Rakovina Therapeutics Showcases Potent AI-Developed ATR Inhibitors with CNS Penetrance at AACR-NCI-EORTC International Conference

On October 27, 2025 Rakovina Therapeutics Inc. ("Rakovina" or the "Company") (TSX-V: RKV)(FSE: 7JO0) reported the successful presentation of new data at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), held October 23–27 in Boston, Massachusetts. The Company’s poster, titled "Novel ATR inhibitors with CNS penetrance developed by artificial intelligence," highlights promising results from its AI-driven kt-5000AI drug discovery program for Ataxia telangiectasia and Rad3-related protein serine/threonine kinase (ATR) inhibitors for cancer therapy.

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Through its collaboration with Variational AI, Rakovina Therapeutics utilized the Enki generative AI platform to identify novel small-molecule candidates predicted to meet a defined target product profile for CNS-penetrant ATR inhibition. Data presented at the conference confirm that multiple lead compounds achieved this profile, demonstrating potent ATR inhibition together with clear evidence of central nervous system exposure.

While multiple ATR inhibitors are in development globally, none have yet demonstrated meaningful central nervous system penetration. Rakovina’s kt-5000AI program is advancing next-generation, AI-designed ATR inhibitors with confirmed CNS exposure, potentially extending the benefits of ATR-targeted therapy to patients with primary brain tumors and brain metastases, where effective treatments remain limited.

In cell-based assays, multiple compounds demonstrated:

>50% inhibition of ATR activity below 200 nM;
potency exceeding reference compounds such as ceralasertib, tuvusertib, and elimusertib;
equal selectivity across the PIKK kinase family compared to reference compounds; and
metabolic stability following incubation with human liver microsomes
In in vivo pharmacokinetic studies, lead compounds demonstrated:

measurable drug concentrations in both plasma and brain tissue following intraperitoneal dosing at 5 mg/kg, indicating CNS penetration; and
good tolerability after single-dose administration, supporting continued optimization and preclinical development
"Presenting at AACR (Free AACR Whitepaper)-NCI-EORTC is an opportunity to highlight Rakovina’s progress in translating AI-discovered compounds into preclinical validation to the scientific community," said Prof. Mads Daugaard, President and Chief Scientific Officer of Rakovina Therapeutics. "ATR is a central regulator of DNA damage repair and a validated target across multiple tumor types. Developing ATR inhibitors capable of penetrating the blood–brain-barrier could expand treatment options for patients with primary brain tumors and brain metastases, areas where few effective therapies exist."

(Press release, Rakovina Therapeutics, OCT 27, 2025, View Source;utm_medium=rss&utm_campaign=rakovina-therapeutics-showcases-potent-ai-developed-atr-inhibitors-with-cns-penetrance-at-aacr-nci-eortc-international-conference [SID1234657036])

Adaptam Therapeutics raises €3 million to pioneer cancer immunotherapi…

On October 27, 2025 Adaptam Therapeutics (‘Adaptam’), a biotech company pioneering cancer immunotherapies specifically targeting immunosuppressive myeloid cells, reported the successful completion of a €3 million (~$3.5 million) pre-seed financing round led by Criteria Bio Ventures.

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This financing round will enable Adaptam to further develop its programs and enter the preclinical phase in multiple oncology indications. As part of the round, Salvatore Cappadona, PhD, and Pablo Cironi, PhD, both from Criteria Bio Ventures, joined the board of directors.

Adaptam is developing first-in-class antibody-based therapeutic programs, including ADCs and bispecific antibodies, that target novel glyco-immune checkpoints, selectively expressed in immunosuppressive myeloid cells.

"Immunosuppressive myeloid cells within tumors present one of the toughest challenges in immunotherapy today. Our goal is to neutralize this obstacle by developing therapies that specifically target these cells, offering patients new hope where traditional approaches have failed," said Asis Palazon, PhD, founder, CEO and CSO of Adaptam. "The support from Criteria Bio Ventures enables us to take a step forward in achieving our mission. We are now actively planning our next funding round to support IND-enabling studies."

Immunotherapy has transformed cancer treatment, offering new solutions to patients worldwide. However, a significant number still fail to respond to these therapies or develop resistance over time. This lack of efficacy is primarily due to the immunosuppressive nature of the tumor microenvironment (TME), which hampers the immune system’s ability to effectively target and destroy cancer cells. Among the main contributors to this immunosuppression are myeloid cells, particularly TAMs, which play a crucial role in inhibiting T-cell responses. This challenge is particularly pronounced in patients with solid tumors, where these myeloid cells create an environment that prevents immune cells from mounting an effective anti-tumoral response.

