On February 27, 2026 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative, non-surgical therapies for urothelial and specialty cancers, reported new post-hoc analyses from the Phase 3 ENVISION trial showing that ZUSDURI (mitomycin) for intravesical solution (formerly known as UGN-102) achieved durable complete response (CR) rates across European Organization for Research and Treatment of Cancer (EORTC) recurrence score groups in patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). A poster including the ENVISION trial EORTC recurrence score analysis will be presented at ASCO (Free ASCO Whitepaper)-GU 2026, which is being held February 26-28, 2026, in San Francisco, CA, and virtually.

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CR rates at three months were 83.9%, 81.2%, and 60.0% in patients with low (1-4), intermediate (5-9), and high (10-17) EORTC recurrence scores, respectively, with the majority of responders across all groups remaining recurrence-free at 24 months.

"These results are particularly meaningful because they demonstrate that ZUSDURI can achieve robust complete response rates, even in patients with a higher baseline risk of recurrence," said Sandip M. Prasad, MD, M.Phil., Director of Genitourinary Surgical Oncology and Vice Chair of Urology at Morristown Medical Center/Atlantic Health System, NJ, and Principal Investigator of the ENVISION trial. "Importantly, the durability of response observed with ZUSDURI across EORTC risk categories highlights a meaningful advance for patients with recurrent LG-IR-NMIBC, a population with limited treatment options."

The Phase 3 ENVISION (NCT05243550) trial evaluated ZUSDURI, a reverse thermal hydrogel administered intravesically containing 75 mg mitomycin, in patients with recurrent LG-IR-NMIBC. In the overall study population, ZUSDURI achieved a CR rate of 79.6% at three months (95% CI: 73.9–84.5), with a Kaplan-Meier probability of remaining event-free at 24 months of 72.2% (95% CI: 64.1–78.8).

In the post-hoc analysis of 240 treated patients stratified by EORTC recurrence score, high CR rates were observed across all risk groups at three months. CR rates were 83.9% (95% CI: 66.3–94.5) in patients with EORTC scores of 1–4, 81.2% (95% CI: 74.9–86.4) in patients with EORTC scores of 5–9, and 60.0% (95% CI: 32.2–83.7) in patients with EORTC scores of 10–17. Among patients achieving a CR, the majority remained recurrence-free at 24 months across all groups, with a Kaplan-Meier probability of remaining event-free of 67.4% (95% CI: 43.2–83.1), 73.7% (95% CI: 64.6–80.8), and 66.7% (95% CI: 28.2–87.8) for the EORTC score groups of 1–4, 5–9, and 10–17, respectively. Across the subgroups, Kaplan-Meier estimate of median duration of response was not reached, reflecting low recurrence event rates during follow-up.

"The consistency of response we’re seeing across EORTC recurrence score groups reinforces the therapeutic benefit of ZUSDURI," said Mark Schoenberg, MD, Chief Medical Officer, UroGen. "These findings build on the strong primary results from ENVISION and further support ZUSDURI as a non-surgical treatment option designed to address the chronic and recurrent nature of this disease."

Despite the post-hoc design and small sample sizes in some subgroups, the results suggest that ZUSDURI may provide durable and clinically meaningful benefit, regardless of baseline recurrence risk. Patients in ENVISION will continue to be followed for recurrence and progression for up to five years. The EORTC is an international academic research organization that conducts large multicenter clinical trials and develops widely validated prognostic and risk-stratification tools. Its bladder cancer recurrence score tables are commonly used to estimate recurrence risk based on established clinical and pathological factors.

About ZUSDURI

ZUSDURI (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin approved for the treatment of adults with recurrent LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel technology (a sustained release, hydrogel-based formulation), ZUSDURI is delivered directly into the bladder by a trained healthcare professional using a urinary catheter in an outpatient setting, thereby enabling the treatment of tumors by non-surgical means.

About Non-Muscle Invasive Bladder Cancer (NMIBC)
LG-IR-NMIBC affects around 82,000 people in the U.S. every year and of those, an estimated 59,000 are recurrent. Bladder cancer primarily affects older populations with increased risk of comorbidities, with the median age of diagnosis being 73 years. Guideline recommendations for the management of NMIBC include transurethral resection of bladder tumor (TURBT) as the standard of care. Up to 70 percent of NMIBC patients experience at least one recurrence, and LG-IR-NMIBC patients are even more likely to recur and face repeated TURBT procedures. Learn more about non-muscle invasive bladder cancer at www.BladderCancerAnswers.com.

