On July 28, 2025 Deciphera Pharmaceuticals, LLC, a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines, and Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; "Ono"), reported that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of vimseltinib for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with clinically relevant physical function deterioration and in whom surgical options have been exhausted or would induce unacceptable morbidity or disability (Press release, Deciphera Pharmaceuticals, JUL 28, 2025, View Source [SID1234654587]).

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The positive CHMP opinion is a scientific recommendation for marketing authorization and one of the final steps before the European Commission (EC), which has the authority to approve medicines in the European Union (EU), issues a decision on Deciphera’s marketing authorization application (MAA) for vimseltinib. This decision is expected in the second quarter of the fiscal year ending March 31, 2026.

"CHMP’s positive opinion is an important milestone for the TGCT community in the European Union (EU), where there are currently no approved treatments for TGCT, and for vimseltinib, which is now one step closer to potential EU regulatory approval," said Ryota Udagawa, President and Chief Executive Officer of Deciphera. "We look forward to building upon vimseltinib’s positive CHMP opinion as we work to bring this medicine to TGCT patients around the world in need of new treatment options."

The positive CHMP opinion is supported by compelling efficacy and safety results from the pivotal Phase 3 MOTION study of vimseltinib in patients with TGCT not amenable to surgery with no prior anti-CSF1/CSF1R therapy (prior therapy with imatinib or nilotinib allowed), compared to placebo, as well as the Phase 1/2 study of vimseltinib. In MOTION, vimseltinib demonstrated a statistically significant and clinically meaningful objective response rate (ORR) at Week 25 in the intent-to-treat (ITT) population, as assessed by blinded independent radiologic review (BIRR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), versus placebo (40% in vimseltinib arm vs 0% in placebo arm, p <0.0001). The primary endpoint was supported by statistically significant and clinically meaningful improvements in active range of motion, patient-reported physical functioning, and patient-reported pain observed in the vimseltinib arm compared to the placebo arm at week 25. The safety profile of vimseltinib is manageable and consistent with results previously disclosed in the Phase 1/2 clinical trial.

About vimseltinib

Vimseltinib is an oral switch-control tyrosine kinase inhibitor specifically designed to selectively and potently inhibit CSF1R. Vimseltinib has been developed using Deciphera’s proprietary switch-control kinase inhibitor platform. ROMVIMZA (vimseltinib) is a kinase inhibitor approved in the United States for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity.

About Tenosynovial Giant Cell Tumor (TGCT)

TGCT is caused by a translocation in colony-stimulating factor 1 (CSF1) gene resulting in overexpression of CSF1 and recruitment of colony-stimulating factor 1 receptor (CSF1R)-positive inflammatory cells into the lesion. TGCT is a rare, non-malignant tumor that develops inside or near joints. TGCT is caused by dysregulation of the CSF1 gene leading to overproduction of CSF1. TGCT is also known as giant cell tumor of the tendon sheath (GCT-TS) or pigmented villonodular synovitis (PVNS), a diffuse-type of TGCT. TGCT is a locally aggressive neoplasm that can grow and cause damage to surrounding tissues and structures inducing pain, swelling, and limitation of movement of the joint. Surgery is the main treatment option; however, these tumors tend to recur, particularly in diffuse-type TGCT. If untreated or if the tumor continually recurs, damage and degeneration may occur in the affected joint and surrounding tissues, which may cause significant disability. For a subset of patients, surgical resection will potentially cause worsening functional limitation or severe morbidity, systemic treatment options are limited and a new therapeutic option for TGCT is needed.

On July 28, 2025 MAIA Biotechnology, Inc. (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) for the treatment of non-small cell lung cancer (NSCLC) (Press release, MAIA Biotechnology, JUL 28, 2025, View Source [SID1234654586]). Ateganosine is currently being evaluated in a pivotal Phase 2 THIO-101 clinical trial evaluating its anti-tumor activity when followed by a checkpoint inhibitor.