"We are thrilled to support Adaptam in its mission to transform cancer treatment by targeting the immunosuppressive cells within the TME. The scientific breakthroughs achieved by Prof. Asis Palazon and his team have laid the groundwork for potentially life-changing therapies," said Pablo Cironi, PhD, chairman of the Adaptam board. "With this strong foundation, we believe Adaptam is well-positioned to deliver new, effective treatments for patients with solid tumors, addressing critical gaps in current immunotherapy options."

"Adaptam’s differentiated approach at the intersection of myeloid-mediated immunosuppression and glycobiology represents a one-of-a-kind vision uniquely positioned to unlock the next frontier in cancer immunotherapy. We are proud to have partnered with Asis Palazon to build this exciting new venture and support its next phase of development. We are confident that Adaptam’s emerging pipeline offers a game-changing opportunity to transform cancer treatment for many patients," said Salvatore Cappadona, PhD, board member of Adaptam.

Adaptam originated from research conducted by Prof. Asis Palazon and his team at CIC bioGUNE in Bilbao, Spain, with expert insights from Criteria Bio Ventures on the ideation, corporate strategy and operational setup of the company. Asis Palazon also received a Caixa Research Health grant from "la Caixa" Foundation in 2021. Some of the core structural and mechanistic discoveries of immune-modulating glycan-binding proteins and their interactions with immune cells were previously published in Nature Communications.

"CIC bioGUNE’s long-standing leadership in glycobiology provided the scientific foundation for Adaptam and we have supported the company from its earliest steps through to today’s preclinical maturation," said Prof. Jesús Jiménez-Barbero, scientific director of CIC bioGUNE.

(Press release, Adaptam Therapeutics, OCT 27, 2025, View Source [SID1234657099])

Cellectar Biosciences Receives Rare Pediatric Disease Designation from U.S. Food and Drug Administration for Iopofosine I 131 in Relapsed or Refractory Pediatric High-Grade Glioma

On October 27, 2025 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, reported the U.S. Food and Drug Administration (FDA) has granted rare pediatric drug designation (RPDD) for iopofosine I 131 in inoperable relapsed or refractory pediatric high-grade glioma (r/r pHGG).

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Iopofosine I 131 is a potential first-in-class, novel cancer targeting agent utilizing a phospholipid ether as a radioconjugate monotherapy. The FDA previously granted Orphan Drug Designation for iopofosine I 131 for the treatment of pHGG.

"Receiving Rare Pediatric Disease Designation for iopofosine I 131 underscores its potential to address one of the most devastating cancers affecting children and young adults. Combined with the encouraging interim results from our CLOVER-2 pHGG study, which showed meaningful improvements in progression-free and overall survival, this designation further validates the promise of our targeted radiotherapeutic approach," stated James Caruso, president and CEO of Cellectar. "We believe iopofosine I 131 represents a compelling opportunity for strategic collaboration to accelerate development and bring a potentially first-in-class therapy to patients who urgently need new options."

The FDA’s Rare Pediatric Disease Designation program is intended to encourage the development of new therapies for serious and life-threatening diseases that primarily affect individuals under 18 years of age. If a New Drug Application (NDA) for iopofosine I 131 is approved, upon reauthorization of the program Cellectar may be eligible to receive a Priority Review Voucher (PRV), which can significantly expedite the review process for future New Drug Applications or Biologic License Applications, may be redeemed to receive priority review for another marketing application or may be sold or transferred.

Pediatric high-grade gliomas are a collection of aggressive tumors affecting the brain and central nervous system. As reported in the literature, median progression free survival (PFS) and overall survival (OS) for patients with relapsed pHGG is poor; approximately 2.25 months and 5.6 months, respectively.

Interim data from CLOVER-2, the company’s ongoing Phase 1b trial of iopofosine I 131 in children, adolescents and young adults with r/r pHGG at multiple sites in the United States and Canada, were highlighted in an oral presentation at the recent American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference on Pediatric Cancer that took place in late September 2025.

