LONDON, UK / ACN Newswire / September 27, 2023 / In the age of early mass dissemination of accessible AI solutions, many specialists and researchers from different scientific, technical and academic fields claim that AI has not yet gone far enough. According to a recent Editorial published in Nature, several research fields which need accurate and accessible data won’t achieve their full potential until they integrate adequate machine-learning systems.

Hyris Onboarding Programs With Hyris both established and emerging test developers can optimize their go-to-market by leveraging the power of AI.

Even if AI tools promise a disruption in the way researchers seek and synthesize useful new substances and tests, we are far from a wholesale revolution yet, also because of the lack of data available to feed centralized AI systems. This poses several challenges to researchers and kit developers in designing and delivering new testing solutions.

Hyris keeps true to its vision, to democratize genetics and health insights, marking a new stage in its partnership policies with newfangled onboarding programs specifically designed to further support researchers and kit developers at every stage.

“Genetic test developing and onboarding has always been faced with inherent challenges, from resource staffing to competence integration, from research funding to ensuring adequate testing volumes,” states Angelica Baccanelli, Head of Quality & Regulation at Hyris. “Adapting to variability in the compliance environment, applying requirements to molecular assays, and developing the proper documentation for the go-to-market can all pose additional risks.”

Amongst many challenges, technological access gaps are still the greatest hindrance to the development of new solutions across different industries. Hyris stands to change this for the better, by leveraging the AI capabilities of its unique genetic testing platform, renowned worldwide for its AI capabilities together with its unique features of portability, accessibility and versatility.

“Researchers and kit developers know well how hard delivering new analytical solutions can be,” continues Baccanelli. “That’s why we increased our commitment to support both emerging players and established manufacturers performing beyond their current analytical capability via new onboarding programs.” Baccanelli goes on, depicting the advantages of such an inclusive approach. “We provide access to our technology and support developers through various stages of the development of new tests via proper education and technical assistance. This win-win approach enables any player to quickly integrate their portfolio with new products and solutions, maximizing their cost per value strategy.”

Hyris’s Onboarding strategy is proving successful across many industries. Such is the case of Luminis, Water Technologies, a leader in microbiome profiling and treatment solutions, which embraced Hyris’ Program to bring on-site qPCR diagnostics to the aquaculture industry, enabling customers to quickly and accurately test for pathogens, viruses, and bacteria, ultimately improving their operations’ overall safety and productivity in such industry. Luminis adopted the Hyris system to develop new qPCR diagnostics kits, enabling its customers to perform genetic analysis on-site rather than sending samples to a lab, significantly reducing turnaround time and allowing for more informed decision-making. Additionally, on-site testing eliminates the need for expensive lab equipment, and operators can now perform testing with minimal training.

“The benefits of on-site qPCR diagnostics are numerous,” explains Lorenzo Colombo, CTO at Hyris, “ensuring faster turnaround time and reduced costs, compared to centralized diagnostic systems. On the other hand, the downsides of such an approach have been the lack of accuracy and the complexity of on-site technologies, making this approach less suitable for day-to-day operations until now. We fixed all these problems, providing highly accurate results whilst requiring minimal training to operate. Hyris can really be used in any setting, even under the harshest conditions.”

Hyris’ distributed technology allows the identification of new and arising needs, even from decentralized areas: this, in turn, enables the design and deployment of fitting solutions at a very early stage of any diagnostic trend, throughout various diverse use cases. Kit developers and lab specialists can now truly collaborate, tapping into different levels of data analysis in real-time to bring innovative tests with superior quality and increased fitness to market; dressing on the cake, all the more quickly and efficiently.

“Too often, centralized diagnostic paradigms risk overlooking local needs, preventing benefits from being shared equitably,” sums up Stefano Lo Priore, co-founder and CEO at Hyris. “This also poses an ethical question, as innovations often fail to benefit those who need them most. Reliable portable diagnostic systems are key to building new capabilities for established and emerging diagnostic service providers. By helping others to deliver their solutions, we also fulfil our mission, generating a much wider impact worldwide.”

The new Onboarding Programs are contributing to making Hyris the first choice for testing labs, test developers, and researchers looking to bring on specific tests involving smaller sample arrays, reduced time to results, and increased efficiencies and profitability.

To discover how to perform beyond your current diagnostic capability, feel free to contact a Hyris expert at info@hyris.net.

