China Medical System (00867) Obtained Exclusive License of a First-line Phosphate-lowering Drug Velphoro(R)

SHENZHEN, CHINA, Feb 4, 2024 – (ACN Newswire) – China Medical System Holdings Limited (“CMS” or the “Group”) is pleased to announce that on 2 February 2024, the Group through its wholly-owned subsidiary entered into a Novation Agreement (the “Novation Agreement”) with Vifor Fresenius Medical Care Renal Pharma Ltd. (“VFMCRP”) and Winhealth Investment (HK) Limited (“Winhealth Investment”) for sucroferric oxyhydroxide chewable tablets Velphoro® (the “Product”).

Winhealth Investment and VFMCRP entered into a License Agreement (the “License Agreement”) for the Product on 28 June 2023. In accordance with the License Agreement, Winhealth Investment gained an exclusive license to registerï¼Œimport, promote, distribute, use and sell the Product in Mainland China, Hong Kong Special Administrative Region, Macao Special Administrative Region and Taiwan Region (the “Territory”). The License Agreement commenced on its effective date and continues to be valid until the fifteenth anniversary of the date of the Product’s first commercial sale in the Territory. Upon the expiration of the aforementioned term, the License Agreement may automatically be renewed for ten years as per certain conditions defined in the License Agreement. Thereafter, unless the parties reach a new agreement, the License Agreement will terminate upon expiration.

In accordance with the Novation Agreement, Winhealth Investment novated its above-mentioned rights and obligations for the Product to a wholly-owned subsidiary of CMS.

Velphoro® (Sucroferric Oxyhydroxide Chewable Tablets )

As of 2 February 2024, the Product is the first iron-based, non-calcium phosphate binder (PB) approved by National Medical Products Administration (NMPA) in China1, filling the gap of phosphorus-lowering treatment for Chinese paediatric patients aged 12 to 18 years old with CKD stages 4-5 or CKD on dialysis.

Velphoro® is a Class 5.1 imported innovative drug, which was approved through the priority review and approval procedure in China in February 2023 for the control of serum phosphorus (sP) levels in adults with chronic kidney disease (CKD) on hemodialysis (HD) or peritoneal dialysis (PD), and meanwhile, for the control of sP levels in paediatric patients 12 years of age and older with CKD stages 4-5 (defined as glomerular filtration rate <30mL/min/1.73 m²) or CKD on dialysis. The Product has been newly included in category B of China’s National Reimbursement Drug List for Basic Medical Insurance, Work-Related Injury Insurance and Maternity Insurance (2023 Version) (the “National Reimbursement Drug List”). There is an issued patent that protects the formulation, usage, particle size and manufacturing methods of the Product in China.

Hyperphosphatemia is a common complication in CKD patients, especially in patients with end-stage renal disease on dialysis, characterized by a high morbidity and a low compliance rate. It is an independent risk factor for nephropathy progression, secondary hyperparathyroidism, cardiovascular events and all-cause mortality in CKD patients2. Controlling sP levels can significantly improve the outcomes of CKD patients.

Since non-calcium PB has no risk of vascular calcification, domestic and foreign guidelines consistently recommend non-calcium PB as first-line treatment for reducing sP levels, and limit the use of calcium-based PB. Velphoro® is a new generation of iron-based, non-calcium PB, reducing sP levels of patients and increasing the sP compliance rate. Velphoro® has been launched in 51 countries/territories including the US, EU and Japan, maintaining a leading position in the global PB market.

It is demonstrated in multiple global clinical studies and real-world research data (as published in academic journals including International Urology and Nephrology, and Clinical Nephrology) and the Chinese instruction of the Product that compared with other PBs, patients maintained on Velphoro® used about 50% fewer PB pills/day3, and the proportion of patients achieving target sP increased by 95%4. Velphoro® has characteristics of good safety5 and patient compliance6 without risk of calcium and heavy metal accumulation. In addition, the Product holds the advantages of unaffected absorption of oral liposoluble vitamin D7, maintaining stable iron parameters8, improving the nutritional status in patients9, reducing hospitalization rates, and alleviating patients’ medical financial burdens10. Velphoro® is expected to further improve the dialysis patients’ quality of life and become a new option of phosphorus-lowering treatment for CKD dialysis patients in China.

CMS continues to invest in and develop differentiated innovative products, providing a continuous source of momentum for the long-term and stable development of the Group. Velphoro® is a newly approved innovative drug in China in 2023 and has been successfully included in category B of the National Reimbursement Drug List. It will rapidly expand the Group’s marketed innovative product portfolio and kidney disease product portfolio, and will synergize with the Group’s marketed products XinHuoSu (recombinant human brain natriuretic peptide for injection), Plendil (felodipine sustained-release tablets) and the innovative drug Desidustat tablets (intended to treat anemia in CKD patients) which is in the clinical development stage for registration in terms of expert network and market resources. It is expected to have a positive impact on the Group’s financial results.

