Roche Showcases Over Ten Upcoming and Pipeline Products in China Debut at CIIE, Unveiling Full Disease Area Strategy

The 8th China International Import Expo (hereinafter referred to as CIIE) has entered the final countdown to its opening. As one of the earliest multinational companies to express support to the Ministry of Commerce and deeply participate in the CIIE, Roche, a "full-time participant," will keep its appointment for the eighth consecutive year. This year, under the theme of "Leading Innovation, Safeguarding Life," Roche will present an immersive display of the deep integration of medical innovation and humanistic care through the artistic concept of the "Dome of Life," interpreting Roche's original aspiration and mission of adhering to innovation and protecting life.

Roche will comprehensively showcase a full portfolio of over 40 products and diverse innovative solutions. Among these, more than ten pipeline products covering various disease areas—set to launch in China soon or in the future—will make their first collective appearance, marking an unprecedented lineup. Highlights include the introduction of Gazyva® (Obinutuzumab), the first anti-CD20 monoclonal antibody to demonstrate positive results in a randomized Phase III clinical trial for lupus nephritis, and the world's first and currently only ocular implant—a groundbreaking ophthalmic solution known as the Port Delivery System (PDS). Additionally, Roche will present for the first time its end-to-end pharmaceutical value chain layout in China, along with a panoramic view of its newly constructed biopharmaceutical production base, which represents a latest investment of 2.04 billion RMB.

"As an important window for China's high-level opening-up and a global platform for sharing innovative achievements, the CIIE has built an irreplaceable strategic stage for foreign enterprises like Roche that are deeply rooted in China. Over the past eight years, it has not only served as a bridge to deepen dialogue with the government and partners but also witnessed nearly 15 of Roche’s global innovative drugs transform from exhibits to commercial products through the 'CIIE Acceleration,' benefiting Chinese patients. This year, as an ‘all-time participant’ attending for the eighth consecutive year, we are showcasing more than ten products making their debut, including those about to be launched in China and future pipeline products. These cover major disease areas such as Alzheimer's disease, Parkinson's disease, hypertension, and metabolic diseases — marking a record-high lineup. This signifies Roche's acceleration from being a leader in oncology and specialty medicines to becoming a comprehensive leader across all disease areas."

China’s continuously optimized business environment and innovation ecosystem have provided fertile ground for foreign enterprises to take root and grow. As Roche's second-largest market globally, the new biopharmaceutical production base we invested over 2 billion yuan in this year in Shanghai marks a key milestone in our localization strategy. As the first base by a multinational pharmaceutical company to achieve localized production of large-molecule antibody biologics in China, it strongly demonstrates Roche's long-term confidence in the Chinese market. Roche, which will celebrate its 100th anniversary in China next year, will continue to increase investment, deepen its presence, and collaborate with partners from all sectors to drive collaborative innovation in the healthcare field, injecting strong momentum into the achievement of the ‘Healthy China 2030’ goals,” said Ms. Amy Bian, General Manager of Roche Pharmaceuticals China.

As a global leading biotechnology company, Roche is accelerating its transformation from a specialist leader in oncology and specialty medicines to a comprehensive leader across all disease areas. At this year's CIIE, Roche is showcasing for the first time over ten products that are about to be launched in China as well as future pipeline products, covering full disease areas such as breast cancer, hematology, neuroscience, ophthalmology, immunology, cardiovascular and metabolic diseases. Among them, several future pipeline products have entered the large-scale Phase III clinical stage, achieving impressive data.

Products and new indications即将在中国上市, including Gazyva in the immunology field.^®(Gazyva) and the ophthalmology breakthrough solution PDS (Port Delivery System) debuted at the CIIE.

● This year, Roche has launched Gazyva.^®(Gazyva) New Indications in Immunotherapy. According to the latest Phase III clinical trial, Gazyova® significantly improves the complete renal response rate (CRR) in patients and is the first anti-CD20 monoclonal antibody to demonstrate CRR benefits in a randomized Phase III clinical trial for lupus nephritis. It has been approved for marketing by the US FDA, received priority review from the EU, and is expected to soon provide a new treatment option for a large population of lupus nephritis patients in China.

● Roche is also continuously exploring innovative drug delivery methods, such as subcutaneous formulations and short-term infusions. Roche's breakthrough ophthalmology solution, PDS (Port Delivery System), made its debut at the CIIE stage. PDS is the world’s first and currently only intravitreal implant, about the size of a grain of rice, surgically placed in the pars plana of the ciliary body. It is permanent and refillable with the anti-VEGF antibody ranibizumab, providing sustained drug release for approximately six months, thereby reducing the need for patients to undergo frequent intravitreal injections and offering a new long-term management solution for patients with retinal diseases.

Future Pipeline Products Make Debut Appearance, Covering Entire Disease Spectrum and Showcasing Roche's Breakthrough Achievements in Frontier Science and Innovation.

