The Mechanism of Action of SinoMab’s Flagship Product SM03 is Successfully Published in the Journal of Immunology, a Reputable Journal on Immunology in the U.S.

HONG KONG, Jun 21, 2022 – (ACN Newswire) – SinoMab BioScience Limited ("SinoMab" or the "Company", together with its subsidiaries, the "Group", stock code: 3681.HK), a Hong Kong listed biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of innovative therapeutics for the treatment of immunological diseases, primarily mAb-based biologics, today announced that, on 10 June 2022, the mechanism of action of its flagship product SM03 (Suciraslimab) is successfully published in the Journal of Immunology, a reputable journal on immunology in the US (link to the paper: https://www.jimmunol.org/content/early/2022/06/10/jimmunol.2100820 ).


Figure: Mechanism of Action of SM03 (Suciraslimab)


The Journal of Immunology (the JI), founded in 1916 and managed and published by the American Association of Immunologists, is the world's leading peer-reviewed journal in the field of immunology, with a 5-year impact factor of 6.029 (Journal Citation Reports 2020), and publishes the latest immune-related findings in basic and clinical research in the field of immunology. It also publishes the latest research papers in the field of immunology, including cellular immunology, immunochemistry and molecular immunology, immunogenetics and immunomodulation, immunopathology and clinical immunology, immunopharmacology, microbial immunology, oncology and transplantation.

The Company's flagship product SM03 (Suciraslimab) is a potential global first-in-target mAb against CD22 for the treatment of rheumatoid arthritis (RA). The patient enrollment for the Phase III clinical trial in China has been completed by the end of 2021, with a total of 530 subjects recruited. The trial is a multi-centre clinical study led by Peking Union Medical College Hospital of the Chinese Academy of Medical Sciences, with clinical centres in 44 hospitals including Gulou Hospital of Nanjing University School of Medicine, the Second Hospital of Harbin Medical University and the First Hospital of Shanxi Medical University. The Company expects to lock the database at the end of June this year, read out the results of the Phase III clinical trial data in early August and will have biologics license application (BLA) in 2023. In addition, the development of Suciraslimab has also received support from the 863 Program, the "12th Five-Year Plan" and the "13th Five-Year Plan" for development of major new drugs, as well as the green channel for "prioritized review and approval" by the Center for Drug Evaluation (CDE). Previously, a phase II clinical trial led by Peking Union Medical College Hospital has demonstrated the efficacy and safety of Suciraslimab for the treatment of RA.

The Company's flagship product Suciraslimab is a potential global first-in-target mAb against CD22 for the treatment of rheumatoid arthritis. The core competitive advantage of this product over the standard therapies currently on the market is its novel and unique mechanism of action, which ensures that Suciraslimab is comparable to other products in terms of efficacy, while having significant advantage in terms of safety, which is a major concern for patients on long-term medication for autoimmune diseases.

Under normal operation of human's immune system, 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. We suggested that the recruitment of these molecules such as SHP-1 could be achieved by conversion of cis-binding CD22 to trans-binding CD22, thus suppressing relevant immune responses.

Due to ageing or genetic predisposition, patients with autoimmune diseases such as RA are unable to convert cis-binding CD22 to trans-binding CD22, and are thus unable to recruit immunosuppressive molecules such as SHP-1 to inhibit or reduce the transmission of antigenic stimuli from B-cell receptors to B-cells, which then generate a series of immune responses, such as the secretion of large amounts of antibodies to attack autoantigens. Our flagship product, Suciraslimab, can facilitate the conversion of cis-binding CD22 to trans-binding CD22, forming a stable CD22 trans-binding structure, thereby restoring the tolerance of B-cells to autoantigens and inhibiting a series of relevant immune responses by B cells to attack the body.

Historical data shows that Suciraslimab has a significant safety advantage compared to other products with comparable efficacy currently available in the market. Existing RA therapies include traditional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) such as methotrexate (MTX), biologic DMARDs (bDMARDs) targeting tumour necrosis factor (TNF), interleukin (IL)-6 receptors and other targets, as well as targeted synthetic DMARDs (tsDMARDs) such as Janus kinase (JAK) inhibitors and other small molecule drugs, all of which have played an important role in the remission of RA patients. However, 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 human's autoimmune system, thus posing a long-term risk for patients with autoimmune diseases who require long-term medication, as the weakening of the immune system will naturally lead to the development of other debilitating diseases. In contrast, the mechanism of action of Suciraslimab is very different from that of existing therapies on the market. We only inhibit the B-cell related immune response by altering the binding of CD22 and recruiting related inhibitory molecules. Suciraslimab only inhibits 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. Therefore, Suciraslimab has a significant safety advantage over other products currently available on the market.

The autoimmune disease drug market has been touted as the next gold mine after oncology drugs. As the "king of drugs" in the world, Humira has topped the global drug ranking for eight years with sales of US$19.832 billion in 2020, making other drugs "bow down". Globally, pharmaceutical giants are focusing on the research and development of drugs in the rheumatic immune field, with the most prominent ones including Pfizer, Novartis, Johnson & Johnson and AbbVie, all with more than a dozen products in development or marketed in their respective pipelines. The global autoimmune disease drugs market is valued at US$113.7 billion in 2018 and is expected to reach US$152.3 billion by 2023 at a CAGR of 6.0%. The market for autoimmune disease drugs in China is expected to grow from RMB13.4 billion in 2018 to RMB37.7 billion in 2030 at a CAGR of 23%. Driven by the global trend of innovation, R&D in rheumatic immune field in China is also gaining momentum. As a leading pharmaceutical innovator in China, Hengrui Pharma has also adopted a strategy of early development, target optimization and expansion of indications in the rheumatic immune field, aiming to fully capitalize on the rapid development of the autoimmune disease market in China. This indicates that SinoMab's mission and vision to become a global leader in innovative therapies for immune and other debilitating diseases are in line with the development trend of the entire pharmaceutical industry. In the foreseeable future, it is believed that SinoMab will help more and more patients suffering from autoimmune diseases and become a leading global biopharmaceutical company focusing on innovative therapies for autoimmune diseases.

