Hua Medicine Published Two Peer-Reviewed Papers in Nature Medicine, an International Top Medical Journal, on the Results of the Phase III Research of Dorzagliatin, a First-In-Class Investigational Diabetes Drug of Hua Medicine

SHANGHAI, CHINA, May 13, 2022 – (ACN Newswire) – Hua Medicine (the "Company", stock code on the main board of the Hong Kong Stock Exchange: 2552.HK) today announces that, two peer-reviewed papers on the Phase III clinical trial results of dorzagliatin, a glucokinase activator (GKA) and first-in-class investigational drug of the Company for the treatment of diabetes, were published online simultaneously by Nature Medicine, an international top medical journal. These two papers described and analyzed the clinical efficacy and safety characteristics of dorzagliatin monotherapy (SEED) in drug-naive Type 2 diabetes (T2D) patients and the combination therapy of dorzagliatin and metformin (DAWN) in patients who failed in metformin adequacy therapy for the treatment of T2D respectively.




It was the first time for Nature Medicine to publish the results of Phase III trials of a GKA, representing the results of large registered clinical studies in China. Dorzagliatin is a new first-in-class GKA antidiabetic drug to successfully complete the Phase III registered clinical study in the world, which was led by Chinese researchers. The two papers are also the first to be published in Nature Medicine with Chinese researchers as the first and corresponding authors of a novel mechanism for treatment of diabetes. Both studies demonstrated that by addressing the defect of the glucose sensor function of glucokinase (GK), dorzagliatin is able to continuously and effectively reduce HbA1c in patients with T2D, and significantly reduce post-meal glucose (2h-PPG) during the treatment period. The percentage of patients admninistered dorzagliatin achieving standard glycemic blood glucose control was demonstrated to be high and with low hypoglycemia incidences. It was also shown that dorzagliatin has good safety and tolerability. In addition, it can continuously improve beta-cell function and reduce insulin resistance.

Dorzagliatin is the first-in-class oral drug developed by Hua Medicine for the treatment of T2D after 10 years of independent research and development, which identifies GK as a therapeutic target. GK plays a critical role in maintaining blood glucose homeostasis in human body, serving as a glucose sensor to sense changes of the blood glucose, and timely stimulates glucose control organs to secrete insulin, GLP-1 or glucagon, so as to effectively regulate blood glucose level and maintain blood glucose homeostasis (4-6.5 mmol/L). Impaired sensitivity of glucose, mainly manifested as impaired glucose stimulated insulin secretion (GSIS) function of pancreatic beta-cells and rise of FPG level blood sugar fluctuations, is the root cause of T2D. Dorzagliatin can act on GK in glucose control organs such as pancreas, liver and intestine. By restoring GK activity in T2D patients, it helps restore the sensitivity of the human body to blood glucose changes, and thus improves the early phase insulin secretion and beta-cell function. In this way, blood glucose homeostasis can be rebuilt to control or delay the progression of T2D, and fundamentally treat diabetes and discontinue medication. Hua Medicine has published over 10 papers on the results of basic and clinical studies to continually elaborate its scientific concept of "restoring sensitivity, rebuilding homeostasis, and treating diabetes at its source". The results of the Phase III trial published by Nature Medicine are the clinical validation of this innovative concept. In March 2021, Hua Medicine submitted the new drug application (NDA) of dorzagliatin to the China National Medical Products Administration (NMPA) for T2D treatment, which was accepted in April. Currently, the NDA of dorzagliatin is under active review by the NMPA. Hua Medicine is fully supporting this process to obtain the approval of dorzagliatin as early as possible.

Nature Medicine is a top journal, focusing on the field of biomedicine. It mainly publishes original research papers that "demonstrate novel insight into disease processes, with direct evidence of the physiological relevance of the results", and has begun to focus on publishing papers of large clinical research in recent years. The impact factor of Nature Medicine has been on the rise. With a 2-year impact factor of 53.44, it has surpassed Nature to be one of the top five medical journals, also including The New England Journal of Medicine (NEJM), The Lancet, The Journal of the American Medical Association (JAMA) and The British Medical Journal (BMJ), known traditionally as four medical journals. Since 2009, Franz Matschinsky, the father of GK, first reported the research and development of GKA in Nature Reviews Drug Discovery, the theoretical research and drug research and development results related to GKA have drawn worldwide attention, and have been highly valued by the international academic and clinical medical communities. Before, the results of the Phase II clinical trial of dorzagliatin were published in the advanced medical journal The Lancet Diabetes and Endocrinology. Since 2014, Hua Medicine has been presenting the results of basic researches and clinical studies of dorzagliatin at the world's largest and most important diabetes conference – the American Diabetes Association (ADA) Scientific Sessions every year. It was through the ADA Scientific Sessions that the editors of Nature Medicine noticed the innovativeness and breakthrough nature of dorzagliatin, and took the initiative to make an appointment with Hua Medicine for scripts. These two newly published papers present the Phase III results of the SEED study and the DAWN study of dorzagliatin, respectively.

