, to achieve one target with multiple points and coordinated blood glucose control. It regulates glucose stimulated secretion of the glycemic controlling hormones insulin, GLP-1 and glucagon in diabetes patients, which leads to the improvement of early-phase insulin secretion and disposition index. It has potential in restoring glucose homeostasis and diabetes remission. Results from two Phase III registered trials of HuaTangNing monotherapy and combination therapy with metformin in metformin tolerated T2D patients have shown that HuaTangNing significantly improves glycemic control with effective reduction of post prandial glucose, low risk of hypoglycemia, well tolerance and safety. HuaTangNing demonstrated a linear correlation between drug dose and plasma exposure, with high target organs distributed in pancreas, intestine and liver. It showed low renal excretion and similar pharmacokinetic profiles at End Stage Renal Disease (ESRD) patients and healthy subjects, which suggest it can be readily used in those patients with renal insufficiency without dose adjustment. The unique mechanism of action, desirable pharmacokinetic, and good safety and tolerability profile establish HuaTangNing as a differentiated new class of anti-diabetes therapy.About Hua MedicineHua Medicine is an innovative drug development company found in China, focused on developing novel therapies for patients worldwide with unmet medical needs. Based on global resources, Hua Medicine teams up with global high-caliber people to develop breakthrough technologies and products, which contribute a global innovation in diabetes care. Targeting the glucose sensor, glucokinase, HuaTangNing (dorzagliatin tablets) as Hua Medicine's cornerstone product, restores glucose sensitivity in T2D patients and has completed registered SEED and DAWN Phase III trials in China. The NDA (New Drug Application) of HuaTangNing has been officially approved by the China National Medical Products Administration (NMPA). This first-in-class glucokinase activator has demonstrated its potential of achieving diabetes remission to help millions of diabetic patients around the world.About BayerBayer is a global enterprise with core competencies in health and agriculture of life science. Its products and services are designed to help human and the earth thrive by supporting the efforts to overcome major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable growth and having a positive impact on business. At the same time, Bayer aims to increase its profitability and create value through innovation and growth. Globally, the brand of Bayer stands for trust, reliability and quality. In the fiscal year of 2020, Bayer had around 100,000 employees, 41.4 billion euros of sales, and 4.9 billion euros of R&D expenses (excluding special programs). For more information, please visit www.bayer.com.About the cooperation between Hua Medicine and BayerIn August 2020, Bayer, a multinational pharmaceutical company, and Hua Medicine, a Chinese innovative drug research and development company, announced a strategic partnership on dorzagliatin, a first-in-class diabetes treatment drug, in China. This partnership aims at leveraging Bayer's prominent advantages in diabetes management in China and Hua Medicine's R&D expertise in diabetes treatment. Both parties are committed to benefiting hundreds of millions of China diabetic patients through new therapeutic options. Under the terms of the agreement, Hua Medicine as the market authorization holder (MAH) shall be responsible for clinical development, registration, product supply and distribution, while Bayer as the promotion service provider shall be responsible for marketing, promotion and medical education activities in China. The Pharmaceuticals China Innovation Center of Bayer facilitated this collaboration. As a global pharmaceutical leader, Bayer is committed to cooperating with external partners to promote breakthrough innovations, bring positive changes to patients, and achieve the goal of "cooperative innovation and joint cure". Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)
More
Apollomics Inc. Expands Leadership Team with Appointment of Jane Wang, PhD as Chief Scientific Officer ACN Newswire

Apollomics Inc. Expands Leadership Team with Appointment of Jane Wang, PhD as Chief Scientific Officer

July 26, 2022
Foster City, CA, and Hangzhou, China, Jul 26, 2022 - (ACN Newswire via SEAPRWire.com) - Apollomics Inc. an innovative biopharmaceutical company committed to the discovery and development of mono- and combination- oncology therapies, today announced the appointment of Jane Wang, PhD as Chief Scientific Officer. In this role, Dr. Wang will lead the drug discovery pipeline for the Company. She will also serve as Apollomics' China General Manager and will report to the Chief Executive Officer. "We are very excited to have Jane join our team," said Guo-Liang Yu, PhD, Co-Founder, Chairman and Chief Executive Officer. "Jane is a drug discovery expert in a number of therapeutic areas, including oncology, with a proven track record advancing compounds from the laboratory to clinical development. With her broad experience, she will make significant contributions to our global research strategy.""I am pleased to join a Company dedicated to the discovery, research, and clinical development of novel agents targeting multiple oncology indications. I look forward to growing our global team to discover and advance new compounds into the clinic," added Jane Wang, Ph.D., Chief Scientific Officer. Dr. Wang brings over 20 years of drug discovery experience in the biopharmaceutical industry. Most recently, she served as Vice President, Medicinal Chemistry at WuXi AppTec where she worked to enhance RNA drug discovery and led multiple teams in medicinal chemistry and synthetic organic chemistry. Prior to WuXi, Dr. Wang spent 12 years on the drug discovery team at Pfizer, Inc. as a senior principal scientist, focusing on diseases in oncology, inflammation, and the central nervous system Previously, she did her postdoc at the U.S. National Institute of Health and at Schering-Plough. Dr. Wang earned a Ph.D. from the University of Maryland Baltimore County and a B.S. in Applied Chemistry from Fudan University. She is an inventor/co-inventor of over 50 patent applications and an author of over 35 publications. About Apollomics Inc.Apollomics Inc. is an innovative biopharmaceutical company committed to the discovery and development of monotherapies and combination therapies of tumor-targeting and immuno-oncology agents. The Company's product pipeline has several programs at different stages of development, including a novel, humanized monoclonal antibodies that restore the body's immune system to recognize and kill cancer cells, and targeted therapies against uncontrolled growth signaling pathways. Apollomics has operating entities in Foster City, California, USA, Hangzhou and Shanghai, China. For more information, please visit www.apollomicsinc.com.Contact Information:Investor Contact:Raymond LowVP Finance, Corporate Controller(925) 451-0712Raymond.Low@apollomicsinc.comU.S. Media Contact:Remy BernardaCorporate Communications(415) 203-6386remy.bernarda@apollomicsinc.comChina Media Contact:Porda Havas International Finance Communications GroupKelly FungGeneral Manager(852) 3150 6763kelly.fung@pordahavas.com Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)
More