Contact Information

Gabriele Salaris, Global Experience Manager, gabriele.salaris@hyris.net +39 345 555 3379

Copyright 2023 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Hong Kong, Sept 25, 2023 – (ACN Newswire) – Wuhan YZY Biopharma Co., Ltd. (“YZY Biopharma” or the “Company”, together with its subsidiaries, the “Group”, stock code: 2496.HK), is officially listed and commenced trading on the Main Board of The Stock Exchange of Hong Kong Limited (“SEHK”) today.

The total number of offer shares under the Global Offering amounts to 11,001,200 shares (assuming the Over-allotment Option do not exercise), with the final offer price determined at HK$16 per offer share. The net proceeds from the Global Offering to be received by the Company, after deduction of the underwriting fees and expenses paid and payable by the Company in connection with the Global Offering, are estimated to be approximately HK$121.4 million. The Hong Kong Public Offering was over-subscribed, where the total number of valid applications amounted to approximately 13.81 times of the total number of Hong Kong offer shares initially available for subscription under the Hong Kong Public Offering. The offer shares initially offered under the International Offering have also been over-subscribed by approximately 1.57 times. The final numbers of Hong Kong offer shares and International offer shares are respectively 1,100,200 and 9,901,000, each representing approximately 10% and 90% of the total number of the offer shares initially available under the Global Offering before any exercise of the Over-allotment Option.

As a biotechnology company dedicated to developing BsAb-based therapies, YZY Biopharma’s core business model is to in-house discover, develop and commercialize BsAb-based therapies to treat cancer-associated complications, cancer and age-related ophthalmologic diseases. The Company carefully selects potential targets for its BsAbs, and has adopted a differentiated clinical development strategy to maximize the clinical and commercial value of its drug candidates. At present, the Company has designed and developed a pipeline of seven clinical-stage drug candidates ; and has developed three T cell-engaging BsAbs, namely M701, M802 and Y150, to simultaneously bind to T cells and tumor cells via tumor-cell specific antigens in immunotherapy. In addition, the Company is also focusing on the development of the TME-targeted BsAbs, including Y101D and Y332. With the increasing trend of population aging and growing cancer incidences in China, it is expected that the clinical demands for effective oncology drugs will increase significantly. M701 (EpCAM × CD3 BsAb) – YZY Biopharma’s core product, now has been selected for the “National Major New Drug Innovation” program under the 12th Five-Year Plan, which the Company believes could be an advantage for its future inclusion into the National Reimbursement Drug List.

The co-founder, chairman, executive director and CEO of YZY Biopharma, Dr. Zhou Pengfei, has over 33 years of extensive experience in the healthcare and pharmaceutical industries, focusing on oncology treatment and innovative drug development. The Company has received supports from CSPC Pharmaceutical Group Limited (“CSPC”), a well-known pharmaceutical company in China in 2018. NBP Pharmaceuticals, a subsidiary of CSPC, reached an equity investment cooperation with YZY Biopharma. With the combined resource of CSPC, the Company’s R&D pipeline construction and clinical research will be improved, and a new situation in the field of tumor immunotherapy will be created.

Dr. Zhou Pengfei, the co-founder, chairman, executive director and CEO of YZY Biopharma said, “Today marked a milestone in YZY Biopharma’s development. YZY Biopharma’s successful debut in the Hong Kong stock market shows global investors’ profound recognition for our strategic model, growth potential, product pipeline and management team. We are so proud of it and would like to express our gratitude to investors for their trust in and support to YZY Biopharma. Looking forward, the Company will adhere to the mission of “discover and develop innovative drugs for the healthier lives of patients”, continue to accelerate the development of drug candidates for cancer treatment. At the same time, the Company will continue to expand its pipeline, enhance manufacturing capabilities and build its commercialization capabilities, and is committed to developing new therapeutic drugs for patients.”

About Wuhan YZY Biopharma Co., Ltd.

Wuhan YZY Biopharma Co., Ltd. is a biotechnology company dedicated to developing bispecific antibody (BsAb)-based therapies to treat cancer-associated complications, cancer and age-related ophthalmologic diseases. Since its establishment in 2010, YZY Biopharma has designed and developed seven product pipelines of drug candidates that have entered the clinical stage. The Company carefully selects potential targets for its BsAbs, and has adopted a differentiated clinical development strategy to maximize the clinical and commercial value of its drug candidates. Adhering to the mission of “discover and develop innovative drugs for the healthier lives of patients”, the Company has been deeply involved in the research and development of BsAb-based therapies for more than ten years, to treat cancer-associated complications, cancer and age-related ophthalmologic diseases.

