Avance Clinical Expands Further into APAC with New Clinical Operations in South Korea

Adelaide, AU & North Carolina, USA, May 8, 2024 – (ACN Newswire) – Avance Clinical, the award-winning Australian and North American market-leading CRO for biotechs, will attend BIO Korea (May 8-10, 2024) and formally open new clinical operations in Seoul, South Korea.

Meet with the team at BIO Korea

Avance Clinical CEO, Yvonne Lungershausen said the decision to open clinical operations in Seoul followed increasing demand from later phase US biotechs, as well as CRO partners for access to the region’s scientific excellence and patient populations.

“In addition, feedback from a recent presentation of our GlobalReady drug development solution to more than 75 Korean biotechs and pharmaceutical companies in Seoul showed a real need for Korean clinical operations with a global pathway,” said Lungershausen.

“It’s clear there is a demand for a mid-sized, agile, and responsive CRO with an in-house regulatory affairs team, and a proven track record of swiftly advancing high-quality clinical programs. This makes us an ideal CRO partner for later phase biotechs that are seeking access to significant patient populations,” she said.

“The new South Korean operations also offer a strategic presence for Avance Clinical’s CRO partners conducting multi-regional or global trials.

In addition, Korean biotechs are utilizing our Australian and United States clinical services as they progress their drug development programs,” said Lungershausen.

“Our Avance Clinical teams in APAC, Europe and the United States, offer our biotech clients world-class quality data and seamless geographic expansions to accelerate their drug development programs and position for success.” 

“Avance Clinical’s study data is accepted by all the main regulatory authorities including the MFDS and FDA. In addition, the Therapeutic Goods Administration (TGA) in Australia and FDA recognises data generated in Korea.” 

“Biotechs are looking for a partner that can start fast with high-quality data that is readily accepted by the US FDA and other regulatory agencies. Backed by our in-house global regulatory affairs team, we can navigate biotechs through regulatory complexities with confidence including FDA, EMA, MFDS and TGA submissions,” she said.

“In addition, our GlobalReady Site Partnership Network of over 2,000 highly qualified sites across the globe ensures maximum efficiency and effectiveness for our biotech clients’ trials,” she said.

Avance Clinical is focussed on accelerating drug development for its biotech clients, from preclinical stages through to Phase III.

“This is our GlobalReady program and we have more than 90 biotech clients leveraging this unique, streamlined multi-phase and multi-region process. With a globalized strategy, we ensure efficiency every step of the way,” she said.

Book a meeting with the team at the Australian Pavilion at BIO Korea to meet with our team of clinical trial experts.

Find out more:

  • Learn about the GlobalReady model
  • For more information about the benefits of running your next study with Avance Clinical contact us
  • Request a Proposal here

Media Contact:
Avance Clinical
Kate Thompson
media@avancecro.com 

About Avance Clinical

Avance Clinical is the largest premium full-service Australian and North American CRO delivering quality clinical trials, with globally accepted data, in Australia, New Zealand and the US for international biotechs. The company’s clients are biotechs completing Phase I to Phase III of their drug development program that requires fast, agile, and adaptive solution-oriented clinical research services.

Frost & Sullivan Awards

Avance Clinical, a Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient for the past four years, has been providing CRO services in the region for more than 26 years.

Pre-clinical through to mid to late phase

Avance Clinical offers pre-clinical services with their experienced ClinicReady team right from pre-clinical through to Phase III clinical services leveraging significant Australian Government incentive rebates of up to 43.5% and rapid start-up regulatory processes.

With experience across more than 120 indications, the CRO can deliver world-class results and high-quality internationally accepted data for FDA and EMA review.

Technology

Avance Clinical uses state-of-the-art technology and gold standard systems across all functional areas to provide clients with the most effective processes. Medidata, Oracle, TrialHub, Certinia, Salesforce, Zelta and Medrio are just some of the technology partners.

www.avancecro.com



Copyright 2024 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Lithuanian Biotech Pioneer ‘Nando’ Embarks on Global Expansion With New Management Team and Innovative Production Line

KAUNAS, LITHUANIA, May 7, 2024 – (ACN Newswire) – In a strategic enhancement of its management team, “Nando” welcomes four seasoned professionals, each bringing a wealth of experience from reputable organizations. Gytis Kubilius, with a solid background in management at “SEB” and “Citadele” banks; Mindaugas Navickas, previously International Sales Manager at “Teltonika Networks”; ArÅ«nas Jusas, former General Manager at “Timac AGRO”; and GiedrÄ— MockienÄ—, who served as HR Manager at UAB “Yara”, are now integral parts of “Nando’s” leadership, aiming to spearhead ambitious development projects.

To cater to the surging demand for microbiological alternatives to mineral fertilizers and plant protection products, “Nando” has invested about €3 million in a unique biotechnology line. This investment boosts production volume, enhances productivity, and ensures competitive pricing to meet the escalating market demand. With a technology that is currently patent-pending, “Nando” exports to over 20 countries, including Great Britain, Ukraine, Estonia, Kazakhstan, Latvia, Poland, Romania and beyond.

Justinas Taruška, CEO of “Nando”, stated, “Our main goal is to feature a highly automated biotechnological production line. This will not only elevate the agro-biotechnology sector’s value in Lithuania but also accelerate sustainable and economically viable agricultural technologies across Europe and other continents.” The new production line is renowned for its unique microorganism purification technology, a rarity in the entire Baltic region. It promises an efficient production of stable, high-yield microbiological products in powder form, a technology with limited competition.

