Tag: BioTech

HighTide Therapeutics Announces First Patient Dosed in Phase 2b Clinical Study Evaluating HTD1801 in NASH (the CENTRICITY study)

ROCKVILLE, MD and SHENZHEN, CHINA, Jan 11, 2023 – (ACN Newswire) – HighTide Therapeutics Inc. ("HighTide"), a globally integrated clinical-stage biopharmaceutical company developing novel multifunctional therapies for metabolic and digestive diseases, today announced the dosing of the first patient in a Phase 2b clinical study evaluating HTD1801 for the treatment of nonalcoholic steatohepatitis ("NASH").

This double-blind, randomized, placebo-controlled, multicentre Phase 2b study will evaluate the effect of HTD1801, 1250 mg twice daily (BID), compared to placebo BID on histologic improvement in adult subjects with NASH and liver fibrosis who also have type 2 diabetes mellitus ("T2DM") or pre-diabetes. The study will enroll approximately 210 subjects with biopsy-confirmed NASH and evidence of stage 2 or stage 3 liver fibrosis. Subjects will receive HTD1801 for up to 60 weeks.

"Nonalcoholic fatty liver disease ("NAFLD") is the most prevalent chronic liver disease worldwide with a global prevalence of 25.2% to 29.8%. Of those with NAFLD, about 20% have NASH. Patients with NASH and T2DM or prediabetes are at increased risk of progressive liver disease and cardiometabolic complications," said Dr. Liping Liu, founder and Chief Executive Officer of HighTide. "This first patient dosing marks a key milestone for the development of HTD1801 for the treatment of patients with NASH, building on data from our Phase 2a study which showed HTD1801 was associated with meaningful improvements in liver fat, markers of liver Injury and fibrosis as well as cardiometabolic factors (HbA1c, lipids, and weight) after 18 weeks."

About NASH

NASH, a severe form of nonalcoholic fatty liver disease (NAFLD), is a chronic, complex liver disease characterized by hepatitis – inflammation of the liver – and liver cell damage, which can lead to fibrosis of the liver. NASH can also lead to cirrhosis and liver cancer. NASH patients with T2DM or impaired glucose tolerance are more likely to progress to more severe disease and to develop complications that lead to increased mortality. Prevalence of NASH is on the rise and may soon surpass hepatitis C as a cause for liver transplant in the U.S. and Europe. Currently, there are no approved therapies for NASH.

About HighTide Therapeutics

HighTide is a globally integrated clinical-stage biopharmaceutical company focusing on the discovery and development of novel multifunctional therapies for metabolic and digestive diseases with significant unmet medical needs. The company's lead drug candidate, HTD1801, is a first-in-class new molecular entity, currently in clinical development for the treatment of type 2 diabetes (T2DM), nonalcoholic steatohepatitis (NASH), severe hypertriglyceridemia (SHTG), and primary sclerosing cholangitis (PSC). HTD1801 has received Fast Track designation from the U.S. FDA for both NASH and PSC, as well as Orphan Drug designation for PSC. In China, HTD1801 has been included in the National Major New Drug Innovation Program. For more information, please visit www.hightidetx.com.

Contacts
Nadia Gao
ir@hightidetx.com


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

Avance Clinical Celebrates GlobalReady Success as more than 40 Biotech Clients Enter Program

San Francisco, Jan 11, 2023 – (ACN Newswire) – More than 40 biotech clients are now taking advantage of Avance Clinical's GlobalReady program which delivers streamlined clinical development from early phase in Australia expanding to sites in North America for later phases. All with the one CRO and dedicated teams across both regions.

Avance Clinical made the announcement at Biotech Showcase 2023 where the team is taking meetings via PartnershipOne. "Given this successful early adoption of GlobalReady we are expecting more than half of our biotech clients to join the program within the next six months, said Avance Clinical CEO Yvonne Lungershausen.

GlobalReady biotech clients are primarily biotechs from the US and Asia, with an increasing number expected from Europe over the next few months.

Avance Clinical is the leading Australian-based biotech CRO with US operations, which has been recognized by Frost & Sullivan for the past 3 years with the prestigious CRO Leadership Award.

