20 ASIAN LEGAL BUSINESS CHINA • 亚洲法律杂志-中国版 FEBRUARY 2024 COMPLIANCE In the face of expanding regulatory landscapes and mounting pressures, legal and compliance professionals are aiming for a “business-oriented’ mindset, emphasizing not just adherence to regulations but alignment with unique business situations. BY HU YANGXIAOXIAO 面对不断增长的监管压力，法律和合规专业人士正致力于采取 “以商业为导向”的思维模式，不仅强调遵守法规，更强调与独 特的商业情境相结合。作者：胡阳潇潇 FROM RISK TO OPPORTUNITY 对话从企风业险合到规机管遇理者： In the stringent regulatory landscapes of the finance and biotech sectors, examining how companies navigate compliance provides valuable insights that extend beyond these industries, offering a broader understanding of corporate compliance practices across various sectors. ALB recently spoke with Tong Chao, head of compliance management and general manager of the legal and compliance team at Zhejiang Orient Financial Holdings Group, and Richard Li, chief legal officer at I-Mab, with the aim to understanding their current focus on compliance, how they use innovative thinking to create a practical and effective compliance system, and how they interact with external lawyers in the field of compliance. Faced with increasing regulatory pressures and the ever-expanding scope of corporate compliance, what approach should be taken for corporate compliance work? Both Tong and Li suggest a “business-oriented” approach. Tong tells ALB that Zhejiang Orient Financial, as the only state-owned listed financial holding group in Zhejiang Province, deals with complex external regulations including state-owned asset supervision, compliance for listed companies, and various financial and quasi-financial business regulations. “Therefore, the sectors our compliance management system needs to focus on can be divided into these three major categories.” Moreover, it is necessary to consider the different business sectors of the group, such as trust, futures, insurance, financial leasing, equity investment, and wealth management, and build corresponding compliance systems. I-Mab has adopted a similar approach to building its compliance system. “A major characteristic of the biotech industry is facing almost the strictest regulatory compliance requirements that span the entire product development lifecycle. Therefore, most biotech companies also build their compliance work systems based on such a product lifecycle regulatory process,” Li tells ALB. Specifically, the early R&D phase of biotech products corresponds to Good Laboratory Practice (GLP) standards; the clinical trial phase follows Good Clinical Practice (GCP) standards; the drug approval process faces regulatory oversight from drug administration authorities and adheres to Good Regulatory Practice (GRP) standards; after the product is marketed, it must comply with Good Manufacturing Practice (GMP) standards to ensure that all involved enterprises meet regulatory requirements. Then, in the product sales and distribution phase, there are Good Service Practice (GSP) standards; even after products are marketed, there is strict ongoing supervision, requiring companies to continue providing Phase IV clinical data or continuously report adverse reactions. This interlinked regulatory process establishes a basic logical framework for the compliance work of biotech companies. Over the past few years, the scope of the term “compliance” has continually expanded, and correspondingly, the workload of corporate legal and compliance teams has also increased. Tong believes this can be understood from two perspectives: “On one hand, it is determined by the nature of compliance management, which can involve various aspects of company operations and inherently has a broad applicability; on the other hand, as various compliance risk incidents come to light, the importance of compliance management is increasingly emphasized, inevitably leading to an expanding coverage of compliance management.” Li interprets this change from a more macroscopic perspective. “In recent years, a major trend has emerged in major judicial jurisdictions around the world, namely legislation and regulation are adapting more rapidly to changes in business practices. New regulations often follow within a year, or even a few months, after a new business model emerges. Moreover, policies and regulations are becoming more detailed, including many specific operational provisions, which lead to increasing regulatory challenges for enterprises. This, in turn, requires more time, money, and talent resources to be focused on compliance work.” In his view, this is both an opportunity and a challenge for corporate compliance personnel. “The challenge lies in the increasing complexity of compliance work, and the internal pressure on
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