The SEED study is a study of dorzagliatin monotherapy. It is a randomized, double-blind and placebo-controlled Phase III registered clinical study in drug naive T2D patients. The study was conducted among 463 T2D patients. The first 24 weeks were randomized, double-blind and placebo-controlled treatment, designed to evaluate the primary efficacy and safety endpoints of dorzagliatin. The subsequent 28 weeks were open-label period for dorzagliatin, designed to continuously observe and evaluate the safety of dorzagliatin. The SEED study was led by Professor Dalong Zhu, the President of the Chinese Diabetes Society, and Director of Medical Center for Endocrine and Metabolic Diseases of Gulou Hospital, affiliated to Medical College of Nanjing University. This study showed that dorzagliatin can effectively reduce the blood glucose of drug naive T2D patients, with good safety and tolerability. The main conclusions of the SEED study include:

Significant and long-lasting efficacy:
— There was a 1.07% HbA1c reduction from baseline in 24 weeks, significantly better than that of the placebo treated group (p<0.001)
— The standard-reaching rate of HbA1c was 42.5% in 24 weeks, significantly higher than that of the placebo treated group (p<0.001)
— Significantly improved beta cell function, with a 3.28 increase in HOMA2-beta in 24 weeks compared with the placebo treated group
— The 2h-PPG observably decreased by 2.33mmol/L compared with the placebo treated group in 24 weeks
— The FPG observably decreased by 0.33mmol/L compared with the placebo treated group in 24 weeks
— The HbA1c continued to remain steady in 52 weeks

Good tolerability and safety:
— The hypoglycemia (<3mmol/L) incidence rate was less than 1% in 24 weeks, and there was no severe hypoglycemia reported
— The hypoglycemia (<3mmol/L) incidence rate was less than 1% in 52 weeks, and there was no severe hypoglycemia reported
— In 52 weeks, there was no drug-related SAE

The DAWN study is a randomized, double-blind, placebo-controlled Phase III study among 767 patients, which uses dorzagliatin combined with metformin to treat T2D patients who failed in metformin adequacy therapy. The first 24 weeks were randomized, double-blind and placebo-controlled treatment, designed to evaluate the primary efficacy and safety endpoints of dorzagliatin. The subsequent 28 weeks were open-label period for dorzagliatin, designed to continuously observe and evaluate the safety of dorzagliatin. The DAWN study was led by Professor Wenying Yang at China-Japan Friendship Hospital, who is the former President of the Chinese Diabetes Society and present Vice President of the Asian Diabetes Association. This study showed that dorzagliatin can effectively reduce the blood glucose of T2D patients who failed in metformin adequacy therapy, with good safety and tolerability. The main conclusions of the DAWN study include:

Significant and long-lasting efficacy:
— The HbA1c reduction was 1.02% from baseline, significantly better than that of the placebo treated group in 24 weeks
— The standard-reaching rate of HbA1c was 44.4% in 24 weeks, significantly higher than 10.7%(p<0.0001) in the placebo treated group
— Significantly improved beta cell function and HOMA2-beta increased by 2.43 compared with the placebo treated group in 24 weeks
— The 2h-PPG observably decreased by 2.48mmol/L compared with the placebo treated group in 24 weeks
— The FPG observably decreased by 0.38mmol/L compared with the placebo treated group in 24 weeks
— The HbA1c continued to remain steady in 52 weeks

Good tolerability and safety:
— The hypoglycemia (<3mmol/L) incidence rate is less than 1% in 24 weeks, and there was no severe hypoglycemia reported
— The hypoglycemia (<3mmol/L) incidence was less than 1% in 52 weeks, and there was no severe hypoglycemia reported
— In 52 weeks, there was no drug-related SAE

Professor Dalong Zhu, the first author of the paper on SEED, said, "The investigator team of dorzagliatin and the R&D team of Hua Medicine have always focused on the clinical needs of patients and adhered to scientific rigor to successfully develop this first-in-class new drug together. The publication of the results of the two Phase III clinical studies on Nature Medicine is another proof of the international academic community recognizing China's new drug development capabilities. As a clinical investigator, I feel very proud and confident about the future of innovative drug development in China. In clinical trials, dorzagliatin has demonstrated long-lasting and stable efficacy, as well as good safety and tolerability. In the meanwhile, it showed significant potentiation in combination trials with SGLT-2 inhibitors and DPP-4 inhibitors. I am very much looking forward to bringing new treatment options with dorzagliatin to Chinese T2D patients soon."