(Press release, UroGen Pharma, FEB 27, 2026, View Source [SID1234663132])

On February 27, 2026, the U.S. Food and Drug Administration ("FDA") reported a Complete Response Letter ("CRL") for the supplemental Biologics License Application ("sBLA") for Zynyz (retifanlimab-dlwr) injection (375mg) for an additional indication for the treatment of adult patients with metastatic non-small cell lung cancer ("NSCLC") in combination with platinum-based chemotherapy. The sBLA was supported by positive efficacy and safety data from the Phase 3 POD1UM-304 trial announced in December 2024.

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The CRL cited inspection findings (not specific to Zynyz) at Catalent Indiana, LLC ("Catalent Indiana"), part of Novo Nordisk, the third-party fill-finish facility referenced in the sBLA. The CRL cited the regulatory compliance of Catalent Indiana as the sole approvability issue, and did not cite other approvability concerns, including Zynyz’s efficacy and safety data in NSCLC or the third-party drug substance manufacturer.

Incyte Corporation is working closely with the FDA and Catalent Indiana to address the CRL and support a potential sBLA resubmission of Zynyz in NSCLC.

(Press release, Incyte, FEB 27, 2026, View Source [SID1234663336])

On February 27, 2026 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative positron emission tomography (PET) radiopharmaceuticals, reported results from the first head-to-head study comparing urinary bladder radioactivity between two prostate-specific membrane antigen (PSMA)-targeted PET radiopharmaceuticals. This prospective, multicenter, intra-patient comparison evaluated urinary radioactivity and lesion detection rates of POSLUMA (flotufolastat F 18) and piflufolastat F 18 in men with low prostate-specific antigen (PSA) biochemical recurrence (BCR) of prostate cancer following radical prostatectomy.

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The study met its primary endpoint, demonstrating statistically significant lower urinary bladder radioactivity with POSLUMA compared with piflufolastat F 18, as measured by mean standardized uptake value (SUVmean). Across 55 evaluable patients, median bladder SUVmean was 10.9 for POSLUMA and 29.0 for piflufolastat F 18, with a median difference of 15.1 (interquartile range, 8.5–27.0; p<0.001). Lower urinary radioactivity may help optimize image assessment in regions close to the bladder and ureters, where small recurrent prostate cancer lesions can be challenging to distinguish from urinary activity.

Secondary analyses showed higher patient-level and region-level detection rates with POSLUMA compared with piflufolastat F 18, including among patients with very low PSA levels (≤0.2 ng/mL). In this subgroup, majority-read patient-level detection rates were 52.4% with POSLUMA and 38.1% with piflufolastat F 18. Detection rates were also higher with POSLUMA in the prostate bed and extra-pelvic regions.

No significant safety concerns were observed for either radiopharmaceutical.

Biochemical recurrence refers to a rising PSA level after surgery in a patient who previously had undetectable PSA and can be an early sign that prostate cancer has returned, even before it is visible on conventional imaging. PET tracers that can help clearly show small areas of recurrent disease at very low PSA levels may support earlier and more informed clinical care decisions1.

"For men who have already undergone surgery for prostate cancer, a rising PSA can be deeply concerning, especially when conventional imaging cannot clearly show whether or where the disease has returned," said Dr. Eugene Teoh, Chief Medical Officer of Blue Earth Diagnostics. "This head-to-head study provides important clinical evidence from a rigorous intra-patient comparison, demonstrating that POSLUMA exhibits significantly lower urinary radioactivity while maintaining meaningful detection capability in men with early biochemical recurrence. Urinary activity can impact image interpretation, which is of particular consideration at very low PSA levels, where precise localization is critical. These results reinforce the role of POSLUMA as a PSMA-PET imaging agent intelligently designed to support confident image assessment in anatomically challenging regions and reflect our continued commitment to advancing molecular imaging through high-quality clinical evidence."

