Industry insights, September 2025

COLLABORATIONS AND PARTNERSHIPS

Sutro Biopharma collaborates with the FDA to advance ADC regulatory standards [1]Sutro Biopharma. Jul 22, 2025. 

Sutro Biopharma announced a research collaboration with the US FDA to develop reference materials that enhance regulatory standards and analytical methods for ADCs. The partnership combines Sutro’s cell-free XpressCF^® technology, enabling precise ADC engineering, with the FDA’s advanced analytical capabilities. Together, they will design studies using representative antigens, payload-linkers, and conjugation sites from approved and investigational ADCs. Findings will be published and are expected to strengthen the FDA’s ability to assess ADC quality.

Adagene partners with ConjugateBio to advance novel ADC [2]Adgene. Jul 7, 2025. 

Adagene Inc. has entered a collaboration with ConjugateBio Inc. to supply a proprietary antibody for use in ConjugateBio’s bispecific ADC programs. The partnership combines Adagene’s antibody discovery expertise with ConjugateBio’s ADC development platform, aiming to deliver safer, more effective therapies. Adagene will receive upfront, milestone, and royalty payments, while retaining non-ADC rights to the partnered antibody.

Biocytogen and Merck KGaA unite on antibody-conjugated LNP delivery [3]Biocytogen. Sep 3, 2025. 

Biocytogen Pharmaceuticals has entered into an evaluation and option agreement with Merck KGaA, Darmstadt, Germany, to advance antibody-conjugated lipid-based delivery solutions for nucleic acid payloads, including antibody-lipid nanoparticles (LNPs). Biocytogen will provide fully human antibodies from its RenMice^® platform for evaluation. Merck KGaA holds an exclusive option to license selected assets in exchange for fees and royalties. The collaboration leverages Biocytogen’s antibody discovery capabilities and Merck KGaA’s expertise in LNPs to drive innovation in next-generation nucleic acid delivery.

PATENT APPROVALS

Diverse Biotech granted patent for antibody-cannabinoid conjugates [4]JUSTIA Patents. 

Diverse Biotech, a leader in cannabinoid-based drug innovation, announced the issuance of a fully granted US Patent, covering novel antibody-cannabinoid conjugate molecules. The company’s technology integrates antibodies with cannabinoids via a specialized linker, enabling targeted delivery to disease sites while locally releasing cannabinoids such as CBD or CGB. This dual mechanism combines precise antibody targeting with cannabinoid-driven effects, including controlled reactive oxygen species generation to induce cell death in cancer and modulate inflammatory environments.

REGULATORY CHANGES AND UPDATES

Singapore adds PCV20 conjugate vaccine to the National Adult Immunisation Schedule [5]Singapore Ministry of Health. Aug 29, 2025. 

From September 1, 2025, Singapore’s Ministry of Health will include PCV20, a 20-valent pneumococcal conjugate vaccine, in the National Adult Immunisation Schedule (NAIS). PVC20 expands protection to seven more pneumococcal strains than PCV13 and is recommended for adults 65+ and immunocompromised adults 18–59.

MARKET TRENDS

WuXi XDC reports strong 1H 2025 results—expands global bioconjugate leadership [6]WuXi XDC. Aug 18, 2025. 

WuXi XDC Cayman, a leading global CRDMO for bioconjugates, reports 62.2% year-on-year revenue growth to RMB 2.7 billion in 1H 2025, with gross profit up 82.2% to RMB 975 million and adjusted net profit before interest up to 69.9% to RMB 733 million. The company expanded its global customer base to 563, signed 37 new iCMC projects, and grew its backlog to $1.3 billion. Key milestones included the GMP release of the DP3 facility in Wuxi and mechanical completion of its Singapore site, on track for GMP release in 1H 2026. WuXi XDC continues advancing frontier technologies to strengthen global leadership in ADCs and bioconjugates.

Pfizer lays off 100 employees at former Seagen HQ [7]The Seattle Times. Aug 26, 2025. 

Pfizer is cutting 100 jobs at its former Seagen global headquarters in Bothell, Washington. The site supports R&D and biologics manufacturing, including bladder cancer ADC Padcev. The layoffs follow earlier closures of a 61,000sq. ft. office, and halted construction of a 270,000sq. ft. Everett plant. The job cuts are part of Pfizer’s broader $7.7 billion cost-saving plan through 2027, aimed at reducing debt after the $43 billion Seagen acquisition and offsetting declining COVID-19 product sales.

RESEARCH AND DEVELOPMENT HIGHLIGHTS

OBI Pharma initiates Phase I/II trial of TROP2-targeted ADC in advanced solid tumors [8]OBI Pharma. Apr 1, 2025. 