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Ateganosine is a first-in-class small molecule that compromises telomere structure and function in cancer cells, leading to rapid tumor cell elimination and specific immune memory. Through telomerase-mediated action, ateganosine reverses intrinsic or acquired resistance to immune checkpoint inhibitors (ICIs).

"FDA’s Fast Track Designation recognizes ateganosine’s potential as a new therapeutic paradigm in cancer treatment science. Ateganosine is the first and only anticancer treatment of its kind that we are aware of in clinical development," stated MAIA Chairman and CEO Vlad Vitoc, M.D. "If we are successful in the Fast Track regulatory pathway, ateganosine could qualify for accelerated FDA approval and robust exclusivity in NSCLC, with a potential FDA decision as early as next year. If approved, ateganosine would have a first-to-market competitive position within a $34 billion NSCLC treatment market with significant unmet medical need."

NSCLC represents one of the largest global oncology indications. The market was valued at $34.1B in 2024 and is projected to reach $68.8B by 2033 with a projected CAGR of 8.1%.1

"This is an important milestone for MAIA’s clinical development program. Ateganosine has demonstrated robust preclinical efficacy and superior clinical median overall survival compared to other FDA-approved treatments for NSCLC patients with prior disease progression on platinum-based chemotherapy and anti-PD-(L)1 antibody. Additionally, advanced NSCLC is a devastating disease that clearly meets the criteria for a serious condition with unmet medical need. Both are key criteria for the Fast Track designation," said K. Robinson Lewis, Vice President, Head of Regulatory and Quality at MAIA. "We intend to utilize the incentives of the Fast Track Program to expedite the development and review of ateganosine and bring patient access sooner."

The FDA Fast Track is a process designed to facilitate development and expedite the review of drugs for treating serious conditions and filling an unmet medical need, as in providing a therapy where none exists or which may be potentially better than available therapy. If relevant criteria are met during the Fast Track process, a drug will be eligible for FDA Accelerated Approval and Priority Review (FDA decision within six months).

MAIA’s most recent data from the pivotal Phase 2 THIO-101 clinical trial of ateganosine as of May 15, 2025 showed median overall survival (OS) of 17.8 months in a heavily pre-treated population. As of the data cut-off date, the patient with the longest survival in the trial had completed 32 cycles of therapy and had 24.3 months survival. Studies of standard-of-care chemotherapy treatments for NSCLC in a similar setting have shown overall survival of 5 to 6 months.

About Ateganosine

Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101 Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate ateganosine’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of ateganosine administered prior to cemiplimab (Libtayo) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of ateganosine administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of ateganosine using Overall Response Rate (ORR) as the primary clinical endpoint. The expansion of the study will assess overall response rates (ORR) in advanced NSCLC patients receiving third line (3L) therapy who were resistant to previous checkpoint inhibitor treatments (CPI) and chemotherapy. Treatment with ateganosine followed by cemiplimab (Libtayo) has shown an acceptable safety profile to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

On July 28, 2025 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a patented, FDA-cleared drug-delivery device, reported the launch of the PanTheR Post-Marketing Registry Study (NCT06805461) (Press release, Renovorx, JUL 28, 2025, View Source [SID1234654585]).

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The initiation of this study demonstrates RenovoRx’s commitment to innovation and RenovoCath’s current and future potential. The study will serve as a critical tool for understanding RenovoCath’s safety and effectiveness in a real-world setting, providing valuable insights into long-term effectiveness and patient outcomes. Patient enrollment is expected to commence before the end of September 2025. Each cancer center participating in the registry study will purchase RenovoCath devices for use in the study from RenovoRx.

A registry study, or post-approval study, is a clinical study that involves collecting data on the long-term use and performance of a medical device, such as RenovoCath, after it has been cleared for market by the FDA. PanTheR is a multi-center, post-marketing observational registry study designed to evaluate the long-term safety of and survival outcomes for patients diagnosed with solid tumors who are treated using RenovoCath for targeted drug delivery. PanTheR will capture real-world data on the utilization of RenovoCath and generate additional safety information across a broader range of solid tumors. This data may be used to inform future clinical trial designs.