In addition to its flagship product Suciraslimab, the Company's core product SN1011 has an expanding scope of indications and continues to receive regulatory approval for new drug applications in China and abroad, and also expects to rapidly initiate Phase II clinical trials for pemphigus vulgaris (PV), multiple sclerosis (MS), systemic lupus erythematosus (SLE) and neuromyelitis optica spectrum disorder (NMOSD) this year. SinoMab also dosed first healthy subject in Phase I clinical trial of its major product SM17 in the U.S. in June 2022. By targeting upstream mediators of the Th2 inflammatory cascade, SM17 is able to control inflammatory airway diseases such as asthma caused by the immune cascade at a relatively early stage and is expected to benefit a large number of patients with severe uncontrolled asthma by satisfying unmet medical needs.

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 RA 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), systemic lupus erythematosus (SLE), pemphigus vulgaris (PV), non-Hodgkin's lymphoma (NHL), asthma, and other diseases with major unmet clinical needs.



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

Breakthrough Cooperation of Legend Capital’s Cross-border Portfolio Companies: Innovent and Etana Jointly Announce the Approval of Bevagen by the BPOM

HONG KONG, Jun 15, 2022 – (ACN Newswire) – On June 14, two of Legend Capital's portfolio companies, Innovent Biologics, Inc. ("Innovent") and PT Etana Biotechnologies Indonesia ("Etana"), jointly announced that the Indonesian Food and Drugs Authority (BPOM) had approved Bevagen (bevacizumab biosimilar), a recombinant humanized anti-VEGF monoclonal antibody drug for five indications including metastatic colorectal cancer (mCRC), metastatic triple negative breast cancer (mTNBC), advanced non-small cell lung cancer(NSCLC), ovarian cancer (OC), and cervical cancer(CC). Under the approval of the BPOM, Bevagen will potentially be the first Chinese antibody drug to be marketed and locally produced in Southeast Asia.

Dr. Michael Yu, Founder, Chairman and CEO of Innovent, said, "We are pleased that under the strategic collaboration with Etana, the approval of Bevagen in Indonesia marked a meaningful step toward bringing Innovent's innovative portfolio into the global market, benefitting patients globally. Pairing Etana's commercial expertise in the local Indonesian market with Bevagen's clinical profile, high-quality production and relative affordability, we are confident that Bevagen will launch to the market quickly and benefit many cancer patients."

Nathan Tirtana, President Director of Etana, said, "Etana appreciates the support of BPOM for approving Bevagen for cancer patients in Indonesia. With this product, we believe we can provide better access to high-quality and affordable biosimilar drug to meet the need of cancer patients in Indonesia. Our next step is to implement the technology transfer and local Bevagen production in Indonesia via collaboration with Innovent."

Legend Capital has been looking for investment and partnership opportunities in the Southeast Asian market since 2019 and ultimately invested in Etana in 2020. By leveraging the advantages of the portfolio ecosystem, Legend Capital has played an active role in promoting the strategic cooperation between Innovent and Etana.

Mr. Frank Hong, Managing Director of Legend Capital, said, "Congratulations to Innovent and Etana for the approval of the first biosimilar in Indonesia. This milestone achievement demonstrates the feasibility of expanding Chinese innovative drugs market access into the emerging markets. The emerging markets along the Belt and Road have significant demand for pharmaceutical products and unmet clinical needs, Chinese innovative therapeutics are particularly well suited to the needs of patients in developing countries given their quality and affordable prices. Legend Capital will continue to explore investment opportunities in the emerging markets and actively pioneer the path for Chinese high-end biologics' overseas expansion, facilitating the globalization of Chinese pharmaceutical companies."

Mr. Fei Qi, Executive Director of Legend Capital, said, "The cross-border investment and industrial collaboration in the Southeast Asian market possess unique challenges: from policy regulation, folk culture to healthcare system complexity. Etana has set up a competitive barrier of 'Access + Manufacturing + Commercialization' in Southeast Asia, and Legend Capital complemented Etana's key 'Business Development' ability by leveraging its healthcare portfolio ecosystem. Legend Capital has provided a series of value-add services in terms of company strategy, business cooperation and subsequent financing to Etana since its investment. Etana has approached and discussed collaboration initiatives with more than 10 Chinese biopharmaceutical companies and plans to introduce more therapeutics that Indonesia currently lacks, such as cancer monoclonal antibodies, COVID vaccines, and antiviral infection drugs. Through the joint efforts of Etana and its partners, we believe that the company will be able to provide high-quality and affordable Chinese innovative drugs to Indonesia, Southeast Asia and even the Islamic world."

Legend Capital has been firmly positioned to invest systematically in the field of innovative medicine. Adhering to the investment philosophy of "Global Vision, Chinese Insights", Legend Capital is looking for truly internationally competitive technologies and teams to solve the unmet clinical needs; many of its portfolio companies have been listed on A-share or H-share successfully, such as Kawin Technology (688687.SH), Innovent Biologics (01801.HK), Hbm (02142.HK), Recbio Technology (2179.HK). At the same time, we also made investments in segment-leading companies such as GluBio Pharmaceutical, Ribo Life Science, PegBio, Exegenesis Bio, Lynk Pharmaceuticals and Innostellar Biotherapeutics.