The company’s chief operating officer, Jarrod Longcor, delivered the update, "Precision Radiotherapy for Incurable Brain Tumors: Phase 1b Dose & Regimen Optimization Study of Iopofosine I 131 in Inoperable Relapsed or Refractory Pediatric High-Grade Glioma, Interim Data Assessment," which showed that all patients receiving a minimum of 55 mCi total administered dose (n=6) experienced an average of 5.4 months of PFS and 8.6 months of OS, ongoing. All patients experienced disease control, which according to the committee for the Response Assessment in Pediatric Neuro-Oncology (RAPNO) does correlate with survival benefit. Three patients who received additional dosing cycles (a minimum of four total infusions) had an average PFS of 8.1 months and an OS of 11.5 months (ranging from 4.9 to 14.9 months), ongoing, with two achieving an objective response (ORR).

Two case studies were highlighted in the oral presentation. Case Study 1 showed a 25-year-old male with diffuse hemispheric glioma with the H3 G34R/V mutation who had three prior therapies and who received a total administered dose of 126.6mCi of iopofosine I 131 over four doses (40mCi/m2/dose) had his target lesion reduced by more than 50% approximately eight months post screening. This patient had PFS of 10.9 months and survival is ongoing at greater than 18 months as of July 25, 2025.

Case Study 2 showed a 15-year-old female with ependymoma who had eight prior therapies and who received a total administered dose of 58.9mCi of iopofosine I 131 over four doses (20mCi/m2/dose) had her target lesion reduced from 252mm2 to approximately 141mm2. This patient had PFS of 11.2 months and her ongoing survival was greater than 17 months as of July 22, 2025.

Iopofosine I 131 was well tolerated and its toxicity profile was consistent with the company’s previously reported safety data. Importantly, patients on iopofosine I 131 did not experience any cardiovascular, renal, or liver toxicities, and no peripheral neuropathy or significant bleeding. The safety profile was consistent with selective targeting of tumor sites with clinically negligible off-target effect outside the hematologic system. The most frequently reported treatment emergent adverse events were hematologic in nature (thrombocytopenia, neutropenia and anemia) and were predictable and manageable. No treatment-related deaths were reported.

The complete presentation can be accessed on the company’s website here.

About Pediatric High-Grade Gliomas
Pediatric high-grade gliomas are a collection of aggressive tumors affecting the brain and central nervous system. The patients enrolled in CLOVER-2 with pHGG (n=14) were diagnosed with diffuse midline gliomas (DMG), ependymomas, diffuse intrinsic pontine gliomas (DIPG), diffuse hemispheric gliomas (DHG) and anaplastic ependymomas. As reported in the literature, median progression free survival (PFS) and overall survival (OS) for patients with relapsed pHGG is poor; approximately 2.25 months and 5.6 months, respectively. While MRI measures of tumor volume change can be helpful and are used as a surrogate in clinical trials, they often fail to predict survival.

About the CLOVER-2 Trial
The Phase 1b trial of iopofosine I 131 consists of children, adolescents and young adults with r/r pHGG at multiple sites in the United States and Canada. The study is designed to evaluate the safety and tolerability of iopofosine I 131 in two dosing cohorts, one cohort receiving two doses at 20mCi/m2 each separated by 14 days for two cycles with a third optional cycle. Patients in the second cohort will receive 10 mCi/m2 each, separated by 14 days for three cycles with a fourth optional cycle. The study will also determine therapeutic activity defined as progression free survival (PFS) and overall survival, antitumor activity defined as the reduction in tumor volume and identify the recommended Phase 2/3 dose of iopofosine I 131 in children, adolescents and young adults with r/r pHGG.

(Press release, Cellectar Biosciences, OCT 27, 2025, View Source [SID1234661196])

Revolution Medicines’ RAS(ON) Multi-Selective Inhibitor Daraxonrasib Granted U.S. FDA Orphan Drug Designation in Pancreatic Cancer

On October 27, 2025 Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to daraxonrasib, the company’s RAS(ON) multi-selective inhibitor, for the treatment of pancreatic cancer.

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"We are gratified the FDA has granted Orphan Drug Designation to daraxonrasib for the treatment of pancreatic cancer, a devastating disease with limited therapeutic options and representing a large unmet medical need," said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. "RAS driver mutations are present in nearly all pancreatic cancer cases, underscoring the urgent need for innovative therapies that target this critical driver of disease progression."

