With the increasing prosperity of the global biopharmaceutical market and rapid technological progress, Chinese medical products have emerged on the international market with their high cost-effectiveness and unique technical advantages. Strong government support and globalization trends have created unprecedented favorable conditions for domestic medical products to go global. Among them, the License-out model dominates in drug exports, while medical device exports rely more on registration or acquisition models.
In recent years, Chinese pharmaceutical companies have actively integrated into the global pharmaceutical business development (BD) trend, not only promoting the research and development process of innovative drugs but also accelerating global sharing and value maximization of technology. In 2023, China's innovative drugs and medical devices saw a high-profile moment of going global. Many local innovative pharmaceutical companies have licensed their products to international pharmaceutical giants at highly competitive prices, with both the volume and amount of license-out transactions reaching new highs; at the same time, several domestic drugs have successfully obtained marketing approvals from overseas regulatory bodies such as the FDA. The globalization of medical devices has also reached a new milestone, marking an acceleration in the internationalization pace of China's medical device industry.
Recently, Frost & Sullivan (Frost & Sullivan, abbreviated as "Frost & Sullivan") joined hands with LeadLeo, a leading venture capital firm in Suzhou Industrial Park, and Jintiancheng, a leading investment banking firm, to co-host the "Ocean Plan" - an industry summit forum on opportunities and challenges for domestic innovative drugs and medical devices to go global. At the forum, Frost & Sullivan, Jintiancheng, and LeadLeo jointly released the highly anticipated "White Paper on the Trends and Strategies of Chinese Innovative Drugs and Medical Devices Going Global in 2024" (hereinafter referred to as the "White Paper"), which conducted an in-depth discussion on topics such as BD transaction-related situations, strategies and experiences, as well as legal risks during the process of going global.
The release ceremony of the 'White Paper' was presided over by Chen Yihui from the Shanghai branch of Industrial Bank Co., Ltd. Yang Xiaocheng, Partner and Managing Director of Frost & Sullivan Greater China, Zhang Zihui, Joint Head of the Healthcare Group at Haitong Securities, and Wu Xuri, Partner at Jintiancheng, served as the initiators for the release of the 'White Paper'. Zhang Zihui, Joint Head of the Healthcare Group at Haitong Securities, made a brief introduction to the content of the white paper on site.
Main Contents of the White Paper
1
Global healthcare market potential
The global medical market shows tremendous potential, with strong demand in developed countries and rapid growth in emerging markets. Chinese medical enterprises are actively going global, seizing opportunities and addressing challenges through different models in various fields. Developed countries have high health expenditures, bringing market opportunities to Chinese biopharmaceutical companies; emerging markets have great growth potential, accelerating market access for Chinese enterprises. Going global can enhance the technical level and brand image of Chinese medical enterprises and help them cope with domestic competition. Against the backdrop of globalization, Chinese medical enterprises need to actively embrace the international market to achieve broader development.
2
Current Situation and Outlook of BD Transactions
01 Global BD License Transactions Overview
Global pharmaceutical business development (BD) licensing transactions remain stable, with License-out becoming the mainstream choice for drug exports, aiding in the international development of the pharmaceutical industry. Despite facing the challenge of the 'patent cliff,' multinational pharmaceutical companies are still actively seeking high-quality external projects to cope with future profit pressures. From 2019 to 2023, the number and total amount of BD transactions in the global biopharmaceutical field remained stable, with relatively small fluctuations in upfront payments. At the 42nd JPMorgan Chase Healthcare Summit, several mergers and acquisitions and BD transactions were concluded, mainly involving areas such as AI pharmaceuticals, RNAi, and ADC, with many being in the early research stages. Leaders of major well-known pharmaceutical companies have varying transaction attitudes and directions due to different corporate conditions and market judgments. In the future, with market demand and technological progress, global pharmaceutical BD transactions are expected to continue growing.
02 Overview of BD Licensing Transactions in China
In 2023, China's pharmaceutical BD licensing transactions were active, showing several significant trends. The number and amount of license-out transactions increased significantly, surpassing license-in transactions for the first time, indicating that China is becoming a global exporter of biopharmaceutical innovation pipelines. Domestic transactions quickly warmed up after a setback but still lagged behind foreign transactions due to regional equity considerations and the financial strength of buyers.
