Scivita Medical Raises Nearly RMB0.4 Billion in Series A Funding Round and Strives to Build A World-leading Platform for Innovative Products in Endoscope and Related Fields

HONG KONG, Apr 26, 2021 – (ACN Newswire) – Scivita Medical Technology Co., Ltd. ("Scivita Medical") today announced that it has raised nearly RMB0.4 Billion in Series A funding round, which has become one of the highest financing projects in the field of endoscope in China in recent years. The investment was jointly led by GL Ventures and Lilly Asia Ventures, with contribution from Matrix Partners China, Medtronic, Chengwei Capital and Shanghai Innochip Investment. The successful completion of the Series A funding round reflects the recognition of Scivita Medical in the field of endoscope and the expectation of its future development from the capital market and industrial strategic partners. Scivita Medical will strive to build the world's leading platform for innovative products in endoscope and related fields.

Founded by Dr. ZHANG Yi and Dr. CHEN Dong, Scivita Medical is headquartered in Suzhou Industrial Park with R&D centers in Suzhou, China, and Tokyo, Japan, focusing on the image processing R&D and technology innovation of endoscope. Scivita Medical is a high-tech enterprise engaged in the field of optical diagnosis and treatment, multidimensional images development, high-performance materials research and precision manufacturing with minimally invasive medical treatment. Scivita Medical's product covers both flexible endoscopy and rigid endoscopy, and has unique advantages in the research and commercialization of all cutting-edge technologies in the field of medical endoscopes. It has ultra-high-definition visualization technology (such as 4K UHD visualization), 3D visualization technology, special light visualization technology (such as fluorescence visualization), ultra-fine endoscopic visualization technology, single-use technology, etc.

According to Frost & Sullivan, it is estimated that by 2024, the overall scale of the global endoscope devices market will grow to USD26.98 billion, and the Chinese endoscope market size will reach RMB42.3 billion, becoming one of the fastest growing medical device sub-industries in the world. With the popularization of minimally invasive diagnosis and treatment technology worldwide, the endoscope industry has also entered a stage of rapid development.

The endoscope industry has higher technical barriers, involving multi-disciplinary and multi-fields, which integrates medicine, optics, materials, precision machinery, electronic engineering, software development and other disciplines, and has more technical content as compared to traditional mechanical manufacturing. At present, the endoscope equipment market presents an oligopolistic situation, with international brands occupying a large market share by relying on first-mover advantages and mature technological advantages. Scivita Medical has successfully achieved breakthroughs in key areas such as optical imaging and image processing of endoscopes, breaking down the technological monopoly of international brand products.

Scivita Medical accurately grasps the clinical needs, and combines innovative technologies in multi-disciplinary fields to develop excellent Chinese products that are recognized by clinical experts worldwide.World's first 2D to 3D " 3D Visualization System" developed by Scivita Medical obtained NMPA certification and CE certification in July 2018, and became the first domestic 3D Visualization System approved by the U.S. FDA launched in the United States in September 2019. The "4K UHD Camera System" independently developed by Scivita Medical obtained NMPA certification in June 2019. It was launched in China as the first domestic 4K UHD camera system and obtained CE certification in July 2019. In August 2020, the "4K UHD Camera System" became the first Chinese 4K product that was certified by the U.S. FDA.

In addition, Scivita Medical has various single-use endoscopy devices with international competitiveness, many of which have entered the clinical, registration, or sales stages in China, the United States, Europe and other countries and regions, respectively. Given that endoscope industry has entered into the era of consumables, Scivita Medical will compete with international brands in the global market with its disruptive single-use technology and leading technological advantages.

Dr. ZHANG Yi, Co-founder of Scivita Medical, said: "The company's founding management team expresses sincere gratitude to the industry's top investment institutions and industry strategic partners for their recognition and support. In the next few years, endoscope products will fully realize the iteration from 'HD' to 'Ultra HD', and from 'reuse' to 'single-use'. Relying on the world's leading technology and strong sustainable R&D strength, and with the support from investment institutions and the continuous attention from our peers, Scivita Medical will form a platform with a comprehensive layout of innovative products in endoscope and related fields. It is committed to using domestic high-quality innovative products to replace and compete with international brand products, and striving to build a world-leading endoscope R&D brand that are rooted in China. The original intention of Scivita Medical is to solve the clinical pain points, making diagnosis and treatment safer and more effective, and help every patient and their family. Scivita Medical will make unremitting efforts for it. "

Michael Nuoqing YI, Co-Chief Investment Officer of Hillhouse and Head of Biomedicine and Medical Devices of GL ventures, said: "With the advancement of hierarchical diagnosis and treatment, the development of minimally invasive surgery and the aging population, the clinical demand for endoscope is rising rapidly and there is a huge room for domestic substitute. Scivita Medical takes a leading position at home and abroad. Its products are independently developed, which covers electronic and optical endoscopes. It has ultra-high-definition visualization technology, 3D visualization technology, special light visualization technology, ultra-fine endoscopic visualization technology and single-use technology. Hillhouse would like to have a long-term companionship with outstanding entrepreneurs like Dr. ZHANG Yi and Dr. CHEN Dong, who are innovative and with excellent management experience. Hillhouse also aims to help Scivita Medical continue to make efforts on R&D and innovation, so as to using domestic high-quality innovative products to replace international brand products, and actively participate in international competition and to benefit more patients."

Dr. CHEN Fei, Managing partner of Lilly Asia Ventures, said: "The technical barrier of endoscope industry is very high. We are very optimistic about the strong technical experience and innovative R&D capabilities of Scivita Medical team in terms of rigid and flexible endoscopes. The 4K UHD Camera System independently developed by Scivita Medical was the first one approved by China National Medical Products Administration and FDA, and it is highly recognized by clinical experts. Leverage on its distinctive product solutions and forward-looking industrial layout, we believe Scivita Medical can become the leader in technological innovation in the field of endoscopy in China and even in the world.

Dr. Eric YU, Partner of Matrix Partners China, said: "Endoscope has a high technical barrier, and the domestic market has long been monopolized by foreign giants. Scivita Medical has strong technical strength in the next generation of 3D, ultra HD and single-use endoscopes, which have all reached or surpassed foreign giants. We look forward to the company's further performance and clinical promotion of the products, which will bring clinical benefits to Chinese doctors and patients.

Dr. SHI Yonghui, Managing Director of the Corporate Development and Venture Capital Department (Greater China) of Medtronic, said: "It is Medtronic's global mission to relieve pain, restore health, and extend life for patients around the world. Medtronic China has always been committed to supporting the application of innovative medical technology in the local market. Since the establishment of the Venture Capital Fund and Innovation Accelerator after 2016, it has invested in and incubated more than 10 medical technology companies. By strategically investing in Scivita Medical, we hope that both parties could carry out multi-level strategic cooperation in the field of endoscope, and finally bring prime medical solutions to thousands of Chinese patients."

YAN Di, Vice president of Chengwei Capital, said: "The current localization rate in the endoscopy industry is less than 10%, and the demand for domestic substitution is strong. We are very pleased to see that Scivita Medical's endoscope products can break through the monopoly of foreign technology and solve the current handicap that local products cannot enter the high-end market. It fills the gap in the high-end endoscope market. It is a domestic brand with rigid and flexible endoscopy technology. We believe that Scivita Medical will become a leader in the field of endoscope and help further development of clinical medicine."

WANG Zhi, Partner of Shanghai Innochip Investment Management Co., Ltd., said: "We are very optimistic about the trend of ultra HD and single-use evolution of medical endoscope systems under the background of the miniaturization of CMOS image sensor chips. This trend is expected to break the monopoly situation occupied by European, American and Japanese companies, and provides Chinese companies with international vision and innovative technology capabilities, represented by Scivita Medical, with opportunities to surpass competitors within the same filed. I believe that Chinese companies will make innovative and high-quality endoscopes, which will benefit to more patients."

Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Starting its Industrial Investment in Biotech Companies, China Medical System (0867.HK) has Accelerated its Flywheel of Innovation

HONG KONG, Apr 26, 2021 – (ACN Newswire) – China Medical System Holdings Limited (0867.HK) ("CMS" or the "Company") has been active in the market this year. From the acquisition of Luqa to enter the medical aesthetic market early this year, the Company has attracted the attention of the market. Recently, it has announced the series of agreement signed with Trinomab Biotech Co., Ltd. ("Trinomab"). CMS will make equity investment in Trinomab, and establish a joint venture (the "Joint Venture") with Trinomab, contributed with cash and related products technologies by CMS and Trinomab respectively. The Joint Venture will entrust CMS with the clinical development and commercialization of all its products in Mainland China, Hong Kong, Macau and Taiwan, and Trinomab with the production of all its products. This collaboration marks the beginning of the CMS's industrial investment in cutting-edge biotech companies.

1. What has CMS seen in Trinomab?

The announcement has drawn even more attention from the market and people are curious about why Trinomab has successfully attracted CMS to make collaboration with it.

Established in 2015, Trinomab was jointly founded by the worldwide known expert Dr. Liao Huaxin and the entrepreneur Mr. Zheng Weihong. It is an innovative global biopharmaceutical company dedicated to the R&D of original natural fully human monoclonal antibodies and providing corresponding scientific services.

Trinomab has a new-generation, world-class, core patented technology platform highly regarded in the industry, the natural fully human monoclonal antibody R&D integrated technology platform HitmAb, which is dedicated to the development of original and efficient natural fully human monoclonal antibodies with independent intellectual property rights, suitable for the infectious diseases, autoimmune diseases and malignant tumors, etc.

As the fourth-generation antibody technology, "natural fully human monoclonal antibodies" refers to fully human antibodies derived from natural human B-cell clones or its gene expression. It is marked by high safety, having broad spectrum to foreign pathogens and strong affinity with pathogen targets, which can solve the problem of anti-drug antibody reaction in the clinical use of antibody drugs developed by traditional technologies.

Based on the HitmAb platform, Trinomab has developed more than 20 new native natural fully human monoclonal antibodies, including those against infectious diseases (e.g., rabies virus, tetanus toxin, cytomegalovirus, respiratory syncytial virus, varicella-zoster virus, novel coronavirus, etc.) and cancers among which, certain antibody products are in the process of rapid industrialization.

For example, the Fully Human Hla Antibody of Trinomab contributed to the Joint Venture is a natural fully human antibody against Staphylococcus Aureus (SA) infection, developed via the HitmAb platform, and is now in the preclinical stage. This product neutralizes the alpha-hemolysin (Hla) released by SA to avoid immune downregulation to B cells and to improve immune response. For severe and high-risk patients with SA colonization, compared with antibiotics which are commonly used clinically, Fully Human Hla Antibody of Trinomab has good safety and the preclinical studies have shown good Hla toxin neutralizing activity. It is expected to solve the problems of high mortality, resistance to treatment and side effects from SA infection.

With its HitmAb platform technology, Trinomab is constantly discovering new antibodies to advance the iteration of antibody drugs. In addition to keeping projects that are in line with its own strategy for self-development, Trinomab co-develops the rest with partners in the industry, which gives CMS (0867.HK) the opportunity to make this collaboration. From the announcement of CMS, we can find that other than to the product to be incorporated into the Joint Venture, the two sides will negotiate to promote the priority collaboration on other specific products, so we can expect more projects to be incorporated into the Joint Venture in the future.

In General, Trinomab owns a cutting-edge technology platform and can continue to promote the R&D and production of innovative drugs through the technology platform. While having great development potential, the strength of Trinomab's team is also quite impressive. So why did Trinomab still gladly accept the olive branch passed by CMS?

We believe that although Trinomab has considerable advantages in technology platform and drug R&D, promoting the clinical development and commercialization of new drugs is a major challenge of the channel resources for pharmaceutical companies, and at present, Trinomab does not have the advantages in the clinical and commercialization capabilities, and the accumulation of these capabilities and resources does not happen overnight. Therefore, CMS, which has rich domestic channel resources and strong commercialization ability, chooses to join hands with Trinomab to achieve a win-win combination, which opens up a fast track of commercialization for its subsequent products, and will play an important role in promoting the overall healthy development of Trinomab.

2. Taking this collaboration as a model, CMS will initiate the industrial investment in biotech companies and accelerate the "flywheel" of innovative R&D

From the above, we can see that CMS is precisely interested in the core technology platform of Trinomab. This kind of collaboration is not without a precedent. As early as in 2018-2019, Trinomab had reached cooperation agreements with Changchun BCHT Biotechnology Co. and Wuxi Biologics, etc. It can be seen that the Trinomab's capability of monoclonal antibody drug R&D based on its patented antibody R&D platform has been fully recognized and supported by well-known companies in the industry.

CMS has been working in the industry for many years and has been highly focused on the two core segments of the pharmaceutical industry chain – R&D and marking. CMS' promotion capability is undeniable, with an academic network covering about 57,000 hospitals and medical institutions nationwide and a professional academic promotion team of about 3,300 staffs. And the Company has created leading market positions for its many branded drugs. It also achieved fruitful results in the past through equity investments in overseas biotech companies or strategic cooperation with leading pharmaceutical companies for collaborative R&D. In the past three years, CMS has rapidly acquired more than 20 innovative products with unique and differentiated competitive advantages, such as Diazepam Nasal Spray, Tildrakizumab, Cyclosporine Eye Drops 0.09%, etc., demonstrating its strong innovation ability.

The collaboration with Trinomab is an active exploration of CMS' industrial investment in innovative biopharmaceutical companies. In the past, the Company has always been focusing on overseas markets, but with this collaboration, it also marks the official opening of CMS' industrial investment in domestic cutting-edge biotech companies.

So, what are the features and advantages of this investment?

a. Exploring a new model for industrial investment and building a unique competitive product innovation capability

Unlike simply building its own R&D team or purely introducing products for sale, CMS has been focusing more on the two core parts of the pharmaceutical industry chain, product competence and promotion capability in its past development. Base on this, in the past, to achieve effective integration of pharmaceutical companies and related resources, the Company's product pipeline was often more product-based, that is, to invest in a company for a certain product. It can be seen that so far CMS has invested in the equity of 8 overseas biotech companies and has made strategic cooperation with 6 leading overseas pharmaceutical companies.

CMS has developed strong product selection capability and is able to continuously find innovative drugs with market potential in this path. However, due to the emphasis on product selection, there is no direct relationship between new products, or between the companies the Company invested in, making it difficult to achieve a unified effect. Based on this, CMS further optimized its investment layout and began to focus on cutting-edge technology platforms to explore new products. The benefits of doing so include not only expanding the number and scope of selected products and achieving effective synergy within the platforms, but also forming an organic iteration of innovative products and achieving deep control of the industrial ecology.

From the collaboration with Trinomab, through equity investment + establishment of the joint venture, CMS has made early involvement in the domestic leading technology platform and innovative resources, and advanced its current pipeline of mainly mid- and late-stage products to the early stage, so as to rapidly enrich the innovation pipeline, and realize the expansion from the "point" of investing in innovative drugs as the core to the "extension" of investing in innovative technology platforms, in order to form an industrial investment model that can be rapidly duplicated in the future. Under this model, CMS will actively explore leading technology platforms for cooperation, so as to continuously strengthen its core competitiveness in innovative R&D and introduce cutting-edge innovation results, to build a unique product innovation capability.

b. Achieving complementary advantages and giving full play to CMS' clinical development and commercialization strengths

Behind the Company's industrial investment in domestic cutting-edge biotech companies lies not only its own financial or product selection strength, but also the strengths in innovative R&D and product commercialization.
From the perspective of clinical promotion ability, the completion of clinical enrollment of 220 patients for the blockbuster innovative drug Tildrakizumab in just around two months fully proves that CMS has the hard strength to quickly enroll patients and promote the clinical development with the synergy of its network and expert resources.