"This rigorous head-to-head study provides high quality evidence that POSLUMA has significantly lower urinary bladder radioactivity compared to piflufolastat F 18, confirming prior studies," said Phillip Kuo, Kuo Radiology LLC. "POSLUMA also exhibited higher detection rates for recurrence compared to piflufolastat F 18, which highlights its potential to improve patient management."

Results from Blue Earth Diagnostics’ head-to-head study have been published in the European Journal of Nuclear Medicine and Molecular Imaging and were just presented at the 2026 ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU), on February 26, 2026, in San Francisco, California.

About the Head-to-Head Comparator Study
A prospective, multicenter, intra-patient head-to-head comparator study evaluating the urinary bladder radioactivity and lesion detection rates of POSLUMA (flotufolastat F 18) and piflufolastat F 18 in men with low prostate-specific antigen (PSA) biochemical recurrence (BCR) of prostate cancer following radical prostatectomy. A total of 55 patients were evaluated with BCR and PSA levels ≤0.5 ng/mL. The study’s primary endpoint was a calculated difference in bladder SUVmean as determined by quantification software. Secondary endpoints were detection rate analyses including patient level and subgroups, PSA level, prostate bed and related subregions, and pelvic lymph nodes.

(Press release, Blue Earth Diagnostics, FEB 27, 2026, View Source [SID1234663134])

On February 27, 2026 Daiichi Sankyo (TSE: 4568) reported that it has submitted a supplemental New Drug Application (sNDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) for ENHERTU (trastuzumab deruxtecan) as an adjuvant therapy for patients with HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization (ISH)+) breast cancer with residual invasive disease after neoadjuvant therapy.

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ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being developed and commercialized by Daiichi Sankyo in Japan.

The sNDA is based on data from the DESTINY‑Breast05 phase 3 trial presented at the 2025 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) (#ESMO25) Congress and subsequently published in The New England Journal of Medicine. In the trial, ENHERTU demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival (IDFS) compared to trastuzumab emtansine (T-DM1) in patients with HER2 positive breast cancer with residual invasive disease following neoadjuvant therapy.

Press Release
ENHERTU Supplemental New Drug Application Submitted in Japan as Adjuvant Therapy for Patients with HER2 Positive Early Breast Cancer
Published : February 27, 2026
Ref: Daiichi Sankyo
Submission based on DESTINY-Breast05 phase 3 trial results, which showed ENHERTU reduced the risk of invasive disease recurrence or death by 53% compared to T-DM1
If approved, ENHERTU has the potential to become a new standard of care in this early breast cancer setting
Tokyo – (February 27, 2026) – Daiichi Sankyo (TSE: 4568) has submitted a supplemental New Drug Application (sNDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) for ENHERTU (trastuzumab deruxtecan) as an adjuvant therapy for patients with HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization (ISH)+) breast cancer with residual invasive disease after neoadjuvant therapy.

ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being developed and commercialized by Daiichi Sankyo in Japan.

The sNDA is based on data from the DESTINY‑Breast05 phase 3 trial presented at the 2025 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) (#ESMO25) Congress and subsequently published in The New England Journal of Medicine. In the trial, ENHERTU demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival (IDFS) compared to trastuzumab emtansine (T-DM1) in patients with HER2 positive breast cancer with residual invasive disease following neoadjuvant therapy.

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"New adjuvant treatment options for breast cancer are needed to help reduce the likelihood of disease recurrence and improve long-term outcomes for more patients," said Yuki Abe, PhD, Head of R&D Division in Japan and Head of Research, Daiichi Sankyo. "This submission demonstrates our commitment to bring ENHERTU to patients in this curative-intent breast cancer setting."

ENHERTU received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) based on DESTINY-Breast05, and a regulatory submission is also under review in the European Union. Two additional submissions are under review in Japan, including ENHERTU in combination with pertuzumab for the first-line treatment of patients with HER2 positive unresectable or recurrent breast cancer based on data from DESTINY-Breast09 and ENHERTU for the treatment of patients with HER2 positive advanced or recurrent solid tumors refractory or intolerant to standard treatments based on HERALD, an investigatorinitiated trial conducted in Japan, DESTINY-PanTumor02, DESTINY-CRC02 and DESTINY-Lung01.

