Taking Stock of U.S.-China Biotechnology Competition

Patrick Beyrer, Research Associate on Global Public Health at the Asia Society Policy Institute’s Center for China Analysis

May 15, 2024


Since the U.S.-China trade and technology relationship took center stage during the Trump administration’s trade war, observers have sought to identify specific industries that could exacerbate tensions between Washington and Beijing. The Chinese biotech sector might be that next, risky frontier. Although long heralded as the new “national security obsession” and “next battleground” for U.S.-China technology decoupling in Beijing and Washington alike, past U.S. policymaking and official enforcement actions on the sector were precise and limited. But this reality is quickly unfurling.

Starting in earnest in late 2022, U.S. officials have continued to ratchet up their rhetoric and actions in a campaign to ensure U.S. leadership in global biotech competition and rulemaking. This flurry of regulation has not limited itself to the water’s edge of diplomacy and statecraft, as entrepreneurs, scientists, and major commercial entities are starting to feel the results of this sea change in policy. The U.S. House Select Committee on Strategic Competition between the United States and the Chinese Communist Party (CCP Select Committee) has spearheaded efforts among U.S. lawmakers to draw up a new playbook for this challenge. Rep. Mike Gallagher, former CCP Select Committee chairman, described new enforcement efforts in biotech as a “moral and ethical battle” to establish technical standards.

Other lawmakers and experts have asserted that biotech competition holds equally critical stakes for innovation and statecraft. In the wrong hands, biotechnologies – which can be used to manipulate DNA, surveil and identify individuals, augment advanced materials and chemical manufacturing, improve energy efficiency, and enable agricultural resilience and abundance – can be used for nefarious and even weaponized ends.

Biotech Competition between U.S. and China

The United States is not the only one seeking to fortify its research and manufacturing base. China’s own internal rhetoric has at times inflamed biotech competition in similarly nationalistic and even existential terms. Since biotech’s identification as a critical emerging technology for independent innovation in the Made in China 2025 policy, CCP attitudes appear fixed; nearly every application of biotech is invaluable to China’s conception of itself as a rising world power.

In April 2022, President Xi Jinping encouraged Chinese scientists to break through “bottlenecks” in key technologies and aspire for major breakthroughs in life sciences research, including biological macromolecules and genetics. Around the same time, he declared food security—an application of agricultural biotech—“an issue of utmost national importance,” describing arable land as the “lifeblood” of the Chinese nation. At provincial, city, and company levels (both state-owned and private), officials have connected the concept of “red genes” in party-building activities to upskilling talent in the biomedical industry. Within the latest State Council work report, both biomanufacturing and life sciences are highlighted as industries primed under the “new productive forces” campaign for China to “build new growth engines” and “open new tracks” for development. These speeches and signals are not simply political theater. Beijing touts major Chinese biotech companies as instrumental to the construction of its civil-military governance model: the “party-army-state.” Biotech corporations’ cooperation with researchers from the People’s Liberation Army (PLA) only reifies this trend.

U.S. Response to China’s Biotech Ambitions

The Biden administration has recognized the challenges posed by China’s biotech ambitions. In September 2022, the White House issued a biotechnology executive order (EO), which accelerates a “whole-of-government approach” to respond to Chinese biotech competition. The administration has delegated various departments to enhance targeted enforcement measures while working with Congress to ratchet up pressure on industry stakeholders to avoid Chinese partnerships of concern.

The Bureau of Industry and Security (BIS) within the Department of Commerce (DOC) has played the largest role in these countermeasures. By scrutinizing the end uses of Chinese biotech companies’ products, especially those relating to unethical biometric surveillance and research ties with military programs, the BIS has steadily added Chinese biotech companies and institutions to its Entity List: 34 in December 2021, 33 in February 2022, and 28 in March 2023. These include both sister companies and affiliates of firms WuXi AppTec and BGI Group, who have both been singled out by lawmakers for their partnerships with the PLA, and in the case of WuXi AppTec, have allegedly transferred U.S. client data without consent, according to intelligence officials.

The Department of the Treasury (USDT) and the Department of Homeland Security (DHS) have followed the DOC’s lead to similar effect. In the same salvo as the 2021 BIS Entity List adjudication, the USDT concurrently instituted sanctions on Chinese biotech companies involved in the illicit drug trade and imposed a set of follow-up sanctions in October 2023. For its part, the DHS has brought enforcement actions against Chinese agricultural and chemical biotech companies under the Uyghur Forced Labor Prevention Act for their ties to forced labor, with the most recent sanctioned companies announced in August and October 2023.