In addition, in terms of commercialization ability, the Company has been in the industry for more than 20 years, with its accumulated extensive industry resources, CMS is able to undertake the commercialization of innovative products and achieve rapid sales growth in its efficient operation system, and ultimately achieve an efficient cash flow cycle. CMS' commercialization ability is not purely based on its sales capability, as we can see the Company's selling expense ratio has been maintained at about 22% for years, which is relatively low compared with the industry level, it can be illustrated that CMS is not only very compliant in sales and promotion, but also attached great importance to differentiation advantages and market demands of products rather than blinded innovation, so as to build strengths in its products and brands and achieve win-win for its own economic benefit and the society.

c. Featured with light assets and high efficiency, CMS is aimed at creating VIC model 2.0

At present, there are mainly three models of the innovative drugs R&D in China, namely, big pharma model (independent R&D), biotech model (license in/out) and VIC model (active capital investment).

The big pharma model is often applied to large pharmaceutical companies, as it requires pharmaceutical companies to have sufficient profit-making products to support their investment in R&D. The model requires companies to focus more on the creation of R&D pipeline, as well as the cultivation of research and sales teams, which is apparently an asset-heavy business model.

The biotech model is an R&D model based on drug licensing and development. Under this model, pharmaceutical companies have the key R&D technologies, so they can generate revenue through "License out" clinical stage products, and diversify their R&D pipeline through "License in".

The VIC model is a combination of "VC (venture capital) + IP (intellectual property) + CRO (R&D outsourcing)", which is also known as the active new drug investment model. Under this model, the party that owns the IP receives venture capital, sets up a project-based company, and collaborates with a CRO in R&D. Similar to this model, CMS' industrial investment in innovative biotech companies is featured by being relatively asset-light, low-cost and highly efficient, which can save investment and achieve high cost-effectiveness. For example, with this model, CMS does not need to build its own labs, factories, etc. It acts more as an industry integrator and predator to explore innovative products and technology platforms, and uses its own advantages to integrate resources and continuously realize the incubation and commercialization of innovative products.

The difference between CMS' industrial investment model and VIC model is that the leading party of VIC model is the capital, whose understanding of the industry and contribution to product innovation is very limited. In contrast, CMS' industrial investment is a more advanced version of the VIC model, in which the leading party is CMS. With accumulated resources in the industry for a long time and deeper understanding of products, CMS is more capable of promoting the R&D and commercialization of innovative drugs, and is able to create a systematic, replicable and long-term competitive industrial investment model of innovative drugs. CMS will also build a highly competitive barrier for itself in the industry, and with the maturing of the platform ecology, its business will be expanded and the business potential will be unleashed continuously.

3. Conclusion

Based upon the current situation of China Medical System (0867.HK), its existing business has maintained a solid development momentum, with its FY20 annual report showing that the turnover up by 14.4% year-on-year to RMB 6.946 billion, net profit up by 30.7% to RMB 2.556 billion; bank balance, cash and realizable acceptance bills totaled RMB 3.114 billion as of December 31, 2020. The excellent performance shows that the Company has the necessary strength to support its industrial investment in innovative drugs and actively explore innovative platforms and projects in the industry.

At the same time, this model is being continuously optimized in order to make it replicable. With the emergence of the platform ecology of the Company, top advantageous resources in the industry will be absorbed, and the platform will eventually become an important birthplace of innovative products. And the value generated from continuous commercialization will in turn feed the entire ecology, and the flywheel of the Company's growth will also be fully accelerated.

From another perspective, CMS is not the "star" chased by capital, but more like a "producer" in the pharmaceutical innovation industry, who constantly incubates quality projects to meet the market demand and realize the continuous leap of its own value through the integration and optimization of industry resources.
Gelonghui Statement: The views in this article are from the original author and do not represent the views and position of Gelongghui. As a special reminder, investment decisions need to be based on independent thinking, the content of this article is for reference only, not as actual operational advice. Trade at your own risk.

Gelonghui Statement: The views in this article are from the original author and do not represent the views and position of Gelongghui. As a special reminder, investment decisions need to be based on independent thinking, the content of this article is for reference only, not as actual operational advice. Trade at your own risk.

By Gelonghui

Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Hua Medicine Announces Acceptance of a New Drug Application for Dorzagliatin in China – First Glucokinase Activator (GKA) Globally

SHANGHAI, CHINA, Apr 23, 2021 – (ACN Newswire) – Hua Medicine (the "Company", Stock Code: 2552.HK), today announced that the New Drug Application (NDA) for dorzagliatin for the treatment of Type 2 Diabetes (T2D) was accepted by the China National Medical Products Administration (NMPA). Dorzagliatin is the first glucokinase activator (GKA) to submit a NDA for the treatment of diabetes, and has the potential to become the first first-in-class drug to be launched in China.

Relying on Hua Medicine's original scientific concept of "repair the sensor, restore homeostasis, and treat the underlying cause of diabetes," the Company has always focused on addressing unmet medical needs since its establishment. The Company is committed to developing breakthrough products with innovative concepts, and advancing and establishing clinical practice and treatment standards globally. Dorzagliatin is the world's first new GKA diabetes drug for which a NDA has been submitted, with a new mechanism of action, new targets, new structures, new formulations and new curative effects. Dorzagliatin is the world's first new oral treatment for diabetes launched by a Chinese biotechnology company. Its mechanism of action directly targets the underlying cause of T2D. By repairing the damaged glucokinase sensor function in diabetic patients, dorzagliatin can significantly improve the beta-cell function and reduce insulin resistance in patients with T2D, effectively control the progress of T2D, and has therapeutic prospects in patients with diabetic nephropathy.

Today, diabetes is a major public health problem. According to a survey published by the British Medical Journal (BMJ) in 2020, based on the diagnostic criteria of the American Diabetes Association (ADA), the total number of diabetic patients in China is approximately 130 million. Compared with the large number of patients, the diagnosis rate of T2D in China is only 43.3%, and the treatment rate is only 49.0%. In recent years, China has emphasized the importance of prevention and treatment of diabetes. The "Healthy China Action (2019-2030)" has clearly defined the goal. By 2030, the diagnosis rate of diabetes among citizens aged 18 and above will reach above 60%, and the standardized management rate will reach above 70%. The diabetes treatment rate, control rate and complication screening rate is expected to continue to increase.

In the past ten years, the global diabetes market has grown rapidly. In 2019, the global expenditures spent on diabetes was approximately 760 billion USD, and the spending in China alone is approximately 109 billion USD. The market potential is exceptionally large. With the successive launches of the China Type 2 Diabetes Prevention and Treatment Guide (2020 Edition) by the Chinese Diabetes Society and the ADA's Diabetes Diagnosis and Treatment Pathway (2021 Edition), the concept of "glucose homeostasis" has become the standard for treatment of diabetes. The development of glucokinase activator for "glucose homeostasis" as the core has also attracted attention.

In December 2020, Hua Medicine announced that it has successfully completed two Phase III registration trials of dorzagliatin, of which SEED (HMM0301) is a monotherapy trial in drug naive T2D patients, and DAWN (HMM0302) is a trial of dorzagliatin combined with metformin in T2D patients who are metformin-tolerant. The two trials demonstrated fast onset, potent, and sustained HbA1c reduction, and significantly reduced 2H-PPG. Dorzagliatin also demonstrated good safety and tolerability, improved beta-cell function and reduced insulin resistance. Two Phase I clinical studies conducted in the first half of 2020 showed that the combination of dorzagliatin with sitagliptin (a DPP-4 inhibitor) and empagliflozin (a SGLT-2 inhibitor) showed a significant synergistic effect in blood glucose control, indicating that dorzagliatin has broad application potential in T2D patients with different glucose control needs at different disease stages. Another Phase I study conducted in patients with end-stage renal impairment showed that dozagliflozin monotherapy can provide treatment opportunities for diabetic nephropathy (DKD), which accounts for about 20%-40% of the T2D population. It has potential to become a hypoglycemic agent for diabetic nephropathy without dosage adjustment.

In the process of preparing for the commercialization of dorzagliatin, in August 2020, Hua Medicine formed a strategic cooperation agreement in China with the global pharmaceutical giant and leader in Chinese diabetes treatment, Bayer. Hua Medicine's innovative capabilities and Bayer's leading advantage in the field of diabetes management in China will enable this world's first innovative drug to benefit Chinese diabetic patients as soon as possible. In September 2020, the Company received the "Drug Manufacturing Permit" for dorzagliatin from the Shanghai Drug Administration, completing the core work of preparation for commercial production.

