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Last update 28 Mar 2026
SSGJ-707
Last update 28 Mar 2026
Overview
Basic Info
Drug Type Bispecific antibody |
Synonyms 707, PF 4404, PF-08634404 + [5] |
Target |
Action inhibitors |
Mechanism PD-1 inhibitors(Programmed cell death protein 1 inhibitors), VEGF inhibitors(Vascular endothelial growth factor inhibitors) |
Therapeutic Areas |
Inactive Indication- |
Originator Organization |
Inactive Organization- |
Drug Highest PhasePhase 3 |
First Approval Date- |
RegulationBreakthrough Therapy (China) |
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Related
16
Clinical Trials associated with SSGJ-707NCT07476287
A PHASE 2 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN PARTICIPANTS WITH PREVIOUSLY UNTREATED TRANSFORMED SMALL CELL LUNG CANCER
This study is being done to learn more about a new medicine called PF-08634404. The study team wants to understand how well PF-08634404 works when given alone or with chemotherapy . Chemotherapy is a type of cancer treatment that uses medicines to destroy cancer cells or stop them from growing. The study is for adults with Transformed Small Cell Lung Cancer (T-SCLC ). T SCLC is a rare lung cancer that happens when one type of lung cancer changes into a more aggressive type after treatment stops working.
To join the study, participants must meet the following conditions:
* Are aged 18 years or older
* Diagnosed with T-SCLC and have not received treatment for this type of lung cancer (a single cycle of chemotherapy may be permitted)
* Prior diagnosis of epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer treated with tyrosine kinase inhibitors (TKIs)
* Have healthy organs based on medical tests and are in good physical condition
After joining the study, adults will be given chemotherapy in addition to the study medicine. After this combination treatment is finished, the study medicine will be continued alone. Adults will receive the treatment through IV infusions (medicine given directly into a vein). All treatments will be done at clinical study sites, where a trained medical team will monitor adults during and after each visit.
To join the study, participants must meet the following conditions:
* Are aged 18 years or older
* Diagnosed with T-SCLC and have not received treatment for this type of lung cancer (a single cycle of chemotherapy may be permitted)
* Prior diagnosis of epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer treated with tyrosine kinase inhibitors (TKIs)
* Have healthy organs based on medical tests and are in good physical condition
After joining the study, adults will be given chemotherapy in addition to the study medicine. After this combination treatment is finished, the study medicine will be continued alone. Adults will receive the treatment through IV infusions (medicine given directly into a vein). All treatments will be done at clinical study sites, where a trained medical team will monitor adults during and after each visit.
Start Date15 May 2026 |
Sponsor / Collaborator |
NCT07489066
AN INTERVENTIONAL, OPEN-LABEL, PHASE 2 STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF PF-08634404 MONOTHERAPY OR IN COMBINATION IN ADULT PARTICIPANTS WITH EARLY-STAGE RESECTABLE OR LOCALLY ADVANCED UNRESECTABLE NON-SMALL CELL LUNG CANCER
This study is being done to learn more about a new medicine called PF-08634404. The study team wants to understand how well it works when given alone or with chemotherapy. The study is for adults with early stage or locally advanced non-small cell lung cancer (NSCLC) that may or may not be removable with surgery.
The study is seeking participants who:
* Are aged 18 years or older
* Have either:
* Early-stage or locally advanced (Stage II or IIIA/B) NSCLC and are a candidate for neoadjuvant therapy, followed by surgical removal of the tumor. Neoadjuvant therapy is a treatment given as a first step to shrink the tumor before surgery.
* Early-stage or locally advanced (Stage II or IIIA/B) NSCLC and are a candidate for adjuvant therapy and did not achieve a pathological complete response (pCR) from approved treatment that was administered before surgery. Adjuvant therapy is an additional cancer treatment given after the primary treatment to lower the risk that the cancer will come back. pCR is defined as absence of viable tumor in all surgically removed samples.
* Locally advanced (Stage III) NSCLC that may not be removable with surgery, was treated with concurrent chemoradiotherapy (cCRT), and is a candidate for additional treatment, otherwise known as consolidation therapy. cCRT is chemotherapy and radiation given simultaneously.
* Be in good physical condition and have healthy organs based on medical tests.
* Do not have known actionable changes in DNA
The study has 3 parts and each participant will be assigned to one part by their doctor based on their disease diagnosis:
* Part A will test PF-08634404 given with chemotherapy in the neoadjuvant setting, followed by surgery.
* Part B will test PF-08634404 alone in adults who already were treated with neoadjuvant chemo-immunotherapy, underwent surgery, and did not achieve pCR per tumor tissue pathology analysis. Neoadjuvant chemo-immunotherapy refers to the combination of chemotherapy with immunotherapy per local standard-of-care, given before surgical removal of the tumor.
