#National Medical Products Administration (NMPA)

[freyrnigeria]

Freyr provides cosmetic regulatory services in China for compliant market entry in accordance with CSAR regulations. Registration of cosmetic products, consultation with regulators, notification, product classification, and review of cosmetic claims are among these services.

[dtnewswire]

The first to receive approval from the National Medical Products Administration for the launch of Levofloxacin Calcium Injection, opening up a new chapter in the domestic anti-tumor drug field for Puli Pharmaceutical!

The first to receive approval from the National Medical Products Administration for the launch of Levofloxacin Calcium Injection, opening up a new chapter in the domestic anti-tumor drug field for Puli Pharmaceutical! Good news! Puli Pharmaceutical's Levofloxacin Calcium Injection has been approved for market by the National Medical Products Administration—— New Product Launch - Zhejiang Puli Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Hainan Puli Pharmaceutical Co., Ltd., recently received a drug registration approval from the National Medical Products Administration (NMPA) for its injection of calcium folinate, which is considered to have been approved for listing through conformity evaluation. This marks that Puli Pharmaceutical's calcium folinate injection has the qualification to be marketed and sold in China. This product is the first approved calcium folinate injection in China and will have a profound impact on the company's expansion into new markets in the field of anti-tumor drugs in China. ▲ Puli Pharmaceutical's Left Folic Acid Calcium Injection Drug Registration Certificate: two.fiveml: twenty-fivemg, fiveml: fiftymg Specifications ▲ Puli Pharmaceutical's Left Folic Acid Calcium Injection Drug Registration Certificate: tenml: one hundredmg, seventeen.fiveml: one hundred and seventy-fivemg Specifications Puli Pharmaceutical's approved Left Folic Acid Calcium Injection marks the birth of the company's first anti-tumor drug in China, opening up a new situation for the development of the company's anti-tumor drug field and officially starting Puli Pharmaceutical's journey in the anti-tumor track. Four specifications have been approved this time, namely two.fiveml: twenty-fivemg, fiveml: fiftymg, tenml: one hundredmg, and seventeen.fiveml: one hundred and seventy-fivemg. Diversified specifications can more accurately meet the diverse needs of clinical medication, avoid drug waste or shortage, and achieve precise drug delivery. one Introduction to Calcium Folinate. Calcium folinate is a folate analogue that can be used as an enhancer in combination with five-fluorouracil chemotherapy drugs for the treatment of gastric cancer and colorectal cancer; It can also be used as an antidote for the subsequent treatment of high-dose methotrexate to reduce toxicity. Calcium folinate is the pharmacological active ingredient of both L-folinate and D-folinate, while D-folinate is essentially an inactive ingredient. Therefore, when used in combination with chemotherapy drugs, calcium folinate only requires half the dose to produce similar therapeutic effects as calcium folinate, and is more efficient than calcium folinate. Levofloxacin calcium injection was first launched in Sweden in one thousand nine hundred and ninety-five, and has since been approved for marketing in Portugal, Iceland, Denmark, and the United Kingdom. In two thousand eleven, Levofloxacin Calcium Injection was approved for sale in the United States under the trade name FUSILEV, licensed by ACROTECHBIOPHARMACIC. At present, Levofloxacin Calcium Injection has been widely marketed and sold worldwide. According to IQVIA data, the global sales of Leftover Calcium Injection will reach approximately one hundred and ten million US dollars in two thousand twenty-three, with the Chinese market accounting for eleven% of sales, ranking third globally. China is one of the main markets for Leftover Calcium Injection. ▲ Data sourced from IQVIA database. According to IQVIA data, water injection accounts for seventy-one% of the global sales of levodopa calcium injection, while powder injection only accounts for twenty-nine%. Water injection is the mainstream dosage form in the global market. At present, the marketed calcium folinate in China is in powder injection form, and the approved calcium folinate injection by Puli Pharmaceutical this time

[priyarao-01]

Artificial Blood Vessels Market: Applications & Innovations

Artificial blood vessels are synthetic constructs designed to replace damaged or diseased blood vessels, offering a life-saving solution for patients with cardiovascular and other vascular diseases. With the rising prevalence of cardiovascular disorders worldwide, the demand for advanced therapeutic interventions like artificial blood vessels has surged. The Global Artificial Blood Vessels Market is projected to expand at a CAGR of 6.89% from 2024 to 2032, driven by key factors such as the increasing incidence of blocked blood vessels and the growing aging population.