Each type of BD transaction has its own characteristics. License-in focuses on introducing advanced foreign technologies and mature products, while License-out favors earlier-stage projects. Domestic transactions emphasize clinical certainty more. In terms of transaction methods, domestic-to-domestic transfers tend towards a risk-sharing cooperation model, reflecting a cautious attitude towards unknown clinical risks.
Source: Frost & Sullivan report
In the segmented track, ADCs, macromolecular drugs, and small molecule drugs remain hotspots for transactions. At the same time, transactions in areas such as autoimmunity and infectious diseases are also increasing to meet diverse clinical needs. Among the top 10 BD transactions in 2023, license-outs dominated, with ADC transactions being particularly prominent, highlighting the innovative advantages of Chinese pharmaceutical companies in overseas transactions and the ADC field.
However, high-quality domestic buyers are still scarce, and transaction volumes are mainly dominated by multinational corporations (MNCs). In terms of projects, domestic sellers such as Myriad Biosciences are popular among international MNCs, but the international commercialization capabilities of large domestic pharmaceutical companies are still insufficient. This contradiction has led to a situation where although Chinese biotech product research has gone global, domestic buyers have limited influence in the international market.
In summary, China's pharmaceutical BD licensing transactions are showing a vigorous development trend, but they also face some challenges. In the future, enhancing the international operational capabilities of domestic buyers and strengthening integration with the international market will be important development directions for China's pharmaceutical industry.
03 Analysis of the Fulfillment of Past BD Transaction Milestones
The past performance of milestone payments in pharmaceutical business development (BD) transactions has been unsatisfactory. Currently, milestone payments worth $7.5 billion are due, but pharmaceutical companies have received less than $1 billion. The high-risk and capital-intensive nature of new drug research and development, along with the uncertainty of clinical data, often lead multinational corporations to choose to stop losses promptly and terminate collaborations. Among the significant deals terminated over the years, many were related to poor product data, unclear commercial prospects, or adjustments in company strategic planning. This indicates that pharmaceutical BD transactions require careful risk assessment and flexible strategy adjustments to cope with market changes.
04 Domestic potential BD transaction targets
The domestic pharmaceutical BD transaction field contains rich opportunities. New technologies, consumer healthcare, and unmet clinical needs in drugs will be key areas for future BD transactions. In the central nervous system diseases area, research and development of Alzheimer's disease and pain medications are particularly attracting attention, with the emergence of new drugs such as Lecanemab and VX-548 bringing new hope to the market. In the oncology field, competition is fierce in the R&D of ADC and RDC drugs, but there are still projects with excellent drug properties worth looking forward to. In metabolic diseases such as diabetes, obesity, and gout, there is an urgent demand for new drugs, especially in the R&D of GLP-1/GIP dual-target drugs and gout treatment medications. In addition, emerging fields such as small nucleic acid drugs and gene editing drugs are attracting more capital and MNC attention due to their unique advantages and potential. The development of these areas will provide a wealth of opportunities for domestic pharmaceutical BD transactions, while also placing higher demands on R&D capabilities and market insight.
Source: Frost & Sullivan report
The White Paper provides an overview of BD transactions globally and in China, delving into the scale, structure, main participants, and transaction models of these transactions. It also conducts an in-depth analysis of the fulfillment status of past BD transaction milestones and reveals potential domestic BD transaction targets, including central nervous system diseases, tumors, metabolic diseases, and other fields. For more detailed content, please refer to the full report.
3
Research on the Overseas Market of Chinese Innovative Drugs
01 Analysis of Overseas Pharmaceutical Market Demand
The global pharmaceutical market continues to grow, with an estimated value of $2 trillion by 2027. The chemical drug market dominates, while the biopharmaceutical market is growing significantly and becoming an important growth point. Developed countries such as the United States and Europe lead the global pharmaceutical market, while emerging markets like China have great potential. The clinical pipeline mainly consists of traditional drugs, but innovative therapies are constantly emerging, with oncology and immunology being hotspots for global research and development. In the future, the pharmaceutical market will continue to grow, with more attention paid to innovative therapies and precision medicine.