The inclusion of new management members, with their extensive international experience, underscores “Nando’s” commitment to employee development and its focus on penetrating foreign markets, including Europe, North and South America, Asian and Africa countries. This strategic move coincides with the launch of the new production line for microbiological products.

Founded in 2007, “Nando” stands at the forefront of the biotech industry, developing and manufacturing microbiological products and chemical additives for agriculture. With one of Northern Europe’s leading R&D centers and partnerships with global research institutions, “Nando” has introduced over 50 innovative products, vital to the agro, livestock. Currently, the company is intensifying its export activities, with operations spanning over 20 countries in Europe, North and South America, Asian and Africa. The “Nando Group” proudly employs more than 50 professionals dedicated to advancing global biotechnology solutions.

Contact Information:
Milda Gauliene
Marketing specialist
milda@nando.lt
+37066475297

SOURCE: Nando

.

View the original press release on newswire.com.



Copyright 2024 ACN Newswire. All rights reserved. http://www.acnnewswire.com

CanSinoBIO CSO Shares the Latest Results of the Company’s Globally Innovative Pneumococcal Vaccine

HONG KONG, Apr 26, 2024 – (ACN Newswire) – On April 20, the 2024 National Vaccines and Health Conference organized by the Chinese Preventive Medicine Association (CPMA) and the Chinese Center for Disease Control and Prevention (China CDC) took place in the Xiong’an New Area of Hebei Province. Dr. Tao Zhu, Chief Scientific Officer (CSO) of CanSino Biologics Inc. (CanSinoBIO), was invited to give a presentation at the conference.

Dr. Zhu introduced the latest progress and breakthrough made in the development of pneumococcal vaccines both in China and abroad, focusing on sharing the latest results from the clinical trials of the company’s globally innovative protein-based pneumococcal vaccine (PBPV). He said that the PBPV is unique in terms of its broader coverage, serotype-independent and simpler production process while triggering good immune memories, and is expected to further improve the protection against pneumococcal diseases. Positive results have been obtained from Phase I clinical trials of the PBPV.

The results of Phase Ia and Phase Ib clinical trials showed that PBPV has a good safety profile in adults aged over 18 years old (including the elderly over 50 years old). A single dose of vaccination was found induce significant binding antibody and functional bactericidal antibody responses against cross-family/clade of Streptococcus pneumoniae, which further demonstrated the broad spectrum and potential public health value of this vaccine candidate.

When talking about the platforms for the development of innovative vaccines as well as the development of multi-valent vaccines and conjugate vaccines, Dr. Zhu said that CanSinoBIO has built five such platforms and a highly competitive pipeline, including multiple vaccine candidates targeting 10-plus indications like meningitis, pneumonia, DPT, shingles, and tuberculosis.

Dr Zhu emphasized the company has developed a comprehensive strategy to combat pneumonia-related illness. He said that CanSinoBIO has laid a solid foundation for the subsequent development of those candidates and their launch in overseas markets with its unique vectors and animal component free media (ACFM). The company is committed to developing pneumococcal vaccines, especially higher-valency serotype vaccines to improve the effectiveness of vaccines.

In the future, CanSinoBIO will continue to drive the innovation and development of vaccines with a global vision by enhancing collaboration with international partners, and contribute more to public health around the world.

About PBPV

PBPV is a globally innovative pneumococcal vaccine candidate. Unlike the 23-valent pneumococcal polysaccharide vaccine (PPV23) and the 13-valent pneumococcal conjugate vaccine (PCV13), PBPV is not serotype-dependent. It mainly adopts antigens that are based on the pneumococcal surface protein A or PspA, which is a highly-conserved protein expressed by virtually all pneumococci. Compared with currently marketed PPV23 and PCV13, PBPV has broader coverage (at least 98% coverage of pneumococcal strains), which can effectively prevent serotype replacement. Meanwhile, this product has a simpler production process than polysaccharide vaccines and conjugate vaccines, facilitating scale-up and quality control.

About CanSinoBIO

Incorporated in 2009, CanSino Biologics Inc. (SSE: 688185, HKEX: 06185) commits to providing high-quality, innovative, and affordable vaccines for global public health security. It possesses five integrated platform technologies upon which the company has established a rich portfolio of a pipeline products preventing more than 10 diseases, including the Aisa’s first and only vaccine for Ebola virus disease Ad5-EBOV, the Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Convidecia® approved in over 10 countries and granted EUL by the WHO, the Asia’s first Group ACYW135 Meningococcal Conjugate Vaccine (CRM197) Menhycia® and the Group A and Group C Meningococcal Conjugate Vaccine (CRM197) Menphecia® approved by NMPA in China. The world’s first inhaled COVID-19 vaccine Convidecia Air® has been approved as a booster dose in China, Morocco, and Indonesia. Additional information can be found online at http://www.cansinotech.com.



Copyright 2024 ACN Newswire. All rights reserved. http://www.acnnewswire.com

New Contaminants, Food Testing & More: analytica Convention 2024 Focuses on Vietnam’s Laboratory Needs

HANOI, Vietnam, Apr 23, 2024 – (ACN Newswire) – In anticipation of the biennial analytica Vietnam Exhibition scheduled for 2025 in Ho Chi Minh City, the analytica Convention 2024 emerges to bridge the gap year, offering an alternative platform for industry stakeholders. Hosted by analytica Vietnam, this event will take place on May 16th at the Melia Hotel Hanoi, promising a comprehensive exploration of the latest advancements, trends, and challenges shaping the analytical and laboratory technology sector.