Copyright 2023 ACN Newswire. All rights reserved. http://www.acnnewswire.com

NEW YORK, NY / ACN Newswire / September 19, 2023 / InSyBio, a leading biotechnology company that has developed a suite of advanced AI tools for biomarker discovery in clinical and multi-omics data, has announced a strategic partnership with Syndesis Health, a leader in global real-world evidence. The partnership aims to leverage the clinical and genomic data on Syntium, Syndesis’ data platform of global healthcare data, to accelerate research and development in several therapeutic areas, including cardiovascular health, oncology, and rare diseases.

The importance of biomarkers

Biomarkers are body characteristics that can be measured, such as the biological molecules found in bodily fluids or tissues, including DNA, antibodies, proteins, or other smaller molecules. They are necessary to predict the effectiveness of drugs and patient outcomes; however, biomarker discovery is a very complex and costly process that often results in poor or inaccurate outcomes due to the use of disparate tools and datasets, and the high complexity of high-throughput -omics data.

InSyBio’s platform simplifies and accelerates the process of biomarker discovery by providing a single, highly accurate, and effective processing pipeline that uses machine learning to analyze biodata. Syntium’s longitudinal datasets, which include clinical, genomic, and other data, are ideal for applying InSyBio’s suite of tools in biomarker discovery. Combining Syntium data with InSyBio’s platform will create a unique opportunity for biopharma and diagnostic companies to uncover breakthrough discoveries with the potential to vastly improve global patient outcomes.

“Precision medicine is still in its infancy and many patients are misdiagnosed or do not get the most beneficial treatment for them. The wealth of Syntium’s data sets when harnessed by our automatic AI-driven technology holds the potential to upend the medical field practices, and highly impact overall healthcare quality at national and international levels. We are looking forward to working with the innovative team of Syndesis Health,” said Labros Digonis, InSyBio CEO.

“We are incredibly excited to embark on this partnership with InSyBio to enable biomarker discovery for cutting-edge healthcare innovation,” said Josh Sutton, Syndesis Health CEO. “Together we seek to raise the bar for global health research and innovation in service of patients worldwide.”

About Syndesis Health

Syndesis Health is the data and technology catalyst to a multi-continent network of healthcare and life sciences organizations. Its primary aim is to enhance global health outcomes and equity through its secure data platform, Syntium, and the Syndesis Health Network, a member community promoting research collaboration, information sharing, and access to common tools.

About InSyBio

InSyBio is an international pioneer biotechnology company revolutionizing the medical �eld through targeted biomarker discovery, highly accurate predictive analytics and the development of personalization tests for drugs. Its solutions provide the R&D departments of Pharma and Research Institutes with the means to meet their most challenging research and innovation goals. This is done through a sophisticated, software-as-a-service, machine learning platform, which comprehensively integrates multi-omics and clinical data, thus reducing the number of samples and additional validation experiments needed.

Contact Information

Leah Patterson 
Chief Marketing Officer 
leah.patterson@syndesis.com 
+1.646.274.1420

 

Copyright 2023 ACN Newswire. All rights reserved. http://www.acnnewswire.com

WINCHESTER, ENGLAND, Sep 15, 2023 – (ACN Newswire) – Cats may not be quite as carnivorous as once thought. Whilst biologically carnivorous, cats are increasingly being fed vegan diets – and thriving! In fact, a ground-breaking new study has just found that cats are healthier, when fed vegan diets. The study, just published in leading scientific journal PLOS ONE, is the largest such study to date. It resulted from an international collaboration led by veterinary Professor Andrew Knight (UK) and co-authored by statisticians Dr Alexander Bauer (Germany) and Hazel Brown (UK). It studied 1,369 cats fed vegan or meat-based pet food, for at least one year. Cats fed vegan diets had better health outcomes for each of seven general health indicators studied.

Average cats fed vegan diets had a 15% lowered risk of needing medication, and were 7% less likely to visit vets more often, which could indicate illness. Forty two percent of cats fed meat suffered from at least one health disorder, whereas this fell to 37% amongst vegan cats. Of the 22 most common health disorders, 15 were most common in cats fed meat, and seven most common in those fed vegan diets. Although these reductions were not statistically significant, collectively they reveal a strong trend. They also translate into cost savings for pet guardians, which may be considerable over the lifetime of a cat, given the costs of illness and veterinary care. Vegan pet foods also offer significant environmental benefits.