* Part C will test PF-08634404 alone in adults with unresectable disease who received cCRT and did not have progressive disease. Progressive disease refers to a condition that grows, spreads, or worsens.
All treatments will be done at clinical study sites, where a trained medical team will monitor adults during and after each visit.
The study is seeking participants who:
* Are aged 18 years or older
* Have either:
* Early-stage or locally advanced (Stage II or IIIA/B) NSCLC and are a candidate for neoadjuvant therapy, followed by surgical removal of the tumor. Neoadjuvant therapy is a treatment given as a first step to shrink the tumor before surgery.
* Early-stage or locally advanced (Stage II or IIIA/B) NSCLC and are a candidate for adjuvant therapy and did not achieve a pathological complete response (pCR) from approved treatment that was administered before surgery. Adjuvant therapy is an additional cancer treatment given after the primary treatment to lower the risk that the cancer will come back. pCR is defined as absence of viable tumor in all surgically removed samples.
* Locally advanced (Stage III) NSCLC that may not be removable with surgery, was treated with concurrent chemoradiotherapy (cCRT), and is a candidate for additional treatment, otherwise known as consolidation therapy. cCRT is chemotherapy and radiation given simultaneously.
* Be in good physical condition and have healthy organs based on medical tests.
* Do not have known actionable changes in DNA
The study has 3 parts and each participant will be assigned to one part by their doctor based on their disease diagnosis:
* Part A will test PF-08634404 given with chemotherapy in the neoadjuvant setting, followed by surgery.
* Part B will test PF-08634404 alone in adults who already were treated with neoadjuvant chemo-immunotherapy, underwent surgery, and did not achieve pCR per tumor tissue pathology analysis. Neoadjuvant chemo-immunotherapy refers to the combination of chemotherapy with immunotherapy per local standard-of-care, given before surgical removal of the tumor.
* Part C will test PF-08634404 alone in adults with unresectable disease who received cCRT and did not have progressive disease. Progressive disease refers to a condition that grows, spreads, or worsens.
All treatments will be done at clinical study sites, where a trained medical team will monitor adults during and after each visit.
Start Date01 Apr 2026 |
Sponsor / Collaborator |
NCT07392892
A PHASE 2/3 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN TREATMENT-NAÏVE PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC GASTRIC, GASTROESOPHAGEAL JUNCTION, OR ESOPHAGEAL ADENOCARCINOMA
This study is being done to learn more about a new medicine called PF-08634404 and how well it works when given with chemotherapy to people with gastroesophageal cancer that is locally advanced (spread to nearby tissues) or has spread to other parts of the body.
To join the study, participants must meet the following conditions:
Be 18 years or older. Have locally advanced or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma Be treatment naïve for advanced or metastatic disease Be in good physical condition and have healthy organs based on medical tests.
The study has two parts:
* In the first part, researchers will check how safe the study medicine in combination with chemotherapy is and how well people respond to it.
* In the second part, they will compare study medicine plus chemotherapy to another approved treatment (nivolumab plus chemotherapy) to see which works better.
The treatment will be given in repeated time periods called cycles.
To join the study, participants must meet the following conditions:
Be 18 years or older. Have locally advanced or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma Be treatment naïve for advanced or metastatic disease Be in good physical condition and have healthy organs based on medical tests.
The study has two parts:
* In the first part, researchers will check how safe the study medicine in combination with chemotherapy is and how well people respond to it.
* In the second part, they will compare study medicine plus chemotherapy to another approved treatment (nivolumab plus chemotherapy) to see which works better.
The treatment will be given in repeated time periods called cycles.
