2025 3Q Earnings

On October 30, 2025 Hanmi reported third quarter financial results for the year 2025 (Presentation, Hanmi, OCT 30, 2025, View Source [SID1234661636]).

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Insmed Reports Third-Quarter 2025 Financial Results and Provides Business Update

On October 30, 2025 Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, reported financial results for the third quarter ended September 30, 2025 and provided a business update.

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"The third quarter of 2025 celebrated the FDA approval of BRINSUPRI and the availability of our second commercial product, underscoring our team’s dedication to bringing forward a first-in-disease therapy for patients with non-cystic fibrosis bronchiectasis. While still early in the U.S. BRINSUPRI launch, we are very encouraged by positive feedback received from both physicians and patients," said Will Lewis, Chair and Chief Executive Officer of Insmed. "This achievement is just the beginning of numerous commercial and clinical catalysts anticipated over the next 18 months across our late-stage programs – ARIKAYCE, brensocatib, and TPIP – and our growing clinical pipeline of first- or best-in-class therapies. With these opportunities ahead, our team is more dedicated than ever to transforming the lives of patients with serious diseases."

Recent Progress and Anticipated Milestones by Program:

ARIKAYCE


ARIKAYCE global revenue grew 22% in the third quarter of 2025 compared to the third quarter of 2024, reflecting year-over-year growth across all geographic regions.


The Company anticipates the topline readout of the Phase 3 ENCORE trial in the first half of 2026 in patients with newly diagnosed or recurrent Mycobacterium avium complex (MAC) lung disease who have not started antibiotics.


Assuming successful results from the ENCORE trial, Insmed plans to submit a supplementary new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for ARIKAYCE in all patients with MAC lung disease in the U.S. in the second half of 2026.

Brensocatib


In August 2025, the FDA approved the Company’s New Drug Application (NDA) for brensocatib for patients with non-cystic fibrosis bronchiectasis (NCFB). BRINSUPRI (brensocatib 25mg and 10mg tablets) was subsequently launched commercially in the U.S.


In October 2025, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the approval of BRINSUPRI (brensocatib 25mg tablets) for the treatment of NCFB in the European Union (EU).


Regulatory submissions for brensocatib for patients with bronchiectasis in the United Kingdom (UK) and Japan have been accepted. Insmed anticipates commercial launches for the EU, UK, and Japan in 2026, pending approval in each territory.


Insmed expects to report topline data from the Phase 2b BiRCh study of brensocatib in patients with chronic rhinosinusitis without nasal polyps (CRSsNP) by early January 2026.


In October 2025, Insmed completed enrollment in the Phase 2b CEDAR study of brensocatib in patients with hidradenitis suppurativa (HS). Insmed now expects to report topline data from CEDAR in the first half of 2026.

TPIP


Insmed anticipates initiating PALM-ILD, a Phase 3 study of treprostinil palmitil inhalation powder (TPIP) in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD), in the fourth quarter of 2025.


Insmed plans to initiate a Phase 3 study of TPIP in patients with pulmonary arterial hypertension (PAH) in early 2026.


The Company anticipates initiating additional Phase 3 studies of TPIP in progressive pulmonary fibrosis (PPF) and idiopathic pulmonary fibrosis (IPF) in the second half of 2026.

Gene Therapy


Insmed completed dosing of the first cohort in the Phase 1 ASCEND clinical study of INS1201, an intrathecally-delivered gene therapy for patients with Duchenne muscular dystrophy (DMD).


The Company’s Investigational New Drug (IND) filing for INS1202, an intrathecally-delivered gene therapy for patients with Amyotrophic lateral sclerosis (ALS), has been cleared by the FDA.


Insmed’s third gene therapy candidate targeting Stargardt disease is currently advancing toward the clinic, with an IND filing expected in the first half of 2026.

Pre-Clinical Programs


Insmed’s research efforts include more than 30 identified pre-clinical programs in development, all of which have the potential to become first-in-class or best-in-class therapies for the indications being pursued.


