SHENZHEN, CHINA, July 16, 2024 – (ACN Newswire) – In July 2024, China Medical System Holdings Limited (“CMS” or the “Group”) has once again been recognized for its outstanding performance and continuous progress in sustainable development. CMS was reincluded in the 2024 Sustainability Yearbook (China Edition) issued by S&P Global, a global-leading corporate sustainability assessment institution, and maintained its “AA” rating in the updated MSCI (Morgan Stanley Capital International) ESG Rating Report.

Re-including in S&P Global’s Sustainability Yearbook (China Edition)

The S&P Global’s 2024 Sustainability Yearbook (China Edition) has been released. With an CSA score of 51 that surpassing 91% global peers in the industry, CMS stood out among more than 1,700 evaluated Chinese companies to be reincluded in the China Yearbook, becoming one of the five selected companies in the pharmaceutical industry.

Receiving “AA” once again in MSCI ESG Rating

In July, MSCI has released the latest ESG rating report for CMS. The Group has maintained “AA” rating, being positioned at the industry leading level globally.

CMS is committed to its ESG vision of “becoming a world-leading sustainable pharmaceutical enterprise,” continuously promoting the deep integration of sustainability concepts with its development strategy. The Group has established an ESG strategy covering various dimensions in operation, along with the Group’s mission and vision, and the expectations of stakeholders. Through a robust governance structure, CMS continuously strengthens ESG management and practices to facilitate the achievement of its ESG strategic goals.

Receiving high appraisal from two international authoritative organizations once again signifies the continuous recognition of the value and effectiveness of CMS’s sustainable development and relevant practice. In the future, CMS will continue to strengthen ESG governance and overall performance in corporate operations, social contributions, and environmental protection, and work together with all stakeholders to promote sustainable development and contribute to the realization of a green, healthy and prosperous future of human beings.

About CMS

CMS is a platform company linking pharmaceutical innovation and commercialization with strong product lifecycle management capability, dedicated to providing competitive products and services to meet unmet medical needs.

CMS focuses on the global first-in-class (FIC) and best-in-class (BIC) innovative products, and efficiently promotes the clinical research, development and commercialization of innovative products, enabling the continuous transformation of scientific research into clinical practices to benefit patients.

CMS deeply engages in several specialty therapeutic fields, and has developed proven commercialization capabilities, extensive networks and expert resources, resulting in leading academic and market positions for its major marketed products. CMS continues to promote the in-depth development of its advantageous specialty fields and expand business boundaries. While strengthening the competitiveness of the cardio-cerebrovascular/gastroenterology business, CMS independently operates its dermatology and medical aesthetics business, and ophthalmology business, aiming to gain leading positions in specialty therapeutic fields, whilst enhancing the scale and efficiency. At the same time, CMS has expanded its business territory to the Southeast Asian market, striving to become a “bridgehead” for global pharmaceutical companies to enter the Southeast Asian market, further escorting the sustainable and healthy development of the Group.

CMS Disclaimer and Forward-Looking Statements

This press release which has been prepared by CMS does not constitute any offer or invitation to purchase or subscribe for any securities, and shall not form the basis for or be relied on in connection with any contract or binding commitment whatsoever. This press release has been prepared by CMS based on information and data which it considers reliable, but CMS makes no representation or warranty, express or implied, whatsoever, and no reliance shall be placed on, the truth, accuracy, completeness, fairness and reasonableness of the contents of this press release. Certain matters discussed in this press release may contain statements regarding the Group’s market opportunity and business prospects that are individually and collectively forward-looking statements. Such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and assumptions that are difficult to predict. Any forward-looking statements and projections made by third parties included in this press release are not adopted by the Group and the Company is not responsible for such third-party statements and projections.

Disclaimer Statement of MSCI

The use by China Medical System Holdings Ltd. of any MSCI ESG Research LLC or its affiliates (“MSCI”) data, and the use of MSCI logos, trademarks, service marks or index names herein, do not constitute a sponsorship, endorsement, recommendation, or promotion of China Medical System Holdings Ltd. by MSCI. MSCI services and data are the property of MSCI or its information providers, and are provided ‘as-is’ and without warranty. MSCI names and logos are trademarks or service marks of MSCI.

Media Contact
China Medical System Holdings Ltd.
CMS Investor Relations
Website: https://web.cms.net.cn/en/home/

Source: China Medical System Holdings Ltd.

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

SHENZHEN, June 25, 2024 – (ACN Newswire) – On June 25, China Medical System Holdings Limited (the “Company”, together with its subsidiaries, the “Group” or “CMS”) announced the completion of dosing for the first subject in the phase III bridging trial of ruxolitinib cream (the “Product”) in atopic dermatitis (“AD”) in China. This is another substantial clinical development milestone for ruxolitinib cream in China, following the approval for Urgent Clinical Import by Hainan Medical Products Administration and approval for marketing in Macau for vitiligo.

This trial is a randomized, double-blind, placebo-controlled phase III clinical trial evaluating the efficacy and safety of ruxolitinib cream in the treatment of atopic dermatitis in Chinese patients. The trial aims to provide more medical evidence to support the Product’s marketing application in China. The trial, led by Professor Shi Yuling, Vice President of Shanghai Skin Disease Hospital, will be conducted in 20 sites nationwide aiming to enroll approximately 192 atopic dermatitis patients.

AD is a chronic, recurrent and inflammatory dermatologic disease, with the main clinical manifestations of dry skin, chronic eczema-like lesions and obvious itching or pruritus, which may seriously affect the quality of life of patients. It is estimated that there are approximately 26 million[1] AD patients in China, of whom about 23 million[2] are mild to moderate. Topical drugs are the most basic treatment for AD. Traditional topical medications such as topical corticosteroids (TCSs) and topical calcineurin inhibitors (TCIs) have long-term adverse reactions or limited efficacy[3] [4], therefore novel treatments are urgently needed, especially for those mild to moderate AD patients who do not need systemic treatment.

