On April 28, 2025 Coherus BioSciences, Inc. ("Coherus," NASDAQ: CHRS), reported data from its ongoing Phase 1 clinical trial evaluating CHS-114, a selective, cytolytic anti-CCR8 antibody, as monotherapy and in combination with toripalimab in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) evaluating two pharmacologically active doses of CHS-114 for dose optimization (Press release, Coherus Biosciences, APR 28, 2025, View Source [SID1234652225]). These data are being presented at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place April 25-30, 2025, in Chicago, Illinois.

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The data showed a confirmed partial response in a heavily pretreated PD-1 refractory patient, a > 50% depletion in CCR8+ Treg, and an increase in CD8+ T cells, consistent with anti-tumor activity and demonstrating proof of mechanism. Importantly, the safety profile was consistent with advanced disease and the known safety profile of toripalimab. These data support continued evaluation of CHS-114 in combination with other therapies, including toripalimab. Results support advancement and ongoing enrolment in Part 3 of the study evaluating CHS-114 with toripalimab in HNSCC (n = 40).

CHS-114 is an afucosylated CCR8 monoclonal antibody and is the only known selective molecule designed to exclusively target human CCR8 with no off-target binding and preferentially kills CCR8+ Tregs within the tumor microenvironment while preserving CD8+ effector T cells and Tregs in normal tissue.

"The data to date demonstrate a robust depletion of Treg cells in tumors, with a manageable safety profile, and a patient with a meaningful clinical response, which is highly encouraging," said Rosh Dias, M.D., Coherus’ Chief Medical Officer. "Furthermore, the profound increase in CD8+ T cells, making these tumors immunologically hot, is exciting as it supports CHS-114 being combined with several treatment modalities including T Cell Engagers. Head and neck cancer is an important strategic focus for Coherus, but CHS-114 has the potential, based on its mechanism of action, to treat many solid tumors, including non-small cell lung cancer and other large, underserved immuno-oncology indications, like colorectal cancer. We look forward to sharing further head and neck and gastric cancer data in the first half of next year."

"One of the biggest challenges in oncology has been finding a treatment that depletes Treg cells and relieves immune suppression in the tumor without causing collateral autoimmune disease or affecting antitumor T cells," said Douglas Adkins, M.D., Professor of Medicine, Director, Section of Head and Neck and Thyroid Medical Oncology, Division of Medical Oncology, Washington University School of Medicine. "These early clinical results are exactly what we’ve been hoping for and demonstrate CHS-114’s ability to remodel the tumor microenvironment in favor of anti-tumor activity. I am looking forward to exploring this treatment combination for solid tumor patients, even beyond head and neck."

Results from Phase 1b dose expansion trial evaluating CHS-114 monotherapy and with toripalimab in HNSCC

This open-label Phase 1b clinical trial evaluated CHS-114 as a single-agent and in combination with toripalimab in 21 patients with advanced solid tumors including HNSCC. Patients received either CHS-114 alone or in combination with toripalimab (240 mg) q3w. The primary endpoint of the study was to determine dose limiting toxicities (DLTs) and treatment emergent adverse events (TEAEs), with the goal of identifying two recommended doses for expansion. Key secondary endpoints included objective response rate (ORR) based on investigator review per RECIST v1.1 as well as pharmacokinetics and pharmacodynamics (PK/PD).

As of the data cutoff date of January 24, 2025:

CHS-114 monotherapy demonstrated Treg cell depletion (range of decrease: 52-97%), and significant increase in CD8+ T cells in the tumor, establishing proof of mechanism and confirming the doses are pharmacologically active.
CHS-114 with toripalimab had promising antitumor activity in HNSCC that warrants continued exploration.
CHS-114 administration leads to a substantial increase in CD8+ T cells in the tumor microenvironment, providing a strong rationale for combining with toripalimab and other drugs such as T cell engagers and bispecifics.
A confirmed partial response was achieved in the high dose cohort of CHS-114 in combination with toripalimab in a heavily pre-treated PD-1 refractory patient (PD-L1 low), demonstrating CHS-114 in combination with toripalimab can potentially overcome PD-1 resistance.
CHS-114 with and without toripalimab had a manageable safety profile in HNSCC patients, with TEAEs consistent with advanced disease and the known safety profile of toripalimab.
Two CHS-114 doses were selected for dose optimization based on safety, peripheral CCR8+ Treg depletion, PK and biomarker data.
These results support continued evaluation of CHS-114 in combination with other drugs including toripalimab, with broad potential applications in many solid tumors with a high density of CCR8+ Treg cells. A second-line HNSCC dose optimization study of CHS-114 in combination with toripalimab in HNSCC and gastric cancer patients is ongoing, with anticipated results in the first half of 2026 The current study design is expected to address the regulatory requirements under Project Optimus1 and support the recommendation of a phase 2 dose by early 2026.