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

SINGAPORE ANNUAL MEETING: DIA and CoRE Gathering Key Healthcare Experts in Neutral Forum to Discuss Regulatory News and Drug Development

Singapore, Jun 15, 2022 – (ACN Newswire) – The COVID-19 pandemic has ushered an increased speed of healthcare innovations with the hope of effectively managing this public health threat. This meeting offers a neutrally organized forum to discuss lessons learned and better prepare the healthcare system for the next challenges. From 12-13 July, representatives from Regulatory agencies, health authorities (Ali Al dalaan,[SFDA] Wen-Yi Hung[TFDA] Shin-ichi Okudaira [PMDA]) Jesusa Joyce N. CIRUNAY [Philippines FDA] and industry leaders (Serena Chan [Syneos Health], Daniela Caiazza [Novotech], Ralf Altenburger[Roche], Yu LIANG [MSD], and many more) meet in person for the first time in two years to foster positive changes in the healthcare environment in the Asia-Pacific. That includes emerging technologies, innovations in cancer care, digital health and improved patient access to novel therapies.



Sessions discussing Digital Health, Decentralized Clinical Trials, and access to Innovative Therapies

Connecting different perspectives and interests in a neutral forum allows an open dialogue and facilitates solutions and concrete action points for today's healthcare challenges, such as:

Fostering digital health adoption in the Asia-Pacific is highly dependent on regulatory frameworks. The session will discuss benefits of digital health, personalised care and what is necessary to improve application in the region.

The dynamics of decentralised clinical trials has the potential to improve patients' experience. Serena Chan (Syneos Health Singapore), Daniela Caiazza (Novotech), and Jerome Armellini (IQVIA Singapore) will discuss how decentralised trials can benefit patients, clinicians, trial sites and sponsors beyond the pandemic setting.

Novel approaches for managing cancer come from innovative cell and gene therapies. Challenges arise when it comes to country-specific regulations. Together with other specialists, Ralf Altenburger (Global Head Cell and Gene Therapy, F. Hoffmann La-Roche) will present where the field is going as an integral part of cancer care.

Building regulatory agility for improved patient access became more aware throughout the pandemic. Ali Al dalaan (SFDA) will present his view on regulatory convergence and discuss with industry leaders how to improve patient access through regulatory agility.

Empowering the ASEAN patients is subject of a townhall format, where all participants wrap up the conference and discuss the efficiency and sustainability of healthcare systems in ASEAN and identify next steps.

About DIA Singapore Annual Meeting
Date: 12-13 July 2022
Location: Grand Copthorne Waterfront Hotel, Singapore
Havelock Road
Singapore 169663
Singapore

Registration information:
Register before the 30th of June and get a 25% discount using the following code: SAM2022
– Register online here: https://bit.ly/3aPsB9o
– Register with one of our Team member: kanchan.patel@DIAglobal.org

About DIA

DIA (founded as the Drug Information Association) is a global association that mobilizes life science professionals from across all areas of expertise to engage with patients, peers, and thought leaders in a neutral environment on the issues of today and the possibilities for tomorrow. As a member-driven, volunteer organization, professionals from 80 countries have affected healthcare outcomes, by engaging with DIA through an unparalleled network, educational offerings, and professional development opportunities.
DIA is based in Washington, DC (US) with regional offices representing the Americas (Horsham, PA, US); Europe, the Middle East, and Africa, (Basel, Switzerland); and Asia (Beijing and Shanghai, China; Mumbai, India; and Tokyo, Japan).

Connect with DIA:
Twitter: https://twitter.com/DrugInfoAssn
LinkedIn: www.linkedin.com/company/dia
Facebook: www.facebook.com/DrugInformationAssociation/
Instagram: www.instagram.com/druginfoassn/

About Centre of Regulatory Excellence (CoRE):

Launched in 2014, CoRE at Duke-NUS Medical School, is the first dedicated Asian centre targeted at addressing the capacity development and policy innovation needs of national health regulators, the biomedical industry, and pharmaceutical and medical device companies. The Centre provides a neutral academic platform to establish regional platforms and networks to exchange knowledge, encourage innovation, promote thought leadership and collaboration in strengthening regulatory science and policy, and health systems frameworks, within and among national regulatory agencies, industry, health ministries and academia.

Contact:

CoRE
Sherna WADIA
Associate Director
Centre of Regulatory Excellence
Duke-NUS Medical School
Email: core@duke-nus.edu.sg

DIA
Kanchan PATEL,
DIA Associate Director, India-Singapore Operations
Email: kanchan.patel@DIAglobal.org

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

SinoMab Dosed First Healthy Subject in Phase I Clinical Trial of SM17 in the U.S.

HONG KONG, Jun 15, 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, today announced that, the first healthy subject has been dosed in the Phase I clinical trial of SM17 in the U.S. SM17 is a First-in-Class (FIC) humanized anti-IL-17RB monoclonal antibody. The subject is currently in a normal condition.

SM17 is the world's first humanized IgG4-k monoclonal antibody targeting IL-17RB. SM17 is currently under development by SinoMab, and was engineered by LifeArc (a leading medical research charity based in the United Kingdom). SM17 was originally developed by Dr. Andrew McKenzie, FRS, who also serves as a member of the Company's Scientific Advisory Board, at the MRC Laboratory of Molecular Biology (LMB).

SM17 could suppress Th2 immune responses by binding to IL-17RB on Type 2 Innate Lymphoid cells (ILC2s), blocking a cascade of responses induced by interleukin-25 (IL-25). IL-25 is a critical cytokine classified as "alarmin", which has shown to be implicated in the pathogenesis of airway viral responses and allergic diseases, such as uncontrolled severe asthma. Uncontrolled severe asthma is associated with increased mortality/ morbidity, diminished quality of life and increased health expenditures. These patients are at a risk of recurrent asthma exacerbations and hospitalizations. The Company expected that targeting upstream mediators of the Th2 inflammatory cascade, such as IL-17RB on ILC2s, will have a broad effect on airway inflammation. The Company believes the huge potential of SM17 could satisfy unmet medical needs in asthma treatment. The Phase I study is a Single Ascending Dose (SAD) and Multiple Ascending Doses (MAD) to investigate the safety, tolerability and pharmacokinetics of SM17 in healthy subjects.