Interagency efforts scrutinizing Chinese biotech across genetics, illicit pharmaceuticals, chemical manufacturing, and biometric technologies have further consolidated departmental efforts with even more significant implications. In a first-ever directive defining additional national security factors for the Committee on Foreign Investment in the United States (CFIUS), a September 2022 EO listed “biotechnology, biomanufacturing and elements of the agricultural industrial base” as areas of fundamental interest for CFIUS review. An additional February 2024 EO proposed measures that would block the high-volume export of U.S. genomic data, health data, and biometric data to China, with Biden administration officials going as far as identifying genomic data export as the most acute threat of the data categories to U.S. national security and commercial interests.

If the administration has orchestrated forceful efforts, then Congress has taken even more direct steps. Although the CCP Select Committee lacks a legislative mandate, its leadership and senior members have found common cause with fellow lawmakers to fast-track legislation that promotes the decoupling of the U.S.-China biotech sectors in sensitive areas. In the Senate, Sen. Marco Rubio reintroduced the GENE Act in June 2023 to require CFIUS reviews of genetic transfers and increase corresponding congressional oversight—a set of measures former chairman Gallagher previously signaled interest in. In July 2023, Gallagher partnered with Rep. Dan Newhouse to propose expanding CFIUS jurisdiction to assess Chinese land purchases near U.S. military sites and consider food security via biotech acquisition as a factor in national security reviews.

These efforts also take on a bipartisan sheen. In February, Rubio teamed up with Senate Intelligence Committee chair Mark Warner to urge the DOC and the USDT to develop a more “robust export control regime” that blunts Chinese biotech influence in the United States. Gallagher and CCP Select Committee ranking member Raja Krishnamoorthi proposed the BIOSECURE Act, which would ensure that “foreign adversary biotech companies,” including BGI Group and WuXi AppTec, are blocked from future U.S. federal contracting and government technology procurement. Gallagher and Krishnamoorthi have also forcefully written to the USDT, the DOC, and the Department of Defense to suggest the addition of BGI, WuXi AppTec, and its sister company, WuXi Biologics, to various entity and sanction lists.

Congressional interest in Chinese biotech’s national security implications has taken other notable forms. Announced in March 2022, the National Security Commission on Emerging Biotechnology (NSCEB) has supported the policy behind the BIOSECURE Act by recommending a federal procurement ban of BGI Group products. Additionally, NCSEB vice chair Michelle Rozo offered testimony at a February hearing of the U.S.-China Economic and Security Review Commission that reaffirmed China’s commitment to achieving food security, securing military advantages, and maintaining genetic resources access through biotech research and applications.

The CCP Select Committee has been equally active in publicly spreading this message. In a field visit to Boston, Gallagher and Krishnamoorthi led a group of lawmakers to meet with U.S. biotech executives to discuss challenges posed by China’s biotech sector, including pharmaceutical dependencies. In the months prior, the CCP Select Committee’s policy recommendations described U.S. dependence on Chinese pharmaceutical supply chains as a “distinct national security risk” and recommended the establishment of corresponding controls on Chinese biotech, including investment restrictions. Another CCP Select Committee report investigated U.S. venture capital firms’ investments in emerging Chinese technology and their ties to biometric surveillance, among other biotech advancements, enabling state control.

Although most of the legislation focused on Chinese biotech has yet to be approved, a combination of public pressure and congressional actions have both directly caused and coincided with major impacts across the Chinese biotech sector. WuXi AppTec’s and WuXi Biologics’ share values have declined nearly 40% and 50%, respectively, in the first several months of 2024, largely due to the announcement of the BIOSECURE Act and the CCP Select Committee’s letters to various federal executive departments and the Pentagon. BGI has since been dumped as a client by major Washington lobbying firms that previously advocated for the company’s U.S. market access. The Biotechnology Innovation Organization similarly cut ties with WuXi AppTec and affirmed biotech as a “national security imperative” after being called out by Gallagher for lobbying against the BIOSECURE Act on behalf of WuXi.