AACR 2025 Presentation Details

Title: Phase 1 study of anti-CCR8 antibody CHS-114 with and without anti-PD-1 antibody toripalimab in patients with advanced solid tumors
Lead Author: Francis Worden, M.D., University of Michigan
Abstract #: CT038
Poster Session: Phase 0 and Phase 1 Clinical Trials
Poster Section 49: Poster board 17
Date and Time: Monday, April 28, 2025, 9:00 a.m. – 12:00 p.m. CDT

Conference Call Information for Investors and Analysts

Coherus Chief Development Officer, Dr. Theresa LaVallee, and Chief Medical Officer, Dr. Rosh Dias, will host a presentation and discussion of new clinical data from the Phase 1 study with CHS-114 with and without anti-PD-1 antibody toripalimab with study investigator, Dr. Douglas Adkins of Washington University.

When: Monday, April 28, 2025, starting at 4:30 p.m. Eastern Time

Investors and analysts are invited to listen into a live audio webcast of the presentation. To access the conference call, please pre-register through the following link to receive dial-in information and a personal PIN to access the live call: View Source

Please dial in 15 minutes early to ensure a timely connection to the call.

Webcast: View Source

An archived webcast will be available on the "Investors" section of the Coherus website at View Source

About the CHS-114 Phase 1 Study

The Phase 1 study (NCT05635643) is a dose escalation, dose optimization, and expansion study evaluating CHS-114 as a monotherapy and in combination with toripalimab, a next-generation PD-1 inhibitor. Arm 1a (first-in-human dose escalation) enrolled 20 patients with advanced solid tumors including 2 patients with HNSCC and evaluated multiple dose levels (5-1200 mg) of CHS-114 monotherapy. Arm 1b evaluated two pharmacologically active doses of CHS-114 monotherapy in 12 HNSCC patients with paired tumor biopsies. Arm 2 evaluated two pharmacologically active doses of CHS-114 with toripalimab in 7 patients. Arm 3 is evaluating two pharmacologically active doses of CHS-114 with toripalimab in 40 patients with second-line HNSCC. Primary objectives are to optimize the CHS-114 dose(s) for expansion and evaluate the safety of CHS-114 with toripalimab. Secondary objectives were to evaluate the safety, PK, and antitumor activity of CHS-114 with and without toripalimab and assess biomarkers, including changes in regulatory T cells (Tregs) and CD8+ T cells in paired tumor biopsies and other immune biomarkers.

About CHS-114

CHS-114, an afucosylated, cytolytic CCR8 monoclonal antibody, is designed to selectively target human CCR8 and preferentially kill CCR8+ Tregs within the tumor microenvironment while preserving CD8+ effector T cells and Tregs in normal tissue. In preclinical studies, CHS-114 induced antibody-dependent cellular cytotoxicity (ADCC) and/or antibody-dependent cellular phagocytosis (ADCP) to deplete tumoral CCR8+ Tregs. In addition, treatment with CHS-114 alone reduced tumor growth in murine models, and enhanced antitumor activity was observed in combination with anti-PD-1 treatment. CHS-114 is currently being evaluated in combination with toripalimab in two Phase 1b clinical trials in patients with advanced solid tumors, including head and neck cancer (NCT05635643) and gastric cancer (NCT06657144).