About ruxolitinib cream

Ruxolitinib cream (Opzelura®), a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, is approved by the U.S. Food and Drug Administration (FDA) for the topical treatment of nonsegmental vitiligo in patients 12 years of age and older, and is the first and only treatment for repigmentation approved for use in the United States[5]. Opzelura is also approved in the U.S. for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable[6]. Use of Opzelura in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants, such as azathioprine or cyclosporine, is not recommended. In Europe, ruxolitinib cream (Opzelura) is approved for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age[7].

Ruxolitinib cream is not approved by the National Medical Products Administration of China (NMPA) for any indication in Mainland of China. However, on 12 August 2023, the Product was approved by Hainan Medical Products Administration for Urgent Clinical Import, and officially became available to applicable patients in the Hainan Boao Lecheng International Medical Tourism Pilot Zone (the “Pilot Zone”) on 18 August, for the topical treatment of non-segmental vitiligo in adults and adolescents aged 12 and above with facial involvement. Benefiting from the Early and Pilot Implementation Policy granted by the state to Hainan Free Trade Port and the Pilot Zone, patients with vitiligo in China can apply for the Product in Boao Super Hospital first and receive treatment from the expert team. The Group is cooperating with Boao Super Hospital to conduct the Real World Research (RWS) for the Product, which could support the registration and launching of the Product in Mainland of China.

Moreover, the Pharmaceutical Administration Bureau (ISAF) of Macau has approved the new drug application of ruxolitinib cream for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age on 11 April 2024, and it may bring a novel therapeutic option to patients with relevant indication in the area.

Incyte has worldwide rights for the development and commercialization of the Product, marketed in the United States and Europe as Opzelura®. CMS has an exclusive license to develop and commercialize the Product in Mainland China, Hong Kong Special Administrative Region, Macau Special Administrative Region, Taiwan Region and eleven Southeast Asian countries (the “Territory”) and a non-exclusive license to manufacture the Product in the Territory.

Opzelura and the Opzelura logo are registered trademarks of Incyte.

CMS continues to pay close attention to patients’ needs, and actively promotes the R&D and clinical application of innovative products to address unmet clinical needs, bringing more quality medical products to patients through differentiated innovation breakthroughs.

About CMS

CMS is a platform company linking pharmaceutical innovation and commercialization with strong product lifecycle management capability, dedicated to providing competitive products and services to meet unmet medical needs.

CMS focuses on the global first-in-class (FIC) and best-in-class (BIC) innovative products, and efficiently promotes the clinical research, development and commercialization of innovative products, enabling the continuous transformation of scientific research into clinical practices to benefit patients.

CMS deeply engages in several specialty therapeutic fields, and has developed proven commercialization capabilities, extensive networks and expert resources, resulting in leading academic and market positions for its major marketed products. CMS continues to promote the in-depth development of its advantageous specialty fields and expand business boundaries. While strengthening the competitiveness of the cardio-cerebrovascular/gastroenterology business, CMS independently operates its dermatology and medical aesthetics business, and ophthalmology business, aiming to gain leading positions in specialty therapeutic fields, whilst enhancing the scale and efficiency. At the same time, CMS has expanded its business territory to the Southeast Asian market, striving to become a “bridgehead” for global pharmaceutical companies to enter the Southeast Asian market, further escorting the sustainable and healthy development of the Group.

Reference:

1. M.R. Laughter, M.B.C. Maymone, S. Mashayekhi, B.W.M. Arents, C. Karimkhani, S.M. Langan, R.P. Dellavalle, C. Flohr, The global burden of atopic dermatitis: lessons from the Global Burden of Disease Study 1990–2017, British Journal of Dermatology, Volume 184, Issue 2, 1 February 2021, Pages 304–309, https://doi.org/10.1111/bjd.19580

2. Chiesa Fuxench ZC, Block JK, Boguniewicz M, Boyle J, Fonacier L, Gelfand JM, Grayson MH, Margolis DJ, Mitchell L, Silverberg JI, Schwartz L, Simpson EL, Ong PY. Atopic Dermatitis in America Study: A Cross-Sectional Study Examining the Prevalence and Disease Burden of Atopic Dermatitis in the US Adult Population. J Invest Dermatol. 2019 Mar;139(3):583-590. doi: 10.1016/j.jid.2018.08.028. Epub 2018 Oct 30. PMID: 30389491

3. “Research Report on the Living Conditions of Atopic Dermatitis Patients in China” August 2020

4. Yimi Survey “Atopic Dermatitis Diagnosis and Cognition Survey” October 2023

5. Drug approval information can be found on the FDA official website, as follows: https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-topical-treatment-addressing-repigmentation-vitiligo-patients-aged-12-and-older 

6. Drug approval information can be found on the Incyte official website, as follows: https://investor.incyte.com/news-releases/news-release-details/incyte-announces-us-fda-approval-opzeluratm-ruxolitinib-cream 

7. Drug approval information can be found on the EMA official website, as follows: https://www.ema.europa.eu/en/medicines/human/EPAR/opzelura 

CMS Disclaimer and Forward-Looking Statements

This press release is not intended to promote any products to you and is not for advertising purposes. This press release does not recommend any drugs, medical devices and/or indications. If you want to know more about the diagnosis and treatment of specific diseases, please follow the opinions or guidance of your doctor or other medical and health professionals. Any treatment-related decisions made by healthcare professionals should be based on the patient’s specific circumstances and in accordance with the drug package insert.

This press release which has been prepared by CMS does not constitute any offer or invitation to purchase or subscribe for any securities, and shall not form the basis for or be relied on in connection with any contract or binding commitment whatsoever. This press release has been prepared by CMS based on information and data which it considers reliable, but CMS makes no representation or warranty, express or implied, whatsoever, and no reliance shall be placed on, the truth, accuracy, completeness, fairness and reasonableness of the contents of this press release. Certain matters discussed in this press release may contain statements regarding the Group’s market opportunity and business prospects that are individually and collectively forward-looking statements. Such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and assumptions that are difficult to predict. Any forward-looking statements and projections made by third parties included in this press release are not adopted by the Group and the Company is not responsible for such third-party statements and projections.

