The transaction market of this year can be characterized as cautious, steady, and retrieving value compared with the active market performance before 2021. The whole competitive landscape in licensing deals is increasingly severe, gradually shifting from quantitative superiority to quality and strategic competitiveness, and the risk tolerance requirements on both parties of the transaction are gradually demanding; on the other hand, cutting-edge and innovative technologies (e.g., Artificial Intelligence (“AI”)) are still highly favored by investors.

相较于2021年以前积极活跃的市场表现，过往一年交易市场以谨慎稳健和重述价值为主风向标。一方面，许可交易的竞争越来越激烈，数量竞争格局逐渐转为质量和战略竞争，对交易双方风险承受能力的要求也越来越高；另一方面，前沿及创新技术（如人工智能AI等新技术）仍备受投资者青睐。

It should be noted that China’s regulatory policy continues actively attracting premium pharmaceutical enterprises, constantly promoting the localization of multinational companies, increasingly providing supports for the market access of high-quality products, and steadily strengthening the governance of related regulatory areas. In return, pharmaceutical enterprises enter into a new era of compliance reorganization under the escalating competitive situation.

需要看到的是，中国监管政策仍在大力吸引优质的医药企业、推进外资企业的本土化、增加引入优质产品的扶持力度，同时还强化医药行业相关监管领域的治理，这也促使医药企业在竞争格局持续演变的当下进入了新一轮的合规重整期。

The State Council, in its opinions related to the continuous strengthening of foreign investment protection in 2023, proposed to reinforce the protection of intellectual property rights in the procurement activities of medicines and medical consumables, and to take timely measures such as refraining from procurement and canceling the qualification of listing for the products that are identified as patent infringing by administrative rulings of the intellectual property administrative department or by effective courts’ judgement. Meanwhile, one of the biggest highlights in the negotiation for 2023 national reimbursement drug list (“NRDL”) is its emphasis on encouraging innovation, with new target drugs emerging constantly in the list, the NRDL is incrementally enabling innovative drugs to benefit patients in China. It is reasonable to anticipate that the innovative characteristics (e.g., the innovative drugs with patent value, or with new therapeutic effects) remain to be important factors in evaluating the competitiveness of products.

国务院在2023年持续加强外商投资保护相关的意见中，提出加强药品和医用耗材采购领域知识产权保护，对经知识产权部门行政裁决或人民法院生效判决认定为专利侵权的产品，及时采取不予采购、取消中选资格等措施。与此同时，2023年国家医保目录准入谈判的最大亮点之一是突出了鼓励创新的导向，新靶点药物逐步被纳入了目录范围，使得创新药快速惠及中国患者。合理预见，具有专利价值的原研属性和具备新疗效等的创新属性将依旧是衡量产品强竞争力的重要因素。

• Elaborated Human Genetic Resources Administration and Ethical Review Regulations Came into Effect
  细化落地的人类遗传资源监管和伦理审查规则
  
  In 2023, the human genetic resources administration embraced the revolution of supervising deregulation and service improvement. In addition to defining "human genetic resources information" in an enumerated manner and clarifying the definition of "foreign entities" in line with practical operation, this latest regulation facilitates and speeds up the compliance management of human genetic resources and international collaboration through simplifying and refining the administrative methods. In terms of ethical review, the new regulation implemented in 2023 pays special emphasis on the activities related to "human" rather than “medical science”, details the requirements of informed consents, and clarifies the ethical supervision of the research activities covered biological samples. It is foreseeable that the well-developed ethical review system will be progressively established in China.
  人类遗传资源监管在2023年迎来深化落实的“放管服”改革，除对“人类遗传资源信息”以列举的方式予以界定、并对管理实践中的关注焦点“外方单位”的情形予以明确外，监管新规通过对行政监管手段的简化和细化有利地推动了人类遗传资源的合规管理和国际合作。伦理审查层面，2023年发布实施的新规将审查对象重点聚焦于“人”而非“医学”、细化知情同意要求、并明确了涉及生物样本的研究的伦理监管，可以预见中国的伦理审查体系的日益完善。

• Gradually Clarify the Compliance Pathways for Cross-border Transmission of Personal Information
  逐步明晰的个人信息出境合规路径
  
  The cyberspace administrative authority phases in the compliance pathways for the personal information cross-border transmission through executing a series of regulations. Besides passing the data security assessment by the Cyberspace Administrative Authority and obtaining the certification for personal information protection, the Regulation regarding the Standard Contract for Cross-border Transmission of Personal Information, which was implemented in 2023, provides a clearer approach under a standard contract and improves the implementations in the performance of the contract. Meanwhile, the competent authorities are also exploring, through the draft for public opinions, deregulation measures to promote the data free flow in a legitimate and efficient way, and we suggest relevant enterprises continuously and closely keep an eye on the updated trends.
  互联网信息安全管理部门通过一系列的配套规定逐步明晰个人信息出境的合规路径，除了通过网络信息安全主管部门的数据出境安全评估、进行个人信息保护认证外，2023年实施的《个人信息出境标准合同办法》对于订立标准合同的个人信息出境路径提供了更加明确的依据、提高了合同实际履约过程中的可操作性。同时，主管部门也在通过征求意见稿的形式探索规范和促进数据依法有序自由流动的“松绑式”监管手段，值得相关企业持续关注。

Along with the detailed administrative rules and tightening regulatory attitudes towards traditional supervision areas such as antitrust and anti-corruption, pharmaceutical enterprises encounter an opportunity to re-examine and optimize their compliance management with the promulgation and advancement of new regulations in the field of corporate social credit.