Start Date02 Mar 2026 |
Sponsor / Collaborator |
100 Clinical Results associated with SSGJ-707
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100 Translational Medicine associated with SSGJ-707
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100 Patents (Medical) associated with SSGJ-707
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32
News (Medical) associated with SSGJ-70704 Mar 2026
Pfizer’s urgency to quickly expand the clinical program of its PD-1xVEGF bispecific antibody highlights a thrilling race to develop a successor to displace Keytruda, the current immuno-oncology king.\n Oncology projects currently take up about 40% of Pfizer’s overall R&D budget. Behind this construction is Jeff Legos, Ph.D., who became the firm’s chief oncology officer last year following a high-profile move from Novartis.After steering positive key pivotal readouts for a trio of Novartis’ blockbusters—Kisqali, Pluvicto and Scemblix—Legos is now tasked with fleshing out Pfizer’s $43 billion Seagen acquisition into an antibody-drug conjugate empire while accelerating a PD-1xVEGF bispecific licensed from 3SBio toward 2028 readouts.For the closely watched PD-1xVEGF competition, Legos’ strategy for Pfizer is anchored by three pillars: speed, breadth and novel combinations.“We are operating under very expedited timelines in terms of the first wave of studies,” Legos said in an interview with Fierce Biotech. Slamming the gasPfizer cleared regulatory requirements and completed the licensing agreement for 3SBio\'s PD-1xVEGF bispecific toward the end of July 2025. For an upfront payment of $1.25 billion and potential milestones of up to $4.8 billion, Pfizer gained ex-China rights to SSGJ-707, now also known as PF-08634404.By the end of 2025, Pfizer would have had regulatory discussions with the FDA and launched seven clinical trials, including three phase 3 studies, for the PD-1xVEGF drug. And the company plans to start another five studies by June this year. Normally, it would take about a year from clinical ideation to a study start, Legos noted.As to breadth, Pfizer is examining all of the existing indications of Merck & Co.’s Keytruda, trying to figure out where the PD-1xVEGF inhibitor can go, with additional considerations paid to disease prevalence and unmet medical need, Legos said. The urgency to quickly expand PF-08634404’s clinical program highlights a thrilling race to develop a successor to displace Keytruda, the current immuno-oncology king. To justify its price tag, Pfizer has talked about how PF-08634404 is differentiated from other candidates from a chemistry and biological mechanism perspective. But the phase 3 programs that Pfizer has outlined so far appear similar—if not identical—to what its rivals Summit Therapeutics/Akeso and BioNTech/Bristol Myers Squibb are undertaking for their PD(L)1xVEGF candidates.Some of the same settings where Pfizer is running phase 3 include a first-line non-small cell lung cancer study pitting PF-08634404 against Keytruda in their respective combinations with chemotherapy across both squamous and nonsquamous histologies, against Roche’s Tecentriq and chemo in first-line extensive-stage small cell lung cancer, and phase 3 tests in first-line gastric cancer and first-line colorectal cancer. PF-08634404 is a tetravalent antibody with four binding domains, two each for PD-1 and VEGF. The structure provides more robust cooperative binding and create a so-called “daisy chain” effect that could bring more cancer-killing T cells to the tumor microenvironment, Legos explained.“Despite that [scientific rationale], it does come down to clinical data, and that’s why we are required to test it in these very well-defined patient populations,” Legos said.Even though Keytruda has established itself as the standard of care in first-line NSCLC, only about 30% of patients benefit from immunotherapy, and only 30% of those patients benefitting experience long-term, durable responses, Legos observed. And in colorectal cancer, immunotherapy remains less effective in microsatellite-stable tumors. The unmet need prompted Pfizer to study whether PF-08634404 can improve patients’ outcomes, he said. Can PD-1xVEGF live up to its promise?Despite billions of dollars being poured into the PD-(L)1xVEGF space, the main criticism against the class is its seemingly weak ability to turn slowing tumor progression into prolonging patients’ lives. Summit and Akeso’s first-in-class ivonescimab recently showed a 26% death risk reduction in Chinese patients with previously treated EGFR-mutated NSCLC at the final analysis of the phase 3 HARMONi-A trial. But when it comes to the global HARMONi trial, the overall survival data failed to meet statistical significance.Legos argues that those data shouldn’t discount the broader potential of the PD-1xVEGF mechanism. Neither PD-1 nor VEGF inhibitor works very well separately in EGFR-mutated NSCLC, so it’s “not so surprising that the overall survival data is more borderline,” he said.And the problem may not be PD-1xVEGF anyway.“When you design a study with smaller patient numbers, in order to meet predefined endpoint around progression-free survival, you may not have enough power to sufficiently demonstrate the overall survival benefit,” Legos said.For PF-08634404, Pfizer plans to make overall survival at least a primary endpoint in all its phase 3 trials.“It comes down to the intention of the trial and your statistical analysis plan up front, and then ultimately the patient population that we are studying,” he said. Answers to the question of whether Pfizer’s PD-1xVEGF drug can be the next Keytruda will start to emerge in 2028, when the company expects readouts from the first wave of its phase 3 programs.However, the landscape of cancer care is forever evolving, and PD-(L)1xVEGF is not the only force that has its eyes on the prize. Notably, Merck is investing aggressively in its Kelun Biotech-partnered TROP2 antibody-drug conjugate sacituzumab tirumotecan (sac-TMT) but has been quiet on its own PD-1xVEGF bispecific after licensing the asset from China’s LaNova Medicines—now part of Sino Biopharm—in late 2024.“I’m not sure it’s an either-or, because they’re doing two very different things,” Legos said of a potential showdown between PD-1xVEGF bispecifics and TROP2 ADCs.ADCs, as targeted missiles to deliver a cancer-killing payload, can achieve immediate cytotoxic cell death.