The first of multiple clinical sites to initiate patient enrollment in the PanTheR study is the University of Vermont (UVM) Cancer Center, with Dr. Conor O’Neill, Assistant Professor at the UVM Larner College of Medicine and surgical oncologist at the UVM Medical Center, serving as Principal Investigator. Additional clinical sites in the post-marketing registry study are expected to initiate enrollment soon.

"PanTheR marks a significant step forward in our commitment to better understand and demonstrate the long-term safety and therapeutic potential of our RenovoCath device," said Leesa Gentry, Chief Clinical Officer of RenovoRx. "By collaborating with leading cancer centers across the U.S, this is a low-cost study that will yield valuable data. By gathering real-world data across diverse cancer types and clinical environments, PanTheR aims to advance innovation and inform evidence-based treatment strategies, which will ultimately enhance care and potentially improve outcomes for future patients facing solid tumors."

"We are very pleased that the UVM Cancer Center has been initiated to begin enrollment in the PanTheR study," Ms. Gentry continued. "The UVM Cancer Center offers leading-edge care, provided by highly skilled oncologists priding themselves on using the latest research and education for informed care. We believe our study will be an excellent fit within University of Vermont’s oncology program."

"We are proud to be part of this important study that holds the potential to transform the way we treat solid tumors," said Dr. Conor O’Neill of the University of Vermont Cancer Center. "I believe the RenovoCath device offers a novel approach for drug delivery, which may have the potential to improve patient outcomes. This study emphasizes our strong commitment to continually advance treatment options offered to our patients by offering access to the latest innovations that have the potential to transform the treatment paradigm for solid tumors."

To learn more about PanTheR (NCT06805461), visit clinicaltrials.gov for details: View Source;rank=1.

About RenovoCath

Based on its FDA clearance, RenovoCath is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system. RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. For further information regarding our RenovoCath Instructions for Use ("IFU"), please see: IFU-10004-Rev.-G-Universal-IFU.pdf.

On July 28, 2025 WuXi AppTec (stock code: 603259.SH / 2359.HK), a global company that provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical and life sciences industry, reported financial results for the first half ending June 30, 2025 ("Reporting Period") (Press release, WuXi AppTec, JUL 28, 2025, View Source;h1-revenue-from-continuing-operations1-up-24-2-yoy-and-adjusted-non-ifrs-net-profit-up-44-4-yoy-backlog-for-continuing-operations-up-37-2-yoy-302514805.html [SID1234654584]):