Professor Xiaoying Li, the co-corresponding author of the paper and Director of the Department of Endocrinology at Zhongshan Hospital affiliated to Fudan University, said, "Nature Medicine is a top journal with a high impact factor. The clinical trial of dorzagliatin is designed in line with the standards of international multinational companies. All the investigators and developers followed a high bar of standards and quality, which led to the creation of such a high-value breakthrough drug. I'm very proud and excited about this achievement. Type 2 diabetes is a critical threat to human health. As clinicians, our involvement in the clinical development of dorzagliatin has given us the opportunity to review the regulating mechanisms of glucose homeostasis and to better understand the process and characteristics of the progression of type 2 diabetes. "

Professor Wenying Yang, the first author of the DAWN paper, said, "I am very excited and happy! Before, the results of Phase II clinical study of dorzagliatin were published in The Lancet Diabetes and Endocrinology, and now the results of Phase III clinical study were published in Nature Medicine. Such achievements are completely on par with the first-in-class diabetes drugs developed by multinational pharmaceutical companies. This is a great recognition on Chinese innovative drugs, the best return to Hua Medicine and Dr. Chen Li's 10 years of hard work, and the most memorable experience for us as clinical investigators. We are fortunate to meet such a good pioneer. I look forward to the launch of dorzagliatin soon!"

Dr. Yi Zhang, Chief Medical Officer, Senior Vice President of Pharma Development of Hua Medicine and the head of clinical development for dorzagliatin, said, "The publication of the results of the two clinical studies, i.e., the SEED study and the DAWN study, on Nature Medicine fully demonstrated the scientific research capabilities of Chinese clinical researchers and Hua Medicine's innovative R&D strengths as a China-based biopharmaceutical company. The Phase III clinical trial of dorzagliatin is the first confirmatory clinical study of GKA drugs completed worldwide. It is also the first clinical trial of a first-in-class investigational diabetes drug led by a Chinese clinical team with Chinese subjects as the research objects. We are very grateful to all clinical researchers for their unremitting efforts and hard work. In the future, Hua Medicine is confident to join hands with partners in various clinical fields to make new breakthroughs in the field of Type 2 diabetes and the whole metabolic diseases."

Dr. Li Chen, Founder, CEO, Chief Scientific Officer of Hua Medicine and corresponding author of both papers, said, "We are very pleased to collaborate with Jennifer Sargent, Editor-in-Chief, to publish the clinical research results of dorzagliatin in Nature Medicine. This illustrates the strong interest and attention of the international medical community on the GK mechanism and GKA drugs. In 1968, Professor Franz Matschinsky, the father of glucokinase, discovered the critical role of GK in glucose-stimulated insulin secretion and proposed glucokinase as a diabetes gene and glucose sensor. The drug development of glucokinase activators has, since then, undergone numerous difficulties and failures. More than 50 years later, I am very pleased to see that Hua Medicine R&D team and Chinese clinical experts, after ten years of hard work, have overcome many R&D difficulties and greatly improved the understanding of glucokinase's role in the regulation of blood glucose homeostasis and diabetes treatment, established the world's leading scientific concept of diabetes treatment, and successfully transformed it into the breakthrough new drug dorzagliatin. The recently results of the DREAM study, further elucidates that dorzagliatin can fundamentally treat T2D and achieve diabetes remission without any glucose-lowering medication after the completion of the SEED study. Hua Medicine is proactively supporting the NMPA approval process to bring this innovative drug to the benefit of Chinese type 2 diabetes patients as soon as possible."

Design of the SEED study
The SEED study is a randomized, double-blind and placebo-controlled Phase III study conducted in 463 drug naive T2D patients. The whole study lasted for 53 weeks, including 52 weeks of treatment and 1 week of safety follow-up. The first 24 weeks were randomized, double-blind and placebo-controlled to assess the efficacy and safety of dorzagliatin. Patients were treated with twice-daily doses of dorzagliatin (75mg) or placebo, randomized 2:1. The subsequent 28-week were the open-label treatment period, during which all subjects were treated with twice-daily doses of dorzagliatin (75mg). The study was conducted at 40 clinical sites across China led by Professor Dalong Zhu, the President of the Chinese Diabetes Society, Director of Medical Center for Endocrine and Metabolic Diseases of Gulou Hospital, affiliated to Medical College of Nanjing University. (Clinical study registration number: NCT03173391)

Design of the DAWN study
The DAWN study is a randomized, double-blind, placebo-controlled Phase III study in 767 Type 2 diabetes patients, which uses dorzagliatin combined with metformin to treat patients who failed in metformin adequacy therapy. During the first 24 weeks of double-blinded treatment, subjects were treated with metformin (Glucophage) at 1,500mg/day as the basic therapy, and they were given twice-daily doses of dorzagliatin (75mg) or placebo, randomized on a 1:1 ratio. During the subsequent 28-week open-label treatment period, all subjects received dorzagliatin 75mg twice daily and 1500mg/day of metformin (Glucophage). The trial was conducted in 72 clinical sites across China led by Professor Wenying Yang of China-Japan Friendship Hospital, the former President of the Chinese Diabetes Society and present Vice President of the Asian Diabetes Association. (Clinical study registration number: NCT03141073)

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 without any antidiabetes medication during the 52-week study period. The Company has obtained the "Drug Manufacturing Permit" of dorzagliatin issued by the Shanghai Municipal Drug Administrative Bureau, 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


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

Q&M Dental net profit, excluding other gains or losses, increased by 25% to S$7.2 million on S$46.8 million of revenue for quarter ended 31 March 2022

SINGAPORE, May 12, 2022 – (ACN Newswire) – Q&M Dental Group (Singapore) Limited, a leading private dental healthcare group in Asia, reported net profit excluding other gains or losses attributable to shareholders of S$7.2 million for the quarter ended 31 March 2022 (1Q2022) compared to S$5.8 million in the corresponding period (1Q2021).