“But frankly, we’re not just looking for improvements in response rates,” Legos continued. “Without engaging the immune system, I think the benefit of just a single modality may be limited in terms of its fullest potential.”Merck is already pairing sac-TMT with Keytruda in phase 3 trials in multiple tumor settings. As to whether a TROP2 ADC can be combined with a PD-1xVEGF bispecific, “those experiments would have to be done,” Legos said. Expanding Pfizer’s oncology pipelineCombination with other novel agents, including ADCs, is already on Legos’ agenda, forming the third pillar of his strategy in hopes of truly differentiating PF-08634404 from its peers. One of the phase 3 studies being planned pairs PF-08634404 with Pfizer’s Astellas-partnered ADC Padcev in first-line bladder cancer, a setting where the Padcev-Keytruda combo has recorded standing ovation-worthy data. Following the Seagen buy, questions persist regarding Pfizer’s ability to build a sustainable ADC pipeline while avoiding the path of Gilead Sciences, which has not produced a new ADC beyond the TROP2-directed Trodelvy in the six years since its $21 billion acquisition of Immunomedics. Pfizer discontinued a B7-H4 ADC a year ago and has repeatedly pared back efforts around its RemeGen-partnered HER2 ADC disitamab vedotin.Legos remains optimistic that new ADCs are coming out of Pfizer. Among eight key readouts that Pfizer expects this year across the group, sigvotatug vedotin, an ADC targeting integrin-beta6, is expected to report phase 3 data in second-line nonsquamous NSCLC in the first half of 2026.With its biology experts and partners, Pfizer is profiling novel antigens to target for next-generation ADCs and is examining “a variety of permutations,” such as bispecific antibody constructions and novel payloads, Legos said.“Instead of just focusing on traditional cytotoxic payloads, which I think have done very well, we’re now leveraging our small-molecule chemistry, and these could be low molecular weight inhibitors, they could be molecular glues, they could be targeted protein degraders,” Legos said. “These can become the basis of payloads where you can deliver very high dose, high concentration of a specific inhibitor directly to the cancer cells, thereby minimizing any safety or tolerability challenges but optimizing a therapeutic index.”The mix-and-match has already begun. Instead of the vedotin payload, Pfizer is testing another integrin beta6 candidate with a TOPO1 payload in phase 1 dose escalation, and is developing a third intravesical molecule with a unique payload in non-muscle invasive bladder cancer to complement Padcev, according to Legos.“We are working on modifying all of those different variables to bring forward what we believe to be a potentially practice-changing ADC in our priority disease areas,” Legos said. The Pfizer oncology pipeline currently includes traditional small molecules, regular antibodies, ADCs and bispecifics, including T-cell engager. But the company does not have any CAR-T projects. Pfizer Ventures was a top investor in Capstan Therapeutics, an in vivo CAR-T biotech that was recently bought by AbbVie. Legos said he’s “fairly agnostic to” modalities and is “completely open […] to pursue innovation wherever it originates.”“We have all of the building blocks that hopefully helps us accelerate the time to patient, but we are open and interested to explore all types of innovation, irrespective of modality,” he said.While the large deals for Seagen and 3SBio’s PD-1xVEGF drug have put rejuvenation of oncology at the top of Pfizer investors’ mind, obesity has grabbed their attention lately in the forms of Pfizer’s $10 billion takeover of Metsera and a $1.9 billion biobucks deal for new GLP-1 therapies from Fosun Pharma.Pointing to oncology’s 40% allocation of Pfizer’s entire R&D budget, Legos said he’s not worried about competition for resources internally with metabolic diseases but sees potential for mutual lessons sharing.“I’m very hopeful about the potential intersections of cancer and the insulin axis as it relates to the future of care,” Legos said. “For a company that actually can be a leader in obesity and in oncology, it’s an opportunity to think about how cancer care is done on the backbone of GLP-1, amylin, GIP as part of the future.”
Phase 3ImmunotherapyLicense out/inAcquisitionPhase 1
12 Jan 2026
AbbVie will pay $650 million upfront for rights outside of China to RemeGen's investigational PD-1/VEGF-targeted bispecific antibody dubbed RC148. Under the deal announced Monday, RemeGen is also eligible to receive potential milestones of up to $4.95 billion, in addition to tiered, double-digit royalties on net sales outside of China.RC148 is currently in Phase II development having been investigated by RemeGen as a monotherapy and in combination regimens across multiple advanced solid tumours. In early clinical studies, the therapy has shown initial favourable antitumour activity in combination with an antibody-drug conjugate (ADC). "By combining the immune checkpoint inhibition and anti-angiogenic activity of RC148 together with the targeted cytotoxic activity of ADCs, we have the potential to identify meaningful options for patients across a range of solid tumours," said Daejin Abidoye, therapeutic area head, oncology, solid tumour and haematology at AbbVie.AbbVie singled out its own investigational ADC, telisotuzumab adizutecan, as a potential partner for RC148 across multiple solid tumours with high unmet need including non–small-cell lung cancer and colorectal cancers.Along with AbbVie, China-sourced bispecific antibodies targeting PD-1/VEGF have been licensed by Pfizer — which paid $1.25 billion upfront for 3SBio's SSGJ-707 — and Merck & Co. — which forked out $588 million upfront for LaNova Medicines' LM-299.Separately on Monday, Summit Therapeutics disclosed that it submitted an application to the FDA seeking approval of its PD-1/VEGF bispecific ivonescimab, in combination with chemotherapy, in second-line or later treatment of patients with EGFR-mutated locally advanced or metastatic non-squamous non–small-cell lung cancer (NSCLC). The filing, made in the fourth quarter of 2025, was based on the Phase III HARMONi trial.