SM17 received Investigational New Drug (IND) approval from U.S. Food and Drug Administration (FDA) on 11 March 2022. Despite the pandemic, SinoMab have soon initiated the first-in-human dose in the Phase I clinical trial. This marks a significant milestone on the collaboration between SinoMab and LifeArc, and demonstrates the efficient implementation of SinoMab's new drug R&D programs.

Melanie Lee, Chief Executive Officer of LifeArc, said: "We applied our antibody capabilities when working with Dr. Andrew McKenzie at the LMB, to firstly generate and select a clinical candidate antibody targeting IL-17RB, and then humanise it. After evaluating and choosing the lead candidate, it was licensed to SinoMab to take forward into clinical development and towards patients. It's so rewarding to know that this antibody is going into trials and could eventually make a difference to people with severe asthma."

Dr. Shui On LEUNG, Chairman, Executive Director and Chief Executive Officer of SinoMab said that: "SM17's successful first-in-human dosing in Phase I clinical trial marked another milestone in our pipeline development. Following our flagship product, SM03 and key product, SN1011, we now have another key asset entering the clinical trial stage. This further assures our potential commercialization prospects and proves our capability for progressing multiple assets of R&D concurrently. We are confident of the enormous prospects for SM17's clinical development as well as our commercialization opportunities in general. Moving forward, we will accelerate implementation of our projects, adhere to our vision of independent innovation to bring benefits to patients and create value for shareholders."

About LifeArc
LifeArc is a self-financing and leading UK medical research charity. It partners and works with academics, industry, charities and patient groups to unlock the potential of early stage science. It has an office in London and scientific research facilities in Stevenage and Edinburgh. It also has a specialist science team working at the Francis Crick Institute in London.

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), systemic lupus erythematosus (SLE), pemphigus vulgaris (PV), non-Hodgkin's lymphoma (NHL), asthma, and other diseases with major unmet clinical needs.


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

Novotech’s APAC and USA Leadership Teams at BIO 2022

SAN DIEGO, CA, Jun 14, 2022 – (ACN Newswire) – Novotech, the leading Asia Pacific biotech specialist CRO which has recently expanded its services to the US, will have key executives from APAC and the US attend BIO 2022 for meetings with biotechs considering the Asia-Pacific region to expedite their clinical trials. #4907

Book a meeting with one of the Novotech experts at BIO here. https://novotech-cro.com/contact

Novotech, which has a reputation for delivering full-service, high-quality expedited clinical trials in Asia-Pacific, can now offer its biotech clients clinical services in the US to support later phase global studies. Novotech now has a workforce of ~2,500 clinical trial professionals across Australia, South Korea, Greater China, Southeast Asia, India, South Africa and the US.

Novotech CEO Dr. John Moller said Novotech's Asia-Pacific and US teams support cost effective expedited clinical research with world-class data, and the most advanced technology including solutions that enable acceleration of clinical trials across the regions.

"The focus on Asia-Pacific for biotech clinical research over the past five years makes the region the fastest growing clinical trial destination with China being the leading location for new trials followed by the US. Asia-Pacific offers a compelling solution for expedited clinical trials especially in oncology with its vast patient populations, less competitive clinical trial landscape, and world-class KOLs, in addition regulatory reforms, such as those in China, have accelerated approval processes. The expansion into the US was a strategic move to provide US-based expertise and infrastructure for our US clients wanting trials in APAC and the US, and for our APAC clients wanting US clinical programs." Clients will receive a seamless service, with a unified approach to systems and SOPs," Moller said.

According to Global Data whitepaper: EVOLUTION OF CLINICAL TRIALS IN THE ASIA PACIFIC REGION COMPARED TO THE US AND THE EU5*, Over the last five years more than 70,000 new clinical trials were registered in the APAC region, the US, and the EU5. The APAC region was the largest contributor, with more than 50% of the trials followed by the US (29%) and the EU5 (17%). The APAC region has become the preferred destination for conducting clinical trials due to its large patient population, ease of regulatory compliance, lower cost of conducting studies, high-quality standards and the presence of top clinical sites.

* https://novotech-cro.com/whitepapers/evolution-clinical-trials-asia-pacific-region-compared-us-and-eu5

About Novotech Health Holdings
Novotech Health Holdings Pte. Ltd. ("Novotech") is the leading Asia-Pacific and US biotech specialist CRO. Novotech has integrated labs and phase I facilities and provides drug development consulting and clinical development services across all phases. It has been instrumental in the success of approximately 3,700 clinical trials across a broad range of therapeutic areas. Novotech is well positioned to serve biopharma clients conducting clinical trials in Asia-Pacific and the US. For more information visit https://novotech-cro.com/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

Malaysian Genomics Resource Centre Berhad Gets Affected Issuer Status Uplifted

PETALING JAYA, Malaysia, Jun 13, 2022 – (ACN Newswire) – Malaysian Genomics Resource Centre Berhad (Bursa: MGRC, 0155), a leading genomics and biopharmaceutical specialist, is pleased to announce that it is uplifted from being classified as an affected listed corporation effective 13 June 2022.


Azri Azerai, Executive Director of Malaysian Genomics

Sasha Nordin, CEO and Dato' Alvin Nesakumar, Executive Director of Malaysian Genomics [L-R]


This followed the decision by Bursa Securities Malaysia Berhad to grant the Group a waiver in submitting a regularisation plan after being classified as an affected listed corporation pursuant to Rule 8.03A of the Listing Requirements. Bursa Securities had made the classification according to Rule 8.03A on 24 December 2019 and Malaysian Genomics had submitted an application seeking approval to exempt the Group from submitting a proposed regularisation plan on 24 March 2022. The waiver was granted on 10 June 2022.