Media Contact
China Medical System Holdings Ltd.
CMS Investor Relations
Website: https://web.cms.net.cn/en/home/

Source: China Medical System Holdings Ltd.

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

• Innovative drug Methylthioninium Chloride Enteric-coated Sustained-release Tablets (Lumeblue®) is an oral diagnostic drug, approved by China’s NMPA for enhancing visualisation of colorectal lesions in adult patients undergoing screening or surveillance colonoscopy.
• The results of the Phase III clinical trial in China show that the Product can significantly improve the detection rate of non-polypoid colorectal lesions (the primary endpoint of the study), leading to an improved detection rate of dangerous lesions such as non-polypoid adenomas (the secondary endpoint).
• The Product can be taken during the bowel preparation step, ensuring that colorectal staining is completed by the time colonoscopy is conducted. This not only enhances the detection rate of colorectal lesions but also potentially simplifies the colonoscopy procedure, making the examination more efficient and improving the screening benefits.
• As of now, CMS’s newly launched innovative portfolio has been expanded to 5 products, continuously generating driving force to the Group’s sustainable and healthy development.

SHENZHEN, June 18, 2024 – (ACN Newswire) – China Medical System Holdings Limited (the “Company”, together with its subsidiaries, the “Group” or “CMS”) is pleased to announce that on 11 June 2024, the New Drug Application (NDA) of the Group’s innovative drug methylthioninium chloride enteric-coated sustained-release tablets (Lumeblue®) (the “Product”) has been approved by the National Medical Products Administration of China (NMPA). The drug registration certificate was obtained on 18 June 2024. The Product is indicated to enhancing visualisation of colorectal lesions in adult patients undergoing screening or surveillance colonoscopy, and it is the first oral methylthioninium chloride enteric-coated sustained-release tablets in China. The Group will synergize with existing gastroenterology products and resources to advance the commercialization and academic promotion related works of the Product in an orderly manner, aiming to achieve nationwide large-scale clinical application as soon as possible so as to benefit patients with colorectal disease.

Lumeblue® is an oral diagnostic drug that uses patented multi-matrix (MMX) technology to deliver active substances directly to the colon and release them locally in a controlled manner. As an enhancer dye, the Product increases the contrast between colorectal lesions and healthy mucosa. The results of the Phase III clinical trial in China show that the Product can significantly improve the detection rate of non-polypoid colorectal lesions (the primary endpoint of the study), leading to an improved detection rate of dangerous lesions such as non-polypoid adenomas (the secondary endpoint)[1]. In addition, the Product can be taken during the bowel preparation step, ensuring that colorectal staining is completed by the time colonoscopy is conducted. This not only enhances the detection rate of colorectal lesions but also potentially simplifies the colonoscopy procedure, making the examination more efficient and improving the screening benefits.

According to the diagnosis and treatment data of the Digestive Endoscopy Branch of the Chinese Medical Association, approximately a total of 28 million gastroenteroscopies were completed nationwide in 2012, including 5.83 million colonoscopies. In 2019, approximately 38.73 million gastroenteroscopies were completed nationwide, an increase of 34.62% compared with 2012[2]. The Chinese consensus of early colorectal cancer screening recommends that people aged 50 to 75 years old should be screened for colorectal cancer regardless of whether they have alarm symptoms[3]. There are approximately 400 million people aged 50 to 75 in China in 2020[4]. With the popularity of early screening for colorectal cancer in China, it is expected to witness a considerable growth of the number of colonoscopies in China in the future.

The Product has been approved by the European Medicines Agency (EMA) to be commercialized in the European Union under the trade name Lumeblue™ in August 2020. The Group obtained an exclusive license for the Product from Cosmo Technologies Ltd, a fully owned subsidiary of Cosmo Pharmaceuticals NV, on 3 December 2020.

Driven by the twin-wheel of “Collaborative R&D and Independent R&D”, CMS has continuously deployed global first-in-class (FIC) and best-in-class (BIC) innovative products guided by patient and clinical demands. With enhancing R&D capabilities in developing differentiated innovative products, CMS has empowered the continuous transformation of scientific research outcomes into clinical application, continuously releasing the value of innovation. As of now, CMS’s newly launched innovative portfolio has been expanded to 5 products, continuously generating driving force to the Group’s sustainable and healthy development. Desidustat Tablets and Methotrexate Injection (rheumatoid arthritis), CMS’s innovative pipeline products, are currently under NDA review in China. Meanwhile, over 10 innovative pipeline products are undergoing clinical trials in China, mainly randomized controlled trials (RCT). CMS is expected to launch differentiated innovative products every year in the future with higher efficiency and more controllable costs, continuing to optimize its product portfolio and build fresh driving forces for the mid- to long-term development of the Company.

About CMS

CMS is a platform company linking pharmaceutical innovation and commercialization with strong product lifecycle management capability, dedicated to providing competitive products and services to meet unmet medical needs.

CMS focuses on the global first-in-class (FIC) and best-in-class (BIC) innovative products, and efficiently promotes the clinical research, development and commercialization of innovative products, enabling the continuous transformation of scientific research into clinical practices to benefit patients.

CMS deeply engages in several specialty therapeutic fields, and has developed proven commercialization capabilities, extensive networks and expert resources, resulting in leading academic and market positions for its major marketed products. CMS continues to promote the in-depth development of its advantageous specialty fields and expand business boundaries. While strengthening the competitiveness of the cardio-cerebrovascular/gastroenterology business, CMS independently operates its dermatology and medical aesthetics business, and ophthalmology business, aiming to gain leading positions in specialty therapeutic fields, whilst enhancing the scale and efficiency. At the same time, CMS has expanded its business territory to the Southeast Asian market, striving to become a “bridgehead” for global pharmaceutical companies to enter the Southeast Asian market, further escorting the sustainable and healthy development of the Group.

