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



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

Rotary Action Group Taps Drug Free Australia to Represent Oceania on a Global Stage

Seaford, Australia–(ACN Newswire – December 23, 2023) – Drug Free Australia has been selected by the Rotary Action Group for Addiction Prevention (RAG AP) to represent the Oceania region. This move underscores its significant contributions to drug education and community outreach.

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(Photo from Pexels)

As a leader in drug prevention, Drug Free Australia will collaborate with international organizations to address pressing drug-related challenges in Oceania. This pivotal role acknowledges its successful strategies and extensive community engagement efforts across Australia.

Josephine Baxter, Executive Officer at Drug Free Australia, remarked, “This opportunity allows us to extend our reach and share our expertise on a larger platform. Our representation of Oceania in this global initiative highlights the critical nature of our mission and the considerable impact of our work.”

Recent data indicate that Australia grapples with significant drug use challenges, particularly among the youth. Drug Free Australia’s approach, pivotal in mitigating these issues, centers around educational programs and robust community outreach.

Baxter added, “Our approach, grounded in evidence-based research, has gained international recognition. We are eager to apply this knowledge throughout the Oceania region in partnership with RAG AP.”

This collaboration between Drug Free Australia and RAG AP is poised to address drug use concerns in Oceania significantly. It aims to scale up the effectiveness of drug prevention initiatives by uniting the expertise and resources of both organizations. The partnership will develop comprehensive strategies encompassing educational programs, policy advocacy, and community involvement, creating a sustainable impact on drug prevention and health promotion.

In Australia, this alliance represents a forward-thinking move to reinforce the nation’s health care and drug prevention strategies. It will enable the exchange of best practices and innovative methods in drug education, aligning with Australia’s health objectives.

Additionally, this collaboration presents Australia an opportunity to lead in the Oceania region by demonstrating effective, community-based drug prevention models. It also lays the groundwork for enhanced support from government and non-governmental entities, fostering a cooperative environment crucial for successfully combating drug-related issues.

Furthermore, Drug Free Australia will leverage its resources and networks to bolster drug prevention efforts across Oceania. The initiative aims to increase awareness and implement effective strategies at local and regional levels. One significant initiative in 2024 will be to identify and support young people as “youth influencers” who will be trained to develop their approaches to drug use prevention and early intervention.

For participation and more information, individuals and organizations can visit Drug Free Australia’s website at https://www.drugfree.org.au/ or engage directly with their community programs.

About Drug Free Australia:

Drug Free Australia is a health charity promoting drug-free lifestyles through education and community engagement. Renowned for volunteer-driven initiatives, the organization raises awareness and provides resources to combat drug use in Australia.

Contact Information:

Contact Person’s Name: Josephine Baxter
Company/Organization Name: Drug Free Australia
Company website: https://www.drugfree.org.au/
Contact Email Address: admin@drugfree.org.au
Phone Number: (+61) 0403 334 002

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/192332



Copyright 2023 ACN Newswire. All rights reserved. http://www.acnnewswire.com

ChemPartner Unveils Highly Anticipated Biology Database

SHANGHAI, Dec 23, 2023 – (ACN Newswire) – ChemPartner, a global leader in drug discovery and development services, today announced the launch of its long-awaited Biology Database. This innovative platform serves as a centralized hub, empowering ChemPartner’s clientele with seamless access to a wealth of information on the organization’s cutting-edge preclinical platforms. The database includes 800+ tumor models, 30+ cancer types, 20,000 genes, 2,300+ pathways, 1,800 SoC data from literature (500 internal), and 30+ analytic modules.

ChemPartner Biology Database - Screenshot of the online Biology Database from ChemPartner
ChemPartner Biology Database – Screenshot of the online Biology Database from ChemPartner

ChemPartner’s renowned biology and pharmacology department, known for its vanguard oncology, immunology, CNS, and metabolic services, has curated an extensive collection of in vitro and in vivo models. The database boasts over 2,000 biochemistry assays, 800 cell lines, 500 patient-derived xenograft (PDX) models, 350 cell-derived xenograft (CDX) models, and 50 syngeneic models. Each model is meticulously characterized with comprehensive data encompassing genomics, pharmacology, histopathology, and relevant clinical information.

