Drugs and Big Health Business

Pharmaceuticals and the Greater Health Industry

The pharmaceuticals and greater health industry is one of the strategic areas where Hong An Xin Chen has made significant deployments. The firm's pharmaceuticals and greater health legal team specializes in providing full-industry-chain, multi-dimensional legal support to pharmaceutical enterprises, medical institutions, biotech companies, and health industry investors, facilitating compliant innovation and sustainable development within the sector.

In the field of pharmaceuticals and greater health, Hong An Xin Chen aims to build a full-lifecycle legal service system covering R&D, production, distribution, and medical services. The team is dedicated to offering professional services for critical aspects such as drug registration and compliance, clinical trial legal risk management, intellectual property portfolio, cross-border technology cooperation, and medical data security to clients including innovative pharmaceutical companies, medical device manufacturers, CRO/CDMO institutions, and internet medical platforms. Closely collaborating with key entities like drug regulatory authorities, top-tier hospitals, pharmaceutical investment funds, and industry associations, the team's services span cutting-edge areas such as pharmaceutical patent litigation, implementation of the Marketing Authorization Holder (MAH) system, GMP/GSP compliance review, medical dispute mediation, healthcare investment and M&A, compliance for AI medical applications, gene therapy ethics review, health insurance product design, legal risk control for medical advertising, cross-border License-in/out transactions, pharmaceutical antitrust and anti-commercial bribery, and international vaccine cooperation. The team boasts extensive practical experience, particularly in global protection of innovative drug rights, construction of compliance systems for medical groups, and IPOs of biopharmaceutical enterprises.

The pharmaceuticals and greater health team of Hong An Xin Chen comprises composite professionals with both medical backgrounds and legal qualifications, including former experts from drug regulatory systems, senior legal executives of multinational pharmaceutical companies, and seasoned lawyers in medical dispute resolution. Its service network comprehensively covers biopharmaceutical industry clusters in regions such as Beijing-Tianjin-Hebei, the Yangtze River Delta, and the Guangdong-Hong Kong-Macao Greater Bay Area. With profound understanding of industry regulatory frameworks and cross-border resource integration capabilities, the team has been consecutively ranked among the leading law firms in the life sciences field by ALB, placed in the first tier of Chambers' China Healthcare & Pharmaceuticals rankings, and recognized as the "Best Pharmaceutical Compliance Team of the Year" by IMLR. Hong An Xin Chen will continue to track transformative trends in cell therapy, digital therapeutics, and internationalization of traditional Chinese medicine, providing forward-looking solutions for clients to navigate complex challenges such as centralized procurement policies, medical insurance negotiations, and cross-border data flows.

Business Types/Service Scope

- Clinical trial agreements and ethical review for pharmaceuticals

- Patent portfolio and intellectual property litigation for innovative drugs

- Establishment of Marketing Authorization Holder (MAH) systems and GMP compliance frameworks for pharmaceutical production

- Registration of medical devices and compliance with FDA/CE certifications

- M&A, restructuring, and listing on STAR Market or B-share market for pharmaceutical enterprises

- Application of medical big data and personal information protection

- Establishment of internet hospitals and compliance for telemedicine

- Cross-border transfer of biological samples and management of human genetic resources

- Antitrust filing and compliance review in the pharmaceutical industry

- Dispute resolution for medical liability damages and crisis management

- Response to medical insurance payment reforms and DRG/DIP policies

- Protection of classic traditional Chinese medicine formulas and international cooperation

- Compliance for pharmaceutical CSOs and innovation of marketing models

- Specialized compliance governance for the medical aesthetics industry

- International vaccine cooperation and emergency use authorization

- Full-process risk control for fundraising, investment, management, and exit of healthcare investment funds

- Construction of ESG systems and compliance disclosure in the pharmaceutical industry

- Cross-border pharmaceutical technology licensing and cross-border OEM agreements