Daraxonrasib is being studied in a global Phase 3 clinical trial, RASolute 302, in patients with second line metastatic pancreatic ductal adenocarcinoma (PDAC). The company has also announced plans to initiate two additional Phase 3 clinical trials in pancreatic cancer: a trial for first line treatment in patients with metastatic PDAC and a trial for adjuvant treatment in patients with resectable PDAC.

Orphan Drug Designation is awarded by the FDA on behalf of selected investigational drugs to encourage the development of therapies for rare diseases, which are defined as conditions affecting fewer than 200,000 individuals in the United States. This designation provides sponsors with several incentives, including tax credits for clinical trial costs, exemption from certain FDA fees, and up to seven years of market exclusivity following approval.

About Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma
Pancreatic cancer is one of the most lethal malignancies, characterized by its typically late-stage diagnosis, resistance to standard chemotherapy, and high mortality rate. In the U.S., recent estimates indicate that approximately 60,000 people will be diagnosed annually with pancreatic cancer1, and about 50,000 people will die from this aggressive disease.

Due to the lack of early symptoms and detection methods, approximately 80% of patients are diagnosed with PDAC at an advanced or metastatic stage. It is the most commonly RAS-addicted of all major cancers, and more than 90% of patients have tumors that harbor RAS mutations2. Metastatic PDAC remains one of the most common causes of cancer-related deaths in the U.S., with a five-year survival rate of approximately 3%3.

About Daraxonrasib
Daraxonrasib (RMC-6236) is an oral, direct RAS(ON) multi-selective inhibitor with the potential to help address a wide range of cancers driven by oncogenic RAS mutations. Daraxonrasib suppresses RAS signaling by blocking the interaction of RAS(ON) with its downstream effectors. It does so by targeting oncogenic RAS mutations G12X, G13X and Q61X that are common drivers of major cancers, including pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC) and colorectal cancer (CRC).

(Press release, Revolution Medicines, OCT 27, 2025, View Source [SID1234657037])

WuXi AppTec Achieves Strong Double-Digit Growth in Revenue and Profit for Q1-Q3 2025 Backlog for Continuing Operations Up 41.2% YoY Further Raises 2025 Full-year Guidance

On October 26, 2025 WuXi AppTec (stock code: 603259.SH / 2359.HK), a global company that provides a broad portfolio of R&D and manufacturing services to enable companies in the pharmaceutical and life sciences industry, reported financial results for the first three quarters ending September 30, 2025 ("Reporting Period"):

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For the first three quarters of 2025, total revenue reached RMB32.86 billion, up 18.6% year-over-year. Revenue from Continuing Operations reached RMB32.45 billion, up 22.5% year-over-year.
Adjusted non-IFRS gross profit reached RMB15.46 billion, with the adjusted non-IFRS gross profit margin up 6.1pts year-over-year to 47.0%.
Net profit attributable to the owners of the Company was RMB12.08 billion, up 84.8% year-over-year; diluted EPS was RMB4.21, up 87.9% year-over-year.
Adjusted non-IFRS net profit attributable to the owners of the Company was RMB10.54 billion, up 43.4% year-over-year; adjusted non-IFRS net profit margin up 5.6pts year-over-year to 32.1%; adjusted non-IFRS diluted EPS was RMB3.68, up 46.0% year-over-year.
With continuous capacity expansion to better meet customer demand, backlog for Continuing Operations reached RMB59.88 billion as of September 30, 2025, up 41.2% year-over-year.
Operating cash flow climbed 35.0% year-over-year to RMB10.87 billion, driven by business growth, increase in operating efficiency, and continued improvement of financial management capabilities.
Sustained and steady business growth as a result of our unique, fully integrated Contract Research, Development and Manufacturing Organization (CRDMO) platform. Driven 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 the first three quarters of 2025, a total of 621 new molecules were added to the small molecule Development and Manufacturing (D&M) pipeline. As of September 30, 2025, our small molecule D&M pipeline reached 3,430 molecules, representing an increase of 15 projects in phase III and commercial stages during the first three quarters of 2025.
Acceleration of global expansion, capacity construction and capability development. In March 2025, both the Changzhou and Taixing API manufacturing sites successfully passed FDA on-site inspections with no single observation. By the end of 2025, total reactor volume of small molecule APIs is expected to reach over 4,000kL. In September 2025, the construction of peptide capacity in Taixing was completed ahead of schedule; the Company’s total reactor volume of Solid Phase Peptide Synthesizers has been increased to more than 100,000L.
Robust shareholder returns. The Company remains committed to rewarding shareholders and actively supporting the Company’s value. This year, the Company has implemented a total of RMB6.88 billion in cash dividends, share repurchases and cancellations, representing more than 70% of the Company’s 2024 net profit attributable to the owners of the Company. Among these, the Company has distributed a total of RMB4.88 billion in cash dividends, including RMB2.83 billion for the 2024 annual cash dividend, RMB1.01 billion for the 2025 special cash dividend and RMB1.03 billion for the 2025 interim dividend. Meanwhile, the Company also completed the repurchase of RMB2.0 billion worth of A-shares in total, all of which have been cancelled.
[1] As disclosed in 2025 Third Quarterly Report, Continuing Operations include WuXi Chemistry, WuXi Testing, WuXi Biology and Others, the scope of which may change following adjustments to the Company’s business strategy.