Source: Frost & Sullivan report
02 Analysis of the Current Situation of Chinese Pharmaceutical Companies Going Global
The overseas expansion journey of Chinese pharmaceutical companies has gradually expanded from bulk drugs to formulations, and then to innovative drugs. As the global focus on bulk drug production shifts to developing countries, China has risen as the world's largest bulk drug manufacturing base due to its cost advantages and R&D strength. In recent years, Chinese pharmaceutical companies have accelerated the internationalization process of innovative drugs through three models: leveraging external partners, joint ventures, and independent overseas development.
Although the 'borrowing a boat to go out to sea' model is flexible and requires low investment, enterprises may lose their voice in R&D and commercialization in overseas markets; the 'joint venture' model helps reduce policy barriers, but cross-cultural communication is a major challenge; the 'self-sourcing' model allows for full control over the entire process, but it carries high risks and requires significant investment. With the improvement of pharmaceutical companies' R&D and innovation capabilities and the intensification of international competition, joint venture and self-sourcing models are gradually gaining attention.
Source: Frost & Sullivan report
Although Chinese pharmaceutical companies mainly focus on the domestic market, they have insufficient overseas expansion. Structurally, biotech companies that emphasize overseas market clinical trials and product commercialization have a higher proportion of overseas revenue. Despite China's significant progress in the field of innovative drugs, its proportion of overseas revenue is still lower than that of international peers. Leading biotech companies such as BeiGene have achieved a higher proportion of overseas revenue through licensing transactions or drug sales.
Overseas clinical trials are mainly concentrated in the United States, with multi-center trials gradually attracting attention. The efficiency of drug registration and cost minimization drive clinical trials in countries such as Australia. In terms of overseas product pipeline layout, leading companies like BeiGene and Hengrui Medicine have rich overseas pipelines and are expected to become the focus of future commercialization.
From 2016 to 2022, the number of License-outs by Chinese pharmaceutical companies increased significantly, mainly focusing on anti-tumor and anti-infection areas, with antibody drugs being the main focus. The transaction amount exceeded $40 billion, with active transactions in the fields of bispecific antibodies and ADCs, indicating the acceleration of internationalization by Chinese innovative pharmaceutical companies. However, target selection is still concentrated in hot areas, leading to fierce competition on the overseas market.
Looking ahead, Chinese pharmaceutical companies need to deepen international cooperation, expand overseas markets, strengthen innovation and research and development, and enhance their core competitiveness to achieve broader international development. This is a challenging path, but it is also a crucial step for China's pharmaceutical industry to achieve global layout and improve its international competitiveness.
The White Paper sorts out the current situation of Chinese pharmaceutical companies going global, including their overseas journey, models, market focus, overseas clinical trials and product pipeline layout, as well as License-out transactions. For more detailed content, please refer to the full report.
03 Opportunities and Challenges for Chinese Pharmaceutical Companies Going Global
Chinese pharmaceutical companies have made significant progress in the field of innovative drugs, but compared with developed countries, there is still a large gap in drug prices, providing huge market space for Chinese pharmaceutical companies to go global. With the continuous improvement of innovation levels, Chinese pharmaceutical companies have gone global through models such as License-out and gradually gained international market recognition. However, the pressure of domestic medical insurance negotiations for price cuts and the difficulties in increasing sales of innovative drugs have led pharmaceutical companies to face the dilemma of declining capital market valuations. Against this backdrop, going global has become a key strategy for Chinese pharmaceutical companies to digest supply and regain market returns.
The international integration of the regulatory system and the improvement of approval processes have provided strong support for Chinese pharmaceutical companies going global. At the same time, the strengthening of CXO enterprises' capabilities and the accumulation of international experience have further promoted the process of new drug research and development and commercialization by Chinese pharmaceutical companies going global. However, during the process of going global, Chinese pharmaceutical companies also face some challenges, such as relying on local clinical data for research and development thinking, and adapting to the market demands of different countries.
