On October 12, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported that 14 studies featuring its technology will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, taking place October 17–21 in Berlin, Germany (Press release, Natera, OCT 12, 2025, View Source [SID1234656565]). The slate includes six oral presentations, reinforcing Natera’s position as a leader in molecular residual disease (MRD) testing across multiple cancer types.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Bladder Cancer Highlights

The IMvigor011 trial, sponsored by Genentech, a member of the Roche Group, has been selected for a Presidential Symposium on October 20. With positive topline results announced in August, this oral presentation will include additional data on Signatera’s ability to predict disease-free survival (DFS) and overall survival (OS) benefit from adjuvant Tecentriq (atezolizumab) in muscle-invasive bladder cancer (MIBC). IMvigor011 is the first prospective, phase III study in MIBC to be read out that uses a bespoke MRD-guided approach.

MRD analysis from the Phase 3 CheckMate 274 trial will also be shared in an oral presentation on October 17. CheckMate 274 randomized high-risk MIBC patients 1:1 to Opdivo (nivolumab) or placebo for ≤ 1 year of adjuvant treatment. The results showed that DFS for Signatera-positive patients treated with nivolumab more than doubled compared to placebo (7.4 months vs 2.8 months; HR: 0.35). In contrast, no significant improvement in DFS was observed with the use of nivolumab among Signatera-negative patients.

Additional ESMO (Free ESMO Whitepaper) Data

Additional oral presentations include results from the SunRISe-4 trial in MIBC, the INTERCEPT trial in colorectal cancer, and Natera’s early cancer detection program.

"Across multiple different Phase 3 trials, we’ve now shown how Signatera MRD can help identify patients with bladder cancer who are most likely to benefit from adjuvant immunotherapy," said Matthew Galsky, M.D., Lillian and Howard Stratton Professor of Medicine at the Icahn School of Medicine at Mount Sinai and Associate Director for Translational Research at the Tisch Cancer Center. "These key studies are building a powerful foundation for bespoke MRD to guide different forms of treatment, improve outcomes for patients with bladder cancer and change medical practice."

"We are proud to showcase the breadth of research using Signatera at this year’s ESMO (Free ESMO Whitepaper) Congress, including oral presentations across bladder, colorectal, breast, and other cancers," said Minetta Liu, M.D., chief medical officer of oncology at Natera. "The diversity of these datasets underscores the growing impact of bespoke MRD assessment in reshaping how we detect and monitor cancer, providing tools to personalize treatment recommendations in oncology–with the ultimate goal of improving outcomes for patients."

Full list of presentations featuring Natera’s technology at ESMO (Free ESMO Whitepaper) includes:

October 17, 2:50 PM CEST | 3068O (Oral Presentation)
Presenter: Matthew D. Galsky, M.D.
Adjuvant nivolumab vs placebo for high-risk muscle-invasive urothelial carcinoma: 5-year efficacy and ctDNA results from CheckMate 274

October 17, 4:40 PM CEST | LBA 112 (Mini Oral Presentation)
Presenter: Andrea Necchi, M.D.
Neoadjuvant gemcitabine intravesical system (TAR-200) + cetrelimab (CET) or CET alone in patients (pts) with muscle-invasive bladder cancer (MIBC): SunRISe-4 (SR-4) primary analysis and biomarker results

October 18, 9:00 AM CEST | 185eP
Presenter: Michael Galo
Treatment response using a tumor-informed circulating DNA test (TIctDNA) comparing with radiologic outcomes in non-small cell lung cancer (NSCLC)

October 18, 12:00 PM CEST | 1132P
Presenter: Floortje Backes, M.D.
Utility of circulating tumor DNA (ctDNA) dynamics for evaluating early treatment response in patients with recurrent/metastatic endometrial (rEC) and recurrent/platinum-resistant ovarian cancer (rPROC)