[2] Net profit attributable to the owners of the Company is prepared in accordance with China Accounting Standards for Business Enterprises (CAS).

[3] In 2024 Q1-Q3 and 2025 Q1-Q3, WuXi AppTec had a fully-diluted weighted average share count of 2,906,724,914 and 2,873,641,499 ordinary shares, respectively.

2025 Full-Year Outlook

With confidence in customers’ ongoing demand for enabling services, our CRDMO business model and management execution, the Company has further raised its full-year guidance.

The Company expects Continuing Operations revenue to resume double-digit growth in 2025, with its year-over-year growth rate raised to 17-18%, up from the prior 13-17%. As a result, the Company expects full-year total revenue of RMB43.5-44.0 billion, up from the prior RMB42.5-43.5 billion.

As it focuses on the core CRDMO business and continuously improved production and operating efficiency, the Company is confident and expects to further improve the adjusted non-IFRS net profit margin in 2025.

The Company is actively advancing global capacity construction; while due to longer-than-expected settlement cycles of certain projects, capex for 2025 is expected to reach RMB5.5-6.0 billion (adjusted from the prior RMB7.0-8.0 billion). Together with business growth, efficiency improvement, and considering the timing differences in project payments, free cash flow for 2025 is expected to increase from RMB5.0-6.0 billion to RMB8.0-8.5 billion.