Dr. Li Chen, founder and CEO of Hua Medicine, said: "We are very pleased that dorzagliatin's NDA application has been accepted by the NMPA. This is a major milestone for Hua Medicine. On the path to first-in-class, first-in-China, Hua Medicine has always strived to stand at the forefront of reform and pharmaceutical innovation, and contribute to the development of China's pharmaceutical industry and its people's health. Diabetes chronic disease management is a major work to protect national health, For the past 10 years Hua Medicine has committed to "China Leading Pharmaceutical Innovation", and actively explored the development and review and approval of China's first innovative drug with the Drug Evaluation Center, and achieved significant achievements in the field of innovative drug development with the spirit of "a sword in ten years." We have achieved breakthrough and developed this global innovative drug, allowing China to join the world in first-in-class drug development. We are very proud of this achievement and we look forward to working with our partners to jointly promote dorzagliatin in China."

About Dorzagliatin
Dorzagliatin is an investigational first-in-class, dual-acting glucokinase activator, designed to control the progressive, degenerative nature of diabetes by restoring glucose homeostasis in patients with Type 2 diabetes. By addressing the defect of the glucose sensor function of glucokinase, dorzagliatin has the potential to restore the impaired glucose homeostasis state of patients with Type 2 diabetes and serve as a first-line standard-of-care therapy for the treatment of the disease, or as a cornerstone therapy when taken in combination with currently approved anti-diabetes drugs. Two Phase III registration trials for dorzagliatin have been completed in China. The Company has obtained the "Drug Manufacturing Permit" of dorzagliatin issued by the Shanghai Municipal Drug Administrative Bureau, and has submitted the NDA for dorzagliatin to the National Medical Products Administration, so as to realize the "First in Global, Start from China" mission objective for the benefit of diabetic patients worldwide.

About Hua Medicine
Hua Medicine is a leading, innovative biotechnology company in China focused on developing novel therapies for diseases with unmet medical needs. Founded by an experienced group of entrepreneurs and international investment firms, Hua Medicine advanced a first-in-class oral drug for the treatment of T2DM into NDA stage and it has successfully completed two Phase III registration trials in China for dorzagliatin. The Company has initiated product life-cycle management studies of this novel diabetes therapy and advanced its use in personalized diabetes care. Hua Medicine is working closely with disease experts and regulatory agencies in China and across the world to advance diabetes care solutions for patients worldwide.

Forward-looking Statement
This article contains the statements regarding the future expectation, plan and prospects for Hua Medicine and the investigational product. The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect as a result of various risks, uncertainties or other legal requirements.

For more information
Hua Medicine
Website: www.huamedicine.com
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Email: ir@huamedicine.com
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Email: pr@huamedicine.com

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Avance Clinical Invited to Present “Decentralized Trials – No Going Back” for Oracle Health Sciences Connect

ADELAIDE, AU, Apr 22, 2021 – (ACN Newswire) – The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award winner Avance Clinical has been invited to present on the future of decentralized clinical trials at the Oracle Health Sciences Connect conference.

Title: Decentralized Trials – No Going Back
Link: https://www.oracle.com/in/industries/life-sciences/health-sciences-connect/sessions/
Time: 23 April, 2021 – 3.05 pm (Australia/Adelaide ACST).

Avance Clinical CEO Yvonne Lungershausen, shared the company's insights on the future of Decentralized Clinical Trials (DCTs) and the technology and patient factors that will determine success. Avance Clinical uses the full range of eClincial technologies to support clients wanting DCTs or a site-based approach while still leveraging advance technology including ePro, eSource and eConsent.

"DCTs are fast becoming the new norm and this is an incredible opportunity for the drug development sector as well as the diverse and remote patient populations that will now have access to clinical trials," said Lungershausen.

"The pandemic has been the catalyst in speeding up the adoption of decentralised clinical trial methods, as people stopped participating in trials and visiting clinics. Trials have stalled putting lives and significant investments at risk."

Yvonne Lungershausen said there are considerable benefits to DCT's including:

– Reduce the scheduling and travel burden on patients – providing care from the comfort of the patient's home.
– Connecting patients to trials on a global scale – patients that were otherwise inaccessible under more traditional trial protocols are now available.

And she said challenges include:

– Missed human-to-human contact and continuity of patient care
– Investigational product distribution to more remote destinations
– Oversight of compliance and study procedures in the patient's home

The presentation also covers advances in artificial intelligence (AI), machine learning, cloud computing and blood self-collection devices which are all revolutionising the decentralized clinical trial process.

– Wearable devices are demonstrating enormous potential whether worn as a wrist strap or an adhesive patch on the body. AI-embedded capabilities allow these devices to measure a patient's heart rate or metabolism remotely. Linked to the cloud through secure networks, clinicians can receive and analyse the data real-time.
– Video calling and electronic reminders, can improve patient compliance in trials – prompting participants to take their medication at the right time or to record in their electronic diary development.
– Technologies are developing to allow patient-centric sampling (self-collection of specimens) with devices that require the use of a lancet and finger prick whereas others do not, making clinical trials even more convenient.

Take the Quiz – Test your Knowledge about Australian Clinical Trials here:
https://www.surveymonkey.com/r/Australian-Clinical-Trials

About Avance Clinical

Australia's Avance Clinical has more than 20-years of experience and is now one of Australia's leading Contract Research Organizations. Avance Clinical facilitates quality drug development by aligning people, skills, and expertise in the pursuit of drug development for a healthier world.

Avance Clinical is committed to providing high-quality clinical research services with its highly experienced team. The collective pool of knowledge and experience at Avance Clinical continually grows through the careful selection of experts who also demonstrate passion in their chosen field. Avance Clinical offers high-quality services in an established clinical trial ecosystem, that includes world-class Investigators and Sites able to access specialized patient groups. Learn more at http://www.avancecro.com.

Other benefits include:
1. The Government R&D grant means up to 43.5% rebate on clinical trial spend
2. Telehealth pivot during COVID-19 pandemic – speed and continuity
3. Site Initiation Visit (SIV) and Study Start achieved in 5-6 weeks
4. No IND required for clinical trials
5. Full GMP material is not mandated for Phase I clinical trials
6. Established clinical trial environment with world-class Investigators and sites
7. Established healthy subject databases and specialized patient populations
8. Five independent Phase 1 facilities across Australia including hospital-based units for critical care
9. Major hospitals with world-class infrastructures and dedicated Clinical Trial Units with a long track-record in FDA compliant research
10. Seasonal studies: Northern hemisphere Sponsors can conduct their studies year-round by taking advantage of Australia's counter-flu and allergy seasons

Media Contact:
media@avancecro.com

Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Sanofi Renews Partnership with Cielo to Strengthen its Talent Acquisition Strategy in Asia

SINGAPORE, Apr 19, 2021 – (ACN Newswire) – Cielo, the world's leading Recruitment Process Outsourcing (RPO) provider, has renewed its partnership with Sanofi, a global biopharmaceutical company, to help them hire the best talent in Asia.

Cielo has been working with Sanofi in Asia since 2018 to provide cutting-edge talent sourcing and recruiting strategies in the region, helping Sanofi transform its approach to talent acquisition. The partnership covers key Asian markets of Singapore, Malaysia, Indonesia, Thailand, Philippines, Hong Kong, Taiwan, Vietnam and Cambodia. Cielo is also Sanofi's RPO partner in the US and Latin America – a testament to our strategic approach and global offering.

"Life sciences leaders such as Sanofi are rapidly transforming their talent acquisition strategies. We are excited to renew our strategic partnership with Sanofi and continue to help them deliver on their commitment in offering innovative healthcare solutions to patients by providing in-demand talent in Asia," said Seb O'Connell, President of EMEA and APAC, Cielo. "We believe that the right talent is a key enabler for any organisation to unlock its true potential and achieve its business goals, and we are proud to support Sanofi."