ADCPhase 2Clinical ResultLicense out/inPhase 3
16 Dec 2025
Continued Investment in Pipeline and Acquired Assets in 2026 to Fuel Long-Term Growth
Reaffirms Full-Year 2025 Adjusted (1) Diluted EPS Guidance (2) and Revises Full-Year 2025 Revenue Guidance (2) to Approximately $62.0 Billion
Full-Year 2026 Revenue Guidance (2) Range of $59.5 to $62.5 Billion
Full-Year 2026 Adjusted (1) Diluted EPS Guidance (2) Range of $2.80 to $3.00
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) today provided its full-year 2026 guidance(2) while revising its November 4, 2025 full-year 2025 Revenue guidance(2) and reaffirming all other components of full-year 2025 financial guidance(2). The accompanying presentation can be found at www.pfizer.com/investors.
FULL-YEAR 2026 REVENUE GUIDANCE(2)
Pfizer anticipates full-year 2026 revenues to be in the range of $59.5 to $62.5 billion, while full-year 2025 revenue guidance(2) is revised to approximately $62.0 billion from the range of $61.0 to $64.0 billion previously. Full-year 2026 revenue guidance(2) includes the expectation of revenues from our COVID-19 products being approximately $1.5 billion lower than what is expected in 2025 plus an expected year-over-year negative revenue impact of approximately $1.5 billion due to certain products experiencing loss of exclusivity (LOE)(2). Pfizer expects full-year 2026 operational(3) revenue growth at the midpoint, excluding both COVID-19 and LOE products, to be approximately 4% year-over-year.
FULL-YEAR 2026 ADJUSTED(1) SI&A and ADJUSTED(1) R&D EXPENSES GUIDANCE(2)
Pfizer anticipates full-year 2026 Adjusted(1) SI&A expenses to be in the range of $12.5 to $13.5 billion, reflecting ongoing progress with our Cost Realignment Program. The company anticipates full-year 2026 Adjusted(1) R&D expenses to be in the range of $10.5 to $11.5 billion, reflecting continued focus on prioritization in key therapeutic areas and maximizing the development of PF-08634404 (a PD-1 x VEGF bispecific antibody in-licensed from 3SBio) as well as multiple clinical programs from Metsera. Consequently, total 2026 Adjusted(1) SI&A and R&D expenses are expected to be in the range of $23.0 to $25.0 billion.
FULL-YEAR 2026 ADJUSTED(1) DILUTED EPS GUIDANCE(2)
Pfizer anticipates full-year 2026 Adjusted(1) diluted EPS to be in a range of $2.80 to $3.00. 2026 Adjusted(1) diluted EPS guidance(2) primarily reflects our expected revenues, anticipated stable gross and operating margins vs full-year 2025 guidance(2), and an anticipated higher tax rate on Adjusted(1) income vs full-year 2025 guidance(2).
A comparison of Pfizer’s 2025 Financial Guidance(2) to its 2026 Financial Guidance(2) is presented below.
2025 Financial Guidance(2)
(as of December 16, 2025)
2026 Financial Guidance(2)
Revenues ($ in billions)
Approximately $62.0
(previously $61.0 – $64.0)
$59.5 – $62.5
COVID-19 Products ($ in billions)
~$6.5
~$5.0
Adjusted(1) SI&A Expenses ($ in billions)
$13.1 – $14.1
$12.5 – $13.5
Adjusted(1) R&D Expenses ($ in billions)
$10.0 – $11.0
$10.5 – $11.5
Effective Tax Rate on Adjusted(1) Income
Approximately 11%
Approximately 15%
Adjusted(1) Diluted EPS
$3.00 – $3.15
$2.80 – $3.00
Financial guidance for Adjusted(1) diluted EPS is calculated using approximately 5.71 billion weighted-average shares outstanding in 2025 and approximately 5.74 billion weighted-average shares outstanding in 2026, and assumes no share repurchases in 2025 or 2026.
CEO COMMENTARY
“2025 was a year of strong execution and strategic progress for Pfizer. We’ve strengthened our foundation, advanced our R&D pipeline and positioned our company for sustainable growth in the post-LOE period. As we move into 2026, we’re focused on serving patients with innovative medicines and vaccines while creating long-term value for our shareholders.”