Dr Ng Chin Siau, Chief Executive Officer of Q&M Dental said, "We are heartened by our continuous strong performance in 1Q2022 following a record-setting year FY2021. Our core dental business will remain strong, and with the abolishing of most of the pandemic restrictions, a positive impact on the economy, we are looking forward to resuming our growth trajectory of expanding our network of clinics in the coming quarters."

Growth & Expansion in Operations

As at 31 March 2022, the Group's number of dental outlets in Singapore has grown to 99, from 85 as at 31 March 2021. Similarly in Malaysia, the number of dental outlets has increased to 41, as compared to 36 previously.

The Group also continues to focus on its expansion into medical diagnostics, with its associated Company, Aoxin Q&M Dental Group Limited and through its recent acquisition of 49% shareholding of Acumen Diagnostics Pte. Ltd., raising Q&M's effective interest in Acumen Diagnostics from 51% to 67%. In the near term, Acumen Diagnostics' clinical testing laboratory will roll out its pipeline of new tests, including PCR assays for dengue, sepsis and, identification of bacterial pathogens and their associated antibiotics resistance in pneumonia and bloodstream infections. Its longer-term plans include the development of new vaccines.

For 1Q2022, revenue contribution from dental and medical clinics was relatively unchanged with a marginal decrease of 2% to S$38.6 million, despite the challenges of the tightening of Safe Management Measures (SMM) due to the rapid spread of the Omicron variant. Revenue contribution from medical laboratory and dental equipment & supplies segment surged by 80% to S$8.2 million on the back of increased revenue from Covid-19 testing from Acumen Diagnostics, the Group's medical laboratory business, which obtained its medical laboratory license in September 2020.

The Group's net profit after tax excluding other gains or losses for 1Q2022 increased by 25% to S$7.2 million, from S$5.8 million in the corresponding period last year, translating to an earnings per share of 0.69 Singapore cent.

As at 31 March 2022, the Group had cash and cash equivalents of S$43.5 million with net assets of S$94.9 million. This translates to Net Asset Value per share of 10.10 cents per share.

Outlook & Further Expansion Plans

With the opening up of the Singapore economy gathering pace in 2022, the country expects to see businesses ramping up in most sectors with those that were most severely affected by the pandemic like F&B, tourism to especially benefit. The government is forecasting GDP growth of between 3.0 to 5.0% in 2022, Barring any major changes in the global macroeconomic and political situation or any new adverse developments in the evolving Covid-19 situation, the Group is cautiously optimistic on its business outlook.
The Group intends to continue executing the business plans outlined below:

– Expansion of network of dental clinics in Singapore and Malaysia

The Group currently operates 99 clinics in Singapore. With the economy opening up in 2022, the Group will also intensively increase its reach through organic growth of its dental clinic network in Singapore. This will be supported by an expansion of its team of dentists to undergird the future growth of its operations in Singapore. We will continue to develop, invest and optimise our digital Artificial Intelligence (AI) guided clinical decision support system to provide the most effective and suitable treatment plans for patients. The Group believes it is well-positioned to cater to the rising demand for primary and high-value specialist dental healthcare services of its patients.

Currently, the Group operates 41 clinics in Malaysia. The clinics are located in Johor (16 dental clinics), Kuala Lumpur (9 dental clinics), Selangor (11 dental clinics), Melaka (4 dental clinics) and 1 dental clinic in Negeri Sembilan.

The Group intends to open at least 30 dental clinics a year from 2021 onwards in Singapore and Malaysia for the next 10 years. The eventual number of dental outlets will depend on available opportunities, pertinent market conditions and the evolving Covid-19 situation.

– Expansion into private dental healthcare market in the People's Republic of China ("PRC")

The main thrust of the Group's proposed expansion in PRC is through organic growth to develop a new and sustainable growth pillar that can yield long term value for the Group.

– Expansion in Southeast Asia

The Group is continuously looking out for strategic opportunities to expand its dental business and regional footprint to other Southeast Asian countries.

– Medical Laboratory

The Group will focus on rolling out its clinical testing laboratory pipeline of new tests including PCR assays for dengue sepsis and identification of bacterial pathogens and their associated antibiotics resistance in pneumonia and bloodstream infections.

Please see links for PDF documents from SGXNET.
Results: https://tinyurl.com/QnM-1Q2022-Result
Press Release: https://tinyurl.com/QnM-1Q-2022-Release

About Q&M Dental Group (Singapore) Limited (QC7.SI)

Q&M Dental Group (Singapore) Limited (QC7.SI) ("Q&M" or together with its subsidiaries, the "Group") is a leading private dental healthcare group in Asia.

The Group owns the largest network of private dental outlets in Singapore, operating 99 dental outlets across the country. Underpinned by about 290 experienced dentists and over 350 supporting staff, the Group sees an average of 40,000 patient visits a month in Singapore. The Group also operates 5 medical clinics and a dental supplies and equipment distribution company.