The Company anticipates submitting an average of one to two INDs per year from its pre-clinical research programs.


Insmed continues to anticipate that the totality of its pre-clinical research programs will comprise less than 20% of overall expenditures.

Corporate Updates


In September 2025, Insmed presented seven abstracts from across its portfolio at the European Respiratory Society (ERS) Congress 2025.


In October 2025, Insmed presented six abstracts from across its portfolio at the American College of Chest Physicians (CHEST) 2025 Annual Meeting.


In October 2025, Insmed announced that it has earned the No. 1 ranking in Science’s 2025 Top Employers Survey, marking the fifth consecutive year in which Insmed achieved the top ranking. The annual survey polls employees in biotechnology, pharmaceutical, and related industries to determine the 20 best employers, as well as their driving characteristics.

Third-Quarter 2025 Financial Results

The following table summarizes Insmed’s third-quarter and year-to-date 2025 and 2024 revenues and revenue growth across all commercial regions:


Three Months Ended
September 30,

Nine Months Ended
September 30,

(in millions)

2025

2024

Growth

2025

2024

Growth

ARIKAYCE

U.S.

$
74.0

$
66.9

11
%

$
206.9

$
187.0

11
%
International

40.3

26.6

52
%

107.6

72.3

49
%
Total

$
114.3

$
93.4

22
%

$
314.5

$
259.3

21
%
BRINSUPRI

U.S.

$
28.1

$


N/A

$
28.1

$


N/A

International





N/A





N/A

Total

$
28.1

$


N/A

$
28.1

$


N/A

Total Revenues

U.S.

$
102.0

$
66.9

53
%

$
235.0

$
187.0

26
%
International

40.3

26.6

52
%

107.6

72.3

49
%
Total

$
142.3

$
93.4

52
%

$
342.6

$
259.3

32
%


Cost of product revenues (excluding amortization of intangibles) was $29.4 million for the third quarter of 2025, compared to $21.2 million for the third quarter of 2024. The increase in cost of product revenues primarily reflects growth in ARIKAYCE sales and BRINSUPRI sales.


Research and development (R&D) expenses were $186.4 million for the third quarter of 2025, compared to $150.8 million for the third quarter of 2024. The increase in R&D expenses was primarily related to increases in compensation and benefit-related expenses and stock-based compensation costs due to an increase in headcount, as well as clinical development and research costs, and manufacturing costs.


Selling, general and administrative (SG&A) expenses for the third quarter of 2025 were $186.4 million, compared to $118.9 million for the third quarter of 2024. The increase in SG&A expenses was primarily related to increases in professional fees and other external expenses, as well as increases in compensation and benefit-related expenses and stock-based compensation costs due to an increase in headcount, both driven by commercial readiness and commercial activities for BRINSUPRI.


For the third quarter of 2025, Insmed reported a net loss of $370.0 million, or $1.75 per share, compared to a net loss of $220.5 million, or $1.27 per share, for the third quarter of 2024.

Balance Sheet, Financial Guidance, and Planned Investments


As of September 30, 2025, Insmed had cash, cash equivalents, and marketable securities totaling approximately $1.7 billion.


Insmed is raising its full-year 2025 global ARIKAYCE revenue guidance to a range of $420 million to $430 million, from a range of $405 million to $425 million previously, representing a range of 15% to 18% year-over-year growth compared to 2024.


The Company plans to continue to invest in the following key activities in 2025:

(i)
commercialization and expansion of BRINSUPRI in the U.S., with advancement of regulatory submissions for brensocatib in Europe, the UK, and Japan;

(ii)
commercialization and expansion of ARIKAYCE globally;

(iii)
advancement of clinical trial programs for brensocatib, including the ongoing Phase 2b BiRCh study in patients with CRSsNP and the Phase 2b CEDAR study in patients with HS;

(iv)
advancement of the Phase 3 ENCORE study for ARIKAYCE, which is intended to satisfy the post-marketing requirement for full approval of its current indication and potentially support label expansion to include all patients with a MAC lung disease;

(v)
advancement of clinical development programs for TPIP, including the initiation of a Phase 3 study in patients with PH-ILD and preparations for separate Phase 3 studies in patients with PAH, PPF, and IPF;

(vi)
advancement of the Phase 1 ASCEND study for INS1201 in DMD; and

(vii)
continued development of its pre-clinical research programs.