To avoid obstacles in going global, Chinese pharmaceutical companies should transform their R&D mindset, ensure detailed experimental data, and fully consider the prevalence of diseases in overseas markets. At the same time, they should explore niche indications and the demand for drugs for small-batch cancer cases, enhancing their overseas competitiveness through differentiated drug advantages. Looking ahead, with the continuous improvement of innovation capabilities and the accumulation of overseas experience, Chinese pharmaceutical companies are expected to play an increasingly important role in the global pharmaceutical industry.
The 'White Paper' sorts out the opportunities and challenges for Chinese pharmaceutical companies going global, pointing out that while they face opportunities such as large market space and improved innovation levels, they also face challenges such as price pressure and a shift in R&D mindset. For more detailed content, please refer to the full report.
4
Research on the Overseas Market of Innovative Medical Devices in China
01 Analysis of Overseas Medical Device Market Demand
The global medical device market is growing steadily, led mainly by the United States and Europe, but the markets in Asia-Pacific and developing countries hold great potential. The scale of the Chinese medical device market has expanded rapidly, and going global has become a key to enhancing competitiveness. In the face of high-quality requirements in overseas markets, Chinese enterprises need to continuously improve their technical level. At the same time, the industrial advantages of countries such as the UK, France, and Germany complement those of China, and cooperation opportunities are also emerging in markets in Latin America and Southeast Asia. With the cooperation frameworks such as the Belt and Road Initiative and RCEP, Chinese enterprises can further expand overseas markets and achieve international development.
Source: Frost & Sullivan report
02 Analysis of the Current Situation of Chinese Medical Device Enterprises Going Global
China's medical device exports have spanned over three decades, starting with low-value consumables and gradually expanding to high-end technologies and products, with continuous enhancement of international competitiveness. In recent years, although export amounts have declined due to the impact of the pandemic, enterprises' stable supply capabilities have won global recognition, and export scale still exceeded $20 billion. The number of overseas registrations for Chinese medical devices continues to grow, facing challenges from registration regulations. The export market is mainly Europe and America, with an increasingly rich variety of categories. Chinese medical device companies have seen significant growth in overseas business, but compared with international peers, there is still a gap in the proportion of international revenue, indicating significant room for improvement in the future. It is necessary to continue strengthening R&D capabilities, improving product quality and service levels, and further expanding overseas markets.
Source: Frost & Sullivan report
03 Analysis of Sub-sectors for Chinese Medical Devices Going Global
The overseas markets for medical devices in China are characterized by different segments. Low-value consumables, as the core of exports, have expanded overseas markets with their cost advantage and supply capabilities, especially during the pandemic, and are expected to further increase their global market share in the future. The total export value of in vitro diagnostic products has been growing year by year, with domestic manufacturers' competitiveness enhancing and demonstrating a diversified overseas strategy. High-value consumables face challenges in product research and development and sales models when going global, but their clinical and technical advantages become the core competitiveness, with huge potential in overseas markets. In the field of medical equipment, although the export of domestic equipment in high-end areas such as imaging and surgical robots is still limited, some products have reached a high-end level and occupied market shares. As domestic enterprises gradually replace imported shares, tapping into overseas market potential has become an inevitable choice.
Source: Frost & Sullivan report
04 Opportunities and Challenges for Chinese Medical Device Enterprises Going Global
The overseas medical device market has high pricing, providing opportunities for Chinese enterprises to go global. However, domestic volume-based procurement policies have led to a significant drop in medical device prices, squeezing profit margins for enterprises. Therefore, Chinese medical device companies are seeking overseas markets to find new growth points. However, there are significant differences in the regulatory requirements for medical device registration across countries, especially in markets like the US and Europe, which require high-standard reviews and certifications. At the same time, international market competition is fierce, and Chinese companies need to strengthen their brand influence and market competitiveness. In recent years, the Chinese medical device industry has shown strong innovation momentum, with many products possessing global competitiveness, providing new opportunities for overseas business. However, choosing the right sales model abroad is also a major challenge, requiring a balance of advantages and disadvantages between distribution and direct sales models, and formulating market expansion strategies suitable for their own development. Facing challenges and opportunities, Chinese medical device companies need to continuously enhance their technical strength, adapt to different market demands, and achieve international development.
