On February 5, 2025 Armaceutica reported US patent granted titled: Bifunctional Compositions for the Treatment of Cancer (Press release, Armaceutica, FEB 5, 2025, View Source [SID1234650068]). This drug, which is often used to treat malaria, is being repurposed by Armaceutica, Inc. to treat various types of cancer.

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Renato Aguilera, Ph.D. and Biology Professor and cancer researcher at the University of Texas at El Paso, published data demonstrating that the drug (pyronaridine, or PND) kills various types of cancer cells.3

Pyronaridine was shown to preferentially kill certain types of leukemia, lymphoma, melanoma, multiple myeloma, lung, ovarian, and breast cancer cells while limiting off-target toxicities in normal, healthy cells.3 That is, pyronaridine had reduced effects on non-cancerous cells with a favorable selective cytotoxicity index (SCI), as compared with cancerous cells.3

Dr. Aguilera’s studies revealed that pyronaridine inhibits the activity of a critical enzyme (topoisomerase II) required for DNA replication and cancer cell division.4

Studies on mice with metastatic human breast cancer showed the group that received pyronaridine had smaller tumor volumes (P<0.0001) and increased longevity than control mice.4 A study on dogs with cancer showed pyronaridine reduced tumor volumes and increased longevity.1 In one case a lymphoma tumor shrunk by 70%.1 A pilot study on terminally-ill humans with late-stage cancers of the breast, lung and liver; pyronaridine appears to have increased longevity.1

The company’s CEO, Ernest Armstrong, said: "Pyronaridine represents a disruptive breakthrough relative to other cancer therapies. Pyronaridine has been proven safe and effective for malaria in at least four phase 3 studies and is an approved drug in parts of Asia and Africa." 2

Patent offices in Australia, Canada, EU, Israel, Japan, Malaysia, Mexico, Philippines, Russia, Thailand and the UK have granted patents corresponding to U S Patent No.: 12,201,626.

If you or a loved one has ever been treated with chemotherapy, you’ll understand how devastating the side effects can be.

Dr. Aguilera stated: "If the drug were available in the US and approved as an anti-cancer treatment, I would take it in an instant, if I came down with cancer."

Armaceutica, Inc. is a US-based pharmaceutical company focused on low-toxicity cancer treatments. Armaceutica is seeking a partner to develop pyronaridine into an approved drug for cancer, a process that will take several years.

References: 1US Patent No.: 12,201,626, Jan. 21, 2025. 2Croft et al., Malaria Journal 2012, 11:270. 3 Villanueva PJ, et al., PLOS One, 5 Nov 2018, 13(11):e0206467. 4 Villanueva PJ, et al., Clinical Cancer Drugs 2021, 8:50-56.

On February 5, 2025 Carisma Therapeutics Inc. (Nasdaq: CARM) ("Carisma" or the "Company"), a leader in macrophage-focused therapeutics, reported that Steven Kelly, President and Chief Executive Officer, will participate in the Oppenheimer 35th Annual Healthcare Life Sciences Conference on Tuesday, February 11 at 4:40 pm ET (Press release, Carisma Therapeutics, FEB 5, 2025, View Source [SID1234650067]).

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An audio webcast of the event will be available on the Company’s Investor Events section of the Investor Relations webpage and will be archived for a limited time following the event.

On February 5, 2025 Boston Scientific Corporation (NYSE: BSX) reported net sales of $4.561 billion during the fourth quarter of 2024, growing 22.4 percent on a reported basis, 23.1 percent on an operational1 basis and 19.5 percent on an organic2 basis, all compared to the prior year period (Press release, Boston Scientific, FEB 5, 2025, View Source [SID1234650066]). The company reported GAAP net income attributable to Boston Scientific common stockholders of $566 million or $0.38 per share (EPS), compared to $504 million or $0.34 per share a year ago and achieved adjusted3 EPS of $0.70 for the period, compared to $0.55 a year ago.