The BIOSECURE Act and Pharmaceutical Firms

Pharmaceutical firms are already responding to the BIOSECURE Act and related tensions through potential supply chain adjustments and contingency plans with an eye on the long term. According to the Financial Times, 23 different U.S. biotech companies have warned of their dependency on the WuXi companies in annual reports since March, with at least five such companies informing investors they will seek alternative manufacturing partners. Analysts additionally expect U.S. firms’ drug development costs to skyrocket in the absence of WuXi and BGI, as WuXi AppTec has been described as a “research superstore” for its U.S. partners and WuXi Biologics stands as the second largest biologic outsourcer in the world. In one recent survey of pharma executives, over 90% of respondents indicated that the BIOSECURE Act’s passage would set back their drug pipelines, with 53% stating it would be extremely difficult to replace Chinese contract development and manufacturing organizations like WuXi.

Overseas Investment in Chinese Biotech

U.S. investors in Chinese biotech have been similarly affected. Last September, the Wall Street Journal reported that the value of Chinese biotech venture deals including U.S. investors in 2022 was $102.6 million—a far cry from the $1.01 billion recorded a year earlier. Firms mentioned in the CCP Select Committee’s venture capital funding report have since attempted to sell off their stakes in different Chinese tech startups.

Downward pressure over the last year on Chinese biotech partnerships and investments has precipitated divestments at the corporate and academic levels, too. In February, German agri-tech giant BASF revealed it would exit from two of its joint venture chemical plants in Xinjiang, while U.S. biotech giant Thermo Fisher Scientific announced it would halt sales of DNA collection kits in Tibet. Notably, both regions are where Chinese biometric surveillance is purportedly used en masse, sometimes via American equipment.

On the academic side, in March 2023, France’s Pasteur Institute ended a partnership with the Chinese Academy of Sciences in Beijing and ceased another research operation in Shanghai. In February 2024, reports emerged that the academic journal Molecular Genetics and Genomic Medicine would retract eighteen genetics papers from China due to concerns over data “inconsistencies” on how human genetic samples were collected from vulnerable populations. Finally, as the long-term renewal of the U.S.-China Science and Technology Agreement continues to hang in the balance, state-to-state-level partnerships on crop gene sequencing and infectious diseases, in addition to other biotech-enabled projects, are liable to cancellation.

To this end, experts have suggested that the large financial impacts stemming from recent enforcement actions show that academics, investors, and corporates are not prepared for an expedited biotech decoupling. During the CCP Select Committee’s biotech hearing, NCSEB chair and Gingko Bioworks CEO Jason Kelly stated that industry conversations on national security have been “surprising” for many biotech entrepreneurs, who must avoid “putting our heads in the sand” on strategic biotech competition with China in the future. As one China biotech scholar has remarked, “the geopolitics and trade and investment parts of the U.S.-China relationship are on totally different planes.” This dynamic could not be more apparent as several key pharma executives traveled to Beijing in March, praising China’s biopharma innovation while announcing a series of expansion initiatives.

Looking forward, renewed congressional focus and public pressure campaigns are poised to further tighten the screws on the Chinese biotech sector, as CCP Select Committee leadership hopes to bring a “big China bill” to the House floor this year and human rights groups raise awareness of Chinese biotech’s more draconian applications. Krishnamoorthi has expressed his dedication to moving the BIOSECURE Act forward for a spring markup session in the House of Representatives, even in the absence of Gallagher.


Regardless of whether pending legislation passes through Congress, U.S.-China biotech decoupling is likely to continue, especially in areas of sensitive research and investment. As studies show that China leads the United States in four of seven major emerging biotech categories, the scramble between Washington and Beijing to lead, apply, and control emerging technology within the biotech sector appears to have only just begun. Speaking to the stakes of this new arena of U.S.-China tensions, Rep. Krishnamoorthi remarked during the CCP Select Committee’s hearing in March that “the competition with the CCP in biotech is make or break… so we must, and we will, win.”

In entering this competitive phase of potential U.S.-China biotech decoupling, Americans outside of the industry or the scientific community are not adequately prepared for its consequences in their daily lives. In addition to China representing the largest and most cost-effective exporter of active pharmaceutical ingredients to the U.S. market, jointly developed drugs, agricultural technologies, and other biotech-enabled solutions have improved countless American lives. As the New York Times has reported, the elimination of companies like WuXi from U.S. supply chains would impact developments in treatments for critical medical conditions, including hearing loss, cystic fibrosis, and leukemia. U.S.-China gene editing research collaborations have created disease-resistant crops while improving their yields. Research published in the Harvard Business Review has shown that China’s integration into a full U.S.-led international regulatory harmonization of cancer clinical trials could save 1 to 2 million lives annually through expediting critical reviews of breakthrough medicines. The collapse of U.S.-China biotech partnerships would spell the end of such jointly developed innovations that harbor the potential to deliver sorely needed global public goods, including saving American lives suffering from diseases such as cancer.