Management Comment

Dr. Ge Li, Chairman and CEO of WuXi AppTec, said, "Reflecting robust customer demand and the strength of our unique CRDMO business model, WuXi AppTec delivered strong double-digit growth in revenue, profit and operating cash flow in the first three quarters of 2025, while our backlog for Continuing Operations reached a record RMB59.9 billion. Based on this momentum, we have further raised our full-year revenue and free cash flow guidance. The strategic divestment of clinical research services enables us to fully focus on our core CRDMO strategy and better meet the evolving needs of our customers. By concentrating on drug discovery, laboratory testing, process development, and manufacturing services, we are accelerating the growth of our global capabilities and capacities, delivering greater value for customers and shareholders, 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; Q1-Q3 2025 Revenue Up 29.3 % YoY , with TIDES Revenue Up 121.1% YoY
Q1-Q3 revenue of WuXi Chemistry reached RMB25.98 billion, up 29.3% year-over-year. With continued optimization of production process and improvement in capacity efficiency driven by the growth of late-stage clinical and commercial projects, Q1-Q3 adjusted non-IFRS gross profit margin of WuXi Chemistry steadily improved 5.8pts year-over-year to 51.3%.
Small molecule drug discovery service ("R") continues to generate downstream opportunities. In the past 12 months, we successfully synthesized and delivered more than 430,000 new compounds to customers. In the meantime, 250 molecules were converted from R to D phase in the first three quarters of 2025. Through our "follow-the-customer" and "follow-the-molecule" strategies, we established trusted partnerships with our customers globally, supporting the sustainable growth of our CRDMO business.
Small molecule D&M service remains strong.
The small molecule CDMO pipeline continued to expand. Q1-Q3 revenue of small molecule D&M services rose 14.1% year-over-year to RMB14.24 billion. In the first three quarters of 2025, 621 new molecules were added to the small molecule D&M pipeline. As of September 30, 2025, our small molecule D&M pipeline reached 3,430 molecules, including 80 commercial projects, 87 in phase III, 374 in phase II and 2,889 in phase I and pre-clinical stages. This represents an increase of 15 projects in the commercial and phase III stages during the first three quarters of 2025.
We continued to build small molecule capacity. In March 2025, both the Changzhou and Taixing API manufacturing sites successfully passed FDA on-site inspections with no single observation. The total reactor volume of small molecule APIs is expected to reach over 4,000kL by the end of 2025.
TIDES business (oligo and peptides) sustains rapid growth.
With the ramp-up of new capacities released sequentially each quarter last year, Q1-Q3 TIDES revenue grew 121.1% year-over-year to RMB7.84 billion. As of September 30, 2025, TIDES backlog grew 17.1% year-over-year.
TIDES D&M customers grew 12% year-over-year, while the number of TIDES molecules grew 34% year-over-year.
In September 2025, the construction of peptide capacity in Taixing was completed ahead of schedule; the Company’s total reactor volume of Solid Phase Peptide Synthesizers has been increased to more than 100,000L.
WuXi Testing: Drug Safety Evaluation Service & Site Management Organization (SMO) Maintain Leading Positions
WuXi Testing revenue reached RMB4.17 billion in Q1-Q3, and Q1-Q3 adjusted non-IFRS gross profit margin was 26.5%.
With development of differentiated capabilities and enhanced operational management, Q3 revenue of lab testing services reached RMB1.08 billion, growing 7.2% year-over-year and 7.5% quarter-over-quarter; while its Q3 adjusted non-IFRS gross profit margin continued to improve quarter-over-quarter. Of which, the revenue of drug safety evaluation services grew 5.9% year-over-year and 13.2% quarter-over-quarter.
Q1-Q3 revenue of lab testing services grew 2.7% year-over-year to RMB2.96 billion. Due to market impact, its Q1-Q3 adjusted non-IFRS gross profit margin declined as pricing was gradually reflected in revenue along with backlog conversion. Of which, drug safety evaluation services revenue resumed positive year-over-year growth, while maintaining an industry-leading position in the Asia-Pacific region.
The Company is committed to actively enabling customers’ global licensing. New modality business continued to develop, while the Company maintained its leading position in areas including nucleic acids, conjugates, mRNA, multispecific antibodies and peptides.
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 Suzhou facility has successfully passed 4 consecutive FDA on-site inspections.
Q1-Q3 revenue for clinical CRO & SMO was down 6.4% year-over-year to RMB1.21 billion due to market pricing impact; of which, SMO revenue was down 0.7% year-over-year as backlog gradually converted into revenue, while maintaining its industry leading position in China.
During the first three quarters of 2025, our clinical CRO business supported customers in obtaining 19 IND approvals and submitting for 2 NDA filings; the SMO business supported 75 new drug approvals for customers. The SMO business has supported 331 new drug approvals in total over the past decade, maintaining significant advantages in multiple areas (endocrinology, dermatology, lung cancer and cardiovascular disease, etc.).
WuXi Biology: Continues to Generate Downstream Opportunities; In Vitro & In Vivo Business Synergies and New Modality Business Drive Growth
WuXi Biology follows the science, continuously strengthens drug discovery capabilities in emerging areas and actively grows overseas businesses. It efficiently generates downstream opportunities for CRDMO model by continuously contributing more than 20% of the Company’s new customers.
Through cross-regional collaboration, comprehensive platform integration and integrated project transformation, we efficiently enable our customers worldwide. WuXi Biology revenue reached RMB1.95 billion in Q1-Q3 2025, a year-over-year increase of 6.6%.
Due to market pricing impact, Q1-Q3 adjusted non-IFRS gross profit margin of WuXi Biology was down 1.0pts to 37.0%. With continuously improved operational efficiency, its Q3 adjusted non-IFRS gross profit margin improved 1.5pts quarter-over-quarter.
We accelerated advancements in in vitro integrated screening technologies and continued to improve in vivo pharmacology capabilities, resulting in rapid year-over-year and quarter-over-quarter revenue growth. With its competitive edge continuously strengthened, the non-oncology business has achieved strong revenue growth, becoming an important contributor to business growth.
New modality drug discovery services continue to perform well, contributing more than 30% of WuXi Biology’s total revenue.
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 Third Quarterly Results Presentation and 2025 Third Quarterly 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. Besides, all other financial information disclosed in this press release is prepared in accordance with the International Financial Reporting Standards Accounting Standards ("IFRSs"), in currency of RMB.

The 2025 Third Quarterly Report of the Company has not been audited.