Conference Call

Insmed will host a conference call beginning today, October 30, 2025, at 8:00 AM Eastern Time. Shareholders and other interested parties may participate in the conference call by dialing (888) 210-2654 (U.S.) and (646) 960-0278 (international) and referencing access code 7862189. The call will also be webcast live on the Company’s website at www.insmed.com.

A replay of the conference call will be accessible approximately 1 hour after its completion through November 6, 2025, by dialing (800) 770-2030 (U.S.) and (609) 800-9909 (international) and referencing access code 7862189. A webcast of the call will also be archived for 90 days under the Investor Relations section of the Company’s website at www.insmed.com.

(Press release, Insmed, OCT 30, 2025, View Source [SID1234657153])

Forlong Dosed First Patient in Phase 2 Clinical Trial of FL115, a novel interleukin-15 (IL-15) superagonist, for nonmuscle invasive bladder cancer (NMIBC)

On October 30, 2025 Forlong Biotechnology, a clinical-stage biotech company focusing on developing transformative cytokine therapies for patients with severe unmet needs, reported that the first patient has been treated in a Phase 2 clinical trial investigating FL115 in combination with Bacillus Calmette-Guérin (BCG). The study will assess the anti-tumor effect of the combination therapy, including Complete Response Rate and Duration for carcinoma in situ (CIS) NMIBC patients, and Disease Free Survival and Relapse Free Survival for papillary (Ta/T1) NMIBC patients.

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FL115 is an engineered IL-15/IL15Rα-Fbody fusion protein aiming to enhance anti-tumor immunity via IL-15-mediated signaling on NK and CD8+ T cells while minimizing complexity from Fc. The start of the Phase 2 clinical trial builds on positive data from the Phase 1 trial where FL115 demonstrated favorable safety and efficacy in the same patient population. As a monotherapy at the recommended dose for expansion, 4/6 patients achieved responses longer than 3 months, of which 2 patients achieving responses longer than 9 months. This dose of FL115 in combination with BCG will be investigated in the Phase 2 trial.

"Dosing the first patient in our Phase 2 trial for FL115 marks a defining moment for Forlong, as we advance our lead candidate further into clinical development and continue to validate the potential of our synthetic immunology platforms," said Dong Wei, Ph.D., Chief Executive Officer of Forlong Biotechnology, "FL115 stands out with favorable safety and preliminary efficacy observed in multiple Phase 1 clinical studies in advanced solid tumors and NMIBC. With FL115 interim data for advanced solid tumor to be presented as Late Breaking Abstract on Nov 8 at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2025), this trial gives us the opportunity to further validate FL115 as potential Best-in-class IL-15 superagonist, and bring new treatment options for cancer patients in need."

The Phase 2 clinical trial plans to enroll three arms: BCG unresponsive CIS NMIBC patients, BCG unresponsive high risk papillary NMIBC patients, and BCG naïve medium/high risk NMIBC patients. The trial will be conducted at over 15 investigator sites in China.

About FL-115

FL115 is an engineered IL-15/IL15Rα-Fbody fusion protein, aiming to enhance anti-tumor immunity via IL-15-mediated signaling on NK and CD8+ T cells while minimizing complexity from Fc. FL115 has demonstrated significant anti-tumor activities as a monotherapy or as part of combination therapy in vivo, and can be manufactured by a robust and efficient process with excellent product stability. Clinically, FL115 has demonstrated favorable safety profile and preliminary clinical responses as a monotherapy, and has the best-in-class potential to synergize with current and emerging T cell-targeting immunotherapies through combination therapy to significantly improve the treatment outcome for patients. It is currently being investigated in combination with Bacillus Calmette-Guérin (BCG) in a Phase 2 clinical trial to evaluate safety and preliminary efficacy in patients with nonmuscle invasive bladder cancer (NMIBC) and in combination with an anti-PD1 monoclonal antibody in a Phase 1b/2 clinical trial to evaluate safety and preliminary efficacy in patients with advanced solid tumors.