October 18, 12:00 PM CEST | 2609P
Presenter: Arnab Basu, MBBS, MPH, FACP, M.D.
Clinical Performance of a Tumor-Informed Whole Genome-Based (WGS) ctDNA Assay for Recurrence Detection and Treatment Response Monitoring in Localized and Advanced/Metastatic Renal Cell Carcinoma (RCC)

October 19, 12:00 PM CEST | 764P
Presenter: Masaaki Miyo, M.D., Ph.D.
Association of ultrasensitive whole genome sequencing (WGS)-based tumor-informed molecular residual disease (MRD) detection with lymph node metastasis (LNM) after local excision of pathological T1 colorectal cancer: Results from DENEB, a CIRCULATE-Japan GALAXY substudy

October 19, 2:45 PM CEST | 734MO (Mini Oral Presentation)
Presenter: Yoshiaki Nakamura, M.D., Ph.D.
Performance of a blood-based, early cancer detection (ECD) screening test for colorectal cancer (CRC) in cell-free (cf)DNA

October 19, 2:50 PM CEST | 732MO (Mini Oral Presentation)
Presenter: Emerick Osterlund, M.D., Ph.D.
Circulating tumor DNA (ctDNA) clearance and correlation with outcome in the INTERCEPT colorectal cancer (CRC) study

October 19, 12:00 PM CEST | 823P
Presenter: Kozo Kataoka, M.D.
A Phase II Study of mFOLFOXIRI Following Metastasectomy in Oligometastatic Colorectal Cancer: (FANTASTIC)

October 19, 3:40 PM CEST | LBA 31 (Oral Presentation)
Presenter: Yara L. Verschoor
Neoadjuvant immunotherapy induces immune activation and responses in MMR-proficient colon cancers

October 20, 12:00 PM CEST | 620TiP
Presenter: Benjamin Verret, M.D.
HEROES: De-escalation of anti-HER2 therapies in HER2-positive metastatic breast cancer with long-term persistent response and undetectable minimal residual disease in circulating tumor DNA

October 20, 12:00 PM CEST | 354P
Presenter: Adrian Lee, Ph.D.
Hormonal and immune mediators of resistance to primary endocrine therapy

October 20, 12:00 PM CEST | 336P
Presenter: Arielle J. Medford, M.D.
Circulating tumor DNA detection in stage 1 HER2 positive and triple negative breast cancer (SAFE-DE)

October 20, 4:30 PM CEST | LBA 8 (Oral Presentation)
Presenter: Thomas B. Powles, MBBS, MRCP, M.D.
IMvigor011: a Phase 3 trial of circulating tumour (ct)DNA-guided adjuvant atezolizumab vs placebo in muscle-invasive bladder cancer

Notes

Tecentriq (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

On October 12, 2025 Moderna, Inc. (NASDAQ:MRNA) reported that clinical, safety and translational data from its Phase 1/2 study evaluating mRNA-4359 in combination with pembrolizumab in checkpoint inhibitor-resistant/refractory(CPI-R/R) melanoma patients will be presented at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, October 17-21, 2025, in Berlin, Germany (Press release, Moderna Therapeutics, OCT 12, 2025, https://feeds.issuerdirect.com/news-release.html?newsid=5823943357532273&symbol=MRNA [SID1234656588]). mRNA-4359 is an investigational immune-evasion targeted cancer antigen therapy (CAT) that encodes epitopes of two common immune escape pathways, PD-L1 and IDO1, to elicit antigen-specific T cell responses that may directly kill tumor cells and deplete tumor suppressor cells.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The presentation includes data from 29 participants with CPI-R/R melanoma who have had ≥1 prior checkpoint inhibitor (CPI) therapy. Participants received the combination therapy at 400 µg (n=14) or 1,000 µg (n=15), given intramuscularly every three weeks for up to nine doses. Across all evaluable patients, the objective response rate (ORR) was 24% and disease control rate (DCR), or the combination of patients achieving tumor response and stable disease, was 60%. Among those with response-evaluable disease and PD-L1+ (TPS≥1%) tumors, the ORR was 67% (6 of 9 participants), with treatment successfully inducing peripheral antigen-specific T cell responses and novel T cell receptor clones. The median duration of response (DOR) was not reached. The improved efficacy in PD-L1+ patients supports PD-L1 as a potential predictive biomarker in this high unmet need population.