Stated Andrew Knight, a Veterinary Professor of Animal Welfare and the study leader:
"For every single general health indicator studied, these cats had better health outcomes when fed vegan diets. This represents a strong and consistent trend. It indicates that pet food manufacturers are now designing and creating vegan pet foods to include all necessary nutrients, but with fewer of the dietary hazards that are prevalent within meat-based pet foods. Cats consuming vegan diets have better health outcomes, as a result."

These results concur with those of other, recent studies. In 2021, leading veterinary nutritionist Dr Sarah Dodd and colleagues published a study of 1,026 cats, of whom 187 were fed vegan diets. Cats fed vegan diets were more frequently reported by their guardians to be in very good health. They had more ideal body condition scores, and were less likely to suffer from gastrointestinal and liver disorders, than cats fed meat. No health disorders were more likely, for cats fed vegan diets. These studies are available via www.SustainablePetFood.info > health.

Prof. Knight stated:
"This offers exciting potential to improve not only feline health, but also to address the very significant environmental impacts of the livestock sector created through pet food production. However, to safeguard the health of our feline friends, it is important that pet guardians feed only commercial vegan pet foods labelled as nutritionally complete, produced by reputable companies with good standards."

www.sustainablepetfood.info
www.aknight.info/articles/pet-food
www.aknight.info/vids

Contact Information
Andrew Knight
Veterinary Professor of Animal Welfare
andrew.knight@winchester.ac.uk

Copyright 2023 ACN Newswire. All rights reserved. http://www.acnnewswire.com

HONG KONG, Sep 13, 2023 – (ACN Newswire) – Wuhan YZY Biopharma Co., Ltd. ("YZY Biopharma" or the "Company", together with its subsidiaries, the "Group", stock code: 2496.HK), a biotechnology company dedicated to developing bispecific antibody (BsAb)-based therapies to treat cancer-associated complications, cancer and age-related ophthalmologic diseases, announced the proposed listing of its shares on the Main Board of The Stock Exchange of Hong Kong Limited ("SEHK") today.

YZY Biopharma plans to offer an aggregate of 11,001,200 H Shares under the Global Offering (subject to the Over-allotment Option), consisting of 9,901,000 International Offer Shares (subject to reallocation and the Over-allotment Option) and 1,100,200 Hong Kong Offer Shares (subject to reallocation), at a price range between HK$16 and HK$20 per H Share.

The Hong Kong public offering will open at 9:00 a.m. on Wednesday, September 13, 2023 and close at 12:00 noon on Monday, September 18, 2023 in Hong Kong. Dealings in shares on SEHK are expected to commence on Monday, September 25, 2023, with the stock code 2496.HK in board lots of 200 H Shares each.

China Securities (International) Corporate Finance Company Limited is the Sole Sponsor, Overall Coordinator, Joint Global Coordinator, Joint Bookrunner and Joint Lead Manager.

A pipeline of drug candidates with market potential
As a biotechnology company dedicated to developing BsAb-based therapies, YZY Biopharma's core business model is to in-house discover, develop and commercialize BsAb-based therapies to treat cancer-associated complications, cancer and age-related ophthalmologic diseases. The Company carefully selects potential targets for its BsAbs, and has adopted a differentiated clinical development strategy to maximize the clinical and commercial value of its drug candidates. The Company has designed and developed a pipeline of seven clinical-stage drug candidates, including (i) Core Product M701, a recombinant BsAb that targets human epithelial cell adhesion molecule (EpCAM)-expressing cancer cells and human cluster of differentiation 3 (CD3)-expressing T cells. (ii) M802 and Y150, T cell-engaging BsAbs for cancer treatment, (iii) Y101D and Y332, tumor microenvironment (TME)-targeted BsAbs, and (iv) Y400, a targeted therapy for the treatment of age-related ophthalmologic diseases.