Cell Line Models – ChemPartner Biology Database

To ensure a smooth and efficient rollout of this substantial volume of data, the database will be introduced in stages. We are delighted to announce that the first stage, featuring cell line data, is now live on https://database.chempartner.com. Subsequent stages will include CDX, syngeneic, and PDX models, followed by biochemistry data.

The Biology Database, a flagship online collaborative platform, prominently features the Tumor Model Database. This revolutionary resource offers an array of features, including:

  • Unified Data Hub: Integration of dispersed tumor model data into a centralized database for efficient management and retrieval, simplifying user access to diverse tumor models.
  • Detailed Annotations: Each model is accompanied by intricate annotations including genomics, pathology, and pharmacology data, enabling rapid understanding of model characteristics and suitability for specific research needs.
  • Rapid Search and Filtering: Multidimensional search and filtering capabilities empower researchers to swiftly locate models based on cancer type, genomic features, drug sensitivity, and more.
  • Data Analysis and Mining: Robust tools facilitate tasks like drug mechanism analysis and biomarker discovery through differential gene expression and drug sensitivity analyses, supporting informed research decisions.
  • Data Visualization: Intuitive charts, statistics, and visualization tools present complex data clearly and concisely, aiding in model selection and analysis.

Dr. Lilly Xu, President of Shanghai ChemPartner, expressed enthusiasm about the launch saying, “We are excited to provide our customers with access to this powerful new resource. This comprehensive database will make it easier for our customers to find and use the right models for their research, propelling drug development towards new heights with better precision, efficacy, and efficiency.”

About ChemPartner

ChemPartner is a leading global CRO and CDMO providing drug discovery, development, and manufacturing services to the pharmaceutical and biotechnology industries. With a team of over 2,000 scientists across multiple countries, ChemPartner offers a comprehensive range of services including preclinical pharmacology, toxicology, drug metabolism and pharmacokinetics, chemistry development, and biologics development. For more information, please visit https://chempartner.com and connect with ChemPartner on LinkedIn, X,  and YouTube.

Contact Information
Sarah Stapleton
Marketing Director
news@chempartner.com 
6504199974 

Related Images

ChemPartner Biology Database
Screenshot of the online Biology Database from ChemPartner

Cell Line Models
Pie chart of cell line models available on the Biology Database from ChemPartner

SOURCE: ChemPartner

View the original press release on newswire.com.



Copyright 2023 ACN Newswire. All rights reserved. http://www.acnnewswire.com

BioMed X Institute and Ono Pharmaceutical Launch New Collaboration in Cancer Research

Heidelberg, Germany, Dec 22, 2023 – (ACN Newswire) – BioMed X announced today a new joint research project with Ono Pharmaceutical Co., Ltd, marking the start of the collaboration between the German biomedical research institute and one of the largest pharmaceutical companies in Japan. The project entitled “New Strategies to Engage Neutrophils in Solid Tumors” will be hosted by the BioMed X Institute in Heidelberg, Germany. The goal of this research project is to design next-generation immunotherapies by leveraging the antitumor effects of neutrophils.

Developing immunotherapies that target T cells has proved highly effective, and it is still a rapidly evolving research area. However, many patients remain resistant to these therapies, necessitating the development of novel immunological strategies. The presence of neutrophils in solid tumors has been well-documented, albeit their role in the tumor microenvironment seems to be paradoxical according to the data accumulated thus far. By uncovering novel neutrophil biology, this project aims to leverage their functions to design novel immunotherapies.