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For the first half of 2025, total revenue reached RMB20.80 billion, up 20.6% year-over-year. Revenue from Continuing Operations reached RMB20.41 billion, up 24.2% year-over-year.
Adjusted non-IFRS gross profit reached RMB9.26 billion, with the adjusted non-IFRS gross profit margin up 4.7pts year-over-year to 44.5%.
Net profit attributable to the owners of the Company was RMB8.56 billion, up 101.9% year-over-year; diluted EPS was RMB2.99, up 106.2% year-over-year.
Adjusted non-IFRS net profit attributable to the owners of the Company was RMB6.31 billion, up 44.4% year-over-year; adjusted non-IFRS net profit margin up 5.0pts year-over-year to 30.4%; adjusted non-IFRS diluted EPS was RMB2.20, up 46.7% year-over-year.
With continuous capacity expansion to better meet customer demand, backlog for Continuing Operations reached RMB56.69 billion as of June 30, 2025, up 37.2% year-over-year.
Operating cash flow climbed 49.1% year-over-year to RMB7.07 billion, driven by business growth, increase in operating efficiency, and continued improvement of financial management capabilities.
The Company’s sustained and steady business growth is the 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 half of 2025, a total of 412 new molecules have been added to the small molecule Development and Manufacturing (D&M) pipeline. As of June 30, 2025, our small molecule D&M pipeline reached 3,409 molecules, representing an increase of 8 projects in phase III and commercial stages during the first half of 2025.
The Company has been accelerating global expansion and capacity construction. 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, and the total reactor volume of Solid Phase Peptide Synthesizers is expected to increase to more than 100,000L.
As an enabler of innovation and a trusted partner and contributor to the global pharmaceutical and life sciences industry, the Company actively advanced sustainability and has been extensively recognized by global rating agencies. The Company has achieved the highest "AAA" rating from MSCI for the first time, becoming the first A-share listed company in the life sciences industry to achieve this milestone. In addition, the Company’s near-term emissions reduction targets have been validated by Science Based Targets initiatives (SBTi). Our accomplishments have also been acknowledged by major global rating agencies, including EcoVadis, CDP, United Nations Global Compact (UNGC), Sustainalytics and FTSE Russell.
The Company remains committed to rewarding shareholders and actively supporting the Company’s value. In the first half of 2025, the Company distributed a total of RMB3.84 billion in cash dividends, including RMB2.83 billion for the 2024 annual cash dividend and RMB1.01 billion for the 2025 special cash dividend. Meanwhile, the Company also completed the repurchase and cancellation of RMB1.0 billion worth of A-shares in the first half. An additional, previously announced RMB1.0 billion worth of A-share repurchase and cancellation plan is currently being implemented, with approximately RMB0.5 billion worth of A-shares repurchased as of now. Moreover, the Company’s Board of Directors approved WuXi AppTec’s first interim dividend plan, distributing RMB3.50 cash dividend for every 10 shares (approximately RMB1.0 billion in total) to shareholders.
[1] As disclosed in 2025 Interim 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 H1 and 2025 H1, WuXi AppTec had a fully-diluted weighted average share count of 2,913,355,532 and 2,897,449,552 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 raised full-year guidance despite external uncertainties.

The Company expects Continuing Operations revenue to resume double-digit growth in 2025, with its year-over-year growth rate raised to 13-17%, up from the prior 10-15%. As a result, the Company expects full-year total revenue of RMB42.5-43.5 billion, up from the prior RMB41.5-43.0 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.

Capex is expected to reach RMB7.0-8.0 billion in 2025. Together with business growth and efficiency improvement, free cash flow is expected to increase from RMB4.0-5.0 billion to RMB5.0-6.0 billion.

Management Comment

Dr. Ge Li, Chairman and CEO of WuXi AppTec, said, "WuXi AppTec once again delivered robust double-digit growth in both revenue and profit in the second quarter, demonstrating the strength of our unique CRDMO business model and the dedication of our global teams. In the first half of 2025, we achieved revenue of RMB20.8 billion, with Continuing Operations revenue growing 24.2% year-over-year, and adjusted non-IFRS net profit growing 44.4% year-over-year, while our backlog for Continuing Operations reached a new record high of RMB56.7 billion."

"Building on this strong momentum and consistent execution, we have raised our 2025 full-year revenue target to RMB42.5-43.5 billion, with Continuing Operations now expected to achieve 13-17% year-over-year double-digit growth, and correspondingly, the free cash flow target up to RMB5.0-6.0 billion. We remain focused on enhancing our core capabilities, expanding capacity, and improving operating efficiency to create greater value for our customers and shareholders."

"Guided by our vision that ‘Every drug can be made and every disease can be treated,’ we are committed to enabling our partners to deliver innovative therapies to patients worldwide. Together, we will continue to advance healthcare innovation and improve lives."

