Recognized as one of the world’s leading medical technology exhibitions, CMEF serves as a platform for innovation, business collaboration, professional education, and international exchange. Building on the successful momentum of the Spring edition, the Autumn edition is set to welcome more than 120,000 healthcare professionals, about 3,000 exhibitors from 21 countries and regions, and visitors from more than 150 countries and regions.

Spanning around 170,000 square meters, the exhibition will showcase innovations across artificial intelligence (AI), precision diagnostics, digital health, intelligent medical devices, surgical robotics, rehabilitation technologies, and connected healthcare solutions, offering attendees a comprehensive view of the trends and technologies shaping the future of healthcare.

A key highlight of this year’s event is the Beijing-Tianjin-Hebei Coordinated Innovation Pavilion in Hall A4, which will demonstrate how regional collaboration is advancing healthcare innovation through the integration of research, engineering, and clinical expertise. Attendees will have the opportunity to explore developments from Beijing’s districts, science and innovation industrial parks, pilot testing platforms, and specialized science and technology enterprises, including AI-assisted diagnosis and treatment, brain computer interfaces (BCIs), smart medical devices, advanced rehabilitation technologies, and elderly care solutions. The pavilion will also host healthcare reform discussions, hospital innovation project presentations, AI-powered mobile medical vehicle demonstrations, “Youcu Plan” project releases, and showcasing of award-winning scientific and technological innovations.

Expanded Showcase of Advanced Medical Technologies

Further strengthening the exhibition’s focus on emerging healthcare technologies, the Medical AI Frontier Zone will feature China’s latest advancements in medical robots, BCIs, embodied AI, healthcare AI models, high-quality datasets, innovative drugs, medical devices, and 5G-enabled technologies. As AI applications continue to evolve beyond medical imaging and diagnostic support into real-world clinical and operational environments, the zone will provide a platform for visitors to explore technologies that are driving healthcare transformation and moving toward broader commercialization.

The International Zone will showcase medical devices, technologies, and healthcare solutions from around the world, fostering exchanges between overseas companies, buyers, and industry stakeholders. The zone is expected to provide valuable insights into global healthcare trends while creating opportunities for international market expansion, partnerships, and business collaboration.

WeSeries Programs to Support Overseas Buyers

To enhance the visitor experience, CMEF Autumn will operate a range of WeSeries programs designed to help overseas buyers efficiently identify products and suppliers aligned with their needs while creating practical business opportunities.

Through the WeTalk stage, companies from sectors including medical robotics, invasive surgery, surgical instruments, emergency and critical care and monitoring ecuiomentand pedlatric healthcar will introduce their products and solutions. Meanwhile, the WeMatch Hub will facilitate one-to-one business meetings between buyers and exhibitors, while the WeTour program will provide English-language guidance, customized exhibition tours, product demonstrations, hands-on experiences, and consultation opportunities with participating companies.

Designed to go beyond product discovery, the WeSeries programs aim to help buyers establish meaningful business connections and transform those engagements into concrete collaboration opportunities.

Complementing the exhibition, CMEF Autumn Edition will host more than 100 conferences, thematic forums, and industry seminars covering topics such as the Outline of the 15th Five-Year Plan, Three-Medical Linkage initiatives, the Medical and Health Foundation Strengthening Project, medical innovation, AI-assisted diagnosis, medical-engineering translation, medical insurance reform, and the future of patient care. Co-located events, including the International Component Manufacturing & Design Show (ICMD), China International Rehabilitation and Personal Health Show (CRS), China International Elderly Care and Nursing Show (CECN), and China International Home Care Exhibition (Lifecare), will further provide a comprehensive view of the healthcare ecosystem.

Exhibitors are expected to unveil more than 1,000 innovative products, creating opportunities for sourcing, partnership development, knowledge exchange, and cross border business growth while supporting the next chapter of healthcare innovation.

Healthcare professionals, industry stakeholders, and innovators are invited to join the 94th China International Medical Equipment Fair Autumn Edition and be part of the conversations, partnerships, and technologies shaping the future of medicine.

If you’re interested in CMEF, please don’t hesitate to register via the following link: https://reg.reed-sinopharm.com/pc/#/login?id=5ddeaa7e26e9472bb78671da18937b6c&channelUuid=b77fee1449a14ff98015fea47f072241

For more information about CMEF Autumn, please visit https://www.cmef.com.cn/en.