On April 28, 2025 Orum Therapeutics, Inc. ("Orum" or the "Company") (KRX: 475830), a public biotechnology company pioneering the field of degrader-antibody conjugates (DACs), reported a strategic update to its pipeline (Press release, Orum Therapeutics, APR 28, 2025, View Source [SID1234652241]). Orum has discontinued further clinical development of ORM-5029, a HER2-targeted GSPT1 degrader-antibody conjugate (DAC). This decision follows an internal assessment of the program’s clinical progress and incorporates information previously disclosed. Concurrently, Orum announced the nomination of a new drug candidate, ORM-1153, in development for the treatment of hematologic malignancies.

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ORM-1153 is a novel DAC engineered using Orum’s proprietary Dual-Precision Targeted Protein Degradation (TPD²) approach, which combines the catalytic protein degradation mechanism of TPDs with the tumor-targeting capabilities of therapeutic antibodies. The candidate targets GSPT1, a translation termination factor highly relevant in hematologic malignancies, and an undisclosed tumor-associated antigen to enhance selectivity and broaden the therapeutic window.

In preclinical studies, ORM-1153 demonstrated potent anti-tumor activity and a favorable safety profile, including in non-human primate models. ORM-1153 demonstrated picomolar potency in target-expressing cell lines and showed greater potency than existing small molecule GSPT1 degraders. In vivo, a single dose of ORM-1153 led to strong anti-tumor activity in relevant xenograft models. Orum plans to advance the program into IND-enabling studies and anticipates presenting additional data at a scientific conference later this year.

"After careful review of available clinical and preclinical data, we have concluded clinical development of ORM-5029," said Sung Joo (SJ) Lee, Ph.D., Founder and CEO of Orum Therapeutics. "This decision reflects our continued commitment to patient safety and our strategic focus on advancing the next generation of degrader-antibody conjugates with a clearly defined risk-benefit profile. We look forward to advancing next-generation programs emerging from our proprietary platform, like ORM-1153."

Dr. Lee continued, "ORM-1153 leverages learnings from all our programs and clinical experience to build potent, selective, and tumor-targeted protein degrader therapeutics that address serious unmet needs in oncology. We remain confident in the promise of our Dual-Precision Targeted Protein Degradation GSPT1 platform and are excited to progress this new candidate toward the clinic."

About Orum’s TPD² Approach

Orum’s unique Dual-Precision Targeted Protein Degradation (TPD²) approach builds novel targeted protein degraders combined with the precise cell delivery mechanisms of antibodies to generate innovative, first-in-class, cell-selective TPDs for the treatment of cancer. Orum has developed new targeted protein degrader payloads to specifically degrade an intracellular target protein within cancer cells via the E3 ubiquitin ligase pathway. Conjugated to antibodies, the payloads are designed to be delivered specifically to target cells and precisely degrade the intracellular target protein of interest.

On April 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 quarter ending March 31, 2025 ("Reporting Period") (Press release, WuXi AppTec, APR 28, 2025, View Source [SID1234652273]):

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Total revenue reached RMB9.65 billion, up 21.0% year-over-year. Revenue from Continuing Operations reached RMB9.39 billion, up 23.1% year-over-year.
Adjusted non-IFRS gross profit reached RMB4.05 billion. Adjusted non-IFRS gross profit margin was 41.9%.
Net profit attributable to the owners of the Company was RMB3.67 billion, up 89.1% year-over-year; diluted EPS was RMB1.28, up 93.9% year-over-year.
Adjusted non-IFRS net profit attributable to the owners of the Company was RMB2.68 billion, up 40.0% year-over-year; adjusted non-IFRS diluted EPS was RMB0.94, up 44.6% year-over-year.
As of March 31, 2025, backlog for Continuing Operations reached RMB52.33 billion, up 47.1% year-over-year.
Operating cash flow climbed 41.8% year-over-year to RMB3.03 billion, driven by business growth, increases in operational 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. WuXi Chemistry’s small molecule Development and Manufacturing (D&M) pipeline has maintained growth, with a total of 203 new molecules added in the first quarter of 2025. As of March 31, 2025, our small molecule D&M pipeline reached 3,393 molecules, with an increase of 5 projects in phase III and commercial stages during the first quarter of 2025.
The Company has been accelerating global D&M capacity expansion. In March 2025, both the Changzhou and Taixing API manufacturing sites successfully passed FDA 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.
[1] Net profit attributable to the owners of the Company is prepared in accordance with China Accounting Standards for Business Enterprises (CAS).