CEO Yvonne Lungershausen said: "These biotech clients are already benefiting from our expansion into North America and GlobalReady. The GlobalReady model is designed to extend biotechs' investments so they can achieve greater clinical development milestones with reduced spend, all with the assurance of FDA-accepted data. GlobalReady gives our biotech clients conducting their early phase studies in Australia and New Zealand a seamless journey into the US to continue their clinical development programs, retaining the same high-quality CRO, which reduces time and cost and delivers quality FDA-accepted data. In addition, the attractive 43.5% rebate on clinical spend in Australia, offers our clients the opportunity to utilize our North American operations expertise and team, whilst maintaining services in Australia to maximize their rebate potential. We often point to the fact that there are currently more than 280 Phase III global trials that have conducted their Phase I study in Australia, which again demonstrates Australian data acceptability with the FDA and other major regulatory authorities."

This seamless GlobalReady journey is designed for success whereby biotechs can:
– Take advantage of the Australian early-phase clinical trial landscape (No IND and 43.5% tax rebate)
– Transition or expand into North America for later phases – without changing CROs (retain study knowledge and processes/team)
– Seamlessly operationalize global dose-escalation and dose-expansion trials across the two regions
– Harness significant speed and cost advantages
– Be assured of quality data – transferable and readily acceptable by the FDA and other regulatory authorities

"We have shown, with our high growth and industry-leading repeat business rates that our focus on gold standard technology paired with solution-orientated clinical experts is the mix our biotech clients need for clinical success," commented Yvonne Lungershausen.

According to Frost & Sullivan as part of the independent analyst review of the company for the CRO Award: "Avance Clinical remains a trusted partner, earning a reputation for delivering the overall best in the CRO industry. With its strong overall performance, Avance Clinical earns Frost & Sullivan's 2022 Asia-Pacific Customer Value Leadership Award in the contract research organization industry."

Find out more:
– Learn about the Australian Advantage here https://www.avancecro.com/the-australian-advantage/
– Learn about the GlobalReady model here https://www.avancecro.com/avance-clinical-north-america-operations/
– For more information about the benefits of running your next study with Avance Clinical contact us: enquiries@avancecro.com

About Avance Clinical

Avance Clinical is the largest premium full-service Australian and US 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 in their early phases of drug development that need fast, agile, and adaptive solution-oriented clinical research services. https://www.avancecro.com/

Frost & Sullivan Awards
Avance Clinical, a Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient for the past three years, has been providing CRO services in the region for more than 24 years.

Pre-clinical through to Phase 1 and 2
Avance Clinical offers pre-clinical services with their experienced ClinicReady team right through to Phase 1 and 2 clinical services leveraging significant Government incentive rebates of up to 43.5% and rapid start-up regulatory processes. With experience across more than 110 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, IBM Watson and Medrio are just some of the technology partners.

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

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

Prenetics Owned ACT Genomics Receives FDA Clearance for ACTOnco, the First Asia-Based Company to Receive Clearance for a Comprehensive Genomic Profiling Test for All Solid Tumors

LONDON AND HONG KONG, Jan 11, 2023 – (ACN Newswire) – Prenetics Global Limited (NASDAQ: PRE) a leader in genomic and diagnostic testing, today announced that ACT Genomics, a company which Prenetics recently acquired a majority stake in, has received clearance from the U.S. Food and Drug Administration (FDA) for ACTOnco, the company's comprehensive genomic profiling test for solid tumors. ACTOnco is intended for use by healthcare professionals to help them inform clinical management decisions in accordance with professional guidelines for cancer patients with solid tumors. This is the first and only Asia-based company to receive FDA clearance for a comprehensive genomic profiling test. ACTOnco is a diagnostic test which:

— provides a comprehensive genomic profiling test that looks at 440 cancer-associated genes;
— provides information to help guide clinical management decisions on the use of targeted oncology therapies, including immunotherapies;
— is intended as a pan-cancer test including breast, colon, endometrial, lung, and other cancers;
— is an FDA-cleared platform for comprehensive genomic profiling assay development for biopharma companies developing precision therapeutics.

The ability to perform a comprehensive genomic profiling test on an individual tumor helps open the door for personalized medicine, and a future where a person is matched with a treatment that targets the specific weaknesses in his or her cancer.

"Today's landmark clearance by the FDA represents a significant advancement in personalized cancer care in Asia and may lead to reimbursement and coverage by private insurers and healthcare systems. The clearance by the FDA further validates our status as a pioneer in the industry and we will continue to invest further in R&D efforts, especially related to early detection of cancer in healthy populations." Said Danny Yeung, Chairman of ACT Genomics and Chief Executive Officer of Prenetics.