Under the financial terms, AstraZeneca will pay insitro $40m upfront, while the agreement includes around $1.46bn in potential development and commercial milestones. In return, AstraZeneca will obtain exclusive global rights to develop selected programmes created through the partnership. insitro will also be eligible to receive single-digit royalties on global sales if any resulting medicines reach the market. The arrangement establishes a pathway for AstraZeneca to progress programmes arising from the AI-powered drug discovery collaboration while providing insitro with milestone-based payments and potential sales-linked royalties.

AI Platform to Investigate Disease Biology

The partnership centres on insitro’s Virtual Human AI platform, which has been trained using large-scale human and cellular data. The biotech uses the platform to identify causal disease biology and investigate the factors that contribute to disease. insitro founder and CEO Daphne Koller said applying AI to complex datasets related to MASH and cardiomyopathies could help the companies unlock greater discovery power and uncover new insights into the genetics behind these conditions.

“Our platform simultaneously deconvolutes disease biology and identifies causal drivers of disease pathologies,” Koller commented.

She added that combining insitro’s expertise with AstraZeneca would enable the partners to scale their work, with the potential to move novel programmes through development stages and to patients more rapidly. The use of AI-powered drug discovery is central to the companies’ plan to identify disease targets and potential therapies in these areas.

AstraZeneca Deepens Focus on MASH

The deal also supports AstraZeneca’s efforts to strengthen its position in the cardiovascular, renal and metabolic (CVRM) segment. The company already markets several medicines in this disease area, including the blockbuster SGLT2 inhibitor, Farxiga (dapagliflozin). Farxiga is now facing generic erosion following its US loss of market exclusivity earlier this year.

Alongside its broader CVRM portfolio, AstraZeneca is seeking to establish a presence in the MASH market. It is currently assessing the potential of AZD2389, a small molecule FAP inhibitor, in Phase II trials. The programme follows the discontinuation of its former antisense oligonucleotide MASH candidate, AZD2693, after it delivered lacklustre results in a Phase II study. Through the new AI-powered drug discovery partnership with insitro, AstraZeneca will seek to identify additional programmes that address the biology underlying MASH and cardiomyopathies.

Jubilant Radiopharma will handle the receipt and handling of AtomVie-manufactured radiopharmaceuticals, support regulatory compliance, and manage last-mile distribution through its U.S. pharmacy network. The arrangement is designed to streamline deliveries to clinical sites while upholding the quality, safety, and regulatory compliance standards required for radiopharmaceutical products.

Bruno Paquin, Chief Executive Officer of AtomVie, said, “As the radiopharmaceutical sector continues to grow, establishing strong logistics and distribution capabilities is essential to ensuring patients and clinical sites receive products reliably and efficiently.”

“We are pleased to partner with Jubilant Radiopharma, whose extensive pharmacy network, regulatory expertise, and commitment to quality make them an ideal collaborator as we expand support for our customers’ clinical development programs, build the infrastructure needed to advance future clinical radiopharmaceutical therapies, and further our goal of transforming patients’ lives with high quality radiopharmaceuticals,” he added.

Shared Focus on Safe and Reliable Delivery

Harsher Singh, Chief Executive Officer, Jubilant Radiopharma, said, “Jubilant Radiopharma is committed to advancing the safe, compliant, and reliable delivery of radiopharmaceutical therapies across North America.”

“As a trusted partner for therapeutic clinical trials and commercialization, we provide the specialized infrastructure, regulatory expertise, therapeutic dispensing capabilities, and national delivery network required to support radiopharmaceuticals throughout their lifecycle. Our collaboration with AtomVie reflects a shared commitment to accelerating innovation and expanding patient access to the next generation of radiopharmaceutical therapies,” he added.

The partnership further strengthens AtomVie’s integrated service offering. By drawing on Jubilant Radiopharma’s established distribution infrastructure and capabilities in clinical trials, therapeutic dispensing, and commercialization, AtomVie and its clients are expected to gain improved access to clinical trial sites and greater operational flexibility as development programs progress. The agreement brings logistics, regulatory support, and distribution together to support radiopharmaceutical logistics across the clinical development process.

