Author | Mao Donglei

Photographers | Tetsuomi Takano, DIA China, Tigermed, CJMMIC, Xinceremed

Proofreader | Tetsuomi Takano (Editor-in-Chief of Pharmaceutical R&D Expert, who is also the President and CEO of t2T Healthcare Co., Ltd.)

"If we take a look at the speakers seated on the stage, can you tell who is from China and who is from Japan?" At the 22nd DIA Japan Annual Meeting held in Tokyo Big Sight from 19th- 21st , Professor Yoshiaki Uyama, Associate Executive Director of the Pharmaceuticals and Medical Devices Agency (PMDA), remarked with a smile during a roundtable discussion he organized: "We are so alike, whether it comes to ethnicity, lifestyle habits, disease patterns, medical practices, or pharmaceutical R&D. Therefore, we should enhance our cooperation." Professor Uyama is a long-standing friend of China's pharmaceutical industry.

The moderator and speakers for the session titled " Delivering Innovative Medicines Faster to Patients in Asia – From Perspective of China-Japan Collaboration in Simultaneous Global Development" on the 22nd DIA Japan Annual Meeting.

Professor Yoshiaki Uyama's remarks set a collaborative tone for the entire annual conference. He further elaborated that inspired by the enthusiasm of Chinese companies recently submitting applications to the Pharmaceuticals and Medical Devices Agency (PMDA), he, as a DIA volunteer, organized this China-Japan symposium. The focal point of Uyama's attention—and a key topic in the China Town Hall session co-hosted by Zhang Dingheng, Project Supervisor at the China Center for Food and Drug International Exchange (CCFDIE), alongside Hitoshi Endo, Director of the PMDA's Asian Training Center and Minister for Bilateral Cooperation—was how to leverage the similarities in ethnicity and disease profiles between China and Japan to integrate both countries into the Multi-Regional Clinical Trial (MRCT) global development framework. This session was moderated by Dr. Su Ling, a DIA Fellow, researcher at Yeehong Business School, and venture partner at Lilly Asia Ventures.

The moderators and speakers for the China Town Hall session.

According to data from PharmaDJ, as of now, four innovative drugs have received NDA in Japan. Meanwhile, between 2023 and 2025, over 19 novel drugs developed by Japanese pharmaceutical companies have been approved by China's National Medical Products Administration (NMPA). During the same week as the annual conference, China's biotech company Innovent Biologics forged a strategic collaboration agreement with Takeda Pharmaceutical worth up to $11.4 billion, centered on immuno-oncology (IO) and antibody-drug conjugate (ADC) therapies. This latest deal further underscores the vibrancy of Sino-Japanese pharmaceutical cooperation.

Sino-Japan Communication under the ICH E17 Framework

Professor Yoshiaki Uyama emphasized that amid the evolving global pharmaceutical R&D landscape, China and Japan—as pivotal forces in Asian pharmaceutical innovation—must strengthen exchanges and collaboration in regulatory science and clinical trial protocol design. Dr. Yasuko Asahina, Deputy Chief Reviewer of the Second Division for New Drug Evaluation at the Pharmaceuticals and Medical Devices Agency (PMDA), provided a regulatory perspective by outlining the "Current Status of China-Japan Pharmaceutical Development Cooperation." Her presentation aimed to foster deeper collaboration between the two nations in drug development, with the goal of accelerating access to innovative medicines for patients across Asia and beyond.

Professor Yan Hou
Research Professor, School of Public Health, Peking University
Doctoral Supervisor

Professor Yan Hou, Research Professor and Doctoral Supervisor at the School of Public Health, Peking University, analyzed the decade-long exploration journey of China, Japan, and South Korea in the fields of drug clinical trials and mutual recognition of scientific regulatory frameworks. She noted that while the three nations have achieved initial progress in regulatory mutual recognition, significant challenges persist due to discrepancies in evaluation criteria and standards among national regulatory agencies.

"Facing escalating industry demands, we need to shift our approach by seeking breakthroughs through academic exchanges," Professor Hou proposed. "By strengthening interdisciplinary academic collaborations, we can support coordinated efforts among regulatory authorities." She suggested establishing a collaborative mechanism led by universities and involving hospitals, industry stakeholders, and other partners to create synergistic outcomes at the institutional level.

