On July 15, 2026, the BIO Sight Salon Forum on Compliance, Financing and Innovative Payments for Biotech Enterprises concluded successfully in Shanghai. As the first landmark industry event covering the entire industrial value chain following the implementation of the new policy under State Council Decree No. 818 — Regulations on the Administration of Clinical Research and Clinical Translation Application of New Biomedical Technologies — this forum featured a Nobel Prize-backed original First-in-class ophthalmic drug and brought together renowned industry figures including policy experts, partners from leading healthcare funds, leading clinicians from Class A tertiary hospitals, and Real-World Evidence service providers. Participants jointly explored compliance development, financing pathways, and sustainable commercial payment systems for biotech enterprises amid the new regulatory cycle. Aaron Gu, an attorney at Han Kun Law Offices, was invited to attend the forum, where he delivered a keynote speech titled "Order No. 818: New Regulations on New Biomedical Technologies / IIT — New Supervision, New Pathways, and New Opportunities," and participated in the panel discussion on "Core Competitiveness of Biotech Enterprises Under the New Policy — Compliance and Clinical Practice," exploring pathways for compliance development alongside prominent industry leaders.
During the keynote session, drawing on the evolving regulatory landscape following the implementation of Decree No. 818, Aaron Gu provided a systematic overview of the regulatory framework for emerging biomedical technologies and the evolving pathway for IIT clinical research in light of the Order No.818 landscape. He also offered an in-depth analysis of the end-to-end compliance requirements under the new policy, while sharing practical insights into the strategic selection of drug, device, and technology development pathways, as well as the operational and commercial considerations involved in cross-border R&D collaboration.
During the panel discussion, Aaron Gu joined a distinguished roster of experts from industry associations, Class A tertiary hospitals, ethics committees, and GMP laboratories for an in-depth exchange. The dialogue centered on core topics including key compliance considerations in cutting-edge sectors such as cell and gene therapy, ethical review standards for clinical research, and enterprise compliance capacity building. Drawing on diverse perspectives spanning policy formulation, clinical practice, and legal compliance, the participants exchanged views and collectively offered insights and recommendations to support biotech enterprises in advancing maturity compliance and achieving breakthroughs in clinical translation amid the new regulatory cycle.
The forum was hosted by China Vision. Focusing on cutting-edge sectors including cell and gene therapies, iPSC-RPE, corneal stem cells, gene therapies for inherited eye diseases, CNS, universal CAR-T/CAR-NK immune cells, siRNA/mRNA nucleic acid drugs, and gene editing, the forum upholds an innovation-driven and compliance-first philosophy. It is dedicated to building a specialized industry exchange platform that connects resources across the policymaking, clinical, capital, and industrial ecosystems, pooling industry wisdom to advance compliant innovation and high-quality development of the biotechnology sector.
Aaron Gu's Profile
Mr. Gu specializes in corporate, regulatory compliance, and transactional services for life sciences, biopharmaceutical, medical and healthcare industries, including biosecurity and human genetic resource issues, clinical trial matters, product marketing authorizations, GxP compliance, Spin off-NewCo transactions, drug licensing and collaboration, as well as regulatory issues involved in venture capital and private equity investments, mergers and acquisitions, and foreign and outbound investments in the life sciences industries. Specifically, Mr. Gu's services cover a full range of products including drugs, medical devices, IVDs, cosmetics, general foods, special foods, animal drugs, animal foods, etc.