The new research team will join nine other research groups at the BioMed X Institute in Heidelberg, Germany. Researchers who are interested in becoming part of this new research group are invited to respond to this international call for application by submitting a project proposal via the BioMed X Career Space at https://career.bio.mx/call/2023-BMX-C03 before February 18, 2024.

Christian Tidona, Founder and Managing Director of the BioMed X Institute: “Oncology and immunology, including tumor immunology, are key areas of expertise at BioMed X. We are proud and honored that Ono has chosen our institute to develop new strategies for engaging neutrophils in cancer therapy”.

Toichi Takino, Senior Executive Officer/Executive Director, Discovery & Research at Ono Pharmaceutical: “We are very pleased to form a partnership with BioMed X in our mission dedicated to overcoming cancer. This innovative research collaboration will engage us with highly talented scientists around the world who possess unique ideas for immunotherapy utilizing neutrophils. We believe that the research team established through this collaboration will lead to the discovery of the next generation of immunotherapy with us”.

About BioMed X

BioMed X is an independent research institute with sites in Heidelberg, Germany, New Haven, Connecticut, XSeed Labs in Ridgefield, Connecticut, and a worldwide network of partner locations. Together with our partners, we identify big biomedical research challenges and provide creative solutions by combining global crowdsourcing with local incubation of the world’s brightest early-career research talents. Each of the highly diverse research teams at BioMed X has access to state-of-the-art research infrastructure and is continuously guided by experienced mentors from academia and industry. At BioMed X, we combine the best of two worlds – academia and industry – and enable breakthrough innovation by making biomedical research more efficient, more agile, and more fun.

About Ono

Ono Pharmaceutical Co., Ltd., headquartered in Osaka, Japan, is an R&D-oriented pharmaceutical company committed to creating innovative medicines in specific areas. Ono focuses its research on oncology, immunology, neurology and specialty research with high medical needs as priority areas for discovery and development of innovative medicines. For further information, please visit the company’s website at https://www.ono-pharma.com/en.

Contact Information
Flavia-Bianca Cristian
Recruiting & Communications Manager
fbc@bio.mx
+49 6221 426 11 706

View the original press release on newswire.com.



Copyright 2023 ACN Newswire. All rights reserved. http://www.acnnewswire.com

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

– Innovative drugs VALTOCO (Diazepam Nasal Spray),ILUMETRI (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/



Copyright 2023 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Acrometa Signs Strategic Cooperation Framework Agreement to Develop Co-Working Lab Space in China

SINGAPORE, Dec 12, 2023 – (ACN Newswire) – ACROMETA Group Limited (“ACROMETA”, or the “Company” and together with its subsidiaries, the “Group”), an established specialist engineering service provider in the field of controlled environments serving mainly the healthcare, biotechnology, pharmaceutical, research and academia sectors, today announced that its 70% owned subsidiary Life Science Incubator Holdings Pte Ltd (“LSI”) signed a strategic cooperation framework agreement (“Agreement”) with its partner Fenglin Healthcare Industry Development (Group) Co. Ltd. (“Fenglin Group”).

(3rd from Right) Fenglin Group Deputy General Manager Mr Pan Taishen and (2nd from Right) AcroMeta Executive Chairman Mr Levin Lee Keng Weng at the signing ceremony
(3rd from Right) Fenglin Group Deputy General Manager Mr Pan Taishen and (2nd from Right) AcroMeta Executive Chairman Mr Levin Lee Keng Weng at the signing ceremony

The Agreement follows an earlier MOU signed in November 2023 to further deepen their collaboration for the co-working laboratory space business in the People’s Republic of China.

The signing ceremony, which was held at the German Center Singapore, was part of a corporate access event which featured a presentation on the co-working laboratory space business, followed by a tour of the facilities for a first-hand look at the laboratory that is fully fitted with state-of-the-art equipment.

