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OverT Bio Announces the Formation of the Clinical Advisory Board to Support the Clinical Development of OVT-101 in Ovarian Cancer and Other Solid Tumors

On March 23, 2026 OverT Bio, a biotechnology company developing next-generation therapies for solid tumors, reported the formation of its Clinical Advisory Board, comprised of internationally recognized leaders in oncology and cellular immunotherapy. The members of OverT’s Clinical Advisory Board are Dr. Kristen Hege, Dr. David Miklos, Dr. Dmitriy Zamarin, and Dr. Robert Wenham.

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The Clinical Advisory Board will provide strategic guidance on OverT’s clinical development plans, including trial design, indication prioritization, and translational strategy, as the company advances its lead asset, OVT-101 towards the clinic. OVT-101 is an off-the-shelf gamma delta CAR-T therapy targeting Claudin-6 and programmed for potency and durability using novel reprogramming strategies discovered with OverT’s massively-parallel overexpression platform. Using DNA barcoding, OverT’s unique platform has analyzed thousands of genes in primary human immune cells and identified which ones make better therapies when challenged by multiple forms of tumor immunosuppression.

"We are honored to welcome this exceptional group of clinicians and scientists to our Clinical Advisory Board," said Dr. Mat Legut, co-founder and CEO of OverT Bio. "Each member brings deep expertise in immune therapies and solid tumor oncology, which will be critical for our success in the clinic."

Kristen Hege, MD is a clinician-scientist and seasoned executive who led the first-in-class BCMA CAR-T program (Abecma) in multiple myeloma from inception through FDA approval at Bristol-Myers Squibb. She was most recently Senior Vice President of Early Clinical Development in Oncology/Hematology and Cell Therapy at BMS. In addition to her corporate leadership, Dr. Hege was the Clinical Professor of Medicine at UCSF, where she cared for patients with blood cancers for nearly three decades. She continues to shape the future of innovative cancer therapies by serving on the board of directors for multiple biotechnology companies.

David Miklos, MD, PhD is the Chief of Stanford’s Bone Marrow Transplant and Cell Therapy Program that provides over 700 cancer cell therapies annually. As a leading clinical expert, he has served as a principal investigator on pivotal trials for several CAR-T cell therapies in lymphoma and multiple myeloma. His translational research focuses on human correlative assays to optimize CAR-T therapy including ctDNA MRD, tumor antigen quantification, CAR-T immune phenotyping (CAR-FACS), and their single cell RNA and DNA characterization.

Dmitriy Zamarin, MD, PhD is the Section Head of Gynecologic Medical Oncology, and co-director of Center of Excellence for Gynecologic Cancers at Icahn School of Medicine at Mount Sinai. He has served as a principal investigator and a translational chair on multiple institutional and cooperative group clinical trials and serves as the translational research co-chair on the NRG Oncology Cervical Cancer committee. His clinical and laboratory research is focused on cancer cell-intrinsic mechanisms of immune recognition and resistance and development of novel therapeutics. Prior to his leadership role at Mount Sinai, he was a physician-scientist at Memorial Sloan Kettering Cancer Center, where he led numerous early-phase clinical trials testing immune-based treatment combinations.

Robert Wenham, MD is the Chair of the Department of Gynecologic Oncology and Senior Member in the Molecular Medicine Program at H. Lee Moffitt Cancer Center and Research Institute. He has directed numerous clinical trials evaluating targeted therapies, immunotherapies, and novel chemotherapeutics for ovarian, cervical, and uterine cancers. Recognized for his commitment to surgical excellence and innovative patient care, he has played a critical role in bringing life-extending therapies from the laboratory directly to the clinic. He has received the Molly Cade Ovarian Cancer Research Award from the Gynecologic Cancer Foundation. Dr. Wenham also serves in vital leadership capacities within national oncology cooperatives, including the Gynecologic Oncology Group (GOG), where he helps shape the national research agenda for women’s cancers.

"Building a Clinical Advisory Board of this caliber is an important step as we translate our platform into the clinic," said Dr. Francesco Galimi, Chief Medical Officer of OverT Bio. "Their collective experience across cellular therapies and solid tumors will be invaluable in shaping a thoughtful and efficient clinical development strategy for our programs."

The formation of the Clinical Advisory Board marks an important milestone as OverT Bio continues to build its clinical strategy and advance its lead program toward first-in-human studies.

