WuXi AppTec Achieves Strong Growth in Revenue and Profit for Q2 and H1 2025, H1 Revenue from Continuing Operations[1] Up 24.2% YoY, and Adjusted Non-IFRS Net Profit Up 44.4% YoY; Backlog for Continuing Operations Up 37.2% YoY

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

Compugen to Present a Pooled Analysis of COM701 Phase 1 trials in Platinum Resistant Ovarian Cancer at ESMO 2025

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

Servier Announces Positive Data from Long-Term Follow-Up Analysis of the Phase 3 AGILE Trial of TIBSOVO® (ivosidenib) in IDH1-mutated Acute Myeloid Leukemia

On July 28, 2025 Servier reported that Blood Advances published long-term data from the Phase 3 AGILE trial evaluating TIBSOVO (ivosidenib) in combination with azacitidine versus placebo-azacitidine in patients with newly diagnosed mutant isocitrate dehydrogenase 1 (mIDH1) acute myeloid leukemia (AML) who were unfit to receive intensive chemotherapy (Press release, Servier, JUL 28, 2025, View Source [SID1234654582]). The post-hoc analysis reports positive long-term follow-up results from the pivotal Phase 3 AGILE trial and continues to demonstrate the sustained survival benefit reported in the previous analysis published in the New England Journal of Medicine (NEJM).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"The clear and robust clinical benefit demonstrated by these long-term analyses – including prolonged overall survival and hematologic recovery – support TIBSOVO as a standard of care treatment for patients with IDH1-mutated AML," said Susan Pandya, M.D., Vice President Clinical Development and Global Head of Oncology LS/LCM, Servier. "These data are a testament to Servier’s industry-leading research in IDH1-mutated cancers, including AML, and demonstrate our steadfast commitment to improving outcomes for patients."

As of data cutoff in June 2022, median follow-up was 28.6 months. Key findings from the newly published analysis include:

Median overall survival (OS) was significantly longer in patients treated with the TIBSOVO combination (29.3 months; 95% CI, 13.2 – not reached) than placebo-azacitidine (7.9 months; 95% CI, 4.1-11.3; hazard ration [HR]=0.42 [0.27, 0.65]; p<.0001).
Hematologic recovery was generally faster and lasted longer in patients in the TIBSOVO arm compared to placebo-azacitidine. Conversion to transfusion independence was more common with TIBSOVO (53.8%) than placebo-azacitidine (17.1%; p=.0004).
Ten (30.3%) of the 33 molecular measurable-residual disease (MRD)-evaluable patients in the TIBSOVO arm converted to an MRD-negative response by Day 1 of Cycle 14, all of whom had a complete response (CR). Seven (70%) of these patients converted to an MRD-negative response by Day 1 of Cycle 7. Of the 23 patients who remained MRD-positive, 19 had a CR and four had a CR with incomplete hematologic recovery (CRi). Two patients (20%) had an MRD-negative response in the placebo-azacitidine arm.
The long-term safety profile of TIBSOVO with azacitidine was consistent with previously reported data. The most commonly reported Grade ≥3 hematologic adverse events (AEs) were anemia (26.4%), neutropenia (30.6%), and febrile neutropenia (27.8%). The most common Grade ≥3 nonhematologic AEs were electrocardiogram QT prolonged (11.1%), pneumonia (22.2%), nausea, (2.8%), hypokalemia (2.8%), and pyrexia (2.8%). There were no new or unexpected safety signals or additional treatment discontinuations due to AEs compared with the primary analysis.
"Long-term results from the AGILE trial underscore the power of TIBSOVO to improve outcomes for patients with IDH1-mutated AML unfit for intensive chemotherapy, a group who historically has had a poor long-term prognosis," said Hartmut Döhner, MD, Professor of Medicine and Director of the Department of Internal Medicine III at the University Hospital Ulm in Germany and Director of the National Center for Tumor Diseases SouthWest (NCT-SW; Ulm site). "These results continue to emphasize the importance of early systematic genetic testing to guide treatment selection for patients – which may lead to improved overall survival rates and a reduction in the risk of death as seen in this study."