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For the full year 2024, the company generated net sales of $16.747 billion, growing 17.6 percent on a reported basis, 18.5 percent on an operational1 basis and 16.4 percent on an organic2 basis. The company reported GAAP net income attributable to Boston Scientific common stockholders of $1.853 billion or $1.25 per share, compared to $1.570 billion or $1.07 per share a year ago, and delivered full year adjusted3 EPS of $2.51, compared to $2.05 a year ago.

"2024 was one of the best years in the history of Boston Scientific, fueled by our innovative portfolio, the launch of our FARAPULSE Pulsed Field Ablation System as well as significant clinical achievements and commercial excellence across businesses and regions," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "We have a strong foundation for growth, and I am incredibly grateful for our talented global team and the opportunity to continue transforming the lives of millions of patients around the world."

Fourth quarter financial results and recent developments:

Reported net sales of $4.561 billion, representing an increase of 22.4 percent on a reported basis, compared to the company’s guidance range of 16.5 to 18.5 percent; 23.1 percent on an operational basis; and 19.5 percent on an organic basis, compared to the company’s guidance range of 14 to 16 percent, all compared to the prior year period.

Reported GAAP net income attributable to Boston Scientific common stockholders of $0.38 per share, compared to the company’s guidance range of $0.41 to $0.43 per share, and achieved adjusted EPS of $0.70 per share, compared to the guidance range of $0.64 to $0.66 per share.

Achieved the following net sales growth in each reportable segment, compared to the prior year period:
MedSurg: 12.4 percent reported, 13.0 percent operational and 7.0 percent organic
Cardiovascular: 28.8 percent reported, 29.5 percent operational and 27.4 percent organic

Achieved the following net sales growth in each region, compared to the prior year period:
United States (U.S.): 30.7 percent reported and operational
Europe, Middle East and Africa (EMEA): 10.8 percent reported and 11.6 percent operational
Asia-Pacific (APAC): 11.1 percent reported and 12.4 percent operational
Latin America and Canada (LACA): 4.6 percent reported and 12.6 percent operational
Emerging Markets4: 12.4 percent reported and 15.2 percent operational

Presented positive 36-month primary endpoint findings from the OPTION clinical trial at the American Heart Association Scientific Sessions demonstrating superior bleeding risk reduction and similar efficacy with the WATCHMAN FLX Left Atrial Appendage Closure Device compared to oral anticoagulation in high-risk patients with atrial fibrillation (AF) post ablation, followed by a late-breaking sub-analysis at AF Symposium 2025 reaffirming positive outcomes with the device in both concomitant and sequential procedures.

Presented positive 12-month primary endpoint findings from phase one of the ADVANTAGE AF clinical trial at AF Symposium 2025 that achieved the safety and effectiveness endpoints for the treatment of patients with persistent AF with the FARAPULSE Pulsed Field Ablation System.

Received U.S. Centers for Medicare & Medicaid Services approval of a new transitional pass-through payment for the AGENT Drug-Coated Balloon effective Jan. 1, 2025, which offers facilities additional reimbursement for outpatient procedures.

Received both U.S. Food and Drug Administration (FDA) approval and CE mark for the Vercise Cartesia X and HX Directional Leads, the first and only 16-contact directional leads designed for more precise targeting for enhanced clinical outcomes using the Vercise Genus Deep Brain Stimulation System.

Completed the acquisition of Axonics, Inc., an innovative medical technology company focused on the development and commercialization of differentiated devices for the treatment of urinary and bowel dysfunction.

Announced and completed the acquisition of Cortex, Inc., a privately held medical technology company focused on the development of a diagnostic mapping solution which aims to identify triggers and drivers outside of the pulmonary veins that are foundational to AF.

Announced agreements to acquire the following companies, subject to customary closing conditions:
Bolt Medical, Inc., a developer of an intravascular lithotripsy advanced laser-based platform for the treatment of coronary and peripheral artery disease which is pending U.S. FDA approval.
Intera Oncology Inc., a medical device company that provides the Intera 3000 Hepatic Artery Infusion Pump and floxuridine, a chemotherapy drug.
1 Operational net sales growth excludes the impact of foreign currency fluctuations.