[2] In 2024 Q1 and 2025 Q1, WuXi AppTec had a fully-diluted weighted average share count of 2,925,052,346 and 2,899,579,930 ordinary shares, respectively.

Management Comment

Dr. Ge Li, Chairman and CEO of WuXi AppTec, said, "Revenue and profit both resumed double-digit growth during the first quarter, and our backlog for Continuing Operations sustained rapid growth, as we maintained our laser focus on leveraging WuXi AppTec’s unique CRDMO platform to expand delivery of enabling services across research, development and manufacturing."

"The Company currently maintains its full-year guidance set at the beginning of the year. We expect revenue from Continuing Operations to grow 10-15% in 2025, and our adjusted non-IFRS net profit margin will further improve."

"WuXi AppTec is dedicated to ‘doing the right thing and doing it right’, as our services drive long-term growth, improve the health of those in need and realize our vision that ‘every drug can be made and every disease can be treated’."

Business Performance by Segments

WuXi Chemistry: CRDMO Business Model Drives Continuous Growth; Q1 2025 Revenue Up 32.9% YoY, with TIDES Revenue Up 187.6% YoY
Q1 revenue of WuXi Chemistry reached RMB7.39 billion, up 32.9% 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 adjusted non-IFRS gross profit margin steadily improved 4.2pts year-over-year to 47.5%.
Small molecule drug discovery service ("R") continues to generate downstream opportunities. In the past 12 months, we successfully synthesized and delivered more than 460,000 new compounds to customers, which resulted in 6% year-over-year growth. 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. In the first quarter, 75 molecules were converted from R to D.
Small molecule D&M service remains strong.
i. The small molecule CDMO pipeline continued to expand. Q1 revenue of small molecule D&M services was up 13.8% year-over-year to RMB3.85 billion. In the first quarter of 2025, 203 new molecules were added to the small molecule D&M pipeline. As of March 31, 2025, our small molecule D&M pipeline reached 3,393 molecules, including 75 commercial projects, 82 in phase III, 368 in phase II and 2,868 in phase I and pre-clinical stages, with an increase of 5 projects in the commercial and phase III stages during the first quarter of 2025.
ii. We continued to build small molecule capacities. In March 2025, both the Changzhou and Taixing API manufacturing sites successfully passed FDA 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, Q1 TIDES revenue grew 187.6% year-over-year to RMB2.24 billion. As of the end of March 2025, TIDES backlog was up 105.5% year-over-year.
ii. TIDES D&M customers grew 14% year-over-year, while the number of TIDES molecules grew 25% year-over-year.
iii. We continued to build peptide capacities 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[3]: Drug Safety Evaluation Service & Site Management Organization (SMO) Maintain Leading Positions
WuXi Testing reached RMB1.29 billion during Q1. Adjusted non-IFRS gross profit margin was 23.4%. Q1 revenue of lab testing services declined 4.9% year-over-year to RMB0.88 billion, due to market impact as pricing gradually reflected in revenue along with backlog conversion, accompanied by a decline in Q1 adjusted non-IFRS GPM. Of which, drug safety evaluation services revenue was down 7.8% year-over-year, while maintaining an industry-leading position in the Asia-Pacific region.
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 is committed to actively enabling customers’ global licensing. WuXi AppTec has supported approximately 40% of successful out-licensed deals from Chinese biotech companies since 2022.
The Suzhou facility has successfully passed 4 consecutive FDA on-site inspections.
Q1 revenue for clinical CRO & SMO declined 2.2% year-over-year to RMB0.41 billion due to market pricing impact. Of which, SMO revenue grew 5.5% year-over-year and maintained the industry leading position in China. During the quarter, our clinical CRO business supported customers to obtain 10 IND approvals.
The SMO business continued steady growth, and supported 28 new drug approvals for customers in the first quarter. Over the past decade, SMO has supported 283 new drug approvals in total, maintaining significant advantages in multiple areas (endocrinology, dermatology, lung cancer and cardiovascular disease, etc.).
[3] As disclosed in the 2025 First Quarterly Report, WuXi Testing here includes only the core business of Continuing Operations (similar to the 2024 baseline).