Focusing on the development of BsAbs in China
Since its establishment, YZY Biopharma focuses on the development of BsAbs in China. BsAb is an artificial protein that recognizes and specifically binds two antigens or epitopes. The advantages of BsAbs include the potential effects on various cancers, the application to retarget effector cells of the immune system and stimulate them through the interaction to achieve an efficient lysis of tumor cells. The applications and research of existing BsAbs are mainly focused on the field of oncology therapy, but also extend to other areas such as hemophilia and ophthalmology. At present, the Company has developed three T cell-engaging BsAbs, namely M701, M802 and Y150. T cell-engaging BsAb is a new class of therapeutic agents designed to simultaneously bind to T cells and tumor cells via tumor-cell specific antigens in immunotherapy. In addition, the Company is also focusing on the development of the TME-targeted BsAbs, including Y101D and Y332. The market size of the PRC oncology market has increased from approximately RMB157.5 billion in 2018 to approximately RMB233.6 billion in 2022, and is expected to reach approximately RMB586.6 billion in 2030. With the increasing trend of population aging and growing cancer incidences in China, it is expected that the clinical demands for effective oncology drugs will increase significantly.

Core product M701 helps improve the quality of life of advanced cancer patients
M701 (EpCAM x CD3 BsAb) – YZY Biopharma's core product, is a recombinant BsAb that targets human EpCAM-expressing cancer cells and human CD3-expressing T cells. The Company is developing M701 primarily for the treatment of malignant ascites (MA) and malignant pleural effusion (MPE), which are severe complications that typically occur in late-stage cancer patients who have widespread metastases to the pleura or peritoneum. It is expected that M701 monotherapy could be used in addition to paracentesis to control MA and MPE, with an aim to improve the effectiveness and reduce the side effects of frequent paracentesis. M701 now has been selected for the "National Major New Drug Innovation" program under the 12th Five-Year Plan, which the Company believes could be an advantage for its future inclusion into the National Reimbursement Drug List.

Technology platforms fueling the R&D of drug candidates
YZY Biopharma has successfully built four platforms, including the self-developed YBODY,
Check-BODY and Nano-YBODY(TM) platform, and the UVAX platform developed in collaboration with WIV. YZY Biopharma's core technology platforms enable to effectively select innovative targets, optimize molecule structure design and accelerate the drug development process. Leveraging the technologies of these platforms, YZY Biopharma is able to design and generate different antibody structures. As such, the Company can select targets and signaling pathways with clinical and commercial value and design and modify the structure of its BsAbs to bind such targets. Therefore, the Company is able to quickly expand its pipeline to include additional BsAbs that direct toward a wide range of targets and signaling pathways, optimize the use of resources and expertise, and achieve the maximized value of the Company's pipeline candidates.

A GMP-compliant CMC platform
The Company has established a GMP-compliant chemistry, manufacturing and control (CMC) platform to leverage its extensive experience in the CMC for BsAbs with various structures. The Company believes such platform will serve as a solid foundation for its large-scale commercial production in the future. CMC refers to activities to properly define methods for manufacturing processes, product characteristics and testing, product storage and release to clinical usage in order to ensure that a pharmaceutical product is safe, effective and consistent among different batches. Although the discovery and protein engineering techniques of BsAbs are now relatively advanced, the development of BsAbs still faces many challenges in the CMC compared to the development of typical mAb drugs, including low expression titer of the target BsAbs, more impurities to remove, less stability of the intermediates, and hurdles in process scale-up. Therefore, the execution of an appropriate CMC development strategy is vital to the success of the overall drug development program. Its CMC strategies include evaluating the stability of the candidate BsAb molecules at the early development stage, choosing the monoclonal cells with high titer and high purity for BsAb production, tailoring purification methods fit for the molecule characteristics, and using sustainable scale-up strategies for large-scale production.

Execution-driven management and R&D teams
The Company's core management team is composed of industry veterans with an average of more than ten years of experience and a track record of discovery, development and commercialization of innovative drugs. The co-founder, chairman and CEO of the Company, Dr. Zhou Pengfei, has over 33 years of extensive experience in the healthcare and pharmaceutical industries, focusing on oncology treatment and innovative drug development. In addition, the Company's department heads and other key technical personnel have served various roles in leading multinational pharmaceutical companies, having complementary experience covering various stages of the entire development lifecycle of drug products, including pre-clinical studies, clinical development, manufacturing and commercialization.

In 2018, NBP Pharmaceuticals, a subsidiary of CSPC Pharmaceutical Group Limited ("CSPC"), a well-known pharmaceutical company in China and YZY Biopharma, reached a equity investment cooperation. With the combined resource of CSPC, the Company's R&D pipeline construction and clinical research will be improved, and a new situation in the field of tumor immunotherapy will be created.