Outside of Singapore, the Group has 41 dental clinics and a dental supplies and equipment distribution company in Malaysia, as well as a dental clinic in the People's Republic of China ("PRC"). Q&M is also the substantial shareholder of Aoxin Q&M Dental Group Limited, a dental Group listed on the Catalist board of the Singapore Exchange that operates dental clinics and hospitals primarily in the north- eastern region of the PRC. The Group aims to expand its operations geographically and vertically through the value chain in Malaysia, the PRC and within the ASEAN region.

The Q&M College of Dentistry was established in 2019 to offer postgraduate dental education as part of its commitment to continual education and professional development of dentists. It offers Singapore's first private postgraduate diploma programme in clinical dentistry.

In 2020, the Group expanded into the medical laboratories and research industry with the strategic investment into Acumen Diagnostics Pte. Ltd. ("Acumen"). Acumen currently focuses on the manufacture, sale and distribution of COVID-19 diagnostic test kits, as well as COVID-19 testing. It is also working to roll out a pipeline of new tests, including PCR assays for dengue, sepsis and, identification of bacterial pathogens and their associated antibiotics resistance in pneumonia and bloodstream infections.

EM2AI Pte Ltd, a wholly-owned subsidiary of the Group that focuses on developing AI-powered solutions to diagnosis and treatment planning has rolled out IDMS, enabling dentists within the Group's network to administer ethical treatment plans for patients.

The Group was listed on the Mainboard of the Singapore Exchange Securities Trading Limited ("SGX- ST") on 26 November 2009. For more information on the Group, please visit www.QandMDental.com.sg

For more information, please contact:
Waterbrooks Consultants Pte Ltd
Wayne Koo
Tel: +65 9338-8166
Email: wayne.koo@waterbrooks.com.sg

Derek Yeo
Tel: +65 9791-4707
Email: derek@waterbrooks.com.sg

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

Novotech Sponsors Pre-ASCO China Summit: Go/No Go Decisions Based on Early Phase Oncology Trials

SYDNEY, May 12, 2022 – (ACN Newswire) – Novotech, the leading Asia Pacific biotech specialist CRO which has recently expanded its CRO services to the US, is pleased to sponsor the Pre-ASCO China Summit 2022 event titled: Go/No Go Decisions Based on Early Phase Oncology Trials ('The Summit').

The Summit will feature insights from leading Novotech experts tapping decades of oncology clinical experience in the APAC region. They include:
– Dr. Ramandeep Sharma, Senior Medical Monitor, Novotech
– Dr. Vivian Gu, Head of Clinical Development & Regulatory, CMO, Novotech China

Register here: https://www.eventbrite.com/e/pre-asco-china-2-gono-go-decisions-based-on-early-phase-oncology-trials-tickets-330427145487

Event Date:
– China Time: 9:00-10:30 AM, Saturday, May 14, 2022
– US EST Time: 9:00-10:30 PM, Friday, May 13, 2022
– US PST Time: 6:00-7:30 PM, Friday, May 13, 2022
Language: English, with Chinese simultaneous translation
Venue: Live Zoom Webinar
Moderator:
– Dr. Li Yan, CMO, Brii Biosciences; Managing Director, United States Chinese Anti-Cancer Association (USCACA)

The Summit will start with a presentation by Novotech's Senior Medical Monitor Dr. Ramandeep Sharma titled: Approaches, Experiences, and considerations for early phase go/no go.

A panel discussion will follow featuring leading clinical specialists including:
– Dr. Jin Li, Shanghai East Hospital
– Dr. Li Yan, CMO, Brii Biosciences; Managing Director, USCACA
– Dr. Ramandeep Sharma, Senior Medical Monitor, Novotech
– Dr. Vivian Gu, Head of Clinical Development & Regulatory, CMO, Novotech China
– Dr. Xiaoxia Yan, Highthink
– Dr. Jianmin Fang, Co-founder, CEO & CSO, RemeGen
– Dr. Joseph Eid, Chief Medical Officer, Hengrui
– Dr. Jon Wigginton, Senior Advisor and Chairman SAB, Cullinan Oncology; Former Head of Immuno-Oncology Early Clinical Development, BMS

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 with a biopharma client base. NCGS 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 well developed," 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.

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
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

Novotech Acquires US CRO NCGS, Expands Global Expertise

Singapore & Charlotte, NC, May 5, 2022 – (ACN Newswire) – Novotech, the leading Asia-Pacific biotech specialist CRO, has acquired US CRO NCGS as part of its expansion program, and can now offer its biotech clients clinical services in the US to support later phase global studies. NCGS, established in 1984 in South Carolina, is a privately held CRO with a biopharma client base and a workforce of about 300 professionals across the US.

Novotech CEO Dr. John Moller said "We are very pleased to acquire such an impressive company with a strong history of quality and delivery in the United States. The company's growth is a real credit to the knowledge and expertise of founder Nancy Snowden and the exceptional team she has formed.