Representatives from AcroMeta, LSI and Fenglin Group present at the event held at the German Centre Singapore
Representatives from AcroMeta, LSI and Fenglin Group present at the event held at the German Centre Singapore

China-incorporated Fenglin Group, the administrative arm of the Shanghai Xuhui government in charge of Life Sciences, aims to establish an integrated ecosystem of local and international stakeholders in Shanghai’s Xuhui District to accelerate biopharmaceutical innovation and development.

Fenglin Group will promote the co-working laboratory space with a focus on overseas biomedical science startups and SMEs planning to develop their business in China. On its part, LSI will use its existing business networks to recommend to Fenglin Group, Singapore and other overseas biomedical sciences companies that intend to have a business foothold in China and need co-working laboratory space.

Mr Levin Lee Keng Weng, ACROMETA’s Executive Chairman, said,

“We extend a warm welcome to all our honoured guests, including the top Management of Fenglin Group. LSI and Fenglin will work closely together to fulfil the goals of our strategic cooperation in the co-working laboratory business.

China’s life sciences industry is an important part of China’s ‘Made in China 2025’ strategy and its rapid growth has seen the birth of thousands of start- ups and SMEs in biotech, agritech, pharmaceuticals, and medical devices doing research and development to bring innovative products into the market. Our co-working laboratory space business will enable them to conduct their R&D without incurring high CAPEX to build the facilities.”

About ACROMETA Group Limited (SGX Stock Code:43F)

ACROMETA (Previously known as ACROMEC Limited) is an established specialist engineering services provider with more than 25 years of experience in the field of controlled environments.

The Group has, over the years, acquired expertise in the design and construction of facilities requiring controlled environments such as laboratories, medical and sterile facilities, and cleanrooms.

ACROMETA’s business is divided into three main business segments: (i) Engineering, procurement, and construction services, specialising in architectural, and mechanical, electrical, and process works within controlled environments; (ii) Maintenance and repair services of facilities and equipment of controlled environments and their supporting infrastructure. (iii) Co-Working Laboratory business; currently operates 6,500 square feet of co-working laboratory space at The German Centre in Singapore, serving SMEs and startups.

The Group mainly serves the healthcare, biotechnology, pharmaceutical, research and academia, and electronics sectors. ACROMETA’s customers include hospitals and medical centres, government agencies, research and development companies or agencies, research and development units of multinational corporations, tertiary educational institutions, pharmaceutical companies, semiconductor manufacturing companies, and multinational engineering companies.

The Company has been listed on the Catalist Board of the Singapore Exchange since 2016. For more information, please visit www.acrometa.com.

Media and Analysts Contact:
ACROMETA Group Limited
Ms. Cheah Lai Min
Chief Financial Officer
Tel: +65 6415 0574
Email: laimin.cheah@acrometa.com                                                            

Waterbrooks Consultants Pte Ltd
Mr. Wayne Koo
Tel: +65 6958 8008 / +65 9338 8166
Email: wayne.koo@waterbrooks.com.sg
Email: query@waterbrooks.com.sg

This media release has been reviewed by the Company’s Sponsor, Evolve Capital Advisory Private Limited (the “Sponsor”). It has not been examined or approved by the Singapore Exchange Securities Trading Limited (the “Exchange”), and the Exchange assumes no responsibility for the contents of this document, including the correctness of any of the statements or opinions made or reports contained in this document.

The contact person for the Sponsor is Mr. Jerry Chua, 138 Robinson Road, #13-02 Oxley Tower, Singapore 068906, jerrychua@evolvecapitalasia.com.



Copyright 2023 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Cryofocus Medtech Obtains NMPA Approval for the AF Cryoablation System

HONG KONG, Dec 12, 2023 – (ACN Newswire) – The innovative medical device company in China with a main focus on the field of minimally-invasive interventional cryotherapy, Cryofocus Medtech (Shanghai) Co., Ltd. (the “Company” or “Cryofocus Medtech”, stock code: 6922.HK), on a voluntary basis to announce that the Company has obtained the marketing approval for its self-developed Atrial Fibrillation Cryoablation System (“AF Cryoablation System”) from the National Medical Products Administration of the People’s Republic of China (the “NMPA”).