(Press release, OverT Bio, MAR 23, 2026, View Source [SID1234663845])

Prestige Biopharma Announces Positive Topline Results from Comparative SAMSON-II Study for HD204, a Potential Biosimilar to Avastin (bevacizumab)

On March 23, 2026 Prestige Biopharma reported positive topline results from its Phase 3 SAMSON-II study evaluating HD204, a proposed biosimilar to Avastin (bevacizumab) in adult patients with advanced non-squamous non-small cell lung cancer (NSCLC).

SAMSON-II is a randomized, double blind, parallel group, multicenter Phase 3 study conducted in 625 patients across 91 centers in 15 countries. Patients were randomized in a 1:1 ratio to receive HD204 or Avastin in combination with standard chemotherapy.

The study met its primary endpoint of overall response rate (ORR) at Week 18, demonstrating clinical equivalence between HD204 and Avastin within the prespecified equivalence margin. ORR at Week 18 was 48.7% in the HD204 arm compared with 46.5% in the Avastin arm. The risk ratio was 1.047 (95% confidence interval [CI]: 0.86–1.27), and the risk difference was 0.022 (95% CI: −0.07–0.11), with both estimates falling within the predefined equivalence range.

Secondary efficacy endpoints were supportive of the primary analysis. Comparable overall response rates were observed at Week 12, and time-to-event outcomes demonstrated similar progression-free survival (PFS) and overall survival (OS) between treatment groups, with no statistically significant differences identified.

HD204 demonstrated a safety and tolerability profile consistent with the established safety experience of bevacizumab. Treatment-related adverse events were reported in 33.9% of patients receiving HD204 and 34.4% of patients receiving Avastin, while treatment-related serious adverse events occurred in 5.2% and 8.3% of patients, respectively. No new or unexpected safety signals were identified.

The clinical outcomes observed in SAMSON-II were consistent with the high degree of analytical and clinical pharmacokinetic (PK) similarity demonstrated between HD204 and Avastin. SAMSON-II results strengthen the collective global experience showing that sensitive analytical characterization and comparative clinical PK studies can reliably predict equivalent clinical performance in biosimilar development. Prestige Biopharma is advancing regulatory pathways for HD204 based on the strong analytical and clinical PK programs, while sharing the SAMSON-II findings to further contribute to the global scientific experience in biosimilar evaluation.

"These results illustrate the increasing precision with which biosimilarity can be established through advanced analytical and clinical PK studies," said Dr. Lisa Park, Chief Executive Officer of Prestige Biopharma. "Our experience with HD204 supports the view that well-designed development programs can reliably anticipate clinical performance, enabling more focused and efficient biosimilar development. By reducing unnecessary clinical burden, such advances can accelerate patient access to high-quality biologic medicines and support more sustainable healthcare systems worldwide."

(Press release, Prestige BioPharma, MAR 23, 2026, View Source [SID1234663844])

WuXi AppTec Beat Full-Year Guidance and Achieved Record Performance in 2025

On March 23, 2026 WuXi AppTec (stock code: 603259.SH / 2359.HK), a leading global pharmaceutical CRDMO (Contract Research, Development, and Manufacturing Organization), reported financial results for the full year ended December 31, 2025 ("Reporting Period"):