Speaking about the partnership, Andrea Paola Poggio, Head of Talent for Sanofi Asia said, "At Sanofi, our employees are key to our success, and we are always looking for talent who are willing to join us to drive our ambition in empowering lives of our patients. As one of the leading providers of RPO for life sciences and being agile and flexible to deliver at a fast speed, Cielo has enabled Sanofi to benefit from scalable talent acquisition solutions, and reduced time-to-hire; key elements to build a diverse & talented workforce with targeted capabilities for a rapidly changing context."

"At Cielo, our teams are driven by an overarching purpose of providing superior experiences and outcomes to our clients and this relentless drive to challenge ourselves to do better fosters a strong sense of trust and mutual respect with our clients. Sanofi's renewed partnership is a validation of this trust and a testament to our Life Sciences domain expertise, commitment and value that we bring to customers," stated Kumar Bhaya, Vice President, Client Solutions APAC, Cielo Talent.

About Cielo

Cielo is the world's leading strategic Recruitment Process Outsourcing (RPO) partner and industry innovator delivering RPO, Total Talent Acquisition, Consulting and Executive Search services in 100+ countries. They design comprehensive, people-centric solutions and leverage Cielo TalentCloud – an award-winning technology suite featuring CRM, AI, automation and analytics capabilities – to help clients find, attract and hire the specific talent to move their businesses forward. To learn more, visit cielotalent.com.

About Sanofi

Sanofi is dedicated to supporting people through their health challenges. They are a global biopharmaceutical company focused on human health. They prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. They stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. To learn more, visit www.sanofi.com

Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Olympus Opens New Global HQ for Therapeutic Solutions Division and U.S. Medical Business

TOKYO, Apr 8, 2021 – (ACN Newswire) – Olympus Corporation ("Olympus" – Director, Representative Executive Officer, President and CEO: Yasuo Takeuchi) announced today the opening of a new facility in Westborough, MA, to serve as the global headquarters for its Therapeutic Solutions Division (TSD) and its medical business in the United States.

Olympus opens global headquarters for Therapeutic Solutions and Medical Business in Westborough, MA, U.S.

New facility features Olympus Continuum Training and Education Center and Olympus OR Innovation Center Showroom

Global Therapeutic Solutions headquarters opening in the U.S. is part of Transform Olympus initiative

Olympus has identified TSD as a strategic focus for growth and shifted its global head of TSD from Tokyo to the U.S. to have better access to a key medical industry cluster and generate growth through stronger business opportunities. Since the Transform Olympus initiatives were unveiled in 2019, many U.S.-based executives have been leading TSD growth; Olympus has dramatically expanded the business with acquisitions, as well as through organic growth.

The new 150,000-square-foot facility in Westborough will accommodate both the U.S. TSD employees and those formerly reporting to Image Stream Medical (ISM) facility located in Littleton, MA, with the exception of the manufacturing employees who will remain in Littleton. The facility will serve as one of several R&D hubs for Olympus, while enabling coordinated and agile management processes to support a global medical technology enterprise. At Olympus Westborough, the Olympus Continuum Training and Education Center will offer hands-on learning opportunities led by top medical experts using advanced medical equipment in a wetlab setting, both in person and virtually via the MedPresence telecollaboration platform. For interactions with customers and prospects, the Olympus OR Innovation Center showroom, also outfitted with the MedPresence platform, will provide an immersive environment for in-person or virtual integrated OR demonstrations.

The new Westborough facility will also provide enhanced opportunities for Olympus to build relationships with potential future employees. Olympus will facilitate relationships with potential job candidates, as well as continued partnerships with universities, colleges, and technical schools in the greater Boston area to bring world-class skills and capabilities to the company.

Nacho Abia, Chief Operating Officer of Olympus Corporation, said, "The U.S. market continues to be the largest in the world because of growing demand for minimally invasive treatment and surgery and the need for remote collaboration under COVID-19, so it's natural that we decided to combine all functions in Massachusetts in one place to facilitate agility and collaboration. This agile and globally-connected way of business will enhance our overall business competitiveness."

About Olympus' Medical business

As a leading medical technology company, our Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce overall costs, and enhance the quality of life for patients and their safety. Olympus' Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments for endoscopic and therapeutic applications. For more information, visit www.olympus-global.com.

For questions or additional information, please contact:

United States
Jennifer Bannan
+1 412-403-8742
jennifer.bannan@olympus.com

Europe, Middle East and Africa
Matthias Gengenbach
+49 15142369420
matthias.gengenbach@olympus-europa.com

Japan and APAC
Yuka Horimoto
+81-90-2490-1071
yuka.horimoto@olympus.com

Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Agilex Biolabs Buys Leading Biolab TetraQ as Part of APAC Expansion Plans

Adelaide/Brisbane, Australia, Apr 7, 2021 – (ACN Newswire) – Agilex Biolabs, Australia's largest and most technologically advanced specialist bioanalytical laboratory for clinical trials, today announced the purchase of leading biolab TetraQ, based out of the University of Queensland.

Agilex Biolabs CEO Jason Valentine said the Board and senior management at Agilex Biolabs were extremely pleased with the purchase of such a high-calibre bioanalytics company.

"TetraQ complements the Agilex Biolabs work in Australia and APAC with its expert staff and years of experience in regulated bioanalytical services," he said.

"The TetraQ purchase is part of our regional expansion plans."

"Agilex Biolabs is already the largest and most technologically advanced biolabs in Australia, and the TetraQ addition to the business will further expand support for biotech clients running trials in Australia."

"We are also looking forward to introducing our clients to the well-established TetraQ toxicology capabilities for their discovery and pre-clinical work in Australia, which can also attract the 43.5% tax rebate."

"The clinical trials bioanalytics sector is one of the fastest-growing services globally with Australia and APAC a preferred location for conducting trials – especially since the COVID-19 pandemic."

TetraQ Director Dr Peter Tapley said he was very pleased that TetraQ was now an Agilex Biolabs company.

"They are the leader in the sector with 24 years of experience, and offer our clients a significantly expanded range of services and technologies," he said.

"Agilex Biolabs is known globally for its comprehensive services, specialist scientists, and the very latest technology. So this is the ideal next step for TetraQ and its staff and clients."

"I am pleased to be working alongside Agilex Biolabs' CEO Jason Valentine as we expand our offering and leverage the synergies that make our two companies leaders in the sector."

Agilex Biolabs specialises in bioanalysis of small molecules and biologics for PK, immunogenicity, biomarkers and immunological pharmacodynamics assessments utilising LC-MS/MS, immunoassay (Mesoscale, Gyrolab, Luminex) and flow cytometry (BD FACSymphony A3, 20 colour cell analyser).

Agilex also offers pharmacodynamics services that include immunobiology services using the latest state-of-the-art technology to support immunology, cell biology and mode of action assays, including:
– Immunophenotyping
– Receptor occupancy
– Cytokine release assays (whole blood or PBMC stimulation assays) and cytokine/biomarker profiling
– PBMC assays and cellular mechanism of action assays (eg: ADCC)

Agilex Biolabs has more than 100 staff which includes 75 dedicated laboratory staff and supports clinical research for biotech clients from US, Europe and APAC.

The company has recently launched the GALEXI(TM) client portal, and has taken delivery of two more Sciex API 6500+(TM) LC-MS/MS systems. Key certifications include OECD GLP Recognition with NATA (Australian Government OECD GLP Compliance monitoring authority) and ISO 17025 Accreditation for global recognition.

About Agilex Biolabs https://www.agilexbiolabs.com/

Agilex Biolabs, Australia's leading bioanalytical laboratory, has more than 20 years' experience in performing regulated bioanalysis, including quality method development, method validation and sample analysis services. We have successfully supported hundreds of preclinical and clinical trials around the world where customers choose Australia for the streamlined regulatory process and access to the world's most attractive R&D rebate of more than 40% on clinical trial work conducted in Australia.

We offer services for both small molecules and biologics for PK, immunogenicity (PD) and biomarker bioanalysis utilising the two platforms of LC-MS/MS and Immunoassay.

About TetraQ www.tetraq.com.au

TetraQ is a Brisbane-based provider of bioanalytical and rodent toxicology and pharmacokinetics services for new drug and vaccine products. Our facility has NATA recognition for compliance with the OECD Principles of Good Laboratory Practice (GLP).