Supported by the Key Laboratory of Analytical Technology for Environmental Quality and Food Safety Control (KLATEFOS), VNU, and VNU Key Laboratory of Geo-Environment and Climate Change Response, the one-day convention comprises of a full-day conference program featuring three distinct streams focusing on the “Emerging Contaminants in Food, Pharma, and Environment”, alongside engaging tabletop presentations by industry leading exhibitors.

With over 20 sponsors expected to gather, a diverse array of more than 30 conference sessions, and an audience exceeding 400 delegates, the event promises an immersive and enriching experience for all attendees.

The convention will commence with opening speeches from the Minister of Science and Technology in Vietnam, followed by Daniel Shi, the Project Director of analytica Vietnam from the event organizer, MMI Asia, Pte Ltd, a subsidiary of Messe München GMBH (MMG). The conference programme boasts an extensive lineup of keynote presentation and panel discussions offering attendees invaluable insights and networking opportunities. Renowned speakers from academia and the industry will share their expertise on a wide array of topics, including pivotal trends and strategies that shapes the spheres of Food, Pharma, and Environment. Attendees can expect thought-provoking discussions on a wide range of topics, including:

– Emerging persistent organic pollutants and their impact on environmental chemistry (Prof. Dr. Pham Hung Viet): Professor Viet will shed light on newly discovered pollutants and the challenges they pose, offering valuable insights and solutions for environmental scientists and chemists.

– The evolving role of food testing in the coming decades (Dr. Nguyen Hung Long): Dr. Long will explore the changing landscape of food safety and quality control, outlining the crucial role food testing will play in the future.

– Utilizing UV spectroscopy with signal transformation for multicomponent dosage form analysis (Assoc. Prof. Vu Dang Hoang): Associate Professor Hoang will delve into a novel analytical technique, showcasing its potential to revolutionize the analysis of complex pharmaceutical formulations.

A highlight of the analytica Convention 2024 will be the tabletop exhibition, featuring leading companies such as ITS Vietnam, DKSH Vietnam, HTI Scientific, Anton Paar Vietnam, LGC, IKA Vietnam, Merck Vietnam, Việt Anh JSC, Kimteco Co.,ltd, ACI Sciences, LMS Technologies Vietnam, Mettler Toledo, Navis, and LabVietConnect, showcasing their latest products and solutions. Attendees will have the unique opportunity to explore cutting-edge instrumentation, software platforms, and laboratory equipment, engaging directly with industry representatives to address their specific needs and requirements.

“We are thrilled to host the analytica Convention 2024 in Vietnam, providing a stage for the industry’s leading players to gather and share critical topics, trends, and strategies in analytical sciences,” said Mr. Michael Wilton, CEO & Managing Director of MMI Asia. “This convention serves as a catalyst for driving innovation, fostering collaboration, and advancing the industry as a whole. We look forward to welcoming participants from across Vietnam and beyond to this exciting event.”

Registration for the analytica Convention 2024 is now open. For more information and to register, please visit www.analyticavietnam.com/analytica-convention-2024. Additionally, booth applications for the highly anticipated analytica Vietnam 2025 are now open. Sign up now to take full advantage of the Early Bird Rate, available until May 30th, 2024, with limited spaces available. 

About analytica Vietnam

analytica Vietnam is the premier trade fair for laboratory technology, analysis, and biotechnology in Southeast Asia. Organized by Messe München, the event brings together industry professionals, researchers, and policymakers to showcase the latest technologies, exchange knowledge, and foster business collaborations. analytica Vietnam features an exhibition, conference, pre-event laboratory tours, buyer-seller programs, and networking opportunities, providing a comprehensive platform for the laboratory and biotechnology industries in the region. The upcoming edition is set to take place from April 2 to 4, 2025 at the SECC – Saigon Exhibition and Convention Center. More details can be found at https://www.analyticavietnam.com/.  

About analytica worldwide 

Messe München is the world’s leading trade fair organizer for laboratory technology, analysis and biotechnology. The international network of exhibitions includes analytica, analytica China, analytica Anacon India & India Lab Expo, analytica Vietnam and analytica Lab Africa. Additional information about these exhibitions and their programs of events is available at http://www.analytica.de.   

About MMI Asia Pte Ltd 

MMI Asia is a full subsidiary of Messe München GMBH (MMG) established in 1992 and one of the world largest and leading exhibition organizers. MMI Asia was set up as the regional headquarter and a wholly-owned subsidiary of MMG to promote global trade expansion by facilitating participation of Asian exhibitors in Messe München fairs worldwide. MMI Asia also provides consultancy in professional trade fair and conference management to government bodies, international trade and promotion organizations, and trade associations.

About Messe München GmbH

Messe München GmbH is one of the world’s leading trade fair organizers with more than 50 trade fairs for capital goods, consumer goods, and new technologies. Every year, Messe München organizes more than 200 events in Munich, Germany, and abroad, attracting over 30,000 exhibitors and 2 million visitors. The company’s mission is to create innovative, sustainable, and profitable platforms for its customers to do business and connect with their target markets.

