Cervical Intraepithelial Neoplasia

Group sales grew by 6%1 at constant exchange rates (CER; 7% in CHF), driven by high demand for newer medicines and diagnostic solutions.Pharmaceuticals Division sales rose by 8% (9% in CHF) on continued strong demand for a broad range of our medicines; top growth drivers were Phesgo (breast cancer), Vabysmo (severe eye diseases), Xolair (allergies) and Hemlibra (haemophilia A).Diagnostics Division sales remained stable with high demand across products and regions offsetting the impact of the recent healthcare pricing reforms in China.Highlights: US approval for Evrysdi tablet for spinal muscular atrophy and Susvimo for the leading cause of diabetes-related blindnessEU approval for Columvi combination with chemotherapy for people with relapsed or refractory diffuse large B-cell lymphomaUS acceptance of supplemental Biologics License Application for Gazyva/Gazyvaro for lupus nephritisTrontinemab for Alzheimer’s disease and NXT007 for haemophilia A to move into phase IIIExclusive collaboration and licensing agreement with Zealand Pharma to co-develop and co-commercialise amylin analogue as a stand-alone therapy as well as a fixed-dose combination with Roche’s lead incretin asset CT-388 for weight lossUnveiling of novel sequencing by expansion (SBX) technology, a new class of next-generation sequencingAnnouncement of plans to invest USD 50 billion in pharmaceuticals and diagnostics in the US in R&D and manufacturing over the next five yearsAnnouncement of plans to establish Roche Genentech Innovation Center Boston Outlook for 2025 confirmed Roche CEO Thomas Schinecker: “We had a good start to the year with Group sales increasing by 6% at constant exchange rates and we achieved a number of important milestones. Based on recent data, two potential new therapies – our investigational Brainshuttle bispecific antibody to treat Alzheimer’s and our investigational next-generation haemophilia A medicine – will move into phase III. Together with Zealand Pharma, we are developing amylin as a potential new stand-alone therapy for weight loss and as a fixed-dose combination with our incretin CT-388. In Diagnostics, we unveiled our breakthrough ‘sequencing by expansion’ technology, offering unparalleled speed, throughput and flexibility combined with high accuracy. We are expanding our already strong US footprint – with currently over 25,000 employees, 15 R&D and 13 manufacturing sites – by investing USD 50 billion, an important step to continue to meet patient needs in the US with highly innovative medicines and diagnostics. We are confident we will continue our positive momentum and confirm our full-year outlook.” Sales CHF millions As % of sales % change January–March 2025 2024 2025 2024 At CER In CHF Group 15,440 14,399 100.0 100.0 6 7 Pharmaceuticals Division 11,949 10,921 77.4 75.8 8 9 United States 6,224 5,692 40.3 39.5 6 9 Europe 2,320 2,200 15.0 15.3 5 5 Japan 671 649 4.3 4.5 3 3 International* 2,734 2,380 17.8 16.5 18 15 Diagnostics Division 3,491 3,478 22.6 24.2 0 0 *Asia-Pacific, CEETRIS (Central Eastern Europe, Türkiye, Russia and Indian subcontinent), Latin America, Middle East, Africa, Canada, others Outlook for 2025 confirmedRoche (SIX: RO, ROG; OTCQX: RHHBY) expects an increase in Group sales in the mid single digit range (CER). Core earnings per share are targeted to develop in the high single digit range (CER). Roche expects to further increase its dividend in Swiss francs. Group salesIn the first three months of 2025, Roche achieved sales growth of 6% (7% in CHF) to CHF 15.4 billion. Strong demand for both pharmaceutical products and diagnostic solutions more than made up for the impact from the loss of exclusivity on Avastin (various types of cancer), Herceptin (breast and gastric cancer), MabThera/Rituxan (blood cancer, rheumatoid arthritis), Esbriet (lung disease), Lucentis (severe eye diseases) and Actemra/RoActemra (rheumatoid arthritis, COVID-19), totalling CHF 0.2 billion, and the impact of the recent healthcare pricing reforms in China. Sales in the Pharmaceuticals Division increased by 8% (9% in CHF) to CHF 11.9 billion, with newer medicines for severe diseases continuing their strong growth. The top five growth drivers – Phesgo, Vabysmo, Xolair, Hemlibra and Xofluza (influenza) – achieved total sales of CHF 3.6 billion. This represents a plus of CHF 0.7 billion at CER compared to the first quarter of 2024. Phesgo achieved sales of CHF 0.6 billion