In addition, the rising demand for minimally invasive surgical procedures is propelling the need for advanced vascular grafts. This surge in demand, coupled with the prevalence of conditions such as peripheral artery disease and aortic diseases, is pushing the artificial blood vessels industry to new heights. As these trends continue, innovations in artificial blood vessel materials and applications are expected to shape the future of vascular healthcare.

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Artificial Blood Vessels: Role of Cardiovascular Diseases and Tissue Engineering

The rising prevalence of cardiovascular diseases (CVDs) is a major factor driving the rapid growth of the artificial blood vessels market. According to the World Health Organization (WHO) , CVDs are the leading cause of death globally, accounting for approximately 18 million deaths annually. This alarming statistic underscores the urgent need for innovative treatments for conditions such as blocked blood vessels, peripheral artery disease (PAD) , and aortic issues, including acute abdominal aortic aneurysms.

Advancements in tissue engineering are further enhancing the development of artificial blood vessels, particularly in the Asia-Pacific region. Countries like China, India, and Japan are experiencing significant growth in their medical infrastructure, which is increasing the demand for artificial blood vessel applications in various cardiovascular procedures.

Notably, China achieved a significant milestone with the approval of the first domestically manufactured artificial blood vessel by Jiangsu Bioda Life Science Co, supported by the National Medical Products Administration (NMPA) . This approval illustrates China’s advancing capabilities in med-tech innovation and regulatory support for advanced medical devices.

Moreover, government healthcare initiatives, such as China’s ‘Healthy China 2030’ strategy, provide a robust foundation for the development of advanced medical technologies, including artificial blood vessels.

Leading Materials in the Artificial Blood Vessels Market: A Comparative Overview

Artificial blood vessels are constructed from various materials, each offering distinct advantages based on their medical applications. The three major types include:

Expanded Polytetrafluoroethylene (ePTFE)

Polyethylene Terephthalate (PET)

Polyurethane

Among these, Expanded Polytetrafluoroethylene (ePTFE) is currently leading the artificial blood vessels market. Its exceptional biocompatibility, flexibility, and durability make ePTFE vessels particularly advantageous for vascular grafting procedures. They significantly minimize the risk of infection and blood clot formation, making them a favored choice in cardiovascular surgeries.

Polyethylene Terephthalate (PET) and Polyurethane are also gaining traction, especially in specialized applications. PET is commonly utilized for large-diameter vascular grafts, while polyurethane is preferred for its elasticity and ability to mimic the properties of natural blood vessels.

With ongoing research and technological advancements, all three materials are expected to see growth. However, ePTFE remains the dominant choice due to its extensive applications in both large-scale vascular reconstructions and smaller peripheral artery repairs.

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Expanding Applications of Artificial Blood Vessels in Modern Medical Procedures

The application of artificial blood vessels is broadening, particularly in the treatment of peripheral artery disease (PAD), hemodialysis, and aortic diseases. With PAD projected to affect around 200 million people worldwide, it has become a significant focus for the industry. Additionally, artificial blood vessels are essential for hemodialysis patients requiring reliable vascular access, especially as the global hemodialysis population grows in North America and Europe. Companies like W.L. Gore & Associates and B. Braun are leading the charge in developing durable and biocompatible solutions to address this rising demand.

In the field of aortic diseases, including abdominal aortic aneurysms, artificial blood vessels play a critical role in preventing fatal ruptures. Market leaders are continuously refining their products to meet the needs of patients, resulting in an influx of innovative solutions tailored for both peripheral and central vascular conditions.

Conclusion: The Promising Future of the Artificial Blood Vessels Market

Emerging technologies, such as 3D bioprinting and nanotechnology, are set to revolutionize the production of personalized vascular grafts, enabling the creation of custom-fit blood vessels that drastically reduce rejection rates and improve surgical outcomes. Additionally, the development of biomimetic materials that mimic the natural behavior of blood vessels will enhance functionality and longevity, facilitating smoother integration with the body and minimizing complications like clotting or infection.