More information about Hyperphosphatemia

The total number of CKD patients reaches 132 million in China, of which nearly 1 million existing patients receive dialysis treatments11, and continues to increase at a rate of approximately 10% per year. The prevalence of hyperphosphatemia reaches 72.1%12 in CKD patients on dialysis, and nearly 50% of dialysis patients need to receive oral PB to control sP levels13. According to the survey in Chinese patients with chronic kidney disease-mineral and bone disorder, combined with real-world findings, on the basis of existing phosphate-lowering treatments, the sP compliance rate of CKD dialysis patients in China is only 24.3%14. The low sP compliance rate is currently the clinical pain point of hyperphosphatemia, and there is an urgent need for more potent drugs with lower pill burden and better adherence to satisfy the clinical treatment demand of hyperphosphatemia.

Reference
1. Drug registration information can be found on the NMPA official website, as follows: https://www.nmpa.gov.cn/datasearch/search-result.html
Or can be found in the public medical insurance materials, as follows
http://www.nhsa.gov.cn/attach/Ypsn2023/YPSW202300180/YPSW202300180-W1(ppt).pdf
2. XQ Yu, et al. Chin J Nephrol, 2018. 34(11): 867-871
3. The Instructions for Sucrose HydroxyIron Oxide Chewable Tablets
4. Coyne DW, et al. Clin Nephrol. 2017 Aug;88(8):59-67.
5. Xie, D., Ye, N. & Li, M., Int Urol Nephrol 50, 905-909 (2018)
6. Floege J, et al. Nephrol Dial Transplant. 2015 Jun;30(6):1037-46
7. Sprague SM,et al.Am J Nephrol. 2016;44(2)104-12
8. Vervloet MG et al. Clin Kidney J 2021;14:1770-9
9. Kalantar-Zadeh K, et al. BMC Nephrol . 2019 0ct 29;20(1):396
10. Kidney Med. 2020 May-Jun; 2(3): 307-316
11. The data of China’s CNRDS reported by academician, Meixiang Chen., on 2023 Annual Conference of Chinese Nephrologist Association.
12. YF Chen, et al. Chin J Blood Purif. 2022; 21(05): 305-308.
13. Kidney International Supplements, 2020, 10(2): e97–185
14. Hong, D. et al. Sci Rep 12, 16694 (2022).

1. This news/article is intended to share cutting-edge medical information. It is only for reference by medical and health professionals for academic purposes and is not for advertising purposes; it does not recommend any drugs, medical devices and/or indications.
2. The information involved in this news/article is for reference only. Please follow the advice 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.

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.

CMS(00867) Joins Hands with Pharmaron to Promote the Singapore Manufacturing Plant Acquisition and CDMO Business in SEA

SHENZHEN, Jan 2, 2024 – (ACN Newswire) – On 29 December, 2023, PharmaGend Global Medical Services Pte. Ltd. (“PharmaGend”), jointly invested by China Medical System Holdings Limited (“CMS”), through its wholly-owned subsidiary CMS MEDICAL VENTURE PTE. LTD., and its non-wholly owned subsidiary Rxilient Health Pte. Ltd., with Pharmaron (Hong Kong) International Limited (“Pharmaron”) * and Healthy Goal Limited (“Legend Fund”), has entered into a lease agreement for the building and property located in Tuas, Singapore and completed the purchase of certain production machines and equipment from Strides Pharma Global Pte. Ltd. ( defined as “Singapore manufacturing plant ”).

Based on over 30 years of global investment and acquisition experience and proven commercialization capabilities, CMS actively implements an internationalization strategy starting from Southeast Asia with the mindset of openness and collaboration. The acquisition of Singapore manufacturing plant will be able to optimize the layout of the CMS’s overseas supply chain and production capacity, ensure the safety of the international supply chain and improve supply stability. In addition, it will help CMS to carry out product cooperation with global partners in the future and promote more cooperation opportunities.

The Singapore manufacturing plant has advanced manufacturing machines, equipment and first-class infrastructure. It had been approved by Health Sciences Authority of Singapore (HSA), U.S. Food and Drug Administration (FDA) and Therapeutic Goods Administration of Australia (TGA). It will serve as the plant and site for PharmaGend to carry out pharmaceutical formulation, finishing, and packaging business, accelerating the formulation Contract Development and Manufacturing Organization (formulation CDMO) business development in Singapore. These progresses will promote the globalization, high-quality, and sustainable healthy development of cooperative parties, and are expected to improve the accessibility of high-quality drugs with unmet clinical needs in emerging markets.

Additionally, CMS is gradually building up a systematic platform in Southeast Asia integrating product introduction, development, manufacture, formulation CDMO, marketing and promotion. The smooth progress of the formulation CDMO cooperation is of great significance to CMS in accelerating its business development in Southeast Asia. Relying on Singapore’s advantages in location, policy and talents, CMS will fully synergize with Pharmaron’s rich global R&D and international CDMO operation capabilities and experience as well as Legend Fund’s capital market influence, to efficiently promote the clinical development and commercialization of innovative products. It is expected to help global pharmaceutical companies to quickly enter the Southeast Asian market, while empowering Chinese pharmaceutical companies to achieve more efficient and high-quality international development, building a medical innovation ecosystem that is mutually beneficial.