Professor Hou emphasized that Multi-Regional Clinical Trials (MRCTs) are becoming the mainstream pathway for global drug registration, yet the pharmaceutical industry faces several challenges, including how to effectively leverage global data for Chinese regulatory submissions. "The guidance principles issued by China's National Medical Products Administration Center for Drug Evaluation (CDE) on accepting overseas clinical data particularly focus on benefit-risk assessments based on MRCT data," she explained. "These guidelines provide clear directions for foreign sponsors and regulatory agencies to evaluate both global and regional evidence."

She further highlighted that China and Japan encounter similar challenges in MRCT implementation, such as limited regional sample sizes, creating unique opportunities for bilateral cooperation. "From an academic perspective, we could develop joint East Asian data pooling strategies," Professor Hou suggested. "By leveraging our respective strengths in statistical methodologies or other validated approaches for regional effect estimation, we could establish a China-Japan MRCT Methodology Working Group."

From MNCs Perspective: China-Japan Multilateral Collaboration Mechanisms

Dr. Chao Zhu,

Head of Medical Sciences at Eli Lilly China and leader of the Drug Development & Medical Affairs Center

Dr. Chao Zhu, Head of Medical Sciences at Eli Lilly China and leader of the Drug Development & Medical Affairs Center, shared insights on global simultaneous drug development strategies—particularly Sino-Japanese cooperation—at the annual conference. He argued that multinational corporations (MNCs) should spearhead market entry into Japan due to their extensive experience in conducting large-scale clinical trials. "As research collaborations evolve to treat China and Japan as an integrated regional cluster, the lessons learned by MNCs throughout this process can provide valuable guidance for domestic biotech firms," he told R&D Insider.

Dr. Zhu illustrated collaboration opportunities through three practical case studies, highlighting China's strategic shift from relying on global bridging strategies using foreign data to creating new R&D pathways through participation in multi-regional clinical trials (MRCTs).

"This represents a paradigm shift," Dr. Zhu emphasized. "Historically, China waited for completion of global development programs before conducting local bridging studies to support regulatory filings, causing delays in patient access to innovative medicines. Today, China participates as an integral part of global development from the outset."

He outlined specific collaboration opportunities, including: MRCT pooling strategies and regional sample size allocation，simultaneous regulatory submissions and approvals across East Asia，joint East Asian development programs and collective efforts to harmonize regulatory requirements.

Through case analyses, Dr. Zhu demonstrated how scientific sample size distribution, streamlined clinical submission packages, and coordinated East Asian development frameworks could achieve mutually beneficial R&D outcomes between China and Japan.

Dr. Jenet Lv
Senior Advisor, Roche Pharmaceutical R&D China Center

Dr. Jenet Lv, Senior Advisor at Roche Pharmaceutical R&D China Center, emphasized that maintaining global alignment while conducting clinical trials in China remains a critical strategic consideration for multinational corporations (MNCs). She noted that over 50% of MNCs now include China in their Multi-Regional Clinical Trials (MRCTs), with some even conducting simultaneous global and China-specific trials. The shared rationale for this approach lies in thorough pre-trial assessments of uncertainties arising from regional variations in medical practices, potential ethnic differences, and other contextual factors.

"Following these evaluations, China is integrated into global development programs due to its massive market potential and the continued necessity of conducting local trials to generate robust clinical evidence supporting regulatory approval," Jenet explained. "However, circumstances may warrant standalone regional trials. For instance, East Asian trials retain significant value by addressing unique regional medical unmet needs."

Dr. Jasmine Wang,

Vice President & Head of Development, Astellas China

Dr. Jasmine Wang, Vice President & Head of Development, Astellas Pharmaceuticals China, underscored that China-Japan collaboration now constitutes an essential strategic pillar for multinational pharmaceutical enterprises expanding their Asian footprint. While Japan maintains global leadership in fundamental scientific research and cutting-edge technologies, she explained, China has developed distinctive strengths in rapid clinical trial execution, cost-efficient development processes, and early-stage innovative drug discovery. The overlapping disease landscapes and patient populations across both countries create a compelling rationale for regionally coordinated development initiatives.

"The consensus among MNCs is clear: China-Japan cooperation must evolve beyond one-way technology transfers or product distribution, transforming instead into truly reciprocal, multilateral partnership frameworks," Dr. Wang proposed. "This requires: 1) Establishing joint clinical research hubs focused on synchronous R&D in oncology and prevalent diseases; 2) Aligning regulatory frameworks between China and Japan to enable cross-border data recognition and parallel review mechanisms; and 3) Combining China's operational agility in clinical development with Japan's scientific depth to forge a globally competitive 'Asian New Drug Development Paradigm.'"