Third Quarter 2025 Results by Segments

Unit: RMB million

Segment

Revenue

Change

Adjusted non-
IFRS Gross
Profit

Change

Adjusted
non-IFRS
Gross Profit
Margin

WuXi Chemistry

9,676.68

22.7 %

5,329.83

40.6 %

55.1 %

WuXi Testing

1,480.83

2.1 %

428.69

-10.0 %

28.9 %

WuXi Biology

695.67

5.9 %

264.49

1.8 %

38.0 %

Others

191.78

163.8 %

161.60

658.4 %

84.3 %

Discontinued Operations (Note 1)

12.47

-96.9 %

12.47

N/A

100.0 %

Total

12,057.43

15.3 %

6,197.08

38.4 %

51.4 %

First Three Quarters 2025 Results by Segments

Unit: RMB million

Segment

Revenue

Change

Adjusted non-
IFRS Gross
Profit

Change

Adjusted
non-IFRS
Gross
Profit
Margin

WuXi Chemistry

25,978.06

29.3 %

13,314.69

45.7 %

51.3 %

WuXi Testing

4,169.47

0.0 %

1,104.58

-26.1 %

26.5 %

WuXi Biology

1,947.27

6.6 %

720.38

3.8 %

37.0 %

Others

355.26

-10.5 %

258.90

24.1 %

72.9 %

Discontinued Operations (Note 1)

406.65

-66.5 %

56.49

N/A

13.9 %

Total

32,856.72

18.6 %

15,455.04

36.3 %

47.0 %

Note 1: In accordance with the IFRSs, the Company has classified the operations for which equity sale agreements were signed or sales were completed during the first three quarters of 2025 or the comparison year as discontinued operations.

Note 2: Any sum of the data above that is inconsistent with the total is due to rounding.

Consolidated Statement of Profit or Loss [4] – Prepared under IFRSs

RMB Million

Three Months Ended September 30,

Nine Months Ended September 30,

2025

2024

2025

2024

Revenue

12,057.4

10,461.1

32,856.7

27,702.0

Cost of sales

(6,050.8)

(6,063.8)

(17,737.9)

(16,603.8)

Gross profit

6,006.6

4,397.3

15,118.9

11,098.2

Other income

280.4

247.6

920.0

758.6

Other gains and losses

188.0

(602.5)

2,637.0

(394.1)

Impairment losses under expected credit losses

("ECL") model, net of reversal

(169.0)

(72.5)

(459.6)

(154.6)

Impairment losses of non-financial assets

(80.0)

–

(153.5)

–

Impairment losses of assets classified as held for sale

–

–

(120.7)

–

Selling and marketing expenses

(175.0)

(189.1)

(569.4)

(546.6)

Administrative expenses

(721.8)

(687.4)

(1,969.5)

(1,964.9)

R&D expenses

(311.2)

(317.7)

(825.7)

(954.0)

Operating Profit

5,018.1

2,775.7

14,577.4

7,842.5

Share of results of associates

199.9

87.1

440.1

202.9

Share of results of joint ventures

0.6

0.2

0.6

(4.0)

Finance costs

(88.8)

(58.2)

(257.6)

(187.2)

Profit before tax

5,129.7

2,804.7

14,760.5

7,854.3

Income tax expense

(1,583.8)

(484.0)

(2,830.9)

(1,252.7)

Profit for the period

3,545.8

2,320.8

11,929.6

6,601.6

Profit for the period attributable to:

Owners of the Company

3,514.6

2,293.1

11,801.9

6,532.9

Non-controlling interests

31.2

27.7

127.6

68.7

3,545.8

2,320.8

11,929.6

6,601.6

[4] If the sum of the data below is inconsistent with the total, it is caused by rounding.

Consolidated Statement of Profit or Loss[5] (continued) – Prepared under IFRSs

Three Months Ended September 30,

Nine Months Ended September 30,

2025

2024

2025

2024

Weighted average number of ordinary shares for calculating EPS

(expressed in shares)

– Basic

2,839,378,755

2,883,580,115

2,839,864,290

2,899,626,297

– Diluted

2,877,629,997

2,889,573,492

2,873,641,499

2,906,724,914

Earnings per share (expressed in RMB per S hare)

– Basic

1.24

0.80

4.16

2.25

– Diluted

1.22

0.79

4.12

2.24

[5] If the sum of the data below is inconsistent with the total, it is caused by rounding.