Contact:
MMI Asia Pte. Ltd.
Joey Ng
Marketing Executive 
+65 9734 7946)
joey@mmiasia.com.sg



Copyright 2024 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Avance Clinical Showcases Clinical Excellence at World Orphan Drug Conference in Boston, April 23-25

North Carolina, USA & Adelaide, Australia, Apr 19, 2024 – (ACN Newswire) – Avance Clinical, the award-winning North American and Australian market-leading CRO for biotechs, will attend World Orphan Drug Conference in Boston (April 23-25, 2024) to share their rare diseases drug development expertise with biotechs (booth #730).

Avance Clinical CEO, Yvonne Lungershausen said that Avance Clinical is dedicated to advancing research and ensuring faster access to therapies that can make a significant difference in patients’ lives.  

“Avance Clinical has deep therapeutic knowledge of this area, completing over 50 trials in rare and orphan diseases globally in the last five years, including Fragile X Syndrome, Duchenne Muscular Dystrophy, Rett Syndrome and Erythropoietic Protoporphyria,” she said. 

Central to the company’s success in this sector is collaboration with disease-specific advocacy groups, patient registries, and tailored recruitment strategies, to enhance patient enrolment and retention.  

Lungershausen said, “We have an extensive understanding of the unique challenges in managing small patient populations. Our patient-centric approach places patients at the heart of our operations, ensuring optimal care through the selection of experienced sites and clinics. 

“Avance Clinical engages with clients early in the planning process to tailor trial designs to accommodate the unique needs and challenges faced by patients with rare diseases, ultimately improving patient access to critical medicines,” she said. 

Avance Clinical is adept at crafting adaptive, patient-focused protocols that adhere to regulatory standards. The company’s innovative approach to study design, combined with over 26 years of experience in delivering FDA and EMA-quality data, positions Avance Clinical as a CRO capable of navigating the complexities of the regulatory landscape efficiently. 

Lungershausen describes Avance Clinical as a mid-sized, agile, and responsive CRO with a proven track record of swiftly advancing high-quality clinical programs. “This makes us an ideal CRO partner for rare disease-focussed biotechs,” she said.  

“Avance Clinical is focussed on accelerating drug development for its biotech clients, from preclinical stages through to Phase III,” she said. 

“This is our GlobalReady program and we have more than 90 biotech clients leveraging this unique, streamlined multi-region process. With a globalized strategy, we ensure efficiency every step of the way,” she said. 

“Biotechs are looking for a partner that can seamlessly help transition rapidly with high-quality data that is readily accepted by the FDA and other regulatory agencies. Our in-house global regulatory affairs team assists biotechs to navigate regulatory complexities with confidence and support our clients with FDA, EMA and TGA submissions,” she said. 

“In addition, our GlobalReady Site Partnership Network of over 1,250 highly qualified sites across the United States ensures maximum efficiency and effectiveness in our biotech’s clinical trials, particularly in rare and orphan indications,” she said. 

New analysis by market research leader Frost & Sullivan shows one of the major challenges for biotechs was finding the right biotech aligned CRO partner. 

“More than 60% of US biotechs experience delays seeking the right CRO partner to accelerate their drug development programs,” Lungershausen said. (See report here). 

The comprehensive report underscores the increasing biotech preference to collaborate with the right sized CROs that can accommodate the fast-paced nature of biotech demands. 

Executive Vice President, North America Operations, John Mann, will attend the conference in Boston alongside Avance’s team of clinical trial experts, including Senior Vice President, Scientific and Regulatory Affairs Kevin Leach and Director of Business Development Clint Henry.

Visit Booth #730 to discuss your upcoming clinical trial, and find out more about the Avance Clinical Advantage, supporting biotechs globally in their clinical development programs.

Book a meeting with the team here 

Find out more: 

Media Contact:  
Avance Clinical 
media@avancecro.com  
Kate Thompson 

About Avance Clinical 

Avance Clinical is the largest premium full-service Australian and North American CRO delivering quality clinical trials, with globally accepted data, in Australia, New Zealand and the US for international biotechs. The company’s clients are biotechs completing Phase I to Phase III of their drug development program that requires fast, agile, and adaptive solution-oriented clinical research services. 

Frost & Sullivan Awards 
Avance Clinical, a Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient for the past four years, has been providing CRO services in the region for more than 26 years. 

Pre-clinical through to mid to late phase 
Avance Clinical offers pre-clinical services with their experienced ClinicReady team right from pre-clinical consultancy through to Phase III clinical services leveraging global reach, supported by significant Australian Government incentive rebates of up to 43.5% and rapid start-up regulatory processes. 

With experience across more than 120 indications, the CRO can deliver world-class results and high-quality internationally accepted data for FDA and EMA review. 

Technology 
Avance Clinical uses state-of-the-art technology and gold standard systems across all functional areas to provide clients with the most effective processes. Medidata, Oracle, TrialHub, Certinia, Salesforce, Zelta and Medrio are just some of the technology partners. 

www.avancecro.com  



Copyright 2024 ACN Newswire. All rights reserved. http://www.acnnewswire.com

DC Healthcare Rides the Wave of Success with New Openings at Publika and Bukit Indah

KUALA LUMPUR, Apr 18, 2024 – (ACN Newswire) – DC Healthcare Holdings Berhad (“DC Healthcare” or the “Group”), an aesthetic medical services provider specialising in the provision of non-invasive and minimally invasive procedures, is pleased to announce the opening of one Dr. Chong Clinic and one DC Body in KL Publika Shopping Gallery as well as one DC Body Johor Bahru Bukit Indah following the successful launch of multiple Dr. Chong Clinics and DC Body outlets across Malaysia. These additions aim to enhance the availability of DC Healthcare’s top-quality wellness and aesthetic services.