(Press release, Forlong Biotechnology, OCT 30, 2025, View Source [SID1234657188])

European Commission Approves KEYTRUDA® (pembrolizumab) as Part of a Treatment Regimen for Adults with Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC) Expressing PD-L1 (CPS >1)

On October 29, 2025 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that the European Commission (EC) has approved KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, as monotherapy for the treatment of resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC) as neoadjuvant treatment, continued as adjuvant treatment in combination with radiation therapy with or without concomitant cisplatin and then as monotherapy in adults whose tumors express PD-L1 with a Combined Positive Score (CPS) ≥1. This approval marks the first and only anti-PD-1 treatment option for certain patients with resectable LA-HNSCC in the European Union (EU) and the third approval for KEYTRUDA in HNSCC in the EU.

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"This approval brings a promising advancement to patients in Europe with resectable locally advanced head and neck squamous cell carcinoma," said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. "We’re proud of the continued progress we’re making to broaden the impact of KEYTRUDA in head and neck cancers and remain focused on working to deliver innovative approaches that have the potential to make a meaningful difference for patients."

The EC approval is based on results from the pivotal Phase 3 KEYNOTE-689 trial. At the trial’s first pre-specified interim analysis, the KEYTRUDA-based perioperative regimen demonstrated a statistically significant and clinically meaningful improvement in event-free survival (EFS), the study’s primary endpoint, compared to adjuvant radiotherapy (with or without cisplatin) alone in patients with tumors expressing PD-L1 (CPS ≥1). The KEYTRUDA-based perioperative regimen reduced the risk of EFS events (defined as disease recurrence, disease progression or death) by 30% (HR=0.70 [95% CI, 0.55-0.89]; p=0.00140) in patients with tumors expressing PD-L1 (CPS ≥1) compared to adjuvant radiotherapy (with or without cisplatin) alone. Among the patients with tumors expressing PD-L1 (CPS ≥1), median EFS was doubled to 59.7 months (95% CI, 37.9-not reached) in the KEYTRUDA arm versus 29.6 months (95% CI, 19.5-41.9) in the comparator arm. The approval follows the positive recommendation from the Committee for Medicinal Products for Human Use received in September 2025.

This approval allows marketing of this KEYTRUDA treatment regimen for this indication in all 27 EU member states, as well as Iceland, Liechtenstein and Norway. Timing for commercial availability of KEYTRUDA for this indication in individual EU countries will depend on multiple factors, including the completion of national reimbursement procedures.

In June 2025, KEYTRUDA was approved in the U.S. for the treatment of adult patients with resectable LA-HNSCC whose tumors express PD-L1 (CPS ≥1) as determined by a U.S. Food and Drug Administration (FDA)-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy with or without cisplatin and then as a single agent. Based on the results from the Phase 3 KEYNOTE-689 trial KEYTRUDA was also approved in Canada, Brazil, Switzerland and several other countries around the globe as a perioperative treatment option for certain patients with resectable LA-HNSCC.

About KEYNOTE-689

KEYNOTE-689 is a randomized, active-controlled, open-label Phase 3 trial (ClinicalTrials.gov, NCT03765918) evaluating KEYTRUDA as neoadjuvant treatment and KEYTRUDA in combination with standard of care radiotherapy (with or without cisplatin) as adjuvant treatment in treatment-naïve patients with newly diagnosed, stage III or IVA resectable LA-HNSCC. Efficacy outcomes are classified by PD-L1 status. The primary endpoint is EFS, which is defined as the time from randomization to the first occurrence of radiographic disease progression; local or distant progression or recurrence; or death due to any cause. The secondary endpoints include overall survival, major pathological response, pathological complete response and safety. The study enrolled 714 patients who were randomized 1:1 to receive:

