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])

On October 26, 2025 Novartis reported that it has entered into an agreement to acquire Avidity Biosciences, Inc. (Nasdaq: RNA), a San Diego-based, biopharmaceutical company focused on a new class of therapeutics enabling RNA delivery to muscle. The acquisition will follow the separation of Avidity’s early-stage precision cardiology programs.

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Avidity is committed to delivering a new class of pioneering RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs) for serious, genetic neuromuscular diseases. The proposed acquisition will bring Avidity’s late-stage neuroscience programs into Novartis and provide Novartis access to a differentiated RNA-targeting delivery platform. These programs are expected to advance the company’s neuroscience strategy and complement the current pipeline with potential first-in-class therapeutic candidates that address the genetic drivers of muscle-damaging conditions.

"Avidity’s pioneering AOC platform for RNA therapeutics ​and its late-stage assets bolster our commitment to delivering innovative, targeted and potentially first-in-class medicines to treat devastating, progressive neuromuscular diseases," said Vas Narasimhan, CEO of Novartis. "The Avidity team has built robust programs with industry-leading delivery of RNA therapeutics to muscle tissue. We look forward to developing these programs to meaningfully change the trajectory of diseases for patients."

The proposed acquisition raises the expected 2024-2029 sales CAGR for Novartis from +5% to +6% CAGR, representing a significant opportunity to deliver substantial shareholder returns over time.

Accelerating innovative RNA science and AOC therapies for patients with neuromuscular disease
The proposed acquisition aligns with the long-term neuroscience strategy of Novartis, expanding the company’s pipeline with potential near-term launches in genetically defined diseases with high unmet need. The Avidity programs feature potential first-in-class, late-stage disease-modifying therapies in myotonic dystrophy type 1 (DM1), a rare progressive neuromuscular disorder with a poor prognosis and no disease-modifying therapies; facioscapulohumeral muscular dystrophy (FSHD), a rare hereditary disorder causing relentless loss of muscle function and progressive disability; and Duchenne muscular dystrophy (DMD), a severe, early-onset disease marked by progressive muscle damage and reduced life expectancy.

The proposed acquisition is expected to create an industry-leading pipeline, building on the Novartis expertise in spinal muscular atrophy and commercialization capabilities in genetic neuromuscular diseases. Avidity aims to deliver meaningful patient benefits by addressing root genetic causes, restoring muscle function, and potentially slowing disease progression. Its AOC platform combines the tissue specificity of monoclonal antibodies with the precision of oligonucleotides, enabling targeted delivery to previously hard-to-reach muscle cells. AOCs carry disease-specific, oligonucleotide payloads intended to correct underlying genetic mechanisms and enable targeted, disease-modifying therapies with the potential to have significant impact on patient lives.

Transaction details
Under the terms of the transactions, which have been unanimously approved by the Boards of Directors of both companies, Novartis, through a merger with a newly formed indirect wholly owned subsidiary, will acquire all outstanding shares of Avidity. Pursuant to the terms of the merger agreement, holders of Avidity common stock will receive USD 72.00 per share in cash at closing, representing a premium of 46% to the closing share price on October 24, 2025, and valuing the company at approximately USD 12bn on a fully diluted basis and representing an enterprise value of approximately USD 11bn at the expected closing date.

Prior to the closing of the merger, Avidity will transfer to SpinCo, a wholly owned subsidiary of Avidity, the early-stage precision cardiology programs and collaborations of Avidity. The transfer includes certain Avidity assets whose transfer will trigger a right of first negotiation with an existing collaboration partner of Avidity. Holders of Avidity common stock will receive (1) a distribution of one share of SpinCo for every ten shares of Avidity they hold and/or (2) a pro rata cash distribution of the proceeds received by Avidity prior to the closing if certain SpinCo assets are, or SpinCo itself is, sold to a third party.

The acquisition by Novartis of Avidity is subject to the completion of a spin-off or a sale of SpinCo and other customary closing conditions, including the receipt of regulatory approvals and the approval of Avidity stockholders. The companies expect the merger to close in the first half of 2026. Until closing, Novartis and Avidity will continue to operate as separate and independent companies.

Novartis Investor Call
Novartis will host a conference call for investors to discuss the transaction on October 27, 2025 at 1 pm CET. Details can be found at View Source

(Press release, Novartis, OCT 26, 2025, View Source [SID1234657019])

On October 24, 2025 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported updated preclinical data from the company’s potent and selective pan KRAS(ON) inhibitor in a poster presentation at the 2025 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) taking place in Boston, MA, October 22-26, 2025.

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"We are excited today to share updated data from our pan KRAS(ON) program which demonstrates a potential best-in-class profile for our lead molecule," said Andrew Robbins, Cogent’s President and Chief Executive Officer. "We look forward to advancing this program with the goal of filing an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) in 2026."