Pfizer and Enodia Therapeutics have entered into a research collaboration and licensing deal potentially worth over $500m, focused on discovering and developing sec61 inhibitors. Under the agreement, Enodia Therapeutics will lead the initial discovery phase, identifying and refining small-molecule candidates before advancing them against multiple targets. Once the collaboration phase concludes, Pfizer will assume responsibility for the subsequent stages, including clinical trials, manufacturing, regulatory submissions, and commercial operations.

The financial terms provide for an upfront fee for Enodia Therapeutics, alongside potential payments linked to research, development, and sales milestones. The biotechnology company will also be eligible for tiered royalties based on future net sales. Legal counsel for Enodia Therapeutics during the transaction was provided by founding partner Alexandra Carrel and MCE Carrel Avocats member Thomas Rocco.

The collaboration brings together Enodia Therapeutics’ drug discovery capabilities and Pfizer’s clinical and commercial resources to advance the development of potential medicines targeting disease-associated proteins. The programme is centred on the discovery and development of sec61 inhibitors, using an approach designed to target harmful proteins before they contribute to disease pathology while preserving normal cellular functions.

Life Science Models Expand Clinical Development

The IQVIA Life Science Models are a collection of domain-specific models that bring together IQVIA’s proprietary expert content, deep life sciences knowledge, and established frameworks governing regulatory compliance and patient privacy. Built using technologies that include NVIDIA Nemotron and supported by Amazon Web Services infrastructure, these models are architected to connect molecular and treatment data with patient journeys and clinical outcomes.

The result is a set of predictive applications that span the breadth of clinical development, offering research teams meaningful foresight before a single trial participant is enrolled. Clinical trial prediction capabilities of this nature have long been a sought-after goal in life sciences, and IQVIA’s new platform moves that goal meaningfully closer to practical, scalable reality.

Key Capabilities Spanning Clinical Development

The platform supports clinical study simulation and protocol optimization, covering critical planning elements such as endpoint selection, patient eligibility criteria, dose selection, and sample size planning. These capabilities are designed to help teams identify potential risks before trials even begin, reducing costly missteps in the execution phase.

In an initial evaluation conducted across 50 trials and 270 endpoints, 85% of the predictions generated by the models were on target or clinically close, a figure that underscores the practical reliability of clinical trial outcomes forecasting at this scale.

Beyond simulation, the IQVIA Life Science Models also enable the creation of digital twins and synthetic controls, tools that support more efficient study designs. Additionally, the platform allows teams to leverage clinical study predictions to inform better real-world planning and market access strategies.

Extending Predictive Clinical Development

Within clinical development specifically, the Life Science Models are positioned as an extension of IQVIA’s broader Predictive Clinical Development approach. The platform enables sponsors to simulate studies and rigorously test key assumptions before moving into full execution. This gives development teams the ability to optimize study design and surface potential risks earlier in the process, when adjustments are far less disruptive and costly.

Clinical trial prediction powered by IQVIA Life Science Models is built on what the company describes as Healthcare-grade AI, reflecting its stated commitment to applying artificial intelligence responsibly, with privacy protection, regulatory compliance, and patient safety as foundational considerations rather than afterthoughts.

The initial work will involve the production of two validation batches of CER-001. These batches represent an important manufacturing milestone within ABIONYX’s regulatory strategy for LCAT deficiency and are also intended to help establish the industrial capabilities required for potential market supply. Manufacturing activities will take place across two OLON sites in France.

ABIONYX will be involved at two key stages of the process:

• The upstream cell-culture production of recombinant human apoA-I
• After purification, the complexation of apoA-I with phospholipids to create CER-001, followed by Fill & Finish

The CER-001 manufacturing partnership therefore extends beyond the immediate production of validation batches. ABIONYX and OLON are establishing a manufacturing framework intended to support the product through potential market entry and subsequent commercial scale-up.

Full-length apoA-I adds manufacturing complexity

CER-001 presents a distinctive manufacturing challenge because it uses full-length recombinant human apoA-I rather than approaches based on short apoA-I-derived peptides. The protein is a 243-amino-acid protein that is subsequently assembled with specific phospholipids to form a biomimetic HDL particle. Producing the protein represents only one part of the manufacturing process. CER-001 also requires the reproducible combination of apoA-I and phospholipids into a homogeneous and stable biological particle with the required pharmaceutical characteristics. This manufacturing complexity is closely associated with the design of CER-001.