"While early, today’s mRNA-4359 melanoma data in highly CPI-refractory metastatic patients are unique in the field and incredibly promising for future development options. We are encouraged by its potential to address such a high unmet need for many patients," said Dr. Kyle Holen, Head of Development, Therapeutics and Oncology, Moderna. "Where other checkpoint inhibitors restore non-specific T cell activity, mRNA-4359 encodes two critical immune escape pathways to help generate new, target-directed T cells. This could enable broader and more durable immune responses for patients who have not had success with prior lines of therapy. We are proud to present these data and to demonstrate the role our mRNA-based therapies could play in transforming the lives of those affected by cancer."

mRNA-4359 in combination with pembrolizumab demonstrated a consistently manageable safety profile, with no new immune-related adverse events (AEs). mRNA-4359 continues to be evaluated in an ongoing phase 1/2 study (NCT05533697) as a monotherapy and in combination with pembrolizumab in patients with advanced melanoma and non-small cell lung cancer (NSCLC).

"After failing to respond to first-line immunotherapy, existing options for PD-L1+ patients are limited, underscoring a clear need for effective, tolerable therapies," said Prof. David J. Pinato, Clinical Professor of Experimental Cancer Therapeutics at Imperial College London and Consultant Medical Oncologist at Imperial College Healthcare NHS Trust and lead author and presenter of the abstract. "mRNA-4359 has the potential to rebalance the tumor microenvironment to overcome this immunotherapy resistance. These data are encouraging as we continue to investigate the potential of mRNA-4359."

The details of the presentation are as follows:

Mini Oral Presentation #1515MO: Clinical Outcomes and PD-L1 Expression Analyses from a Trial of mRNA-4359 Plus Pembrolizumab in Checkpoint Inhibitor-Resistant/Refractory (CPI-R/R) Melanoma

Time: Friday, October 17, 2025, 2:00 – 3:30 PM CET

Location: Nuremberg Auditorium – Hall 5.2

Presenter: David J. Pinato

Moderna’s Oncology Investor & Analyst Event

Moderna will host a live webcast for investors and analysts on Friday, October 17, 2025, at 6:00 PM CET (12:00 PM ET), which will be available under "Events and Presentations" in the Investors section of the Moderna website at investors.modernatx.com. A replay of the webcast will be archived on Moderna’s website for at least 30 days following the presentation.

About mRNA-4359

mRNA-4359 is an immune-evasion targeted cancer antigen therapy that encodes broad epitopes of PD-L1 and IDO1. With its dual mechanism of action, it elicits antigen-specific T-cell responses to simultaneously: (1) kill tumor cells expressing PD-L1 and IDO1, and (2) deplete immunosuppressive cells that shield the tumor from attack. This is hypothesized to rebalance the tumor microenvironment into an immune-permissive state, supporting sustained and durable anti-tumor activity with a manageable safety profile.

On October 12, 2025 Arcus Biosciences, Inc. (NYSE: RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for patients with cancer, reported the first OS results from Arm A1 of the Phase 2 EDGE-Gastric study in patients with locally advanced unresectable or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma (Press release, Arcus Biosciences, OCT 12, 2025, View Source [SID1234656566]). The ongoing, multi-arm, global Phase 2 EDGE-Gastric study is evaluating the safety and efficacy of various combinations of the Fc-silent anti-TIGIT antibody domvanalimab plus the anti-PD-1 monoclonal antibody zimberelimab and chemotherapy in this patient population. This study was conducted in partnership with Gilead Sciences. These results will be presented in a mini oral session at the ESMO (Free ESMO Whitepaper) 2025 Congress (Presentation Number 2112MO).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"It is impressive to see that 50 percent of the patients enrolled in Arm A1 of the EDGE-Gastric study went on to live for more than two years," said Dr. Sun Young Rha, professor of Medical Oncology in the Department of Internal Medicine and the director of Songdang Institute for Cancer Research, Yonsei University College of Medicine, Yonsei University Health System in Seoul, Korea. "A 26.7-month median overall survival is well beyond what would be required to demonstrate clinically meaningful benefit over standard of care."