Poster Details
The poster will be accessible on the ‘Posters and Publications’ page of Cogent’s website.

Title: Identification of CGT1263, a Potent KRAS Inhibitor with Selectivity for Mutant KRAS over HRAS and NRAS
Session Date and Time: Poster Session B, Friday, October 24, 2025 – 12:30 p.m. – 4:00 p.m. ET
Poster Number: B024
Abstract Number: B024

Mutations in KRAS are among the most prevalent mutations found in cancer, occurring most often in colorectal cancer, non-small cell lung cancer and pancreatic cancer. The poster presented today describes Cogent’s internally developed KRAS(ON/OFF) inhibitor CGT1263, showing clear selectivity over HRAS and NRAS, with picomolar (pM) activity across a broad panel of KRAS mutant cell lines. In addition, the poster also characterizes CGT1815 (the prodrug of CGT1263), which is designed to optimize human pharmacokinetic performance, supported by pharmacokinetics data from both CGT1815 and CGT1263 across multiple species. Finally, the poster highlights that CGT1815 demonstrates superior efficacy in KRASG12D and KRASG12V tumor growth inhibition studies when compared to RMC-6236.

(Press release, Cogent Biosciences, OCT 24, 2025, View Source [SID1234657021])

On October 24, 2025 Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence (AI) company dedicated to developing cancer therapies and transforming the cost, pace, and timeline of oncology drug discovery and development, reported that Lantern management will be presenting at the ThinkEquity Conference on Thursday, October 30, 2025, at 11:30 a.m. ET at the Mandarin Oriental in New York, NY.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Webcast Link: https://event.summitcast.com/view/NX3WagbdCmRzBGMxdc3ia6/PHQjUdexHoGaqcCtp9NPCD

Conference Registration Link: View Source

Lantern Pharma management will be available for one-on-one meetings held throughout the conference.

(Press release, Lantern Pharma, OCT 24, 2025, View Source [SID1234656996])

On October 24, 2025 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported updated data from the global Phase 1 clinical trial of zocilurtatug pelitecan (zoci), formerly known as ZL-1310, (NCT06179069) demonstrating robust and durable responses in heavily pre-treated patients with extensive-stage small cell lung cancer (ES-SCLC). This data will be presented as an oral presentation and was included as part of the press program 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 22–26, 2025, in Boston, Massachusetts.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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 strong and durable antitumor activity we have observed with zoci, alongside a well-tolerated safety profile, highlights its potential to be a best-in-class, DLL3-targeted antibody-drug conjugate for small cell lung cancer," said Rafael G. Amado, M.D., President, Head of Global Research and Development, Zai Lab. "Advancing this program from Phase 1 to a global, registrational study in less than two years reflects the speed, scientific rigor, and executional excellence of our team, and marks a major milestone for Zai Lab as we advance our global programs. Furthermore, we are rapidly expanding zoci’s development into other areas of high unmet need, including first-line small cell lung cancer and neuroendocrine carcinoma, both expected to enter the registrational phase next year."

The presentation includes updated results from the Phase 1 monotherapy dose escalation and dose expansion portion of the study from 115 patients across six dose cohorts (0.8 mg/kg, 1.2 mg/kg, 1.6 mg/kg, 2.0 mg/kg, 2.4 mg/kg, and 2.8 mg/kg) as of the data cut-off date of September 15, 2025. 102 patients had the opportunity of at least one post-baseline tumor assessment per Response Evaluation Criteria in Solid Tumors version 1:1 (RECIST v1.1).

All patients in this multicenter study had progressed following platinum-based chemotherapy, and 90% of patients had progressed after immune checkpoint inhibitors. Of all patients, 44% had failed two prior lines of therapy, making this a highly pretreated population with limited therapeutic options. Eleven patients received a prior DLL3 bi-specific antibody. A total of 32% of patients had brain metastases at baseline. This study included patients in the United States, Spain, and China.

Key efficacy results include (n=102):

Zoci demonstrated a high response rate across all dose levels in patients with ES-SCLC who progressed on or after platinum-based chemotherapy. Efficacy was consistent over time with additional patients and longer follow-up.
In a subset of patients (n=53) receiving zoci as a second-line treatment, the best overall response rate (ORR) observed among patients in the 1.6 mg/kg arm (n=19) was 68%.
A high response rate was also observed in patients (n=32) with brain metastasis at baseline, including an ORR of 80% for patients without prior brain radiotherapy.
Three out of seven patients who progressed after prior tarlatamab, responded. Enrollment of tarlatamab pretreated patients continues.
The estimated median duration of response (DoR) is 6.1 months, and median progression-free survival is 5.4 months across all doses and all lines of therapy. Responses were durable and clinically meaningful in this heavily pre-treated and difficult-to-treat population. In the dose finding cohort of the study, enrollment continues for 1.2 mg/kg and 1.6 mg/kg, with nearly half of responders still ongoing at data cut-off. Enrollment is expected to complete in Q4 2025.
Responses occurred early in treatment with a median time to confirmed objective response of 6 weeks.
Key safety findings include (n=115):