Dr. Hua Chien Chen, Chief Executive Officer of ACT Genomics, said "It was a tremendous team and scientific effort to develop ACTOnco. Asia contributes 48% of the new cancer cases and 55 % of the cancer deaths in the world. The disease imposes a serious burden on Asia. While precision medicine provides an advantage in disease diagnosis and treatment planning and has become a routine clinical practice in the west, it is not the case in Asia. ACT Genomics is the first biotech company in Asia that received market authorization for a cancer comprehensive genomic profiling assay. Unlike most of the currently marketed tests developed by US companies using mainly clinical samples from Western countries, the ACTOnco assay was developed and validated using half of the Western clinical samples and half of the Asia clinical samples. ACTOnco enables physicians to gain better insights into the genetic underpinnings of each patient's illness and helps them to formulate the best treatment decisions. Having ACTOnco cleared by the FDA will open new opportunities for patients to get the best cancer care. With this incredible milestone achieved, we will continuously promote precision medicine in Asia and our company mission to turn genomics into action."

About ACT Genomics
ACT Genomics is an innovation-driven cancer solution provider with offices in Taipei, Hong Kong, Singapore, Tokyo, Bangkok, and the United Kingdom. With its Next-Generation Sequencing (NGS) technology, CAP-accredited laboratories, experienced bioinformatics team, and proprietary AI algorithms, ACT Genomics provides optimal cancer treatment planning, immunotherapy evaluation, cancer relapse & drug resistance monitoring, as well as cancer risk assessment services to medical professionals. Its mission is to "Turn Genomics into Action". To learn more about ACT Genomics, visit www.actgenomics.com.

About Prenetics
Founded in 2014, Prenetics is a major global diagnostic and genetic testing company with the mission to bring health closer to millions of people globally and decentralize healthcare by making the three pillars – Consumer Health, Clinical Care and Medical & Cancer Genomics – comprehensive and accessible to anyone, at anytime and anywhere. Prenetics is led by visionary entrepreneur, Danny Yeung, with operations across nine locations, including the United Kingdom, Hong Kong, India, South Africa, and Southeast Asia. Prenetics develops consumer genetic testing and early colorectal cancer screening and provides COVID-19 testing, rapid point of care and at-home diagnostic testing and medical genetic testing. Prenetics is listed on NASDAQ with the ticker PRE. To learn more about Prenetics, visit www.prenetics.com.

Investor Relations Contact:
investors@prenetics.com

ICR Westwicke:
Caroline Corner +415 202 5678 Email: caroline.corner@westwicke.com

Forward-Looking Statements
In addition to historical information, this release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terminology such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "should," "plan," "expect," "predict," "potential," or the negative of these terms or other similar expressions. These statements are based on estimates and forecasts and reflect the views, assumptions, expectations, and opinions of Prenetics and ACT Genomics. Any such estimates and assumptions, expectations, forecasts, views or opinions, whether or not identified in this press release, should be regarded as indicative, preliminary and for illustrative purposes only and should not be relied upon as being necessarily indicative of future results. These statements include, but are not limited to, statements by our management or the board regarding expectations for the closing of the acquisition, statements of plans, objectives, and expectations of synergy between Prenetics and ACT by our management or the board or by ACT or ACT's management or board. Our expectations and beliefs regarding these matters may not materialize, and actual results in future periods are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Because of these uncertainties, you should not make any investment decisions based on our estimates or forward-looking statements. All information provided in this press release is as of the date of this press release. Prenetics does not undertake any obligation to update any forward-looking statement, whether as a result of new information, future developments, or otherwise, except as required under applicable law.



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

China Biotech Services subsidiary AMDL nominated as Top Clinical Laboratory Services Company in APAC 2022 and receives CAP Accreditation Certificate

HONG KONG, Jan 10, 2023 – (ACN Newswire) – China Biotech Services Holdings Limited (the "Group"; stock code: 8037. HK) has announced that its subsidiary, Asia Molecular Diagnostics Laboratory (AMDL), has been nominated as the Top Clinical Laboratory Services Company in APAC 2022 and has received the College of American Pathologists (CAP) Accreditation Certificate for providing next-generation sequencing (NGS) Oncology clinical testing services.




With world-leading NGS-based clinical testing products and services for oncologists and a high-standard molecular-level clinical laboratory, and as the sole distributor of Pillar Biosciences products in Asia, it's no surprise that AMDL has been named one of the industry's Top Clinical Laboratory Services Companies in APAC 2022 by Life Sciences Review.