Dr Chong Clinic – KL Publika Shopping Gallery continues the Group’s offering of premier aesthetic services, building on the reputation of excellence that DC Healthcare has established. Meanwhile, DC Body – KL Publika Shopping Gallery and Johor Bahru Bukit Indah represent an innovative leap for DC Healthcare, extending the Group’s offerings into specialised weight management, personalised nutrition counselling and body contouring.

Dr. Chong Tze Sheng, Managing Director of DC Healthcare said, “The positive feedback from our customers from the recent outlets openings of Dr Chong Clinic and DC Body in Ipoh, Johor, Penang and Selangor has inspired us to continue growing. Our new facilities at Publika and Bukit Indah reinforce our commitment to meet the demand for professional wellness and beauty services. We look forward to serving more customers in these new locations.”

He added, “The selection of Publika aligns with the Group’s strategy to integrate into areas that support the lifestyle preferences of our clients. Both new establishments are designed to meet the high standards of care and professionalism expected from DC Healthcare.”

In 2024, DC Healthcare has expanded its reach by opening four Dr. Chong Clinics located in Taman Molek (Johor Bahru), Bandar Seri Botani (Ipoh), Auto City (Pulau Pinang), and Publika (Kuala Lumpur), as well as four DC Body outlets in USJ Taipan (Selangor), Auto City (Pulau Pinang), Publika (Kuala Lumpur), and Bukit Indah (Johor Bahru). With these latest additions, DC Healthcare now operates a total of 17 medical aesthetic clinics and 4 DC Body outlets nationwide, significantly enhancing the accessibility and availability of its premium wellness and aesthetic services to a broader audience.

Managing Director of DC Healthcare, Dr. Chong Tze Sheng
Managing Director of DC Healthcare, Dr. Chong Tze Sheng
Dr Chong Clinic located at Publika
Dr Chong Clinic located at Publika
DC Body located at Publika
DC Body located at Publika

 



Copyright 2024 ACN Newswire. All rights reserved. http://www.acnnewswire.com

SinoMab BioScience preclinical results of SM17 on atopic dermatitis (AD) published on International Scientific Journal Allergy

HONG KONG, Apr 16, 2024 – (ACN Newswire) – SinoMab BioScience Limited (Stock Code: 3681.HK, “SinoMab” or the “Company”), a Hong Kong-based biopharmaceutical company dedicated to the research, development, manufacturing and commercialisation of therapeutics for the treatment of immunological diseases, is pleased to announce that the preclinical works of SM17, a humanised IgG4 monoclonal antibody against IL-17RB, is published on Allergy, an official journal of the European Academy of Allergy and Clinical Immunology (EAACI), on 9 April, 2024. This article compared the efficacy of SM17 in alleviating symptoms of atopic dermatitis (AD) with that of FDA approved JAK1 inhibitor in a preclinical setting (animal data), and confirmed that animals treated with SM17 exhibited a similar, if not better, therapeutic responses than those treated with the FDA approved JAK1 inhibitor. The publication in this international, peer-reviewed and well-cited journal Allergy establishes the scientific validity of SM17 on the treatment of AD, and highlights the potential of SM17 as a revolutionary product in this field.

SM17 is a novel, first-in-class (FIC) IgG4 monoclonal antibody targeting IL-17RB (also known as interleukin 25 (IL-25) receptor) with the potential for treating atopic dermatitis, asthma, idiopathic pulmonary fibrosis and other immunological and autoimmune disorders. In Phase I clinical trials (NCT05332834) performed in the US, SM17 showed a good safety profile with no drug-related serious adverse event (SAE) reported, demonstrating superiority over other JAK1 inhibitor in safety and tolerability.

AD is a chronic inflammatory skin disease that is characterised by intense itching and recurrent blisters. AD patients are known to have low treatment satisfaction and there exists a huge unmet medical need for a safer and more efficacious treatment option. AD is driven by Th2 immunity where IL-25 is one of the key mediators that drives the whole cascade of events leading to ILC2 and Th2 cell activation, resulting in inflammatory skin swelling, itching, skin irritation and other symptoms characteristic of AD. The Company has developed SM17, a IgG4 monoclonal antibody, that targets a co-receptor for IL-25 (also known as IL-17RB), with the purpose of blocking the early (upstream) events induced by IL-25, in the hope of achieving a differentiating treatment modality for AD that is fast-acting, efficacious and safe. Current products in the market are either fast-acting and efficacious but with safety concerns (JAK1 inhibitor) or relatively slow to respond and less efficacious yet with better safety profile (anti-IL-4Ra antibody). The Allergy article and the results of the US Phase I study scientifically validated the favourable efficacies and good safety profile of SM17 for treating AD.

In addition to AD, SM17 is found to exhibit therapeutic potentials for treating asthma, idiopathic pulmonary fibrosis and other type 2 immunological disorders. Studies to explore the therapeutic potential of these indications are on-going.