Encik Azri Azerai, Executive Director of Malaysian Genomics, said, "I am extremely thankful to the team for working diligently to get Malaysian Genomics out of the affected issuer classification status and welcome this news from the regulator. Our diversification into biopharmaceutical services, in particular the distribution of immunotherapy and cell therapies, has supported the financial performance of the Group. I believe that we can grow together, as a team."

In a recent announcement on its 3Q 2022 performance, Malaysian Genomics reported a profit before tax (PBT) of RM1.96 million compared with PBT of RM0.2 million in 3Q 2021. Earnings per share (EPS) stood at 1.60 sen for 3Q 2022 compared with EPS of 0.19 sen in the corresponding quarter of the previous financial year.

Mr. Sasha Nordin, Chief Executive Officer of Malaysian Genomics said, "We will continue to seek opportunities through collaborations and partnerships targeting new consumer and market segments, including those beyond Malaysia, as we strive to widen our reach and capitalise on heightened awareness on health issues across the region and farther afield. We look forward to introducing new products and markets in the near future."

Dato' Alvin Nesakumar, Executive Director of MGRC, said, "As we have shared before, we are also moving towards offering our products and services through adopting a business-to-consumer strategy to complement our business-to-business approach because trends are changing and technology enables us to reach out directly to consumers. This new approach will give us better insight into what the market needs."

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

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

SinoMab Announces IND APPLICATION FOR SN1011 ACCEPTED BY NMPA CDE

HONG KONG, Jun 9, 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, on 6 June 2022, an Investigational New Drug application ("IND", for neuromyelitis optica spectrum disorder ("NMOSD")) for SN1011 has been filed with and accepted by the Center for Drug Evaluation (the "CDE") of the National Medical Products Administration of China (the "NMPA"). The Company plans to initiate the Phase II clinical study in China upon approval of the present IND. The present IND submission, once granted, will enable the Company to conduct clinical program in China for treatment of NMOSD.

SN1011 is the Company's third generation, covalent reversible BTK inhibitor with improved safety, higher selectivity and superior efficacy and for the long-term treatment of systemic lupus erythematous, pemphigus vulgaris, multiple sclerosis, rheumatoid arthritis, and other immunological diseases. SN1011 differentiates from existing BTK inhibitors currently available in the market in terms of mechanism of action, affinity, selectivity and safety.

The Phase I clinical study (first-in-human clinical trial) of SN1011 was conducted in Australia and China in 2019 and completed in July 2021, which has demonstrated improved safety and good pharmacokinetics profile. Currently, the IND application for SN1011 in the treatment of systemic lupus erythematosus (SLE), pemphigus vulgaris (PV) and multiple sclerosis (MS) have been approved by NMPA, the Company plans to launch the Phase II clinical study of SN1011 for pemphigus in the third quarter of 2022. The Company is also planning an IND submission for multiple sclerosis (MS) in the U.S. in the second quarter of 2022, thereby accelerating the initiation of a global phase II trial in the third quarter of 2022.

NMOSD is an autoimmune-mediated inflammatory demyelinating disease of the central nervous system with predominant involvement of the optic nerve and spinal cord. The pathogenesis of NMOSD is mainly associated with aquaporin-4 (AQP4) antibodies and is a separate disease entity from multiple sclerosis, with severe optic neuritis and longitudinal extensive transverse myelitis as the main clinical features. However, the cause of NMOSD is unknown, with a combination of environmental factors such as smoking, low vitamin D levels, EBV infection and genetic susceptibility contributing to the development of the disease.

In 2020, according to inpatient registration data published in China, the incidence of NMOSD is about 0.278 (100,000 people/year), with children at 0.075 (100,000 people/year) and adults at 0.347 (100,000 people/year). NMOSD is seen at all ages, with young adults being the most common, with the average age of onset being 40 years. NMOSD is a highly recurrent and disabling disease, with 40-60% of patients experiencing a recurrence within one year and 90% within three years, and 50% of patients with a natural course of the disease having severe visual or motor impairment within 5-10 years. Currently, there are only three drugs officially approved by the US FDA or the European Union for the treatment of NMOSD, including complement inhibitors, IL-6 receptor blockers and B-lymphocyte-depleting agents. On 30 April 2021, the NMPA officially approved satralizumab for treatment of AQP4-IgG positive patients over the age of 12 years, making it the first drug approved for NMOSD treatment indications in mainland China. An IND application for NMOSD for SN1011 of SinoMab has been accepted by the CDE of the NMPA, and once approved, will facilitate the clinical research and development of new drugs for NMOSD in China.

Dr. Shui On LEUNG, Chairman, Executive Director and Chief Executive Officer of SinoMab said that: "NOMSD is the fourth indication of SN1011 in China following the approvals of IND application for systemic lupus erythematosus (SLE), pemphigus vulgaris (PV) and multiple sclerosis (MS), and is also the third IND application submitted by the Company to the regulatory authority this year, which fully reflects the team's ability to simultaneously advance the research and development of multiple drug candidates and to effectively execute and communicate. The potential indications for SN1011 continue to expand, BTK inhibitor has a wide range of applications in the field of treatment of autoimmune diseases and huge future market potential. We believe that if the SN1011 product is successfully approved and commercialized in the future, it is expected to bring positive benefits to the Company, provide new options for the treatment of various autoimmune diseases and bring hope to the majority of patients."

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), systemic lupus erythematosus (SLE), pemphigus vulgaris (PV), non-Hodgkin's lymphoma (NHL), asthma, and other diseases with major unmet clinical needs.


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Hua Medicine Announces Dorzagliatin can Restore Glucose Sensitivity and Early Phase Insulin Secretion in T2DM and GCK-MODY Patients at ADA 2022

SHANGHAI, CHINA, Jun 7, 2022 – (ACN Newswire) – Hua Medicine (the "Company", stock code: 2552.HK) today announces that several clinical findings were presented on its global first-in-class drug, glucokinase activator (GKA) dorzagliatin, at the 82nd American Diabetes Association (ADA) Annual Scientific Sessions. A post-hoc analysis that involved two Phase III clinical trials of dorzagliatin indicated that dorzagliatin can significantly improve early phase insulin secretion and glucose sensitivity of patients of Type 2 diabetes (T2D).