2 Organic net sales growth excludes the impact of foreign currency fluctuations and net sales attributable to acquisitions and divestitures for which there are less than a full period of comparable net sales.

3 Adjusted EPS excludes the impacts of certain charges (credits) which may include amortization expense, goodwill and other intangible asset impairment charges, acquisition/divestiture-related net charges (credits), investment portfolio net losses (gains) and impairments, restructuring and restructuring-related net charges (credits), certain litigation-related net charges (credits), European Union Medical Device Regulation (EU MDR) implementation costs, debt extinguishment net charges, deferred tax expenses (benefits) and certain discrete tax items.

4 Periodically, we assess our list of Emerging Markets countries, and effective January 1, 2023, modified our list to include all countries except the United States, Western and Central Europe, Japan, Australia, New Zealand and Canada.

Fourth quarter net sales by business and region:

Increase/(Decrease)

Three Months Ended
December 31,

Reported
Basis

Impact of
Foreign
Currency
Fluctuations

Operational
Basis

Impact of
Recent
Acquisitions/
Divestitures

Organic
Basis

(in millions)

2024

2023

Endoscopy

$ 690

$ 645

7.0 %

0.6 %

7.6 %

(0.7) %

7.0 %

Urology

630

527

19.5 %

0.5 %

20.1 %

(12.2) %

7.9 %

Neuromodulation

299

269

11.4 %

0.5 %

11.9 %

(6.4) %

5.5 %

MedSurg

1,619

1,441

12.4 %

0.6 %

13.0 %

(6.0) %

7.0 %

Cardiology

2,297

1,751

31.1 %

0.8 %

31.9 %

— %

31.9 %

Peripheral Interventions

645

533

21.0 %

0.8 %

21.7 %

(9.2) %

12.5 %

Cardiovascular

2,942

2,285

28.8 %

0.8 %

29.5 %

(2.2) %

27.4 %

Net Sales

$ 4,561

$ 3,725

22.4 %

0.7 %

23.1 %

(3.6) %

19.5 %

Increase/(Decrease)

Three Months Ended
December 31,

Reported
Basis

Impact of
Foreign
Currency
Fluctuations

Operational
Basis

(in millions)

2024

2023

U.S.

$ 2,893

$ 2,213

30.7 %

— %

30.7 %

EMEA

830

749

10.8 %

0.9 %

11.6 %

APAC

684

616

11.1 %

1.2 %

12.4 %

LACA

155

148

4.6 %

8.0 %

12.6 %

Net Sales

$ 4,561

$ 3,725

22.4 %

0.7 %

23.1 %

Emerging Markets4

$ 668

$ 595

12.4 %

2.8 %

15.2 %

Amounts may not foot due to rounding. Growth rates are based on actual, non-rounded amounts and may not recalculate precisely.

Net sales growth rates that exclude the impact of foreign currency fluctuations and/or the impact of acquisitions/divestitures are not prepared in
accordance with GAAP.

Full year net sales by business and region:

Increase/(Decrease)

Year Ended

December 31,

Reported
Basis

Impact of
Foreign
Currency
Fluctuations

Operational
Basis

Impact of
Recent
Acquisitions /
Divestitures

Organic
Basis

(in millions)

2024

2023

Endoscopy

$ 2,687

$ 2,482

8.3 %

0.6 %

8.9 %

(1.0) %

8.0 %

Urology

2,200

1,964

12.0 %

0.5 %

12.5 %

(3.3) %

9.3 %

Neuromodulation

1,106

976

13.3 %

0.4 %

13.7 %

(11.0) %

2.7 %

MedSurg

5,993

5,422

10.5 %

0.6 %

11.1 %

(3.6) %

7.5 %

Cardiology

8,344

6,709

24.4 %

1.0 %

25.4 %

— %

25.4 %

Peripheral Interventions

2,410

2,110

14.2 %

1.2 %

15.5 %

(4.6) %

10.9 %

Cardiovascular

10,755

8,819

22.0 %

1.1 %

23.0 %

(1.1) %

21.9 %

Net Sales

$ 16,747

$ 14,240

17.6 %

0.9 %

18.5 %

(2.1) %

16.4 %

Increase/(Decrease)

Year Ended

December 31,

Reported
Basis

Impact of
Foreign
Currency
Fluctuations

Operational
Basis

(in millions)

2024

2023

U.S.