"These survival results add to the totality of data for domvanalimab and the role of anti-TIGIT-based combinations for the treatment of different cancers and reinforce our conviction that an Fc-silent anti-TIGIT antibody may provide differentiated efficacy and safety," said Richard Markus, M.D., Ph.D., chief medical officer of Arcus. "These promising results reinforce our confidence in the ongoing Phase 3 STAR-221 study."

In addition to describing OS data, this presentation also includes updated progression-free survival (PFS) and objective response rate (ORR) data, which are consistent with prior reports on this study. At data cutoff (DCO, March 3, 2025), safety and efficacy were evaluated in all patients enrolled and treated (n=41), and median study follow-up was 26.4 months. Efficacy was observed across all PD-L1 subgroups. With a median time on treatment of 49 weeks (range: <1-117 weeks), the domvanalimab plus zimberelimab and chemotherapy regimen demonstrated sustained efficacy with longer follow-up.

Summary of EDGE-Gastric Arm A1 Efficacy Results:

Overall*

(N = 41)

PD-L1 Positive (TAP ≥1%)

(n = 29)

PD-L1 High

(TAP ≥5%)

(n = 16)

Median OS, months (90% CI)

26.7 (18.4, NE)

26.7 (19.5, NE)

NE (17.4, NE)

24 months OS rate, % (90% CI)

50.2 (36.3, 62.6)

53.8 (37.3, 67.7)

56.3 (33.9, 73.6)

Median PFS, months (90% CI)

12.9 (9.8, 14.6)

13.2 (11.3, 15.2)

14.5 (11.3, NE)

24 months PFS rate, % (90% CI)

25.9 (14.8, 38.5)

24.9 (12.1, 39.9)

31.3 (14.0, 50.2)

Confirmed ORR, % (n) per RECIST v1.1
(90% CI)

59% (24)
(45%, 72%)

62% (18)
(45%, 77%)

69% (11)
(45%, 87%)

One patient did not have tissue available for central laboratory TAP scoring (SP263 assay). Local lab results showed the patient was PD-L1 low according to 22C3 assay.

*All pts who enrolled and received study treatment.
CI: confidence interval
NE: not estimable
TAP: tumor area positivity

No unexpected safety signals were observed at the time of data cutoff. The regimen of domvanalimab plus zimberelimab and chemotherapy was generally well tolerated and had a safety profile that is consistent with that of anti-PD-1 plus chemotherapy. Immune-mediated treatment-emergent adverse events related to domvanalimab and/or zimberelimab occurred in 9 patients (22%), and infusion-related reactions occurred in 3 patients (7%).

Domvanalimab and zimberelimab are investigational molecules, and neither Gilead nor Arcus has received approval from any regulatory authority for any use globally, and their safety and efficacy have not been established.

About the EDGE-Gastric Study

The ongoing, multi-arm, multi-cohort global Phase 2 EDGE-Gastric trial (NCT05329766) is evaluating the safety and efficacy of various combinations of the Fc-silent anti-TIGIT antibody domvanalimab and the anti-PD-1 antibody zimberelimab in patients with locally advanced unresectable or metastatic gastric (G), gastroesophageal junction (GEJ) or esophageal (E) adenocarcinoma. Patients in Arm A1, with previously untreated G/GEJ/E adenocarcinoma, received 1600mg of domvanalimab intravenously (IV) every four weeks (Q4W) plus 480mg of zimberelimab IV Q4W + FOLFOX (oxaliplatin 85 mg/m2 IV, leucovorin 400mg/m2 IV, fluorouracil 400mg/m2 IV bolus + 2400mg/m2 continuous 46-48-hour IV infusion) every two weeks.