Business Performance by Segments

WuXi Chemistry: CRDMO Business Model Drives Continuous Growth; H1 2025 Revenue Up 33.5% YoY, with TIDES Revenue Up 141.6% YoY
H1 revenue of WuXi Chemistry reached RMB16.30 billion, up 33.5% 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, H1 adjusted non-IFRS gross profit margin steadily improved 5.2pts year-over-year to 49.0%.
Small molecule drug discovery service ("R") continues to generate downstream opportunities. In the past 12 months, we successfully synthesized and delivered more than 440,000 new compounds to customers. In the meantime, 158 molecules were converted from R to D phase in the first half 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.
i. The small molecule CDMO pipeline continued to expand. H1 revenue of small molecule D&M services rose 17.5% year-over-year to RMB8.68 billion. In the first half of 2025, 412 new molecules were added to the small molecule D&M pipeline. As of June 30, 2025, our small molecule D&M pipeline reached 3,409 molecules, including 76 commercial projects, 84 in phase III, 368 in phase II and 2,881 in phase I and pre-clinical stages. That represents an increase of 8 projects in the commercial and phase III stages during the first half of 2025.
ii. 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.
i. With the ramp-up of new capacities released sequentially each quarter last year, H1 TIDES revenue grew 141.6% year-over-year to RMB5.03 billion. As of June 30, 2025, TIDES backlog was up 48.8% year-over-year.
ii. TIDES D&M customers grew 12% year-over-year, while the number of TIDES molecules grew 16% year-over-year.
iii. We continued to build peptide capacity in Taixing. Total reactor volume of Solid Phase Peptide Synthesizers is expected to increase to over 100,000L by the end of 2025.
WuXi Testing[4]: Drug Safety Evaluation Service & Site Management Organization (SMO) Maintain Leading Positions
WuXi Testing revenue reached RMB2.69 billion in H1, and H1 adjusted non-IFRS gross profit margin was 25.1%.
Q2 revenue of lab testing services reached RMB1.00 billion, growing 5.5% year-over-year and 13.2% quarter-over-quarter. Of which, drug safety evaluation services revenue grew 3.4% year-over-year and 10.2% quarter-over-quarter.
H1 revenue of lab testing services grew 0.4% year-over-year to RMB1.89 billion. Due to market impact, its H1 adjusted non-IFRS GPM declined as pricing gradually reflected in revenue along with backlog conversion. Of which, drug safety evaluation services revenue was down 2.2% year-over-year, 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 Suzhou facility has successfully passed 4 consecutive FDA on-site inspections.
H1 revenue for clinical CRO & SMO declined 4.7% year-over-year to RMB0.80 billion due to market pricing impact. Of which, SMO revenue grew 1.5% year-over-year and maintained the industry leading position in China.
During the first half of 2025, our clinical CRO business supported customers to obtain 12 IND approvals and submit for 2 NDA filings; the SMO business supported 61 new drug approvals for customers. The SMO business has supported 317 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 and continuously strengthens drug discovery capabilities in emerging areas. It efficiently generates downstream opportunities for CRDMO model by continuously contributing more than 20% of the Company’s new customers.
Through platform integration, cross-regional collaboration and comprehensive service transformation, we efficiently enable our customers. WuXi Biology revenue reached RMB1.25 billion in H1 2025, a year-over-year increase of 7.1%. Due to market pricing impact, H1 adjusted non-IFRS gross profit margin was down 0.7pts to 36.4%.
We accelerated advancements in in vitro integrated screening technologies and in vivo pharmacology capabilities, driving continued rapid year-over-year revenue growth. The constantly improved competitive edge in non-oncology business has laid a solid foundation for sustained growth throughout the year.
New modality drug discovery services continue to perform well, contributing more than 30% of WuXi Biology’s total revenue.
[4] As disclosed in the 2025 First Quarterly Report, WuXi Testing here includes only the core business of Continuing Operations (similar to the 2024 baseline).

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 Interim Results Presentation and 2025 Interim 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 Interim Report of the Company has not been audited.