Zoci continues to demonstrate a well-tolerated safety profile with longer follow-up, particularly at the 1.2 or 1.6mg/kg dose level.
In the 1.6 mg/kg dose cohort, Grade 3 or higher treatment-related adverse events (TRAE) occurred in 13% of patients and serious TRAEs occurred in 9%. No patients were discontinued due to toxicity.
There were two cases of pneumonitis and interstitial lung disease, both Grade 1, in the 72 patients treated at 1.2 or 1.6 mg/kg dose.
Across all dose cohorts, Grade 3 or higher TRAEs occurred in 20% of patients and serious TRAEs in 8%. The most common Grade 3 or higher TRAEs were anemia (10%) and neutropenia (11%). There were five patients who discontinued due to TRAEs, all in the higher dose levels.
"DLL3 represents a validated target in extensive-stage small cell lung cancer, where there is high need for new therapies given the disease’s aggressive nature and limited treatment options," said Grace Dy, M.D., Roswell Park Comprehensive Cancer Center, Buffalo, NY, and study investigator. "These new Phase 1 results for zoci, including data that show rapid and sustained responses among the patient population, especially those with poor prognostic factors, are the latest clinical evidence that further demonstrate zoci’s potential as a differentiated, DLL3-targeted ADC."

Global Phase 3 Registrational Study Opens for Patient Enrollment

The Phase 3 registrational clinical trial of zoci is a multicenter study that will enroll approximately 665 patients globally, including in North America, Asia, and Europe. The randomized, open-label study is designed to further evaluate the safety and efficacy of zoci compared to investigator’s choice single agent therapy (ICT) in patients with relapsed SCLC who have progressed on or after platinum-based first-line therapy as second-line therapy or one line of chemotherapy followed by tarlatamab. The primary endpoints are ORR assessed by Blinded Independent Central Review (BICR) per RECIST v1.1 for interim analysis and overall survival as the primary analysis. Secondary endpoints include duration of response, progression-free survival and safety.

To learn more about the Phase 3 clinical trial program and study locations, please visit ClinicalTrials.gov (identifier: NCT07218146).

Zai Lab will hold an investor conference call and webcast to highlight updated zoci data presented at the 2025 AACR (Free AACR Whitepaper)-NCI-EORTC International Conference and outline next steps in clinical development.

Details regarding the webcast and conference call are as follows:

Date/Time: October 24, 2025, at 11 a.m. ET / 11 p.m. HKT, please register at:
Webcast presentation (preferred): View Source
Dial-in: View Source
Presenter: Rafael G. Amado, M.D., President and Head of Global Research and Development, Zai Lab

Details regarding the zoci oral presentation are as follows:

Title: Phase 1 trial of ZL-1310, a DLL3-targeted ADC, in patients with previously treated extensive-stage small cell lung cancer
Presenter: Grace K. Dy, M.D., Roswell Park Comprehensive Cancer Center, Buffalo, NY
Session Title: Plenary Session 3: Antibody Drug Conjugates
Date/Time: Friday, October 24, 2025, 9:17 a.m. – 9:27 a.m. ET (presentation), 9:27 a.m. – 9:45 a.m. ET (panel discussion)
Location: Hynes Convention Center, Level 3, Ballroom AB

About Small Cell Lung Cancer and Zocilurtatug Pelitecan (zoci)

Small cell lung cancer (SCLC) is one of the most aggressive and lethal solid tumors, accounting for ~15% of the approximately 2.5 million patients diagnosed with lung cancer worldwide each year1,2. Additionally, two-thirds of all SCLC patients are diagnosed at extensive stage3.

DLL3 is an antigen overexpressed in many neuroendocrine tumors, such as SCLC, and is often associated with poor clinical outcomes. Zocilurtatug pelitecan (zoci), formerly known as ZL-1310, comprises a humanized anti-DLL3 monoclonal antibody connected via a cleavable linker to a novel camptothecin derivative (a topoisomerase 1 inhibitor) as its payload. The compound was designed with a novel ADC technology platform called TMALIN, which leverages the tumor microenvironment to overcome challenges associated with first-generation ADC therapies.

Zoci received an Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) in January 2025, recognizing its potential to treat patients with SCLC.

About the Webcast and Conference Call

All participants must use the link provided above to complete the online registration process in advance of the conference call. Dial-in details will be in the confirmation email which the participant will receive upon registering.

A replay will be available shortly after the call and can be accessed by visiting the Company’s website.

(Press release, Zai Laboratory, OCT 24, 2025, View Source [SID1234656995])