About the STAR-221 Study

The ongoing, global STAR-221 trial (NCT05568095) enrolled approximately 1,050 participants with locally advanced unresectable or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma. The primary endpoints of the study are overall survival in PD-L1-high tumors, PD-L1-positive tumors and in the intent-to-treat population (all PD-L1 levels); secondary endpoints include progression-free survival, objective response rate and duration of response. Participants were randomized 1:1 between two arms:

1600mg of domvanalimab intravenously (IV) every four weeks plus 480mg of zimberelimab IV every four weeks plus FOLFOX (oxaliplatin, leucovorin, fluorouracil) every two weeks or 1200mg of domvanalimab plus 360mg of zimberelimab every three weeks plus CAPOX (capecitabine and oxaliplatin) every three weeks
240mg of nivolumab IV every two weeks plus FOLFOX every two weeks or 360mg of nivolumab plus CAPOX every three weeks
About Domvanalimab

Domvanalimab is the first and most clinically advanced Fc-silent investigational monoclonal antibody that is specifically designed with Fc-silent properties to block and bind to the T-cell immunoreceptor with Ig and ITIM domains (TIGIT), a checkpoint receptor on immune cells that acts as a brake on the anticancer immune response. By binding to TIGIT with Fc-silent properties, domvanalimab is believed to work by freeing up immune-activating pathways and activate immune cells to attack and kill cancer cells without depleting the peripheral regulatory T cells important in avoiding immune-related toxicity.

Combined inhibition of both TIGIT and programmed cell death protein-1 (PD-1) is believed to significantly enhance immune cell activation, as these checkpoint receptors play distinct, complementary roles in anti-tumor activity. Domvanalimab is being evaluated in combination with anti-PD-1 monoclonal antibodies, including zimberelimab in multiple ongoing and planned early and late-stage clinical studies in various tumor types.

About Zimberelimab

Zimberelimab is an anti-programmed cell death protein-1 (PD-1) monoclonal antibody that binds PD-1, with the goal of restoring the antitumor activity of T cells. Zimberelimab has demonstrated high affinity, selectivity and potency in various tumor types.

Zimberelimab is being evaluated in the U.S. and globally as a foundational anti-PD-1 treatment option in multiple ongoing clinical studies in combination with other immunotherapies. Guangzhou Gloria Biosciences Co. Ltd., which holds commercialization rights for zimberelimab in greater China, has obtained approval for zimberelimab for the treatment of recurrent or metastatic cervical cancer and for relapsed or refractory classical Hodgkin’s lymphoma. Zimberelimab is not approved for any use in the U.S. or other regions outside of China. Gloria conducts its development and commercialization activities independent of Arcus and Gilead.

On October 12, 2025 Incyte (Nasdaq:INCY) reported that results from Phase 1 proof-of-concept studies of INCA33890, a promising TGFβR2×PD-1-directed bispecific antibody, and INCB161734, a novel, selective and orally bioavailable KRAS G12D inhibitor, will be highlighted as oral presentations at the upcoming European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025 in Berlin (Press release, Incyte, OCT 12, 2025, View Source [SID1234656567]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are encouraged by the positive findings being presented with our TGFβR2×PD-1 and KRAS G12D inhibitor programs, which validate our rationale for advancing the development of these novel investigational compounds," said Pablo J. Cagnoni, M.D., President and Head of Research and Development, Incyte. "There remains a significant need for new treatment options for patients with advanced solid tumors like colorectal cancer and pancreatic ductal adenocarcinoma and we look forward to providing updates on these clinical development programs."

Details on INCA33890 and INCB161734 oral presentations at ESMO (Free ESMO Whitepaper) include:

INCA33890 (PD-1/TGFβR2)​

A Phase 1 Study Of INCA33890, A PD-1/TGFβR2 Bispecific Antibody, For Advanced Solid Tumours​
(Session Title: Mini oral session: Investigational immunotherapy. [October 17, 8:00 – 9:30 a.m. ET [2:00 – 3:30 p.m. CEST]. Abstract #1522.)