OBI Pharma has announced the start of a Phase I/II clinical trial of OBI-902, a novel TROP2-targeting ADC developed with its proprietary GlcoOBI^® technology. The study, led by Dr Apostolia M. Tsimberidou at MD Anderson Cancer Center, will evaluate safety, pharmacokinetics, and preliminary efficacy in patients with advanced solid tumors. Preclinical data presented at AACR 2025 showed OBI-902 achieved superior stability, favorable pharmacokinetics, and durable antitumor activity compared with other TROP2 ADCs.

Avenzo Therapeutics receives FDA IND clearance for bispecific ADC, AVZO-103 [9]Avzeno Therapeutics. Sep 2, 2025. 

Avenzo Therapeutics announced FDA clearance of its IND for AVZO-103, a potential best-in-class Nectin4/TROP2 bispecific ADC. The company also exercised its exclusive option with VelaVigo, securing global development, manufacturing, and commercialization rights. A Phase I/II trial is planned for later this year to evaluate safety, tolerability, and preliminary activity in advanced solid tumors as monotherapy and in combination.

Duality Bio ADC trial success strengthens BioNTech’s oncology pipeline [10]BioNTech. Sep 5, 2025. 

BioNTech and Duality Biologics reported that their HER2-target ADC, transtuzumab pamirtecan (BNT323/DB-1303), met the endpoint of progression-free survival in a Phase III trial for HER2-positive unresectable or metastatic breast cancer, outperforming Roche’s Kadcycla. The 288-patient study drove BioNTech shares up 11%. DualityBio plans regulatory discussions in China, with global expansion also underway. The ADC, licensed by BioNTech in 2023, is additionally being evaluated in the global DYNASTY-Breast02 trial for HER2-low breast cancer.

CLINICAL TRIALS AND RESEARCH

CytomX continues Phase I study despite patient death [11]CytomX. Aug 13, 2025. 

CytomX Therapeutics reported a patient death in its Phase I colorectal cancer trial of CX-2051, an EpCAM-targeted, conditionally activated ADC. The fatality, linked to treatment-related acute kidney injury in a patient with a solitary kidney, was reviewed by an independent safety committee, which recommended the study continue. The event was reported to the FDA on July 18, 2025. The trial, with 73 patients enrolled, remains on track for a data readout in Q1 2026. CX-2051 delivers a topoisomerase-1 inhibitor payload.

Abzena’s customer MBrace reports positive preclinical data on EphA5-targeted ADC using ThioBridge technology [12]Abzena. Aug 14, 2025. 

MBrace has published preclinical data on MBRC-101, an EphA5-targeted ADC designed with Abzena’s ThioBridge^® conjugation technology. MBRC-101 couples a humanized anti-EphA5 antibody with MMAE, achieving a stable drug-to-antibody ratio (DAR) that enhances efficacy while minimizing off-target effects. Data showed complete tumor regression in multiple xenograft models and favorable tolerability in toxicology studies. EphA5, expressed in several solid tumors, represents a novel therapeutic target. MBCR-101 is now in a Phase I/Ib first-in-hum trial for patients with advanced solid tumors.

ALX Oncology doses first patient in Phase I trial of EGRF-targeted ADC [13]ALX Oncology. Aug 19, 2025. 

AXL Oncology announced dosing of the first patient in its Phase I trial evaluating ALX2004, a novel EGFR-targeted ADC for advanced EGFR-expressing solid tumors, including NSCLC, HNSCC, and CRC. ALX2004 combines an affinity-tuned EGFR antibody with a proprietary topoisomerase I inhibitor payload and optimized linker, designed to maximize therapeutic window and reduce toxicity. Preclinical studies demonstrate dose-dependent tumor activity, favorable safety, and no EGRF-related skin toxicity or payload-related lung toxicity. The study will evaluate dose escalation, dose exploration, and expansion. Initial safety data are expected in the first half of 2026.

Huadong Medicine reports positive early data from Phase I study of ROR1 ADC HDM2005 [14]PR Newswire. Sep 5, 2025. 

Huadong Medicine announced encouraging preliminary results from its Phase I trial of HDM 2005, a receptor tyrosine kinase-like orphan receptor 1 (ROR1)-targeting ADC, in relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL) and classical Hodgkin lymphoma (cHL). Among 29 patients enrolled, HDM2005 showed a favorable safety profile with no discontinuations due to treatment-related adverse events. In the 1.8 and 2.5mg/kg cohorts, mantle cell lymphoma patients achieved a 50% objective response rate, while two cHL patients achieved complete responses. HDM2005, which received FDA Orphan Drug Designation for mantle cell lymphoma in 2025, is being studied globally in hematological malignancies and solid tumors.

CONFERENCES, EVENTS, AND PUBLICATIONS

Daiichi Sankyo showcases ADC advances in lung cancer at WCLC 2025 [15]Daiichi Sankyo. Aug 14, 2025. 