Total revenue reached RMB 45.46 billion, up 15.8% YoY. Revenue from Continuing Operations reached RMB 43.42 billion, up 21.4% YoY.
Adjusted non-IFRS gross profit margin up 6.6pts YoY to 48.2%.
Adjusted non-IFRS net profit attributable to the owners of the Company up 41.3% YoY to RMB 14.96 billion; adjusted non-IFRS net profit margin up 5.9pts YoY to 32.9%; adjusted non-IFRS diluted EPS up 41.4% YoY to RMB 5.16.
Net profit attributable to the owners of the Company[1] up 102.6% YoY to RMB 19.15 billion; diluted EPS up 102.8% YoY to RMB 6.61.
With continuous capacity expansion to better meet customer demand, backlog for Continuing Operations reached RMB 58.00 billion as of year-end, up 28.8% YoY.
Adjusted operating cash flow[2] up 39.1% YoY to RMB 16.67 billion, driven by sustained business growth and enhanced operational efficiency and financial management.
Sustained and steady business growth driven by our unique, fully integrated Contract Research, Development and Manufacturing Organization (CRDMO) platform. Guided by "follow the molecule" and "win the molecule" strategies, WuXi Chemistry’s small molecule CRDMO pipeline continues to efficiently convert and capture high-quality molecules, delivering sustained business growth. In 2025, we added 839 new molecules to the small molecule Development and Manufacturing (D&M) pipeline, bringing the total to 3,452 molecules as of year-end. Notably, commercial and phase III projects increased by 22 during the year.
Accelerating global expansion, capacity construction and capability development. In 2025, Changzhou, Taixing and Jinshan API sites successfully passed FDA on-site inspections with no single observation. By year-end, our total reactor volume of small molecule APIs has reached over 4,000kL, while total reactor volume of Solid Phase Peptide Synthesizers has reached over 100,000L.
Driving sustainability, embracing initiatives, with sustained recognition by leading global ratings. In 2025, we achieved our first MSCI "AAA" and CDP Climate Change "A" ratings, maintained CDP Water Security "A" and EcoVadis "Gold" ratings. Meanwhile, our near-term GHG emissions reduction targets have been successfully validated by SBTi. As a committed UNGC participant and PSCI Supplier Partner, we actively embrace global initiatives and are dedicated to integrating sustainability into our business strategy and operations.
Unwavering commitment to safeguarding customers’ IP and adhering to the highest standards of quality & compliance. In 2025, the Company completed 741 quality audits and inspections conducted by global customers, regulatory authorities and independent third parties, as well as 60 information security audits by global customers, all with no critical findings. Currently, 20 of our main sites are ISO/IEC 27001 certified, covering all main sites in China.
[1] Net profit attributable to the owners of the Company is prepared in accordance with China Accounting Standards for Business Enterprises (CAS).

[2] Adjusted operating cash flow and adjusted free cash flow exclude income tax payments related to significant transactions (i.e., partial equity sales of WuXi XDC and the sale of the China-based clinical research service businesses) disclosed in the Company’s announcements.

2026 Outlook

With customers’ ongoing demand for enabling services, our CRDMO business model and management execution, the Company is confident to sustain rapid business growth. We expect total revenue to reach RMB 51.3-53.0 billion in 2026, with Continuing Operations revenue growing 18-22% YoY.

By continuously driving quality growth, realizing scale efficiency and enhancing operational excellence, while proactively managing new capacity ramp-up and FX challenges, we are confident in maintaining a stable and resilient adjusted non-IFRS NPM in 2026.

2026 capex is expected to reach RMB 6.5-7.5 billion. Along with business growth and efficiency improvements, adjusted free cash flow[2] is expected to reach RMB 10.5-11.5 billion.

While accelerating global capacity and capability enhancement, we remain committed to rewarding shareholders. We propose a cash dividend distribution plan totaling a record RMB 5.7 billion in 2026.

To invest in talents for long-term shared growth, we propose to launch the 2026 H-share Incentive Trust Plan, which will grant no more than HKD1.5 billion H-shares upon achieving RMB 51.3 billion revenue in 2026, and an additional HKD1.0 billion H-shares upon reaching RMB 53.0 billion and above. Underlying H-shares will be purchased in the open market at prevailing market prices, with no dilution to existing shareholders.

Management Comment

Dr. Ge Li, Chairman and CEO of WuXi AppTec, said, "In 2025, WuXi AppTec achieved record performance with strong growth in revenue, profit and cash flow. Meanwhile, our backlog for Continuing Operations reached RMB 58.0 billion – a 28.8% YoY increase, demonstrating the strength of our unique CRDMO business model and the exceptional execution of our global team."

"Entering 2026, with a sharpened focus on our core CRDMO strategy, we are accelerating the growth of our global capabilities and capacity, further improving production and operational efficiency, and delivering greater value for customers and shareholders. For 2026, we expect total revenue to reach RMB 51.3-53.0 billion, reflecting rapid growth of 18-22% YoY in Continuing Operations revenue, and adjusted free cash flow of RMB 10.5-11.5 billion."

"For 25 years, WuXi AppTec has been dedicated to lowering barriers to R&D and advancing healthcare innovation worldwide. Staying true to our founding aspiration, we will remain committed to ‘doing the right thing and doing it right’, enabling our partners to deliver life-saving therapies to patients in need, and advancing our vision that ‘every drug can be made and every disease can be treated’."