due to growing demand across regions, notably China and the US, while Vabysmo continued to witness strong uptake, generating sales of CHF 1.0 billion on increased demand in all regions. Sales of Avastin, Herceptin, MabThera/Rituxan, Esbriet, Lucentis and Actemra/RoActemra decreased by a combined CHF 0.2 billion (CER) due to the impact of loss of exclusivity. In the United States, sales rose by 6%. Xolair, Phesgo, Vabysmo, Polivy (blood cancer) and Ocrevus (multiple sclerosis) were the main growth drivers. This growth more than compensated for the reduced sales of medicines with expired patents and the decline in sales of Tecentriq (cancer immunotherapy). Sales in Europe grew by 5% as the strong uptake of Vabysmo, Polivy, Ocrevus, Phesgo and Hemlibra more than compensated for the decline in sales of medicines with expired patents and lower sales of Perjeta (breast cancer) due to the ongoing conversion of patients to Phesgo. In Japan, sales increased by 3% due to growth in sales of Phesgo, Vabysmo, PiaSky (rare blood disorder), Tamiflu (influenza) and Alecensa (lung cancer). This growth more than compensated for the impact of price cuts as well as biosimilar erosion. Sales in the International region grew by 18%, led by China. In China, sales rose by 14%, driven by demand for Xofluza and Phesgo. The Diagnostics Division sales remained stable at CHF 3.5 billion as growth in demand, notably for immunodiagnostic products and pathology solutions, offset the impact of the recent healthcare pricing reforms in China. Sales in the Europe, Middle East and Africa (EMEA) region increased by 4% due to higher sales of immunodiagnostic products, clinical chemistry tests and advanced staining solutions. In North America, sales rose by 7%, driven by growth across all customer areas. Sales in Asia-Pacific decreased by 15% due to the impact of the healthcare pricing reforms in China. Pharmaceuticals: key developments Compound Milestone Regulatory ColumviBlood cancer European Commission approves Columvi as the first bispecific antibody for diffuse large B-cell lymphoma (DLBCL) after initial therapy The approval is based on the phase III STARGLO study, where Columvi in combination with chemotherapy showed a 41% reduction in the risk of death compared to MabThera/Rituxan plus chemotherapy.DLBCL is an aggressive cancer with a high risk of progression, meaning urgent and effective treatments are needed for people who relapse or have refractory disease.This Columvi regimen offers a much needed off-the-shelf and fixed-duration treatment option for those ineligible for transplant. More information: Media Release, 14 April 2025 Gazyva/GazyvaroLupus nephritis FDA accepts supplemental Biologics License Application for Gazyva/Gazyvaro for the treatment of lupus nephritis Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody in a randomised phase III study to demonstrate a complete renal response benefit.The filing application is based on data from the phase III REGENCY study, where Gazyva/Gazyvaro showed superiority over standard therapy alone in people with active lupus nephritis.Lupus nephritis affects 1.7 million people worldwide; up to one-third of people on current treatments will progress to end-stage kidney disease within 10 years. More information: Media Release, 5 March 2025 ColumviBlood cancer CHMP recommends EU approval of Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) Columvi plus chemotherapy showed a 41% reduction in the risk of death in the pivotal phase III STARGLO study.DLBCL – an aggressive disease with a high risk of progression – remains an area of high unmet need, especially for treatments that can be initiated soon after the cancer returns.If approved, this off-the-shelf, fixed-duration Columvi combination will be the first bispecific antibody regimen available for patients with DLBCL following relapse. More information: Media Release, 28 February 2025 EvrysdiSpinal muscular atrophy FDA approves Evrysdi tablet as first and only tablet for spinal muscular atrophy (SMA) Evrysdi is the only non-invasive disease-modifying SMA treatment and is approved in over 100 countries.Evrysdi tablet can be stored at room temperature and offers the same demonstrated efficacy and safety as the currently available oral solution.New tablet formulation may provide greater freedom and independence for people with SMA thanks to simplified dose administration. More information: Media Release, 12 February 2025 SusvimoSevere