PFIZER TO HOST CONFERENCE CALL
Pfizer will host a live conference call and webcast today, December 16, 2025, at 8:00 AM EST. To access the live conference call as well as view the Full-Year 2026 Financial Guidance presentation, visit our website at pfizer.com/investors.
You can also listen to the conference call by dialing either 800-456-4352 in the U.S. and Canada or 785-424-1086 outside of the U.S. and Canada. The passcode is “71848”.
The transcript and webcast replay of the call will be made available on our website at pfizer.com/investors within 24 hours after the end of the live conference call and will be accessible for at least 90 days.
(1)
Adjusted income and Adjusted diluted earnings per share (EPS) are defined as U.S. GAAP net income attributable to Pfizer Inc. common shareholders and U.S. GAAP diluted EPS attributable to Pfizer Inc. common shareholders before the impact of amortization of intangible assets, certain acquisition-related items, discontinued operations, and certain significant items. Adjusted income and its components and Adjusted diluted EPS measures are not, and should not be viewed as, substitutes for U.S. GAAP net income and its components and diluted EPS(4), have no standardized meaning prescribed by U.S. GAAP and may not be comparable to the calculation of similar measures of other companies. See the Non-GAAP Financial Measure: Adjusted Income section of Management’s Discussion and Analysis of Financial Condition and Results of Operations in Pfizer’s 2024 Annual Report on Form 10-K for a definition of each component of Adjusted income as well as other relevant information.
(2)
Pfizer does not provide guidance for U.S. generally accepted accounting principles (GAAP) Reported financial measures (other than revenues) or a reconciliation of forward-looking non-GAAP financial measures to the most directly comparable GAAP Reported financial measures on a forward-looking basis because it is unable to predict with reasonable certainty the ultimate outcome of unusual gains and losses, certain acquisition-related expenses, gains and losses from equity securities, actuarial gains and losses from pension and postretirement plan remeasurements, potential future asset impairments and pending litigation without unreasonable effort. These items are uncertain, depend on various factors, and could have a material impact on U.S. GAAP Reported results for the guidance period.
Financial guidance for full-year 2026 reflects the following:
Our financial guidance for full-year 2025 reflects assumptions that are consistent with those outlined in Note (1) within Pfizer’s Q3-25 Earnings Release.
(3)
References to operational variances in this press release pertain to period-over-period changes that exclude the impact of foreign exchange rates. Although exchange rate changes are part of Pfizer’s business, they are not within Pfizer’s control and because they can mask positive or negative trends in the business, Pfizer believes presenting operational variances excluding these foreign exchange changes provides useful information to evaluate Pfizer’s results.
(4)
Revenues is defined as revenues in accordance with U.S. GAAP. Reported net income and its components are defined as net income attributable to Pfizer Inc. common shareholders and its components in accordance with U.S. GAAP. Reported diluted EPS is defined as diluted EPS attributable to Pfizer Inc. common shareholders in accordance with U.S. GAAP.
DISCLOSURE NOTICE: The information contained in this press release is as of December 16, 2025. Pfizer assumes no obligation to update forward-looking statements contained in this release or the webcast as the result of new information or future events or developments.
This press release and the webcast contain or may contain forward-looking information about, among other topics, our anticipated operating and financial performance, including financial guidance and projections; reorganizations; business plans, strategy, goals and prospects; expectations for our product pipeline (including products from completed or anticipated acquisitions), in-line products and product candidates, including anticipated regulatory submissions, data read-outs, study starts, approvals, launches, discontinuations, clinical trial results and other developing data, revenue contribution and projections, pricing and reimbursement, market dynamics, including demand, market size and utilization rates and growth, performance, timing and duration of exclusivity and potential benefits; the impact and potential impact of tariffs and pricing dynamics; strategic reviews; leverage and capital allocation objectives; an enterprise-wide cost realignment program (including anticipated costs, savings and potential benefits); a Manufacturing Optimization Program to reduce our cost of goods sold (including anticipated costs, savings and potential benefits); dividends and share repurchases; plans for and prospects of our acquisitions, dispositions and other business development activities, including our acquisition of Seagen, our acquisition of Metsera and our licensing agreement with 3SBio, and our ability to successfully capitalize on growth opportunities and prospects; our voluntary agreement with the U.S. Government designed to lower drug costs for U.S. patients and to include Pfizer products in a direct purchasing platform, and Pfizer’s plans to further invest in U.S. manufacturing; manufacturing and product supply; our ongoing efforts to respond to COVID-19; our expectations regarding the impact of COVID-19 on our business, operations and financial results; and the expected seasonality of demand for certain of our products. Given their forward-looking nature, these statements involve substantial risks, uncertainties and potentially inaccurate assumptions and we cannot assure you that any outcome expressed in these forward-looking statements will be realized in whole or in part. You can identify these statements by the fact that they use future dates or use words such as “will,” “may,” “could,” “likely,” “ongoing,” “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” “assume,” “target,” “forecast,” “guidance,” “goal,” “objective,” “aim,” “seek,” “potential,” “hope” and other words and terms of similar meaning. Pfizer’s financial guidance is based on estimates and assumptions that are subject to significant uncertainties.
