Volition Announces Abstract Demonstrating Risk Stratification in Lung Cancer Presented at the European Lung Cancer Conference

On March 26, 2026 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, reported the presentation of an abstract at the European Lung Cancer Conference (ELCC) in Copenhagen, Denmark this week. The poster highlighted the use of its Nu.Q Cancer assays in the management of lung cancer patients.

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Poster 244P : Preoperative Nucleosome Liquid Biopsy for Prognostic Stratification in Lung Cancer With Treatment Correlation1

Joint lead author Dr. Pei-Hsing Chen, Assistant Professor, Surgical Department, National Taiwan University Hospital, Taipei City, Taiwan, said:

"A key finding from this study was that measuring preoperative H3K27Me3-nucleosomes using Volition’s simple blood test allows us to identify which Non Small Cell Lung Cancer patients are most likely to benefit from closer follow-ups or secondary cancer treatment.

"While high H3K27Me3-nucleosome levels predicted poorer recurrence-free and overall survival outcomes, low H3K27me3 levels indicated significantly better outcomes.

"Volition’s Nu.Q H3K27Me3-nucleosome levels may also help identify micro-metastatic disease and support systemic treatment decision-making in high-risk patients.

"The Nu.Q Cancer technology supports a practical approach to empower clinicians to make more informed treatment decisions and provides valuable new monitoring capabilities throughout the patient journey."

Dr Andrew Retter, Medical Consultant, Volition, said:

"Nu.Q Cancer represents a significant advancement in lung cancer patient management, offering clinicians an additional tool to enhance precision in treatment selection and monitoring.

"Research conducted by our long-term collaborators in Taiwan and Lyon1-4 consistently demonstrates that our Nu.Q Cancer technology empowers clinicians to make more informed treatment decisions and provides valuable new monitoring capabilities throughout the patient journey.

"By enriching clinical prognostication, Nu.Q Cancer helps identify the most appropriate treatment pathway for an individual patient, supporting efforts to improve overall survival and deliver patient-centred care.

"We are now on the path to the first use of Nu.Q in clinical practice, an exciting prospect which is core to Volition’s mission, using our tests to help save lives"

Pei-Hsing Chen et al "Nucleosome Liquid Biopsy for Prognostic Stratification in Lung Cancer With Treatment Correlation" Poster 244P ELCC 2026
Grolleau E, et al. Circulating H3K27 Methylated Nucleosome Plasma Concentration: Synergistic Information with Circulating Tumor DNA Molecular Profiling. Biomolecules. 2023;13(8):1255. View Source
Couraud S, et al Baseline values of circulating nucleosomes in Lung Cancer: NUCLEO-LUNG study. ELCC 2024 Poster
Marie Piecyk et al, "H3K27Me3-nucleosome is a strong prognostic biomarker in Non-Small Cell Lung Cancer: interim results from the analysis of up to 832 patients at baseline" Poster 395 ELCC 2025

(Press release, VolitionRX, MAR 26, 2026, View Source [SID1234663958])

Innovent Announces 2025 Annual Results and Business Updates

On March 26, 2026 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic, and other major diseases, reported its 2025 annual results and long-term strategic blueprint.

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Dr. Michael Yu, Founder, Chairman of the Board and CEO of Innovent, stated: "2025 marks the most successful year in Innovent’s history. We achieved historic breakthroughs across three areas: business scale, financial strength, and global innovation. We successfully upgraded our strategy from an oncology-focused leader to a ‘dual-engine growth model’ driven by oncology and general biomedicine portfolio.

Encouragingly, we delivered our first full year of net profit, marking a formal entry into an era of sustainable profitability. Our robust cash reserves and positive operating cash flow will provide strong support for strategic growth. On the innovation front, three global high-potential assets advanced into or near global registrational clinical development, targeting a combined addressable market value of over US$60 billion. Meanwhile, we accelerated the global value realization of our pipeline through multiple landmark strategic collaborations, laying a solid foundation for global expansion. Total deal value reached over US$22 billion in the past year, accounting for more than 10% of China’s innovative pharmaceutical sector outbound licensing value in 2025[1].