Dr. Shui On LEUNG, Executive Director, Chairman and Chief Executive Officer of SinoMab said that: “SinoMab focuses on the development of innovative products through scientific excellence, with the goal of identifying differentiating products that address immunological diseases of unmet medical needs. We are pleased that evidence demonstrating the advantageous therapeutic potential of SM17 for treating AD is scientifically confirmed and endorsed by being published on the renowned peer-reviewed journal Allergy. The global market size for AD is estimated to reach US 27.68 billion by 2030, according to a new report by Grand View Research, Inc. Currently, the two most prescribed products for AD are the FDA approved anti-IL-4Ra antibody and JAK1 inhibitor. Studies indicated that JAK1 inhibitor is comparatively faster acting and achieving better response than anti-IL-4Ra antibody. However, JAK1 inhibitor has a black box warning, making anti-IL-4Ra antibody more receptive in the medical community due to its better safety profile. Our results indicated that SM17 appeared to have the best of both worlds: SM17 is comparable to (if not better than) JAK1 inhibitor in “time to response (anti-itching)”(unpublished data), and “therapeutic efficacies” in a preclinical model, as illustrated in the Allergy article, and comparable to (if not better than) anti-IL-4Ra antibody in tolerability and safety as demonstrated in our US Phase I study. SM17 is an innovative product with differentiating therapeutic and safety properties that compete favourably with existing treatment options. The preclinical results will be confirmed in human in a proof of concept clinical trial in AD patients that was initiated in April 2024.”

About SinoMab BioScience Limited

SinoMab BioScience Limited is dedicated to the research, development, manufacturing and commercialization 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 (Suciraslimab) is a potential global first-in-class 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-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, multiple sclerosis (MS), neuromyelitis optica spectrum disorder (NMOSD), asthma, and other diseases with major unmet clinical needs.

About Allergy

Allergy, the official journal of the European Academy of Allergy and Clinical Immunology (EAACI), aims to advance, impact and communicate all aspects of the discipline of Allergy/Immunology including educational, basic, translational and clinical research and maintain contact between basic and clinical Allergy/Immunology.

Allergy is an international journal with contributors and readers from all countries. Allergy publishes original articles, reviews, position papers, guidelines, editorials, news and commentaries, letters to the editors and correspondences.

For more information about SM17, please read the published article on Allergy.

Link http://doi.org/10.1111/all.16120

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. Amy Yang

Email:

sinomab@financialpr.hk

Tel:

(852) 2610 0846

Fax: (852) 2610 0842

 



Copyright 2024 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Chiron AS in Trondheim, Norway, Has Developed The World’s First Commercial Microplastic Reference Materials

TRONDHEIM, NORWAY, Apr 9, 2024 – (ACN Newswire) – Chiron AS, now part of ZeptoMetrix®, has developed the world’s very first commercially available microplastic reference materials. This revolutionary new product range, called MicroPRefs®, was developed in close collaboration with the Norwegian Institute for Water Research (NIVA) and was made possible by grants from the EU project EUROqCHARM and Innovation Norway.

Chiron by ZeptoMetrix

Chiron by ZeptoMetrix

Microplastic particles are found in large quantities in water, soil, and in the air. Plastic pollution of various kinds breaks down in nature into tiny particles. These range in size from macro- to nano-sized particles. Microplastics are also carriers of various environmental toxins such as PFAS (per- and poly-fluoroalkyl substances) and brominated flame retardants, and cause significant environmental and health risks to communities around the world.

“In order to measure the quantity and type of microplastic substances present, there is a need for a yardstick or a ‘reference material,’ which is a material developed in the laboratory that can be used for comparison. ZeptoMetrix’s Chiron AS business has now developed the very first commercially available microplastic reference materials for the six most abundant plastics in nature. New variants will follow successively throughout this year,” stated Huiling Liu, Ph.D., Senior Director, R&D Analytical Reference Materials.

MicroPRefs® microplastic reference materials feature a novel tablet format containing a defined number of particles. The particles produced are of known plastic type and were designed to provide sizes and shapes that mimic microplastics found in nature. The tablets are dissolved in water and then analyzed using various methods and in parallel with real samples from nature.

The first single polymer tablets produced contain microplastic particles ranging in size between 50 and 300 micron. Multi-polymer tablets contain a mixture of three different plastic types. Further variants containing different size, quantity and combinations of plastics are planned to support researchers in their endeavors.

“The need to monitor microplastics in our surroundings is paramount to protecting the ongoing health of our communities. ZeptoMetrix is committed to fostering innovations that will help solve real-world issues as laboratories around the world can now deliver microplastics test results with greater confidence,” stated Evangeline Gonzalez, President of ZeptoMetrix. “In addition, our scientists are partnering with industry organizations and leading laboratories to incorporate microplastics into our innovative proficiency testing programs.”

About ZeptoMetrix

Chiron AS is part of ZeptoMetrix®, an Antylia Scientific company. ZeptoMetrix is the industry leader and manufacturer for innovative solutions solving challenges in the evolving Diagnostic Microbiology, Infectious Disease, and Oncology markets, as well as Analytical Reference Materials for the Applied Markets. We focus on our customers’ success by providing premium product quality, reliability, and expert technical knowledge, enabling our customers to develop and advance many applications across diagnostics, pharmaceutical, environmental, food and beverage industries. From in-stock solutions to custom control and panel development, our scientific teams provide our customers with comprehensive, performance-oriented, and cost-effective products and services that positively impact the field of clinical diagnostics, analytical testing and contribute to a healthier world. ZeptoMetrix is a division of Antylia Scientific, an operating company of premier life science and diagnostic brands, including Cole-Parmer, Environmental Express and ZeptoMetrix.