Our bioanalytical facility is located at the Royal Brisbane and Women's Hospital, and our in-life studies are run in a custom unit at the St Lucia campus of The University of Queensland. These two arms of TetraQ offer co-ordinated support for clients bringing pharmaceutical products to market.

TetraQ's bioanalytical facility determines small molecule and protein concentrations in matrices including plasma, serum, urine and tissue homogenates. We can develop and validate methods to support pharmacokinetic (PK) sample analysis for both pre-clinical and clinical studies.

We also offer pharmacodynamic (PD) analysis of biomarkers based on commercial ELISA kits or Meso Scale Discovery multiplex technology.

Agilex Biolabs Media Contact:
Kate Newton
Media@AgilexBiolabs.com

Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Avantor Named Best Bioprocessing Supplier in Single-Use Manufacturing at Asia-Pacific Bioprocessing Excellence Awards 2021

Singapore, Apr 6, 2021 – (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, was named Best Bioprocessing Supplier in Single-Use Manufacturing at the Asia-Pacific Bioprocessing Excellence Awards 2021 held recently.

The award recognizes Avantor's contributions in facilitating biomanufacturing excellence with enhanced speed, reduced cost and superior quality, and reaffirms its critical role in biomanufacturing of biologics. Avantor was also awarded Best Company in Bioprocessing Excellence for Single-use Solutions at Biologics Manufacturing Korea 2020.

Narayana Rao Rapolu, Vice President, Biopharma Asia Middle East & Africa for the Company said, "Avantor has long been an open-architecture, single-use provider, offering complete design, manufacturing and logistics to support every stage of the biomanufacturing process. Our work in biopharma has never been more important. From the small-scale bench, to pilot plant and full commercial manufacturing, we enable our customers to reach the market with new treatments for patients – faster, safer and smarter."

Significance of single-use technologies:
– Robust and scalable, enabling transformative treatments to reach more patients globally.
– According to BioPharm International, a publication that integrates the science and business of biopharmaceuticals, single-use technologies are used in nearly 85% of pre-commercial manufacturing of biologics.
– Applications of biologics include monoclonal antibodies (mAbs) used in therapeutic solutions for immune-oncology and immunotherapy and cell and gene therapies which help to treat challenging illnesses, such as some cancers and genetic diseases.

For more information about Avantor's single-use solutions for biopharma manufacturing, watch this video: https://youtu.be/mfjZEfO_RVM.

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. One of our greatest strengths comes from having a global infrastructure that is strategically located to support the needs of our customers. 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.

For information, visit avantorsciences.com and find us on:
LinkedIn: https://www.linkedin.com/company/avantorinc/
Twitter: https://twitter.com/Avantor_News
Facebook: https://www.facebook.com/Avantorinc/

About Asia-Pacific Bioprocessing Excellence Award 2021 (ABEA)

The Asia-Pacific Bioprocessing Excellence Awards seeks to give recognition to exceptional bioprocessing experts, organizations and technologies that facilitate biomanufacturing excellence with enhanced speed, reduced cost, and superior quality. 2021 marks the fifth year of ABEA, which was first established in 2017 and backed by industry requests.

AMEA Media Contact
Christina Koh
Director – Communications, AMEA
Avantor
Phone: +65 9170 0169
Email: Christina.Koh@avantorsciences.com

Source: Avantor and Financial News

Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com

China Medical System (0867.HK): Accelerating Development and Stepping to a New Height Driven by Innovation

HONG KONG, Apr 2, 2021 – (ACN Newswire) – As the earning season approaches, once again listed pharmaceutical companies are attracting the attention of the public. Recently, China Medical System Holdings Limited ("CMS" or the "Company") has released its annual results, with both revenue and profit higher than market expectations. According to its 2020 annual results, turnover is up by 14.4% to RMB6.946 billion; net profit up by 30.7% to RMB2.556 billion; basic earnings per share up to RMB1.024, with a proposed final dividend of RMB0.20 per share.

In the past, influenced by expectations of the effects of China's centralized procurement policy and the Company's product transition, CMS's valuation in the capital market was once under pressure, but with the Company's strategic transformation from a CSO to an innovative pharmaceutical company, coupled with its own solid business growth, its share price has gained a significant increase in the past few months, but is still relatively low in the capital market. The Company's current dynamic P/E ratio is only about 13x, with a market value of HK$ 39.4 billion. However, market values of innovative pharmaceutical companies without profits such as BeiGene and Junshi Biosciences have well exceeded HK$50 billion or even HK$100 billion in HKEX. This shows that the share price of the Company does not reflect its real value after its transformation. It's worth digging deeper into the innovative pipeline of the Company to take a look at its long-term growth potential and the inevitability of valuation increase.

1. Firm in transition, the Company is using S&D model to drive its innovative development

Looking back at its history, the Company began introducing exclusive or original drugs from multinational pharmaceutical companies through rights control or exclusive sales agreement early in 2010, creating a unique "CMS Model". Under this model, the Company has accumulated a strong network of overseas upstream resources and good reputation, and formed a strong product evaluation system. However, considering the potential impacts of the Company's existing products, which are all original or exclusive drugs with expired patents or no patents, and China's centralized procurement policy on performance growth, CMS began to actively adjust its business strategy and transformed into an innovative pharmaceutical company at full speed since the end of 2017.

The true meaning of rebirth lies in the courage to kill your past self. As a CSO leader, CMS takes advantage of its competences in deployment of innovative drugs in its gradual transformation, and has formed a development path that is different from most other biotechs and innovative pharmaceutical companies.

First of all, the Company's original business has maintained a steady growth over the years and generated strong cash flow, which has given itself the confidence to further expand its business, while its long-term accumulated resources and networks overseas have also given it more opportunities to quickly deploy overseas innovative resources. For various reasons, CMS has transformed itself into a venture investor in overseas pharmaceutical companies and actively promoted its presence in the innovative drug field. Through equity investment in overseas biotech companies and strategic cooperation, the Company has rapidly formed a R&D pipeline covering a number of innovative products in just around three years.

The following are some highlights of the Company's deployment of innovative drugs:

a) Excellent BD capability and mature system help CMS enter into the innovative drug field quickly
Compared with the R&D (research & development) path, which is common in pharmaceutical companies, the Company adopts an S&D (search & development) model, i.e., gradually enriching its innovative pipeline through global search for quality innovative drug projects and early R&D participation. This model particularly tests the Company's ability to screen and evaluate products.

Looking back at the Company's history, as a leading CSO company, CMS' unique vision and product selection ability has been fully verified by the introduction of a series of blockbuster original products with clear efficacy, sufficient clinical evidence and competitive differentiation in the past. The Company has also achieved excellent performance with these quality products for a long time. And with the transition, this long-tested ability is continuing to help its selection of innovative products.

In fact, as the fastest way to deploy innovative drugs, the Company has also polished a complete and mature BD system. From top-level design, introduction strategy, clinical development in China, to the match with existing products and sales teams, and even product commercialization, CMS has built a thorough mechanism and cultural foundation that are suitable for the growth and commercialization of innovative drugs.

In the past three years, CMS has quickly acquired more than 20 innovative products with unique competitive advantages, including Diazepam Nasal Spray, Tildrakizumab, Cyclosporine Eye Drops 0.09%, etc., and achieved great results, which fully validates its strong and sustainable BD capability and forms a competitive moat, providing CMS with opportunities to achieve a higher premium valuation.

b) Avoiding competition in overpopular products, CMS tries to find "diamond in the rough" with a differentiated product selection strategy
In fact, according to its footprint in innovative product deployment, due to its innate promotion-driven genes, the Company is more capable of exploring new products from the perspective of marketing and promotion. It does not blindly pile up popular products, but takes cost effectiveness, market potential and whether meeting unmet market needs as the benchmarks, and takes a long-term view of the commercial prospects and the localization value of the innovative pipeline.