These achievements not only validate the foresight of our strategy but also highlight our uniqueness of strong growth and high certainty within China’s biopharma industry. Guided by our Vision 2030 to become a global premier biopharmaceutical company, we will continue to drive progress across four core pillars: revenue, profitability, innovative pipeline and organizational capabilities, creating sustainable value for patients, shareholders and society."

Revenue Set New Height, Achieved Full-Year Profitability with Strong Cash Position

Total revenue reached RMB 13.0 billion, representing a year-on-year increase of 38.4%. Product revenue amounted to RMB 11.9 billion, up 44.6% year-on-year. From the commercial launch of its first product in 2019 to 18 approved products and surpassing RMB 10 billion revenue milestone, Innovent accomplished this in only 7 years, setting a new growth benchmark for China’s innovative biopharmaceutical industry.

The Company achieved its first full year of net profit. IFRS net profit reached RMB 814 million, and Non-IFRS net profit rose to RMB 1.72 billion, marking a structural inflection in profitability and entry into a sustainable earnings era.

Operating efficiency continued to improve. Gross margin improved 2.3 percentage points to 87.2%. Selling and administrative expense ratio declined 2.9 percentage points to 48.0%. EBITDA surged to RMB 1.99 billion (2024: RMB 412 million). As of December 31, 2025, cash reserves totaled RMB 24.3 billion (~US$3.5 billion). Additionally, the Company also generated positive operating cash flow, providing strong financial support for long-term development. [2]

Dual-Engine Strategy Fully Implemented, Commercial Foundation Strengthened

China Leading Oncology Brand with Synergistic Value of Innovative Portfolio

Innovent has established a leading oncology brand in China. Cornerstone products including TYVYT (sintilimab injection), BYVASDA (bevacizumab injection) and HALPRYZA (rituximab injection) have benefited millions of Chinese cancer patients.

In addition, five small-molecule targeted oncology drugs—Limertinib (EGFR TKI), DOVBLERON (Taletrectinib, ROS1i), Dupert (fulzerasib, KRAS G12Ci), JAYPIRCA (Pirtobrutinib, BTKi), and Retsevmo (selpercatinib, RETi) — were successfully included in the 2025 National Reimbursement Drug List (NRDL), further strengthening the competitiveness and commercial performance of Innovent’s oncology portfolio.

General Biomedicine Franchise Emerged as a New Growth Engine

Benefiting from forward-looking strategic layout, Innovent’s general biomedicine portfolio delivered strong momentum in 2025.

SYCUME (Teprotumumab, IGF-1R antibody), China’s first innovative therapy for thyroid eye disease in 70 years; Mazdutide, the world’s first and only approved GCG/GLP-1 dual-receptor agonist for obesity and type 2 diabetes; and SINTBILO (tafolecimab injection), the first China-domestic PCSK9 inhibitor included in the NRDL—all exhibited robust performance. PECONDLE (picankibart injection, IL-23p19 antibody), the anchor asset in autoimmune diseases, was also approved at the end of 2025.

Within a single year, the general biomedicine portfolio has become a second core engine driving high-speed growth. Today, Innovent possesses one of the highest-quality commercial portfolio and pipeline in the industry, supported by a fully established commercial network, reinforcing its solid commercial foundation.

Year of Globalization: Pipeline Value Unlocked, Growth Potential Expanded

2025 marked a breakthrough year for the Company’s globalization strategy, unlocking substantial long-term growth potential. Innovent successfully advanced three core assets into or near global Phase 3 clinical trials. According to its partner estimates, these late-stage assets target a combined total addressable market (TAM) of over US$60 billion, including:

IBI363 (PD-1/IL-2α-bias): Next-gen IO cornerstone, potential TAM over US$40 billion for first wave of indications

In collaboration with Takeda, IBI363 is being advanced globally. The first global MRCT Phase 3 in IO-resistant squamous NSCLC has been initiated. PoC in IO-resistant non-squamous NSCLC is completed, with a new global Phase 3 planned subject to the PoC results and regulatory communications. A Phase 3 trial in 3L colorectal cancer (CRC) in China is planned for 2026. A Phase 2 trial in IO-naïve mucosal/acral melanoma is underway in China. PoC studies in 1L NSCLC and 1L CRC are ongoing.
IBI343 (CLDN18.2 ADC): Cornerstone for gastrointestinal cancers, potential TAM over US$8 billion