By retaining full-length apoA-I within an HDL-like particle, CER-001 is designed to reproduce key structural and functional properties of naturally occurring nascent HDL and enable biological activity throughout the circulation. Over the course of development, ABIONYX has established considerable manufacturing experience around CER-001.

Its process, intellectual property and accumulated manufacturing know-how form an important part of the asset’s differentiation and create a meaningful technological barrier to replication. The CER-001 manufacturing partnership with OLON is intended to build on that experience by establishing a robust, reproducible and scalable manufacturing process suitable for potential commercial supply.

Validation batches set the foundation for scale-up

The immediate focus of the collaboration is the successful manufacture of the two validation batches. However, the longer-term objective is to ensure that manufacturing infrastructure and capabilities needed to supply the market are established if CER-001 receives regulatory approval. With OLON, ABIONYX is moving beyond manufacturing CER-001 solely for clinical development and beginning to put in place the infrastructure needed for potential commercialization.

The validation batches provide the immediate manufacturing milestone, while the broader strategic objective is to develop a scalable manufacturing platform that can support CER-001 from a potential first market entry in LCAT deficiency to a substantially broader opportunity in sepsis.

Cyrille TUPIN, Chief Executive Officer of ABIONYX Pharma, said, “CER-001 is a demanding biologic to manufacture. We produce the full-length, 243-amino-acid human apoA-I protein and then assemble it with specific phospholipids into a biomimetic HDL particle. Building a reliable and scalable process around that complexity has taken years of development and know-how. Thanks to OLON, we are now putting that manufacturing capability in place for the next stage of CER-001: first through our regulatory strategy in LCAT deficiency and, in parallel, through Phase 2b development in sepsis.”

One platform supports LCAT deficiency and sepsis programs

Andrea Conforto, M&S VP CDMO Biotech OLON, said, “Our work with ABIONYX brings together several areas of OLON’s biomanufacturing expertise, from the upstream production of a full-length recombinant protein, the complexation of apoA-I with phospholipids and Fill & Finish. The validation batches represent an important first milestone, but the manufacturing strategy has been designed from the outset with the longer-term requirements of CER-001 in mind. The program reflects our ability to manage complex biologics manufacturing processes and to support innovative products as they progress from clinical development towards potential commercial supply.”

The manufacturing investment also forms part of ABIONYX’s wider strategy for CER-001. In LCAT deficiency, an ultra-rare genetic disease, the company is pursuing a regulatory pathway intended to provide CER-001 with a potential first route to market. The two validation batches under the OLON program are an important step in preparing the manufacturing package supporting that strategy.

At the same time, ABIONYX is advancing CER-001 into Phase 2b development in sepsis, where it is evaluating the potential of the same full-length apoA-I biologic in a much larger patient population with significant unmet medical need. While the two programs differ in scale and development pathway, they use the same underlying product and manufacturing platform. The industrial capabilities being established for LCAT deficiency can therefore support the longer-term development of CER-001, including its development in sepsis. For ABIONYX, the strategy is to pursue a potential first market entry for CER-001 through the rare-disease pathway while continuing to develop the same proprietary biologic in sepsis, where the potential patient population is substantially larger.

The acquisition will establish a footprint for GE HealthCare in the time-critical ‘final mile’ of U.S. PET radiopharmaceutical supply and allow PDx to participate in other high growth areas beyond its own product portfolio. SOFIE Biosciences operates a U.S. network comprising 15 CMO sites and 21 cyclotrons, along with a theranostics-focused Contract Development and Manufacturing Organization (CDMO) site. Through the transaction, GE HealthCare expects to broaden its presence in the U.S. radiopharmaceutical industry and support reliable patient access to novel radiopharmaceuticals.

The acquisition will also expand GE HealthCare’s ability to provide solutions across the theranostics pathway, covering:

• Cyclotrons
• Imaging technology
• Digital workflow tools
• Radiotherapeutics infrastructure

“As part of GE HealthCare, SOFIE Biosciences is expected to grow in the low double digits, and enables us to participate across the radiopharmaceutical value stream, meeting customer demand through a mix of GE HealthCare owned and partner facilities. SOFIE Biosciences has a highly skilled team with deep expertise serving U.S. customers, including manufacturing our Flyrcado™ (flurpiridaz F18 injection) product,” said Kevin O’Neill, President & CEO of the PDx segment at GE HealthCare.