Among the factors that could cause actual results to differ materially from past results and future plans and projected future results are the following:
Risks Related to Our Business, Industry and Operations, and Business Development:
the outcome of research and development (R&D) activities, including the ability to meet anticipated pre-clinical or clinical endpoints, commencement and/or completion dates for our pre-clinical or clinical trials, regulatory submission dates, and/or regulatory approval and/or launch dates; the possibility of unfavorable pre-clinical and clinical trial results, including the possibility of unfavorable new pre-clinical or clinical data and further analyses of existing pre-clinical or clinical data; risks associated with preliminary, early stage or interim data; the risk that pre-clinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when additional data from our pipeline programs will be published in scientific journal publications and, if so, when and with what modifications and interpretations; and uncertainties regarding the future development of our product candidates, including whether or when our product candidates will advance to future studies or phases of development or whether or when regulatory applications may be filed for any of our product candidates, including as a result of clinical trial data or regulatory feedback that could impact the future development of our product candidates, including our vaccine candidates such as our next generation pneumococcal conjugate vaccine candidate;
our ability to successfully address comments received from regulatory authorities such as the U.S. Food and Drug Administration or the European Medicines Agency, or obtain approval for new products and indications from regulators on a timely basis or at all;
regulatory decisions impacting labeling, approval or authorization, including the scope of indicated patient populations, product dosage, manufacturing processes, safety and/or other matters, including decisions relating to emerging developments regarding potential product impurities; uncertainties regarding the ability to obtain or maintain, and the scope of, recommendations by technical or advisory committees, and the timing of, and ability to obtain, pricing approvals and product launches, all of which could impact the availability or commercial potential of our products and product candidates;
claims and concerns that may arise regarding the safety or efficacy of in-line products and product candidates, including claims and concerns that may arise from the conduct or outcome of post-approval clinical trials, pharmacovigilance or Risk Evaluation and Mitigation Strategies, which could impact marketing approval, product labeling, and/or availability or commercial potential;
the success and impact of external business development activities, such as the November 2025 acquisition of Metsera, including the ability to identify and execute on potential business development opportunities; the ability to satisfy the conditions to closing of announced transactions in the anticipated time frame or at all, including the possibility that such transactions do not close; the ability to realize the anticipated benefits of any such transactions in the anticipated time frame or at all; the potential need for and impact of additional equity or debt financing to pursue these opportunities, which has in the past and could in the future result in increased leverage and/or a downgrade of our credit ratings and could limit our ability to obtain future financing; challenges integrating the businesses and operations; disruption to business or operations relationships; risks related to growing revenues for certain acquired or partnered products; significant transaction costs; and unknown liabilities;
competition, including from new product entrants, in-line branded products, generic products, private label products, biosimilars and product candidates that treat or prevent diseases and conditions similar to those treated or intended to be prevented by our in-line products and product candidates;
the ability to successfully market both new and existing products, including biosimilars;
difficulties or delays in manufacturing, sales or marketing; supply disruptions, shortages or stock-outs at our facilities or third-party facilities that we rely on; and legal or regulatory actions;
the impact of public health outbreaks, epidemics or pandemics (such as COVID-19) on our business, operations and financial condition and results, including impacts on our employees, manufacturing, supply chain, sales and marketing, R&D and clinical trials;
risks and uncertainties related to Comirnaty and Paxlovid or any potential future COVID-19 vaccines, treatments or combinations, including, among others, the risk that as the market for COVID-19 products remains endemic and seasonal and/or COVID-19 infection rates do not follow prior patterns, demand for our COVID-19 products has and may continue to be reduced or not meet expectations, which has in the past and may continue to lead to reduced revenues, excess inventory or other unanticipated charges; risks related to our ability to develop, receive regulatory approval for, and commercialize variant adapted vaccines, combinations and/or treatments; uncertainties related to recommendations and coverage for, and the public’s adherence to, vaccines, boosters, treatments or combinations, including uncertainties related to the potential impact of narrowing recommended patient populations; whether or when our EUAs or biologics licenses will expire, terminate or be revoked; risks related to our ability to accurately predict or achieve our revenue forecasts for Comirnaty and Paxlovid or any potential future COVID-19 vaccines or treatments; and potential third-party royalties or other claims related to Comirnaty and Paxlovid;
trends toward managed care and healthcare cost containment, and our ability to obtain or maintain timely or adequate pricing or favorable formulary placement for our products;
interest rate and foreign currency exchange rate fluctuations, including the impact of global trade tensions, as well as currency devaluations and monetary policy actions in countries experiencing high inflation or deflation rates;