Business Performance by Segment

WuXi Chemistry: CRDMO Business Model Drives Continuous Growth; 2025 Revenue Up 25.5% YoY, with TIDES Revenue Up 96.0% YoY
WuXi Chemistry’s 2025 revenue reached RMB 36.47 billion, up 25.5% YoY. With continued optimization of production processes and improvements in capacity efficiency driven by the growth of late-stage clinical and commercial projects, 2025 adjusted non-IFRS gross profit margin of WuXi Chemistry steadily improved 5.9pts YoY to 52.3%.
Small molecule drug discovery service ("R") continues to generate downstream opportunities. In 2025, we successfully synthesized and delivered more than 420,000 new compounds to global customers. Meanwhile, 310 molecules were converted from R to D phase. Guided by our "follow-the-customer" and "follow-the-molecule" strategies, we have built trusted partnerships that underpin the sustainable growth of our CRDMO business.
Small molecule D&M service remains strong.
i. The small molecule CDMO pipeline continued to expand. In 2025, small molecule D&M revenue rose 11.4% YoY to RMB 19.92 billion. We added 839 new molecules to the small molecule D&M pipeline. As of year-end, our pipeline reached 3,452 molecules, including 83 commercial projects, 91 in phase III, 377 in phase II and 2,901 in phase I and pre-clinical stages. Notably, commercial and phase III projects increased by 22 in 2025.
ii. We continued to build small molecule capacity. In 2025, our Changzhou, Taixing and Jinshan API sites successfully passed FDA on-site inspections with no single observation. By year-end, total reactor volume of small molecule APIs reached over 4,000kL.
TIDES business (oligo and peptides) sustains rapid growth.
i. With the sequential ramp-up of new capacity released in 2024, 2025 TIDES revenue grew 96.0% YoY to RMB 11.37 billion. As of year-end, TIDES backlog increased 20.2% YoY.
ii. TIDES D&M customers grew 25% YoY, while the number molecules grew 45% YoY.
iii. In September 2025, we completed Taixing peptide capacity construction ahead of schedule. The Company’s total reactor volume of Solid Phase Peptide Synthesizers has reached over 100,000L.
WuXi Testing[3]: Strengthening Differentiated Capabilities and Operational Management; 2025 Revenue Back to Positive YoY Growth of 4.7%, Drug Safety Evaluation Services Maintained Leading Position
In 2025, WuXi Testing revenue resumed positive growth, up 4.7% YoY to RMB 4.04 billion. Of which, drug safety evaluation services revenue grew 4.6% YoY, maintaining an industry-leading position in the Asia-Pacific region.
Due to market impact, WuXi Testing’s 2025 adjusted non-IFRS gross profit margin declined YoY as pricing gradually reflected in revenue through backlog conversion, yet continued to improve sequentially each quarter driven by differentiated capabilities and enhanced operational management.
The Company is committed to actively enabling customers in global licensing deals. New modality business continued to develop, with revenue contribution increasing to more than 30% in 2025, while the Company maintained its leading position in nucleic acids, conjugates, multispecific antibodies and peptides, etc.
The Company continued to advance automation. DMPK successfully launched its proprietary all-in-one compound identification software, enhancing efficiency in spectral interpretation and metabolite identification for nucleic acids and peptides by 83%.
The facilities in Suzhou and Shanghai successfully passed multiple inspections by FDA, OECD, NMPA and PMDA.
[3] As disclosed in the 2025 Annual Report, WuXi Testing refers to Continuing Operations only (not including clinical research service businesses); historical data has been adjusted accordingly.

WuXi Biology: Continues to Follow the Science & Generate Downstream Opportunities; 2025 Revenue Back to Positive YoY growth of 5.2%, In Vivo & In Vitro Synergies and New Modalities Drove Growth
WuXi Biology follows the science and strategically builds differentiated capabilities of drug discovery in emerging areas. It actively expands global business and efficiently generates downstream opportunities for the CRDMO model by continuously contributing more than 20% of the Company’s new customers.
We efficiently enable our global customers through integrated in vitro & in vivo drug discovery capabilities, cross-regional collaboration and end-to-end solutions in emerging areas. 2025 WuXi Biology revenue resumed positive growth, up 5.2% YoY to RMB 2.68 billion.
Due to market pricing impact, 2025 adjusted non-IFRS gross profit margin of WuXi Biology was down 1.9pts to 36.9%. WuXi Biology closely follows market dynamics and maintains flexible pricing strategy, maximizing its value in generating downstream opportunities.
We achieved rapid revenue growth driven by accelerated progress in integrated in vitro screening and enhanced in vivo pharmacology capabilities. Non-oncology business maintained a competitive edge, serving as a key growth contributor.
New modality business continues to drive growth, with revenue contribution increasing to more than 30% in 2025, supported by rapid new customer expansion in nucleic acids, antibody conjugates and peptides, etc.
This release provides a summary of the results and does not intend to provide a complete statement relating to the Company, its securities, or any relevant matters herein that a recipient may need in order to evaluate the Company. For additional information, please refer to the WuXi AppTec 2025 Annual Results Presentation and 2025 Annual Report disclosed on the Company’s official website, as well as the Company’s disclosure documents and information on the Shanghai Stock Exchange, the Stock Exchange of Hong Kong Limited website. Investors are advised to exercise caution and be aware of the investment risks in trading Company shares.