“We will leverage our scale and expertise in radiopharmaceutical manufacturing across the U.S., Europe and Japan to further invest in and grow SOFIE Biosciences, helping improve patient access, strengthen reliability of supply, and support the next generation of precision care products,” he added.

PET Radiopharmaceuticals Support Growing Precision Medicine Pipeline

PET radiopharmaceuticals are used in precision medicine to visualize metabolic and molecular activity and are increasingly being used to deliver targeted therapies across a range of disease areas. F18 labeled PET radiopharmaceuticals have a 110-minute half-life, making PET CMOs important to timely and reliable patient access to existing and pipeline products.

The radiopharmaceutical pipeline is also expanding rapidly across the industry, with approximately 20 PET radiotracers and over 30 radiotherapeutics currently under development. These include SOFIE Biosciences’ Phase III F18 Fibroblast Activation Protein Inhibitor (FAPI) asset, FAPI-74, for which GE HealthCare already holds outside-of-U.S. rights. FAPI has the potential to further expand an already fast-growing global PET imaging market and is showing strong potential for diagnostic and theranostic use across a range of oncologic and non-oncologic indications.

GE HealthCare will continue to drive and expand access to its existing proprietary F18 radiopharmaceutical products while advancing its pipeline of new products through SOFIE Biosciences and PDx’s other established CMO partners across the U.S.

SOFIE Biosciences to Continue Serving Customers

Following the transaction close, SOFIE Biosciences will continue operating as an independent manufacturing partner to its customers. The company will supply its existing product portfolio, including products from other leading radiopharmaceutical providers.

Patrick Phelps, SOFIE Biosciences co-founder, President & CEO, said, “As demand continues to increase for F18 products, and pipelines for new diagnostics and therapeutics continue to expand, joining GE HealthCare marks an exciting step in our journey as a leading U.S. CMO. With Trilantic North America’s support, we have significantly expanded our capabilities and scale, and we share GE HealthCare’s ambition to improve patient outcomes by delivering on the promise of radiopharmaceuticals as we look ahead to our next phase of growth.”

Ted Rosenwasser, Partner, Trilantic North America, said, “We are incredibly proud of what Patrick and the SOFIE Biosciences team have accomplished during our partnership. SOFIE Biosciences has grown significantly, investing in its network and manufacturing capabilities to help meet growing demand and enable increased and reliable patient access to critical products. GE HealthCare’s legacy and global expertise make it a natural partner to support SOFIE Biosciences’ continued growth and help expand access for U.S. patients to novel diagnostic and therapeutic radiopharmaceuticals.”

GE HealthCare’s Pharmaceutical Diagnostics segment is a global leader in imaging agents used to support 140 million procedures in 2025, equivalent to four patient procedures every second. For more than 40 years, GE HealthCare’s imaging agents have been routinely used across care pathways to support diagnosis.

Around 6,000 trade visitors travelled to Nuremberg. Most came from Germany, but many others also came from Austria, Switzerland, Italy, the Netherlands, the Czech Republic, Poland, Türkiye, Slovenia, France and Japan. They see POWTECH TECHNOPHARM as the ideal platform for finding inspiration for their own projects, discovering practical solutions, gaining an overview of the market and expanding their network. As a multi-sector trade fair, POWTECH TECHNOPHARM brings together various process industries, facilitating the transfer of knowledge across sector boundaries. Specifically, numerous discussions centred on the challenges of the future in terms of smart, flexible and efficient plants.

“The current economic climate is posing major challenges for many companies across various sectors. The passionate discussions that took place during the three days of the trade fair demonstrate to us just how great the need is – particularly at this time – for face-to-face interaction and a shared platform for the processing community,” said Stefanie Leege, Head of Brand Strategy at POWTECH TECHNOPHARM, in summary after the trade fair.

The exhibitors confirmed the high quality of the visitors and were pleased to have held in-depth discussions about specific projects. The proportion of visitors involved in investment and procurement decisions was, as usual, high at around 90 percent.  A total of 96 percent of visitors were satisfied with their visit to the trade fair, and 93 percent are already planning to visit POWTECH TECHNOPHARM again in 2028.