In recent years, there have been pharmaceutical companies who spend a lot of money to buy some seemingly sexy, but very competitive drugs. Taking PD-1 for example, its R&D costs hundreds of millions of dollars, but the competition between pharmaceutical companies is fierce. With the price reduction caused by national centralized procurement, it is clear there has been serious involution in this field. This is the kind of fields that CMS has been intentionally avoiding in its selection process. The innovative drugs that the Company has acquired all have differentiated competitive edges and considerable market potential. Taking the products mentioned above as examples, Diazepam Nasal Spray is an innovative drug targeting acute repetitive seizures that is convenient to use outside the medical setting with a very rapid onset of action; Tildrakizumab is a novel monoclonal antibody targeting IL-23 with high cost-effectiveness for the treatment of psoriasis; Cyclosporine Eye Drops 0.09% is a novel, preservative-free, clear ophthalmic solution using a globally patented nanotechnology for the treatment of dry eye.

In addition, let's take the Methotrexate Pre-filled Syringe/Pen introduced by the Company last year as an example to see the characteristics of its deployment of innovative drugs. Methotrexate is an API with a long history, and is referred to in many articles as one of the ten landmark drugs in human history, while many biological agents under development now are also clinically compared with methotrexate injections for equivalence. But even so, as an inexpensive and efficacious old drug, there are severe gastrointestinal side effects in oral preparations resulting in decreased patient compliance, and there is currently neither pre-filled methotrexate injection products approved, nor methotrexate injectables for the treatment of RA on Chinese market. It is based on this typical unmet clinical need that the Company chose to introduce this drug to fill the market gap.

c) Rapid clinical advancement capability with significant organizational and institutional strengths
Although CMS does not have a CMO with a strong background for the time being, its medical team and clinical capabilities should not be underestimated. In terms of clinical works, CMS plays its resource advantages in clinical development by strictly controlling the core clinical processes such as clinical protocol formulation, patient enrollment and quality control, and cooperates with CROs to jointly promote clinical projects in China.

Most of CMS's innovative drugs are in late clinical stages or already marketed in the U.S. or Europe. So, in the design of clinical trials in China, the Company's medical team needs to refer to the clinical protocols of its overseas partners, and then make adjustments and innovations to make the protocols suitable for the Chinese market. Currently, all of the registration trials are progressing smoothly. In addition, with its 3,000+ professional promotion staff and a wide range of hospital and physician resources, CMS has the solid strength needed to quickly enroll clinical patients and promote the clinical development of products. For example, on March 11, the Company announced that it had completed enrollment of all 220 subjects required in the registration bridging trial of its blockbuster innovative drug Tildrakizumab in China in just 2.5 months.

d) Strong academic promotion capability helps commercialization of innovative drugs
With more than two decades of successful experience in academic promotion, the Company has accumulated extensive industrial and network resources to carry out the commercialization of innovative products in the future. Its well-established system has also been providing great support to the commercialization of innovative products whether in terms of compliance management, digitalization, or team management and training.

The Company has repeatedly mentioned in financial reports its efforts in refining management and compliant marketing, such as optimizing organizational structure, strengthening application of digital tools, enhancing compliance training, etc. Meanwhile, the Company has made continuous efforts on digital promotion for many years, thanks to which, its selling expense ratio has remained at around 22% for years, which is at a relatively low level in the industry. In addition, the Company has a professional team and organizational system. By the end of 2020, the Company's academic promotion system has covered about 57,000 hospitals and medical institutions nationwide, with 3,300 professional academic promotion staff. As a company noted for sales and promotion ability, its strong professional academic promotion capability and compliant and efficient system will bring broad market prospects for its innovative products once commercialized.

2. Great market potential for the innovative pipeline and great room for growth for the Company

According to the Company's financial report, by the end of 2020, the Company has more than 20 innovative products with relatively high innovation level, high market potential and competitive differentiation advantages, among which, 9 products have been approved for marketing in the U.S. and/or Europe, and 3 products are in the registration clinical trials in China.

According to the R&D progress of its products, the Company is expected to have a number of blockbuster products marketed in succession, which may provide new growth points for the Company.

Next, let's take a look at some of the blockbuster products that are expected to be marketed soon as well as their market potential:

a) Diazepam Nasal Spray
The product is indicated for acute repetitive seizures in patients six years of age and older, and is expected to be marketed this year. It has received marketing approval from the U.S. FDA, and the Company has completed dosing and blood sample collection of all subjects in the registration trial in China in 2020, and is expected to submit an NDA in the near future.

According to Chinese epidemiological data, it is estimated that there are approximately 6 million active epilepsy patients in China, with an additional 400,000 new patients each year. According to the 2002 WHO Demonstration Project, only 37% of Chinese patients with active epilepsy received medication with a treatment gap of 63%, which means only about 2 million patients with active epilepsy received regular treatment. Of the 2 million patients, 20-30% are out of effective control, with an average of nearly 70 recurrent seizures per year. Therefore, it can be estimated that the product's target patient population is at least 400,000, assuming an average of 30 seizures per person per year, and a selling price of RMB300 per spray (with reference to the selling price of about US$300 per spray in the U.S.), the market potential of the product will exceed RMB3 billion per year.

b) Cyclosporine Eye Drops 0.09%
Expected to be launched next year, Cyclosporine Eye Drops 0.09% is used to increase tear production in patients with dry eye, and has a global nanotechnology patent. The Company received the clinical trial notice of the product from NMPA of China in June 2020 and completed the first subject dosing in December, expecting the product to be launched in 2022.

Data shows that the incidence of dry eye in China is about 21-30%, while epidemiological data shows that patients with moderate-to-severe dry eye account for about 40% of dry eye patients. According to this projection, there are over 100 million patients with moderate-to-severe dry eye in China. Since there are various channels of treatment for eye diseases in China, assuming a 10% hospital visit rate for patients with moderate-to-severe dry eye, the target treatment population would be about 10 million. In terms of treatment cost, the clinical study of Cyclosporine Eye Drops 0.09% shows significant improvement in the primary endpoint after 12 weeks of treatment with 2 doses of the product per day, so assuming a 12-week treatment course of the product and a treatment cost of RMB25 per dose (with reference to the selling price of about RMB25 per dose of Zirun(R) 0.05% Cyclosporine Eye Drops (II) of Sinqi Ophthalmic Medications), the product would cost about RMB4,000 per treatment course. Combined with the target population of about 10 million projected above, the market potential for this drug will exceed RMB3 billion if the Company could cover 8% of the patients.

c) Tildrakizumab
Tildrakizumab is used for the treatment of moderate-to-severe plaque psoriasis, and has already been approved for marketing in the U.S., Europe, Australia, and Japan. In China, with the completion of all subject enrollment in the registration clinical trial, the product is expected to be marketed in 2022.

Chinese epidemiological data shows that the incidence of psoriasis in China is about 0.47%, with a total number of patients exceeding 6.5 million. Among them, about 30%, or 2 million patients, are with moderate-to-severe psoriasis. Regarding the current market size of monoclonal antibodies for psoriasis in China, according to the prices of monoclonal antibodies already approved, which generally cost tens of thousands to hundreds of thousands in RMB for annual treatment, and taking into account the price reduction in NRDL price negotiations, RMB100,000 can be taken as the average annual treatment cost. Assuming that the penetration rate of biologics in patients with moderate-to-severe psoriasis can reach about 20% in the future, the entire market size of monoclonal antibodies for psoriasis will exceed RMB40 billion. With the Company's strong sales and promotion ability, assuming that the product takes 12% of the market share in the future, the peak sales could reach about RMB5 billion.

d) Others
By 2023, the Company's products such as Plenity (an innovative weight loss product), Desidustat (indicated for CKD anemia), Methotrexate Pre-filled Syringe/Pen (pre-filled injectables indicated for RA) and Methylene Blue MMX (enhancing lesion detection during colonoscopy) are expected to be approved for marketing, all of which also have a market potential of at least RMB1 billion.

Taking Methotrexate Pre-filled Syringe/Pen as an example, it is easy to use, convenient for self-administration at home, and strikes a greater balance of efficacy and safety, excellent tolerability and compliance. With 5 million RA patients in China, the peak sales of this product is estimated to exceed RMB1 billion . Methylene Blue MMX is also a product with promising market potential. It has been clinically proven to improve the detection of all lesions during colonoscopy and is easy to use. If it is included into the routine procedure of full-spectrum colonoscopy in the future, the sales potential of this product is estimated to be at least RMB1 billion as there about 10 million colonoscopy cases in total in China.