Reference:

1. The results of the Phase III clinical trial in China was published and can be found at: https://web.cms.net.cn/en/2022/12/positive-results-for-china-phase-iii-clinical-trial-of-methylthioninium-chloride-enteric-coated-sustained-release-tablets/

2. The diagnosis and treatment data of the Digestive Endoscopy Branch of the Chinese Medical Association

3. Chinese consensus of early colorectal cancer screening (2019, Shanghai)，Chinese Journal of Internal Medicine，DOI： 10.3760/cma.j.issn.0578-1426.2019.10.004

4. CHINA POPULATION CENSUS YEARBOOK 2020, can be found at： https://www.stats.gov.cn/sj/pcsj/rkpc/7rp/zk/indexch.htm

CMS Disclaimer and Forward-Looking Statements

This press release is not intended to promote any products to you and is not for advertising purposes. This press release does not recommend any drugs, medical devices and/or indications. If you want to know more about the diagnosis and treatment of specific diseases, please follow the opinions or guidance of your doctor or other medical and health professionals. Any treatment-related decisions made by healthcare professionals should be based on the patient’s specific circumstances and in accordance with the drug package insert.

This press release which has been prepared by CMS does not constitute any offer or invitation to purchase or subscribe for any securities, and shall not form the basis for or be relied on in connection with any contract or binding commitment whatsoever. This press release has been prepared by CMS based on information and data which it considers reliable, but CMS makes no representation or warranty, express or implied, whatsoever, and no reliance shall be placed on, the truth, accuracy, completeness, fairness and reasonableness of the contents of this press release. Certain matters discussed in this press release may contain statements regarding the Group’s market opportunity and business prospects that are individually and collectively forward-looking statements. Such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and assumptions that are difficult to predict. Any forward-looking statements and projections made by third parties included in this press release are not adopted by the Group and the Company is not responsible for such third-party statements and projections.

Media Contact
China Medical System Holdings Ltd.
CMS Investor Relations
Website: https://web.cms.net.cn/en/home/

Source: China Medical System Holdings Ltd.

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

• Desidustat Tablets are novel, oral HIF-PHI for treating anaemia in non-dialysis adult chronic kidney disease patients. The Product is administrated orally, thus expecting to improve the treatment compliance of patients and to meet the unmet treatment needs in the field of CKD anaemia, including both dialysis and non-dialysis patients. 
• China Phase III trial of the Product has demonstrated positive results. The primary endpoint has indicated that Desidustat is more effective than placebo in increasing Hb level.
• Currently, 4 innovative drugs of CMS have entered into commercialization stage. Meanwhile, continuous advance of products’ clinical development and registration process such as Desidustat Tablets is expected to enrich the Group’s marketed innovative product portfolio, and generate new driving force to the Group’s sustainable and healthy development.

SHENZHEN, CHINA, Apr 23, 2024 – (ACN Newswire) – China Medical System Holdings Limited (“CMS” or the “Group”) is pleased to announce that on 22 April 2024, the New Drug Application (NDA) of Desidustat Tablets  (“Desidustat Tablets” or the “Product”) has been accepted by the National Medical Products Administration of China (NMPA). The Product is a novel, oral Hypoxia-Inducible Factor-Prolyl Hydroxylase Inhibitor (HIF-PHI) for treating anaemia in non-dialysis adult, Chronic Kidney Disease (CKD) patients.

CKD involves the gradual loss of functioning of kidneys and eventually leads to kidney failure. If kidneys are healthy, they will naturally secrete beneficial levels of a hormone called Erythropoietin (EPO), which encourages red blood cell production. If the kidneys are impaired, they will produce reduced levels or tire of EPO production completely, leading to anaemia. HIF-PHI promotes erythropoiesis through increasing endogenous erythropoietin, improving iron availability and reducing hepcidin.

It is estimated that more than 120 million people are living with CKD in China[1]. Anaemia is one of the frequent complications of CKD. A survey in China showed that the prevalence of anaemia in patients at CKD stage 1 to 5 were 22.0%, 37.0%, 45.4%, 85.1%, and 98.2%, respectively[2]. The target-achieving rate (the haemoglobin (Hb) level reaching the target value (110~120g / L)) was only 8.2% for anaemia patients in non-dialysis CKD and 35.2% for haemodialysis CKD, showing a large unmet healthcare need[3].

China Phase III trial of the Product has demonstrated positive results. The primary endpoint of the Hb mean change from baseline to the period of Week 7-9 has indicated that, Desidustat is more effective than placebo in increasing Hb level. The least squares mean and 95% CI of Hb change from baseline to the period of Week 7-9, using covariance model analysis, has shown an increase of 16.38 g/l [95%CI: 14.50, 18.26] in the Desidustat group and a decrease of 1.13 g/l [95%CI: -3.68, 1.41] in the placebo group, for a between-group difference of 17.52 g/l [95%CI:14.353, 20.681], with the lower limit of 95% CI above 0.

The Product is administrated orally, thus expecting to improve the treatment compliance of patients and to meet the unmet treatment needs in the field of CKD anaemia, including both dialysis and non-dialysis patients. Desidustat Tablets have been approved for marketing in India.

CMS INTERNATIONAL DEVELOPMENT AND MANAGEMENT LIMITED, a wholly-owned subsidiary of the Group, obtained an exclusive license for the Product from Zydus Lifesciences Limited (earlier known as Cadila Healthcare Limited) on 20 January 2020.

Reference:

1. ZhangL, WangF, WangL, et al. Prevalence of chronic kidney disease in China: a cross-sectional survey[J]. Lancet, 2012, 379(9818):815-822. DOI: 10.1016/S0140-6736(12)60033-6

2. Chinese expert consensus on diagnosis and therapy of renal anaemia (the 2014 revised edition), Chinese Journal of Nephrology, 2014;30:712-716

3. Chinese expert consensus on diagnosis and therapy of renal anaemia (the 2018 revised edition), Chinese Journal of Nephrology, 2018, 34(11): 860-866

CMS Disclaimer and Forward-Looking Statements

This press release is not intended to promote any products to you and is not for advertising purposes. This press release does not recommend any drugs, medical devices and/or indications. If you want to know more about the diagnosis and treatment of specific diseases, please follow the opinions or guidance of your doctor or other medical and health professionals. Any treatment-related decisions made by healthcare professionals should be based on the patient’s specific circumstances and in accordance with the drug package insert.