International participation remains a key pillar

Summing up the event, Robert Hild, Managing Director of the VDMA Air Handling Technology Association, said: “This year’s POWTECH TECHNOPHARM has once again demonstrated that, even in challenging times there’s something Germany can rely on: the innovative strength of its industry and its clear focus on problem-solving, from climate protection and energy efficiency to clean and safe processes.” According to the VDMA, exports of air handling technology and process engineering machinery and apparatus showed an overall positive trend in the first half of 2026, albeit with significant differences between countries and regions. Whilst exports of process engineering to China rose sharply, the air handling technology sector saw significant growth, particularly from France and Switzerland.

POWTECH TECHNOPHARM 2026 also met the requirements for a high degree of international participation: 45 percent of exhibitors travelled to Nuremberg from 29 countries, whilst 40 percent of visitors came from 66 countries. “We see it as an important sign that companies from so many countries have come to Nuremberg and that the number of countries represented by exhibitors has actually increased. We want to further strengthen this important international and cross-sector exchange,” said Leege. Johannes Schmid-Wiedersheim, Managing Director of the VDMA Process Engineering Machinery and Apparatus Division, also said: “The latest figures show just how important international markets are for the process engineering sector. Germany needs better conditions for investment and faster approval procedures to ensure that innovative and resource-efficient technologies continue to be developed here in the future. Because of this, a broad international presence remains of key importance to companies.”

Knowledge and innovation for sustainable process engineering

The extensive supporting programme demonstrated the fact that POWTECH TECHNOPHARM is more than just a product exhibition. Here, there were numerous opportunities for professional discussion and networking. At the EXPERT FORUM, experts delivered 88 specialist presentations, providing insights into topics such as pharmaceutical processing, Smart Industry, energy efficiency and recycling, as well as ‘The Future of Processing’. The themed pavilions ‘Pharma in Focus’ and ‘Recycling in Focus’ brought together specialised solutions. The participating companies provided further inspiration for innovative solutions across the entire process chain, as well as more efficient, resource-efficient and safe production processes at the DSIV Process Solutions Pavilion and the VDMA special exhibition ‘Clean Air – Smart Processing’, as well as through VDMA guided tours on battery production. The daily live demonstrations on explosion protection provided a practical insight. In addition, the IND EX® Explosion Safety Forum provided a platform for international professional dialogue on safety, standards and the latest findings in the field of explosion protection.

A focus on networking and young talent

A key aspect of POWTECH TECHNOPHARM is the dialogue and networking within the processing community. International exchanges between associations plays an important role in this regard: Representatives from DSIV (Deutscher Schüttgut-Industrie Verband e. V.) in Germany, SHAPA (Solids Handling & Processing Association) in the UK, APPIE (Association of Powder Process Industry and Engineering) in Japan and Techsolids in Spain came together at the international meeting point for bulk solids associations to discuss business and cooperation opportunities in their respective markets.

The WOMEN4PROCESSING networking meet-up once again brought together women from the processing industry. The event was first held at the trade fair in 2025 and was continued following its successful debut. With the ‘Young Innovators’ joint stand and the ‘Student Day’, POWTECH TECHNOPHARM also turned its attention to the next generation. Guided tours and career talks brought students and those starting out in their careers together with companies and experts in process engineering.

Next processing community meet-up: 2028

After three busy days at the trade fair, attention is already turning to the next edition. The next POWTECH TECHNOPHARM will take place from 26 to 28 September 2028 at the Nuremberg Exhibition Centre, once again in conjunction with PARTEC, the international congress on particle technology – alongside FACHPACK, the European trade fair for packaging, technology and processes. Registration for exhibitors is now open.

“This is a deliberate first step to reignite Sanofi’s innovation engine. Our long-standing alliance with Regeneron has transformed the therapeutic landscape for millions of patients with type 2 inflammation-related diseases and created one of the world’s leading immunology businesses,” said Belén Garijo , CEO of Sanofi.

Four Long-Acting Antibodies Added to Collaboration

Under the expanded licensing and collaboration agreement, Sanofi and Regeneron will co-develop and co-commercialize four novel long-acting antibodies invented by Regeneron. The programs target interleukin-13 (IL-13), the bispecific IL-4xIL-13, interleukin-4 (IL-4), and the interleukin-4 receptor alpha (IL-4Rα). The anti-IL-13 antibody REGN20423 is currently in a Phase 1 clinical trial in atopic dermatitis, while the three other antibodies are expected to enter clinical trials in 2027. Regeneron will also have the option to bring Sanofi’s Phase 2/3 investigational Nanobody VHH bispecific therapy targeting TSLP and IL-13 into the collaboration. This option can be exercised after completion of its Phase 3 studies in chronic obstructive pulmonary disease.