CMS Stated: Pharmaron is an internationally leading service provider for new drug development and production, providing high-quality services to global companies and helping to reduce costs and increase efficiency of R&D in the pharmaceutical industry. Legend Fund has strong capital market influence and rich healthcare industry resources. This cooperation maximizes advantage of each party, and we will leverage Singapore’s favorable geographical and market environment, jointly promote the development and production of high-quality pharmaceutical products, introduce global novel and quality drugs that meet clinical needs to Southeast Asian patients, safeguarding patients’ quality of life.

*PharmaGend is 33.8% owned by CMS’s wholly-owned subsidiary, and 11.2% owned by Rxilient Health, 35% owned by Pharmaron, and 20% owned by Legend Fund.

Media Contact
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Contact: CMS Investor Relations
Email: ir@cms.net.cn
Website: https://web.cms.net.cn/en/home/

China Medical System: 4 Products Have Been Newly Included or Continued to be Included in the NRDL

– Innovative drugs VALTOCO (Diazepam Nasal Spray)ï¼ŒILUMETRI (Tildrakizumab Injection) and rare disease drug Tetrabenazine Tablets have been newly included in China’s National Reimbursement Drug List(NRDL), XinHuoSu (Recombinant Human Brain Natriuretic Peptide for Injection) has continued to be included in NRDL.

– China Medical System actively responds to national policies to promote innovative products to be included in the NRDL. Up to now, 3 innovative drugs that have been approved for marketing (Diazepam Nasal Spray, Tildrakizumab Injection and Methotrexate Injection-psoriasis) have all been included in the NRDL, further improving the accessibility and affordability of the drugs and allowing innovative products to benefit more patients.

– The new/continued inclusion of the 4 products in the NRDL will be conducive to promoting the market coverage of the products and building professional brand power, and will have a positive effect on CMS’s business development.

SHENZHEN, Dec 13, 2023 – (ACN Newswire) – China Medical System Holdings Limited is pleased to announce that according to a notice issued by National Healthcare Security Administration and the Ministry of Human Resources and Social Security of the People’s Republic of China on 13 December 2023, innovative drugs Diazepam Nasal Spray (VALTOCO) and Tildrakizumab Injection (ILUMETRI) and rare disease drug Tetrabenazine Tablets have been newly included in category B of China’s National Reimbursement Drug List for Basic Medical Insurance, Work-Related Injury Insurance and Maternity Insurance (2023 Version) (the “National Reimbursement Drug List”) and Recombinant Human Brain Natriuretic Peptide for Injection (XinHuoSu) has continued to be included in category B of the National Reimbursement Drug List, which shall be officially implemented from 1 January 2024. In addition, innovative drug Methotrexate Injection (Metoject) indicated for psoriasis approved in March 2023 has been included in category A of the National Reimbursement Drug List.

Basic Information of the Products

VALTOCO (Diazepam Nasal Spray)

VALTOCO has been approved for marketing in China in June 2023. It is the first nasal spray formulation of diazepam in China and the first drug approved in China for the treatment of seizure clusters. VALTOCO is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e. seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy 6 years of age and older.

VALTOCO is a proprietary formulation of diazepam administered through the nasal mucosa with high bioavailability, outstanding absorbability, tolerance and reliability. VALTOCO has a unique combination of Vitamin E-based solvents and Intravail® absorption enhancer. Intravail® transmucosal absorption enhancement technology enables the non-invasive delivery of a broad range of proteins, peptides and small-molecule drugs. VALTOCO is administered intranasally. Under prescription from a doctor and guidance from medical staff, VALTOCO can be administered anytime and anywhere with a rapid onset of action. It has the differentiated advantages of seizure rescue and convenient administration, meeting the current clinical need of acute treatment of domestic epilepsy patients with cluster seizures.

CMS was assigned the relevant assets of VALTOCO for the exclusive use of such assets in the Territory (mainland China, Hong Kong, Macau, Taiwan, and Singapore) from A&B (HK) Company Limited through an asset assignment and exclusive license agreement with Neurelis, Inc., a U.S. company.

ILUMETRI (Tildrakizumab Injection)

ILUMETRI has been approved for marketing in China in May 2023. It is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. ILUMETRI is a humanized lgG1/κ monoclonal antibody designed to selectively bind to the p19 subunit of interleukin-23 (IL-23) and inhibit its interaction with the IL-23 receptor, leading to inhibition of the release of pro-inflammatory cytokines and chemokines.

The results of the extended study of Phase III clinical trial in China demonstrated that the primary efficacy assessment indicator PASI 75 response rate continued to increase over treatment time. The PASI 75 response rate reached a high level after 28 weeks of treatment with ILUMETRI and maintained at 91.3% at week 52, and ILUMETRI showed good long-term safety and tolerance. ILUMETRI only requires 4 administrations per year over maintenance period, which may result in higher patient compliance.