The AF Cryoablation System of Cryofocus Medtech, consisting of the cryoablation equipment, the balloon cryoablation catheter, the disposable intracardiac mapping catheter and the adjustable curved guide catheter, is the first cardiac product that applies cryoballoon with liquid nitrogen as the refrigerant for the treatment of drug-refractory recurrent symptomatic paroxysmal atrial fibrillation. Using liquid nitrogen as the refrigerant, the target tissue is rapidly cooled down by the ultra-low temperature generated by the liquid nitrogen, and the ablation range can be precisely controlled to achieve the therapeutic effect of necrosis of aberrant myocardial cells, which greatly improves the effectiveness and safety of the product. Unlike traditional point-by-point radiofrequency ablation, cryotherapy technology can realize one-time comprehensive ablation, which is safe, effective, convenient and reproducible. The cryoballoon ablation has become one of the standard methods to realize pulmonary vein isolation.

As the first cryoablation technology platform company in China that uses liquid nitrogen as the main cryogenic source, Cryofocus Medtech has overcome many key difficulties in the clinical application of liquid nitrogen cryogen and developed the original liquid nitrogen cryoablation technology in China, which can efficiently isolate pulmonary veins. Combined with ultra-vacuum heat insulation technology, the freezing medium can be transported to a treatment site under low pressure and the balloon temperature can be accurately controlled and monitored in real time, further improving the safety and effectiveness of the AF Cryoablation System. Meanwhile, in contrast to nitrous oxide (Nâ‚‚O) as a freezing medium, nitrogen gas is safe, readily available and environmentally friendly, which is better for clinical promotion and application.

The approval of the AF Cryoablation System in China markets marks an important milestone in the business development of Cryofocus Medtech in vascular interventional cryotherapy. It will further enrich the Company’s product portfolio, meet diversified market demands, and effectively enhance the Company’s core competitiveness. Cryofocus Medtech is a global leader in minimally-invasive interventional cryotherapy, with extensive presence in two fast-growing areas, i.e. vascular Intervention and natural orifice transluminal endoscopic surgery (NOTES). The Company continues to launch multiple innovative cryoablation products to meet the urgent clinical treatment needs in China.

In the first half of 2023, Cryofocus Medtech continues to achieve positive progress in both product pipeline development and business operations. As of June 30, 2023, the Cryo-RDN System, developed by the Company to treat patients with refractory hypertension using an innovative 360-degree cryoballoon ablation technology on a circumferential surface, has also entered clinical trials of registration. The Company expects to obtain approval from the NMPA in the second half of 2025 and the Cryo-RDN System is expected to be the world’s first cryoablation product that specifically focuses on the treatment of hypertension. Meanwhile, the Company’s Asthma Cryoablation System and COPD Cryospray System entered into the confirmatory clinical trial phase in March 2023. It is expected to submit the product registration submission to the NMPA in the second half of 2025. In addition, as of June 30, 2023, Cryofocus Medtech submitted the registration application for the Cryoadhesion System, and it is expected to obtain approval from the NMPA for the product in the first quarter of 2024.

In the future, Cryofocus Medtech will continue to adhere to independent innovation, continuously promote the clinical development and commercialization of product candidates, further expand the product portfolio, and allow advanced cryoablation technology to benefit a large population of patients.  

About Cryofocus Medtech (Shanghai) Co., Ltd. (6922.HK)

Cryofocus Medtech is an innovative medical device company in China with a main focus on the field of minimally-invasive interventional cryotherapy. Since its inception in 2013, the Company has developed a comprehensive product portfolio mainly focusing on two therapeutic areas: vascular interventional therapy and natural orifice transluminal endoscopic surgery, or NOTES. The product pipeline of Cryofocus Medtech includes a variety of cryotherapy systems and surgical consumables, four of which were recognized as “innovative medical devices” by the NMPA or its provincial counterparts, according to Frost & Sullivan. The Company’s major product, the AF Cryoablation System, has demonstrated good efficacy and safety profiles in clinical trials.