“The Regeneron-Sanofi Alliance has been one of the most productive in the history of biopharmaceuticals. This agreement builds on that foundation to bring the next generation of immunotherapy medicines to patients even faster,” said Leonard S. Schleifer , MD, Ph.D., Co-Chairman of the Board, President and CEO of Regeneron. “By expanding our Alliance, we are positioning promising new long-acting antibodies for rapid global impact of the kind our joint work on Dupixent has already achieved.”

$1 Billion Upfront Payment and Global Development Structure

Under the terms of the agreement, Regeneron will receive an upfront payment of $1 billion from Sanofi. The deal also includes potential milestone payments related to development, regulatory approvals, and commercialization of up to an additional $7 billion. Sanofi and Regeneron will share development and commercialization costs for the new programs and will split future profits from potential products globally on a 50/50 basis. Regeneron will lead research and development activities, while Sanofi will lead global commercial efforts. The existing profit-sharing agreement for Dupixent will remain unchanged.

“The clinical and commercial alliance between the two companies dates back to 2003 and has resulted in several approved medicines to date, including Dupixent, which has redefined the standard of care for people with type 2 inflammatory diseases and is now one of the most widely used commercial antibodies for any disease, with more than 1.5 million active patients worldwide,” said George D. Yancopoulos , MD, Ph.D., Co-Chairman of the Board, President and Chief Scientific Officer of Regeneron, and lead inventor of Dupixent.

“By combining Regeneron’s world-class expertise in scientific discovery and antibody development with Sanofi’s global capabilities and reach, we hope to once again deliver the next wave of innovation in immunology,” he added.

“Until now, patients living with MCT8 deficiency and their families had no FDA-approved treatment option,” said Marina Zemskova, M.D., Deputy Director of the Division of General Endocrinology in the FDA’s Center for Drug Evaluation and Research.

MCT8 deficiency is a rare genetic disorder that primarily affects males. It results from a faulty gene that provides instructions for making the MCT8 transporter, a critical protein responsible for carrying thyroid hormone into the brain. Without the MCT8 transporter, thyroid hormone cannot cross the blood-brain barrier. As a result, the brain receives too little of the hormone, while excessive levels accumulate in the bloodstream. Patients with MCT8 deficiency can experience debilitating effects, including the inability to walk or sit independently, absent or severely limited speech, intellectual disability, feeding difficulties and chronic stress on the heart and metabolism.

Tiratricol Addresses Elevated Thyroid Hormone Levels

The treatment challenge associated with MCT8 deficiency is linked to the malfunctioning transporter required to deliver thyroid hormone into cells. “The challenge in treating MCT8 deficiency has always been that the protein needed to deliver thyroid hormone into cells is the one that isn’t working,” said Hylton V. Joffe, M.D., MMSc, Director of the Office of Cardiology, Hematology, Endocrinology, and Nephrology in the FDA’s Center for Drug Evaluation and Research.

“This drug sidesteps that problem, as its active ingredient, tiratricol, can enter cells on its own without relying on the broken transporter, leading to a decrease in the elevated blood thyroid hormone levels,” he added.

The effectiveness of Emcitate was assessed through two clinical studies involving patients ranging from infants to adults. These included an international, multi-center, randomized, placebo-controlled trial (NCT05579327) and a longer-term open-label study. Across the two studies, patients receiving Emcitate experienced reductions in excess thyroid hormone levels in the bloodstream, along with improvements in cardiovascular and metabolic symptoms affected by thyroid levels, including systolic blood pressure and heart rate.

Once-Daily Emcitate Treatment

Emcitate is administered once daily as a liquid suspension and can be taken by mouth or through a feeding tube for patients who have difficulty swallowing. This provides an administration option for patients with a wide range of abilities. The most common side effects reported were diarrhea, vomiting, rash and excessive sweating. Patients who are taking another thyroid medication should consult their healthcare provider before beginning Emcitate because the two medications should not be used together. Emcitate received Orphan Drug, Rare Pediatric Disease, Fast Track and Breakthrough Therapy designations, along with Priority Review. The approval of Emcitate was granted to Egetis Therapeutics US Inc.