$ 10,210

$ 8,425

21.2 %

— %

21.2 %

EMEA

3,228

2,856

13.0 %

0.8 %

13.8 %

APAC

2,686

2,400

11.9 %

3.7 %

15.7 %

LACA

624

560

11.4 %

2.6 %

14.1 %

Net Sales

$ 16,747

$ 14,240

17.6 %

0.9 %

18.5 %

Emerging Markets4

$ 2,680

$ 2,310

16.1 %

3.6 %

19.6 %

Amounts may not foot due to rounding. Growth rates are based on actual, non-rounded amounts and may not recalculate precisely.

Net sales growth rates that exclude the impact of foreign currency fluctuations and/or the impact of acquisitions/divestitures are not prepared in
accordance with U.S. GAAP.

Guidance for Full Year and First Quarter 2025

The company estimates net sales growth for the full year 2025, versus the prior year period, to be in a range of approximately 12.5 to 14.5 percent on a reported basis, and approximately 10 to 12 percent on an organic basis. Full year organic net sales guidance excludes the impact of foreign currency fluctuations and net sales attributable to acquisitions and divestitures for which there are less than a full period of comparable net sales. The company estimates EPS on a GAAP basis in a range of $1.86 to $1.93 and estimates adjusted EPS, excluding certain charges (credits), of $2.80 to $2.87.

The company estimates net sales growth for the first quarter of 2025, versus the prior year period, to be in a range of approximately 17 to 19 percent on a reported basis, and approximately 14 to 16 percent on an organic basis. First quarter organic net sales guidance excludes the impact of foreign currency fluctuations and net sales attributable to acquisitions and divestitures for which there are less than a full period of comparable net sales. The company estimates EPS on a GAAP basis in a range of $0.43 to $0.45 and estimates adjusted EPS, excluding certain charges (credits), of $0.66 to $0.68.

Conference Call Information

Boston Scientific management will be discussing these results with analysts on a conference call today at 8:00 a.m. ET. The company will webcast the call to interested parties through its website: investors.bostonscientific.com. Please see the website for details on how to access the webcast. The webcast will be available for approximately one year on the Boston Scientific website.

On February 5, 2025 Shanghai Henlius Biotech, Inc. (2696.HK) reported that its anti-PD-1 mAb, HANSIZHUANG (serplulimab, marketed as Hetronifly in Europe), has been officially approved by the European Commission (EC) for use in combination with carboplatin and etoposide as a first-line treatment of adult patients with ES-SCLC (Press release, Shanghai Henlius Biotech, FEB 5, 2025, View Source [SID1234650065]). This approval establishes serplulimab as the first and only anti-PD-1 mAb approved in the EU for the treatment of ES-SCLC.

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Serplulimab is the world’s first anti-PD-1 mAb approved for first-line treatment of ES-SCLC. Underpinned by clinical needs, Henlius has carried out a differentiated and multi-dimensional layout of serplulimab in the fields of lung cancer and gastrointestinal cancer. To date, more than 4,800 subjects have been enrolled worldwide for clinical trials of serplulimab. In 2023, Henlius entered into a collaboration with Intas Pharmaceuticals, granting Intas exclusive rights to develop and commercialise serplulimab in over 50 countries across Europe and India. This latest approval covers all 27 EU member states as well as the European Economic Area countries, including Norway, Iceland, and Liechtenstein. Commercialisation in Europe will be led by Intas’ subsidiary, Accord Healthcare Ltd ("Accord").

Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, stated: "The approval of serplulimab in the EU represents another significant step forward in our mission to benefit patients worldwide. This milestone not only underscores our leadership in innovative drug development and global strategy, but also brings new hope to ES-SCLC patients in Europe and beyond. Moving forward, we will continue to collaborate with our partners to enhance the accessibility of advanced therapies and work together to make a meaningful difference in patients’ lives."