INCB161734 (KRAS G12D)​

Preliminary Phase 1 Results Of INCB161734, A Novel Oral KRAS G12D Inhibitor, In Patients With Advanced Or Metastatic Solid Tumors​
(Session Title: Proffered paper session: Developmental therapeutics. [October 19, 8:45 – 10:20 a.m. ET [2:45 – 4:20 p.m. CEST]. Abstract #916O.)

Analyst Event and Webcast
The data from the ESMO (Free ESMO Whitepaper) oral presentations and additional results from the INCA33890 in patients with microsatellite stable (MSS) colorectal cancer and INCB161734 in pancreatic ductal adenocarcinoma (PDAC) will also be discussed at an in-person analyst and investor event on Sunday, October 19, 2025, from 1:30 – 3:00 p.m. ET (7:30 – 9:00 p.m. CEST) at ESMO (Free ESMO Whitepaper).

The event will be webcasted and can be accessed via the Events and Presentations tab of the Investor section of Incyte.com and it will be available for replay for 30 days.

More information regarding the 2025 ESMO (Free ESMO Whitepaper) Congress can be found at: View Source

On October 11, 2025 C-Ray Therapeutics (Chengdu) Co.,Ltd reported congratulations to its strategic partner, Biokin Pharmaceutical, on receiving implied approval from the National Medical Products Administration (NMPA) for the clinical trial application of [177Lu]-BL-ARC001 Injection, the company’s first radiopharmaceutical and a Class 1 innovative biologic (Press release, C-Ray Therapeutics, OCT 11, 2025, View Source [SID1234656563]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This milestone approval marks Biokin’s entry into the fast-growing Radiopharmaceutical Drug Conjugate (RDC) field and reinforces its leadership in large-molecule oncology therapies (ADC/GNC/ARC). The company’s flagship asset BL-B01D1 (a first-in-class EGFR×HER3 bispecific ADC) set a record-breaking global licensing deal of USD 8.4 billion, underscoring Biokin’s innovation strength and global vision.

As the core CRDMO partner for the [177Lu]-BL-ARC001 program, C-Ray Therapeutics (Chengdu) Co.,Ltd provided end-to-end services including radiolabeling process development, quality studies, and registration batch manufacturing. Leveraging China’s first fully automated GMP-grade radiopharmaceutical production line, C-Ray completed process development and quality studies in just five months, followed by registration batch production in only seven months. This digitalized, automated model not only eliminates traditional manual risks but also ensures efficiency, consistency, and product quality.

C-Ray also made significant breakthroughs in cold-chain logistics, addressing long-distance, multi-center transport challenges for radiopharmaceuticals.

"C-Ray Therapeutics (Chengdu) Co.,Ltd has been an indispensable partner in the [177Lu]-BL-ARC001 program," said a Biokin executive. "Their expertise, execution speed, and customer-first mindset have accelerated our timeline while ensuring top-quality results. C-Ray’s automated GMP production line and innovative logistics solutions overcame critical challenges in this field, and we look forward to continuing our partnership in advancing this important therapy."

Moving forward, C-Ray Therapeutics (Chengdu) Co.,Ltd will continue supporting Biokin with clinical supply and distribution through its automated production line and China’s first international-standard radiopharmaceutical cold-chain system, ensuring smooth multi-center clinical research.

Biokin joins other leading Chinese pharma companies, including Kelun, Hengrui, Yunnan Baiyao, and Fosun, in expanding from ADCs and bispecifics into RDCs, pushing China’s radiopharmaceutical industry toward a new era of integrated diagnosis and therapy.

As a key integrator in this wave, C-Ray Therapeutics (Chengdu) Co.,Ltd has delivered over 50 CRDMO projects (35 CRO and 15 CDMO programs) covering the full lifecycle of radiopharmaceuticals—from early research and IND filing to clinical and commercial supply. With a strong isotope supply chain, including 14 projects involving Ac-225, C-Ray is committed to enabling partners to lead the global RDC race and bringing precision medicine to more patients.