Daiichi Sankyo presented new data across its DXd ADC portfolio at the IASLC World Conference on Lung Cancer (WCLC). A late-breaking oral presentation highlighted results from the Phase II IDeate-Lung01 trial of ifinatamab deruztecan (I-DXd), showing potential as the first B7-H3-directed ADC for patients with pretreated extensive-stage small cell lung cancer (SCLC).

WuXi highlights global CRDMO capabilities at ISPE 2025 Singapore [16]WuXi XDC. Sep 3, 2025. 

WuXi XDC participated in the ISPE Singapore Conference, highlighting innovation in ADC development and manufacturing. Dr Jun Hu, VP of WuXi XDC, delivered a keynote on empowering global partners and joined panel discussions on industry challenges and future directions. As part of the event, >20 multinational and regional pharma companies toured WuXi XDC’s new Singapore site, offering end-to-end services from antibody intermediates to drug products.

IDEAYA and Hengrui present positive Phase I data for IDE849 in SCLC at WCLC 2025 [17]IDAEA Bioscience. Sep 7, 2025. 

IDEAYA Bioscience and Hengrui Pharma reported encouraging Phase I results for IDE849, a DLL3-targeting topoisomerase-1 ADC, at WCLC 2025. Among evaluable SCLC patients treated at doses ≥2.4mg/kg, IDE849 achieved a 73.2% overall response rate (ORR) and 47.9% confirmed ORR. In second-line patients, ORR reached 77.1% with 60% confirmed responses, and in those with brain metastases, confirmed ORR was 66.7%. Median progression-free survival (PFS) was 6.7 months across all patients, with not-yet-reached PFS in 2L SCLC. Safety was manageable, with Grade ≥3 treatment-related adverse events in 48% of patients and only 2% discontinuations. IDEAYA holds global rights to IDE849 outside China.

Summary

The bioconjugation field continues accelerating with notable partnerships, regulatory updates, and strong clinical progress. Adagene partnered with ConjugateBio to advance bispecific ADCs, while Biocytogen and Merck KGaA entered an agreement to develop antibody-conjugated LNPs for nucleic acid delivery. Sutro Biopharma also announced a collaboration with the FDA to establish new ADC regulatory standards.

Market activity saw WuXi XDC report 62% revenue growth, bolstered by expanding global capacity, while Pfizer implemented cost-saving layoffs at the former Seagen HQ. Regulatory news included Singapore’s addition of the PCV20 conjugate vaccine to its immunization schedule.

On the clinical front, OBI Pharma initiated trials for its TROP2 ADC, Avenzo secured FDA clearance for a bispecific ADC, and BioNTech with DualityBio reported Phase III success for a HER2 ADC. Additional highlights included IDEAYA and Hengrui’s DLL3 ADC data in SCLC, Huadong’s promising ROR1 ADC results, and Daiichi Sankyo’s B7-H3 ADC trial updates at WCLC 2025.

References

1. Sutro Biopharma. Jul 22, 2025. 

2. Adgene. Jul 7, 2025.

3. Biocytogen. Sep 3, 2025. 

4. JUSTIA Patents.

5. Singapore Ministry of Health. Aug 29, 2025.

6. WuXi XDC. Aug 18, 2025.

7. The Seattle Times. Aug 26, 2025.

8. OBI Pharma. Apr 1, 2025.

9. Avzeno Therapeutics. Sep 2, 2025.

10. BioNTech. Sep 5, 2025.

11. CytomX. Aug 13, 2025.

12. Abzena. Aug 14, 2025. 

13. ALX Oncology. Aug 19, 2025.

14. PR Newswire. Sep 5, 2025.

15. Daiichi Sankyo. Aug 14, 2025.

16. WuXi XDC. Sep 3, 2025.

17. IDAEA Bioscience. Sep 7, 2025.

Affiliation

David Simpson is a member of the Editorial Advisory Board at Bioconjugation Insights and is CEO of IKSUDA Therapeutics, Newcastle Upon Tyne, UK

Authorship & Conflict of Interest

Contributions: The named author takes responsibility for the integrity of the work as a whole, and has given his approval for this version to be published.

Acknowledgements: None.

Disclosure and potential conflicts of interest: The author has no conflicts of interest.

Funding declaration: The author received no financial support for the research, authorship and/or publication of this article.

Article & copyright information

Copyright: Published by Bioconjugation Insights under Creative Commons License Deed CC BY NC ND 4.0 which allows anyone to copy, distribute, and transmit the article provided it is properly attributed in the manner specified below. No commercial use without permission.

Attribution: Copyright © 2025 David Simpson. Published by Bioconjugation Insights under Creative Commons License Deed CC BY NC ND 4.0.

Article source: Invited.

Revised manuscript received: Sep 18, 2025.

Publication date: Oct 1, 2025.