She concluded that by dismantling traditional cooperation barriers and cultivating an integrated ecosystem characterized by complementary resource deployment, regulatory harmonization, and market integration, China and Japan could jointly set new benchmarks for pharmaceutical innovation across Asia and the global market.

Performance and Challenges of Chinese Companies Expanding into the Japanese Market

Chinese pharmaceutical companies participating in the event, including Henlius, CSPC Pharmaceutical Group, and Suzhou Evopoint Biosciences, which already have specific projects undergoing clinical trials in Japan, were present. Li Jin, the Global Regulatory Affairs Leader of Henlius, who attended the DIA Japan Annual Meeting for the first time, stated that currently, three of their products are advancing through clinical trials in Japan, and they have also recruited approximately six local employees.

"The flexibility, innovation, and eagerness to take action demonstrated by Chinese companies have inspired me to join Henlius," said Dr. Ebihara Keiko, the General Manager of Local Registration responsible for Japanese registration. Having previously worked for major pharmaceutical companies such as Merck, Eli Lilly, and Roche, she told PharmaDJ that these qualities of Chinese companies are key factors contributing to innovation and efficiency. However, she also pointed out that some habits and cultural aspects of Chinese companies need to be adjusted to adapt to the Japanese market.

Dr. Hu Yonghan, the Chief Technology Officer of Evopoint Biosciences, highlighted in an interview that the key factors leading to the collaboration with Astellas on this May 30th,included a high degree of alignment in the field of gastric cancer targets between the two parties. Based on Astellas' existing antibody platform, Evopoint Biosciences’s Claudin 18.2 ADC demonstrated outstanding performance in terms of affinity, stability, and preclinical efficacy, effectively addressing unmet needs in terms of efficacy and safety. After conducting a systematic evaluation of multiple products targeting the same class of targets, Astellas considered Evopoint Bioscience’s product to have the best overall data and significant differentiation advantages. From the perspective of disease demand, there is an urgent clinical need for Claudin 18.2 target drugs in the Asian market. As a multinational pharmaceutical company with a comprehensive pipeline layout, Astellas is seeking to achieve full coverage in the field of gastric cancer Claudin 18.2 targets, and Evopoint Biosciences’s product highly aligns with its strategic direction.

Dr. Hu emphasized, "This collaboration was not easy to achieve. The regulatory review standards for pharmaceuticals in Japan are extremely stringent."

Other Chinese enterprise representatives believe that Chinese companies have diverse models for expanding overseas, including building their own teams to independently conduct clinical trials (such as BeiGene, Haihe Pharmaceutical, and Henlius) or opting for licensing agreements (such as Hutchmed, Ascentage Pharma, and Innovent Biologics). This expert suggests adopting a comprehensive model, selecting different development paths for early-stage products, and providing integrated upstream-to-downstream supporting services in business collaborations, which offer broad development prospects. However, the biggest challenge lies in the acceptance of foreign companies in the Japanese market, necessitating the assistance of local partners for communication. Some Japanese companies prefer Japanese-language services and attention to detail. "Once cultural trust is established and service standards are met, collaborating with local partners becomes faster and simpler," said this Chinese entrepreneur.

In the CRO sector, domestic CRO companies such as Tigermed, Xinhua Medical, and Taimei Medical have shown high activity. Among them, Tigermed set up an exhibition booth for the first time and successfully organized a satellite symposium. Representatives from various CROs stated that they have been receiving an increasing number of inquiries from Chinese companies regarding filings in Japan, prompting them to expand their service businesses for overseas expansion into Japan. It is reported that the Chinese delegation was large-scale, with approximately over 40 members attending.

Dr. Xu Ping, the initiator of the China-Japan Medical and New Materials Innovation Center (CJMMIC), pointed out that for domestic biotech companies, establishing an effective dialogue mechanism with local industry associations or regulatory agencies is crucial. "If Chinese companies can leverage professional platforms to communicate with relevant parties in Japan, it will be like obtaining a precise navigation map, enabling them to effectively avoid risks and detours when expanding into the Japanese market," he told PharmaDJ.