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.
WuXi Biology’s Q1 revenue rose 8.2% year-over-year to RMB0.61 billion. Due to market pricing impact, Q1 adjusted non-IFRS gross profit margin was down 2.2pts to 36.3%.
The Company continuously leverage synergies between in vitro and in vivo platforms, and efficiently supports customer demand for one-stop drug discovery service platform. Revenue of the in vitro integrated screening platform grew 28.9% year-over-year. Revenue of the in vivo pharmacology platform grew 9.4% year-over-year, driven by accelerated advancements in focused disease areas. 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.
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 First Quarterly Results Presentation and 2025 First 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 First Quarterly Report of the Company has not been audited.

Results by Segments

Unit: RMB million

Segment

Revenue

Change

Adjusted
non-IFRS
Gross Profit

Change

Adjusted non-
IFRS Gross
Profit Margin

WuXi Chemistry

7,390.97

32.9 %

3,509.84

45.7 %

47.5 %

WuXi Testing

1,292.32

(4.0) %

301.90

(40.2) %

23.4 %

WuXi Biology

607.07

8.2 %

220.42

2.1 %

36.3 %

Others

99.73

(36.1) %

14.51

(17.4) %

14.6 %

Discontinued
Operations (Note 1)

264.50

(25.6) %

1.64

N/A

0.6 %

Total

9,654.60

21.0 %

4,048.32

31.0 %

41.9 %

Note 1: In accordance with the IFRSs, the Company has classified the operations for which equity sale agreements were signed 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[4] – Prepared under IFRSs

RMB Million

Quarter Ended

March 31, 2025

Quarter Ended

March 31, 2024

Revenue

9,654.6

7,981.9

Cost of sales

(5,641.5)

(4,976.2)

Gross profit

4,013.1

3,005.7

Other income

311.4

242.0

Other gains and losses

1,073.3

192.9

Impairment losses under expected credit losses ("ECL") model, net of reversal

(153.1)

(19.7)

Impairment losses of non-financial assets

(69.5)

–

Selling and marketing expenses

(194.1)

(179.1)

Administrative expenses

(597.8)

(610.5)

R&D expenses

(224.4)

(306.4)

Operating Profit

4,158.9

2,324.9

Share of results of associates

63.9

33.9

Share of results of joint ventures

0.1

0.2

Finance costs

(80.2)

(61.7)

Profit before tax

4,142.7

2,297.4

Income tax expense

(564.4)

(338.5)

Profit for the period

3,578.3

1,958.9

Profit for the period attributable to:

Owners of the Company

3,536.3

1,942.2

Non-controlling interests

42.0

16.6

3,578.3

1,958.9

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

Quarter Ended

March 31, 2025

Quarter Ended

March 31, 2024

Weighted average number of ordinary shares for calculating EPS
(expressed in shares)

– Basic

2,846,244,009

2,919,696,373

– Diluted

2,899,579,930

2,925,052,346

Earnings per share

(expressed in RMB per Share)

