China’s National Medical Products Administration (NMPA) has approved Elbasvir, an innovative 1-class drug developed by YiChang HEC ChangJiang Pharmaceutical Co., Ltd. This drug, to be marketed under the brand name Dongyinghe, is indicated for the treatment of adult chronic hepatitis C virus (HCV) infections in genotypes 1, 2, 3, and 6, including patients with compensated liver cirrhosis. The approval highlights China’s ongoing commitment to enhancing pharmaceutical innovation and regulatory efficiency.

Key Policy Highlights

1. Innovative Treatment Option
   • Indication: Elbasvir is approved for use in combination with netasavir capsules to treat HCV infections, offering a new therapeutic choice for patients.
   • Patient Population: Targets both treatment-naïve and interferon-treated patients, expanding accessibility to effective therapy.
2. Regulatory Efficiency
   • Approval Process: The rapid approval reflects NMPA’s efforts to accelerate the market entry of innovative drugs, aligning with global regulatory standards and practices.
3. Market Implications
   • Therapeutic Landscape: Elbasvir’s entry diversifies treatment options for HCV, potentially improving patient outcomes and reducing the disease burden.
   • Competitive Edge: The drug’s approval underscores China’s progress in developing domestically innovated therapies competitive with international standards.

Policy Orientation and Industry Implications
The approval of Elbasvir underscores China’s strategic focus on:

• Innovation Support: Encouraging domestic R&D of first-in-class drugs to address unmet clinical needs.
• Regulatory Streamlining: Accelerating approval processes to bring novel therapies to market faster.
• Public Health Impact: Enhancing treatment accessibility and outcomes for HCV patients, contributing to public health goals.

Conclusion
Elbasvir’s approval marks another milestone in China’s journey toward becoming a global leader in pharmaceutical innovation. This development not only benefits HCV patients by providing a new treatment option but also signals China’s growing capability in developing and regulating innovative therapies. Stakeholders in the healthcare sector should leverage this momentum to drive further advancements in drug development and regulatory science.-China Health Reform Pulse

Policy Source: https://www.nmpa.gov.cn/zhuanti/cxylqx/cxypxx/20250327113342139.html

China’s National Medical Products Administration (NMPA) has approved the innovative anti-influenza drug Masutrelavir (brand name: 伊速达) developed by Jiangxi Kerui Pharmaceutical Co., Ltd. This first-in-class drug offers a new treatment option for influenza patients, highlighting China’s progress in pharmaceutical innovation and regulatory efficiency.

Key Policy Highlights

1. Innovative Mechanism of Action
   • Target: Masutrelavir is a polymerase acidic protein (PA) inhibitor, distinguishing itself from traditional neuraminidase inhibitors by intervening earlier in the viral life cycle to prevent mature virus formation.
   • Clinical Efficacy: Phase III clinical trial data published in Nature Medicine showed significant reductions in symptom resolution time and viral load, with excellent safety and low resistance rates.
2. Regulatory Efficiency
   • Approval Timeline: The rapid approval reflects NMPA’s commitment to accelerating the market entry of innovative drugs, aligning with global regulatory standards.
3. Market Implications
   • New Treatment Option: Masutrelavir provides a one-dose treatment regimen, enhancing patient compliance and offering a competitive edge over existing therapies like oseltamivir and baloxavir.
   • Market Stabilization: The drug’s entry is expected to diversify treatment options and potentially stabilize the influenza medication market.

Policy Orientation and Industry Implications
The approval underscores China’s strategic focus on:

• Innovation Support: Encouraging domestic R&D of first-in-class drugs.
• Regulatory Streamlining: Accelerating approval processes for high-impact innovations.
• Public Health: Enhancing treatment accessibility and outcomes for influenza patients.

Conclusion
Masutrelavir’s approval marks a significant step in China’s journey toward becoming a global leader in pharmaceutical innovation. Stakeholders in the healthcare sector should leverage this momentum to drive further advancements in drug development and regulatory science.-China Health Reform Pulse

Policy Source: https://www.nmpa.gov.cn/zhuanti/cxylqx/cxypxx/20250327113047141.html

China’s National Medical Products Administration (NMPA) held a meeting on March 24, 2025, to advance the national medical device sampling inspection work for 2025. The meeting reviewed the achievements of the 2024 inspection work, analyzed the current situation, and deployed key tasks for 2025. This initiative reflects China’s ongoing commitment to enhancing the quality and safety of medical devices through rigorous regulatory measures.

Key Policy Highlights

1. Implementation of the “Four Strictest” Requirements
   • Regulatory Stringency: Ensuring strict compliance with regulatory standards across all levels of medical device supervision.
   • Quality Assurance: Focusing on maintaining high-quality standards to safeguard public health and safety.
2. Work Philosophy
   • Core Principles: Adhering to the principles of “political guidance, strong regulation, safety assurance, development promotion, and people-oriented benefits.”
   • Task Completion: Successfully fulfilling the national supervision and sampling inspection tasks for 2024, which contributed to product quality improvement and public safety.
3. 2025 Inspection Work Deployment
   • Responsibility Implementation: Requiring all levels of drug regulatory authorities to earnestly fulfill their inspection responsibilities.
   • Organizational Management: Strengthening organizational and managerial efforts to ensure efficient execution of inspection tasks.
   • Mechanism Improvement: Refining operational mechanisms to enhance the effectiveness of the inspection work.
   • Service and Quality Assurance: Ensuring that inspection work effectively supports regulatory efforts and guarantees product quality and safety.

Policy Orientation and Industry Implications
The deployment of the 2025 medical device sampling inspection work highlights China’s strategic focus on:

• Quality and Safety: Prioritizing the quality and safety of medical devices to protect public health.
• Regulatory Efficiency: Enhancing the efficiency and effectiveness of regulatory measures to ensure compliance across the industry.
• Industry Development: Supporting the high-quality development of the medical device industry through robust regulatory frameworks.

Conclusion
China’s approach to medical device sampling inspection work sets a benchmark for regional regulation, emphasizing accountability, transparency, and quality-driven growth. Companies in the medical device sector should align with these guidelines to strengthen their quality management systems and leverage regulatory support for competitive advantages.-China Health Reform Pulse

Policy Source: https://www.nmpa.gov.cn/yaowen/ypjgyw/hyxx/ylqxhyxx/20250326151420158.html