For investors and stakeholders, the market presents considerable opportunities, particularly in advanced vascular graft development and minimally invasive surgical procedures. As demand continues to rise, especially in emerging markets like Asia-Pacific, the artificial blood vessels industry is set for substantial growth and innovation in the years to come.

Explore our Latest Release for the 2024-2032 Market Analysis

FAQs:

Q1) What are artificial blood vessels made of? A: Artificial blood vessels are typically made from materials like Expanded Polytetrafluoroethylene (ePTFE), Polyethylene Terephthalate (PET), and Polyurethane, which offer durability, biocompatibility, and flexibility.

Q2) What is artificial blood? A: Artificial blood is a substitute that mimics the function of real blood, used in transfusions when human blood is unavailable or unsuitable.

Q3) What are the key applications of artificial blood vessels? A: Artificial blood vessels are widely used in treating peripheral artery disease, hemodialysis, and aortic diseases, providing vital solutions in cardiovascular surgeries and dialysis procedures.

[jamesjohnsan]

The Legal Status of Nootropics Capsules Around the World

Nootropics, which are sometimes called "smart drugs" or cognitive enhancers, have become famous because they can help with memory, focus, and brain function in general. However, the laws about these vitamins are very different from one country to the next. Learning about the laws is very important if you want to use nootropics or journey with them. This guide will help you understand the complicated subject of nootropics capsules, their legal position, and how you can buy nootropics capsules around the world.

Understanding Nootropics Capsules

Nootropic pills are dietary supplements meant to improve brain function. They might contain natural ingredients like Ginkgo biloba and Bacopa Monnieri or man-made ingredients like Piracetam and Modafinil. People who want to improve their mental performance, such as students and workers, take these capsules. Even though they claim many health benefits, these items are not always legal everywhere.

The Legal Landscape of Nootropics

How nootropics are categorized and regulated depends on factors such as local health laws, people's feelings about them, and the regulatory agencies in each country. Let's examine how nootropics are seen and controlled in different parts of the world.

Nootropics in North America

United States

The Dietary Supplement Health and Education Act (DSHEA) says that the Food and Drug Administration (FDA) oversees dietary supplements in the United States. This includes nootropics. For a quick look at the law situation, here it is:

Over-the-Counter Nootropics: Many nootropics, like caffeine and L-theanine, are widely used and can be bought without a prescription.

Prescription Nootropics: Some nootropics, like Modafinil, are better controlled because they are prescription drugs.

Regulations: The FDA ensures that nootropics sold as dietary supplements are safe, have the correct labels, and don't have any dangerous ingredients. That said, they don't check out these vitamins before selling them.

Canada

Health Canada is in charge of regulating nootropics. It is the government department in charge of public health.

Natural Health Products: Many nootropics are natural health products (NHPs), which means they need a product license to be sold. This ensures their work and safety.

Prescription Requirements: Some people improving cognitive abilities need medication, like in the US.

Availability: You can quickly get some nootropics, like Ginkgo Biloba and Bacopa Monnieri, but you need a prescription to get others, like Modafinil.

Nootropics in Europe

European Union

The European Union (EU) has a complicated set of rules for nootropics, and these rules are different in each member country:

EU Regulations: To ensure their safety, dietary products must follow specific rules set by the EU. However, laws can differ from country to country.

Member Countries: Some countries have tighter rules. In Germany and France, for instance, some nootropics are considered medicines and need a prescription.

Popular Nootropics: you can easily find supplements like Rhodiola Rosea and Omega-3 fatty acids in the EU.

United Kingdom

After Brexit, the UK will follow its own rules that are not part of the EU's:

Regulatory Body: The Medicines and Healthcare Goods Regulatory Agency (MHRA) keeps nootropics safe.

Legal Status: You can buy a lot of nootropics without a prescription, but harder ones need a prescription.

Common Nootropics: Ginkgo Biloba, Bacopa Monnieri, and L-theanine are common nootropics that are easy to get.

Nootropics in Asia

China

There are strict rules about nootropics in China:

Regulations: The National Medical Products Administration (NMPA) sets rules for food supplements, which include nootropics.

Legal Status: A lot of nootropics are health foods and need to be approved by the government before they can be sold. More potent nootropics are thought of as prescription drugs.