– Basic

1.24

0.67

– Diluted

1.24

0.66

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

Consolidated Statement of Financial Position[5] – Prepared under IFRSs

RMB Million

March 31,

December 31,

2025

2024

Non-current Assets

Property, plant and equipment

25,260.3

25,267.8

Right-of-use assets

1,938.3

1,874.8

Goodwill

972.1

972.4

Other intangible assets

535.4

601.0

Interests in associates

2,106.9

2,322.2

Interests in joint ventures

3.4

3.4

Deferred tax assets

489.8

473.1

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

8,707.8

8,943.4

Other non-current assets

144.8

114.7

Biological assets

1,045.2

1,063.0

Total Non-current Assets

41,204.0

41,635.7

Current Assets

Inventories

4,647.0

3,532.1

Contract costs

903.5

912.2

Biological assets

941.2

955.5

Amounts due from related parties

91.9

89.3

Trade and other receivables

9,269.2

9,643.7

Contract assets

876.2

988.8

Income tax recoverable

89.7

87.2

Financial assets at FVTPL

901.0

1,234.0

Derivative financial instruments

0.6

–

Other current assets

736.5

734.1

Pledged bank deposits

10.2

22.1

Term deposits with initial term of over three
months

4,826.1

4,865.6

Bank balances and cash

20,014.9

13,434.3

43,308.1

36,498.8

Assets classified as held for sale

–

2,191.3

Total Current Assets

43,308.1

38,690.2

Total Assets

84,512.1

80,325.8

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

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

RMB Million

March 31,

December 31,

2025

2024

Current Liabilities

Trade and other payables

6,863.6

7,025.5

Amounts due to related parties

7.5

15.3

Derivative financial instruments

63.1

202.0

Contract liabilities

2,349.8

2,251.0

Bank borrowings

4,829.4

1,278.6

Lease liabilities

211.5

224.2

Income tax payables

1,035.7

870.8

Convertible bonds

3,513.3

3,493.1

18,873.8

15,360.6

Liabilities associated with assets classified as
held for sale

–

865.5

Total Current Liabilities

18,873.8

16,226.1

Non-current Liabilities

Bank borrowings

763.3

2,959.5

Deferred tax liabilities

493.8

522.4

Deferred income

976.6

985.6

Lease liabilities

625.8

546.6

Total Non-current Liabilities

2,859.5

5,014.1

Total Liabilities

21,733.3

21,240.2

Net Assets

62,778.8

59,085.6

Capital and Reserves

Share capital

2,888.0

2,888.0

Reserves

59,444.4

55,744.7

Equity attributable to owners of the Company

62,332.4

58,632.7

Non-controlling interests

446.4

452.9

Total Equity

62,778.8

59,085.6

[6] 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[7]

RMB Million

Quarter Ended

March 31,

Quarter Ended

March 31,

2025

2024

Net profit attributable to the owners of the Company under CAS

3,672.0

1,942.2

GAAP difference[8]

(135.7)

–

Net profit attributable to the owners of the Company under IFRSs

3,536.3

1,942.2

Add:

Share-based compensation expenses

34.4

87.8

Issuance expenses of convertible bonds

9.8

–

Foreign exchange related losses

178.0

14.4

Amortization of acquired intangible assets from merger and acquisition

7.1

13.6

Losses from impairment and disposal of non-financial assets

65.0

–

Gains from divestiture and restructuring initiatives

(56.4)

–

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

3,774.1

2,058.0

Add:

Realized and unrealized gains from venture capital investments

(1,096.3)

(144.7)

Realized and unrealized share of gains from joint ventures

(0.1)

(0.2)

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

2,677.7

1,913.1

On April 28, 2025 Obsidian Therapeutics, Inc., a clinical-stage biotechnology company pioneering engineered cell and gene therapies, reported the publication of an abstract with preclinical data from their cytoDRiVE platform for poster presentation at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting 2025 (Press release, Obsidian Therapeutics, APR 28, 2025, View Source [SID1234652289]).

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Obsidian will present novel applications of its cytoDRiVE platform, demonstrating the breadth and versatility of their regulation technology. To date, cytoDRiVE technology has been used to successfully regulate the timing and level of several different classes of therapeutic protein via fusion to drug-responsive domains (DRDs).1 In OBX-115, Obsidian’s lead clinical TIL program which has demonstrated promising activity in patients with ICI-resistant advanced melanoma2, this technology enables regulation of membrane-bound IL15 using the small-molecule drug acetazolamide.

The poster for abstract AMA30 expands beyond the direct DRD-fusion approach leveraged to-date, providing proof-of-concept for a novel approach whereby regulation of an artificial transcription factor is used to enable gene-ON and gene-OFF states with ligand binding. This approach unlocks numerous additional applications for cytoDRiVE, including the ability to regulate secreted proteins and expression of mRNA or siRNA. These capabilities become important in the context of gene and cell therapies where precise and variable genetic control is needed to manage disease, and where repeat dosing of other complex biologics is challenging.