Breakthrough Innovation to Address Unmet Clinical Needs

Lung cancer is the most common cancer worldwide in terms of incidence and mortality. According to GLOBOCAN 2022, there were over 2.48 million new cases of lung cancer globally in 2022, accounting for 12.4% of all new cancer cases.[1] Small cell lung cancer (SCLC), which accounts for 15% to 20% of all lung cancers, is characterised by high malignancy, early metastasis, rapid progression, and poor prognosis. Among SCLC patients, approximately 30% to 40% are diagnosed at a limited stage, while the remaining cases are in extensive stage. In the EU, the prevalence of SCLC ranges from 1 to 5 per 10,000 people.[2] In December 2022, serplulimab received orphan drug designation from the EC for the treatment of SCLC. The orphan-drug designation granted by the EC is beneficial for serplulimab to enjoy certain policy supports in the R&D, registration and commercialisation in the treatment of SCLC in the EU. In September 2024, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending Hetronifly for approval in the EU.

The approval of serplulimab by the EC is primarily based on data from the ASTRUM-005 study, a randomized, double-blind, placebo-controlled international multi-centre Phase 3 study evaluating the efficacy and safety event profile of serplulimab in combination with chemotherapy versus placebo with chemotherapy as a first-line treatment for ES-SCLC. The study has set up a total of 128 sites across countries including China, Poland, Turkey, and Georgia, enrolling 585 subjects, of whom around 31.5% were Caucasians. Results from ASTRUM-005 were first presented orally at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and later published in the Journal of the American Medical Association (JAMA), making it the first SCLC immunotherapy study to publish on JAMA. Based on ASTRUM-005, serplulimab has been approved in China, Southeast Asian countries, and the EU for the first-line treatment of ES-SCLC, establishing it as the world’s first anti-PD-1 mAb approved for the indication. Additionally, Henlius is conducting a head-to-head bridging trial in the U.S. comparing serplulimab with atezolizumab, the current standard of care, to further support its U.S. regulatory submission.

Global Expansion to Benefit More Patients

Henlius’ commitment to stringent quality standards has been instrumental in achieving EC approval for serplulimab. In 2023, Henlius’ manufacturing facilities and production lines of serplulimab successfully passed EU GMP inspections, ensuring a stable and high-quality supply of serplulimab for the European market. Henlius operates three facilities in Shanghai—Xuhui Facility, Songjiang First Plant, and Songjiang Second Plant—with a total commercial capacity of 48,000 litres, ensuring consistent global supply to regions including China, Europe, Latin America, the Middle East, North America, and Southeast Asia. The company has implemented a comprehensive quality management system in line with international standards, covering the entire product continuum ranging from R&D to material management, product manufacturing, quality control, product supply management and post-marketing surveillance. The company’s facilities and quality systems have been audited and certified by regulatory authorities including the National Medical Products Agency (NMPA), European Medicines Agency (EMA), United States Food and Drug Administration (FDA), and international business partners.

Henlius has established a robust global presence through partnerships with Accord, KGbio, and Fosun Pharma, extending its reach to over 70 countries and regions, including the U.S., Europe, Southeast Asia, and emerging markets. Looking ahead, Henlius will continue to work closely with its partners to expand the availability of serplulimab to more countries and regions, providing broader treatment options to patients worldwide.

About Serplulimab

HANSIZHUANG (recombinant humanized anti-PD-1 monoclonal antibody injection, generic name: serplulimab injection) is the first anti-PD-1 mAb for the first-line treatment of SCLC and has been approved in China, the EU and several SEA countries. Focusing on lung and gastrointestinal cancer, the synergy of HANSIZHUANG with in-house products of the company and innovative therapies are being actively promoted. Up to date, HANSIZHUANG has been approved by the National Medicinal Products Administration (NMPA) for the treatment of squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC) and non-squamous non-small cell lung cancer (nsNSCLC). Serplulimab was granted orphan drug designations by the FDA and the EC for the treatment of SCLC, and its bridging head-to-head trial in the United States to compare HANSIZHUANG to standard of care atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC is well under way.