This press release which has been prepared by CMS does not constitute any offer or invitation to purchase or subscribe for any securities, and shall not form the basis for or be relied on in connection with any contract or binding commitment whatsoever.

Media Contact
Brand: China Medical System Holdings Ltd.
Contact: CMS Investor Relations
Website: https://web.cms.net.cn/en/home/

Source: China Medical System Holdings Ltd.

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

NEW YORK, Apr 16, 2024 – (ACN Newswire) – A new article on Autonomix Medical Inc. (NASDAQ: AMIX), featuring the company’s groundbreaking approach to peripheral nervous system (PNS) disorders, has been published by Benzinga. The Benzinga article delves into the critical role of the PNS in human health and highlights how Autonomix Medical is pioneering with its catheter-based microchip sensing array technology.

The article provides a comprehensive look at how Autonomix Medical is redefining treatment protocols for nerve-related disorders. By targeting the root causes associated with the PNS, rather than just managing symptoms, Autonomix Medical’s technology offers a novel solution that combines both detection and ablation of problematic nerves in a single procedure. This approach, likened to a “GPS” for nerve treatment, allows for precise identification and treatment of the nerves involved, enhancing the accuracy and effectiveness of procedures.

In a notable application, the company is focusing its efforts on managing pancreatic cancer pain — a condition notoriously difficult to treat due to its proximity to critical nerves. The technology’s high sensitivity in detecting neural signals—up to 3,000 times greater than existing technologies — promises not only to improve outcomes in pain management but also to significantly reduce the need for opioids, addressing a major public health challenge.

This exposure in Benzinga underscores the potential of Autonomix Medical’s technology to transform the field of electrophysiology and pain management, potentially tapping into a market exceeding $100 billion. As the company progresses with its clinical trials, the successful implementation of its technology could revolutionize treatment approaches for a wide range of diseases, offering hope to millions of patients worldwide.

To read the full article, click here.

More Pancreatic Cancer News:

• Candel Therapeutics, Inc. ((Nasdaq: CADL) announced that the FDA has granted Orphan Drug Designation to their advanced biological immunotherapy, CAN-2409, for treating pancreatic cancer, following promising phase 2 clinical trial results that more than doubled median overall survival when added to standard care.
• RenovoRx, Inc. (Nasdaq: RNXT) announced an $11.1 million private placement, extending their financial runway into 2026, which will support the continuation and completion of their pivotal Phase III TIGeR-PaC clinical trial for pancreatic cancer. This funding also facilitates the expansion of their Trans-Arterial Micro-Perfusion (TAMP) clinical development pipeline into additional cancer indications.

Note: The details provided in this press release are based on information featured in the Benzinga article and do not constitute forward-looking statements.

For more information, contact:
Plato Data Intelligence
144 E44th St
New York NY 10017
PlatoAiStream.com
Zephyr@platodata.io

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

HONG KONG, China and WILMINGTON, Del., Apr 1, 2024 – (ACN Newswire) – China Medical System Holdings Limited (“CMS” or the “Group”) and Incyte (Nasdaq:INCY) (“Incyte”) are pleased to announce that on 31 March 2024, that the Group, through a wholly-owned dermatology medical aesthetic subsidiary of the Company (“CMS Skinhealth”), and Incyte entered into a Collaboration and License Agreement for the development and commercialization of povorcitinib (the “Product”), a selective oral JAK1 inhibitor, to research, develop, register and commercialize the Product in Mainland China, Hong Kong, Macao, Taiwan Region and eleven Southeast Asian countries (the “Territory”) and a non-exclusive license to manufacture the Product in CMS’ Territory.

Under the terms of the agreement, CMS will make an upfront payment to Incyte and Incyte is eligible to receive additional potential development and commercial milestones and royalties on net sales of the licensed product in CMS’ territory.

CMS will receive an exclusive license to develop and commercialize and a non-exclusive license to manufacture povorcitinib in autoimmune and inflammatory dermatologic diseases, including non-segmental vitiligo, hidradenitis suppurativa (HS), prurigo nodularis (PN), asthma and chronic spontaneous urticaria, for patients in mainland China, Hong Kong, Macau, Taiwan and certain countries in Southeast Asia.

“We are excited to announce the addition of this collaboration for povorcitinib, expanding our relationship with CMS in the Dermatology space beyond ruxolitinib cream, to include two products with the potential to help patients with limited treatment options,” said Herve Hoppenot, Chief Executive Officer, Incyte. “There remains a significant need for new, innovative treatment for vitiligo and other immune-mediated dermatologic conditions, and we look forward to working together with the CMS team to bringing these products to market in China.”

Mr. Huang Anjun, the general manager of CMS Skinhealth, stated that, “We expect that this collaboration will enhance CMS Skinhealth’s portfolio of potential treatments for vitiligo that, if approved, will provide differentiated treatment options for vitiligo patients in China. Upon approval, povorcitinib is poised to synergize with the innovative drugs in the commercialization stage of our pipeline ILUMETRI (tildrakizumab injection), original drugs including Hirudoid (mucopolysaccharide polysulfate cream) and Aethoxysklerol (polidocanol injection) in terms of our network and market resources, which will help the Product to realize its clinical and commercial value.”

The transaction is effective immediately upon the execution of the Collaboration and License Agreement.

About Povorcitinib

Povorcitinib is a selective oral small-molecule JAK1 inhibitor, with compound and use patents in certain countries/regions in the Territory. Currently, povorcitinib is in Phase 3 clinical trials for non-segmental vitiligo and HS in multiple countries outside of China. Additionally, Phase 2 clinical studies of povorcitinib for PN, asthma and chronic spontaneous urticaria are also ongoing.