Interim analysis from the China-Japan Phase 3 clinical trial in 3L gastric cancer is expected in 2026. Phase 3 in 3L pancreatic cancer in China was initiated in 2025. PoC studies in 1L gastric and 1L pancreatic cancer are ongoing.
IBI324 (VEGF/ANG2): Potential best-in-class retinaltherapy, potential TAM US$15 billion

Our partner Ollin Biosciences reported positive top-line results from the Phase 1b JADE head-to-head study against faricimab in wAMD and DME patients in the US. Innovent is working closely with Ollin to engage global regulators in 2026 and advance IBI324 into global Phase 3 trials.
Diversified Partnerships to Accelerate Global Innovation

Total deal value from Innovent’s global collaborations reached over US$22 billion in 2025, representing over 10% of China’s innovative pharma outbound licensing value. These partnerships not only accelerate global pipeline development but also help build core capabilities for Innovent to become a truly world-class biopharma.

With Takeda: Landmark "IO + ADC" collaboration under a co-development and co-commercialization ("Co-Co") model for IBI363 to build its global R&D and commercialization capabilities.
With Eli Lilly: Seventh partnership with an end-to-end innovation model to jointly develop novel oncology and immunology molecules, enhancing full lifecycle R&D frameworks and decision-making from a multinational perspective.
With Roche: Leveraging global oncology resources to advance IBI3009 (DLL3 ADC) worldwide.
With Ollin: Utilizing global ophthalmology expertise to accelerate IBI324’s clinical development and market positioning.
High-Quality Manufacturing Standards

Total operational capacity of 140,000 liters, accounting for 20% of China’s total biologic manufacturing capacity. Site 1 houses 60,000 liters of antibody capacity and ADC commercial lines; Site 2 has 80,000 liters of antibody capacity, supporting global supply and CDMO services.
Sustainable Development and ESG Commitment

8,000 employees worldwide, with global R&D centers in San Francisco Bay Area, Shanghai and Suzhou.
Over 3,000 new cancer patients initiate Innovent therapies daily; more than 6 million patients have benefited to date.
Maintained MSCI ESG AAA rating, leading China’s biopharmaceutical industry.
First innovative biopharma constituent of the Hang Seng Index ("blue-chip" status).
Launched community health initiatives including the MV ‘Weight Management Made Easy’ and documentary ‘Down in Weight, Up in Life’ to promote science-based healthy weight management.
Published patient education materials on thyroid eye disease and weight management to enhance public health awareness.
Implemented multiple patient assistance programs, benefiting over 200,000 patients with drug donations valued at over RMB 3.6 billion.
Received honors including "Healthcare Public Welfare Pioneer" and "China Public Welfare Enterprise".
Created over 2,200 jobs for new graduates.
Cumulative taxes and contributions exceeding RMB 6 billion.
Vision 2030: From China Leader to Global Premier Biopharma

Entering 2026, Innovent celebrates its 15th anniversary. Building on its strong foundation, the Company reaffirms Vision 2030: to evolve into a global premier biopharmaceutical company.

Revenue: Target RMB 20 billion by 2027 with continued expansion thereafter. International revenue will become a new growth driver in the future.
Profitability: Maintain high-quality growth while steadily improving profit margins benchmarking industry-leading levels.
Pipeline: Focus on advancing high-value assets including IBI363, IBI343 and IBI324. Push next-generation oncology and general biomedicine molecules into global early-stage and PoC studies. Target at least 5 molecules in global MRCT Phase 3 by 2030.
Organization: Established a US R&D and operating team of nearly 100 people. Through deep partnerships with Takeda, Lilly, Ollin, Roche and others, Innovent is rapidly building global R&D, regulatory and commercial capabilities. These growing global competencies will further support independent development, enabling Innovent to leap forward into a fully independent, world-class biopharmaceutical enterprise.