TIBSOVO was approved by the U.S. Food and Drug Administration (FDA) in combination with azacitidine for the treatment of patients with newly diagnosed IDH1-mutated AML in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy, in May 2022 under Priority Review. The supplemental New Drug Application (sNDA) for TIBSOVO was reviewed by the FDA under its Real-Time Oncology Review (RTOR) pilot program, which aims to ensure that safe and effective treatments are available to patients as early as possible.

H1 and Q2 2025 results

On July 28, 2025 AstraZeneca’s Chief Executive Officer, Pascal Soriot, reported on the results and said (Press release, AstraZeneca, JUL 28, 2025, View Source [SID1234654581]):

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"Our strong momentum in revenue growth continued through the first half of the year and the delivery from our broad and diverse pipeline has been excellent, with 12 positive key Phase III trial readouts including for baxdrostat, gefurulimab, and Tagrisso in just the past few weeks.

As we enter our next phase of growth, we have pledged $50 billion to continue to grow in the US, which includes the largest manufacturing investment in AstraZeneca’s history, set for Virginia. This landmark investment reflects not only America’s importance but also our confidence in our innovative medicines to transform global health and power AstraZeneca’s ambition to deliver $80 billion revenue by 2030."

Immutep Announces Abstracts Accepted for Presentation at the European Society for Medical Oncology Congress 2025

On July 28, 2025 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a late-stage immunotherapy company targeting cancer and autoimmune diseases, reported three abstracts for clinical trials evaluating its first-in-class MHC Class II agonist, eftilagimod alfa (efti), have been accepted for presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025 taking place 17-21 October in Berlin, Germany (Press release, Immutep, JUL 28, 2025, View Source [SID1234654580]).

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A Proffered Paper oral presentation will detail results from EFTISARC-NEO, a Phase II investigator-initiated trial in resectable soft tissue sarcoma, and data from the INSIGHT-003 Phase I investigator-initiated trial in first-line non-small cell lung cancer (1L NSCLC) has been accepted for poster presentation. Additionally, an abstract on the Company’s pivotal TACTI-004 Phase III in 1L NSCLC has been accepted for a Trials in Progress ePoster. Details of the presentations are as follows:

Title: EFTISARC-NEO: A phase II study of neoadjuvant eftilagimod alpha, pembrolizumab and radiotherapy in patients with resectable soft tissue sarcoma
Presenter: Katarzyna Kozak, M.D., Ph.D., Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland
Session Category: Proffered Paper
Session Title: Sarcoma
Presentation #: 2686O
Date and Time: Sunday, 19 October 2025 at 16:30 – 18:00 PM CET

Title: Eftilagimod alpha (soluble LAG-3 protein) combined with 1st line chemo-immunotherapy in metastatic non-squamous non-small cell lung cancer (NSCLC) –Updates from INSIGHT-003 (IKF614)
Presenter: Dr. med. Akin Atmaca, Department of Hematology and Oncology, Krankenhaus Nordwest, UCT-University Cancer Center, Frankfurt, Germany
Session Category: Poster
Session Title: NSCLC, metastatic
Presentation #: 1857P
Date and Time: Saturday, 18 October 2025 at 12:00 – 12:45 PM CET

Title: TACTI-004, a double-blinded, randomised phase 3 trial of eftilagimod alfa plus pembrolizumab (P) + chemotherapy (C) vs placebo + P + C in 1st line advanced/metastatic NSCLC
Presenter: Prof. Dr. med. Hans-Georg Kopp, Robert Bosch Hospital, Stuttgart, Germany
Session Category: ePoster
Session Title: NSCLC, metastatic
Presentation #: 2086eTiP

Proffered Papers at ESMO (Free ESMO Whitepaper) are oral presentations of original data of superior quality, followed by expert discussion and perspectives.

Abstracts will be made available on the ESMO (Free ESMO Whitepaper) website on 13 October 2025 at 00.05 CET. The posters will be available on the Posters & Publications section of Immutep’s website after their presentations.