Corporations and academia are not ready for a full U.S.-China biotech decoupling, nor do they seek it. As enforcement from Washington grows broader and more restrictive, U.S. biotech firms, institutions, and researchers will face difficult choices when evaluating relationships with Chinese partners. Although changes are certainly necessary within the United States’ posture toward biotech cooperation with China, if decoupling is pursued to its fullest extent, the impacts on the U.S. economy and innovation ecosystem may prove severe. With U.S.-China competition likely to persist, remaining avenues for scientific cooperation, including in biotech, will likely have far-reaching consequences for the rest of the world.


The author would like to acknowledge the members of the Cure4Cancer team, as well as other contributors from the Center for China Analysis (CCA), Asia Society Policy Institute (ASPI), for their review and input on the article.

How to Find and Enroll in a Cancer Clinical Trial

Participating in a cancer clinical trial can offer patients access to cutting-edge treatments and contribute to advancements in cancer care. The process of finding and enrolling in a clinical trial involves several key steps. Firstly, individuals can start their search for clinical trials by consulting with their doctor to explore suitable options based on their cancer type and stage. Additionally, online resources such as databases provided by institutions like the National Cancer Institute (NCI), TrialCheck®, and ClinicalTrials.gov can help individuals identify trials that may be suitable for them based on various factors like study location and trial type.

Understanding eligibility criteria is crucial when considering participation in a clinical trial. Each trial has specific guidelines outlining who can participate, such as age, gender, cancer type, and stage. It is essential to review these criteria carefully to determine if a particular trial is a good fit. If needed, individuals can seek clarification from their doctors or contact the study organizers directly for assistance with understanding the requirements. Moreover, contacting the study organizers after identifying a potential trial helps initiate the process of eligibility determination, which may involve appointments and eligibility tests.

Before enrolling in a clinical trial, individuals should thoroughly review the study description, which outlines the protocol detailing the study procedures and safeguards put in place to protect participants’ well-being. It is recommended to discuss the study description with healthcare providers and prepare questions to clarify any uncertainties. Prior to participation, individuals must go through the informed consent process, where the research team explains the trial’s purpose, duration, potential risks and benefits, and confidentiality of medical information. Informed consent is an ongoing process throughout the trial, allowing participants to stay informed about the study’s progress and any identified risks or side effects.

For more information on finding and enrolling in a clinical trial, visit the Memorial Sloan Kettering Cancer Center website.

We Need a Global System for Testing and Approving Cancer Treatments

Bobby Daly, Justin Finnegan, Bob T. Li, and Jing Qian

Harvard Business Review, October 18, 2022

The lack of a standardized international system for approving new cancer therapies undergoing clinical trials has led to the loss of approximately 2 million lives each year. The authors propose that by establishing harmonized regulations for oncology therapies’ approvals globally, the number of annual cancer-related deaths could be reduced by 10% to 20%, saving 1 to 2 million lives. They highlight the success of the U.S.’s Project Orbis, an initiative by the FDA Oncology Center of Excellence, in streamlining the approval process for new cancer treatments and suggest expanding this framework internationally. Standardizing criteria across participating nations would expedite drug approvals, making treatments accessible to patients sooner, consequently extending the lives of those in critical need.

The article delves into the potential impact of concurrent international regulatory approvals by examining specific case studies of two drugs – pembrolizumab and enzalutamide. The FDA approved pembrolizumab for metastatic non-small cell lung cancer (NSCLC) in 2016, significantly prolonging the lives of patients. However, delays in approvals in other countries have prevented patients from benefiting from this life-saving drug. Similarly, enzalutamide, approved by the FDA in 2012 for late-stage prostate cancer, faced delays in global approvals, particularly in China. The authors estimate that hundreds of thousands of patient life-years could have been saved if these drugs had been approved globally simultaneously with the U.S.