In addition, AMDL has recently received the Accreditation Certificate from CAP, which is recognized as one of the industry's leaders in medical laboratory quality assurance. It has developed detailed checklists for all aspects of clinical laboratory disciplines and has strict requirements for laboratory quality standards. AMDL obtaining the authoritative certification from CAP proves that the company has reached an advanced level in terms of quality, management mode, testing accuracy and other aspects.

By leveraging next-generation sequencing (NGS) technology and FDA-approved companion diagnostic (CDx), namely the oncoReveal(TM) Dx Lung and Colon Cancer Assay and MiSeqDx developed by Pillar Biosciences, AMDL will provide precision diagnostic tests for the qualitative detection of somatic mutations in DNA derived from lung and colon cancer tumors. Working toward CAP accreditation, the AMDL platform can offer a simplified and standalone testing workflow that helps local healthcare professionals, oncologists, and researchers obtain results in seven to nine working days, significantly reducing the overall timeline.

The CAP certification also provides a good endorsement for AMDL to promote the test kit in Hong Kong and Asia on a large scale, which is conducive to the rapid commercialization of the test kit and brings new achievements to China Biotech Services.

About China Biotech Services Holdings (Stock Code: 8037.HK)
China Biotech Services Holdings Limited is listed on GEM of Hong Kong Stock Exchange and was included in MSCI Hong Kong Micro Cap Index in May 2018. The Group focuses on two main areas, namely, precision diagnostics and cancer treatments.


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

Malaysian Genomics Explores R&D Collaboration with SIRIM

PETALING JAYA, Malaysia, Jan 9, 2023 – (ACN Newswire) – Malaysian Genomics Resource Centre Berhad (Bursa: MGRC, 0155), a leading genomics and biopharmaceutical specialist, is pleased to announce a strategic cooperation with SIRIM Berhad, to explore the commercialisation of joint research and development (R&D) projects in the medical and biotechnology fields.
Encik Sasha Nordin, Chief Executive Officer of Malaysian Genomics


SIRIM Berhad is wholly owned by the Malaysian Government, and is focused on R&D, standardisation and quality. The organisation acts as a catalyst for industrial development through programmes involving technology and standardisation.

Under the strategic cooperation, both parties will evaluate the potential commercial value of a range of genomics-driven biotechnology R&D projects. These include developing biofuels and biopharmaceuticals, companion diagnostic tests for cancer treatment, and bioactive cosmeceuticals.

Encik Sasha Nordin, Chief Executive Officer of Malaysian Genomics, said, "SIRIM and Malaysian Genomics have complementary experiences, resources, and technology assets. Teams from both organisations have met to explore their research and develop interests in precision medicine, food security, and products for the consumer market. This strategic collaboration will pave the way for individual agreements specific to projects for which commercial opportunities have been identified."

President and Group Chief Executive Officer of SIRIM Berhad, Dato' Indera Dr Ahmad Sabirin Arshad said, "We look forward to working closely with Malaysian Genomics on R&D projects that can benefit the country and domestic industries. This strategic collaboration will expedite the relevant processes to ensure that both parties can explore the commercial viability of projects, before commencing research, development and commercialisation."

The parties of this two-year strategic collaboration will also jointly source for suitable private and public institutional partners for the funding and commercialisation of these projects.

Malaysian Genomics Resource Centre Berhad: 0155 [BURSA: MGRC] [RIC: MGRC:KL] [BBG: MGRC:MK], http://www.mgrc.com.my/

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

HighTide Therapeutics Raises $107 Million in Series C/C+ Financing to Advance Innovative Pipeline and Business Collaborations

ROCKVILLE, MD and SHENZHEN, CHINA, Jan 5, 2023 – (ACN Newswire) – HighTide Therapeutics Inc. ("HighTide"), a globally integrated clinical-stage biopharmaceutical company developing novel multifunctional therapies for metabolic and digestive diseases, today announced the closing of a $107 million Series C/C+ financing led by the TCM Healthcare Fund of Guangdong, managed by China Development Bank Capital. Other investors included Yuexiu Fund and Yuthai Fund.

Proceeds of the financing will be used to advance multiple global development programs, including mid-to-late-stage clinical trials, and the commercialization and business development of the company's robust pipeline. HighTide's lead candidate HTD1801, is a novel multifunctional molecule, being developed for the treatment of patients suffering from complex metabolic and digestive diseases.