About Vitiligo

Vitiligo is a chronic autoimmune disease characterized by depigmentation of the skin, which results from the loss of pigment-producing cells known as melanocytes. Overactivity of the JAK signaling pathway is believed to drive inflammation involved in the pathogenesis and progression of vitiligo.

It is estimated that there are approximately 14 million vitiligo patients in China and 6.5 million in the eleven Southeast Asian countries respectively. Non-segmental vitiligo patients account for approximately 85% of them[1]. Vitiligo can occur at any age, although many patients with vitiligo will experience initial onset before the age of 30[2]. Currently, therapeutic options for vitiligo are limited, and the condition is difficult to treat, especially for patients with moderate to severe extensive vitiligo.

About Hidradenitis Suppurativa (HS)

HS is a chronic recurrent inflammatory skin condition characterized by the presence of painful inflammatory nodules, abscesses, ruptures, as well as the formation of sinus tracts and scarring. Overactivity of the JAK signaling pathway is believed to drive inflammation involved in the pathogenesis and progression of HS[3].

It is estimated that there are approximately 470 thousand HS patients in China, about 75% of whom are moderate to severe patients[4]. Additionally, it is estimated that there are approximately 13 thousand HS patients in the six Southeast Asian countries, comprising Thailand, Singapore, Malaysia, Philippine, Vietnam and Indonesia. HS has been included in the second batch of the Rare Disease List in China. Given the debilitating nature of condition, it can have a profoundly negative effect on patients’ quality of life. However, currently in China, there are no biologics or small molecule medicines approved by the National Medical Products Administration for the treatment of HS, creating an urgent need for effective therapeutic options[5].

About CMS Skinhealth

CMS’s Dermatology and Medical Aesthetic Business “CMS Skinhealth” regards dermatology prescription products as its core, and extends to dermatology-grade skincare products and light medical aesthetic products, continually optimizing full lifecycle skin-health management solutions, and gradually moving toward becoming “the largest and most professional skin-health management company in China “. Relying on its strong clinical development and commercialization advantages, CMS will realize the commercialization of povorcitinib in the Territory as soon as possible to meet the clinical needs of oral vitiligo drugs with efficacy and benefit relevant patients.

About Incyte

A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe and Asia.

For additional information on Incyte, please visit Incyte.com or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube.

About CMS

CMS is a platform company linking pharmaceutical innovation and commercialization with strong product lifecycle management capability, dedicated to providing competitive products and services to meet unmet medical needs.

CMS focuses on the global first-in-class (FIC) and best-in-class (BIC) innovative products, and efficiently promotes the clinical research, development and commercialization of innovative products, enabling the continuous transformation of scientific research into clinical practices to benefit patients.

CMS deeply engages in several specialty therapeutic fields, and has developed proven commercialization capabilities, extensive networks and expert resources, resulting in leading academic and market positions for its major marketed products. CMS continues to promote the in-depth development of its advantageous specialty fields and expand business boundaries. While strengthening the competitiveness of the cardio-cerebrovascular/gastroenterology business, CMS independently operates its dermatology and medical aesthetics business, and ophthalmology business, aiming to gain leading positions in specialty therapeutic fields, whilst enhancing the scale and efficiency. At the same time, CMS has expanded its business territory to the Southeast Asian market, striving to become a “bridgehead” for global pharmaceutical companies to enter the Southeast Asian market, further escorting the sustainable and healthy development of the Group.

Incyte Forward-Looking Statements

Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding whether and when povorcitinib will be approved for use in mainland China, Hong Kong, Macau, Taiwan or Southeast Asia; whether and when CMS will bring povorcitinib to market in mainland China, Hong Kong, Macau, Taiwan or Southeast Asia; the potential of povorcitinib to treat patients with vitiligo, hidradenitis superativa or for any other indication; the potential for Incyte to receive royalties and payments from CMS for development and commercial milestones; and the potential for Incyte to broaden its ability to bring new medicines to patients in Asia and elsewhere, contain predictions, estimates and other forward-looking statements.

These forward-looking statements are based on Incyte’s current expectations and are subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; Incyte’s dependence on its relationships with its collaboration partners; the efficacy or safety of Incyte’s products and the products of its collaboration partners; the acceptance of Incyte’s products and the products of its collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; and other risks detailed from time to time in Incyte’s reports filed with the Securities and Exchange Commission, including our quarterly report on Form 10-Q for the quarter ended December 31, 2023. Incyte disclaims any intent or obligation to update these forward-looking statements.

CMS Forward-Looking Statements

This press release is not intended to promote any products to you and is not for advertising purposes. This press release does not recommend any drugs, medical devices and/or indications. If you want to know more about the diagnosis and treatment of specific diseases, please follow the opinions or guidance of your doctor or other medical and health professionals. Any treatment-related decisions made by healthcare professionals should be based on the patient’s specific circumstances and in accordance with the drug package insert.

This press release which has been prepared by CMS does not constitute any offer or invitation to purchase or subscribe for any securities, and shall not form the basis for or be relied on in connection with any contract or binding commitment whatsoever. This press release has been prepared by CMS based on information and data which it considers reliable, but CMS makes no representation or warranty, express or implied, whatsoever, and no reliance shall be placed on, the truth, accuracy, completeness, fairness and reasonableness of the contents of this press release. This press release may not be all inclusive and may not contain all of the information that you may consider material. Any liability in respect of the contents of or any omission from this press release is expressly excluded.

Certain matters discussed in this press release may contain statements regarding the Group’s market opportunity and business prospects that are individually and collectively forward-looking statements. Such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and assumptions that are difficult to predict. The Group assumes no obligation to update any forward-looking information contained in this press release. Any forward-looking statements and projections made by third parties included in this press release are not adopted by the Group and the Company is not responsible for such third-party statements and projections.