The results of 4 pivotal trials of HANSIZHUANG were published in the Journal of the American Medical Association (JAMA), Nature Medicine, Cancer Cell and British Journal of Cancer, respectively. Furthermore, HANSIZHUANG was respectively recommended by the CSCO Guidelines for Small Cell Lung Cancer, the CSCO Guidelines for Non-Small Cell Lung Cancer, the CSCO Guidelines for Esophageal Cancer, the CSCO Clinical Practice Guidelines on Immune Checkpoint Inhibitor, the China Guidelines for Radiotherapy of Esophageal Cancer, and other definitive guides, providing valuable references for clinical diagnosis and treatment of tumours.

On February 5, 2025 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported the completion of patient enrollment in the global Phase III clinical trial (HARMONi-6/AK112-306) evaluating ivonescimab, its independently developed PD-1/VEGF bispecific antibody (Press release, Akeso Biopharma, FEB 5, 2025, View Source [SID1234650064]). This clinical study, conducted in China, compares ivonescimab in combination with platinum-based chemotherapy to tislelizumab (a PD-1 inhibitor) combined with platinum-based chemotherapy as a first-line treatment for squamous non-small cell lung cancer (sq-NSCLC).

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In addition, several international Phase III clinical trials of ivonescimab are underway. These clinical studies include the HARMONi-3 clinical trial, which compares ivonescimab plus chemotherapy to pembrolizumab plus chemotherapy for the first-line treatment of both sq-NSCLC and non-squamous NSCLC (nsq-NSCLC). This trial is being efficiently led by Summit Therapeutics, Akeso’s global partner for ivonescimab.

The HARMONi-6/AK112-306 trial is one of six registrational/Phase III studies worldwide for ivonescimab for lung cancer. It is also one of six studies where PD-1/L1 inhibitors are used as comparators. This initiative is a critical step in advancing cancer immunotherapy, establishing superior global treatment standards, and exploring the full clinical and commercial potential of ivonescimab within Akeso’s portfolio.

Ivonescimab, in combination with chemotherapy, has already been approved in China for the treatment of EGFR-TKI-resistant, non-squamous NSCLC. The New Drug Application (sNDA) for ivonescimab monotherapy as a first-line treatment for PD-L1-positive NSCLC (in comparison to pembrolizumab) is currently under review and has been granted priority status in China.

As a next-generation, highly efficacious cancer immunotherapy, ivonescimab is also in multiple Phase III studies beyond lung cancer. These studies include ongoing Phase III trials for PD-L1-positive head and neck squamous carcinoma (vs. pembrolizumab), first-line treatment of biliary tract cancer (with chemotherapy vs. durvalumab + chemotherapy), and the first-line treatment of pancreatic cancer. Clinical trials of ivonescimab for the first-line treatment of triple-negative breast cancer, colorectal cancer, hepatocellular carcinoma, ovarian cancer and gastric cancer, are also in progress.

As these studies progress, ivonescimab has the potential to redefine the standard of care in immuno-oncology around the world, with its clinical and commercial potential realized on a global scale.

Data indicates that the annual incidence of advanced, driver gene-negative sq-NSCLC exceeds 520,000 cases, with many patients ineligible for anti-angiogenesis treatments like bevacizumab. While PD-1/L1 inhibitors combined with chemotherapy have become the global standard of care, including in the U.S. and China, the prognosis for these patients remains poor, highlighting a critical unmet need. Phase III studies show that ivonescimab, targeting both PD-1 and VEGF, offers a synergistic anti-tumor effect with a favorable safety profile. This makes ivonescimab a promising alternative for sq-NSCLC patients who cannot receive bevacizumab due to bleeding risks. Ivonescimab is poised to transform first-line treatment for locally advanced or metastatic sq-NSCLC, providing a safer and more effective immunotherapy option that exceeds current treatment standards.