Dr. Uemura Akio, a senior advisor at DIA, believes that for Chinese companies to gain a good reputation in Japan, they must deliver on their promises and conduct themselves in accordance with local business culture and customs. " 'Trustworthiness' is the quality most valued by the Japanese. Please note that if Chinese companies intend to explore the Japanese market, all their actions will be closely observed and evaluated by the Japanese industrial community. Therefore, it is essential to fully understand how Japan perceives China and, at the same time, deeply consider what clinical value Chinese products can truly bring to Japanese patients."

Why and How Japan’s companies actively going into the Chinese market?

Investment experts Shinichiro Fuse from TPG Life Sciences Innovations, based in Boston, and Jesamine Wang coincidentally highlighted in their reports the rapid emergence of China's pharmaceutical innovation ecosystem in recent years.

 Shinichiro Fuse

TPG Life Sciences Innovations

"China's pharmaceutical innovation is transitioning from a follower to a value exporter. Our early-stage projects have become important BD (Business Development) targets for multinational corporations, establishing themselves as a force that cannot be overlooked in the global drug R&D landscape," said Na Wang. On October 27, Astellas announced the establishment of its first China Innovation R&D Center in the International Medical Innovation Park of the Beijing Economic-Technological Development Area.

In contrast, Japan's pharmaceutical industry appears relatively passive and lagging in industrial collaboration. Dr. Hiroyoshi Saito, Senior Advisor at Daiichi Sankyo, who has long been engaged in industrial exchanges between China and Japan, told R&D Insight that there exists a one-sided enthusiasm in Sino-Japanese pharmaceutical collaboration: Chinese companies demonstrate strong willingness and proactive actions for cooperation, while Japanese enterprises appear relatively conservative.

"The Japanese pharmaceutical industry must deeply reflect on this current situation," Saito pointed out. "Why, despite possessing strong scientific research capabilities and Nobel-level academic achievements, does it move so slowly in industrial collaboration? Is this due to conservative market positioning, insufficient emphasis on international collaboration strategies, or shortcomings in the industrial transformation mechanism?"

Tetsuomi Takano, Editor-in-Chief of Pharmaceutical R&D experts and President & CEO of t2T Healthcare Inc., also noted that apart from major Japanese multinational pharmaceutical companies headquartered in Japan, such as Takeda, Astellas, and Daiichi Sankyo, many Japanese pharmaceutical companies remain "overly conservative" in their approach to China, focusing their business efforts on traditional markets in Japan, the United States, and Europe. The vast majority of Japanese pharmaceutical companies remain extremely cautious about "venturing into the Chinese market."

To address this,  Shinichiro Fuse proposed eight reform recommendations to revitalize Japan's pharmaceutical industry. These include creating "benchmark successful cases," developing blockbuster drugs, leveraging the mobility of U.S. talent to fill management gaps, raising funds from the United States and the European Union, strengthening the infrastructure of domestic CDMOs and CROs in Japan, tapping into the inherent technological potential of Japanese pharmaceutical companies, emphasizing capital efficiency, advising the government not to prioritize specific therapeutic modalities, and attracting U.S./EU companies to conduct first-in-human trials and international multi-center clinical trials in Japan.

Hiromichi Mizuno,

Deputy General Manager of Shionogi & Co., Ltd. (China) and Head of New Drug Development

Hiromichi Mizuno, Deputy General Manager of Shionogi & Co., Ltd. (China) and Head of New Drug Development stated that within Japan's corporate blueprint for revitalizing innovation and implementing outward development strategies, in addition to the highly valued European and U.S. markets, venturing into China also presents a promising option.

He further elaborated on the strategies adopted by Japanese enterprises when collaborating with Chinese clinical trial institutions. "China boasts a vast territory and a large number of medical institutions. Currently, Chinese research institutions and researchers demonstrate immense enthusiasm and a high level of professionalism in conducting Good Clinical Practice (GCP) and MRCTs," he remarked.

Dr. Xiang Anbo, the Head of Clinical Development at CSPC Pharmaceutical Group, delivered a speech.

In response to the Japanese pharmaceutical industry's interest in China's clinical research environment and their plans to expand into the Chinese market, Dr. Xiang Anbo, the Head of Clinical Development at CSPC Pharmaceutical Group with over a decade of work experience in Japan, shared in Japanese with the Japanese enterprises present at the venue his insights on patient recruitment for clinical trials in China.