eye diseases FDA approves Susvimo as the first and only continuous-delivery treatment for the leading cause of diabetes-related blindness Susvimo is the first and only continuous-delivery treatment that offers an alternative to regular eye injections to treat diabetic macular edema (DME).With as few as two treatments per year, Susvimo may help people with DME maintain their vision.Approval marks the second indication for Susvimo in addition to neovascular or ‘wet’ age-related macular degeneration (nAMD). More information: Media Release, 4 February 2025 Phase III, pivotal and other key read-outs TrontinemabAlzheimer’s disease Roche presents novel therapeutic and diagnostic advancements in Alzheimer’s at AD/PD 2025 New trontinemab data continue to support rapid and deep, dose-dependent reduction of amyloid plaques in phase Ib/IIa Brainshuttle AD study.Data on the Elecsys pTau181 plasma test demonstrate potential to accurately rule out amyloid pathology, one of the hallmarks of Alzheimer’s disease.Roche will initiate a phase III programme for trontinemab later this year based on totality of data. More information: Media Release, 3 April 2025 OcrevusMultiple sclerosis Roche provides update on phase III Ocrevus high dose study in people with relapsing multiple sclerosis MUSETTE trial was designed to determine whether a higher dose of the currently approved Ocrevus IV 600 mg would provide additional benefit to people living with relapsing multiple sclerosis.The trial did not meet its primary endpoint; results support Ocrevus IV 600 mg as the optimal dose to slow disability progression.High dose was well tolerated with an overall comparable safety profile to Ocrevus IV 600 mg and no new safety signals observed. More information: Media Release, 2 April 2025 XolairAllergies Phase III study shows Xolair may be more effective with fewer side effects than oral immunotherapy for the treatment of food allergies First-ever head-to-head trial comparing Xolair and oral immunotherapyResults were featured as late-breakers at the 2025 AAAAI Annual Meeting.Xolair is the only US FDA-approved medicine to reduce allergic reactions in children and adults with one or more food allergies. More information: Media Release, 2 March 2025 Other US investment announcement Roche announces plans to invest USD 50 billion in pharmaceuticals and diagnostics in the United States over the next five years USD 50 billion commitment includes new state-of-the-art research and development (R&D) sites, new and expanded manufacturing facilities in Indiana, Pennsylvania, Massachusetts and California and an additional site location to be announced soon.Investments will create more than 12,000 new jobs: 1,000 at Roche and more than 11,000 in support of new US manufacturing capabilities. Roche already has a significant existing US presence with more than 25,000 employees, 15 R&D centres and 13 manufacturing sites. More information: Media Release, 22 April 2025 Zealand Pharmaagreement Roche enters into an exclusive collaboration and licensing agreement with Zealand Pharma to co-develop and co-commercialise petrelintide as a potential foundational therapy for people with overweight and obesity Agreement allows for a range of potentially best-in-class therapy options as monotherapy and fixed-dose combination with Roche’s lead incretin asset CT-388.Collaboration will complement Roche’s portfolio in the field of cardiovascular, renal and metabolic (CVRM) diseases.Obesity is a heterogeneous disease with over 200 related comorbidities, including cardiovascular and metabolic diseases, and is expected to impact over 4 billion people globally by 2035. More information: Media Release, 12 March 2025 Roche Genentech Innovation Center Roche announces launch of Roche Genentech Innovation Center Boston based at Harvard’s Enterprise Research Campus in Allston The new centre will be a hub for both Roche and Genentech, bringing together expertise in cardiovascular, renal and metabolic diseases, as well as for data science and AI specialists to drive innovation in drug discovery and development.Roche will be the first to join Harvard’s Enterprise Research Campus in Allston, taking a suite in the first phase of the project’s cutting-edge lab space.Starting with a lease of 30,000 square feet (approx. 