HighTide has successfully completed multiple clinical trials of HTD1801 and continues to advance its global development programs as follows:

— A Phase 2 clinical study in type 2 diabetes (T2DM) is near completion;
— A Phase 2b clinical study in nonalcoholic steatohepatitis (NASH) has been initiated; and
— A successful End-of-Phase 2 (EOP2) meeting was held with the U.S. Food and Drug Administration (FDA) based on the positive findings from the Phase 2 clinical study in primary sclerosing cholangitis (PSC).

"After completing a successful $60 million Series B+ round at the end of 2020, we are thrilled to have well-recognized investors participate in our C/C+ round. We are grateful that our investors have such strong confidence in HighTide's team, the commercial value of our pipeline, and future development prospects," said Liping Liu, Ph.D., founder and Chief Executive Officer of HighTide. "The Series C/C+ financing is a significant milestone for HighTide. It will enable us to move aggressively to accelerate the clinical and commercial development of our innovative pipeline and external business collaborations."

About HighTide Therapeutics
HighTide is a globally integrated clinical-stage biopharmaceutical company focusing on the discovery and development of novel multifunctional therapies for metabolic and digestive diseases with significant unmet medical needs. The company's lead drug candidate, HTD1801, is a first-in-class new molecular entity, currently in clinical development for the treatment of type 2 diabetes (T2DM), nonalcoholic steatohepatitis (NASH), severe hypertriglyceridemia (SHTG), and primary sclerosing cholangitis (PSC). The U.S. Food and Drug Administration (FDA) granted Fast Track designation to HTD1801 for both NASH and PSC, as well as Orphan Drug designation for PSC. In China, HTD1801 has been included in the National Major New Drug Innovation Program. For more information, please visit www.hightidetx.com.

Contacts:

Investors
Nadia Gao
ir@hightidetx.com
+86-134-8219-0265

Media
Karl Schmieder
karl@messaginglab.com
+1-646-515-3392


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

Shares of Major Global Medical Device Manufacturer OrbusNeich Medical Group Commence Trading on the Main Board of The Stock Exchange of Hong Kong

HONG KONG, Dec 23, 2022 – (ACN Newswire) – Shares of OrbusNeich Medical Group Holdings Limited ("OrbusNeich" or the "Group"), a major global medical device manufacturer specialized in interventional instruments for percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA) procedures, today commenced trading on the Main Board of The Stock Exchange of Hong Kong Limited ("HKEX"), under the stock code 6929.


Mr. Teddy Chien, Chairman Emeritus and Founder (right) and Mr. David Chien, Chairman, Executive Director, Chief Executive Officer (left), together strike the ceremonial gong, marking the Group's listing on the Main Board of HKEX

Mr. David Chien, Chairman, Executive Director, Chief Executive Officer (right) presents a souvenir to HKEX

OrbusNeich makes a generous donation of HK$3,000,000 to HKEX Foundation to secure the auspicious stock code number "6929". Mr. David Chien, Chairman, Executive Director, Chief Executive Officer (right) presents the cheque to HKEX

(From left to right): John Chow,Executive Director and Head of Business Development; Jason Chen, Executive Director, Chief Financial Officer and Company Secretary; Gloria Tam, Independent Non-executive Director; Denise Lau, Executive Director and Chief Operating Officer; Teddy Chien, Chairman Emeritus and Founder; David Chien, Chairman, Executive Director and Chief Executive Officer; George Lau, Independent Non-executive Director; Angus Chan, Independent Non-executive Director


About OrbusNeich Medical Group Holdings Limited
OrbusNeich is a major global medical device manufacturer specialized in interventional instruments for percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA) procedures. Headquartered in Hong Kong, China, OrbusNeich sells products to over 70 countries and regions worldwide, and it is also the only PCI balloon manufacturer headquartered in China that ranked among the top 6 players in all major overseas PCI balloon markets including Japan (Ranked No. 2), Europe (Ranked No. 4), and the U.S. (Ranked No. 6) in terms of sales volume of PCI balloons in 2021 in accordance with the CIC Report. In addition, in terms of sales volume of PTA balloons in 2021, it ranked No. 3 in Japan and No. 4 in the U.S., respectively. It also specializes in coronary stent products and is actively expanding into neuro vascular intervention and structural heart disease areas. OrbusNeich owns more than 180 granted patents globally. Its in-house R&D team has over twenty years of product development experience and has developed proprietary, world leading technologies.