Copyright 2023 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Moderna Reviews its Environmental, Social and Governance (ESG) Progress and Ambitions at Second ESG Investor Event

Cambridge, MA, Dec 11, 2023 – (ACN Newswire) – Moderna, Inc. (NASDAQ:MRNA) today will provide an update on its Environmental, Social and Governance (ESG) strategy at its second ESG Investor Event. Building off its inaugural ESG Day in November 2022, the Company will highlight the year’s progress on its ESG journey and future work to further impact global health and protect the environment.

“Our mRNA platform science has benefited patients around the world and with that comes great responsibility as science alone will not solve the world’s greatest health challenges,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We are committed to moving beyond the power of our technology – tackling enduring health disparities, engaging with our communities, and recognizing that human health and planetary health are intricately linked. We look forward to building on our substantial ESG progress to become the best version of Moderna.”

Moderna’s ESG strategy is articulated around five areas:

Medicines for Patients: Moderna is leveraging its platform for many medicines, from vaccines to protect hundreds of millions of people from common viruses for which no vaccines are available today, to several rare disease therapies with tremendous opportunity for impact. Within its clinical trials, Moderna believes a committed approach to offering equal healthcare accessibility is achievable and necessary. The Company is also committed to using its platform to help rapidly respond to the greatest public health threats, pursuing a pipeline of priority programs relevant for outbreak response and pandemic preparedness. Moderna has long prioritized strategic collaborations to benefit global health, including its partnership with The Coalition for Epidemic Preparedness Innovations (CEPI), and Moderna’s mRNA Access program, a collaborative effort that enables researchers around the world to utilize Moderna’s mRNA technology.

Environment: Moderna is progressing on its journey toward net-zero carbon emissions (Scopes 1 & 2) by 2030. The Company has advanced its overall environmental sustainability program, including through implementing its sustainability strategy, enhancing its disclosure of key performance indicators, submitting its first CDP Climate Change questionnaire, and initiating a climate risk and scenario analysis. These efforts support internal and external stakeholder expectations for sustainable operations and Moderna’s adaptation to a low-carbon economy.

Employees & Culture: Moderna consistently ranks as a top employer and achieves above benchmark scores on engagement, culture and belonging. Moderna continues to foster a culture where every employee can meaningfully contribute to the Company’s mission, an effort that serves to attract and retain the best talent. By living the Company’s values and mindsets every day, the Moderna team is not only advancing mRNA science, but also building an organization that cares deeply for patients, employees, the environment, and the community.

Community: Moderna is committed to having a positive impact on communities around the world. Moderna’s purpose-driven employees continue to exemplify the Company’s mission, with nearly two out of three employees participating in volunteering activities or contributing as part of Moderna’s newly instituted employee matching program. The Moderna Charitable Foundation continues to provide financial support to organizations and causes that promote public health, advance scientific education, and advocate for belonging, inclusion, and diversity.

Governance & Ethics: Moderna prioritizes accountability and transparency around its ESG efforts, including through the publication of its second annual ESG report and continued commitment to disclosing key metrics. Moderna has initiated an ESG materiality assessment, which includes broad stakeholder surveys, and is also leveraging AI to build a dynamic analysis of material topics.

“Delivering on our ESG ambitions is made possible by a strong culture that embeds the values of transparency, accountability and ownership at all levels of the organization,” said Shannon Thyme Klinger, Moderna’s Chief Legal Officer, Corporate Secretary and President of the Moderna Foundation. “The same determination that goes into our innovation carries over into our commitment to positively impact the communities in which we work and live.”