About DESTINY-Breast05

DESTINY-Breast05 is a global, multicenter, randomized, open-label, phase 3 trial evaluating the efficacy and safety of ENHERTU (5.4 mg/kg) versus T-DM1 in patients with HER2 positive early breast cancer with residual invasive disease in breast or axillary lymph nodes following neoadjuvant therapy and a high risk of recurrence. High risk of recurrence was defined as presentation with inoperable cancer (prior to neoadjuvant therapy) or pathologically positive axillary lymph nodes following neoadjuvant therapy.

The primary endpoint of DESTINY-Breast05 is investigator-assessed IDFS, which is defined as the time from randomization until first invasive local, axillary or distant recurrence or death from any cause. The key secondary endpoint is investigator-assessed disease-free survival. Other secondary endpoints include overall survival, distant recurrence-free interval, brain metastases-free interval and safety.

DESTINY-Breast05 enrolled 1,635 patients in Asia, Europe, North America, Oceania and South America. For more information about the trial, visit ClinicalTrials.gov.
About ENHERTU

ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, ENHERTU is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform. ENHERTU consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

ENHERTU (5.4 mg/kg) in combination with pertuzumab is approved in the U.S. as a first-line treatment for adult patients with unresectable or metastatic HER2 positive (IHC 3+ or ISH+) breast cancer, as determined by an FDA-approved test, based on the results from the DESTINY-Breast09 trial.

ENHERTU (5.4 mg/kg) is approved in more than 90 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial.

ENHERTU (5.4 mg/kg) is approved in more than 90 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.

ENHERTU (5.4 mg/kg) is approved in more than 60 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 low (IHC 1+ or IHC 2+/ ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally approved test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial.

ENHERTU (5.4 mg/kg) is approved in more than 70 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ENHERTU (6.4 mg/kg) is approved in more than 80 countries/regions worldwide for the treatment of adult patients with locally advanced or metastatic HER2 positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01, DESTINY-Gastric02 and/or DESTINY-Gastric04 trials.

ENHERTU (5.4 mg/kg) is approved in more than 10 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02 trials. Continued approval in the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

About the ENHERTU Clinical Development Program

A comprehensive global clinical development program is underway evaluating the efficacy and safety of ENHERTU as a monotherapy or in combination or sequentially with other cancer medicines across multiple HER2 targetable cancers.

About the Daiichi Sankyo and AstraZeneca Collaboration

Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize ENHERTU in March 2019 and DATROWAY in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of ENHERTU and DATROWAY.

About the ADC Portfolio of Daiichi Sankyo

The Daiichi Sankyo ADC portfolio consists of eight ADCs in clinical development crafted from ADC technology discovered in-house by Daiichi Sankyo.

The DXd ADC Technology platform of Daiichi Sankyo consists of seven ADCs in clinical development where each ADC is comprised of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADCs include ENHERTU and DATROWAY, which are being jointly developed and commercialized globally with AstraZeneca, and ifinatamab deruxtecan (I-DXd), raludotatug deruxtecan (R-DXd) and patritumab deruxtecan (HER3-DXd), which are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939 and DS3790 are being developed by Daiichi Sankyo.

An additional ADC being developed by Daiichi Sankyo is DS3610, which consists of an antibody attached to a novel payload that acts as an agonist of STING.

Ifinatamab deruxtecan, raludotatug deruxtecan, patritumab deruxtecan, DS-3939, DS3610 and DS3790 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established.
About HER2 Positive Early Breast Cancer

Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.1 More than two million breast cancer cases were diagnosed in 2022, with more than 665,000 deaths globally.1 In Japan, breast cancer is the most common cancer in women, with approximately 92,000 cases diagnosed and 17,600 deaths in 2022.2

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors including breast cancer.3 HER2 protein overexpression may occur as a result of HER2 gene amplification and is often associated with aggressive disease and poor prognosis in breast cancer.3 Approximately one in five cases of breast cancer is considered HER2 positive.4

For patients with HER2 positive early breast cancer, achieving pathologic complete response (pCR) with neoadjuvant treatment is the earliest indicator of improved long-term survival.5 However, approximately half of patients who receive neoadjuvant treatment do not experience pCR, putting them at increased risk of disease recurrence.6,7,8,9,10

Despite receiving additional treatment for residual disease in the post-neoadjuvant setting, some patients still experience invasive disease or death and current treatment options have shown limited impact on central nervous system recurrence. 11 Once patients are diagnosed with metastatic disease, the five-year survival rate drops from nearly 90% to approximately 30%.12

Post-neoadjuvant therapy represents a key opportunity to minimize the risk of recurrence and prevent progression to metastatic disease for patients with residual disease. New treatment options are needed in the early breast cancer setting to help reduce the likelihood of disease progression and improve long-term outcomes for more patients.