"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 well developed," Moller said.

Nancy C.G. Snowden, founder and CEO of NCGS, said the company was excited about becoming part of Novotech operations globally and supporting Novotech's clients with their US clinical programs. "We have a similar cultural fit and focus on excellence, so joining Novotech will be seamless for both ours and Novotech's clients. Novotech and NCGS have a collaboration history of over a decade which will also support the seamless integration," said Snowden.

"NCGS focuses on complex areas of clinical development; oncology, hematology, infectious disease, and CNS in both adult and pediatric populations. Our lean organizational structure and nimble operational model with highly tenured staff have been specifically designed to overcome the challenges inhibiting our industry today. We have the ability to pivot in real time as the needs of the trial evolve," Sowden said.

Novotech serves biotechs globally, leveraging deep relationships built with hundreds of Asia-Pacific sites over the last 25 years. NCGS compliments this with a broad US site base and hundreds of investigators with relationships spanning nearly four decades.

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

About Novotech Health Holdings

Novotech Health Holdings Pte. Ltd. ("Novotech") is a leading Asia-Pacific biotech specialist CRO with integrated labs and phase I facilities providing drug development consulting and clinical development services. Novotech Holdings is well positioned to serve biopharmaceutical clients conducting clinical trials in Asia and globally. For further information, visit https://novotech-cro.com/.

About NCGS

NCGS Incorporated, founded in 1984, is a full-service CRO that specializes in conducting and managing clinical trials. NCGS has supported the development of more than 70 approved pharma-biotech, diagnostic and device products with over 80 indications during its nearly four decades of operation. For more information, please visit https://www.ncgs.com/sponsors/.

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

Avantor Announces Investment in Manufacturing and Distribution Hub in Singapore to Serve Rapidly Growing Asia Pacific Biopharma Industry

Singapore, May 5, 2022 – (ACN Newswire) – Avantor, Inc. (NYSE: AVTR), a leading global provider of mission-critical products and services to customers in the life sciences, advanced technologies and applied materials industries, today announced it will create a new manufacturing and distribution Hub in Singapore, by integrating its existing distribution facility with new manufacturing operations. The new Hub, which brings Avantor solutions closer to regional customers and strengthens global supply chain capabilities, will be fully operational early next year.


Avantor announced it will create a new Manufacturing and Distribution Hub in Singapore by integrating its existing distribution facility with new manufacturing operations.


"The Singapore Manufacturing and Distribution Hub will enable Avantor to better serve the fast-growing Asia Pacific Biopharma market by facilitating shorter lead times, enhancing supply chain security and increasing capacity in the region," said Christophe Couturier, Executive Vice President, AMEA, Avantor. "The Hub will boost regional innovation and serve as an industry benchmark for Singapore and Asia Pacific's global quality and regulatory standards, and demonstrates Avantor's commitment to growing our presence in the region."

The new Hub will provide a range of services including quality control and inventory management expertise, and feature cGMP manufacturing suites and testing labs for process ingredients and excipients.

About Avantor

Avantor, a Fortune 500 company, is a leading global provider of mission-critical products and services to customers in the biopharma, healthcare, education & government, and advanced technologies & applied materials industries. Our portfolio is used in virtually every stage of the most important research, development and production activities in the industries we serve. Our global footprint enables us to serve more than 225,000 customer locations and gives us extensive access to research laboratories and scientists in more than 180 countries. We set science in motion to create a better world.

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Regional Media Contact
Christina Koh
Director, Communications – AMEA
Avantor
M: +65 9720 0169
Christina.Koh@avantorsciences.com

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

Malaysian Genomics Resource Centre Berhad Supports Yayasan Seri Negara’s Ramadhan Initiative

PETALING JAYA, Malaysia, Apr 28, 2022 – (ACN Newswire) – Malaysian Genomics Resource Centre Berhad (Bursa: MGRC, 0155), a leading genomics and biopharmaceutical specialist, is pleased to support Yayasan Seri Negara's (YSN) Ihya Ramadhan 2022 programme through a monetary donation to help those in need.


Dato' Seri Mazlan Lazim, Patron of Yayasan Seri Negara and Encik Azri Azerai, Executive Director of Malaysian Genomics Resource Centre [L-R]


The Ihya Ramadhan 2022 programme will be held in several locations throughout the country and involves the breaking of fast and the giving of monetary aid to orphans and the underprivileged.

Encik Azri Azerai, Executive Director of Malaysian Genomics, said, "We are happy and honoured to be able to assist YSN in their Ihya Ramadhan 2022 programme. Every little bit helps, and we want to do our part in easing the burden of those in need such as orphans and the underprivileged."

Malaysian Genomics' cash aid will be distributed to orphans and the underprivileged at the Shah Alam district police headquarters during the Ihya Ramadhan 2022 programme held at the location on 27 April 2022 at 6pm.