(Press release, Innovent Biologics, MAR 26, 2026, View Source [SID1234663957])

Caris Life Sciences Advances Precision Oncology with New AI Insights Predicting Brain Metastases Risk in Breast and Lung Cancer

On March 26, 2026 Caris Life Sciences (NASDAQ: CAI), a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer, reported the addition of two new Caris AI Insights signatures included in the Caris Molecular Tumor Board Report. These signatures assess the risk of patients developing brain metastases in breast and lung cancer. The addition of these two signatures brings the total number of proprietary Caris AI insights to seven, providing deeper insights to physicians and patients. This report, available upon request when ordering MI Cancer Seek at no additional cost, provides clinicians with additional insights across all tumor types with specific algorithms for treatment decisions for colon, breast, ovarian, pancreatic and lung cancer.

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Caris Life Sciences is accelerating the future of precision oncology by utilizing the world’s most complete multimodal real‑world dataset through its proprietary CodeAI platform, now exceeding over half a million patients tested with Whole Exome Sequencing (WES) and Whole Transcriptome Sequencing (WTS), H&E and IHC images with longitudinal follow-up clinical data. The novel Caris signatures for breast cancer and non-small cell lung cancer (NSCLC) predict a patient’s risk of brain metastases. Brain metastases are a common and serious complication for a subset of breast and lung cancer patients, so identifying the risk for this type of complication early is a meaningful step to support more informed clinical decision‑making.

"Insights from these proprietary Caris AI signatures give us a forward-looking view of which patients may be at elevated risk for brain metastases, allowing us to help guide clinicians to shift from passive surveillance to more proactive monitoring," said Caris President David Spetzler, MS, PhD, MBA. "Advanced clinical AI tools like Caris AI Insights are helping future-proof cancer care by integrating molecular intelligence into everyday decision making, so that we can personalize care earlier and with greater precision."

The brain metastases signatures were trained on a large set of 12,994 NSCLC cases and 3,371 breast cancer cases with matched survival outcomes. The signatures generate a personalized predictive score using each patient’s WES and WTS data. Results are visualized as Kaplan‑Meier curves, providing clinicians with an intuitive view of the likelihood and rate of brain metastasis development based on the patient’s molecular profile.

Caris received FDA approval in November 2024 for MI Cancer Seek. This tissue-based assay is the first and only simultaneous WES and WTS-based assay with FDA-approved companion diagnostic (CDx) indications for molecular profiling of solid tumors.

A study is in progress with collaborators of the Caris Precision Oncology Alliance (POA) to highlight how risk prediction for brain metastases in breast and lung cancer patients is achieved using Caris AI Insights. The Caris POA is a global network of leading cancer centers and research groups that collaborate to advance precision oncology and biomarker-driven research.

(Press release, Caris Life Sciences, MAR 26, 2026, View Source [SID1234663956])

C-Ray Therapeutics and SHINE Technologies Enter Strategic Partnership for Exclusive Distribution of No-Carrier-Added Lu-177 in Mainland China

On March 26, 2026 C-Ray Therapeutics (Chengdu, China), a global radiopharmaceutical CRDMO, reported the execution of a Master Radioisotope Supply Agreement with SHINE Technologies, LLC (Janesville, Wisconsin, USA), establishing a long-term, GMP-compliant supply of no-carrier-added lutetium-177 (n.c.a. Lu-177) and granting C-Ray exclusive distribution rights for this critical medical isotope across mainland China — excluding certain pre-existing SHINE partnerships.

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Under the agreement, C-Ray will serve as SHINE’s exclusive distribution partner in mainland China, supplying n.c.a. Lu-177 to Chinese radiopharmaceutical developers, biotechnology companies, and healthcare institutions. C-Ray will leverage its integrated, 28,000-square-meter Chengdu facility to provide downstream services including isotope conjugation, fill-and-finish, and quality control — delivering an end-to-end, ready-to-use isotope solution that substantially lowers the barrier for domestic companies to access internationally benchmarked radioisotope supply.