Contact Information
Nancie Geddings
Global Business Development Leader
nancie.geddings@antylia.com
1-843-277-5230

Related Files
Chiron AS Develops the World’s First Commercial Microplastic Reference Materials

SOURCE: ZeptoMetrix

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View the original press release on newswire.com.



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Sino Biopharm (1177.HK) Announces 2023 Annual Results

HONG KONG, Mar 29, 2024 – (ACN Newswire) – Sino Biopharmaceutical Limited (“Sino Biopharm” or the “Company”, together with its subsidiaries, the “Group”) (HKEX:1177), a leading innovation-driven pharmaceutical conglomerate in the PRC, has announced its audited financial results for the year ended 31 December 2023.

During the year, the Group recorded revenue of approximately RMB26.20 billion, an increase of approximately 0.7% over last year. Profit attributable to the owners of the parent company was approximately RMB2.33 billion. Earnings per share attributable to the owners of the parent company were approximately RMB12.59 cents, a decrease of approximately 7.8% over last year, which was mainly due to the lower financial performance of an associate over last year. Excluding the profit attributable to the owners of the parent from the discontinued operations, the share of profits and losses of associates and a joint venture (net of related tax and non-controlling interests), one-off adjustments for the impairment and fair value changes of certain assets and liabilities (net of related tax and noncontrolling interests), fair value (gains)/losses of current equity investments, share-based payments (net of related non-controlling interests), loss on extinguishment of partial convertible bond, fair value gain of convertible bond embedded derivative component, effective interest expenses, exchange gain and fair value losses of derivative financial instruments in relation to foreign currency forward contracts of the convertible bond debt component, adjusted non-HKFRS profit attributable to the owners of the parent was approximately RMB2.59 billion, an increase of around 1.5% over last year. The Group’s liquidity remains strong, with total fund reserve at approximately RMB21.13 billion, including cash and bank balances classified under current assets of approximately RMB9.45 billion, bank deposit classified under non-current assets of approximately RMB7.31 billion, and the wealth management products of approximately RMB4.37 billion in aggregate.

The Board of Directors has recommended a final dividend payment of HK3 cents per share (2022: HK6 cents). Together with the interim dividend of HK2 cents already paid, the total dividend for the year amounted to HK5 cents (2022: HK12 cents).

Sales: Strong and effective sales system continued to drive sales and revenue of innovative products

On the strong foundation its generic drug business provides, the Company is transforming at full steam powered by innovation, with innovative products business driving revenue growth and contributing an increasing share to its revenue every year. Revenue from innovative products amounted to RMB9.89 billion, up by 13.3% year-on-year, and accounted for 37.8% of the Group’s total revenue.

During the year, the sales of oncology medicines amounted to approximately RMB8.80 billion, representing approximately 33.6% of the Group’s revenue. The sales of surgery/analgesia and liver disease amounted to approximately RMB3.75 billion and RMB3.82 billion, respectively, representing approximately 14.3% and 14.6% of the Group’s revenue, respectively. In addition, sales contributions from various areas such as respiratory, cardio-cerebral vascular medicines and others were progressing simultaneously. Among them, the sales of respiratory and cardio-cerebral vascular medicines accounted for approximately 11.3% and 10.5% of the Group’s revenue, respectively.

R&D: Vigorously conducted innovative product R&D and actively applied for patents

The Group has continued to focus its R&D efforts on new medicines in the four therapeutic areas of oncology, liver diseases, respiratory system and surgery/analgesia. As at the end of the reporting period, the Group had 145 products under development, including 60 oncology products, 9 liver disease products, 31 respiratory system products, and 15 surgery/analgesia products, of which 67 were Category I innovative products.

The Group also attaches tremendous importance to the protection of intellectual property rights and encourages its member enterprises to file patent applications in order to enhance the Group’s core competitiveness. During the reporting period, the Group filed 841 new patent applications and received 264 patent invention approvals. As at the end of the reporting period, the Group had accumulated 4,311 effective patents and patent applications and obtained 1,595 patent invention approvals.

Prospects: Enhanced the efficiency of R&D in the four main therapeutic areas and actively promoted the dual-pronged development strategy

With the COVID-19 pandemic gradually subsiding, the economic and social order has returned to normal, and the pharmaceutical industry is expected to recover. The Group has been closely monitoring the development of the country, society and industry, and has made timely adjustments to its development strategies, focused on the operation of core assets to realize rapid business development and steady improvement in results.

Sino Biopharm is committed to “be a leading global pharmaceutical company through delivering innovative therapies for patients”. The Group has stepped up its R&D investment in medicines and built strong internal R&D capabilities. At the same time, it has vigorously promoted business development and strategic cooperation, striving to become the best partner for global pharmaceutical and biotechnology enterprises. At present, the Group has entered the harvest period of its innovative development. In the next three years, more than 10 innovative products are expected to be launched to market, and another 30 or more innovative products under R&D have the potential to be launched by 2030, which will further promote the high-quality development, strengthen the Group’s dominance in the four aforementioned therapeutic areas and provide strong impetus for its future sustainable growth. Meanwhile, the Group will adhere to its dual-pronged approach in the implementation of its globalization strategy, so as to become an important platform of global innovation. Through this approach, the Group will introduce global pharmaceutical innovations to China to benefit Chinese patients, and also go global and open up new markets to accelerate the satisfaction of unmet clinical needs worldwide.