Looking forward, the Company will adhere to the mission of "discover and develop innovative drugs for the healthier lives of patients", continue to accelerate the development of drug candidates for cancer treatment and invest more resources in clinical development and preclinical studies of these drug candidates At the same time, the Company will continue to expand its pipeline through in-house R&D efforts and collaborations, continue to enhance manufacturing capabilities and build its commercialization capabilities, and is committed to developing new therapeutic drugs for Chinese patients.

About Wuhan YZY Biopharma Co., Ltd.
Wuhan YZY Biopharma Co., Ltd. is a biotechnology company dedicated to developing bispecific antibody (BsAb)-based therapies to treat cancer-associated complications, cancer and age-related ophthalmologic diseases. Since its establishment in 2010, YZY Biopharma has designed and developed seven product pipelines of drug candidates that have entered the clinical stage. The Company carefully selects potential targets for its BsAbs, and has adopted a differentiated clinical development strategy to maximize the clinical and commercial value of its drug candidates. Adhering to the mission of "discover and develop innovative drugs for the healthier lives of patients", the Company has been deeply involved in the research and development of BsAb-based therapies for more than ten years, to treat cancer-associated complications, cancer and age-related ophthalmologic diseases.


Copyright 2023 ACN Newswire. All rights reserved. http://www.acnnewswire.com

PARIS, FRANCE, Sep 12, 2023 – (ACN Newswire) – Ad Scientiam, a global leader in digital biomarkers, has announced a partnership with Sanofi to launch MS-DETECT, an international, multicenter, longitudinal study. MS-DETECT aims to evaluate the ability of MSCopilot(R), a medical software device, to detect early signs of disability worsening in people with multiple sclerosis (PwMS). The study will draw upon Ad Scientiam's expertise in MS and is financially supported by Sanofi.

Multiple Sclerosis (MS) is a chronic immune-mediated disease of the central nervous system that affects 2.8 million people worldwide. The disease is characterized by early inflammatory demyelination and subsequent neurodegeneration. Current clinical evaluation of PwMS relies mainly on the Expanded Disability Status Scale (EDSS), which has several limitations. To improve on these assessments, Ad Scientiam has developed MSCopilot(R), a software medical device that addresses four dimensions: ambulation/mobility, upper extremity function, cognition, and low-contrast visual acuity.

MS-DETECT's main objective is to determine MSCopilot(R)'s ability to identify subtle and early disability worsening. This will be performed by evaluating MSCopilot(R) individual and/or composite scores as compared to the Multiple Sclerosis Functional Composite (MSFC) and the EDSS.

"MS-DETECT is a pioneering large-scale longitudinal study that explores digital biomarkers for the early detection of disease progression. This study will provide important data to both clinicians and people living with MS," according to Dr. Saad Zinai, Chief Medical Officer at Ad Scientiam.

"Disability worsening in MS has been recently redefined and we now know that this progression can occur independently of relapses. With MS-DETECT, we have an opportunity to develop a digital solution to help detect and monitor the effects of smoldering disease, and evolve treatment goals for MS patients," explains Su-Peing Ng, Global Head of Medical Affairs – Specialty Care at Sanofi.

The study also aims to assess the MSCopilot(R) performance, safety, usability and satisfaction with the solution.

"Disease progression can be hard to detect in routine practice. I believe these novel digital biomarkers are key to help clinicians make appropriate treatment decisions and, ultimately, improve patients' care," said Prof. Patrick Vermersch (Lille, France), Coordinating Investigator and Chairman of the Study Steering Committee.

The MS-DETECT study will include 314 PwMS and will be conducted in the United States, Canada, Germany, Italy, Spain, Denmark and France. Several investigative sites have already been initiated in North America and Europe and first patients are expected to participate in the study during Q3 2023.
Check our LinkedIn, Facebook, Instagram pages or visit adscientiam.com

Contact Information
Saad Zinai
Chief Medical Officer
szinai@adscientiam.com
+33768008666

Matthieu Lamy
President
mlamy@adscientiam.com
+33768008666

Copyright 2023 ACN Newswire. All rights reserved. http://www.acnnewswire.com

HONG KONG, Sep 12, 2023 – (ACN Newswire) – A Hong Kong-based biopharmaceutical company dedicated to the research, development, manufacturing and commercialisation of therapeutics for the treatment of immunological diseases- SinoMab BioScience Limited (Stock Code: 3681.HK, "SinoMab" or the "Company"), is pleased to announce that the Investigational New Drug application ("IND"), for the treatment of patients with atopic dermatitis ("AD") for the Company's First-in-Class (FIC) therapeutic product SM17, was approved by the National Medical Products Administration of China (the "NMPA") on 8 September 2023. The Company plans to initiate a Phase I clinical study in China in the fourth quarter of this year to investigate the safety profile of SM17 in Chinese population and to initiate the clinical development program of SM17 for the treatment of allergic diseases.