Consolidated Statement of Financial Position[6] – Prepared under IFRSs

RMB Million

September 3 0 ,

December 31,

2025

2024

Non-current Assets

Property, plant and equipment

25,662.5

25,267.8

Right-of-use assets

1,837.0

1,874.8

Goodwill

866.0

972.4

Other intangible assets

420.1

601.0

Interests in associates

1,939.2

2,322.2

Interests in joint ventures

3.9

3.4

Deferred tax assets

512.9

473.1

Financial assets at fair value through profit or
loss ("FVTPL")

8,350.8

8,943.4

Other non-current assets

115.7

114.7

Biological assets

1,085.7

1,063.0

Total Non-current Assets

40,793.8

41,635.7

Current Assets

Inventories

6,011.0

3,532.1

Contract costs

929.0

912.2

Biological assets

903.7

955.5

Amounts due from related parties

115.5

89.3

Trade and other receivables

10,731.6

9,643.7

Contract assets

819.0

988.8

Income tax recoverable

42.8

87.2

Financial assets at FVTPL

3,561.0

1,234.0

Derivative financial instruments

1.8

–

Other current assets

742.3

734.1

Pledged bank deposits

57.5

22.1

Term deposits with initial term of over three
months

3,921.4

4,865.6

Bank balances and cash

25,459.9

13,434.3

53,296.6

36,498.8

Assets classified as held for sale

515.7

2,191.3

Total Current Assets

53,812.3

38,690.2

Total Assets

94,606.1

80,325.8

[6] If the sum of the data below is inconsistent with the total, it is caused by rounding.

Consolidated Statement of Financial Position (continued)[7]– Prepared under IFRSs

RMB Million

September 3 0 ,

December 31,

2025

2024

Current Liabilities

Trade and other payables

7,746.5

7,025.5

Amounts due to related parties

7.9

15.3

Derivative financial instruments

2.9

202.0

Contract liabilities

2,565.7

2,251.0

Bank borrowings

5,282.1

1,278.6

Lease liabilities

179.9

224.2

Income tax payables

2,249.9

870.8

Convertible bonds

1,294.5

3,493.1

19,329.3

15,360.6

Liabilities directly associated with assets
classified as held for sale

109.0

865.5

Total Current Liabilities

19,438.3

16,226.1

Non-current Liabilities

Bank borrowings

1,799.1

2,959.5

Deferred tax liabilities

433.7

522.4

Deferred income

929.9

985.6

Lease liabilities

532.7

546.6

Total Non-current Liabilities

3,695.4

5,014.1

Total Liabilities

23,133.6

21,240.2

Net Assets

71,472.5

59,085.6

Capital and Reserves

Share capital

2,965.7

2,888.0

Reserves

67,982.4

55,744.7

Equity attributable to owners of the Company

70,948.1

58,632.7

Non-controlling interests

524.4

452.9

Total Equity

71,472.5

59,085.6

[7] If the sum of the data below is inconsistent with the total, it is caused by rounding.

Adjusted Non-IFRS Net Profit Attributable to the Owners of the Company[8]

RMB Million

Three Months Ended September 30,

Nine Months Ended September 30,

2025

2024

2025

2024

Net p rofit attributable to the owners of the Company under CAS

3,514.6

2,293.1

12,075.5

6,532.9

GAAP difference[9]

–

–

(273.6)

–

Net p rofit attributable to the owners of the Company under IFRSs

3,514.6

2,293.1

11,801.9

6,532.9

Add:

Share-based compensation expenses

249.9

79.4

426.3

244.4

Issuance expenses of convertible bonds

8.7

–

28.4

–

Foreign exchange related losses

100.0

629.8

548.0

658.7

Amortization of acquired intangible assets from merger and
acquisition

6.7

13.3

20.5

40.3

Gains or losses from divestiture, restructuring and resource
integration initiatives

88.4

–

228.3

–

Non-IFRS net profit attributable to the owners of the Company

3,968.5

3,015.6

13,053.5

7,476.3

Add:

Realized and unrealized losses(gains) from venture capital
investments

254.4

(41.9)

(2,515.7)

(134.6)

Realized and unrealized share of (gains)losses from joint ventures

(0.6)

(0.2)

(0.6)

4.0

Adjusted non-IFRS net profit attributable to the owners of the
Company

4,222.3

2,973.5

10,537.1

7,345.7

(Press release, WuXi AppTec, OCT 26, 2025, View Source [SID1234657022])