(Press release, Daiichi Sankyo, FEB 27, 2026, View Source [SID1234663091])

On February 27, 2026 WuXi XDC Cayman Inc. ("WuXi XDC", stock code: 2268.HK), a leading global CRDMO (Contract Research, Development, and Manufacturing Organization) specializing in antibody-drug conjugates (ADCs) and other bioconjugates, reported a strategic collaboration with Earendil Labs on WuXi XDC’s proprietary WuXiTecan-2 payload-linker technology platform. Earendil Labs is an AI-powered biotech company focused on researching and developing next-generation innovative biologics for the treatment of autoimmune diseases, cancer, and other conditions with unmet medical needs. This collaboration marks the establishment of a robust strategic partnership aimed at accelerating the development of next-generation ADCs by synergistically combining WuXi XDC’s globally leading ADC technology platform with Earendil Labs’ cutting-edge AI-driven antibody discovery and development capabilities to address significant unmet medical needs.

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Under the agreement, WuXi XDC will grant Earendil Labs an exclusive global license to its proprietary WuXiTecan-2 payload-linker technology for use against multiple specific targets. Earendil Labs will utilize this technology to conjugate antibodies and bispecific antibodies discovered through its AI platform and to advance the development of the ADC candidates against these specific targets. The total potential deal value could reach up to approximately $885 million, comprising an upfront payment, and certain development, regulatory, and sales milestone payments. Additionally, WuXi XDC will be eligible to receive tiered royalties on net sales upon commercialization of any resulting ADC products.

Leveraging its world-leading integrated CRDMO platform, WuXi XDC will also fully support the Chemical, Manufacturing, and Controls (CMC) development and manufacturing of the ADC components within the collaboration. Earendil Labs will focus on subsequent product development, global regulatory submissions, and commercialization. This complementary partnership ensures maximized resource utilization and efficient project progression.

Jimmy Li, PhD, CEO of WuXi XDC, stated, "We are very pleased to establish this strategic partnership with Earendil Labs. This collaboration not only fully demonstrates the value of our WuXiTecan-2 payload-linker technology platform but also marks another significant milestone for WuXi XDC in empowering cutting-edge innovation alongside our partners. Earendil Labs has generated bispecific antibodies with differentiated advantages using its unique AI platform. Combining these with our WuXiTecan-2 technology helps develop more effective and safer next-generation ADCs. We look forward to supporting Earendil Labs in accelerating the R&D and commercialization of their ADCs through our integrated, end-to-end CRDMO service platform, ultimately benefiting patients worldwide."

Jian Peng, PhD, CEO of Earendil Labs, said, "Partnering with WuXi XDC represents a critical step in our mission to transform biopharmaceutical R&D through AI. WuXi XDC possesses a globally recognized and validated ADC technology platform and end-to-end manufacturing capabilities. This collaboration is a powerful alliance between frontier AI exploration and WuXi XDC’s integrated CRDMO services. We eagerly anticipate working closely with WuXi XDC to drive innovative breakthroughs through technological integration, empowering high-quality development in the global biopharma industry and contributing to the health of patients globally."

Zhenping Zhu, MD, PhD, President & co-CEO of Earendil Labs, added, "ADCs are emerging as a promising class of therapeutics in the treatment of cancer and many other human diseases. At Earendil Labs, we are developing a rich pipeline of bispecific / multi-specific ADCs utilizing our cutting-edge AI and high-throughput biology plaforms. We believe WuXiTecan-2 payload-linker technology will significantly enhance the success rate and speed of our novel ADC development, ultimately bringing these potentially life-transforming treatments to patients worldwide as soon as possible."

(Press release, Earendil Labs, FEB 27, 2026, View Source [SID1234663135])