Second 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

8,910.40

34.0 %

4,475.02

52.4 %

50.2 %

WuXi Testing

1,396.33

1.6 %

373.99

-27.1 %

26.8 %

WuXi Biology

644.53

6.0 %

235.47

7.8 %

36.5 %

Others

93.89

-55.7 %

67.23

-55.3 %

71.6 %

Discontinued
Operations (Note 1)

99.54

-76.1 %

57.93

N/A

58.2 %

Total

11,144.69

20.4 %

5,209.65

38.0 %

46.7 %

First Half 2025 Results by Segments

Unit: RMB million

Segment

Revenue

Change

Adjusted
non-IFRS
Gross Profit

Change

Adjusted non-
IFRS Gross
Profit Margin

WuXi Chemistry

16,301.37

33.5 %

7,984.86

49.4 %

49.0 %

WuXi Testing

2,688.65

-1.2 %

675.89

-33.6 %

25.1 %

WuXi Biology

1,251.60

7.1 %

455.89

5.0 %

36.4 %

Others

163.48

-49.6 %

97.31

-48.0 %

59.5 %

Discontinued
Operations (Note 1)

394.18

-51.7 %

44.02

N/A

11.2 %

Total

20,799.28

20.6 %

9,257.96

34.9 %

44.5 %

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 Reporting Period 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[5] – Prepared under IFRSs

RMB Million

Three Months Ended June 30,

Six Months Ended June 30,

2025

2024

2025

2024

Revenue

11,144.7

9,259.0

20,799.3

17,240.9

Cost of sales

(6,045.5)

(5,563.8)

(11,687.0)

(10,540.0)

Gross profit

5,099.2

3,695.1

9,112.2

6,700.9

Other income

328.2

269.0

639.5

511.0

Other gains and losses

1,375.7

15.5

2,448.9

208.4

Impairment losses under expected credit losses

("ECL") model, net of reversal

(137.5)

(62.4)

(290.6)

(82.1)

Impairment losses of non-financial assets

(4.0)

–

(73.5)

–

Impairment losses of assets classified as held for sale

(120.7)

–

(120.7)

–

Selling and marketing expenses

(200.3)

(178.4)

(394.4)

(357.5)

Administrative expenses

(649.9)

(667.0)

(1,247.7)

(1,277.5)

R&D expenses

(290.0)

(329.9)

(514.4)

(636.3)

Operating Profit

5,400.5

2,741.9

9,559.4

5,066.8

Share of results of associates

176.3

81.9

240.2

115.8

Share of results of joint ventures

–

(4.4)

0.1

(4.2)

Finance costs

(88.6)

(67.3)

(168.8)

(128.9)

Profit before tax

5,488.1

2,752.2

9,630.8

5,049.6

Income tax expense

(682.6)

(430.2)

(1,247.1)

(768.7)

Profit for the period

4,805.5

2,322.0

8,383.8

4,280.8

Profit for the period attributable to:

Owners of the Company

4,751.1

2,297.6

8,287.3

4,239.8

Non-controlling interests

54.4

24.4

96.4

41.0

4,805.5

2,322.0

8,383.8

4,280.8

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

Consolidated Statement of Profit or Loss[6] (continued) – Prepared under IFRSs

Three Months Ended June 30,

Six Months Ended June 30,

2025

2024

2025

2024

Weighted average number of ordinary shares for calculating EPS

(expressed in shares)

– Basic

2,834,045,549

2,895,745,826

2,840,111,082

2,907,737,554

– Diluted

2,892,304,153

2,899,828,193

2,897,449,552

2,913,355,532

Earnings per share (expressed in RMB per Share)