Source: Frost & Sullivan report
The White Paper analyzes the overseas markets for innovative medical devices in China, covering overseas demand, the current situation of enterprises going global, analysis of segmented markets (listing four specific sub-markets), as well as the opportunities and challenges faced. For more detailed content, please refer to the full report.
5
Overview of Laws and Regulations Governing Overseas Transactions of Drugs and Medical Devices
01 Overview of Laws and Regulations Governing Overseas Transactions of Drugs and Medical Devices
The transaction of pharmaceutical and medical device technology licenses, especially cross-border transactions, involves a complex legal and regulatory system. Both parties involved in the transaction need to comply with basic laws such as the Civil Code and Patent Law, while also adhering to professional regulatory regulations in the pharmaceutical and medical device industry to ensure compliance throughout the entire lifecycle. There are also strict regulations regarding taxation, technology import and export, cross-border data transmission, etc. In addition, it is necessary to consider the laws of the other country and international treaties. To ensure the smooth progress of the transaction, both parties should fully understand and comply with relevant laws and regulations to avoid legal risks.
02 Main legal issues in pharmaceutical and medical device overseas transactions
The overseas transaction of pharmaceuticals and medical devices involves multiple key legal issues. The transaction contract needs to specify licensing terms, fee allocation, milestone payments, and sales distribution mechanisms. The licensor should ensure they own complete intellectual property rights to avoid infringement. The contract should define the difference between intellectual property transfer and licensing, protect intellectual property rights, and clarify jurisdiction and legal choice. At the same time, the impact of third-party rights, competition law, and anti-monopoly law needs to be considered. The contract should include breach of contract and dispute resolution mechanisms to protect the interests of both parties. The introduction of a joint steering committee can coordinate cooperation details and deal with emergencies. In terms of anti-corruption compliance, all parties need to comply with domestic and international anti-bribery regulations and may agree in the transaction documents to follow the licensor's management system. At the same time, attention should be paid to cross-border transmission of sensitive personal information and human genetic resource information, comply with regulatory systems of various countries, and fulfill approval or filing procedures. In addition, attention should also be paid to transaction details such as pharmaceutical and medical device MAH clauses, production and supply, commercial arrangements, as well as core legal issues such as technology import and export control and tax supervision.
03 Key Points of Intellectual Property Concerns in Overseas Transactions of Pharmaceuticals and Medical Devices
In the overseas transaction of pharmaceuticals and medical devices, intellectual property rights are a core concern. Firstly, the ownership of intellectual property rights should be clarified to avoid subsequent disputes; secondly, licensing rights should be defined to ensure the rights and interests of both parties; at the same time, attention should be paid to the layout and compliance issues of intellectual property rights, conducting patent freedom-to-operate analyses to reduce infringement risks. In addition, tax issues related to intellectual property rights also need to be considered to ensure tax compliance. Finally, an intellectual property dispute resolution mechanism should be established to provide legal protection for transactions. Considering these key points comprehensively helps to reduce the intellectual property risks in overseas transactions of pharmaceuticals and medical devices.
The 'White Paper' sorts out the legal and regulatory system involved in pharmaceutical and medical device overseas transactions, key legal issues, and points of attention regarding intellectual property rights. It discusses the basic laws and industry supervision regulations that need to be complied with, paying attention to core issues such as contract terms, intellectual property ownership, and licensing permissions. For more detailed content, please refer to the full report.
Highlights of the Conference
The first half of this forum was presented byYu Zhengchun, Senior Partner at JintianchengThe lawyer served as the moderator.
Guiding Unit of This Event,He Jia, Deputy Director of the Suzhou Industrial Park Enterprise Development Service CenterA speech was delivered, with opening remarks made by Gao Gehui, a senior partner at Jintiancheng Law Firm.