Net profit attributable to the owners of the Company is prepared in accordance with China Accounting Standards for Business Enterprises (CAS), in currency of RMB. All other financial information disclosed in this press release is prepared in accordance with the International Financial Reporting Standards Accounting Standards ("IFRS"), in currency of RMB.

(Press release, WuXi AppTec, MAR 23, 2026, View Source [SID1234663843])

GlycoNex Inc. and Nippon Kayaku Co., Ltd. Enter Collaboration to Advance Next-Generation ADC Candidate GNX201-ADC

On March 23, 2026 GlycoNex, Inc. (4168, hereinafter referred to as GNX), a clinical-stage biotechnology company focused on the development of glycan-directed cancer immunotherapies, reported that it has entered into a collaboration agreement with Nippon Kayaku Co., Ltd. ("Nippon Kayaku") to advance GNX201-ADC, a next-generation antibody-drug conjugate (ADC) candidate for the treatment of solid tumors. Under the agreement, the two companies will jointly support preclinical development activities for GNX201-ADC, leveraging their respective expertise in antibody engineering and oncology drug development.

The collaboration will center on research and development activities for GNX201-ADC including optimization of the ADC construct and generation of preclinical data to support regulatory submissions. GNX201-ADC is designed as a protease-activated ADC that remains stable in circulation and is selectively activated in the tumor microenvironment, enabling targeted delivery of its cytotoxic payload while minimizing effects on normal tissues. This differentiated pro-antibody activation strategy is intended to improve therapeutic index and reduce on-target toxicity compared with conventional ADC approaches. Initial development efforts will focus on solid tumors characterized by high levels of glycan antigens.

"GlycoNex has long been dedicated to advancing anti-glycan antibodies and tumor glycobiology, and ADCs represent a natural extension of that scientific focus," said Dr. Mei-Chun Yang, CEO of GlycoNex. "We are honored to collaborate with Nippon Kayaku to combine our complementary R&D strengths, clinical development capabilities, and regulatory expertise to accelerate GNX201-ADC and advance the program toward clinical studies."

GNX201-ADC leverages GlycoNex’s "Antibody Lock" technology, incorporating a protease-activated pro-ADC that is "turned on" when the masking peptide is removed in the tumor microenvironment and turned off with the masked domain when in circulation. This selective activation allows GNX201-ADC to target tumors without harming healthy tissue. The design aims to reduce the risk of on-target toxicity and associated adverse effects observed with conventional ADC approaches.

"We are pleased to partner with GlycoNex on GNX201-ADC, a program that brings a differentiated pro-antibody activation concept into an ADC modality," said Akira Masuda, General Manager of Pharmaceutical Research Laboratories of Nippon Kayaku. "By combining GlycoNex’s expertise in tumor-associated glycan targeting with Nippon Kayaku’s experience in oncology-related pharmaceuticals, we aim to advance preclinical development and generate the data needed to support future clinical evaluation and treatment options for patients."

This collaboration further strengthens GlycoNex’s growing ADC pipeline and reflects its broader strategy of leveraging glycan-directed antibody technologies to develop novel precision oncology therapies. For Nippon Kayaku, the partnership expands its oncology research portfolio through access to a differentiated targeting modality with potential application across multiple solid tumor indications.

(Press release, GlycoNex, MAR 23, 2026, View Source [SID1234663841])

KELUN-BIOTECH ANNOUNCED 2025 ANNUAL RESULTS: MULTIPLE PRODUCTS SUCCESSFULLY LAUNCHED WITH TIERED PIPELINE READY FOR TAKE-OFF

On March 23, 2026 Sichuan Kelun-Biotech Pharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", Stock Code: 6990.HK) reported its audited consolidated results for the year ended 31 December 2025 (the "Reporting Period").