● In the field of breast cancer, Giredestrant, a next-generation oral SERD (Selective Estrogen Receptor Degrader) independently developed by Roche, offers new hope for breast cancer patients to overcome clinical drug resistance. The evERA study, the first head-to-head Phase III trial of an all-oral combination therapy to yield positive results, demonstrated that in ER+ advanced breast cancer patients previously treated with CDK4/6 inhibitors, the combination of Giredestrant and Everolimus significantly improved progression-free survival (PFS) compared to the standard endocrine therapy plus Everolimus regimen.

● In the field of hematology, NXT007 is Roche's new-generation innovative drug for hemophilia, which is expected to provide a better treatment option for people with hemophilia A. In addition, Roche has officially entered the multiple myeloma field. Cevostamab is an innovative T-cell redirecting bispecific antibody that is expected to offer an important alternative treatment option for multiple myeloma patients who are resistant to existing therapies.

● In the field of neuroscience, in addition to the already covered rare disease areas, Roche has two potential drug pipelines for Alzheimer's disease and Parkinson's disease that could cover a broader patient population. According to the latest clinical data released, Roche's next-generation anti-amyloid drug Trontinemab has achieved milestone progress in treating Alzheimer’s disease, demonstrating the advantages of Roche's proprietary Brain Shuttle technology, while showing highly controllable safety, drawing significant industry attention. Additionally, recent research and long-term follow-up data indicate that Roche's first-in-class anti-alpha-synuclein antibody prasinezumab has shown additional clinical benefits when added to standard symptomatic treatment in early-stage Parkinson’s disease patients.

● In the field of ophthalmology, Roche's next-generation ophthalmic drug Vamikibart (Vamikibart monoclonal antibody) is a monoclonal antibody specifically designed for intraocular use, targeting interleukin-6 (IL-6), a key mechanism in the inflammatory vicious cycle of uveitis (UME). According to the latest Phase III research results, targeted IL-6 therapy can significantly improve vision and reduce central retinal thickness (CST). Chinese patients were enrolled simultaneously with the global population in two Phase III studies, demonstrating China's scientific research capabilities and providing more localized data support for Chinese UME patients.

● In the field of cardiovascular and metabolic diseases, Roche continues to expand its product pipeline to address the significant unmet needs of patients. In the metabolic space, Roche has introduced four diversified R&D pipelines this time, covering various administration methods from oral to injectable, with innovative mechanisms of action to comprehensively meet the complex clinical needs of obese patients. Roche's subcutaneous RNA interference (RNAi) therapy, Zilebesiran, requires only two doses per year, enhancing treatment convenience and compliance for hypertensive patients, and is expected to become a new option for long-term disease management in many patients with poorly controlled hypertension. Roche’s first-in-class FGF21 analog drug, pegozafermin, may bring new hope to the large patient population suffering from Metabolic Dysfunction-Associated Steatohepatitis (MASH), a condition with limited treatment options.

As one of the earliest foreign-invested enterprises to enter China, Roche will celebrate its 100th anniversary in China next year. Roche has always practiced the long-term principle of deepening its roots in China and resonating with the Chinese market through concrete actions. Among large multinational pharmaceutical companies, Roche was the first to establish and continuously upgrade and improve an end-to-end complete pharmaceutical value chain, covering early-stage research and development, drug development, manufacturing, marketing, and open collaboration. Roche has recently announced an investment of 2.04 billion RMB to build a new biopharmaceutical production base, strengthening its supply chain and localized production layout in China, thereby comprehensively reinforcing the end-to-end complete pharmaceutical value chain. Located just 300 meters away from Roche Pharma’s China headquarters, the base will initially be used for the localized production of the innovative ophthalmic drug Lucentis® (Faricimab Injection), which is currently under intensive construction and is expected to achieve phased progress by the end of next year.

The progress of healthcare is not only a leap in technology but also the transmission of warmth. Roche has always believed that true healthcare innovation is the integration of science and humanity. At this year's CIIE, Roche presents an immersive display of the deep fusion between healthcare innovation and humanistic care through the artistic representation of the "Dome of Life," interpreting Roche’s original aspiration and mission to uphold innovation and protect life. In addition, Roche has created the core exhibition area called the "Healing Space." This area features a giant DNA art installation, which forms a clever visual and emotional connection with Roche's "Cure Mates" series of dolls. Through the presentation of real patient photos and stories, it conveys the power of life, allowing the public to experience up close the heartwarming intersection of medical innovation and humanistic care, and together illuminate a healthy and bright future.

In addition, Roche has created multiple immersive and creative interactive installations, offering audiences a brand-new interactive experience in disease education. By participating effortlessly, people can perceive the charm of cutting-edge medicine and enhance their health management awareness. Meanwhile, Roche showcased several AI solutions independently developed or supported in areas spanning research, diagnosis, treatment, and patient management, committing to precisely empower the entire medical process. During the exhibition, Roche also collaborated with partners to present more than ten significant product launches, covering fields such as digital healthcare and medical innovation, highlighting the latest clinical advancements and cross-disciplinary collaboration achievements.