To establish a global system, the authors propose several key steps, including strengthening regulatory bodies, defining requirements for ethnicity-specific trials, standardizing manufacturing inspections, planning for approvals in secondary markets, and reforming insurance coverage for life-prolonging treatments. These measures aim to streamline the drug approval process, accelerate patient access to innovative treatments, and ultimately reduce the staggering number of cancer-related deaths worldwide. The authors acknowledge the challenges in implementing these changes but emphasize the urgent need to address the significant loss of lives to cancer each year, making the effort worthwhile and crucial.

To read the full article, please visit the Harvard Business Review website.

First Drug Targeting HER2-Mutant Non-Small Cell Lung Cancer Approved by FDA

Memorial Sloan Kettering Cancer Center, August 12 2022

The U.S. Food and Drug Administration (FDA) recently sanctioned the use of trastuzumab deruxtecan, also known as T-DXd or Enhertu®, for treating advanced non-small cell lung cancer (NSCLC) marked by mutant HER2. This drug, previously employed for HER2-positive breast cancer, has now garnered approval for NSCLC with mutant HER2. Memorial Sloan Kettering Cancer Center’s (MSK) study on trastuzumab deruxtecan, conducted by researchers and led by Bob Li, emphasized the benefits of the drug in combating HER2-mutant NSCLC. The promising results of the research were presented at the European Society for Medical Oncology (ESMO) Congress 2021 and were later published in The New England Journal of Medicine (NEJM).

Traditionally, treating HER2-mutant NSCLC has been challenging, with previous approaches yielding inconsistent outcomes. Approximately 3% of nonsquamous NSCLC cases are fueled by HER2 genetic mutations, affecting patients who are typically younger, female, never-smokers, and prone to poor prognoses and brain metastases. While HER2 gene targeting has revolutionized cancer treatment in breast and gastric cancers, no HER2-targeted therapies were approved for NSCLC until trastuzumab deruxtecan. The phase 2 DESTINY-Lung01 trial, involving 91 patients across North America, Europe, and Asia, showed promising results with 54.9% of patients

experiencing a confirmed objective response and almost all patients displaying disease control and tumor size reduction. Notably, trastuzumab deruxtecan is the first antibody-drug conjugate utilized for lung cancer, the primary therapy targeting HER2 mutations in lung cancer, and the first HER2-targeted treatment for lung cancer to receive a Breakthrough Therapy designation from the FDA, earning accelerated approval.

In conclusion, the approval of trastuzumab deruxtecan marks a significant advancement in precision medicine for NSCLC, especially for patients with HER2-mutant tumors. The success of this drug signifies a breakthrough in the treatment landscape for a subset of NSCLC patients who previously had limited therapeutic options. The study’s outcomes bring hope for improved outcomes and better quality of life for individuals grappling with HER2-mutant NSCLC, demonstrating the valuable contributions of MSK’s research and the potential for personalized treatment strategies in oncology.

To read the full article, visit the Memorial Sloan Kettering Cancer Center website.

Fact Sheet: President Biden Reignites Cancer Moonshot to End Cancer as We Know It

The White House, February 2, 2022

President Joe Biden has reinvigorated the Cancer Moonshot initiative, initially launched during his time as Vice President in 2016, with a renewed focus on accelerating progress against cancer. The administration aims to reduce the death rate from cancer by at least 50% over the next 25 years while enhancing the experience of individuals living with and surviving cancer. This effort builds upon recent advancements in cancer therapeutics, diagnostics, and patient care, coupled with lessons from the COVID-19 pandemic, to set ambitious goals for combating cancer.

The Biden-Harris Administration is committed to addressing cancer disparities, improving access to cancer screenings that were postponed due to the pandemic, and advancing cancer research and treatments. The administration emphasizes the importance of early detection, prevention strategies, and equitable access to cutting-edge cancer diagnostics and therapies across all communities. By leveraging public-private partnerships and bipartisan support, significant progress has been made in cancer research and treatment, with a focus on personalized medicine, targeted therapies, and innovative approaches such as immunotherapies and cancer vaccines.

To achieve the newly set national goals for the Cancer Moonshot, President Biden’s administration seeks to mobilize the entire government through White House leadership and the formation of a Cancer Cabinet comprising various departments and agencies. A strong emphasis is placed on promoting cancer screening and early detection to reduce missed screenings during the pandemic and improve access to preventive measures. By fostering collaboration among stakeholders, including government entities, private sector partners, healthcare providers, and the research community, the administration aims to drive forward initiatives that will significantly impact cancer outcomes and patient experiences in the years to come.