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

Legend Capital’s Portfolio Company Xbiome Acquires Clinical-Stage Program Targeting Ulcerative Colitis

HONG KONG, Apr 27, 2022 – (ACN Newswire) – Legend Capital's portfolio company Xbiome Inc., an industry-leading and AI-driven microbiome therapeutics company, recently announced that it acquired the clinical-stage M201 program from Assembly Biosciences, Inc., a clinical-stage biotechnology company developing innovative therapeutics targeting hepatitis B virus and other viral diseases.



Founded in 2017, Xbiome is an industry-leading and AI-driven microbiome therapeutics company focusing on tackling unmet medical needs through various modalities of microbiome therapeutics. The acquisition has reflected Xbiome's leading position in the rising field of microbiome therapeutics and has added a third clinical-stage program to Xbiome's rapidly growing pipeline.

The M201 program is designed for patients with mild to moderate ulcerative colitis. Xbiome will develop M201 leveraging its AI and data platform; it is expected to commence the M201 Phase 1b clinical trial in 2022 in the US and the program will become part of Xbiome's Global Innovation Center, where Xbiome will work closely with its global technology team in Europe and Asia in order to enhance and support the continued development of M201.

Yan Tan, Founder and Chief Executive Officer of Xbiome, said: "This acquisition demonstrates our commitment to developing an enhanced treatment for ulcerative colitis, as well as our broader commitment to strategically growing our pipeline to pioneer medical breakthroughs. The announcement marks a pivotal step in Xbiome's continued global impact as an industry leader in AI-driven microbiome therapeutics and the expansion of our recently established Global Innovation Center. We look forward to progressing the M201 clinical trial in the US in the very near future."

Legend Capital led Xbiome's Series B financing round in 2019 and continued to support the company's development by following up in its Series B+ financing round in 2020. Closely following the deep integration of the medical and health industry and technology, Legend Capital has built a solid portfolio in the medical AI sector in recent years. In addition to Xbiome, Legend Capital also invested in a number of other leading medical AI companies, such as StoneWise, an AI technology-driven innovative drug R&D platform company, Lunit & Deepwise Healthcare, AI medical imaging companies, Deep Informatics++, an AI medical pathological diagnosis company, Genome Wisdom, a genomic big data company, and Ayshealth Technology, an AI medical chronic disease management system company.


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

Legend Capital Portfolio: Korean Medical AI Company Lunit to List on KOSDAQ in 2Q2022

HONG KONG, Apr 26, 2022 – (ACN Newswire) – Legend Capital's portfolio company Lunit, a Korean Medical AI company, recently announced a preliminary approval from the Korea Exchange for initial public offering (IPO) on the KOSDAQ market, and it plans to submit a registration statement within the second quarter of 2022.




Founded in 2013, Lunit is a company with the world's top-notch AI technology focusing on R&D of medical software to assist tumor diagnosis and treatment. It utilizes advanced AI technology to process medical image data, which helps doctors to make accurate clinical decisions in diagnosis and treatment. Lunit's flagship products are Lunit INSIGHT, an AI image analysis solution for cancer screening, and Lunit SCOPE, an AI biomarker platform for cancer treatment.

According to Korean media reports, Lunit is considered one of the most promising medical AI IPOs in Korea in the first half of 2022. After the listing, Lunit plans to use the secured funding for R&D of AI products and global market development, laying the cornerstone for sustainable growth.

Lunit has partnered with global medical device giants such as GE Healthcare, Philips, and FujiFilm to supply products to about 600 medical sites in more than 40 countries worldwide. In addition, Lunit is also focusing on its biomarker business by signing an exclusive business contract with Guardant Health, a leading global liquid biopsy company.

Brandon Suh, CEO of Lunit, said: "Lunit is the first deep learning-based medical AI company in Korea with a specialized AI research team and medical team, developing AI solutions for cancer diagnosis and treatment. As our AI technologies and products are acknowledged globally, we will strive to continuously grow and pioneer the global medical AI market by going public."

Legend Capital has invested in Lunit 4 times in 2018, 2019, and 2021; it is one of the company's main investors and has long supported its development. Closely following the deep integration of medical and health industry and technology, Legend Capital has built a solid portfolio in medical AI sector in recent years. In addition to Lunit, Legend Capital also invested in a number of other leading medical AI companies, such as Xbiome, an AI-based microbiome drug development company, StoneWise, an AI technology-driven innovative drug R&D platform company, Deepwise Healthcare, an AI medical imaging company, Deep Informatics++, an AI medical pathological diagnosis company, Genome Wisdom, a genomic big data company, and Ayshealth Technology, an AI medical chronic disease management system company.


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

Legend Capital’s Co-founded Company Innostellar Biotherapeutics: IRD Gene Therapy Product was Approved for Clinical Trial in China

HONG KONG, Apr 24, 2022 – (ACN Newswire) – Shanghai Langsheng Biotechnology Co., Ltd., a subsidiary of Legend Capital's co-founded company Innostellar Biotherapeutics, announced that the clinical trial application of its product LX101 injection for the treatment of patients with Rpe65 biallelic mutation-associated inherited retinal degenerations (IRD) was approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China.