KEYTRUDA (200 mg intravenously [IV] every three weeks [Q3W] for two cycles) as neoadjuvant therapy prior to surgery, followed by either KEYTRUDA (200 mg IV Q3W for 15 cycles) plus standard of care radiotherapy with cisplatin (100 mg/m2 IV Q3W for three cycles) as adjuvant therapy following surgery for high-risk patients or KEYTRUDA (200 mg IV Q3W for 15 cycles) plus standard of care radiotherapy without cisplatin as adjuvant therapy following surgery for low-risk patients; or
No neoadjuvant therapy prior to surgery, followed by adjuvant standard of care radiotherapy with cisplatin (100 mg/m2 IV Q3W for three cycles) as adjuvant therapy following surgery for high-risk patients or standard of care radiotherapy without cisplatin as adjuvant therapy following surgery for low-risk patients.
About head and neck cancer

Head and neck cancer describes a number of different tumors that develop in or around the throat, larynx, nose, sinuses and mouth. It is estimated there were more than 947,200 new cases of head and neck cancer diagnosed and more than 482,400 deaths from the disease in 2022 globally. In Europe, it is estimated there were approximately 161,900 new cases of head and neck cancer and more than 72,500 deaths from the disease in 2022. These data include cancers of the oral cavity, pharynx and larynx. Most head and neck cancers are squamous cell carcinomas, which begin in the flat, squamous cells that make up the thin mucosal lining of the head and neck. Locally advanced head and neck squamous cell carcinoma is cancer that has spread from where it started to nearby tissue or lymph nodes but has not yet spread to distant parts of the body. There are several factors that greatly increase the risk of developing head and neck cancer, including tobacco and alcohol use and human papillomavirus.

(Press release, Merck & Co, OCT 29, 2025, View Source [SID1234657105])

I-MAB (Nasdaq: IMAB) Transitions to NovaBridge Biosciences (Nasdaq: NBP) with Trading Effective October 30, 2025 New Brand and Logo to Reflect Strategic Transformation to a Global Biotech Platform

On October 29, 2025 NovaBridge Biosciences (NovaBridge or the Company) reported that it has changed its corporate name from I-Mab to NovaBridge Biosciences. The change was overwhelmingly approved by shareholders at the Company’s Extraordinary General Meeting held on October 24, 2025, and by the Company’s Board of Directors. The Company’s American Depositary Shares (ADSs) will trade on Nasdaq under the new name and a new ticker symbol, "NBP", effective at the opening of trading on October 30, 2025, replacing its current symbol "IMAB" (Nasdaq: IMAB).

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The new corporate brand, including a new website (www.novabridge.com), marks an important step in the Company’s strategic transformation to a global biotechnology platform company committed to accelerating access to innovative medicines for patients worldwide.

In connection with the name change and ticker symbol change, no action is required from current shareholders and the Company’s CUSIP number will remain the same. Historical trading data of the Company’s ADSs prior to October 30, 2025 may not yet be available on certain third-party websites and apps when searching for "NovaBridge Biosciences" and/or "NBP", in which case such data may temporarily be found under "I-MAB" and/or "IMAB".

"Our new corporate branding successfully conveys the key elements of our new strategy, bridging collaboration, translational science, and execution to rapidly progress transformative therapies and strategically create significant value for patients and investors," said Mr. Fu Wei, Executive Chairman of NovaBridge. "Our proposed dual listing on both Nasdaq and HKEX, a key element of our global growth strategy, will enable us to broaden and diversify our investor base, and enhance trading liquidity and access to capital, while strengthening our presence with key stakeholders in the rapidly growing Asian market."

