Can Digital Patient Management Become Pharma's New Pathway Under Regulatory Reforms?

The new regulations issued by the National Medical Products Administration (NMPA) in early July sparked significant upheaval across the industry, triggering a series of discussions on the development of the pharmaceutical sector. Perspectives on the new policy vary widely, with interpretations ranging from beneficial to detrimental, and from encouraging to restrictive. However, from a different perspective, the introduction of these new regulations has not altered the fundamental trajectory of the pharmaceutical industry’s development. The sector will continue to accelerate its growth in the future. That said, with stricter standards in place, the industry must identify new solutions to align with the evolving R&D environment.

In the new landscape, digital technologies may become the key to breaking through bottlenecks in the pharmaceutical industry. Over the past few years, the integration between the pharmaceutical industry and digital technologies has grown increasingly tight. From multinational corporations (MNCs) to domestic biotech startups, companies have effectively incorporated digital solutions into their workflows to support product research and development, manufacturing, or sales.

Therefore, we aim to draw upon the discussions held by experts during the inaugural session of the “Encountering the Future: Industry Transformation in the Era of Intelligent Technological Change” salon series. This event was organized on July 31, 2021, by the Digital Healthcare Committee (hereinafter referred to as the “Committee”) of the China Europe International Business School Alumni Healthcare Industry Association (CAHA), and co-organized by LinkDoc Technology. Through this analysis, we seek to explore how digitalization and the pharmaceutical industry can be organically integrated to create synergies that empower clinical practice amidst the evolving landscape of the pharmaceutical sector.

For leading pharmaceutical companies, greater capabilities entail greater responsibilities. Consequently, their strategic focus on products has evolved beyond merely developing better drugs to encompass holistic, full-cycle management of the entire patient journey.

CAHA President, AstraZeneca’s Global Executive Vice President, President of International Business and China, Mr. Lei WangHe stated, “From a traditional perspective, pharmaceutical companies should focus solely on treatment. However, I have always believed that we should provide comprehensive care for patients throughout their entire journey. I often tell my colleagues that, taking patients with myocardial infarction as an example, if many of them unfortunately die due to delays in emergency care, it represents a tremendous loss for everyone. For this reason, we are committed to establishing Chest Pain Centers, enabling more patients to receive percutaneous coronary intervention (PCI) within the optimal window for rescue, thereby ensuring their long-term survival.”

Peng Xin, Medical Director at Jiangsu HengruiHere is a real-world case from my own work: “For instance, consider our recently launched thrombopoietin (TPO) receptor agonist, a medication that increases platelet counts. Previous study data have shown that many patients experience a decline in platelet levels after discontinuing the drug. Therefore, this medication actually requires long-term adherence. Consequently, throughout the course of treatment, effective patient management is paramount. By doing so, we can ensure that more patients benefit from our product post-launch, enable every patient to consistently perceive our care and commitment, and ultimately extend their survival.”

However, solutions encompassing the entire patient journey are still gradually taking shape, and several challenges are emerging from this business model, awaiting resolution by the industry.

Gao Rong, General Manager of Eli Lilly and Company Trading (Shanghai) Co., Ltd. and Head of Commercial Operations, Eli Lilly ChinaThe discussion focused on payment-related challenges: “A major issue in current patient services is payment. In China, there is a significant reluctance to pay for intangible services. While this willingness has gradually been established in the consumer goods sector, it remains underdeveloped in more specialized fields such as healthcare, where the concept of paying for professional services is still evolving slowly. For instance, when patients visit a doctor, the consultation fee they pay does not adequately reflect the extensive experience an excellent physician has accumulated over a lifetime. This discrepancy has given rise to many new business models in our operational context. Patients have a strong demand for services; effective disease management involves more than just using a product—it requires complementary support services to ensure the product achieves optimal outcomes.”

In cross-sector collaborations between pharmaceuticals and digitalization, communication and collaboration are critical. It is essential to establish a unified terminology and communication logic to ensure the accuracy of information assessment and transmission throughout the partnership. This represents the significant value that LinkDoc brings to the pharmaceutical industry.

Zhang Tianze, President of the CAHA Digital Health Committee, Founder and CEO of LinkDoc TechnologyTo use a vivid analogy: “It is like everyone coming together to build a towering skyscraper that pierces the clouds, ultimately aiming to solve a major problem. However, during the construction process, participants must first be able to collaborate using a common language. Once this linguistic coordination mechanism is disrupted, the difficulty of completing the tower increases significantly. For instance, in the field of lung cancer, if the top 50 principal investigators (PIs) in China truly adopted a unified data standard to share new insights and address emerging challenges, our collective understanding of lung cancer diagnosis and treatment would undoubtedly deepen rapidly. Therefore, Care Data serves as the infrastructure we aim to provide for precise, digital collaboration in clinical practice. Leveraging our robust data technologies, this initiative ultimately culminates in Care Life, which is precisely what we are working on today.”