Founded in 2020, Innostellar Biotherapeutics is a biopharmaceutical startup company focusing on gene therapy for innovative drug discovery, manufacture, and commercialization. Its core team consists of scientists and professionals from world-renowned institutions and biopharmaceutical companies. Since its establishment, Innostellar Biotherapeutics has been working closely with top-notch clinical scientists from hospitals around China and focusing on urgent needs of patients with genetic diseases and chronic diseases. The company has laid a firm foundation in the proof-of-concept development of a number of pipelines, process technology development, and quality system.

Inherited retinal degeneration (IRD) caused by the Rpe65 gene mutation is a typical rare disease that leads to blindness and has no effective treatment in the past. As a breakthrough technology, gene therapy provides the possibility to compensate or fix defective genes and fundamentally reinstate the normal gene functions. According to the early data of related products abroad, the treatment helped IRD patients in vision improvement and maintained therapeutic qualities for long term.

Dr. Fenghua WANG, CEO of Innostellar Biotherapeutics, said: "This is an important milestone for our company since its founding. LX101 has gradually demonstrated its therapeutic potential since we cooperated with the National Clinical Research Center for Eye Diseases in 2021 to carry out the first IIT clinical research of IRD gene therapy in China. We expect LX101 to benefit more patients with the therapeutic breakthroughs and maximal treatment effects. We also expect gene therapy to provide effective solutions for improving life of people with genetic and chronic diseases.

Innostellar Biotherapeutics was co-founded by Legend Capital and its founding team. As the earliest investor in the company, Legend Capital and the Innostellar team worked together on company structure organization design, strategy decision, and pipeline planning. With constant support to the development of Innostellar Biotherapeutics, Legend Capital has backed the company in its two rounds of financing. Legend Capital has long been committed to systemic investment in the field of innovative medicine. Adhering to the investment philosophy of "Global Vision, Chinese Perspective", Legend Capital is looking for truly internationally competitive technologies and teams to solve the unmet clinical needs; many of its portfolio companies have listed on A-share or H-share successfully, such as Kawin Technology (688687.SH), Innovent Biologics (01801.HK), Harbour BioMed (02142.HK), and Recbio Technology (02179.HK). At the same time, Legend Capital also have made investments in leading companies in the segment like Suzhou Ribo Life Science, Pegbio, Exegenesis Bio, Lynk Pharmaceuticals, and Glubio.



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

EC Healthcare expects sales volume to increase 35% Y-o-Y to no less than HK$3 billion for the Year

HONG KONG, Apr 21, 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 expected performance of the Group's sales volume for the Year ended 31 March 2022 (the "Year").

Benefiting from the diversified business portfolio and continuous improvement in operation efficiency, the Group's business grew steadily against market headwinds. During the 104 business days of compulsory closure, the Group was able to boost sales in the local market and in Mainland China through proactive client engagement via online channel and e-commerce campaigns; stimulate cross-selling among different medical disciplines; actively expand anti-epidemic related medical services and complete acquisitions of certain medical establishments to expand the Group's market share in healthcare market. The Group also expanded business via organic growth and M&A so as to further consolidate its leading position.

Despite the adverse economic conditions resulting from the fifth outbreak of COVID-19 with continuous travel restrictions, social distancing restrictions and the compulsory closure of all beauty parlors, the Group's business performance remains stable. The Group expects to record sales volume of no less than HK$3 billion for the Year, representing a no less than 35% Year-on-Year ("Y-o-Y") increase. The overall sales performance of the Group for the second half of Year is expected to record a no less than 15% Y-o-Y increase.

Benefiting from the strong demand on medical services and the Group's effective integration of medical assets, the sales volume of medical services offered by the Group is expected to record a no less than 55% Y-o-Y increase for the Year, despite the absence of medical tourists due to the lockdown. The sales volume of medical services in Hong Kong offered by the Group for the second half of Year is expected to record a no less than 25% Y-o-Y increase.

Mainland China authorities have been tightening the regulation of the medical aesthetic market. Leveraging the Group's leading position and strong brand strength in the medical aesthetic market, the Group was able to further consolidate the market. The Group's sales volume in Mainland China is expected to record a no less than 18% Y-o-Y increase for the Year, and a no less than 8% Y-o-Y increase for the second half of the Year.

Mr. Eddy Tang, Chairman, Executive Director and Chief Executive Officer of EC Healthcare said, "Looking ahead, the Group is optimistic about its business performance, which is expected to benefit from the government electronic consumption voucher scheme and the prevalence and increasing demand for anti-epidemic medical services. The Group will also benefit from the strong demand after the business reopening under the easing of COVID-19 prevention measures on 21 April 2022 by the Hong Kong Government. The Group will continue to fully support and cooperate with the Hong Kong Government's anti-epidemic policy, also implement new strategies to seize opportunities and expand the scope of healthcare services, continue to develop its businesses through organic growth and mergers & acquisitions, with particular focus on information technology, branding and service so as to increase the Group's market share."

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 is a constituent stock of the Hang Seng Composite Index and the MSCI Hong Kong Small Cap Index.

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 2019 and 2020

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


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