2,800 square metres), Roche intends to invest over the coming years into a research and development presence with eventually up to 500 employees. More information: Media Release, 7 March 2025 Gazyva/GazyvaroLupus nephritis New England Journal of Medicine publishes new data for Gazyva/Gazyvaro which shows superiority over standard therapy in people with active lupus nephritis Nearly half of patients on Gazyva/Gazyvaro plus standard therapy achieved a complete renal response (CRR), with a statistically significant and clinically meaningful improvement, compared to standard treatment alone.Analysis showed consistent CRR benefit across patient subgroups, highlighting potential to treat a broad patient population with high unmet need.Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody in a phase III study to demonstrate CRR benefit, which is associated with preservation of kidney function and delay or prevention of end-stage kidney disease. More information: Media Release, 7 February 2025 Enlarged Corporate Executive Committee change Change to the Roche Enlarged Corporate Executive Committee Wafaa Mamilli joins Roche as Chief Digital Technology Officer (CDTO), reporting to Group CEO Thomas Schinecker.She became a member of the Enlarged Corporate Executive Committee starting 10 February 2025. She is based at Genentech in South San Francisco. More information: Media Release, 29 January 2025 Pharmaceuticals sales Sales CHF millions As % of sales % change January–March 2025 2024 2025 2024 At CER In CHF Pharmaceuticals Division 11,949 10,921 100.0 100.0 8 9 United States 6,224 5,692 52.1 52.1 6 9 Europe 2,320 2,200 19.4 20.1 5 5 Japan 671 649 5.6 5.9 3 3 International 2,734 2,380 22.9 21.9 18 15 International: Asia-Pacific, CEETRIS (Central Eastern Europe, Türkiye, Russia and Indian subcontinent), Latin America, Middle East, Africa, Canada, others Top 20 best-selling pharmaceuticals Total United States Europe Japan International CHF m % CHF m % CHF m % CHF m % CHF m % OcrevusMultiple sclerosis 1,778 6 1,247 3 344 11 - - 187 16 HemlibraHaemophilia A 1,165 11 610 0 247 7 82 3 226 72 VabysmoEye diseases (nAMD, DME, RVO) 1,018 18 718 7 197 42 32 35 71 101 TecentriqCancer immunotherapy 870 0 411 -8 220 5 81 -5 158 21 Perjeta2Breast cancer 840 -10 342 -3 144 -16 18 -51 336 -9 Xolair2Asthma 645 26 645 26 - - - - - - Actemra/RoActemra2RA, COVID-19 619 -1 294 3 152 -19 71 5 102 26 PhesgoBreast cancer 593 52 179 38 199 18 40 115 175 142 Kadcyla2Breast cancer 506 5 201 5 135 -7 21 -3 149 21 EvrysdiSpinal muscular atrophy 420 18 160 15 145 6 20 0 95 56 AlecensaLung cancer 397 11 130 21 68 -6 49 12 150 12 PolivyBlood cancer 358 42 156 30 94 74 44 2 64 80 MabThera/Rituxan2Blood cancer, RA 298 -16 181 -14 35 -10 3 -17 79 -23 Activase/TNKase2Cardiac diseases 297 -2 285 -2 - - - - 12 -9 Herceptin2Breast and gastric cancer 292 -20 60 -12 77 0 2 -56 153 -29 Avastin2Various cancer types 274 -15 80 -21 14 -33 36 -30 144 -3 Gazyva/Gazyvaro2Blood cancer 249 15 131 27 60 -3 8 46 50 11 XofluzaInfluenza 159 234 14 239 - * - - 145 234 Pulmozyme2Cystic fibrosis 123 10 84 22 18 -9 - -26 21 -10 Tamiflu2Influenza 100 56 9 * 26 114 13 81 52 17 * Over 500%DME: diabetic macular edema / nAMD: neovascular or ‘wet’ age-related macular degeneration / RVO: retinal vein occlusion / RA: rheumatoid arthritis Diagnostics: key developments Product Milestone SBX technology Roche unveils a new class of next-generation sequencing with its novel sequencing by expansion technology Roche’s innovative sequencing by expansion (SBX) technology represents a leap forward in next-generation sequencing (NGS), which is playing a vital role in decoding complex diseases like cancer, immune disorders and neurodegenerative conditions.Combined with an innovative, high-throughput sensor module, SBX uses expanded synthetic molecules to determine the DNA sequence of a target molecule, creating an ultra-rapid, scalable and flexible technology.Reducing the time from sample to genome from days to hours, this novel approach could significantly speed up genomic research, as well as translational and clinical applications in the years to come. More information: Media Release, 20 February 2025 PATHWAY HER2 (4B5) test Roche receives FDA approval for the first companion diagnostic to identify patients with HER2-ultralow metastatic breast cancer eligible for ENHERTU As seen in the DESTINY-Breast06 trial, approximately 20–25 percent of hormone receptor (HR)-positive, HER2-negative breast cancer patients may be considered HER2-ultralow. These patients may now be eligible for a targeted treatment, which could significantly improve their