随着反垄断和反腐败等传统监管领域治理规则的细化和监管态势的加强企业社会信用等监管新规的出台推动着医药企业迎来重审并优化自身合规管理的契机。

• Antitrust Investigations Continually and Intensively Proceed
  持续发力的反垄断调查
  
  Antitrust investigations and supervisions are closely tied up with the healthcare industry. Among the typical cases disclosed in 2023 with respect to the special campaign for antitrust, five out of twenty-three cases are from the healthcare industry, and the violated matters mainly relate to the execution of monopoly agreements and abuse of a dominant market position, with fines amounting to 100 million RMB. Pharmaceutical enterprises, aim to properly mitigate the violation risks, are recommended to timely keep track of the law enforcement and conduct regular compliance reviews towards the market competition situation, clauses in the distribution agreements and the performance of distributors, etc.
  医药行业向来是反垄断执法的重点关注领域，2023年披露的民生领域反垄断执法专项行动的典型案例中，23个案例中的5个就与医药行业相关，违法类型主要涉及达成并实施垄断协议和滥用市场支配地位，罚款金额高达亿元。医药企业应及时关注监管部门的执法口径，并对企业的市场竞争情况、产品购销协议约定、经销商的履行情况等进行定期合规审查，以更好地降低垄断违法风险。

• Nation-Wide Anti-Corruption Campaign in the Healthcare Industry
  全国医药领域反腐治理
  
  In 2023, the centralized rectification work of corruption in the healthcare industry underscores comprehensive governance in all aspects, entire chain, full coverage. This committed to rehabilitating the fair market environment in the pharmaceutical and medical device purchase and sales activities, and further reducing and maintaining the sales expenses and costs of products. Complying with laws and regulations and internalizing the healthcare industry’s self-regulatory rules into enterprises’ compliance management systems will furnish pharmaceutical enterprises to a stable and sustainable future.
  2023年医药领域的腐败问题集中整治工作强调全领域、全链条、全覆盖的系统治理，旨在恢复药械购销领域的公平市场环境、进一步降低和压实产品的销售费用成本。在反腐治理常态化的当下，遵守法律法规并将行业自律性规则内化至自身合规管理体系的建设将为医药企业行稳致远保驾护航。

• Social Credit System is Taking the Initial Shape
  社会信用体系建设初见雏形
  
  China has been stepping into an initiate stage to establish and consolidate the governance and regulations regarding the social credit systems in recent years, which making up for the lack of unified and consistent laws and regulations to govern the social credit system in various industries and fields. Discredit pharmaceutical enterprises might face restrictions in the access of NRDL, volume-based procurement activities, listing and bidding qualifications, etc. Therefore, there is of necessity and urgency to incorporate the credit monitoring process into the enterprise’s daily legal and compliance risk management.
  为解决各行业、各领域信用建设“无法可依”的问题，中国的社会信用监管制度规则在近年来迈入初期建设阶段。失信医药企业在医保目录准入、医药集中采购、挂网资格等方面将可能面临限制，将信用监控纳入公司日常法律和合规风险管理具有其必要性和迫切性。

• Ethical Review of Science and Technology Activities Promotes Healthcare Industry Upwards to Good Development
  科技伦理审查推动行业向上向善发展
  
  The healthcare industry is the key supervised area in the science and technology ethics administration. Under the upwards to good technology development background, the effectiveness of Measures for Ethical Review of Science and Technology (Trial Implementation) in 2023 gives direct guidance to enterprises in related industries. The newly released regulation illustrates the scope of scientific and technological activities which is compulsorily under the ethical review in the form of examples, and specifies the legal responsibilities which force enterprises to reinforce the self-disciplining standard and comply with regulatory requirements for ethics of science and technology.
  医疗健康领域作为科技伦理的重点监管对象，在科技发展向上向善的背景下2023年《科技伦理审查办法（试行）》的落地让企业有法可依，以例举的形式明确了需要进行科技伦理审查的科技活动范围和违反的法律责任，促使企业自主规范并遵循科技伦理监管要求。

• Legal Challenges Continuously Attaching to the Implementation of AI
  法律挑战时刻伴随着AI运用
  
  AI, as the most commercially promising technology application, is progressively intermingling and interacting with multidimensional big data generated from healthcare industry, such as target discovery, compound synthesis, and optimization of clinical trial design. AI is a new impetus to the healthcare industry while triggering ethical and legal challenges. Pharmaceutical enterprises are recommended to pay close attention to the potential legal risks such as open-source risks, operational/algorithmic compliance, intellectual property infringement protection, personal information protection, and the ownership of outputs before engaging in AI application activities.
  AI作为最具有商业前景的技术应用，已逐步与医疗健康领域中形成的多维大数据进行交融和交互，在靶点发现、化合物合成以及临床试验设计优化等多个细分领域被运用，为医药行业带来了新动力的同时也引发伦理和法律挑战。医药企业在参与AI应用活动前应侧重分析开源风险、运营/算法合规、知识产权侵权保护、个人信息保护、输出成果归属等法律要素。