Webcast Information

To register for the live webcast of Moderna’s ESG Investor Event, visit https://moderna-esg-day-2023.open-exchange.net/registration. The archived webcast will be available under “Events and Presentations” in the Investors section of the Moderna website for one year following the call: https://investors.modernatx.com.

About Moderna

Moderna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how we treat and prevent disease for everyone. By working at the intersection of science, technology and health for more than a decade, the company has developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID-19 vaccines.

Moderna’s mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team driven by the Moderna values and mindsets to responsibly change the future of human health, Moderna strives to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: Moderna’s ability to leverage its mRNA platform for pandemic preparedness; Moderna’s commitment to achieving net-zero carbon emissions in its global operations for Scopes 1 and 2 by 2030; the potential of Moderna’s mRNA platform for addressing rare diseases and common viruses for which no vaccines are available today; and Moderna’s implementation of its environmental sustainability program. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading “Risk Factors” in Moderna’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date of this press release

Moderna Contacts
Media:
Chris Ridley
Vice President, Communications
617-800-3651
Chris.Ridley@modernatx.com

Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
617-209-5834
Lavina.Talukdar@modernatx.com



Copyright 2023 ACN Newswire. All rights reserved. http://www.acnnewswire.com

As Health Systems Struggle With Nursing Shortages, CGFNS International Sees a Sharp Rise in Nurses Seeking to Migrate to the U.S.

PHILADELPHIA, PA, Dec 6, 2023 – (ACN Newswire) – In a report published today, CGFNS International revealed that in 2023, it issued its highest-ever number of occupational visa certifications to nurses and other skilled health workers seeking to migrate to the U.S., where health systems confront a staffing crisis.

CGFNS 2023 Nurse Migration Report
CGFNS 2023 Nurse Migration Report

The company, a non-profit that verifies credentials for immigration authorities and state licensing boards, said it issued nearly 27,000 of its VisaScreen® certificates during the government fiscal year that ended in October. That is more than twice the number of certificates CGFNS issued the previous year.

The increase continues a six-year upward trend, during which the annual number of VisaScreen® certificates has quadrupled. Over this time, U.S. health systems have increasingly scrambled to fill staff vacancies amid a longstanding nursing shortage that was aggravated by pandemic-era challenges and is projected to worsen through the end of the decade.

In the report, CGFNS stated that higher levels of nurse immigration in recent years are likely to have peaked, even as the nursing shortage widens. This is because, barring intervention, U.S. visa availability is declining to pre-pandemic levels.

Download the 2023 Nurse Migration Report: Navigating Nursing Shortages and Immigration Barriers.

Data in the report were derived from applicant information submitted to the VisaScreen® Service and the CGFNS Credentials Evaluation Service, two leading pathways through which foreign-educated nurses and other healthcare professionals can migrate to and work in the U.S.

Other key findings in the report:

– The Philippines continues to be by far the largest source of immigrant nurses for the U.S., accounting for more than 60% of the total VisaScreen® certificates issued by CGFNS. 

– In 2023, the vast majority (85%) of certificates were issued to registered nurses (RNs), with another 14% issued to clinical laboratory scientists. 

– More than three-quarters (78%) of those applying for certificates were seeking permanent green cards, up from 64% in 2018 and up nine percentage points in just the past year, showing a strong trend toward permanent migration among nurses.

“Recruitment of nurses from outside the U.S. by using best practices has been critical to helping U.S. health systems cope with extraordinary staffing challenges and to ensure patient safety. With many thousands of qualified foreign-trained nurses willing and waiting to migrate to meet this present need, now is not the time to further restrict their numbers, especially when nurses want to come to the U.S. to advance their careers,” said Peter Preziosi, President and CEO of CGFNS.

Contact Information
David St. John
dstjohn@cgfns.org



Copyright 2023 ACN Newswire. All rights reserved. http://www.acnnewswire.com

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.

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/



Copyright 2023 ACN Newswire. All rights reserved. http://www.acnnewswire.com