Tislelizumab

SHANGHAI, Aug. 28, 2025 /PRNewswire/ -- Asieris Pharmaceuticals today released its 2025 Semi-Annual Report, highlighting strong growth momentum. The company's Commercial Operation 2.0 has begun to deliver results, with sales rising steadily and first-half targets achieved. APL-1702, a breakthrough therapy for precancerous cervical lesions, is in the final stages before its China launch. Hexvix®, China's first approved blue-light imaging agent for bladder cancer, marks a new era for photodynamic blue-light cystoscopy. Meanwhile, the company's pipeline continued to advance, with achievements presented at major international academic conferences. As of the end of this reporting period, Asieris has 12 products in the pipeline and 16 ongoing research projects. The company holds approximately RMB 1.825 billion in cash, cash equivalents, and trading financial assets, providing a solid foundation for continued growth. Operating Revenue Up 61.8% YoY as Commercial Operation 2.0 Delivers Early Results In the first half of 2025, despite intensifying market competition, the company steadily advanced Commercial Operation 2.0, strengthening its commercial framework and improving operational efficiency. During the reporting period, operating revenue reached RMB 130 million, up 61.8% year over year, achieving the first-half business targets set at the beginning of the year. Building on Commercial Operation 2.0, the company continued to refine market strategies and strengthen execution, driving steady sale growth of its two marketed products, Ouyoubi and Dipaite. In the first half of the year, the company's enhanced evidence-based promotion and a stronger academic network laid a robust foundation for improving outcomes for patients with breast cancer. Ouyoubi was selected for the sixth batch of Shanghai Catalog of Innovative and Priority Biopharmaceutical Products, a move expected to broaden patient access. Meanwhile, the company has been actively preparing for the launch of Ounalin (eribulin mesylate injection), expanding its portfolio to address both early- and late-stage breast cancers. For Dipaite, the commercial team has proactively adapted to evolving treatment paradigms, precisely targeting clinical scenarios. Through medical education programs, the company has enhanced physicians' experience in managing renal cancer patients across the care continuum, improving patient adherence and treatment duration. Efforts to secure both hospital formulary listings and pharmacy access have accelerated, further improving patient access to therapy. Strong sales of Ouyoubi and Dipaite highlight the company's strengthening commercialization capabilities. As the company's first commercialized products, they provide a solid foundation for the launch and market uptake of its subsequent core products. Breakthrough Innovation Poised for Imminent Market Impact In women's health, APL-1702, a first-in-class treatment set to debut in China, is on track to become the world's first non-invasive therapy for high-grade squamous intraepithelial lesion (HSIL) of the cervix, supported by robust clinical evidence and validated in an international Phase III trial. Following the acceptance of its marketing application by China's National Medical Products Administration (NMPA) in May 2024, the company has made APL-1702 a strategic priority. The regulatory review is progressing smoothly, with the NMPA having initiated a second round of technical evaluation. APL-1702's innovation, clinical promise, and societal value have earned strong endorsement from gynecology and pharmaceutical experts. With cervical lesions increasingly affecting younger women in China and current treatments relying on cervical excision, managing precancerous lesions during the critical fertility-preservation window has become a major challenge. Experts believe APL-1702 could address this unmet clinical need, transform the treatment landscape, and support the development of a fertility-friendly society. To fast-track the commercialization of APL-1702, the company has undertaken multiple pre-launch initiatives. Phase III trial results have been presented at leading academic conferences, and more than 10 expert advisory meetings have been held to support updates to clinical guidelines and consensus. At the China International Import Expo, the product was showcased globally, and the company signed medium- to long-term strategic partnerships with the China Women's Development Foundation and the Cancer Foundation of China. All of these projects were launched in the first half of 2025. To improve access and affordability, disease-burden and policy research have been conducted. The company is also accelerating the build-out of its commercial team, implementing an omni-channel strategy focused on public hospitals, and optimizing the supply chain to ensure patients can benefit immediately upon approval. In urologic oncology, Hexvix®, China's first approved imaging agent for bladder cancer, has ushered in a new era of blue-light cystoscopy. The company is actively supporting its partner R.WOLF in advancing the regulatory review of the SYSTEM BLUE blue-light cystoscopy system in China, with approval targeted by the end of 2025. Once approved, the system, combined with Hexvix®, is expected to improve outcomes for patients nationwide. To expand market opportunities and strengthen strategic control, the company plans to introduce its single-use blue-light flexible cystoscope to China and accelerate regulatory approval. The aim is to allow patients to fully benefit from blue-light cystoscopy by avoiding unnecessary surgical trauma, preserving bladder function, enhancing quality of life, and reducing total five-year treatment costs through earlier diagnosis. The company is refining its launch strategy for Hexvix®, initially targeting patients with strong willingness to pay out-of-pocket or coverage through commercial insurance, focusing on urology centers in top-tier and oncology hospitals in major cities. Over time, as clinical guidelines are updated and urology expert endorsements are established, coupled with the launch of single-use blue-light cystoscopes, the company plans to gradually expand penetration into urology centers across key hospitals nationwide, achieving