Firstly, to expedite the enrollment of the first patient, parallel approaches should be adopted during the Site Start-Up phase. Select leading medical institutions that can prioritize ethical review, and simultaneously submit materials to both the Center for Drug Evaluation (CDE) and the Ethics Committee. Additionally, patients should be proactively identified and prepared in advance according to the trial protocol requirements. For instance, prepare for patients who have failed standard treatments after a certain duration or those who require a washout period after using other medications. Meanwhile, ensure the contract signing and drug preparation are completed. Once CDE approval is obtained, immediately convene a kick-off meeting to conduct informed consent, patient screening, and examinations for the target patients.

Secondly, the following strategies can be employed to recruit more patients:

1. Medical Institution Collaboration: Internally, promote joint recommendations from the responsible departments and relevant departments within the hospital (e.g., for analgesic trials, collaborate with the surgical and gynecological departments). Externally, seek collaboration between participating centers and primary-level hospitals for patient referrals.

2. Patient Organization Utilization: Educate patients and their families through WeChat groups and employ electronic Patient-Reported Outcomes (ePRO) and Decentralized Clinical Trials (DCT) to reduce the burden of medical visits for patients.

3. Database Utilization: Integrate electronic medical records and regional health records to efficiently and accurately screen suitable patients. "When the first patient receives the first dose, members of the project team (including QA, medical managers, project managers, CRAs, etc.) will be present on-site to evaluate the process and make immediate improvements if any issues are identified," Dr. Xiang emphasized.

Several traditional Japanese enterprises at the meeting expressed that, through introductions by numerous Chinese experts and the insights gained into China's reforms and changes during the three-day DIA Japan Annual Meeting, they have begun to gain confidence in their future expansion into the Chinese market.

The China Town Hall Session and Highlights from China at the 22nd DIA Japan Annual Meeting:

Senior Inspector Lv Shuchao from the Center for Food and Drug Inspection and Verification (CFDI) of the National Medical Products Administration (NMPA) delivered an online speech titled "New Technologies Empower Clinical Trial Inspections of Innovative Drugs: Promoting a Leap in Quality." She introduced how the NMPA utilizes digital and intelligent technologies to enhance the regulatory efficiency and quality of clinical trials. The CFDI is achieving unified scheduling of pharmaceutical inspection tasks and automation of risk assessment through an intelligent inspection management platform and AI-assisted tools, driving the regulatory system's upgrade from institutionalization to intelligence and safeguarding the high-quality development of innovative drugs with technological means.

Xu Lei, Deputy Head of the Pudong New Area of Shanghai, presented the practical achievements of Pudong in building a world-class biopharmaceutical industrial cluster with the theme "Source Innovation, Global Chain Aggregation - Pudong Accelerates the Construction of a World-Class Biopharmaceutical Industrial Cluster." She introduced that the annual output value of Pudong's biopharmaceutical industry has exceeded 440 billion yuan, making it an important hub for the research and development of innovative drugs and clinical trials across the country. She emphasized that Pudong is creating an internationally first-class innovation ecosystem through institutional innovation, cross-border R&D facilitation, and intellectual property protection mechanisms, aiming not only to become a national innovation hub but also a frontier for global openness and cooperation.

Li Jin, Global Regulatory Affairs Head of Henlius, and Dr. Ebihara Keiko, the Local General Manager of Registration responsible for the company's registration in Japan.

The China and Japan teams of Tigermed made their debut at the DIA Japan Annual Meeting and set up an exhibition booth. The picture shows the post-meeting group photo of the Tigermed China-Japan team.

The Tigermed team organized a satellite session at the DIA Japan Annual Meeting. Ms. Sun Lixia, Vice President and Head of the Solutions Department of Tigermed, was invited to attend and delivered a report titled "Unlocking the Opportunities of Real-World Evidence (RWE) in China" at the satellite session.

The China-Japan Medical Market Innovation Center (CJMMIC) assists Chinese enterprises in understanding the demand characteristics and regulatory requirements of the Japanese market, promoting cooperation between China and Japan in multiple aspects such as pharmaceutical R&D and clinical trials.

Xinceremed Teams from took a group photo with Dr. Marwan Fathallah, the Global CEO of DIA, at the DIA Japan Annual Meeting.

Group photo of the teams from PharmaDJ and Pharmaceutical R&D Experts.