For more details, please visit the Group's official website: https://orbusneich.com/


Copyright 2022 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Pharmaron: Fulfilling the “Green” and “Low-carbon” Mission and Striving to Improve Sustainability

HONG KONG, Dec 20, 2022 – (ACN Newswire) – Pharmaron (Stock Code: 300759.SZ/3759.HK) is a premier R&D service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development and manufacturing service capabilities throughout the entire drug discovery, preclinical and clinical development process across multiple therapeutic modalities, including small molecules, biologics and CGT products. With around 17,000 employees, and operations in China, U.S., and U.K., Pharmaron has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan and China.


"Green" and "low carbon" have remained the keywords along Pharmaron's development. Pharmaron set it's first five-year environmental targets in 2016 and achieved reduction of water consumption and the energy consumption per RMB10,000 of output value by 25% and 20% in 2020, respectively, which showed solid results in energy savings and emissions reduction. In 2021, Pharmaron further developed the 2021-2025 Environmental Targets based on the characteristics of its industry and align with the United Nations (UN)'s advocacy for climate action, as well as the peak carbon emissions and carbon neutrality targets of the countries where it operates. Pharmaron will continue to taking concrete actions toward the targets and further improve its environmental management system, resource savings exercises, waste & pollutant reduction effort, and green facility upgrades. Moreover, Pharmaron will continuously promoting green chemistry practices and establishing more suitable and efficient processes to reduce waste and pollutants.

At the corporate level, Pharmaron incorporated ESG governance into the overall corporate governance and operations and is committed to continuously improving its ESG governance and management systems through updating the policies and systems, initiating targeted campaigns, increasing operational transparency, etc. According to its 2021 Environmental, Social and Governance Report, as the global COVID-19 pandemic continued, Pharmaron's team continues to be guided by its mission "to support its partners' success in discovery, development and commercialization of innovative medicines" and continue to develop its fully integrated end-to-end clinical service platform.

Pharmaron built a three-tiered ESG governance with clear responsibilities to ensure the effective implementation of its ESG strategies. In addition, Pharmaron place high emphasis on interactions and alignment of priorities with stakeholders on various ESG topics, through regular questionnaire surveys and interviews, to better address the expectations of different stakeholders.

Pharmaron provides its customers with high-quality, high value-added services and novel solutions. Its quality assurance system seamlessly manages the entire product lifecycle from customer acceptance through raw material procurement, R&D service execution, and quality inspection onto R&D product delivery and more; its complete set of information security management strategies served to protect information security and ensure the confidentiality, integrity, and availability of the information assets; its five-level intellectual property rights (IPR) protection system consisting of "Management Safeguard, Policy Safeguard, Legal Document Safeguard, Training Safeguard, and Technical Safeguard" was effective in delivering reinforced IPR protection. It remained committed to the "Honesty, Credibility, Mutual Benefit and Win-Win" principles when engaging with its suppliers. It managed and controlled environmental and social risks in the supply chain relating to core issues, such as business integrity, business information security, supply chain labor rights, and supply chain environmental protection. It implemented transparent procurement to maintain a fair environment for its prospective suppliers.

The research and development of new medicines are fundamental to human health and wellness. In the coming year, Pharmaron will, as always, fulfill its responsibilities for all stakeholders including the society, environment, investors/shareholders, employees, customers, supply chain, etc. It will follow its ESG commitments to being green, sustainable and transparent as well as strive to continuously improve economic, environmental and social sustainability.


Copyright 2022 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Novotech is Gold Sponsor at Biotech Showcase 2023

SYDNEY, AU, Dec 20, 2022 – (ACN Newswire) – Novotech, the Asia Pacific centered biotech specialist CRO is proud to be Gold Sponsor at Biotech Showcase 2023. Novotech CEO Dr. John Moller and experts from the Novotech US and Asia Pacific teams will be attending the conference.

Meetings can be scheduled via the PartneringOne portal. https://informaconnect.com/biotech-showcase/partnering/

Novotech will share the Asia Pacific advantages for expedited clinical trials, where biotechs have access to Novotech's vast patient populations, strong local regulatory knowledge, extensive site and KOL networks, and reputation for data quality.

Novotech has more than 50 Leading Site Partnership agreements with major medical research institutions in Asia Pacific delivering exclusive benefits for sponsors.

The latest industry research publication by GlobalData and Novotech found almost 50% of new trials globally have sites in Asia Pacific. According to the new publication titled "State of the Global Biotech Landscape: Where the Opportunities Lie", demand for Asia Pacific trial sites is strong with almost half of the more than 27,000 clinical trials initiated in 2021 having sites in Asia Pacific. The data shows almost 12,900 of the new trials had sites in Asia Pacific.