Professor Wenying Yang of the China-Japan Friendship Hospital, and former Chairman of the Chinese Diabetes Society and currently serving as Vice President of the Asian Association for Study of Diabetes and Hua Medicine's medical team, conducted a multivariate logistic regression analysis of the two Phase III clinical trials of dorzagliatin monotherapy (SEED), for which she participated in, and metformin add-on (DAWN), for which she served as lead principal investigator. The analysis found significant correlation between subjects who reached blood glucose control rate after treatment and the improvement in select key measures of beta-cell secretion function, such as early phase insulin secretion index and disposition index. The study further indicated that as a global first-in-class GKA drug, dorzagliatin can restore the deteriorated glucose sensing function of glucokinase (GK) in T2D patients, systematically improve islet beta-cell function, improve early phase insulin secretion and glucose sensitivity, and thereby restore the ability of T2D patients to regulate blood glucose autonomously and promote glycosylated hemoglobin levels in T2D patients (HbA1c< 7%).

Conducted by Professor Jianhua Ma, Director of the Department of Endocrinology, Nanjing First Hospital, Standing Member of the Chinese Diabetes Society, the results of the DREAM study were also presented at ADA 2022. It is the first time that the result on diabetes remission of dorzagliatin was presented at an international academic conference, attracting widespread attention from the participants. The DREAM study is a non-drug intervention observational clinical study initiated by certain researchers participating in the SEED study. The main purpose of this study is to evaluate the remission of diabetes for 52 weeks after patients who completed the SEED study and whose blood glucose reached control targets, and stopped taking dorzagliatin as well as any other glucose-lowering medication. The results of the study showed that during the observation period when no anti-diabetes drugs were administered, the remission rate was 65.2% at 52 weeks. HbA1c, FPG and 2h-PPG levels were sustained during the 52 weeks after dorzagliatin discontinuation and beta-cell function remained stable. The study indicated that dorzagliatin has a promising treatment option for achieving remission of diabetes in newly diagnosed unmediated patients by rapidly restoring early phase insulin secretion and lasting improvement of beta-cell function.

Another clinical study called SENSITIZE also provided clinical scientific data of dorzagliatin in improving insulin secretion and glucose sensitivity. The study, initiated by Professor Juliana Chan, an internationally recognized endocrinologist from the Chinese University of Hong Kong, explored the effects of dorzagliatin on patients with recent onset T2D and glucokinase-maturity-onset diabetes of the young (GCK-MODY or MODY-2). The study results of SENSITIZE were presented to the public for the first time at the ADA Annual Scientific Sessions. The study results, using glucose clamp technique, showed that dorzagliatin can significantly improve second phase insulin secretion and glucose sensitivity in GCK-MODY patients and can significantly improve basal insulin secretion rates in patients with recent onset T2D. As the speaker of the oral presentation and one of the researchers of the SENSITIZE study, Professor Elaine Chow from the Chinese University of Hong Kong, won the 2022 Women's Interprofessional Network of the American Diabetes Association (WIN ADA) abstract award in the category of Clinical Diabetes, Epidemiology, and Diabetes Complications in recognition of her outstanding results and significant contributions in the SENSITIZE study and the whole field of diabetes research. The potential application of dorzagliatin in this special rare disease population of GCK-MODY, has attracted the attention of the international diabetes research field.

The WIN ADA abstract award category of Clinical Diabetes, Epidemiology, and Diabetes Complications is an important part of WIN ADA awards, voted by WIN ADA Advisory Group, consisting of expert clinicians, scientists, educators, public health practitioners, and other diabetes professionals. The awards are established to recognize outstanding women who have made significant contributions to diabetes research, clinical care, public health, education, and related areas.

Dr. Li Chen, Founder, CEO and Chief Scientific Officer of Hua Medicine, said, "In 2012, Hua Medicine proposed the development of GKA based on the concept of glucose homeostasis, the core of which is to treat diabetes from the root cause of T2D, addressing the issues of glucose sensitivity and insulin resistance. Concept innovation is the main focus of new drug innovation research, and Hua Medicine has spent ten years to select a safe and effective dosing regimen and clinical study proposal suitable for most diabetic patients in China, thereby contributing to the successful development of GKA. The clinical findings presented at the ADA 2022 further demonstrate the scientific concept of dorzagliatin to 'repair the sensor, restore homeostasis, and treat the underlying cause of diabetes'. The findings also provide a scientific basis for studies on dorzagliatin monotherapy and as a cornerstone drug in combination with other OADs for the treatment of T2D, as well as for achieving remission and regression of diabetes in patients with recent onset of T2D, and boost our confidence to further personalize diabetes treatment and to cure diabetes."

About Dorzagliatin
Dorzagliatin is an investigational first-in-class, dual-acting glucokinase activator, designed to control the progressive and degenerative nature of diabetes by restoring glucose homeostasis in patients with Type 2 diabetes. By fixing the defect of the glucose sensor function of glucokinase, dorzagliatin has the potential to restore the impaired insulin and GLP-1 secretion of patients with Type 2 diabetes and serve as a cornerstone therapy targeting the root cause of the disease. Two Phase III registered trials for dorzagliatin monotherapy and the combination of dorzagliatin and metformin respectively have been completed in China, as well as the studies on drug mechanism synergy with sitagliptin (DPP-4 inhibitor) and empagliflozin (SGLT-2 inhibitor). In an investigator-initiated study named as DREAM, a 65.2% diabetes remission rate was observed when they stopped dorzagliatin and no other antidiabetes medication was taken during the 52-week study period. The Company has obtained the "Drug Manufacturing Permit" of dorzagliatin issued by the Shanghai Medical Products Administration, and has submitted its NDA to the National Medical Products Administration in order to realize the "First in Global, Start from China" mission for the benefits of diabetic patients worldwide.