Shen Sheng, Director of the Healthcare Group at Haitong SecuritiesA keynote speech titled 'Global and Domestic Biopharmaceutical BD Transaction Tracking Report' was delivered, introducing an overview of global and domestic BD licensing transactions, analyzing past BD transaction milestone achievements, potential domestic BD targets, and the development trends of BD transactions by medical device companies.
Huang Haoyu, former executive of Roche and Takeda Pharmaceutical, former general manager of XinnorinSharing centered around the theme of 'MNC M&A Trends and Transaction Practices', the session first reviewed typical domestic biotech mergers and acquisitions over the past year, analyzed the trends in overseas MNC acquisitions of domestic biotech companies, and from the perspective of the acquired party, examined key issues in the transaction practices of domestic biotech company mergers and acquisitions.
Guan Tao, CEO of Hangzhou Gehia Biopharmaceutical Co., Ltd.A speech was delivered under the title 'BD Transaction Negotiation Strategies and Experience Sharing', which provided an in-depth interpretation from aspects such as the value assessment logic of innovative drugs, new drug research and development based on a value system, BD transaction negotiation strategies, and skills.
The roundtable session followed,Hu Xuan, Director of the Healthcare Group at Haitong SecuritiesThe panelists participating in the roundtable discussion includeChen Hongbo, Senior Advisor on Strategic Development, Senior Advisor at Warburg Pincus Investment in the US, Former Vice President of Eli Lilly China, and Global Vice President at GSK,Gu Leming, former executive at Johnson & Johnson and Philips China, and current partner at Yuansheng Venture Capital,Dr. Liu Qian, Shanghai Wish Biotechnology Co., Ltd.,Dr. Wang Yiyi, Co-founder of Wuxi Zhikang Hongyi Biotechnology Co., Ltd.,VP Chen Qixun of Jiangsu Famaisheng Medical Technology Co., Ltd.,Zhang Wei, Director and General Manager of Dite Medical Technology (Suzhou) Co., Ltd.,Xu Yuxin, Investment Director of SDIC China Merchants Asset Management Co., Ltd.The guests engaged in an in-depth exchange on topics such as considerations for pharmaceutical and medical device companies in choosing their overseas expansion paths, discussions on regional advantages, and suggestions for avoiding pitfalls.
After the tea break, the forum entered the second half of its agenda, which was presented byJintiancheng Partner Wu XuriThe lawyer served as the moderator.
Huang Jingjing, Senior Partner at JintianchengFirst, we present the sharing on 'Compliance Issues in MNC Mergers and Acquisitions of Domestic Biotech Enterprises'. This includes an enumeration of cases and key points related to MNC mergers and acquisitions of domestic Biotech enterprises, along with compliance recommendations such as emphasizing daily compliance, timely communication, and teamwork.
Subsequently,Ding Yijü, Head of M&A Department at Haitong Bank Macau BranchJiao delivered a speech on the topic 'Overseas M&A Transaction Process and Risk Control', explaining the cross-border M&A process. Combining practical transaction cases, he focused on analyzing project development, due diligence, agreement negotiation and main transaction documents, external regulatory approvals, and price adjustment mechanisms.
The second roundtable session begins.Lu Xuezhong, Senior Partner at JintianchengThe lawyer chaired the discussion of this group, and the roundtable was attended byWang Zhe, Director of the Healthcare Group at Haitong Securities,Liu Tingting, a senior lawyer at Jintiancheng,Liu Donghai, Director of PWC's Corporate Financing and M&A Services,Lin Jian, BD and PR Director of Yaotang (Shanghai) Biotechnology Co., Ltd.,Chen Haosi, Assistant General Manager of Xiyuan Anjian Medicine (Beijing) Co., Ltd.andDr. Cheng Ying, Director and Business Development Director of Shanghai Kezhou Pharmaceutical R&D Co., Ltd.The guests comprehensively discussed the key points of BD transaction negotiations and deal term design, legal and other related risk prevention.
Finally, byZhou Han, Director and Senior Partner of the Management Committee of Jintiancheng Suzhou BranchThe lawyer delivered a closing speech. The event has come to a successful conclusion.