To read the full article, visit The White House website.

U.S.-China Cancer Collaboration Could Open Door For New “Ping-Pong Diplomacy”: Kevin Rudd

Russell Flannery, Forbes, August 28, 2021

Former Australia Prime Minister Kevin Rudd, who is currently the CEO of the Asia Society, suggested that a joint effort between the U.S. and China in fighting cancer could be akin to the historic ping-pong diplomacy that helped thaw bilateral relations in the 1970s. Rudd expressed optimism about leveraging cancer collaboration to bridge gaps between the two nations amidst other challenges in the relationship.

The 2021 Forbes China Healthcare Summit centered on advancing the global fight against cancer with a focus on achieving progress in the post-pandemic era. Amid the ongoing COVID-19 pandemic, which has claimed millions of lives worldwide, the summit highlighted the critical importance of addressing cancer, a disease projected to cause close to 10 million deaths this year. The vulnerability of cancer patients to COVID-19 was emphasized, underlining the urgency of heightened collaboration and research in cancer treatment.

Participants at the summit included key figures from the healthcare and oncology sectors, discussing strategies to combat cancer at a global level. The event also touched on the bipartisan nature of cancer research and treatment efforts in the U.S., transcending political boundaries. Notable figures like Joe Biden’s previous involvement in promoting cancer research, and the potential for international collaboration in this realm, were highlighted as avenues for significant progress in the fight against cancer. The summit aimed to foster dialogue and cooperation among stakeholders to make strides in cancer treatment and drug research on a global scale.

To read the full article, visit Forbes.com

Bloomberg New Economy International Cancer Coalition

Bloomberg New Economy

The Bloomberg New Economy International Cancer Coalition is a collaborative effort that brings together academia, industry, government, patient advocacy, and policy think tanks with a focus on leveraging technology and collaboration to accelerate cancer cures and prevention worldwide post-pandemic. The main goals and objectives of the coalition include improving diagnostics infrastructure and data sharing to increase access to testing, optimizing clinical trial protocols to promote patient-centricity, harmonizing regulations globally to lower barriers to patient-centric care, and enhancing public awareness and patient empowerment through education. The coalition aims to drive thought leadership and commitments in these key areas to contribute to global health equity.

Co-chaired by Kevin Rudd and Stefan Oelrich, the International Cancer Coalition includes CEOs and senior representatives from leading global pharmaceutical, biotech, and diagnostic companies, regulatory bodies, as well as researchers and academics from major cancer centers and universities worldwide. Kevin Rudd, the former Prime Minister of Australia, brings extensive experience in global leadership, including roles in various organizations such as the Asia Society, Harvard University, and the United Nations. Stefan Oelrich, President of Bayer Pharmaceuticals, brings a wealth of experience from his tenure at Sanofi and Bayer AG, with a focus on leading pharmaceutical divisions and global business units.

Members of the coalition, such as Monica Bertagnolli from the National Cancer Institute and Bob Li from Memorial Sloan Kettering Cancer Center, are accomplished professionals in the field of oncology. Monica Bertagnolli, as the NCI Director and a professor at Harvard Medical School, has made substantial contributions to clinical oncology, particularly in gastrointestinal cancer research and clinical trials initiatives. Bob Li, a physician-scientist at Memorial Sloan Kettering Cancer Center, specializes in novel drug development for lung cancers and solid tumors, leading pivotal international clinical trials resulting in FDA approvals for targeted therapies. The coalition’s collaborative efforts aim to transform cancer treatment through innovation, research, and patient-centric care.

For more information on the International Cancer Coalition, visit Bloomberg New Economy.

Project Orbis – A framework for concurrent submission and review of oncology products

U.S. Food and Drug Administration, March 4, 2023

Project Orbis, initiated by the FDA Oncology Center of Excellence (OCE) in May 2019, aims to facilitate concurrent submission and review of oncology products among international partners. The collaboration among global regulators under Project Orbis enables patients with cancer to access treatments earlier in countries where regulatory delays are significant, regardless of FDA approval status. This framework is particularly beneficial for oncology drug development as pivotal clinical trials are often conducted globally, emphasizing the importance of establishing consistent global standards for effective trial design.