outcomes.The PATHWAY HER2 (4B5) test, the first and only FDA approved companion diagnostic for assessing HER2-low status since 2022, is now also approved to aid in the assessment of HER2-ultralow status for metastatic breast cancer patients.HER2 interpretation in breast cancer is evolving. With the introduction of HER2-low and now HER2-ultralow classifications, Roche continues to lead in HER2 diagnostics, helping to expand patient access to personalised treatment. More information: Media Release, 31 January 2025 Diagnostics sales Sales CHF millions As % of sales % change January–March 2025 2024 2025 2024 At CER In CHF Diagnostics Division 3,491 3,478 100.0 100.0 0 0 Customer areas3 Core Lab 1,904 1,926 54.5 55.4 -1 -1 Molecular Lab 634 611 18.2 17.6 2 4 Near Patient Care 536 569 15.4 16.3 -5 -6 Pathology Lab 417 372 11.9 10.7 11 12 Regions Europe, Middle East, Africa 1,236 1,188 35.4 34.2 4 4 North America 1,154 1,055 33.1 30.3 7 9 Asia-Pacific 853 992 24.4 28.5 -15 -14 Latin America 248 243 7.1 7.0 11 2 More information on Roche performance in the first quarter of 2025: Q1 2025 presentationAppendix with tables About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharmaceuticals with data insights from the clinical practice. For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law.References[1] Unless otherwise stated, all growth rates and comparisons to the previous year in this document are at constant exchange rates (CER: average rates 2024) and all total figures quoted are reported in CHF.[2] Products launched before 2015.[3] Core Lab: diagnostics solutions in the areas of immunoassays, clinical chemistry and CustomBiotech.Molecular Lab: diagnostics solutions for pathogen detection and monitoring, donor screening, sexual health and genomics, genomic tumour profiling.Near Patient Care: diagnostics solutions in emergency rooms, medical practices and directly with patients, including integrated personalised diabetes management.Pathology Lab: diagnostics solutions for tissue biopsies and companion diagnostics.In 2025, sales in the Pathology Lab customer area include sales previously reported in the Molecular Lab customer area to foster business transparency and harmonisation in the use of solutions in the area of cervical intraepithelial neoplasia technology (CINtec). The comparative information for 2024 has been restated accordingly.In 2025, sales in the Core Lab customer area include sales previously reported in the Near Patient Care customer area to centralise digital healthcare solutions within Roche Information Solutions. The comparative information for 2024 has been restated accordingly. Cautionary statement regarding forward-looking statementsThis document contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this document, such as: (1) pricing and product initiatives of competitors; (2) legislative and regulatory developments and economic conditions; (3) delay or inability in obtaining regulatory approvals or bringing products to market; (4) fluctuations in currency exchange rates and general financial market conditions; (5) uncertainties in the discovery, development or marketing of new products or new uses of existing products, including without limitation negative results of clinical trials or research projects, unexpected side effects of pipeline or marketed products; (6) increased government pricing pressures; (7) interruptions in production; (8) loss of or inability to obtain adequate protection for intellectual property rights; (9) litigation; (10) loss of key executives or other employees; and (11) adverse publicity and news coverage. The statement regarding earnings per share growth is not a profit forecast and should not be interpreted to mean that Roche’s earnings or earnings per share for this or any subsequent period will necessarily match or exceed the historical published earnings or earnings per share of Roche. Roche Global Media RelationsPhone: +41 61 688 88 88 / e-mail: media.relations@roche.com Hans Trees, PhDPhone: +41 79 407 72 58 Sileia UrechPhone: +41 79 935 81 48 Nathalie AltermattPhone: +41 79 771 05 25 Lorena CorfasPhone: +41 79 568 24 95 Simon GoldsboroughPhone: +44 797 32 72 915 Karsten KleinePhone: +41 79 461 86 83 Nina MählitzPhone: +41 79 327 54 74 Kirti PandeyPhone: +49 172 636 72 62 Yvette PetillonPhone: +41 79 961 92 50 Dr Rebekka SchnellPhone: +41 79 205 27 03 Roche Investor Relations Dr Bruno EschliPhone: +41 61 687 52 84e-mail: bruno.eschli@roche.com Dr Sabine BorngräberPhone: +41 61 688 80 27e-mail: sabine.borngraeber@roche.com Dr Birgit MasjostPhone: +41 61 688 48 14e-mail: birgit.masjost@roche.com Investor Relations North America Loren KalmPhone: +1 650 225 3217e-mail: kalm.loren@gene.com Attachments 25042025_Roche_Q1_2025_EN Communications appendix tables_Q1 2025 Sales