Details of the poster presentation are as follows:

Title: Drug-responsive domains coupled with cognate small-molecule ligands drive synthetic gene-ON or -OFF circuits to regulate expression of therapeutic proteins (Abstract AMA30)
Presenting Author: Michael Gallo (Obsidian Therapeutics)
Poster: Tuesday, May 13, 6:00-7:30pm CT
Abstract: AMA30
1 Inniss et. al. Commun Biol 2025
2 Chesney, ASCO (Free ASCO Whitepaper) 2025

About OBX-115
Obsidian’s lead investigational cytoTIL15 program, OBX-115, is a novel engineered tumor-derived autologous T cell immunotherapy (tumor-infiltrating lymphocyte [TIL] cell therapy) armored with pharmacologically regulatable membrane-bound IL15 (mbIL15). OBX-115 has the potential to become a meaningful therapeutic option for patients with advanced or metastatic melanoma and other solid tumors by leveraging the expected benefits of mbIL15 and Obsidian’s proprietary, differentiated manufacturing process to enhance persistence, antitumor activity, and clinical safety of TIL cell therapy. Obsidian is investigating OBX-115 in the phase 1/2 Agni-01 multicenter trial in patients with advanced solid tumors (NCT06060613).

On April 28, 2025 Crown Bioscience, a global contract research organization (CRO) headquartered in the United States and a part of JSR Life Sciences and Japan-based JSR Corporation, reported at AACR (Free AACR Whitepaper) 2025 its cutting-edge 3D bone marrow niche (BMN) in vitro models to advance hematological cancer research (Press release, Crown Bioscience, APR 28, 2025, View Source [SID1234652226]). Providing both the physical environment (cell-cell interactions), and the growth factor cocktail that hematological cancer cells require to thrive and proliferate, this innovative model provides a dynamic platform for studying liquid malignancies such as acute myeloid leukemia (AML) and multiple myeloma (MM).

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The system incorporates key cellular components—stromal cells and endothelial cells—within biofunctional hydrogels seeded with patient-derived tumor cells, optionally supplemented with autologous immune cells. By accurately capturing the essential tumor microenvironment, the niche provides a physiologically relevant system that offers insight into tumor behavior, immune evasion, and drug resistance, outperforming classic suspension assays when it comes to cell viability, assay versatility, and clinical predictivity.

"Crown Bioscience is proud to unveil this high-content imaging-based 3D BMN platform that offers a unique and robust high-throughput drug screening in primary patient cells that allows testing of malignancies and toxicities at scale," said Ludovic Bourré, Vice President, Research and Innovation, Crown Bioscience. "Until now, bone marrow research has lagged behind solid tumor research due to lack of relevant in vitro models. With these BMN technological advances, we are now able to help researchers understand how cancer survives therapies once it reaches the bone marrow. This allows them to guide the selection of drug candidates with fewer off-target or bone marrow-related side effects and to overcome drug resistance mechanisms."

Researchers can realize significant benefits with the BMN models including:

The use of more predictive ex vivo data to increase accuracy in cancer cell response

The ability to screen compounds for hematological toxicity earlier in the drug development process

Enhanced translational insight for more informed in vivo studies, helping to reduce animal use and speed up drug development

Enabling the creation of more effective, targeted treatments through adhesion-mediated drug resistance modeling

Unlocking new potential in stem cell, hematological malignancy, and bone-marrow-specific oncology studies
The introduction of the BMN platform seamlessly integrates into Crown Bioscience’s expertise in 3D organoid-like cell cultures, drug resistance models, and AML mouse models and bridges a gap between in vitro and in vivo models.

Bourré said, "This is a very exciting advancement for researchers and with this offering that integrates into Crown Bioscience’s existing solutions, we’re able to continually foster innovation and accelerate drug development."

Crown Bioscience will be presenting a poster at AACR (Free AACR Whitepaper), with details below.

3D Bone Marrow Niche: Scalable and Physiologically Relevant Ex Vivo Drug Screening Platform for Acute Myeloid Leukemia and Multiple Myeloma
Session Category: Experimental and Molecular Therapeutics
Session Title: Drug Discovery Assay Technologies
Session Date and Time: April 29 at 2:00PM CT
Location: Poster section 16
Poster Board Number: 21
Published Abstract Number: 5493