Availability: Synthetic nootropics are controlled more strictly, while herbal nootropics like Ginkgo Biloba are used by many.

Japan

Japan handles nootropics in a way that is both culturally and legally unique:

Regulatory Body: The Ministry of Health, Labour, and Welfare (MHLW) regulates dietary additives.

Legal Status: You can buy a lot of nootropics over the counter, but their claims are closely watched to make sure they don't give you false information.

Cultural Attitudes: People strongly prefer natural supplements and traditional treatment.

India

India is changing the rules that govern nootropics:

Regulatory Body: The Food Safety and Standards Authority of India (FSSAI) regulates dietary additives.

Legal Status: There are a lot of herbal nootropics on the market that are considered Ayurvedic goods. A license is usually needed to get synthetic nootropics.

Market Presence: The market for both natural and artificial nootropics is growing.

Nootropics in Australia and New Zealand

Australia

There are strict rules about dietary additives in Australia:

Regulatory Body: Nootropics are regulated by the Therapeutic Goods Administration (TGA).

Legal Status: A lot of nootropics need to be registered with the TGA. To get some, like Modafinil, you need a prescription.

Availability: A lot of people take herbal supplements like Bacopa Monnieri, but synthetic nootropics are subject to tighter rules.

New Zealand

Australia and New Zealand both take the same approach:

Regulatory Body: Medsafe is in charge of overseeing dietary additives.

Legal Status: You can buy some nootropics without a prescription, but harder ones need a prescription.

Availability: It is easier to get natural nootropics than manufactured ones.

Nootropics in South America

Brazil

Brazil has rules about food supplements that are very specific:

Regulatory Body: The National Health Surveillance Agency (ANVISA) is in charge of overseeing nootropics.

Legal Status: A lot of nootropics are health products and need to be approved by the government before they can be sold.

Market Trends: People are becoming more interested in natural and artificial nootropics.

Argentina and Other Countries

Regulations: Many South American countries, like Brazil, have rules about nootropics that are similar to those in Brazil.

Availability: The laws covering and making nootropics available can differ

Nootropics in Africa

South Africa

South Africa is becoming a bigger market for nootropics:

Regulatory Body: The South African Health Products Regulatory Authority (SAHPRA) oversees dietary supplements.

Legal Status: Many nootropics can be bought as health supplements, but more substantial brain boosters might need a prescription.

Public Perception: More and more people are learning about and interested in nootropics.

Other African Countries

General Overview: In general, nootropics are not all the same according to the law. Different countries have different levels of regulation.

Market Presence: Access may be limited in areas that could be better developed.

Global Trends and Future Outlook

The rules that govern nootropics are constantly changing. These are some new trends:

Increased Research: More continued scientific study could lead to better rules.

Stricter Controls: Synthetic nootropics may be subject to tighter controls in some areas.

Greater Acceptance: Natural nootropics are becoming more popular around the world.

Tips for Purchasing and Using Nootropics Legally

Follow these tips to make sure you're buying and using nootropics legally:

Buy from Reputable Sources: Pick well-known names and stores you can trust.

Check Local Regulations: Know how nootropics are treated by the law in your country and any you plan to visit.

Consult Healthcare Professionals: Before taking any new supplement, always talk to a doctor or nurse.

Conclusion

To use nootropic capsules safely and effectively, it is essential to know their legal position. Laws are very different in different parts of the world, so it's essential to know the rules in your area. The future of nootropics regulation is likely to change, bringing new opportunities and challenges. This will happen as the study continues and public interest grows.

[insideoutvietnam]

1-Laser and 2-Laser 6-Color TBNK Reagents from Cytek® Biosciences Approved for Clinical Use in China

FREMONT, Calif., May 28, 2024 (GLOBE NEWSWIRE) — Today Cytek Biosciences, Inc. (Nasdaq: CTKB) announced that its 1-laser and 2-laser 6-color TBNK reagent cocktails have received China National Medical Products Administration (NMPA) approval for clinical diagnostic use on the Cytek® Northern Lights™-Clinical (NL-CLC™) cell analysis systems in hospitals, laboratories and clinics across China. This…

[nmparegistrationfiling]

Unraveling the Mysteries of NMPA Registration/Filing

Navigating the labyrinthine world of regulatory compliance can feel like setting sail into uncharted waters. For businesses seeking to expand their market reach into China, one crucial aspect often veiled in complexity is the NMPA (National Medical Products Administration) registration or filing process. Much like a skilled navigator, understanding this process is paramount to successfully charting a course through the regulatory landscape.