CMS obtained an exclusive license for ILUMETRI from Sun Pharmaceutical Industries Ltd. in June 2019.

Tetrabenazine Tablets

Tetrabenazine Tablets has been approved for marketing in China in May 2023. It is indicated for the treatment of Huntington’s disease. Tetrabenazine tablets, as a first-line drug for Huntington’s disease, is expected to provide another more accessible and affordable drug option for patients with the rare disease.

CMS obtained an exclusive license for Tetrabenazine Tablets from Sun Pharmaceutical Industries Ltd. in August 2019.

XinHuoSu (Recombinant Human Brain Natriuretic Peptide for Injection)

XinHuoSu is the only Recombinant Human Brain Natriuretic Peptide (rhBNP) medicine available in the Chinese market and is indicated for the treatment of acute decompensated heart failure. XinHuoSu can quickly ease the symptoms and signs of heart failure in patients with heart failure and improve the quality of life of patients. It has been recommended by multiple authoritative guidelines and consensus.

XinHuoSu is owned and manufactured by a wholly-owned subsidiary of Tibet Rhodiola Pharmaceutical Holding Company (a company listed on the Shanghai Stock Exchange with stock code: 600211) (the “Tibet Pharmaceutical”). CMS holds approximately 37.36% of the shares of Tibet Pharmaceutical. CMS obtained the exclusive sale and distribution right of XinHuoSu from Tibet Pharmaceutical in March 2008.

Impacts on the Company

CMS actively responds to national policies to promote innovative products to be included in the National Reimbursement Drug List. Up to now, three innovative drugs that have been approved for marketing (VALTOCO, ILUMETRI and Metoject) have all been included in the National Reimbursement Drug List, further improving the accessibility and affordability of the drugs and allowing innovative products to benefit more patients. At the same time, the new/continued inclusion of the four products in the National Reimbursement Drug List will be conducive to promoting the market coverage of the products and building professional brand power, and will have a positive effect on CMS’s business development.

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/

Nitinotes Surgical in Full Swing: Impressive Board Appointment, Over 90 Patients Treated, 400+ Sutures Performed, and a $10.1M Series B Funding Round Closure

Nitinotes, developers of EndoZip™, a revolutionary, fully automated suturing device, announced the appointment of Mr. John Barr as the new Chairman of the Board of Directors. Barr has over 40 years of experience in MedTech, including his significant role at Apollo Endosurgery as the Chairman of the Board. This experience positions him perfectly to lead the strategic thinking as Nitinotes prepares for the EU market entry and further develops the EndoZip system.

Mr. John Barr, Nitinote’s new Chairman

This significant appointment coincides with a period of remarkable clinical achievements for Nitinotes. To date, over 90 patients have successfully undergone procedures using the EndoZip™ system, with more than 400 sutures performed by 14 different physicians, showcasing the device’s efficacy and reliability in the field of obesity treatment.

EndoZip™: Pioneering a New Era in Endoscopic Obesity Treatment

EndoZip™, Nitinotes’ flagship product, is a state-of-the-art robotic endoscopic fully automated suturing system designed to transform the landscape of endoscopic gastroplasty procedures.

EndoZip™ offers a minimally invasive approach, making it a viable option for patients with obesity class I & II, who are not suitable candidates for traditional bariatric surgery. Its innovative design ensures consistent and safe suturing, which is crucial for patient outcomes, and represents a major advancement in the treatment of obesity.

EndoZip™: Setting a New Standard in Obesity Treatment

EndoZip™ is revolutionizing the treatment of obesity. This technology is a game-changer in the medical field because of its ease of use, short learning curve, and potential for significant scale-up.

Amidst challenging times, Nitinotes has successfully secured funding, reflecting the strong confidence in the vision and technology.

CEO Raz Bar-On shared his perspective on this exciting phase: “The world is waking up to the significance of Endoscopic Sleeve Gastroplasty (ESG), and we’re right there, at the forefront of this medical revolution, to lead the change.”

About Nitinotes: A Leader in Innovative Obesity Treatment

The Nitinotes company is on the cutting edge of medical technology, focusing on innovative solutions for obesity treatment.

The company’s flagship product, EndoZip™, is a groundbreaking robotic fully automated endoscopic suturing system that offers a minimally invasive approach for obesity class I & II patients. Its unique design ensures consistent, safe suturing, at the press of a button, marking a significant advancement in obesity treatment.

Join Nitinotes’s Journey

For more information about Nitinotes and the revolutionary EndoZip™ system, visit Nitinotes’ Website at https://nitinotesurgical.com/ and follow the company’s activity on Nitinotes’ LinkedIn Page.

Contact Information
NITINOTES SURGICAL
info@nitinotesurgical.com
+97248876698

Raz Bar-On
CEO
razbaron@nitinotesurgical.com
+972502008225

Avigail Porat
Content Marketing Manager
avigail@humanbrands.marketing
+972545882895

Related Images

Related Image Mr. John Barr Mr. John Barr, Nitinote’s new Chairman

Related Image EndoZip™ System EndoZip™ is the first automated suturing system, designed to transform the landscape of endoscopic gastroplasty.