SM17 is a novel, First-in-Class (FIC), humanized, IgG4-k monoclonal antibody which is capable of modulating Type II allergic reaction by targeting the receptor of a critical "alarmin" molecule interleukin 25 (IL-25). SM17 could suppress Th2 immune responses by binding to IL-25 receptor (also known as IL-17RB) on Type 2 Innate Lymphoid cells (ILC2s) and Type 2 helper T (Th2) cells, to block a cascade of responses induced by IL-25 and suppress the release of the downstream Th2 cytokines such as IL-4, IL-5 and IL-13.

IL-25 is a critical cytokine classified as "alarmin", which has shown to be implicated in the pathogenesis of autoimmune and inflammatory skin diseases, such as AD. Patients with AD also have an increasing all-cause mortality rate and disease-specific mortality rate in the following diseases, which include infections, respiratory diseases, gastrointestinal diseases and oncologic diseases. Current approved therapies for AD, including biologics, can significantly improve eczema area and severity index and patient's quality of life. However, there are still some patients who show irresponsiveness to those approved therapies. AD lacks universally effective treatment methods and there is an urgent need to fill the market gap with suitable medications.

AD, as a common chronic disease, is showing an increasing prevalence in China, indicating a wide market space for potential treatments. According to Frost & Sullivan, there were approximately 65.7 million AD patients in China in 2019 and is expected to grow to 81.7 million in 2030, and 30% of which will be moderate-to-severe patients. China's AD medicine market was US$600 million in 2019, and is expected to grow to US$1.5 billion in 2024, and is expected to increase to US$4.3 billion in 2030, indicating a considerable market size. We believe that therapies targeting upstream of the Th2 inflammatory cytokine pathway, such as IL-25 receptor, will have broad effects on skin inflammation, implicating a great potential for SM17 as a differentiating, safer and more effective products for the treatment of atopic dermatitis.

The Company actively promoted the indication research of SM17, laying a foundation for subsequent proof of concept and commercialization. Currently, a Phase I study for SM17 conducted in the US is near completion, with the Last Subject Last Visit (LPLV) scheduled later this month (September 2023). As of the date of this announcement, no drug-related serious adverse event has been reported, suggesting the product is well tolerated in human and shows a very good safety profile. The IND application of SM17 for the treatment of asthma diseases was approved by the NMPA on 11 August 2023 and its Phase I clinical study in China will also be initiated shortly.

Dr. Shui On LEUNG, Executive Director, Chairman and Chief Executive Officer of the Company, said, "As the number of AD patients continues to grow, its unmet need in China is becoming increasingly recognized. The IND application of SM17 for AD has been approved by the NMPA, which fully reflects the recognition of the differentiated advantages of SM17 in the field of AD and has a bright future. We will initiate a Phase I clinical study and a clinical development plan of SM17 for the treatment of allergic diseases in China soon, striving to provide more effective medical solutions for Chinese patients. Currently, SM17 has obtained IND approvals from the NMPA for the treatment of asthma and AD, while our Phase I study for SM17 conducted in the US is near completion. This strategic layout would assist us to move forward our business development into the international market. In the future, we will also continue to make in-depth strategies in the field of immunological diseases, leverage our scientific research strengths, continuously expand the population of indications, provide breakthrough scientific treatment solutions for the research of immunological diseases and more safe and effective treatment options for the patients, so as to consolidate the Company's leading market position, and aim to become a global leader in the innovative treatment of immunological diseases."

About SinoMab BioScience Limited
SinoMab BioScience Limited is dedicated to the research, development, manufacturing and commercialisation of therapeutics for the treatment of immunological diseases. The R&D headquarters is located in Hong Kong and the production base is located in mainland China. The Company's flagship product SM03 is a potential global first-in-target mAb against CD22 for the treatment of rheumatoid arthritis (RA) and has completed the Phase III clinical trial for rheumatoid arthritis in China, which has been recognized as one of the significant special projects of Significant New Drugs Development of the Twelfth Five-Year Plan Period and the Thirteenth Five-Year Plan Period. In addition, the Company possesses other potential first-in-target and first-in-class drug candidates, some of which are already in clinical stage, with their indications covering rheumatoid arthritis (RA), Alzheimer's disease, systemic lupus erythematosus (SLE), pemphigus (PV), multiple sclerosis (MS), neuromyelitis optica spectrum disorder (NMOSD), non-Hodgkin's lymphoma (NHL), asthma, and other diseases with major unmet clinical needs.