Looking ahead, the Group will further focus on its core business and innovation, and continue to improve R&D efficiency and quality in the four major therapeutic areas. It will also actively accelerate the deployment for globalization of its business and is expected to achieve faster growth in 2024.

About Sino Biopharmaceutical Limited (HKEX:1177)

Sino Biopharmaceutical Limited is a leading Chinese pharmaceutical company continuing to invest in Oncology, Hepatology, Respiratory and Surgery, exploring innovative therapies to improve the lives of patients. The company has strong manufacturing capabilities and broad patient access across China. Sino Biopharmaceutical Limited is committed to bring innovation to address unmet healthcare needs globally. The company was listed on the Hong Kong Stock Exchange in 2000, and was selected as a component of the MSCI Global Standard Index in China in 2013; In 2018, it was selected as a constituent stock of Hang Seng Index; The company has been listed in the “Top 50 Global Pharmaceutical Enterprises” published by the authoritative American magazine Pharmaceutical Manager for five consecutive years, and has been rated as the “Top 50 Best Companies in Asia Pacific” by Forbes (Asia) for three consecutive years.

For more information, please visit: www.sinobiopharm.com



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Avance Clinical at World Vaccine Congress to Share Latest Vaccine Clinical Trial News Including an HIV-1 Study

Adelaide, AU & North Carolina, USA, Mar 28, 2024 – (ACN Newswire) – Avance Clinical, the award-winning Australian and North American market-leading CRO for biotechs, will attend World Vaccine Congress in Washington DC (April 1-4, 2024) and share the latest clinical trial client news including the Uvax Bio announcement. (Booth #267)

Avance Clinical CEO, Yvonne Lungershausen said the World Vaccine Congress was an important event for the company’s US and Australian teams as they continue to excel in biotech vaccine CRO services.

Lungershausen said Avance Clinical is a mid-sized, agile, and responsive CRO with a proven track record of swiftly advancing high-quality clinical programs. “This makes us an ideal CRO partner for vaccine focussed biotechs,” she said. Lungershausen said the company has had significant vaccine client successes in infectious diseases, including COVID-19 and RSV, as well as other diseases such as Hypertension and Psoriasis.

She said Avance Clinical is proud to be working with many innovative vaccine biotech companies including Uvax Bio who have just announced another milestone in their Phase I HIV study. Mary Giffear, Uvax Bio’s Director of Clinical Operations reported, “we have completed enrollment in our Phase 1 study of the Company’s HIV-1 vaccine candidates, UVAX-1107 and UVAX-1197, and the Australia-based trial is on schedule.”

Lungershausen said Avance Clinical is focussed on accelerating drug development for its biotech clients, from preclinical stages through to Phase III.

“This is our GlobalReady program and we have more than 90 biotech clients leveraging this unique, streamlined multi-region process. With a globalized strategy, we ensure efficiency every step of the way,” she said.

“Biotechs are looking for a partner that can seamlessly help transition them with the ability to start fast with high-quality data that is readily accepted by the US Food and Drug Administration (FDA) and other regulatory agencies. Our in-house global regulatory affairs team assists biotechs to navigate regulatory complexities with confidence and work to support our clients with FDA, EMA and TGA submissions,” she said.

“In addition, our GlobalReady Site Partnership Network of over 1,250 highly qualified sites across the United States ensures maximum efficiency and effectiveness in our biotech’s clinical trials,” she said.

Another key advantage for vaccine biotechs is that Avance Clinical is accredited as a gene technology CRO which allows it to manage pre-clinical and clinical trials for vaccines and GMO therapies.

The Office of the Gene Technology Regulator (OGTR) has developed globally compliant regulations and accreditations which are in line with international guidelines.

Avance Clinical’s Chief Scientific Officer Dr. Gabriel Kremmidiotis said: “This means that as an OGTR accredited CRO we can support our international biotech clients with extensive OGTR knowledge and experience to accelerate their clinical research. Indeed, we would argue the clarity around the OGTR regulations makes Australia one of the most attractive destinations for Cell and Gene Technology research,” he said.

Find out more:

  • Learn about the GlobalReady model
  • For more information about the benefits of running your next study with Avance Clinical contact us
  • Request a Proposal here

Media Contact:
Avance Clinical
media@avancecro.com
Kate Thompson

About Avance Clinical

Avance Clinical is the largest premium full-service Australian and North American CRO delivering quality clinical trials, with globally accepted data, in Australia, New Zealand and the US for international biotechs. The company’s clients are biotechs completing Phase I to Phase III of their drug development program that requires fast, agile, and adaptive solution-oriented clinical research services.

Frost & Sullivan Awards
Avance Clinical, a Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient for the past four years, has been providing CRO services in the region for more than 26 years.

Pre-clinical through to mid to late phase
Avance Clinical offers pre-clinical services with their experienced ClinicReady team right from pre-clinical through to Phase III clinical services leveraging significant Australian Government incentive rebates of up to 43.5% and rapid start-up regulatory processes.

With experience across more than 120 indications, the CRO can deliver world-class results and high-quality internationally accepted data for FDA and EMA review.

Technology
Avance Clinical uses state-of-the-art technology and gold standard systems across all functional areas to provide clients with the most effective processes. Medidata, Oracle, TrialHub, Certinia, Salesforce, Zelta and Medrio are just some of the technology partners.

www.avancecro.com



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