This data-to-application logic aligns perfectly with the methodology of evidence-based medicine research. Consequently, numerous pharmaceutical companies have already partnered with LinkDoc to leverage its data platform and technical capabilities in empowering their drug development efforts.

Wan Yuntao, Vice President of CSPC Pharmaceutical Group and President of the Clinical Development DivisionHe stated, “Our extensive real-world patient data—including diagnostic information, genetic testing results, and treatment records—can help pharmaceutical companies better develop clinical technologies. This includes patient adherence during clinical trials, as well as long-term follow-up conducted after treatment completion. These persistent challenges pose significant obstacles to oncology clinical research. However, they may be addressed through a more robust database or digital platform. Therefore, I believe LinkDoc has substantial opportunities for future development in this area, and the commercial value of LinkDoc’s solutions has not yet been fully realized.”

Zhao Hong, President and CEO of SciClone PharmaceuticalsHe also provided his perspective on the collaboration with LinkDoc: “Although approximately 80% of patients in China receive treatment at public hospitals, the future development of the healthcare market will inevitably trend toward differentiation. Given that each patient has unique needs, diverse treatment channels will certainly emerge. For instance, some patients may consult specialists in hospitals but complete their subsequent medication purchases outside the hospital setting. Therefore, the pilot pathway we initiated with LinkDoc leverages internet healthcare services, utilizing LinkDoc’s Patient Care Coordination (PCC) to continuously address patients’ medication access issues. In turn, by leveraging real-world data, we can re-explore new clinical application opportunities for our products and even expand into new indications.”

In addition to digital platforms such as Lingke, other industry players are also entering the field from different angles, striving to develop solutions that cover the entire patient lifecycle.Secretary-General of the CAHA Digital Health Special Committee,Jin Ge, CEO of Rendong Medicine“We have been consistently advancing work in this area. Patient-centric, full-cycle management is a core principle of our approach, although I anticipate that role-specific divisions of labor will become increasingly refined. As an enterprise built on next-generation sequencing (NGS), we have conducted extensive research in testing and inspection in recent years, translating these efforts into a series of products delivered under the Laboratory Developed Tests (LDT) model. Our inherent advantage lies in our close proximity to both physicians and patients; however, our follow-up and data management capabilities may not be as comprehensive as those of LinkDoc. Therefore, we look forward to future opportunities for integrating with LinkDoc’s ecosystem to create a more complete service system centered around the entire patient journey.”

Bi Yuanfeng, Co-founder and COO of VCBeatIt was specifically highlighted that digital therapeutics can play a pivotal role in patient management: “Nowadays, the concept of ‘ecosystem’ is frequently discussed. In essence, an ecosystem connects all stakeholders through an integrated system. Only when such a system delivers benefits to enterprises, patients, and even the government can it be truly established and sustained. I believe digital therapeutics represent precisely such a system. Digital therapeutics enable the integration of various treatment solutions—including pharmaceuticals, medical devices, and surgical interventions—at a higher dimensional level. Therefore, I strongly endorse the value and potential of digital therapeutics.”

The CDE’s release of new policies has been interpreted by some as an effort to standardize the industry, while others view it merely as a formal codification of practices previously employed in real-world settings.Wu Jisheng, Chief Medical Officer of Suzhou Zelixir BiopharmaceuticalsHe stated, “In fact, for over a month now, we have been debating the policies issued by the state. The core issue under discussion is whether new anti-tumor drugs must demonstrate clinical value. In other words, they must offer superior efficacy with comparable safety, or improved safety and tolerability with comparable efficacy. Personally, I believe that the Center for Drug Evaluation (CDE) has always maintained a clear stance on this matter, particularly for first-line treatments, which must unequivocally demonstrate clinical value. It is just that there may not have been an official document to formalize this position in the past.”

Although policies have imposed higher requirements for the innovativeness and clinical breakthroughs of new drugs, from the perspective of objective industry development patterns, the transition from imitation to innovation is an inevitable trend in industrial evolution.