China Medical System: NDA for Additional RA Indication of Methotrexate Injection Accepted in China

– The New Drug Application for an additional rheumatoid arthritis (RA) indication of Methotrexate Injection has been accepted by NMPA, which is a new milestone following the China approval for psoriasis indication of Methotrexate Injection. The Product is expected to become the first methotrexate (MTX) prefilled injection to treat RA by subcutaneous administration in China.

– The China bridge clinical trial of the Product’s RA indication reached the main endpoint; The results of secondary efficacy indicators suggest that the efficacy of the product is significantly better than that of MTX tablets or there is a trend of better. The product also has some advantages over MTX tablets in gastrointestinal safety.

– MTX is recognized internationally as the first choice first-line and anchor drug for RA. As a small-volume MTX prefilled injection with various strengths, the Product is expected to provide a safer, more effective, more convenient and more accurate administration scheme for active RA adult patients.

– Clinical development of the Group’s innovative products proceeds steadily, with innovative outcomes generated successively: 3 obtained marketing approval (Diazepam Nasal Spray, Tildrakizumab Solution for Injection, Methotrexate Injection-psoriasis indication); 2 under NDA review (Methylthioninium Chloride Enteric-coated Sustained-release Tablets and Methotrexate Injection-RA indication); over 10 registrational clinical trials are ongoing.

SHENZHEN, CHINA – China Medical System Holdings Limited ( “CMS” or the “Group”) announced that on 4 December 2023, the New Drug Application (NDA) for an additional indication of its innovative product, Methotrexate Injection (the “Product”), has been accepted by the National Medical Products Administration of China (NMPA). The Product is a small-volume methotrexate injection with various strengths, which is intended to be used to treat active rheumatoid arthritis (RA) in adult patients.

Methotrexate is recognized internationally as the first choice first-line and anchor drug for RA. The Product is expected to become the first methotrexate prefilled injection to treat RA by subcutaneous administration in China, providing a safer, more effective, more convenient and more accurate administration scheme for active RA adult patients.

According to the communication with NMPA, the bridge clinical trial of the Product in China (the “Study”) aims to compare the changes of DAS28-ESR score of patients with RA treated by methotrexate injection and methotrexate tablets compared with the baseline, and to judge whether the non-inferiority is established. The Study reached the preset main endpoint, and the experimental group (given the Product) was not inferior to the control group (given methotrexate tablets). In addition, the results of secondary efficacy indicators suggest that the efficacy of the Product is significantly better than that of methotrexate tablets or there is a trend of better. The results also show that some of the curative effects that can be observed in the early stage of the Product are more obvious than those of methotrexate tablets, suggesting that the curative effect of the Product appears earlier. The Product has some advantages over methotrexate tablets in gastrointestinal safety, and no new safety risks have been found in the Study.

In March 2023, the Product, the first MTX pre-filled injection for subcutaneous administration in China, was approved for marketing in China for the treatment of severe recalcitrant disabling psoriasis, which is not adequately responsive to other forms of therapy such as phototherapy, PUVA, and retinoids. The Product was also announced as a Reference Listed Drug by NMPA in July 2021.

At present, the Product has been approved for marketing in more than 40 countries and regions around the world, including the European Union, Australia, China, etc.

The Group obtained a long-term effective and exclusive license for the Product from medac Gesellschaft für klinische Spezialpräparate m.b.H on 21 September 2020.

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.

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Contact: CMS Investor Relations

Email: ir@cms.net.cn

Website: https://web.cms.net.cn/en/home/

MedTech Innovations and Digital Breakthroughs: Announcing the 2023 Pharma IT Summit for a Future-Ready Pharmaceutical Landscape

MUMBAI, INDIA, Nov 30, 2023 – (ACN Newswire) – A notable pharmaceutical company in India faced significant challenges in overseeing its complex IT infrastructure. Obsolete legacy systems, inconsistent data sources, and the need to comply with strict regulatory requirements hampered innovation and operational effectiveness. Consequently, the company launched a broad Pharma IT initiative. A cloud-based infrastructure was implemented to centralise data storage, guaranteeing scalability and accessibility. The incorporation of cutting-edge analytics tools enhanced research and development, promoting data-driven decision-making. Concurrently, a strong cybersecurity framework was established to ensure adherence to regulatory mandates and protect confidential patient data.

The Pharma IT transformation yielded impressive outcomes. The implementation of advanced analytics resulted in an impressive 20% reduction in drug development cycles, while a streamlined infrastructure led to a noteworthy 30% reduction in operational costs. The cybersecurity measures improved the company’s reputation for data security in addition to complying with regulations. The company not only overcame immediate difficulties by implementing state-of-the-art Pharma IT solutions, but it also established itself as a market leader in India’s very competitive pharmaceutical sector. This transformation was a great success and demonstrated how important IT is to driving innovation, efficiency, and compliance in India’s ever-expanding pharmaceutical industry.