Kelun-Biotech is leveraging its core strengths and proprietary OptiDC technology platform to continue deepening its presence in the ADC and novel DC drug field. The company is actively advancing cutting-edge modalities including bispecific ADCs, RDCs, iADCs, and DACs, building a differentiated pipeline with strong global competitiveness. At the same time, Kelun-Biotech is steadily advancing product commercialization, achieving transformational growth across its business. To date, the company has four products with eight indications approved for marketing in China, including Sacituzumab Tirumotecan (佳泰莱), Trastuzumab Botidotin (舒泰莱), Tagitanlimab (科泰莱), and Cetuximab N01 (达泰莱). Among them, three products with five indications have been included in the 2025 National Reimbursement Drug List (NRDL), establishing a fully integrated drug development ecosystem that spans R&D through commercialization.

As of now, the company has built a robust pipeline of more than 30 drug candidates, with over 10 in the clinical stage, and are gradually expanding into broader non-oncology therapeutic areas such as autoimmune diseases and metabolic disorders. Looking ahead, the company will leverage its innovative and differentiated pipeline to deliver high-quality therapeutic solutions for major unmet medical needs worldwide.

Core ADC Products’ Commercialization Realized to Solidify Long-term Performance Foundation

Sac-TMT (sacituzumab tirumotecan, TROP2 ADC) (also known as SKB264/MK-2870) (佳泰莱)

TNBC:

The Company received marketing authorization in China from the NMPA for sac-TMT in adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting).
The Company has initiated a Phase 3 registrational study of sac-TMT monotherapy versus ICC for 1L advanced TNBC.
HR+/HER2- BC:

In February 2026, a new indication application for sac-TMT for the treatment of adult patients with HR+/HER2- BC who have received prior endocrine therapy (ET) and at least one line of chemotherapy in advanced setting has been approved for marketing by the NMPA.
A Phase 3 registrational study of sac-TMT versus ICC for treatment of patients with HR+/HER2- BC who received prior ET is in progress.
EGFR-mutant NSCLC:

In March 2025, the Company received marketing authorization in China from the NMPA for sac-TMT for the treatment of adult patients with EGFR mutant-positive NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy. This is the first TROP2 ADC drug approved for marketing in LC globally.
In October 2025, the company received marketing authorization in China from the NMPA for sac-TMT for the treatment of adult patients with EGFR mutant-positive NSCLC who progressed after treatment with EGFR-TKI therapy. This is the first ADC globally to show an OS benefit compared with platinum doublet chemotherapy and be approved for advanced NSCLC following progression on only TKI therapy (2L).
The Phase 3 registrational study of sac-TMT combined with osimertinib as first-line treatment of EGFR-mutant NSCLC and a Phase 2 study of sac-TMT monotherapy or in combination with osimertinib as neoadjuvant therapy for EGFR-mutant NSCLC are in progress.
EGFR-wild type NSCLC:

The Phase 3 registrational study of sac-TMT in combination with KEYTRUDA[1] (pembrolizumab) versus pembrolizumab as first-line treatment of PD-L1 positive NSCLC met its primary endpoint. This is the first Phase 3 clinical trial of ADC combined with immune checkpoint inhibitor to achieve its primary endpoint in the first-line treatment of NSCLC.
In January 2026, sac-TMT in combination with pembrolizumab for the first-line treatment of PD-L1 positive NSCLC were granted Breakthrough Therapy Designation by the NMPA.
The Phase 3 registrational study of sac-TMT in combination with pembrolizumab as first-line treatment of PD-L1 negative NSCLC is in progress.
Other indications: The company is actively exploring the potential of sac-TMT both as a monotherapy and in combination with other therapies for treating other solid tumors, including GC, EC, CC, OC, UC, CRPC, HNSCC, and TC, etc.