Contacts:
CMS
Investor Relations: ir@cms.net.cn

Incyte
Media: media@incyte.com
Investors: ir@incyte.com

Reference

1. Ezzedine K, Eleftheriadou V, Whitton M, van Geel N. Vitiligo. Lancet. 2015 Jul 4;386(9988):74-84. doi: 10.1016/S0140-6736(14)60763-7. Epub 2015 Jan 15. PMID: 25596811

2. Frisoli M, et al. Vitiligo: mechanisms of pathogenesis and treatment. Annu. Rev. Immunol. 2020;38(1):621-648

3. Solimani, F., Meier, K., & Ghoreschi, K. (2019). Emerging topical and systemic JAK inhibitors in dermatology. Frontiers in immunology, 10, 2847

4. Prevalence of Acne Inversa (Hidradenitis Suppurativa) in China: A Nationwide Cross-Sectional Epidemiological Study

5. Diagnosis and treatment of acne inversa/hidradenitis suppurativa in China: an expert consensus statement (2021 version)

Media Contact
Brand: China Medical System Holdings Ltd.
Contact: CMS Investor Relations
Website: https://web.cms.net.cn/en/home/

Source: China Medical System Holdings Ltd.

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

SHENZHEN, Mar 28, 2024 – (ACN Newswire) – On March 27, 2024, China Medical System (“CMS” or the “Company”) released its 2023 annual results. The Company recorded a turnover of RMB8,013 million, a year-on-year decrease of 12.4%; in the case that all medicines were directly sold by the Group, the turnover would be RMB 9,472 million, a year-on-year decrease of 9.8%. Profit for the year was RMB2,384 million, and normalized profit for the year that excluding provisions of impairment losses on related assets was RMB2,709 million. The results announcement shows that in 2023, the Company has affected by the implementation of the National Volume Based Procurement (the “National VBP”) of its three marketed original products (sales of these three products recorded a decrease of RMB1,708.7 million, and the sales of them for the second half of the year declined approximately 50% compared with the second half of last year), resulting in temporary turbulence and decline of its overall operation performance. Although three products have not been selected in the National VBP, they are all original medicines for chronic diseases with oral administration, with good brand recognition and large retail market shares. Therefore, the overall impact from National VBP could be expected. The Company’s exclusive non-VBP products has continued to grow. In addition, the Company’s newly marketed innovative product portfolio has been expanded to 4 drugs, and the commercialization and large-scale clinical application of innovative products has provided the Company fresh driving forces. Based on above, CMS has successfully entered into its “New Period” of innovation and internationalization development.

4 innovative drugs have started large-scale clinical application, unveiling CMS’s first year of commercialization era of innovative drugs.

In 2023, CMS delivered quality innovation outcomes. Its three innovative drugs, Diazepam Nasal Spray (VALTOCO), Tildrakizumab Injection (ILUMETRI), Methotrexate Injection-psoriasis (METOJECT), have been included in the National Reimbursement Drug List (NRDL) after obtaining approvals of marketing in China, and have steadily entered into the commercialization stage, further enriching CMS’s marketed product matrix in the specialty therapeutical fields, and supporting CMS to accelerate commercialization process of innovative products.

In addition, in February 2024, CMS obtained the exclusive license of the first-line phosphorus-lowering innovative drug Sucroferric Oxyhydroxide Chewable Tablets (VELPHORO), which has been newly included in the China NRDL and issued its first prescription in China. As of now, CMS’s 4 innovative drugs have officially started large-scale clinical application in China, marked as the start of the CMS’s commercialization era of innovative products

The differentiated innovation pipeline stands as an important driver of the Company’s high-quality development. Driven by the twin-wheel of “Collaborative R&D and Independent R&D”, CMS has continuously deployed global first-in-class (FIC) and best-in-class (BIC) innovative products guided by patient and clinical demands, and has enhanced its R&D capabilities of differentiated innovative products to empower the continuous transformation of scientific research outcomes into clinical application. As of now, CMS has deployed approximately 30 innovative products. Among them, 2 products, Methotrexate Injection – rheumatoid arthritis (RA) and Methylthioninium Chloride Enteric-coated Sustained-release Tablets, are currently under NDA review in China. Meanwhile, over 10 innovative products are undergoing clinical trials in China, mainly randomized controlled trials (RCT). Furthermore, the Company has about 10 self-developed R&D innovation projects, covering large molecules, small molecules, siRNA, etc., among which Highly Selective TYK2 Inhibitor CMS-D001 tablets and GnRH Receptor Antagonist CMS-D002 capsules have obtained IND approvals in early 2024.

CMS states that innovation products expected to be continuously launched every year with higher efficiency and more controllable costs starting from 2023, continuing to energize the Company’s mid- to long-term development. CMS is ready to embrace a brighter future full of opportunities.

Rooted in specialty therapeutical fields, empowering products to achieve clinical and commercial values

Commercialization capability is one of CMS’s core competitiveness. By continuously reinforcing and integrating its commercialization platform, the Company has further consolidated its specialty therapeutic fields focused operation system, and has promoted the independent operation of its three major business segments including cardio-cerebrovascular/gastroenterology, dermatology/medical aesthetics, and ophthalmology. Simultaneously, by leveraging upgraded compliance control system and supporting digital tools, CMS has continuously optimized its professional academic promotion capabilities guided by clinical evidence, and built a number of agile and efficient specialty therapeutical fields-focused commercialization teams.

The Dermatology and Medical Aesthetic Business “CMS Skinhealth” regards dermatology prescription products as its core, and extends to dermatology-grade skincare products and light medical aesthetic products, continually optimizing full lifecycle skin-health management solutions. CMS Skinhealth has officially initiated the promotion of ILUMETRI, relying on the accumulated academic platform of existing marketed products including Hirudoid (the repair agent for skin barrier with multiple functions) and Aethoxysklerol (a German original brand for the treatment of sclerotherapy of varicose veins with years of clinical application). Meanwhile, CMS Skinhealth has obtained the exclusive licenses for the commercialization of three regenerative medical aesthetic products, including Poly-L-lactic Acid Microparticle Filler Injection, Polycaprolactone Microsphere Gel for Injection and Calcium Hydroxylapatite Microsphere Gel for Injection, enriching its regenerative medical aesthetic product portfolio and enhancing the Company’s competitiveness.