What is NMPA Registration/Filing?

NMPA registration or filing is the gateway for medical products seeking access to the vast Chinese market. This process involves submitting detailed documentation and undergoing rigorous evaluation to ensure compliance with Chinese regulatory standards. Essentially, it's akin to obtaining a visa for your medical product to enter and thrive in the Chinese market.

Decoding the Process: Navigating the Regulatory Rapids

Understanding the Basics

Before delving into the intricacies of NMPA NMPA Registration/Filing, let's grasp the fundamental concepts:

NMPA: China's equivalent of the FDA (Food and Drug Administration) in the United States.

Registration vs. Filing: While registration involves a comprehensive review process for higher-risk products, filing is a more streamlined procedure suited for lower-risk items.

The Regulatory Odyssey Begins

Embarking on the journey of NMPA registration/filing demands meticulous planning and strategic maneuvering. Here's a snapshot of the expedition:

Preparation: Just as a well-equipped vessel ensures a smoother voyage, thorough preparation is key. This entails compiling all necessary documentation, including product specifications, clinical trial data, and quality management records.

Submission: Like casting off from the harbor, submitting your application signals the commencement of your regulatory voyage. Ensuring all documents are complete and accurate is vital to avoid navigational hazards along the way.

Evaluation: As your application sets sail, it undergoes scrutiny by the NMPA. This phase involves meticulous examination of your product's safety, efficacy, and compliance with Chinese regulations. Much like weathering a storm, this stage requires resilience and patience.

Approval: Upon successfully navigating the evaluation process, your product receives the green light for market entry. Receiving NMPA approval is akin to reaching the shores of a new market, brimming with opportunities for growth and expansion.

Navigating the Regulatory Rapids: Tips and Strategies

Charting a Course for Success

Engage Local Expertise: Just as a seasoned navigator relies on local guides, partnering with regulatory consultants well-versed in Chinese regulations can provide invaluable assistance.

Stay Updated: The regulatory landscape is ever-evolving, akin to shifting tides. Keeping abreast of changes and updates ensures your compliance strategy remains agile and adaptable.

Prioritize Quality: Quality is the compass guiding your regulatory journey. Upholding stringent quality standards not only expedites the approval process but also fosters trust among consumers.

Embracing Challenges as Opportunities

Navigating the waters of NMPA registration/filing may present challenges, but each obstacle is an opportunity for growth and learning. Rather than viewing regulatory compliance as a hindrance, perceive it as a vital component of your market expansion strategy.

Conclusion: Setting Sail for Success

In the realm of medical product regulation, navigating the NMPA registration/filing process is akin to embarking on a daring expedition. By understanding the intricacies of this regulatory voyage and adopting a strategic approach, businesses can chart a course for success in the vast and lucrative Chinese market. Just as skilled navigators brave the seas with confidence, let your business venture forth into the realm of NMPA compliance, guided by expertise, diligence, and a spirit of adventure. Bon voyage!

[freyrsolutionschina]

China is one of the fastest-growing markets for Medical Devices, where the demand for devices is majorly met through imports. NMPA (National Medical Products Administration) ,formerly known as CFDA and the Centre for Medical Device Evaluation (CMDE) are responsible for the review of the Medical Device import registration applications of all the three (03) classes of devices (Class I, II & III). As per NMPA regulations, an NMPA legal agent must be appointed to serve as a representative of overseas pharmaceutical and medical device companies applying for China Medical Device Registration.

[businessresearchreportss]

Navigating Regulatory Landscape: Insights into China Other Joint Reconstruction Procedures Market

The current regulatory landscape for other joint reconstruction procedures in China. However, some general insights and considerations that were relevant as of my last update. Keep in mind that regulations may have evolved, and it's crucial to consult the latest sources or regulatory authorities for the most current information.

