Life sciences and medical health

Life Sciences and Healthcare

The life sciences and healthcare industry is one of the core areas of Hong An Xin Chen's strategic布局. The firm's life sciences and healthcare legal team specializes in providing full-chain, interdisciplinary legal services to biopharmaceutical enterprises, research institutions, medical organizations, and health industry investors, promoting the deep integration of technological innovation and compliant development.

In the field of life sciences and healthcare, Hong An Xin Chen aims to build a full-ecosystem legal support system covering "R&D - transformation - application". Focusing on cutting-edge tracks such as gene therapy, cell therapy, precision medicine, and digital health, the team provides professional support for key links including clinical trial compliance, biotechnological patent portfolio, human genetic resources management, cross-border R&D cooperation, and medical AI ethics review for clients such as biotech companies, CGT (cell and gene therapy) enterprises, medical laboratories, and internet medical platforms. The team deeply collaborates with drug regulatory authorities, National Health Commission, research institutes, medical investment funds, and international pharmaceutical organizations, covering emerging fields such as biopharmaceutical technology licensing (License-in/out), compliant launch of IVD (in vitro diagnostic) products, design of legal frameworks for real-world studies (RWS), intellectual property protection for medical AI algorithms, compliant operation of biological sample banks, risk control for medical robot applications, multinational multi-center clinical trials (MRCT), cross-border medical data transmission, and construction of biosafety law compliance systems. It has benchmark service experience especially in high-risk and high-value fields such as commercialization of gene editing technology, patent攻防 for biosimilars, and commercial development of medical big data.

The life sciences and healthcare team of Hong An Xin Chen is led by composite experts with both biomedical backgrounds and legal practical experience, including former compliance officers of international pharmaceutical companies, consultants to the National Medical Products Administration, and transnational medical dispute arbitration experts, with a service network radiating major global biopharmaceutical industry clusters. With deep insight into industry technology trends and regulatory logic, the team has consecutively ranked in the Chambers Asia-Pacific Life Sciences First Tier for many years and won IMLR's "Best Chinese Law Firm for Gene and Cell Therapy", and has led the compilation of industry standard documents such as the Medical Health Data Compliance White Paper. Hong An Xin Chen will continue to track the evolution of disruptive technologies such as brain-computer interfaces, synthetic biology, and medical metaverse, providing strategic solutions for clients to address technical ethics review, cross-border regulatory conflicts, and industrial capitalization challenges.

Business Types/Service Scope

- Cross-border licensing and cooperative development agreements for biopharmaceutical technologies

- Full-process compliance for IND/NDA of gene and cell therapy products

- Approval for outbound human genetic resources and data compliance

- Certification of medical AI medical devices and intellectual property protection for algorithms

- Design of legal frameworks for biological sample bank construction and informed consent

- Construction of compliance systems for real-world studies (RWS)

- Registration of in vitro diagnostic (IVD) reagents and compliance with LDT models

- Ethical review of clinical applications of medical robots

- Patent challenges for biosimilars and application of Bolar exceptions

- Compliance for commercial development of medical health big data

- Legal risk management for multinational multi-center clinical trials (MRCT)

- Transformation of scientific and technological achievements of medical institutions and capital contribution in the form of shares

- Legal risk prevention and control for medical metaverse application scenarios

- Compliance for科创板/Hong Kong Stock Connect 18A listing of biopharmaceutical enterprises

- Prevention and control of medical research corruption and compliance investigations

- Legal support for compassionate use of emergency medical technologies

- Laboratory risk control under the background of the Biosafety Law

- Antitrust and anti-unfair competition in the medical health field

- Ethics and clinical application compliance for brain-computer interface technologies