The Ophthalmology Business “CMS Vision” continues to improve its organizational structure and operating system, and actively promotes the identification, development and commercialization of urgently needed clinical solutions. Innovative medical device, EyeOP1 Glaucoma Treatment Device, has completed market access in many provinces and cities, and is synergized with the exclusive marketed product Augentropfen Stulln Mono Eye Drops in marketing and promotion. VEGFA/ANG2 Tetravalent Bispecific Antibody, a class I innovative biological agent, is under the phase I clinical trial stage in China.

The results announcement shows that as of the end of 2023, CMS has approximately 4,400 professional academic promotional personnel, and its promotion network has covered over 50,000 hospitals and medical institutions across China and nearly 250,000 retail pharmacies. CMS’s marketed products portfolio mainly includes exclusive branded drugs, with the successive approvals of innovative products in 2023, the Company’s future growth potential will be further released. At the same time, leveraging the accumulated advantages in cardio-cerebrovascular, gastroenterology, central nervous system, ophthalmology, dermatology and other specialty therapeutical fields, and its strong professional academic promotion capabilities, compliant and efficient management system, CMS has further enhanced its business efficiency and competitiveness to create broad commercial potential for its innovative products and exclusive products.

Accelerating international business development, forging new growth engines

Guided by the local unmet medical needs, CMS’s Southeast Asian business company “Rxilient Health”, leveraged the Group’s advantageous resource and operated by a local team with rich pharmaceutical industry expertise, has rapidly introduced a diverse product portfolio and established a business network covering various Southeast Asian countries. In March 2023, Rxilient Health entered into a collaboration agreement with Junshi Biosciences, leveraging Rxilient Health’s drug registration and commercialization advantages and Junshi Biosciences’s strong R&D strength, two parties to collaboratively develop and commercialize intravenous toripalimab, one of the key Chinese innovative drugs going overseas, in nine Southeast Asia countries.

In December 2023, CMS and Rxilient Health joined hands with Pharmaron and others to jointly complete the acquisition of a manufacture plant in Singapore and accelerate the process of CDMO business. This cooperation is expected to improve the accessibility of quality drugs with unmet clinical needs in emerging markets and help global pharmaceutical companies to quickly enter markets such as Southeast Asia. The acquisition of Singapore manufacturing plant will optimize the CMS’s overseas supply chain and manufacturing capabilities, and enhance the stability of its international supply chain. Moreover, it will facilitate CMS to carry out product collaborations with its global partners in the future, continuously building a collaborative, mutually beneficial pharmaceutical innovation ecosystem.

The Share Award Schemes enhances employee enthusiasm and creativity, enabling long-term binding towards a shared future for all.

In order to maintain the momentum of innovation and accelerate the commercialization process of innovative products, on March 27, CMS announced the adoption of the “Share Award Scheme Related to CMS New Products”, which using the Company’s own funds to purchase its shares. No more than 100 million Shares will be granted to the Group’s core management and key personnel at nil consideration, subject to the satisfaction of certain performance targets and in compliance with the CMS Scheme to encourage them to continue to make outstanding contributions to the launch and sales of new products.

According to the announcement, the schemes will determine “the stipulated performance targets” based on the overall financial performance of the Group, the cumulative sales revenue of a specified product or products, number of new products launched during any specified period. Among them, the “performance targets” associated with The First Batch of Share Awards include: launching 10 new products from 2020 to 2024. The cumulative total sales revenue of three blockbuster innovative drugs: METOJECT, VALTOCO, and VELPHORO in the three years from 2024 to 2026 will reach RMB2.5 billion. “Performance targets” associated with the future share awards include: the rolling share award scheme for the sales of new products, and to launch 12 new products from 2025 to 2027.

In addition, the three independently operated business segments of “CMS Skinhealth”, “CMS Vision” and “Rxilient Health” will formulate the separate Share Award Schemes based on their respective business development situations. ILUMETRI, as a significant innovative product of “CMS Skinhealth”, will be included in the assessment under the separate Share Award Scheme of “CMS Skinhealth”.

By continuously improving the long-term incentive mechanism, CMS closely links employee interests with the Company’s innovation development, maximizing employee enthusiasm to serve the Company’s long-term development diligently and responsibly. Furthermore, the schemes releases sufficient confidence to the capital market for the CMS’s steady development in the future.

Looking ahead, CMS will embrace “New CMS and New Era” after the short period of turbulence.

While accelerating its development under the guidance of innovation, CMS is firmly ushering in a new era. At the beginning of 2024, the term “innovative drugs” has been included in the government work report for the first time, indicating that innovative drugs have a leading strategic position among domestic emerging industries and have received great attention from the government. It will benefit pharmaceutical companies with advanced R&D capabilities, rich pipeline layouts, and mature commercialization systems.

CMS is diligent and devoted to innovation, and has always adhered to its mission of providing competitive products and services to meet unmet medical needs. With the gradual digestion of national VBP implementation impacts on its existing products, and the further deepening of its innovation development, CMS has been well-prepared for a brighter future going forward and will return to the track of sustained and healthy growth. Under its compliant and efficient commercialization system, the Company’s innovative products and exclusive drugs will grow steadily. Concurrently, it is expected that more differentiated innovative products will be continuously launched with higher efficiency and more controllable costs every year in the future, continuously optimizing the Company’s marketed product structure. As a mature pharmaceutical company with excellent historical performance, although the turbulence of adjustment period is inevitable, with the continuous enhancement of its innovation strength, CMS will surely usher in a new cycle of performance growth.

Media Contact
Brand: China Medical System Holdings Ltd.
Contact: CMS Investor Relations
Email: ir@cms.net.cn
Website: https://web.cms.net.cn/en/home/

Source: China Medical System Holdings Ltd.

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