For more insights into the China Other Joint Reconstruction Procedures market segments, download a free report sample

CFDA (China Food and Drug Administration): In China, medical devices, including those used in joint reconstruction procedures, are regulated by the National Medical Products Administration (NMPA), formerly known as the China Food and Drug Administration (CFDA). It's essential to understand and comply with the registration and approval processes for these devices.

Regulatory Approval Process: Companies looking to market and sell joint reconstruction devices in China typically need to go through a regulatory approval process. This may include submitting documentation demonstrating the safety and efficacy of the devices. Understanding the specific requirements and submission processes outlined by the NMPA is crucial.

Local Representation: Establishing a local presence or partnering with a local distributor can be beneficial. Having a local representative can facilitate communication with regulatory authorities and ensure that your company is compliant with local regulations.

Quality Standards: Compliance with international quality standards, such as ISO 13485, is often required for regulatory approval. Ensure that your manufacturing processes adhere to these standards, as they may play a role in the approval process.

Clinical Trials: Depending on the nature of the joint reconstruction devices, clinical trials may be required for regulatory approval. Understanding the specific requirements for conducting clinical trials in China and obtaining ethical approvals is essential.

Changes in Regulations: Keep abreast of any changes or updates in the regulatory landscape. Regulatory requirements can evolve, and staying informed will help your company adapt its strategies accordingly.

Cultural and Language Considerations: Effective communication with regulatory authorities may require an understanding of Chinese language and culture. This can be achieved by having bilingual staff or partnering with individuals or firms familiar with the local context.

Market Access Challenges: In addition to regulatory compliance, be aware of other market access challenges, such as reimbursement policies, pricing strategies, and competition within the Chinese market.

It's crucial to consult with legal and regulatory experts specializing in the medical device industry in China to navigate the specific requirements and changes in the regulatory landscape. Additionally, direct communication with the NMPA or other relevant authorities can provide the most up-to-date and accurate information.

[chinemagazine]

Yuanruida obtient l'avantage du premier arrivé dans le traitement de la LAL à cellules B r/r en Chine

CASI Pharmaceuticals et Juventas Cell Therapy ont récemment reçu l'approbation de l'administration pour Yuanruida

CASI Pharmaceuticals et Juventas Cell Therapy ont récemment reçu l’approbation de la National Medical Products Administration (NMPA) de Chine pour Yuanruida (Inaticabtagene Autoleucel/CNCT19), une thérapie CAR-T nationale ciblant le CD19 pour la leucémie lymphoïde aiguë à cellules B en rechute/réfractaire (r/r Cellule B ALL). Cette approbation positionne les deux sociétés comme des pionnières…

[moremedtech]

Shanghai Unveils Advanced Synchrotron-Based Proton Therapy Facility for Enhanced Cancer Treatment

Shanghai Unveils an Advanced Synchrotron-Based Proton Therapy Facility for Enhanced Cancer Treatment CHINA, October 29, 2023 - Proton therapy is an advanced form of radiation therapy that uses protons instead of X-rays to treat cancer. Due to its precise nature, it significantly reduces damage to surrounding normal tissue. The Bragg peak of proton beams ensures that there's almost no dose after the peak, protecting essential organs from unnecessary radiation. With over 103 proton therapy centers operational worldwide and more than 280,000 patients treated, this technology is revolutionizing the way cancer is treated. This study is published in Nuclear Science and Techniques Volume 34, researchers from Shanghai Institute of Applied Physics, Chinese Academy of Sciences and Shanghai Advanced Research Institute, Chinese Academy of Sciences, has been successfully developed and certified by the National Medical Products Administration (NMPA). This cutting-edge proton therapy facility, based on synchrotron technology, is a significant leap forward in the realm of China made high-tech medical apparatus for cancer treatment. The SAPT facility is located at the Shanghai Ruijin Hospital Proton Therapy Center. The construction of this sophisticated facility encompassed two phases. In the initial phase, four beam lines were developed in three treatment rooms. The second phase saw the introduction of a 360° rotating gantry room. The facility's accelerator system includes a 7-MeV proton LINAC, a synchrotron, two rotating gantries, and corresponding transport beamlines. Each of the facility’s four treatment rooms is equipped with a beam delivery system, a positioning system, image-guided radiotherapy (IGRT), a treatment control system (TCS), a treatment plan system (TPS), an oncology information system (OIS), and a quality assurance (QA) system. With the pinpoint accuracy of the whole system, treatment is precise, ensuring optimal results with minimal side effects. Following rigorous third-party inspections and tests for medical devices, the SAPT facility underwent a clinical trial with 47 patients. These patients, aged between 32 and 80, had tumors located in various regions, including the chest, abdomen, spine, and head and neck. Results were promising: the local control rate of the tumor was 100%, and no severe adverse reactions were noted. The SAPT facility demonstrated remarkable reliability, with an availability rate of over 98.5% during the clinical trial period. With the SAPT facility now officially registered and certified, it will open its doors for patient treatment in July 2023. This facility is expected to enhance the cancer treatment power in the region, offering a more precise method with less side effects to tackle various forms of tumors. As the need for such advanced treatment grows globally, the successful establishment and operation of the SAPT facility in Shanghai serve as a beacon of hope and an innovation model in the medical world. Funding information: The work is supported by the major projects for strategic emerging industries of the Shanghai local government and National Key R&D Program of China. More Information: DOI: 10.1007/s41365-023-01293-1 Read the full article