About Hua Medicine
Hua Medicine is an innovative drug development company in China focused on developing novel therapies for patients worldwide with unmet medical needs. Hua Medicine teams up with global high caliber people and integrates global resources to explore breakthrough technologies and products and accelerate global innovation in diabetes care. Targeting the glucose sensor glucokinase, dorzagliatin, a novel oral diabetes drug restoring glucose sensitivity in T2D patients, has completed SEED and DAWN registration trials, and filed NDA in China. This global first-in-class glucokinase activator (GKA) has demonstrated its potential of achieving diabetes remission to help millions of diabetic patients around the world.

For more information
Hua Medicine
Website: www.huamedicine.com

Investors
Email: ir@huamedicine.com

Media
Email: pr@huamedicine.com


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Novotech Sponsors Endpoints ASCO 2022 Expert Panel on Accelerating Oncology Clinical Trials in China

SYDNEY, Jun 6, 2022 – (ACN Newswire) – Novotech, the leading Asia Pacific biotech specialist CRO which has recently expanded its services to the US, is sponsoring the Endpoints ASCO22 "Accelerating clinical development in China and the US".

Register here https://asco22.endpts.com/
TUESDAY, JUNE 7
11:00am – 11:45am ET (1:00 – 1:45 local time)
Novotech Booth at ASCO #14115

The virtual session will cover the latest on the clinical trial landscape and infrastructure in China and includes Novotech's DCT partner, Obvio Health, on DCT strategies for patient-centric, oncology study design and execution.

According to the Endpoints ASCO session: "China and the US are the world's largest oncology research destinations, and the clinical research bridge between them supports accelerated clinical development from early to late phase trials while ensuring the inclusion of MRCT data packages in future regulatory applications. With experienced clinical teams in both regions, Novotech will share real-world success strategies for biotechs undertaking global clinical development programs."

The expert panel features:
– Jin Li, Professor of the Department of Oncology, Shanghai East Hospital
– Peter Luo, Co-Founder, Chief Executive Officer and Chairman, Adagene
– Vivian Gu, Head of CDR China CMO Novotech
– Nancy Snowden, Head of US Operations, Novotech
– Susan Dallabrida, CEO and Chairman SPRIM, ObvioHealth

Moderated by: Arsalan Arif, Publisher & Founder Endpoints News

China offers a compelling solution for expedited clinical trials especially in oncology with its vast patient populations and world-class KLOs.

According to Global Data whitepaper: EVOLUTION OF CLINICAL TRIALS IN THE ASIA PACIFIC REGION COMPARED TO THE US AND THE EU5*, over the past 5 years the growth of oncology trials (CAGR of 25%) in China outpaced other countries. This growth was associated with a significant increase in cancer incidence, development of innovative products by domestic companies, focus on immuno-oncology, and leadership in cell therapy. China also recorded the largest number of new trials, followed by the US. In China, the number of new trials doubled during 2017-2021. Notably, China's regulatory reforms have accelerated drug approval by reducing the overall review and process. In addition, over the last five years more 70,000 new clinical trials were registered in the APAC region, the US, and the EU5. The APAC region was the largest contributor, with more than 50% of the trials followed by the US (29%) and the EU5 (17%).

The APAC region has become the preferred destination for conducting clinical trials due to its large patient population, ease of regulatory compliance, low cost of conducting studies, high-quality standards and the presence of top clinical institutions acting as sites. Earlier this month, Novotech announced the acquisition of US CRO, NCGS as part of a US service expansion program for its global base of clients. Novotech, which has a reputation for delivering full-service, high-quality expedited clinical trials in Asia-Pacific, can now offer its biotech clients clinical services in the US to support later phase global studies.

NCGS was established in 1984 in South Carolina and has a workforce of about 300 professionals across the US.

Novotech CEO Dr. John Moller said: "This is a strategic move to provide US-based expertise and infrastructure for our US clients wanting trials in APAC and the US, and for our APAC clients wanting US clinical programs."
"Clients will receive seamless service, with a unified approach to systems and SOPs," Moller said. Novotech has recently been benchmarked as a top 10 CRO among the world's leading CROs, and has signed 45 Leading Site Partnership agreements over the last 3 years.

With more than 2,000 highly experienced professionals, clients benefit from strong site and Key Opinion Leader relationships, deep regulatory expertise, and the ability to accelerate clinical trials across the Asia Pacific and in particular China. Novotech recently announced a partnership and investment in tech firm Prospection to support accelerated clinical trials with healthcare data analytics using real-world data. Novotech has also partnered with virtual research organisation ObvioHealth to expedite trials leveraging remote technologies. This patient-centric approach improves subject retention and allows sponsors to reach populations outside major cities for clinical trial participation.

* https://novotech-cro.com/whitepapers/evolution-clinical-trials-asia-pacific-region-compared-us-and-eu5

About Novotech Health Holdings
Novotech Health Holdings Pte. Ltd. ("Novotech") is a leading Asia-Pacific biotech specialist CRO and consists of two operating brands, Novotech and PPC. Novotech is a CRO with integrated labs and phase I facilities providing drug development consulting and clinical development services. It has been instrumental in the success of approximately 3,700 clinical trials across all trial phases and broad range of therapeutic areas. Novotech is well positioned to serve biopharmaceutical clients conducting clinical trials in Asia and globally. 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

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EC Healthcare Forms a Joint Venture with KaiLong and Asia Allied Infrastructure

HONG KONG, Jun 6, 2022 – (ACN Newswire) – EC Healthcare (the "Company", which together with its subsidiaries is referred to as the "Group", SEHK stock code: 2138), the largest non-hospital medical group in Hong Kong*, is pleased to announce that the Group formed a joint venture company (the "JV Company") with a real estate investment management company, KaiLong Group ("KaiLong") and Asia Allied Infrastructure Holdings Limited ("AAI", SEHK stock code: 0711) to co-build a premium purpose-built medical grade building (the "Medical Building") in Hong Kong. The Group will be the anchor tenant of the Medical Building upon completion.