An overview of the 14th Edition Of the Pharma IT Summit:

Recognized as the “world’s pharmacy,” India’s pharmaceutical industry stands at the forefront of groundbreaking innovation, particularly in the realm of life-saving medicines. Within the global pharmaceutical sector, India has emerged as a significant and ascendant player. The industry holds a pivotal role in the worldwide healthcare system, with market projections anticipating a reach of $1.5 trillion by 2023. Furthermore, it constitutes a substantial portion of India’s GDP, contributing over 5% to the nation’s economic output. Notably, India claims the title of the largest supplier of generic drugs globally, with a staggering 20% of the world’s supply originating from the country. The sector is poised for continued expansion, with forecasts indicating a market size of $100 billion by the year 2025.

The 14th Edition of the Pharma IT Summit is dedicated to propelling pharmaceutical technology forward through a commitment to collaboration, innovation, and education. This conference serves as a platform for in-depth discussions on crucial topics such as AI & ML, digital transformation, Industry 4.0, cybersecurity, and more. Whether you are a seasoned professional in the pharmaceutical industry, a tech expert, or someone intrigued by the latest advancements in the field, the Pharma IT Summit offers valuable insights for everyone involved. This summit stands as a testament to the dynamic intersection of pharmaceuticals and technology, fostering an environment where ideas converge to shape the future of healthcare.

Addressing the ever-growing concern about cybersecurity in the pharmaceutical sector, the summit will delve into topics like:

Creating a Culture of Innovation: The Vital Role of Government in Pharma
Digital Disruption in Pharma: Challenges and Opportunities
The era of digital adoption – Industry 4.0
The Role of technology in Accelerating Drug Discovery and Development
Unleashing the Potential of AI and Data Analytics in Pharmaceutical Innovation
Cybersecurity in Pharma: Risks and Mitigation Strategies

Who can attend?

The Exito DevOps Summit will be attended by top executives and leaders like CIO’s, CTO’s, Head of Cloud Security, Engineering Directors, Directors of IT, Heads of UI/UX, Product Managers, APP developers, Chief Architects, Network Engineers from a variety of industries including Government, Foreign Utilities, Telecom, Education, Healthcare, Manufacturing,Logistics & Supply, Ecommerce & Retail, BFSI & Fintech, Pharma & Life sciences, Construction and Hospitality.

About Exito:

Exito, which means success in Spanish, embodies our commitment to the success of our customers. Each year, we host over 240 virtual and in-person conferences globally, bringing together audiences with world-class thought leaders and C-level executives across industries. Our meticulously crafted agendas, based on extensive research and valuable industry insights, facilitate business, knowledge transfer, deal flow, and impactful messaging for brands.

For Media Enquiries, contact:
Kasturi Nayak (Sr. Marketing Executive)
Kasturi.nayak@exito-e.com
Enquiry@exito-e.com
Exito Media Concepts

Indonesia’s ITS Launches 7 MedTech Devices Based on Various Integrated Technologies

SURABAYA, Indonesia, Nov 9, 2023 – (ACN Newswire) – Sepuluh Nopember Institute of Technology (ITS), a leading university in Indonesia, with PT Tekno Sains Medika and PT Bina Makmur Abadi, has developed seven medical devices using integrated digital technologies, in a significant boost to the country’s nascent MedTech industry.

The seven devices use integrated 3D design and digital fabrication technology. Through fabrication technology, products can be customized and made based on consumer request. It is expected that the use of this technology can help speed up the handling of medical cases, said Djoko Kuswanto, ITS lecturer and medical equipment inventor.

ITS launches seven medical technology devices using integrated 3D design and digital fabrication technology – a boost to the country’s MedTech industry [IMAGE: ITS].

The new products include AMO3D, a 3D-printed implant mold based on patient data; GUO3D, a 3D-printed work support tool; and PRO3D, a 3D-printed body protective device made using patient-specific scans. These tools are the only ones in Indonesia that combine innovation and digital technology for use in healthcare settings.

ITS has also created products called HUMA3D in the form of a mannequin, and TSM.Bones, a replica of human bones for educational purposes and clinical training for aspiring medical professionals.

The final products are RiseHand, a tool that assists patients with amputated fingers in grasping objects, and Surgical Instrument, a range of tools for surgical operations, including scissors, knives, and tweezers.

These medtech products, which were launched at the 35th Hospital Expo, Jakarta Convention Center on October 18 have been used by several hospitals and universities in Indonesia, and hundreds of units of the devices have been ordered. So the quality of these products is no less competitive comparing with products from developed countries, Kuswanto said.

Bambang Pramujati, ITS Deputy Rector, said: The launch of these medtech devices is proof of ITS’ commitment to developing technology in the health sector. The large volume of imported medical equipment and the rapid development of technology prompted ITS to develop the medical equipment by increasing the domestic component level to above 40 percent.