[freyrsolutions]

Medical Devices, NMPA, Cybersecurity, CAC, Regulatory Affairs, China, Cybersecurity Administration of China, National Medical Products Administration

[cavenewstimes]

Nubeqa™ (darolutamide) approved for additional prostate cancer indication in China

Nubeqa™ (darolutamide) approved for additional prostate cancer indication in China, Berlin, March 20, 2023 – The Chinese National Medical Products Administration (NMPA) has approved the oral androgen receptor inhibitor (ARi) Nubeqa™ (darolutamide) in combination with docetaxel for the treatment of…, 2023-03-20 00:00:00, Berlin, March 20, 2023 – The Chinese National Medical Products Administration…

[gilberthbolanos]

Insilico Medicine's 3CLpro inhibitor ISM-3312 cleared to enter clinic in China for COVID-19

Insilico Medicine Inc. has received IND clearance from China’s National Medical Products Administration (NMPA) for ISM-3312, an orally available 3CLpro inhibitor for the treatment of COVID-19. ISM-3312 has a novel molecular structure and was optimized from compounds designed by Chemistry42, Insilico’s generative chemistry AI platform. Insilico Medicine’s 3CLpro inhibitor ISM-3312 cleared to enter…

[innovationtrends]

Pulmonary Arterial Hypertension Market Share, Analysis Report Trends by Types, Applications and Forecast 2028

The pulmonary arterial hypertension market is expected to grow from US$ 7,369.89 million in 2021 to US$ 10,889.08 million by 2028; it is estimated to grow at a CAGR of 5.8% from 2022 to 2028.

The pulmonary arterial hypertension market is segmented on the basis of drug, type, route of administration, distribution channel, and geography. The report offers insights and in-depth analysis of the pulmonary arterial hypertension market, emphasizing various parameters such as dynamics, trends, and opportunities of the market and competitive landscape analysis of leading market players across various regions. It also includes the impact analysis of COVID–19 pandemic on pulmonary arterial hypertension market across the regions.

Grab PDF to Know More (Including Table, Full TOC and Figures) @ https://www.theinsightpartners.com/sample/TIPRE00005221/  

Rising Approvals of Pulmonary Arterial Hypertension Drugs Drives Market Growth

In September 2022, Toray Industries, Inc. received approval from China’s National Medical Products Administration (NMPA) for Careload tablets to treat pulmonary arterial hypertension (PAH). Careload is an orally administered sustained-release formulation of beraprost sodium, a prostacyclin derivative (PGI2).

In May 2022, United Therapeutic Corporation received US Food and Drug Administration (FDA) approval for Tyvaso DPI (treprostinil) inhalation powder to treat pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) and pulmonary arterial hypertension (PAH; WHO Group 1) to enhance exercise ability.

In November 2021, the US FDA granted tentative approval for Yutrepia (treprostinil) inhalation powder. Yutrepia is indicated to treat PAH to improve exercise ability in adult patients with New York Heart Association (NYHA) Functional Class II-III symptoms.