SHANGHAI, April 18, 2025 /PRNewswire/ -- Asieris Pharmaceuticals today released its 2024 Annual Report, highlighting a bold and determined journey forward. With a specialty pharma strategy and operational efficiency, the company exceeded its commercialization targets and advanced its innovative products — APL-1702 and APL-1706 (Hexvix®) — toward market launch. R&D efforts also gained strong momentum, with 12 products in the pipeline and 16 ongoing research projects. As of the end of the reporting period, Asieris held approximately RMB 1.89 billion in cash, cash equivalents, and trading financial assets, providing a solid foundation for continued growth. Revenue Tops RMB 200M in 1st Year of Commercialization, with the specialized commercialization platform poised for action 2024 marked Asieris' first full year of commercialization. The company has made strides in refining market strategies and ensuring high-quality execution, while effectively managing costs and expenses. Asieris posted operating revenue of RMB 202 million, demonstrating robust growth and successfully reaching break-even targets in commercial operations. During the reporting period, the company's two commercialized products, Ouyoubi and Dipaite, saw strong uptake, reaching over 1,000 and 500 target hospitals respectively. Sales grew rapidly, with Ouyoubi capturing 27% of the neratinib tablet market and Dipaite securing 12% of the pazopanib tablet market. To further strengthen its presence in key focus areas, the company introduced multiple products and established sales partnerships in women's health and genitourinary (GU) tumors. In March 2025, it licensed-in the eribulin mesylate injection, a novel microtubule inhibitor for the treatment of advanced breast cancer. With this addition, the company's breast cancer portfolio now covers both early and late-stage disease. To further enhance commercialization efficiency, the company has launched its Commercial Operation 2.0 — building on past successes to create a leaner, more agile operating model. Key initiatives include appointing a seasoned Chief Commercial Officer to lead the function end-to-end; streamlining the organizational structure and strengthening commercial capabilities; and strategically expanding the team in line with priority areas and product launch timelines. The company has also set clear five-year business targets, including accelerating growth for existing products, preparing for the commercial rollout of Hexvix® and APL-1702, introducing new products within core therapeutic areas, maximizing synergies across the pipeline, and driving sales efficiency to the next level. Accelerating product launches to build momentum for sales In women's health, APL-1702, a combination of drug and medical device designed for photodynamic non-surgical treatment of cervical high-grade squamous intraepithelial lesions (HSIL), is making steady progress toward market approval. In May 2024, the product's marketing application was officially accepted by the National Medical Products Administration (NMPA). As of the report's release, the Center for Drug Evaluation (CDE), NMPA had completed the first round of technical reviews, covering toxicology, clinical data, biostatistics, clinical pharmacology, and pharmaceutical quality. During the reporting period, the Inspection Center also wrapped up its Good Clinical Practice (GCP) inspection. The company has since received written feedback and is actively coordinating its responses to help expedite the review process and bring APL-1702 one step closer to approval. As a first-in-class treatment set to debut in China, APL-1702 is on track to become the world's first non-invasive therapy for HSIL — supported by robust clinical evidence and validated through an international Phase III trial. Experts note that, with China facing demographic pressures and a rising incidence of cervical intraepithelial neoplasia (CIN) among younger women, surgical excision of the cervix poses increasing challenges — especially during the critical period of fertility preservation. APL-1702 is expected to bridge this critical treatment