Trastuzumab botidotin (HER2 ADC, also known as A166, 舒泰莱)

In October 2025, trastuzumab botidotin was approved for marketing by the NMPA for adult patients with HER2+ BC who have received one or more prior anti-HER2 therapy. This is the first domestically developed HER2 ADC approved for 2L+ HER2+ BC in China.
An open, multicenter Phase 2 clinical study of trastuzumab botidotin in the treatment of HER2+ BC that previously received a topoisomerase inhibitor ADC is in progress.
Key Clinical Data Highlighted at International Academic Conferences and in Top Journals

Results from the Phase 3 study of sac-TMT for the treatment of 2L EGFR-mutant NSCLC were selected for LBA and presented as an oral report in the Presidential Symposium session at the 2025 ESMO (Free ESMO Whitepaper) Congress. Sac-TMT achieved statistically significant and clinically meaningful improvements in ORR, PFS, and OS compared to chemotherapy. The study findings were published simultaneously online at the New England Journal of Medicine and in the first issue of 2026.
Results from the study of sac-TMT for the treatment of 3L EGFR-mutant NSCLC were presented as an oral report at the ASCO (Free ASCO Whitepaper) Annual Meeting and published at the British Medical Journal. The final OS analysis of this study will be selected for LBA and presented as a mini oral report at the 2026 ELCC.
Results from the Phase 3 study of sac-TMT for the treatment of 2L+ HR+/HER2-BC were selected for LBA and presented as an oral report at the 2025 ESMO (Free ESMO Whitepaper) Congress.
Results from the Phase 3 study of trastuzumab botidotin for the treatment of 2L+ HER2+ BC were selected for LBA and presented as an oral report at the 2025 ESMO (Free ESMO Whitepaper) Congress.
Sustained Value Release of ADCs Under Development with Tiered Advancement of Innovation Pipeline

Phase 2 clinical stage

SKB315 (CLDN18.2 ADC):

The Phase 1b clinical trial of SKB315 is in progress, for the treatment of GC/GEJC/PDAC, etc.
Results of a Phase 1 study of SKB315 in patients with advanced solid tumors including GC/GEJC were presented at 2025 ESMO (Free ESMO Whitepaper) Congress in October 2025.
SKB410/MK-3120 (Nectin-4 ADC):

Its partner MSD has launched 4 global Phase 1/2 clinical trial of SKB410/MK-3120 in advanced solid tumor including bladder cancer, etc.
SKB571/MK-2750 (novel bsADC): The Phase 2 clinical trial in China is ongoing.

SKB518 (novel ADC with a potential FIC target): The Phase 2 clinical trials are ongoing in China.

SKB500 (novel ADC): The Phase 2 study is ongoing in China.

Phase 1 clinical stage

SKB107 (RDC)[2]: The Phase 1 study is ongoing.

SKB535/MK-6204 (novel ADC with potential FIC target): The Phase 1 clinical trial for SKB535 is ongoing in China.

SKB445 (novel ADC with potential FIC target): The Phase 1 clinical trials for SKB445 is ongoing in China.

SKB105/CR-003 (ITGB6 ADC): In January 2026, an IND application was approved by the CDE of NMPA for the treatment of advanced solid tumor. A Phase 1/2 trial is ongoing in China.

Strategic Layout of Non-DC Assets with Focus on Combination Therapy & Indication Expansion

Drug candidates for oncology

Tagitanlimab (PD-L1 mAb, also known as A167) (科泰莱): In January 2025, the Company received marketing authorization of tagitanlimab used in combination with cisplatin and gemcitabine for the first-line treatment of NPC from NMPA. Tagitanlimab is the first PD-L1 mAb globally to receive authorization for the first-line treatment of NPC.
In May 2025, the results of a Phase 3 clinical study of tagitanlimab in combination with cisplatin and gemcitabine for the first-line treatment of NPC were presented at the ASCO (Free ASCO Whitepaper) Annual Meeting.
Cetuximab N01 (EGFR mAb, also known as A140) (达泰莱):

In February 2025, the Company received marketing authorization in China from the NMPA for Cetuximab N01 Injection used in combination with FOLFOX or FOLFIRI regimens for first-line treatment of RAS wild-type mCRC.
Lunbotinib Fumarate Capsules (RET inhibitor, also known as A400/EP0031)(宁泰莱)[3]：

An NDA was accepted for review by the CDE of the NMPA of China for the 1L+ treatment of RET-fusion positive NSCLC.
The company is also conducting a Phase 1b/2 clinical study for RET+ MTC and solid tumor in China.
Ellipses Pharma is progressing their phase 2 clinical study globally outside of China.
In May 2025, results from the Phase 1 study of Lunbotinib Fumarate Capsules in patients with advanced RET-mutant MTC were presented at the ASCO (Free ASCO Whitepaper) Annual Meeting.
SKB118/CR-001 (PD-1/VEGF bsAb):

In January 2026, Crescent Biopharma announced the regulatory clearance of the IND application for SKB118 by FDA to initiate its global ASCEND Phase 1/2 clinical trial for the treatment of advanced solid tumors, and the first patient has been dosed in February, 2026.
The company is planning to initiate the Phase 1/2 clinical study for SKB118 in China in the first half of 2026.
Drug candidates for autoimmune diseases

SKB378/WIN378 (TSLP mAb):

In January 2025, an IND application for SKB378 for the treatment of COPD was approved by the NMPA.
Its collaboration partner, Windward Bio, has launched the Phase 2 POLARIS global trial in patients with asthma.
SKB575 (TSLP/undisclosed target bsAb): In March 2026, an IND application for SKB575 for the treatment of atopic dermatitis was approved by the NMPA.