"NovaBridge’s new brand identity successfully aligns with our strategic transition to a global biotech platform. The recent presentation of encouraging updated Phase 1 monotherapy data at the Triple Meeting1 for givastomig, a potential best-in-class Claudin 18.2-directed therapy for gastric cancers, and the formation of our new subsidiary, Visara, and its recent acquisition of VIS-101, a second-in-class potentially best-in-class bifunctional VEGF-A/ANG2 targeted biologic, provide positive validation of our new strategy. We continue to progress givastomig towards a global randomized Phase 2 study, expected to achieve enrollment of the first patient in Q1 2026," said Sean Fu, PhD, Chief Executive Officer of NovaBridge. "We are pleased by the positive momentum from our new strategy, accented by our new corporate brand, and are optimistic that our global biotech platform will enable us to realize the full potential of innovative medicines and create value for patients and investors."

The NovaBridge Business Model and Pipeline

The Company intends to partner with leading innovators to identify and accelerate high-value assets. Our model integrates rigorous asset selection, bespoke translational strategies, and efficient clinical execution. With the backing of CBC Group, we leverage deep local insights and global capabilities to develop the most promising drug candidates across a range of therapeutic categories.

The Company will utilize a "hub-and-spoke" model to create and advance specialized subsidiary companies (spokes) which maintain operational focus and agility. By focusing each spoke on a specific asset or therapeutic area, the Company can optimally manage risk and create value through potential partnering transactions.

Pipeline:

Givastomig, a potential best-in-class Claudin 18.2 X 4-1BB bispecific antibody, is in Phase 1b clinical trials for the potential treatment of gastric cancer and other Claudin 18.2-positive gastrointestinal malignancies. A global, randomized Phase 2 study is planned, with the enrollment of the first patient targeted in Q1 2026. Givastomig is being jointly developed through a global partnership with ABL Bio, in which NovaBridge is the lead party and shares worldwide rights, excluding Greater China and South Korea, equally with ABL Bio.

Ragistomig is an anti-PD-L1 X 4-1BB bispecific antibody. Built on Phase 1 clinical data, an ongoing Phase 1b study designed to expand the therapeutic index is expected to yield results in 2H 2026. The program is being jointly developed with ABL Bio.

Uliledlimab targets CD73, the rate-limiting enzyme critical for adenosine-driven immunosuppression in the tumor microenvironment. Progression free survival (PFS) data are expected in 2H 2026 from an ongoing randomized Phase 2 trial evaluating uliledlimab + toripalimab compared to pembrolizumab alone or toripalimab alone in a CD73 selected population. NovaBridge owns worldwide rights to uliledlimab outside of Greater China.

VIS-101, acquired by Visara, a newly formed NovaBridge subsidiary, under the new business model, is a bifunctional biologic targeting VEGF-A and ANG2, currently in Phase 2 development

VIS-101 is a novel bifunctional biologic targeting VEGF-A and ANG-2, and a more potent molecule that could potentially provide more durable treatment benefits for patients with wet AMD, DME, and retinal vein occlusion (RVO) than current standard of care. VIS-101 has completed initial safety and dose-escalation studies in both the US and China, and is currently completing a randomized, dose-ranging Phase 2 study in China. VIS-101 is anticipated to be Phase 3-ready in 2026.

Acquisition completed by a newly formed subsidiary, Visara. Visara, a clinical-stage biopharmaceutical company focusing on the development of best-in-class ophthalmic therapeutics, was launched with an approximately $37M capital infusion from NovaBridge and the contribution of certain rights by a strategic partner. NovaBridge is the majority shareholder of Visara, and Visara controls global rights to VIS-101.

Visara is led by Co-Founder and Executive Chairman Emmett T. Cunningham, Jr., MD, PhD, MPH. Dr. Cunningham has been a physician, innovator, entrepreneur, and investor for more than 25 years, formerly serving as Senior Managing Director at Blackstone Group L.P. and Managing Director at Clarus Ventures, LLC. Dr. Cunningham is also an internationally recognized specialist in infectious and inflammatory eye disease with over 450 co-authored publications.

1. 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) is also known as the Triple Meeting, held in Boston, Massachusetts October 22-26, 2025

(Press release, I-Mab Biopharma, OCT 29, 2025, View Source [SID1234660986])