Besides collaborating with Airlangga University Hospital (RSUA) for the research and trials phase, the development of the new medical devices also involved the use of locally sourced components and the support of digital technology, said Pramujati.

Digital 3D printing technology, artificial intelligence (AI), as well as augmented reality (AR) and virtual reality (VR), can be used to improve health facilities in Indonesia, Pramujati said.

Nike Besta Sari, Director of PT Tekno Sains Medika, said: The price of the products is lower compared to other similar products. For example, HUMA3D is being sold for just under Rp50 million (around US$3,200), which makes it cheaper compared to similar products that cost hundreds of millions of rupiah.

Using locally-made components, the new devices are produced on a pre-order system. Sales pricing is less than that of imported products, but does not reduce product quality, Sari said, adding that the company would be holding development workshops regarding the healthcare tools at various locations throughout Indonesia.

By Yashinta Difa Pramudyani, Edit by Anton Santoso, COPYRIGHT (c) ANTARA 2023

Clinical Squared and PlatoHealth Join Forces to Revolutionize Healthcare with Advanced Data Orchestration Powered by AI

Washington, D.C., Sept 21, 2023 – (ACN Newswire) – Clinical Squared (C 2 ) and Platohealth.ai are delighted to announce a groundbreaking partnership that promises to reshape the healthcare landscape. Their collaboration brings together the healthcare expertise of C2 and the cutting-edge AI and machine learning capabilities of Plato.ai to create innovative solutions.

Clinical Squared, a leader in healthcare market expertise, data architecture, software development, consultation and implementation services, will lend its extensive industry knowledge to Plato.ai’s platform. In turn, Plato.ai will provide advanced AI and machine learning mechanisms to enhance C2’s products and services.

This strategic partnership aims to deliver more efficient and effective healthcare solutions for consumers, organizations and the broader healthcare ecosystem.

Marquis Allen, CEO of C2

“We are thrilled to partner with PlatoHealth.ai in our mission to transform healthcare experiences and outcomes using cutting-edge technology. Our collaboration represents a significant milestone for Clinical Squared as we leverage Plato.ai’s superior AI capabilities to power our data navigation and orchestration tools for consumers and enterprises in the healthcare sector.”

Bryan Feinberg, CEO of PlatoHealth

“This announcement comes at an opportune moment for both companies and we are excited to join forces with Clinical Squared to create transformative healthcare solutions powered by AI and machine learning. This partnership underscores our commitment to improving patient outcomes and healthcare processes. We look forward to the exciting innovations that will emerge from this collaboration.”

Key Highlights of the Partnership:

Healthcare Expertise: Clinical Squared’s deep healthcare domain expertise will enrich Plato.ai’s AI models, ensuring that they are tailored to the specific needs of the healthcare industry.

Advanced AI: Plato.ai’s advanced AI and machine learning mechanisms will be integrated into C2 products, enhancing their capabilities for healthcare organizations and technology users of varying skill levels

Innovation: The partnership aims to drive innovation in healthcare by developing solutions that provide security and portability of data as well as deep analytical context for users of the products they collaborate on.

Enhanced Patient Outcomes: By combining industry knowledge with AI-driven insights, the collaboration seeks to contribute to better patient outcomes and overall healthcare quality.

This partnership represents a significant step forward in the quest to harness the power of technology for the betterment of healthcare. Together, Clinical Squared and Plato.ai are committed to creating solutions that address the unique challenges of the healthcare industry, improving efficiency, and ultimately delivering better care to patients.

For more information about Clinical Squared and PlatoHealth.AI, please visit their respective websites:
Clinical Squared: https://www.clinicalsquared.com/about-us/
Plato.ai: https://Platohealth.ai

Contacts:

Bryan Feinberg
CEO, Plato Technologies Inc.
Zephyr@platodata.io

Marquis Allen
CEO, Clincial Squared
marquis.allen@clinicalsquared.com

China Medical System Gained Exclusive License of an Anti-Ischemic Stroke Class 1 Innovative Drug

l Y-3, a Class 1 Innovative Drug injection, is used to alleviate neurological symptoms and dysfunction of daily activities caused by acute ischemic stroke. The Product has a clear mechanism of action, which is conducive to exerting brain cytoprotection effects. Meanwhile, the Product has a rapid anti-depression and anti-anxiety function, and is expected to become the first new type of brain cytoprotectant that treats both stroke and post-stroke depression.

l The product will enrich the cardio-cerebrovascular (including the central nervous system) pipeline of the Group. After approved for marketing in China, it is expected to meet the clinical needs of drug with both safety and efficacy, providing new treatment options to ischemic stroke patients in China.

SHENZHEN, CHINA, Aug 24, 2023 – (ACN Newswire) – On August 24, China Medical System Holdings Limited (“CMS” or the “Group”) announced that the Group entered into a Collaboration Agreement (the “Agreement”) with Nanjing NeuroDawn Pharmaceutical Co. Ltd. (“NeuroDawn Pharmaceutical”), for anti-ischemic stroke brain cytoprotectant and class 1 innovative drug Y-3 injection (“Y-3 injection” or the “Product”), and gained an exclusive promotion right of the Product in Mainland China, Hong Kong Special Administrative Region and Macao Special Administrative Region. The term of the Agreement is permanent.