The Group has conditionally agreed to make initial capital contributions to the JV Company of up to HK$275 million, which will represent 30% of the total enlarged issued share capital of the JV Company. The Group will also enter into a lease for the entire Building for an initial term of 5 years with an option to extend a further 5 years. The Building is expected to complete construction by the fourth quarter of 2024.

The Medical Building will be located in the core commercial district in Tsim Sha Tsui on Cameron Road with an estimated lettable floor area of approximately 103,000 square feet. This unprecedented medical tenant-landlord collaboration aims to transform the space into a one-of-a-kind medical grade building envisioned to drive the growth and future strategy of the Group. The Group will also have the naming rights to the Medical Building, which is expected to raise the Group's brand awareness. The Group will customise medical space configurations in the Medical Building designed to accommodate specialised medical equipment, enabling the Group to deliver one-stop premium medical and medical aesthetic services. The Group target to consolidate its clinics currently scattered across different buildings in Kowloon and anticipates the purpose-built building to enhance medical and healthcare services quality and operational efficiency.

Ms. Ada Wong, Executive Director, Chief Strategy Officer & Chief Investment Officer of EC Healthcare said, "The Medical Building will become the centrepiece of our Group's premium medical and healthcare services in Hong Kong. This strategic move underpins the Group's commitment to building up an enclosed healthcare ecosystem focused on high quality customer services and reinforce the Group's leading position as a one-stop comprehensive healthcare and medical service provider. Upon completion, the Medical Building will be a key pillar of the Group's strategy, offering a truly seamless experience of medical and healthcare services within a single building for its customers.

We are excited to form this unprecedented medical tenant-landlord collaboration and jointly build this project. With the combination of our Group's market leading expertise in healthcare services and our partners KaiLong's and AAI's strong real estate and construction experience, we look forward to elevating the provision of top quality medical and healthcare services to the next level in Hong Kong and beyond."

Mr. Ivan Ho, CEO Hong Kong of KaiLong Group, said "We are excited to partner with a well-established medical group, EC Healthcare and Asia Allied Infrastructure to build a purpose-built medical centre located at the heart of Tsim Sha Tsui in order to capture the growing demand for medical real estate in Hong Kong."

Mr. Dominic Pang, Chairman of Asia Allied Infrastructure, said, "AAI is delighted to be cooperating with EC Healthcare and KaiLong for this meaningful establishment. Contributing to the betterment of the lives of the Hong Kong people has always been AAI's corporate focus. With the society being increasingly conscious about health and wellness, we believe this project will not only be beneficial to the JV partners but also to the wider community."

About EC Healthcare
EC Healthcare is Hong Kong's largest non-hospital medical service provider*, leveraging its core businesses of preventive and precision medicine, and committed to developing medical artificial intelligence by integrating its multi-disciplinary medical services. The move, which is supported by the Group's high-end branding and quality customer services, is aimed at offering customers safe and effective healthcare and medical services with professionalism.

The Group principally engages in the provision of one-stop medical and health care services in Greater China. The Group provides a full range of services and products under its well-known brands, including those of its one-stop aesthetic medical solutions provider DR REBORN which has ranked first in Hong Kong by sales for years, primary care clinics jointly established with Tencent Doctorwork, chiropractic services centre SPINE Central, New York Spine and Physiotherapy Center NYMG, health management centre re:HEALTH, a vaccine centre Hong Kong Professional Vaccine HKPV, a comprehensive dental centre UMH DENTAL CARE, a diagnostic and imaging centre HKAI, an oncology treatment centre reVIVE, a day procedure centre HKMED, a specialty clinic SPECIALISTS CENTRAL and NEW MEDICAL CENTER, obstetrics and gynaecology specialist ZENITH MEDICAL CENTER AND PRENATAL DIAGNOSIS CENTRE, specialists central, a paediatric center PRIME CARE, cardiology center HONG KONG INTERNATIONAL CARDIOLOGY CENTER, PathLab Medical Laboratories, a professional hair care center HAIR FOREST, Ophthalmology Center VIVID EYE and EC Veterinary Hospital and Imaging Center.

*According to independent research conducted by Frost and Sullivan in terms of revenue in 2020 and 2021
KaiLong Group

KaiLong Group is a leading real estate investment management company, which offers comprehensive investment and asset management services for a wide range of institutional and individual investors. The company is dedicated to identifying, evaluating, acquiring and managing quality assets for investors. Founded in 2014, KaiLong Group has offices in Shanghai, Hong Kong, Beijing, Chengdu, Dalian and Guangzhou.

About Asia Allied Infrastructure Holdings Limited
Asia Allied Infrastructure Holdings Limited ("Asia Allied Infrastructure") is listed on the Main Board of the Hong Kong Stock Exchange under stock code 00711. The Group operates businesses such as construction engineering and management, property development and assets leasing, security and facility management, tunnel management, non-franchised bus services, as well as medical technology and healthcare. Its subsidiary "Chun Wo" is a renowned construction contractor and property developer in Hong Kong. Chun Wo's solid construction experience and professional capabilities have enabled the Group to seize suitable development opportunities, allowing the Group to enhance its overall profitability and investment value.

For further information, please contact:
iPR Ogilvy Limited
Callis Lau / Lorraine Luk / Charmaine Ip
Tel: (852) 2136 6952 / 2169 0467 / 3920 7649
Fax: (852) 3170 6606
Email: ech@iprogilvy.com


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