Drug candidates for other non-oncology diseases

SKB336 (FXI/FXIa mAb): The company completed Phase 1 clinical trial in China.

Multiple Products First Included in National Reimbursement Drug List with Accelerated Market Coverage

In 2025, the Company witnessed an explosive growth in the commercialization of its innovative achievements. The Company has also filed an NDA for Lunbotinib Fumarate Capsules and expects to commence its commercialization in the second half of 2026 or the first half of 2027, subject to regulatory communications and marketing approval. To date, the company’s initial commercial product portfolio, consisting of five products, has taken shape.

Supported by national innovation policies, the Company has successfully secured the first-time inclusion of three of its commercialized products, namely 佳泰莱, 科泰莱 and 达泰莱, in the National Reimbursement Drug List (國家醫保藥品目錄), which officially took effect on January 1, 2026, and is expected to benefit more patients faster and better.

Steady Advancement of Global Collaboration and Comprehensive Strength Authoritatively Recognized

Collaboration with MSD: As at the date of this announcement, MSD is evaluating initiated 17 ongoing Phase 3 global clinical studies of sac-TMT as a monotherapy or with pembrolizumab or other agents for several types of cancer, including BC, LC, gynecological cancers, GI cancer and GU cancer. In addition to sac-TMT, the company is also collaborating with MSD on certain ADC assets to continuously explore favorable ADC pipeline portfolios.

Collaboration with Ellipses Pharma: The Company has deepened its collaboration with Ellipses Pharma on A400/EP0031, which has cleared by the FDA to progress into Phase 2 clinical development. As at December 31, 2025, a total of 39 clinical sites in the United States, Europe and UAE were set up for Lunbotinib Fumarate Capsules.

Collaboration with Windward Bio: In January 2025, the Company and Harbour BioMed had entered into an exclusive license agreement with Windward Bio, under which the Company and Harbour BioMed granted Windward Bio an exclusive license for the research, development, manufacturing and commercialization of SKB378/WIN378 globally (excluding Greater China and several Southeast and West Asian countries). Windward Bio has launched the Phase 2 POLARIS global trial in patients with asthma.

Collaboration with Crescent Biopharma. In December 2025, the company and Crescent Biopharma entered into a strategic collaboration for SKB105/CR-003 and SKB118 (a PD1 x VEGF bsAb, also known as CR-001). Under the collaboration, the company granted Crescent Biopharma exclusive rights to research, develop, manufacture and commercialize SKB105/CR-003 in the United States, Europe and all other markets outside of Greater China. In return, the compamy obtained exclusive rights from Crescent Biopharma to research, develop, manufacture and commercialize SKB118/CR-001 in Greater China.

Continuous Improvement of ESG Capabilities to Consolidate the Foundation for Sustainable Development

Through the establishment and continuous improvement of the ESG governance structure, the Company comprehensively enhances ESG performance ability and ensures the Company’s sustainable development. In May 2025, the company was awarded "Best ESG" by Extel. In March 2026, the Company had received a rating of "AA" in the MSCI ESG Rating Assessment.

Outlook

In 2026, Kelun-Biotech will continue to drive innovation and strengthen its operational capabilities, steadily advancing towards becoming a world-class biopharmaceutical company. Specifically, the Company will implement the following development strategies: advancing differentiated pipelines targeting indications with significant medical needs; innovating on and optimizing payload-linker strategies and novel DC designs and structures, while expanding applications in non-oncology diseases; enhancing its end-to-end drug development and commercialization capabilities; expanding business landscape and strategic partnerships and improve our capabilities for the development, registration and commercialization of our products in ex-China market; and optimizing its operational systems with the aim of becoming a leading global biopharmaceutical company.

(Press release, Kelun, MAR 23, 2026, View Source [SID1234663840])