A Critical Isotope, a Strategic Supply

Lu-177 is among the most widely used therapeutic radioisotopes in targeted radiopharmaceutical therapy (TRT) globally, with approved and investigational applications across prostate cancer, neuroendocrine tumors (NETs), and a growing range of oncology indications. Its favorable physical half-life, beta emission energy, and co-imaging capability have made it the cornerstone isotope of the RDC field.

Supply security has long been a practical constraint on pipeline development in China. This partnership addresses that gap directly: SHINE’s Cassiopeia facility — one of North America’s largest n.c.a. Lu-177 production sites — will supply C-Ray under terms meeting both Chinese and U.S. regulatory standards, while C-Ray’s on-the-ground infrastructure ensures reliable last-mile delivery to clients across mainland China.

Leadership Perspectives

"This partnership is a significant step in C-Ray’s strategic supply diversification. Stable, multi-source isotope access is a core competitive advantage for us and our clients. Building on our leadership in Ac-225 supply, securing a reliable, high-quality source of n.c.a. Lu-177 — along with exclusive distribution rights — directly strengthens our clients’ pipeline continuity and reinforces our commitment to building a resilient radiopharmaceutical ecosystem in China. With our integrated platform and deep project management experience, we are confident in our ability to translate premium isotope supply into real patient outcomes and accelerated clinical translation across the industry."
— Haitao Qiao, General Manager, C-Ray Therapeutics

"We are pleased to partner with C-Ray. This partnership reflects SHINE’s ability to serve growing demand for n.c.a. Lu-177 in China while maintaining strong supply for customers in the U.S. and other global markets. By combining C-Ray’s integrated development and manufacturing platform with our large-scale isotope production, we can help advance pipeline innovation and expand patient access to life-saving targeted radioligand therapies."
— Greg Piefer, Founder and CEO, SHINE Technologies

(Press release, C-Ray Therapeutics, MAR 26, 2026, View Source [SID1234663955])

CStone Updated Clinical Progress and Key Phase I/II Data for CS2009 (PD-1/VEGF/CTLA-4 Trispecific Antibody)

On March 26, 2026 CStone Pharmaceuticals (HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of therapeutics for oncology, immunology, inflammation, and other key disease areas, reported encouraging clinical progress for CS2009, a novel PD-1/VEGF/CTLA-4 trispecific antibody.

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Dr. Jason Yang, CEO, President of R&D, and Executive Director at CStone, stated, "Based on the latest clinical data for CS2009, we are confident in its potential to transform treatment paradigms across a broad spectrum of tumor types. Driven by its unique molecular design, CS2009 offers key mechanistic differentiation. To date, approximately 200 patients have been enrolled, demonstrating an outstanding safety profile with no observation of the severe toxicities commonly associated with combination regimens containing CTLA-4 and PD-(L)1 inhibitors.

In terms of efficacy, CS2009 has delivered compelling results across multiple indications: as a monotherapy in first-line NSCLC, it achieved an ORR of 90% in patients with PD-L1 TPS ≥ 50%. Significant benefits were also observed in historically difficult-to-treat ‘cold tumors’, including IO-pretreated advanced NSCLC, non-clear cell renal cell carcinoma (nccRCC), and soft tissue sarcoma (STS). Furthermore, Phase II studies evaluating CS2009 in combination with standard chemotherapy for first-line NSCLC, CRC, and other indications have yielded high objective response rates.

We look forward to presenting additional Phase I and Phase II data at this year’s ASCO (Free ASCO Whitepaper) and/or ESMO (Free ESMO Whitepaper) congresses. Currently, we are engaged in advanced partnership discussions with several global multinational pharmaceutical companies and aim to initiate multiple Phase III MRCT by the end of 2026."

Rapid Patient Enrollment with Phase I/II Data Supporting Favorable Safety and Efficacy

The global multi-center Phase I/II clinical trial for CS2009 is actively ongoing in Australia and China, and its Investigational New Drug (IND) application for Phase II has been approved by the U.S. Food and Drug Administration (FDA). As of mid-March 2026, a total of 113 patients with advanced solid tumors have been enrolled in Phase I, with a median follow-up of approximately six months. 85 patients have been enrolled in Phase II.