– Basic

1.68

0.79

2.92

1.46

– Diluted

1.66

0.79

2.89

1.45

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

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

RMB Million

June 30,

December 31,

2025

2024

Non-current Assets

Property, plant and equipment

25,725.6

25,267.8

Right-of-use assets

1,901.4

1,874.8

Goodwill

971.6

972.4

Other intangible assets

511.7

601.0

Interests in associates

1,887.1

2,322.2

Interests in joint ventures

3.4

3.4

Deferred tax assets

511.1

473.1

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

8,504.4

8,943.4

Other non-current assets

153.6

114.7

Biological assets

1,065.1

1,063.0

Total Non-current Assets

41,235.0

41,635.7

Current Assets

Inventories

5,293.6

3,532.1

Contract costs

925.8

912.2

Biological assets

931.8

955.5

Amounts due from related parties

85.9

89.3

Trade and other receivables

9,137.4

9,643.7

Contract assets

825.7

988.8

Income tax recoverable

39.8

87.2

Financial assets at FVTPL

2,942.4

1,234.0

Derivative financial instruments

2.6

–

Other current assets

735.6

734.1

Pledged bank deposits

12.2

22.1

Term deposits with initial term of over three months

3,937.5

4,865.6

Bank balances and cash

17,535.5

13,434.3

42,406.0

36,498.8

Assets classified as held for sale

182.8

2,191.3

Total Current Assets

42,588.7

38,690.2

Total Assets

83,823.8

80,325.8

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

Consolidated Statement of Financial Position (continued)[8]– Prepared under IFRSs

RMB Million

June 30,

December 31,

2025

2024

Current Liabilities

Trade and other payables

7,410.2

7,025.5

Amounts due to related parties

12.5

15.3

Derivative financial instruments

–

202.0

Contract liabilities

2,227.1

2,251.0

Bank borrowings

5,798.2

1,278.6

Lease liabilities

220.9

224.2

Income tax payables

1,296.3

870.8

Convertible bonds

3,517.4

3,493.1

20,482.6

15,360.6

Liabilities directly associated with assets
classified as held for sale

36.4

865.5

Total Current Liabilities

20,518.9

16,226.1

Non-current Liabilities

Bank borrowings

904.9

2,959.5

Deferred tax liabilities

439.4

522.4

Deferred income

959.4

985.6

Lease liabilities

592.1

546.6

Total Non-current Liabilities

2,895.8

5,014.1

Total Liabilities

23,414.7

21,240.2

Net Assets

60,409.1

59,085.6

Capital and Reserves

Share capital

2,872.2

2,888.0

Reserves

57,039.5

55,744.7

Equity attributable to owners of the Company

59,911.7

58,632.7

Non-controlling interests

497.4

452.9

Total Equity

60,409.1

59,085.6

[8] 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[9]

RMB Million

Three Months Ended June 30,

Six Months Ended June 30,

2025

2024

2025

2024

Net profit attributable to the owners of the Company under CAS

4,888.9

2,297.6

8,560.9

4,239.8

GAAP difference[10]

(137.9)

–

(273.6)

–

Net profit attributable to the owners of the Company under IFRSs

4,751.1

2,297.6

8,287.3

4,239.8

Add:

Share-based compensation expenses

142.0

77.2

176.4

165.0

Issuance expenses of convertible bonds

9.8

–

19.6

–

Foreign exchange related losses

270.0

14.6

448.0

29.0

Amortization of acquired intangible assets from merger and
acquisition

6.7

13.4

13.8

27.0

Gains or losses from divestiture, restructuring and resource
integration initiatives

131.3

–

139.9

–

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

5,310.9

2,402.7

9,085.0

4,460.7

Add:

Realized and unrealized (gains)losses from venture capital investments

(1,673.8)

51.9

(2,770.1)

(92.7)

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

(0.0)

4.4

(0.1)

4.2

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

3,637.1

2,459.1

6,314.8

4,372.2

On July 28, 2025 Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in predictive computational drug target discovery powered by AI/ML, reported that it will present a pooled analysis of data from three Phase 1 trials evaluating COM701 as monotherapy and combination therapy in heavily pretreated platinum resistant ovarian cancer patients at ESMO (Free ESMO Whitepaper) 2025, being held on October 17-21, 2025, in Berlin, Germany (Press release, Compugen, JUL 28, 2025, View Source [SID1234654583]).

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Poster details:
Title: COM701 in Ovarian Cancer: A Pooled Analysis of 3 Phase 1 Clinical Trials
Speaker: Dr. Oladapo Yeku, Massachusetts General Hospital, Boston, MA, U.S.
Poster presentation number: 1196P
Date of poster presentation: Saturday, October 18; 12:00-12:45 CEST

The poster will be available in the publications section of Compugen’s website, www.cgen.com