broad access to blue-light cystoscopy. Focusing on Core Areas to Accelerate Key Programs Guided by its strategic priorities, several of Asieris' pipeline candidates have made solid progress and been highlighted at international academic conferences, showcasing the company's robust R&D capabilities and clinical development expertise in its focus areas. These achievements further underscore the "first-in-class" and "best-in-class" potential of multiple pipeline products. In women's health, breast cancer, and gynecologic oncology, the results of the international, multicenter Phase III trial of APL-1702 were selected for an oral presentation at the 2025 International Photodynamic Association (IPA) World Congress. The company has also reached agreement with the U.S. FDA on the design of another Phase III trial to support potential U.S. approval of APL-1702 and is seeking overseas partners to prepare for the U.S. IND submission. APL-2302, a potential best-in-class USP1 inhibitor, has received IND approval from both the U.S. FDA and China's NMPA for Phase I/IIa trials in advanced solid tumors, with the first Phase Ia subject enrolled in March 2025. Data to date indicate favorable safety, tolerability, and pharmacokinetic profiles. Preclinical studies of APL-2501 (CLDN6/9 ADC) and research on its proprietary linker platform were selected for poster presentations at the 2025 American Association for Cancer Research (AACR) Annual Meeting. The program has progressed as planned into CMC and GLP toxicology studies, with toxicology-grade material expected by year-end and toxicology studies to follow. IND submission is targeted for mid-2026. In urologic oncology, APL-2401, a potential best-in-class FGFR2/3 inhibitor, is in the IND-enabling phase. Its research findings were selected for poster presentation at the 2025 American Association for Cancer Research (AACR) Annual Meeting, with IND approval anticipated by the end of 2025. APL-1202, in combination with tislelizumab, has completed a Phase I/II trial as neoadjuvant therapy for muscle-invasive bladder cancer, demonstrating positive efficacy signals. The Phase II analysis results have been selected for poster presentation at the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU). In other disease areas, APL-1401, a DBH inhibitor for moderate-to-severe active ulcerative colitis, has shown positive preliminary results in a Phase Ib trial, providing a strong foundation for further studies. APL-1202, for the treatment of free-living amoebae (FLA) infections, has received IND approval from China's NMPA. The company has also signed an investigational drug supply agreement under the Expanded Access IND Program with the Centers for Disease Control and Prevention (CDC) of the United States. Subject to CDC expert evaluation, the drug may be used for the treatment of FLA infections. Dr. Kevin Pan, Founder, Chairman and CEO of Asieris Pharmaceuticals, commented, "In the first half of 2025, the company reached multiple milestones, steadily fulfilling our growth expectations. A remarkable achievement is the smooth progression of the regulatory review for APL-1702, our breakthrough therapy for precancerous cervical lesions, now entering the final stages ahead of its China launch and set to benefit patients soon. At the same time, robust growth of our existing commercial products has strengthened our commercialization foundation and reinforced our confidence. Our pipeline's latest achievements and clinical progress have garnered wide recognition at leading international conferences, underscoring our strong R&D capabilities and innovative edge. With relentless focus on innovation and execution, we are confident that Asieris will continue to transform patient care, deliver solid returns to shareholders, and create lasting value for society." Disclaimer: This document is intended to disclose the company's latest developments and is not a product promotion advertisement. 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. The aforementioned content includes forward-looking statements concerning the company's future plans and development strategies. These statements do not represent binding commitments by the company to investors. Investors are cautioned to consider investment risks. 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BeOne Medicines’ anti-PD-1 antibody Tevimbra (tislelizumab) bagged a fifth lung cancer indication in the EU, with the European Commission (EC) authorising it for non–small-cell lung cancer (NSCLC) in the neoadjuvant/adjuvant setting.Specifically, Tevimbra is now indicated in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by Tevimbra monotherapy as adjuvant treatment, for adults with resectable NSCLC at high risk of recurrence.The latest clearance is backed by compelling data from the Phase III RATIONALE-315 study. The trial previously met its dual primary endpoints of event-free survival (EFS) and major pathologic response at the interim analyses.OS cherry on topResults from the trial’s preplanned final analysis — to be presented at the World Conference on Lung Cancer (WCLC) next month — showed that the Tevimbra-based regimen delivered a significant and clinically meaningful overall survival (OS) benefit versus chemotherapy plus placebo, yielding a hazard ratio (HR) of 0.65. The company noted that Tevimbra is only the second PD-1 inhibitor to achieve this critical endpoint in the perioperative NSCLC setting."Delivering a statistically significant [OS] benefit…alongside the [EC’s] approval of Tevimbra in perioperative resectable NSCLC marks a pivotal moment for patients and physicians," said Mark Lanasa, chief medical officer of solid tumours at BeOne.The final analysis further indicated that the earlier EFS benefit was sustained (HR = 0.58), with benefits observed across major subgroups regardless of PD-L1 expression, disease stage and histology.Tevimbra is already approved in the EU for first-line gastric or gastroesophageal junction adenocarcinoma, unresectable oesophageal squamous cell carcinoma (ESCC), second-line ESCC after platinum chemotherapy, first-line extensive-stage small-cell lung cancer, multiple NSCLC indications across first- and second-line settings, and most recently first-line nasopharyngeal carcinoma.