gap and contribute to the creation of a more fertility-friendly healthcare landscape. To drive the commercialization of APL-1702, the company has hosted eight expert advisory meetings, focusing on Phase III clinical data, the current landscape of HSIL diagnosis and treatment, and unmet clinical needs. These sessions earned strong endorsement from leading gynecological and pharmaceutical experts, who recognized the innovation and clinical value APL-1702 brings to the table. The company has also made meaningful progress in building strategic partnerships with government agencies and leading academic associations. In collaboration with the Cancer Foundation of China, the company unveiled the first real-world showcase of its innovative cervical cancer prevention and control system at the 7th China International Import Expo (CIIE). It also signed medium- to long-term strategic cooperation agreements with both the China Women's Development Foundation and the Cancer Foundation of China during the event. The partnerships are set to roll out in 2025. The Women's Health Division has conducted extensive market and industry research, gaining deep insights into the needs of doctors and patients and broader commercial landscape. Based on this analysis, the team has finalized key launch strategies and mapped out a commercialization roadmap, laying the groundwork for a swift market rollout once approval is secured. Given the relative scarcity of innovation in the gynecological field, APL-1702 stands out as a meaningful breakthrough, backed by solid clinical evidence and proven efficacy. The company will continue to prioritize APL-1702 and its photodynamic drug-device combination platform, in a bid to build a comprehensive, tiered gynecological portfolio. This strategy will center on product iteration and indication expansion, while leveraging synergies across the pipeline to drive broader growth. In urological tumors, after the marketing application for Hexvix® was accepted in November 2023, the company's dynamic and highly skilled team sprang into action to support the review and approval process. As a result, Hexvix® received NMPA approval in November 2024, seven months ahead of the expected timeline. The product has since made history as the first diagnostic imaging agent approved in China for photodynamic blue light cystoscopy in bladder cancer detection. The Oncology Business Unit is fine-tuning the launch strategy for Hexvix®, initially targeting patients with commercial insurance or those willing to pay out-of-pocket. The early rollout will cover the special and international medical departments of top-tier hospitals in major cities, as well as premium foreign-invested and private urology specialty hospitals. As clinical guidelines are released and endorsements from leading urology experts are established, the launch will be paired with the introduction of disposable blue light cystoscopes. Together, these efforts aim to accelerate the adoption of blue light cystoscopy in general hospitals and foster an integrated approach to the diagnosis and treatment of bladder cancer. Focusing on strategic expansion in key areas and fast-tracking high-impact R&D initiatives Aligned with its strategic vision, Asieris has made significant strides in clinical development in 2024, with its global clinical initiatives progressing efficiently. In the fields of women's health, breast cancer, and gynecological tumors, Asieris has made remarkable progress. Building on the strong results of the international multicenter Phase III study of APL-1702, the company received feedback from its communication meeting with the U.S. FDA in December 2024, culminating in an agreement on a new Phase III clinical design to support the U.S. launch of APL-1702. Asieris is now actively seeking international partners to advance the U.S. Phase III clinical trial application. Additionally, APL-1702 is also being investigated for its potential in HPV virus clearance. Meanwhile, the U.S. FDA and China's NMPA approved the Phase I/IIa clinical trial applications for APL-2302 (a USP1 small molecule inhibitor) in advanced solid tumors in October 2024 and January 2025, respectively, with the first patient enrolled in Phase Ia in March 2025. Progress on APL-2501 (CLDN6/9 ADC) is also on track, with its preclinical research and unique linker platform selected for a poster presentation at the 2025 American Association for Cancer Research Annual Meeting (AACR 2025). In the field of urologic oncology, the Phase II clinical trial of oral APL-1202 in combination with tislelizumab as a neoadjuvant therapy for muscle-invasive bladder cancer (MIBC) was successfully completed in September 2024, delivering encouraging efficacy signals. Among protocol-eligible patients, the pathological complete response (pCR) rates were 41% for the combination arm versus 20% for monotherapy. The combination was particularly effective in patients with low PD-L1 expression, where it achieved a pCR rate of 42% compared to just 11% with monotherapy. Meanwhile, APL-2401 — a dual FGFR2/3 small molecule inhibitor — has entered IND-enabling studies, with its findings selected for a poster presentation at AACR 2025. In addition, the investigational new drug (IND) application for APL-1202 in the treatment of free-living amoebae (FLA) infections was approved by the NMPA in June 2024. In January 2025, the company signed an investigational drug supply agreement under the Expanded Access IND Program with the Centers for Disease Control and Prevention (CDC) in the United States for APL-1202, subject to evaluation by CDC experts, to be used for treating FLA infections. Dr. Kevin Pan, Founder, Chairman and CEO of Asieris Pharmaceuticals, commented, "2024 marks our first full year of commercialization. We delivered strong growth across our marketed products and reached a milestone by breaking even in our commercial operations. Our pipeline is entering a critical sprint toward market launch and is set to power the next wave of performance growth. While reinforcing our commercial capabilities, we're also accelerating clinical programs with a strategic focus on women's health and urological oncology. We're building a robust pipeline of first-in-class and highly-differentiated fast-follow therapies, while actively expanding into global markets to unlock the full value of our assets. With relentless innovation and execution, we are confident that Asieris will continue to make a meaningful difference for patients, deliver solid returns to shareholders, and create lasting value for society." Note: As of the date of this publication, APL-1702 has not been approved for the treatment of cervical high-grade squamous intraepithelial lesions (HSIL). This article is intended to disclose the latest development of these products, not to serve as a promotional advertisement for the products. The relevant information is not intended for patients but is provided solely for the reference of healthcare professionals. If you like to learn more about these diseases, please consult healthcare professionals. SOURCE Asieris WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

TUESDAY, July 9, 2024 -- A new urine test might help doctors more easily screen for cervical cancer, researchers report. The test looks for proteins generated by a type of cancer-causing human papillomavirus, HPV 16. HPV strains 16 and 18 are responsible for nearly all cervical cancers, according to the National Cancer Institute. These proteins, called E7 proteins, are associated with a high risk of cervical cancer, researchers said. “Our new urine test can detect HPV16 E7 proteins, which are critical markers of cervical cancer risk, at extremely low levels,” said lead researcher Etsuro Ito , a professor of biology at Waseda University in Japan. “This means that women may be able to screen for cervical cancer without the discomfort and inconvenience of a traditional Pap test.” The test detected E7 proteins in 80% of women with Stage 1 cervical intraepithelial neoplasia (CIN), a precursor to cervical cancer. It also found the proteins in 71% of women with Stage 2 CIN and 38% of women with Stage 3 CIN, results show. “We believe that the E7 oncoprotein is critical in the early stages of HPV-related cervical carcinogenesis and E7 may play a more significant role in the progression of CIN1 and CIN2 than in CIN3,” Ito said in a university news release. The availability of a simple urine test could aid efforts to eradicate cervical cancer by eliminating barriers related to screening, researchers said. “This new method holds great promise for early detection and prevention of cervical cancer,” Ito said. “We are optimistic that further development and validation of this assay will lead to its widespread use in clinical settings.” The study was recently published in the journal Microorganisms . Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.