Since its establishment, Project Orbis has processed numerous oncology marketing applications and successfully approved several oncology drugs for patients worldwide. By enhancing international cooperation and streamlining the review process, Project Orbis has played a pivotal role in accelerating patient access to innovative cancer therapies. The success of Project Orbis has been attributed to the collaboration with international regulatory counterparts such as Australia, Canada, and other countries that have joined as Project Orbis Partners (POP) to enhance the efficiency of oncology product reviews.

The core team behind Project Orbis comprises dedicated professionals like R. Angelo de Claro, Dianne Spillman, Lauren Tesh Hotaki, Yinghua Wang, and Tina MacAulay, each bringing unique expertise and experience to drive the initiative forward. These team members play integral roles in managing applications, facilitating international communication, and overseeing the review process with foreign regulatory counterparts. As Project Orbis continues to evolve and expand its reach, the framework is expected to further streamline oncology product reviews and promote faster access to life-saving therapies for patients around the globe.

To read more about Project Orbis, visit the FDA site.

Memorial Sloan Kettering and the Chinese Thoracic Oncology Group Urge International Harmonization to Accelerate Cancer Drug Approvals at Annual Event

Memorial Sloan Kettering Cancer Center, December 28, 2022

The fifth annual MSK-CTONG Symposium highlighted the importance of global regulatory harmonization in clinical trials to expedite access to cancer treatments for patients worldwide. The symposium, hosted online for a global audience in December 2022, showcased collaborations between the Chinese Thoracic Oncology Group (CTONG) and Memorial Sloan Kettering Cancer Center (MSK) to advance scientific, educational, and regulatory aspects of clinical trials for new cancer therapies. This initiative aims to benefit millions of patients by accelerating testing and approvals of cancer treatments through international partnerships.

The MSK-CTONG collaboration, focusing on precision cancer therapies for lung cancer, aims to enhance patient access to international clinical trials and facilitate educational exchanges between healthcare professionals in the U.S. and China. The symposium highlighted the significant role of international regulatory harmonization in potentially saving 1-2 million lives annually, as demonstrated by a recent MSK-led study in collaboration with Asia Society and the Bloomberg New Economy International Cancer Coalition. The collaboration between MSK and CTONG seeks to promote greater access to new cancer drugs and foster global regulatory dialogue across borders.

Furthermore, the Symposium addressed the strategic importance of initiatives like Project Orbis, led by the FDA Oncology Center of Excellence, in accelerating timelines for new drug applications through simultaneous regulatory reviews by various countries. The event emphasized the need for enhanced international collaboration to streamline regulatory processes, improve quality of care, and facilitate faster access to innovative cancer medicines. By promoting regulatory harmonization, partnerships like MSK-CTONG and Project Orbis aim to drive advancements in cancer treatment on a global scale, benefiting diverse patient populations across different regions.

To read the full article, please visit the Memorial Sloan Kettering Cancer Center website.

History of International Council for Harmonisation (ICH)

ICH Official Website

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) was established to address the need for harmonization in the evaluation and regulation of medicinal products. The realization of the importance of independent product evaluation emerged at different times globally and was often driven by tragic incidents like the thalidomide case in Europe in the 1960s. As the industry expanded internationally, varying technical requirements in different countries led to duplicative and costly procedures to market products globally. This highlighted the urgent need for rationalizing and harmonizing regulations to reduce healthcare costs, streamline R&D expenses, and meet public demands for timely access to safe treatments.

The initiation of ICH in the 1980s by the European Commission set the stage for harmonization efforts. Discussions among Europe, Japan, and the US on regulatory harmonization led to the formation of ICH at the World Health Organization Conference of Drug Regulatory Authorities in 1989. The collaboration between regulatory authorities and industry stakeholders culminated in ICH’s establishment in 1990 to focus on harmonizing safety, quality, and efficacy standards for new medicines. Over the years, ICH has evolved, developing guidelines on various topics, such as MedDRA and the Common Technical Document, to streamline regulatory processes across regions.

As ICH enters its fourth decade, the focus has shifted to extending harmonization benefits globally. Organizational reforms in 2015 aimed to increase international outreach, enhance governance structures, and disseminate information to a wider stakeholder audience. These changes have solidified ICH as a legal entity, fostering stable operations and enabling greater industry and regulatory participation. The establishment of the ICH Association with an Assembly as the governing body underscores the commitment to advancing global pharmaceutical regulatory harmonization efforts in a collaborative environment.

Find out more about the ICH on their website.