3. Conclusion

To conclude, CMS's advantages in deployment of innovative products come from two aspects. On the one hand, the Company's strong BD ability built up in its long-term development gives it the confidence and strength to quickly enter the innovative drug field, and at the same time, it does not blindly chase after popular products, but focuses on digging overseas quality innovative products with relatively high market potential and unmet market demand using its differentiated product selection strategy. On the other hand, the resource advantages based on the strong marketing and promotion system empower the Company with rapid clinical advancement ability and strong academic promotion ability, which strongly supports the clinical development and commercialization of innovative products. Based on all these, CMS has made remarkable achievements in its transformation, and it is believed that with the marketing of blockbuster innovative products, the Company's value will be re-recognized by the market and its valuation will usher in a new leap.

After CMS released its annual results, several institutions have published research reports that are optimistic about the Company's transformation focusing on innovative drugs and its long-term potential. First Shanghai Financial Group emphasized CMS's unique vision of product selection, strong profitability of BD projects, and high efficiency in clinical development of blockbuster innovative products. It projected that CMS will have six innovative drugs marketed in China in the next three years, and with the Company's strong academic promotion ability and the products' own differentiation advantages, it's believed that once these products are marketed, they're expected to bring considerable contribution to the Company's performance. Industrial Securities mentioned that the Company's Cyclosporine Eye Drops 0.09% and Tildrakizumab are expected to be approved in 2022 and four other innovative products to be approved in 2023. With the successive launch of these innovative products, the Company's product mix is expected to be significantly optimized.

In addition, Citi reported that the Company's management is committed to acquiring licenses for five competitive innovative drugs each year, and the nasal spray for epilepsy is also planned to be launched in China this year, which are expected to continuously contribute to its revenue; meanwhile, the Company has several other drugs that are expected to be launched in China in the next few years, based on which Citi raised its earnings forecast for 2021 and 2022 by 39% and 57%, respectively. At the same time, Citi raised its target price of CMS by 134% to HK$26 from HK$11.1, with a "buy" rating.

In summary, it is not difficult to find that all these institutions have full recognition of CMS in its presence in the innovative drug field. They have all raised their target prices of the Company based upon the Company's performance and potential. Compared with ordinary investors, professional institutions tend to have a deeper understanding of the industry and the enterprise. These bullish reports have all shown that, despite the fact that the Company's share price has almost doubled in the year, they still have full confidence in the Company's future potential.

Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Azelis releases ‘Action 2025’, confirming sustainability as a key driver in growth strategy

SINGAPORE, Mar 31, 2021 – (ACN Newswire) – Azelis, an innovation service provider, is excited to release its sustainability strategy, 'Action 2025', reinforcing its commitment to become the world-leading provider of sustainable solutions and services in the specialty chemicals and food ingredients distribution industry. Through its sustainability program and strategy, Azelis wants to turn the sustainability aspirations of its principals and customers into innovative sustainable solutions.

Highlights & rationale
– Azelis' sustainability commitments and efforts have further matured and are now crystalized into 'Action 2025', its new sustainability strategy.
– With its strategy, Azelis aspires to become the world-leading distributor of sustainable solutions and services in the specialty chemicals and food ingredients distribution industry.
– Together with digitalization and innovation, sustainability is a key strategic driver for Azelis' future growth.

Azelis' sustainability journey started in 2015 when the company defined the fundamentals of its sustainability program, following the Paris Agreement on climate change and the release of the 2030 Agenda for Sustainable Development by the United Nations.

The Azelis sustainability program is based on the United Nations Global Compact (UN GC) initiative, ISO 26000 and the Global Reporting Initiative (GRI). The program consists of four pillars – each with goals and KPIs – and with every pillar Azelis also contributes to the selected United Nation's Sustainable Development Goals (SDGs).

– People – we will be recognized as a global employer of choice for our industry
– Products and innovation – we will be the leader in distribution of sustainable, innovative and safe chemicals
– Governance – we will be fair in business practices and compliant with all laws and regulations, embedding trust and ethics in the foundation of our operations
– Environment – we will continually reduce the environmental impact of our operations

'Action 2025'

In its ongoing transition to an even more sustainable business model, the company has redefined its sustainability strategy – based on the four pillars set out above – and set targets for 2025. To reach these 2025 targets, Azelis will both be launching several new initiatives in the coming years and intensifying other initiatives which are already being implemented.

One very important target for Azelis is to continue to identify sustainable products within its extensive product portfolio to bring additional value to customers, helping them to achieve their sustainability goals with more environmentally-friendly products. This identification of the sustainable product portfolio is done in close collaboration with Azelis' principals who are equally dedicated to contributing to a sustainable future. Being a proud member of Together for Sustainability (TfS) and measuring and reporting on sustainability efforts within the EcoVadis framework, Azelis will continue with sustainability assessments to help its suppliers in developing sustainability practices, improve the sustainability standards in the value chain and work on the reputation of the chemical industry.

'Action 2025' is based on learnings the company gathered from in-depth interviews with suppliers and customers, results and improvement suggestions from its EcoVadis assessment, input from Azelis business representatives, and the materiality assessment exercise Azelis performed last year in the context of its first sustainability report. Azelis is committed to publishing sustainability reports annually, communicating on progress and provide further information in this important area.

Dr. Hans Joachim Muller, Azelis Chief Executive Officer, states: "We are part of a global industry that plays a significant role in the economy of the world and we have an obligation to utilize the world's resources in a sustainable manner. Aligned with our brand promise 'Innovation through formulation', it is our aspiration to contribute to a more sustainable future by connecting and empowering both principals and customers to work on the development of sustainable chemical solutions through innovation. Our innovations catalyze sustainability in the market segments we serve and their value chains, and will help realize concepts such as circular economy. Our sustainability reputation and our EcoVadis Gold ratings have already positively influenced commercial decisions of some our partners. It remains crucial to our sustainability ambitions that we continue to work with the best partners who equally respect human rights, environment and fair business practices."

Maria J. Almenar Martin, Group SHEQ & Sustainability Director, adds: "Our sustainability ambitions have been captured in a more formalized way since the creation of our sustainability program back in 2015 and have now entered a new phase with the launch of our 2025 sustainability strategy. In an ever-changing industry and world, Azelis' ambitions for a sustainable future will never stop. We want to engage our current and potential partners to contribute to our sustainable cause, next to converting the sustainability aspirations of our principals and customers into innovative sustainable solutions. We also wish to set an example for our peers and motivate them to also embark on the journey to a sustainable business model."

To become a world-leading innovation service provider in the specialty chemicals and food ingredients distribution industry, Azelis has identified digitalization, innovation and sustainability as its growth drivers. Through Azelis' connected solutions, the company is leading the way in customer engagement, whilst providing the digital insight that will drive new levels of chemical innovation. With its redefined sustainability strategy, Azelis is building a resilient, thriving and responsible business. Through these commitments, the company will meet the needs of its stakeholders, whilst also creating a positive and widespread impact on the environment and communities around the world. 'Innovation through formulation' is Azelis' passion and promise to every colleague, customer and partner, as the company combines products, ingredients and ideas – providing the expertise that will always matter in our changing world.

Learn more about 'Action 2025' with this animation video. https://www.youtube.com/watch?v=JzUGfxubX5o

Contact information
Azelis
Sarah Van Alsenoy
Corporate Communications Business Partner
T: +32 499 22 36 62
E: sarah.vanalsenoy@azelis.com

About Azelis

Azelis is a leading distributor of specialty chemicals and food ingredients present in over 50 countries across the globe with around 2,500 employees. Our knowledgeable teams of industry, market and technical experts are each dedicated to a specific market within Life Sciences and Industrial Chemicals. We offer a lateral value chain of complementary products to about 43,000 customers, creating a turnover of EUR2.22 billion (2020).

Throughout our extensive network of more than 60 application laboratories, our award-winning technical staff help customers develop formulations. We combine a global reach with a local focus to offer a reliable, integrated service to local customers and attractive business opportunities to principals. And we believe in building and nurturing solid, honest and transparent relationships with our people and partners.

Impact through ideas. Innovation through formulation.

www.azelis.com

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