Y-3 Injection is a Class 1 innovative drug – small molecule compound, which is used to alleviate neurological symptoms and dysfunction of daily activities caused by acute ischemic stroke. The mechanism of action of the Product is to dissociate PSD-95 and nNOS coupling and activate α2-GABAA receptors. With dual-target intervention at the same time and its clear mechanism of action, the Product is conducive to exerting brain cytoprotection effects. Meanwhile, the Product has a rapid anti-depression and anti-anxiety function, and is expected to become the first new type of brain cytoprotectant that treats both stroke and post-stroke depression.

Stroke is a major non-communicable disease that seriously endangers the health of Chinese people. The overall lifetime risk of stroke in China is 39.9%, ranking the first in the world. The number of new cases of ischemic stroke in China was approximately 2.87 million in 2019, and the incidence rate substantially increased by 226.5% from 1990 to 2019, with a large patient population. Stroke has the characteristics of high disability rate and heavy economic burden. There is an urgent clinical need for evidence-based drugs to reduce family and social burdens.

In January 2023, The Phase I clinical trial of the Product in China has been completed and the results showed a good overall safety. The Product is currently in the Phase II clinical trial in China. If approved for marketing in China, it will bring new treatment options to ischemic stroke patients in China, meet the clinical needs of drug with both safety and efficacy, and thus benefit the patients.

CMS has been deeply engaged in the cardio-cerebrovascula/central nervous system therapeutic fields for years and possesses XinHuoSu (recombinant human brain natriuretic peptide for injection), Deanxit (flupentixol and melitracen tablets) and VALTOCO (the first diazepam nasal spray approved in China), etc. The Group has also established a compliant and efficient commercialization system in the cardio-cerebrovascular and central nervous system fields. In the future, the Group will continue to prioritize patients and clinical needs, strategically deploy more differentiated innovative drugs, and consistently expand the product portfolio in the Group’s advantageous specialty fields, benefiting a greater number of patients.

For further detailed information, please visit the following link for the announcement, “Voluntary and Business Update Announcement Gaining Exclusive License of an Anti-Ischemic Stroke Class 1 Innovative Drug” issued by CMS on August 24 2023.

About NEURODAWN PHARMACEUTICAL

NeuroDawn Pharmaceutical, based in Nanjing, China, is an innovation and R&D-driven new drug company, focusing on the research and development of new drugs for central nervous system (CNS) diseases. NeuroDawn Pharmaceutical has established a comprehensive internal R&D platform, including chemical synthesis, biological screening, CMC (chemistry, manufacturing and control) development, DMPK (drug metabolism and pharmacokinetics) research, in vivo pharmacology research, toxicology research and clinical research, etc. In addition, NeuroDawn Pharmaceutical has integrated clinical resources for neurological diseases in China and established close collaboration with more than one hundred leading hospitals in China to provide comprehensive and complete technical services and professional guidance for clinical studies.

About CMS

CMS focuses on developing first- or best-in-class innovative products and has made the layout of about 30 differentiated pipeline products with strong market potential. CMS deeply engages in 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 strengthen the competitiveness of its cardio-cerebrovascular/gastroenterology business, and independently operated dermatology and medical aesthetic business, and ophthalmology business, whilst enhancing the scale and efficiency. CMS also entered into the Southeast Asian market to create new opportunities to further enhance the sustainable development of the Group.

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.

Asia HSE Summit 2023: Taking Health & Safety to The Next Level

KUALA LUMPUR, Aug 24, 2023 – (ACN Newswire) – Stay up-to-date with the latest developments in the health and safety sector at ASIA HSE SUMMIT, which will be held on 11-12 September 2023 at the Royale Chulan Kuala Lumpur.

The Summit will bring together Health, Safety, and Environment (HSE) experts from a wide range of industries to explore the latest approaches to optimizing HSE performance, as well as the most effective strategies for enhancing workplace safety. Topics such as risk assessment and management, employee training and awareness, data security and privacy, ergonomic considerations and well-being will be discussed in order to improve health and safety in the digital era.

Attendees of the conference will be provided with ground-breaking strategies to develop, implement, and monitor HSE programs that abide by industry regulations. Through interactive sessions and expert interaction, participants will gain access to the tools and resources needed to establish a successful and sustainable HSE programs that meet industry-set standards. This can help create a safer and more productive work environment, leading to greater efficiency and profitability.

Don't miss out on this chance to join HSE professionals from Asia and beyond to learn how to stay ahead of the curve in the rapidly-evolving health and safety landscape. The seats are limited, register now with HRDF CLAIMABLE.

Registration Link: www.asiahsesummit.com/contact-7
Official website: www.asiahsesummit.com/

For further inquiries, please contact:
Amina
+601161888699
amina@cteventasia.com

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