Dr. Lan Shi, Vice President of Scientific Affairs at TigermedIt is believed that the pharmaceutical industry has progressed from generic manufacturing to "imitative innovation." The fact that the industry has reached this stage after years of development is already a significant achievement. Moreover, it is gradually advancing from imitative innovation toward developing "First-in-Class" drugs. Data on clinical trials show a marked increase in overall volume from 2014 to the present. Furthermore, the number of Class 1 new drugs has also risen rapidly. Unlike the period before 2015, when the market was dominated by generic drugs, we are now seeing emerging achievements in cutting-edge fields such as gene therapy and cell therapy. This indicates that the industry is striving in this direction. However, just as one cannot expect a child who has just learned to walk to run immediately, progress must be steady and gradual, without undue haste.

Guo Anfeng, Chief Commercial Officer of LinkDoc Technology and President of the Digital Business PlatformA more in-depth exploration of industry homogenization: “Before the launch of Opdivo (O drug) in 2018, competition in China’s oncology drug market was actually quite limited, as many drugs targeting specific biomarkers were exclusive. Starting in 2018, the approval of several imported and domestically produced PD-1 monoclonal antibodies kicked off the era of intense cutthroat competition in China’s oncology drug market. Currently, we observe severe homogenization in the drug pipelines of numerous innovative enterprises, particularly concerning several hot targets. This phenomenon implies that previous oncology drug commercialization strategies are likely no longer suited to future commercial needs. Therefore, in future oncology drug marketing, digital commercial platforms will become a critical link in closing the loop across the entire ecosystem.”

Amid the overall positive development trends in the innovative drug industry, the new policy released by the Center for Drug Evaluation (CDE) is primarily aimed at addressing the issue of excessive homogenization in certain therapeutic areas. However, the emergence of this problem has, to some extent, been constrained by the development of China’s pharmaceutical industry.

Yang Jianxin, Chief Medical Officer of CStone PharmaceuticalsDuring the salon, the causes of homogenization were discussed: “I believe the key reason lies in the fact that the current level of innovation in China’s biopharmaceutical industry is not yet sufficiently high. This is particularly true for first-in-class innovation, which is extremely challenging and carries a very high risk of failure. Frankly speaking, even if there were a 10% success rate for developing a first-in-class new drug, I myself would hesitate to undertake such an endeavor. Most players are reluctant to take this risk, as the industry has not yet reached the requisite level of capability. Therefore, at the current stage, it is inevitable that we remain in a phase characterized by ‘Me-too’ or ‘Fast-follow’ strategies.”

In addition to having a certain impact on domestic innovative enterprises, the new policy is not without implications for multinational pharmaceutical companies.Ho Kit Chan, Head of Regional Clinical Operations, Mainland China and Hong Kong, Bristol Myers SquibbThis brings us to a challenge they encountered in their actual work: “When conducting clinical trials in China, particularly head-to-head studies, we often encounter certain issues. For instance, we previously had a product for which the comparator drug was manufactured by a traditional domestic pharmaceutical company. Despite exploring numerous approaches, we were unable to procure this drug for use as a comparator. In the United States and Europe, there are many specialized channel companies that exclusively supply comparator drugs for clinical trials. Therefore, I hope that this area will receive more focused attention in the future.”

Dr. Wang Zaiqi, Chairman and CEO of Advenchen LaboratoriesIn summarizing the discussion on this topic, it was stated: “A great drug must not only address patients’ unmet needs but also generate industry demand. Following this line of thought, I believe that for our innovations to succeed, we must ultimately return to clinical data. However, much of the current data in China is not robust enough to withstand rigorous scrutiny. Therefore, there is a genuine need for high-quality data to help us truly understand patients, so that we can determine what types of products they require. If we do not even know where the needs lie, and insist on pushing our products onto others under the assumption that they are superior, we will ultimately fail to demonstrate clinical value.”

In summary, the CDE’s recent announcement is likely to have a significant impact on products with high levels of homogeneity. Nevertheless, it will have a more positive overall effect on steering the pharmaceutical industry toward innovation. Following the policy release, the pharmaceutical sector must proactively address the new challenges posed by the CDE, ensuring that its products better align with actual clinical needs. In this process, digital technologies may serve as a key catalyst for transformation within the pharmaceutical industry.

Dr. Guo Tong, Executive Vice President of LinkDoc Technology and Head of Enterprise BusinessIt is believed that the release of these guidelines represents a significant boon for data technology companies, exemplified by ZeroCr Tech, as new drug development guided by clinical value requires data support at every stage. For instance, under the trend toward precision diagnosis and treatment, patient recruitment criteria have become increasingly stringent. Leveraging large-scale foundational data and algorithmic matching to rapidly and accurately identify target patients can shorten clinical trial timelines and substantially reduce costs.