Download the report here https://novotech-cro.com/whitepapers/state-global-biotech-landscape-where-opportunities-lie

The report also noted that the Asia Pacific region, which has more than 6,772 trial sites each with access to an average of 2,136 million people, has considerable underutilized capacity presenting an opportunity for growth in multinational trials in the region.

Novotech this month was awarded the Frost & Sullivan Company of the Year Award 2022 for Best Practices in the Asia-Pacific contract research organization industry. Novotech has been a recipient of the Frost & Sullivan Asia Pacific Best Practices awards since 2006.

Frost & Sullivan said: "Our approach involves the deployment of best practices and strategic analytics across a value chain. Against this backdrop, Frost & Sullivan recognizes Novotech for its valuable achievement. Novotech addresses the global drug development market's unmet needs with a strong leadership focus that incorporates client-centric strategies with best-practice implementation. From feasibility assessments to regulatory submission support, data management, medical monitoring, and project management, the company provides a 360-degree approach to drug development for its biotech clients."

Novotech also recently produced a new publication for biotechs considering China for their clinical research, and the relevant processes required for global regulatory approvals. The report details regulatory requirements for biotechs including NDA and IND processes as well as ex-US research guidance for a successful US FDA approval pathway. Novotech provides the relevant regulatory knowledge and drug development pathways specifically designed to support the US FDA approval process, avoiding delays and additional costs.

Download whitepaper here https://novotech-cro.com/whitepapers/china-biotech-landscape-opportunities-china-and-path-usfda-approval

Novotech has also recently been benchmarked as a top 10 CRO among the world's leading CROs, is a finalist in the prestigious Scrip awards, and has just been awarded the Gene & Cell Therapy Excellence Award.

About Novotech – https://novotech-cro.com

Novotech is internationally recognized as the leading Asia Pacific centred contract research organization (CRO) with global execution capabilities. Novotech is a clinical CRO with labs, phase I facilities, and drug development consulting services. It has accumulated experience in over 3,700 pre-clinical and clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biopharmaceutical clients conducting clinical trials in Asia, the US and globally. Novotech has over 2500 staff working across our offices in 13 geographies. For more information visit https://novotech-cro.com/contact

Media Contact
David James
E: communications@novotech-cro.com
AU: +61 2 8218 2144
USA: +1 415 951 3228
Asia: +65 3159 3427

Copyright 2022 ACN Newswire. All rights reserved. http://www.acnnewswire.com

SinoMab Awarded the “Most Valuable Pharmaceutical and Medical Company” in the Selection of the “7th Hong Kong Golden Stocks Awards”

HONG KONG, Dec 19, 2022 – (ACN Newswire) – SinoMab BioScience Limited ("SinoMab" or the "Company", together with its subsidiaries, the "Group", stock code: 3681.HK), a Hong Kong-based biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases, is pleased to announce that the Company was awarded the "Most Valuable Pharmaceutical and Medical Company" at the "7th Hong Kong Golden Stocks Awards Ceremony" held in Hangzhou today.
The Company Awarded the "Most Valuable Pharmaceutical and Medical Company"


The "Most Valuable Pharmaceutical and Medical Company" award aims to recognize Hong Kong-listed pharmaceutical and medical companies that have a healthy corporate governance structure, prominent industry status, sound governance structure, good main business, and the ability to provide investors with sustainable and stable values. SinoMab was awarded the "Most Valuable Pharmaceutical and Medical Company", highlighting the attention and recognition of the industry and investors on the Company's value and innovation capabilities, which is a great encouragement and even a spur to SinoMab.

SinoMab is the first Hong Kong-based listed biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of therapeutics, primarily monoclonal antibody ("mAb")-based biologics, for the treatment of immunological diseases. With R&D headquarter in Hong Kong and production base in China, the Company strives to become a leading global biopharmaceutical company for the development of novel drugs to fulfil unmet medical needs through its Hong Kong-based innovative R&D, and PRC-based manufacturing capabilities.

Currently, various candidate products for all-field indications of autoimmune diseases in SinoMab's layout have started clinical trials successively and are progressing steadily. In particular, SM03 (Suciraslimab), the Company's flagship product, is a potential global first-in target mAb for the treatment of rheumatoid arthritis ("RA") and other immunological diseases such as Alzheimer's disease ("AD"), systemic lupus erythematosus ("SLE"), Sjogren's syndrome ("SS") as well as non-Hodgkin's lymphoma ("NHL"). The Phase III clinical trial of SM03 for treatment of RA completed its enrollment on 31 December 2021, and is expected to complete the last subject visit (FV) in December 2022, read out clinical data in the first quarter of 2023 and submit a New Drug Application ("NDA") to the National Medical Products Administration (the "NMPA") of the People's Republic of China ("PRC") for commercialization in the second half of 2023 at the earliest.