1. Phase I Data Reinforces an Excellent Safety Profile:

CS2009 demonstrates a favorable safety and tolerability profile across all six dose levels evaluated, with no dose-limiting toxicities (DLTs) observed and the maximum tolerated dose (MTD) not reached.
The incidence of Grade ≥3 TRAEs was 23%; Grade ≥3 immune-related adverse events (irAEs) was 12.4%; and Grade ≥3 VEGF-related TRAEs was 4.4%. No excessive toxicities that typically occurred in combination therapies containing CTLA-4 and PD-(L)1 were observed.
2. Broad Antitumor Activity Observed in Heavily-Pretreated NSCLC and "Cold Tumors":
Antitumor activity was observed across all dose levels, with robust efficacy signals in multiple tumor types.

At the 30 mg/kg, Q3W, CS2009 monotherapy achieved an ORR of 25% (6/24) and a DCR of 58.3% (14/24) in AGA-negative, later-line NSCLC patients.
Across dose levels, CS2009 monotherapy resulted in an ORR of 40% and a DCR of 100% in patients with nccRCC (n=5).
Across dose levels, CS2009 monotherapy resulted in an ORR of 33.3% and a DCR of 66.7% in patients with STS (n=9).
Phase II Data Reveal Transformative Potential of CS2009: 90% ORR with Monotherapy in First-Line NSCLC and Excellent Tolerability in Combination Regimens for First-Line NSCLC and CRC

The global multi-center Phase II clinical trial employs a multi-cohort parallel expansion design to evaluate the efficacy and safety of CS2009 monotherapy and combination therapy across 15 cohorts in 9 solid tumor types, including NSCLC, CRC, extensive-stage small cell lung cancer (ES-SCLC), cervical cancer (CC), gastric or gastroesophageal junction cancer (GC/GEJC), esophageal squamous cell carcinoma (ESCC), platinum-resistant ovarian cancer (PROC), triple-negative breast cancer (TNBC), and hepatocellular carcinoma (HCC).

1. Monotherapy Shows Striking Efficacy in First-line NSCLC:
CS2009 monotherapy (20 mg/30 mg, Q3W) achieved an ORR of 90% (9/10) and a DCR of 100% (10/10) in first-line NSCLC patients with PD-L1 TPS≥50% (n=10).

2. Combination Therapies Demonstrate Favorable Tolerability and Promising Efficacy
Safety data from multiple cohorts of CS2009 combined with standard chemotherapy showed that the combinations were well-tolerated across tumor types, with CS2009 without increasing the incidence or severity of chemotherapy-related adverse events. Initial potent antitumor activity was observed with combination treatment in first-line NSCLC and first-line CRC.

Efficient and Clearly-Defined Global Development Strategy

CStone plans to initiate the first set of Phase III global MRCTs for CS2009 by the end of 2026, focusing on indications including NSCLC, CRC, and SCLC.

Additional Phase I and Phase II clinical data for CS2009 are expected to be presented at the 2026 ASCO (Free ASCO Whitepaper) and/or ESMO (Free ESMO Whitepaper) Annual Meetings.

About CS2009 (PD-1/VEGF/CTLA-4 Trispecific Antibody)

CS2009, an innovative trispecific antibody designed and developed by CStone, with the potential to be first- or best-in-class. It combines three clinically validated targets—PD-1, VEGFA, and CTLA-4—and exerts multidimensional antitumor effects through synergistic actions. Specifically, anti-PD-1 activity reverses T cell exhaustion, anti-CTLA-4 activity promotes T cell activation and proliferation, while anti-VEGFA activity blocks tumor angiogenesis and improves the tumor micro-environment (TME). In the TME, anti-PD-1 and anti-CTLA-4 activities are significantly enhanced by crosslinking with VEGFA. Meanwhile, CS2009 preferentially blocks PD-1 and CTLA-4 on double-positive tumor-infiltrating T cells while minimizing interference with CTLA-4 regulation in peripheral T cells.

(Press release, CStone Pharmaceauticals, MAR 26, 2026, View Source [SID1234663954])