In July 2021, The Janssen Pharmaceutical Companies of Johnson & Johnson received FDA approval for UPTRAVI (selexipag) injection for intravenous (IV) to treat PAH; WHO Group I in adult patients with WHO functional class (FC) II–III, who are temporarily unable to take oral therapy.

In August 2021, Aerami Therapeutics, Inc. announced that the FDA granted the company orphan drug designation for imatinib to treat PAH patients. AER– 901, a drug-device combination product candidate for inhaled imatinib for the treatment of PAH, is in a Phase 1 trial with completion targeted for the end of 2021.

Drug-Based Insights

Based on drug, the pulmonary arterial hypertension market is segmented into endothelin receptor antagonists (ERAs), prostacyclin and prostacyclin analogs, sGC stimulators, and pde-5 dipsticks. The prostacyclin and prostacyclin analogs segment held the largest market share in 2021 and is anticipated to register the highest CAGR during 2022–2028. Prostacyclin is a small lipid eicosanoid molecule, also known as prostaglandin, I-2 (PGI-2), produced by endothelial cells and acts locally, inhibiting platelet activation and causing vasodilation. Prostacyclin dilates blood vessels, improves blood flow by preventing the proliferation of vascular smooth muscle cells, and prevents blood clotting by inhibiting platelet aggregation. Prostacyclin analogs have been developed as therapies for PAH. PAH prostacyclin analogs are synthetic forms of prostacyclin, a natural substance produced in the body. Patients affected by PAH tend to have reduced prostacyclin levels, leading to blood vessel constriction and hypertension. PAH prostacyclin analogs supplement the requirement and mimic the action of natural prostacyclin to reduce pulmonary hypertension and reduce associated symptoms.

Route of Administration-Based Insights

Based on route of administration, the pulmonary arterial hypertension market is segmented into oral, intravenous/subcutaneous, and inhalational. The oral segment held the largest market share in 2021 and is anticipated to register the highest CAGR during the forecast period. Orally administered agents used for the treatment of symptomatic, moderate-to-severe PAH include sildenafil and the endothelin (ET) receptor antagonists (ERAs), bosentan and sitaxentan (sitaxsentan), and abrisentan oral ET(A) receptor-selective ERA, with higher ET receptor affinity than bosentan. Moreover, new oral drugs for treating PAH include macitentan, riociguat, and treprostinil. Ambrisentan is an endothelin receptor antagonist indicated for treating PAH; WHO Group 1 and delay clinical worsening. In combination with tadalafil, ambrisentan is indicated to reduce the risks of disease progression and hospitalization for worsening PAH, and to improve exercise ability.

Distribution Channel-Based Insights

Based on distribution channel, the pulmonary arterial hypertension market is segmented into hospital pharmacies and clinics, online pharmacies, and retail pharmacies. The hospital pharmacies and clinics segment held the largest market share in 2021 and is anticipated to register the highest CAGR during the forecast period. Hospital pharmacy strives to continuously maintain and improve patients' medication management and pharmaceutical care to the highest standards in a hospital setting. Pharmacists in this field are responsible for dispensing medications, quality testing, formulating and re-formulating dosage forms, monitoring, reporting drug safety, and preparing budgets for medications.

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China grants emergency approval for homegrown ECMO

BEIJING, -- China's National Medical Products Administration (NMPA) said Thursday that it has given emergency approval to the country's first homegrown extracorporeal membrane oxygenation (ECMO) device and its accompanying kit.

The ECMO device and its supply kit, developed by Shenzhen-based Chinabridge Medical, can support adult patients with acute respiratory or cardiopulmonary failures that other treatments cannot control and who are facing risks of deterioration or even death, according to the NMPA.

The NMPA said the products have independent intellectual property rights, and their performance indicators are on a par with similar foreign products.

[rnewspost]

Two Chinese anti-SARS-CoV-2 drugs conditionally approved for marketing

Credit: Unsplash/CC0 Public Domain Two Chinese oral anti-SARS-CoV-2 drugs, Xiannuoxin (simnotrelvir/ritonavir) and VV116 (deuremidevir hydrobromide), were conditionally approved for marketing by China’s National Medical Products Administration (NMPA) in late January after urgent review and approval under the Special Examination and Approval of Drugs Policy. Both drugs are intended for the…