Under normal operation of the human immune system, the B-cell receptor (BCR) pathway would be activated and create strong signals in response to foreign ("non-self") antigens and trigger a series of B-cell immune responses. To differentiate from our "self" antigens, our body would recruit molecules, like SHP-1, to inhibit or reduce BCR-induced signaling, thereby suppressing B-cell immune responses. SM03 can be used to recruit such immunosuppressive molecules as SHP-1 by conversion of cis-binding CD22 to trans-binding CD22, forming a stable CD22 trans-binding structure, thereby restoring the tolerance of B cells to our "self" antigens and inhibiting a series of immune responses of B cells to attack our "self" antigens, thus suppressing relevant immune responses.

Most of the mechanisms of action of existing RA therapies will result in the depletion or death of B cells, which can have a series of side effects on the human autoimmune system. In contrast, SM03 suppresses the autoimmune response by regulating the function of B cells and does not damage the B-cells and does not affect the normal function of B-cells in the immune system. Data from the Phase II clinical trial showed that SM03 has a comparable response rate and a significant safety advantage over competing products currently available on the market.

In addition, SN1011, a key product of the Company, has obtained four IND approvals from the NMPA for the treatment of SLE, pemphigus ("PV"), multiple sclerosis ("MS"), neuromyelitis optica spectrum disorder ("NMOSD") respectively. At the same time, the Company is planning an IND submission for MS in the U.S. SM17 (a humanized anti-IL-7RB monoclonal antibody for injection), another key product of the Company, its first healthy subject had been successfully dosed in a Phase I First-in-Human (FIH) clinical trial in the U.S. in June this year and the subjects are currently in normal condition.

Previously, SinoMab appointed Mr. Shanchun WANG as the President (China) of the Company, mainly responsible for the China operation. Mr. Wang has rich experience in the pharmaceutical industry for more than 30 years, served as the executive director of Sino Biopharmaceutical Limited and the president of Chia Tai – Tianqing Pharmaceutical Group Co. Ltd., and is a specialist that granted the special government allowances of the State Council and awarded as a national model worker. SinoMab's dedication to the field of autoimmune diseases and its vision of growing into a global leader in novel treatments of immunological diseases is highly consistent with the development model of Mr. Wang's service enterprises in the past. As one of the leaders in the biopharmaceuticals enterprise in China with rich experience and practical achievements in corporate strategic management, organizational management, innovation research and development and product commercialization, Mr. Wang's engagement as the President (China) of the Company will help expediting the Company's development from a global drug research and development enterprise to a biopharmaceutical company bearing commercialization capabilities and international perspective.

Dr. Shui On LEUNG, Chairman, Executive Director and Chief Executive Officer of SinoMab said that: "The Company is deeply honored to be awarded the "Most Valuable Pharmaceutical and Medical Company" in the selection of the "7th Hong Kong Golden Stocks Awards", which reflects the capital market's recognition of the Company's value, innovation capabilities and growth potential, and is a great encouragement to the Company. In the future, the Company will, in line with its original purposes, endeavor to discover and develop innovative drug targets, explore therapies for immune diseases, accelerate R&D and clinical trials of various products, and at the same time further expand the product pipeline and potential indications, accelerate the realization of product commercialization, strive to bring benefits to patients and create values for shareholders and investors. With the imminent completion of the Phase III clinical trial of its flagship product SM03, the Company is poised for a new leap of increase in value."

About the Selection of the "7th Hong Kong Golden Stocks Awards"
The selection of the "7th Hong Kong Golden Stocks Awards" was jointly organized by Zhitongcaijing.com, a leading Hong Kong and US stock information platform in China, with RoyalFlush Finance and China Galaxy Securities. This selection was rigorous and attracted over 1,000 entries from Hong Kong-listed companies, covering traditional industries such as petrochemicals, finance, and automobiles, as well as emerging industries such as chips, Internet, and medical and pharmaceuticals, which are leading the transformation of China's economy.

About SinoMab BioScience Limited
SinoMab BioScience Limited (stock code: 3681.HK) is dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases. The Company's flagship product SM03 is a potential global first-in-target mAb against CD22 for the treatment of rheumatoid arthritis (RA) and is currently in 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.


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