This press release is issued by Financial PR (HK) Limited on behalf of SinoMab BioScience Limited. For further information, please contact:

Financial PR (HK) Limited
Contact: Ms. Chloe Chiu / Ms. Serena Zhang / Ms. Willa Xue
Email: sinomab@financialpr.hk
Tel: (852) 2610 0846
Fax: (852) 2610 0842


Copyright 2023 ACN Newswire. All rights reserved. http://www.acnnewswire.com

LOS ALTOS, CA, Sep 6, 2023 – (ACN Newswire) – UroViu Corporation, the developer of a suite of portable, self-contained, and versatile sterile single-use endoscopy solutions, announces Ali Amiri as its first President and COO, to drive a largescale commercial expansion after several products successfully launched in the U.S. over the last 18 months.

Amiri will be leading the quality, operations, regulatory, and sales and marketing teams, and overseeing the company's global commercial operation while driving product, commercial, and customer excellence. He will be responsible for the design and execution of strategies required to achieve UroViu's short- and mid-term goals. Amiri will also advise the UroViu Board on its long-term strategies and product roadmap.

Amiri brings a wealth of global industry experience and expertise to UroViu, having served in a variety of leadership roles at KARL STORZ for over three decades. There, he led the upstream and downstream marketing teams and strategies, driving consistent revenue growth and outpacing market benchmarks annually for two decades. Most recently, Amiri served as the Vice President, Operations at KARL STORZ Endoscopy-America, where he also contributed as a long-term member of its Executive Committee.

UroViu's Always Ready endoscopy platform offers a unique design that delivers the safety profile of a sterile single-use endoscope while minimizing the portion disposed of after each case. By using a reusable handle with embedded electronics, UroViu has the lowest carbon footprint among all suppliers of sterile single-use endoscopes. The highly portable handle allows the care to be brought to anywhere the patient is. UroViu leverages market and customer insights, creative design, state-of-the-art technology, and scale to create products to support a significant share of 200+ million minimally invasive procedures worldwide.

"As UroViu expands its product portfolio within gynecology and urology with new features that go beyond our exclusive towerless sterile single-use endoscope design, we remain focused on our mission to expand and improve patient access to state-of-the-art diagnostic and therapeutic procedures while also improving efficiency and productivity of providers," said UroViu's founder and Chief Executive Officer Bruce OuYang. "We are very excited to have Ali Amiri leading UroViu's operation and commercialization. Tapping into Ali's broad expertise and strategic mindset, we are well positioned to establish UroViu as a global market leader in the smart and versatile sterile single-use multi-modality diagnostic and therapeutic imaging device market."

"Sterile single-use endoscopes, artificial intelligence, and robotics will continue to evolve and improve delivery of care. UroViu's product roadmap is at the cross- section of these disruptive trends. Its differentiated product offering is aligned with today's site-of-service shifts to an outpatient setting. The company's industry-leading approach to innovation re-imagines product design and aims to enhance patient experience, reduce cost, improve clinical outcomes, and deliver a superior customer experience," adds Ali Amiri. "I am excited to help grow UroViu's global presence with a data-driven approach and positive impact on the entire value chain of healthcare delivery."

Visit https://www.uroviu.com for more information.

About UroViu Corp

UroViu has developed a proprietary, portable single-use endoscopic platform of minimally invasive devices to address the issues of device cross contaminations, patient discomfort, and workflow inefficiencies. From this platform, UroViu already has four (4) FDA-cleared products launched and adopted by offices and clinics of urology, gynecology and urogynecology in the USA.

UroViu holds key patents for portable single-use endoscopes and is expanding its IP portfolio to include scope-drug, scope-device, and robotic-assisted surgery applications. UroViu is also actively partnering with drug and device companies for comprehensive disease management.

UroViu is led by pioneers in the field of portable single-use endoscope innovation and manufacturing and operated by an experienced medical device management team in Asia and USA.

Contact Information
Lisa Sorbo
Marketing Manager, UroViu Corp
marketing@uroviu.com
650-878-6686

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