any significant issues involving our largest wholesale distributors or government customers, which account for a substantial portion of our revenues;
the impact of the increased presence of counterfeit medicines, vaccines or other products in the pharmaceutical supply chain;
any significant issues related to the outsourcing of certain operational and staff functions to third parties;
any significant issues related to our JVs and other third-party business arrangements, including modifications or disputes related to supply agreements or other contracts with customers including governments or other payors;
uncertainties related to general economic, political, business, industry, regulatory and market conditions including, without limitation, uncertainties related to the impact on us, our customers, suppliers and lenders and counterparties to our foreign-exchange and interest-rate agreements of challenging global economic conditions, such as inflation or interest rate fluctuations, and recent and possible future changes in global financial markets;
the exposure of our operations globally to possible capital and exchange controls, economic conditions, expropriation, sanctions, tariffs and/or other restrictive government actions, changes in intellectual property legal protections and remedies, unstable governments and legal systems and inter-governmental disputes;
risks and uncertainties related to issued or future executive orders or other new, or changes in, laws, regulations or policy regarding tariffs or other trade policy and/or the impact of any potential U.S. Governmental shutdowns, including impacts on governmental agencies due to a shutdown;
the risk and impact of tariffs on our business, which is subject to a number of factors including, but not limited to, restrictions on trade, the effective date and duration of such tariffs, countries included in the scope of tariffs, changes to amounts of tariffs, and potential retaliatory tariffs or other retaliatory actions imposed by other countries;
the impact of disruptions related to climate change and natural disasters;
any changes in business, political and economic conditions due to actual or threatened terrorist activity, geopolitical instability, political or civil unrest or military action, including the ongoing conflicts between Russia and Ukraine and in the Middle East and the resulting economic or other consequences;
the impact of product recalls, withdrawals and other unusual items, including uncertainties related to regulator-directed risk evaluations and assessments, such as our ongoing evaluation of our product portfolio for the potential presence or formation of nitrosamines, and our voluntary withdrawal of all lots of Oxbryta in all markets where it is approved and any regulatory or other impact on Oxbryta and other sickle cell disease assets;
trade buying patterns;
the risk of an impairment charge related to our intangible assets, goodwill or equity-method investments;
the impact of, and risks and uncertainties related to, restructurings and internal reorganizations, as well as any other corporate strategic initiatives and growth strategies, and cost-reduction and productivity initiatives, including any potential future phases, each of which requires upfront costs but may fail to yield anticipated benefits and may result in unexpected costs, organizational disruption, adverse effects on employee morale, retention issues or other unintended consequences;
the ability to successfully achieve our climate-related goals and progress our environmental sustainability and other priorities;
Risks Related to Government Regulation and Legal Proceedings:
the impact of any U.S. healthcare reform or legislation, including executive orders or other change in laws, regulations or policy, or any significant spending reduction or cost control efforts affecting Medicare, Medicaid, the 340B Drug Pricing Program or other publicly funded or subsidized health programs, including the Inflation Reduction Act of 2022 (IRA) and the IRA Medicare Part D Redesign, or changes in the tax treatment of employer-sponsored health insurance that may be implemented;
risks and uncertainties related to the impact of Pfizer’s voluntary agreement with the U.S. Government designed to lower drug costs for U.S. patients and to include Pfizer products in a direct purchasing platform, and Pfizer’s plans to further invest in U.S. manufacturing, including risks relating to entering into definitive agreements with the U.S. Government and the initiation of new tariffs not subject to Pfizer’s grace period;
U.S. federal or state legislation or regulatory action and/or policy efforts affecting, among other things, pharmaceutical product pricing, including international reference pricing, including Most-Favored-Nation drug pricing, intellectual property, reimbursement or access to or recommendations for our medicines and vaccines, tax changes or other restrictions on U.S. direct-to-consumer advertising; limitations on interactions with healthcare professionals and other industry stakeholders; as well as pricing pressures for our products as a result of highly competitive biopharmaceutical markets;
risks and uncertainties related to changes to vaccine or other healthcare policy in the U.S., including the U.S. Food and Drug Administration's recently adopted policy of disclosing Complete Response Letters for unapproved drug candidates and the attendant risk of disclosure of trade secrets or confidential commercial information;
legislation or regulatory action in markets outside of the U.S., such as China or Europe, including, without limitation, laws related to pharmaceutical product pricing, intellectual property, medical regulation, environmental protections, data protection and cybersecurity, reimbursement or access, including, in particular, continued government-mandated reductions in prices and access restrictions for certain products to control costs in those markets;
legal defense costs, insurance expenses, settlement costs and contingencies, including without limitation, those related to legal proceedings and actual or alleged environmental contamination;
the risk and impact of an adverse decision or settlement and risk related to the adequacy of reserves related to legal proceedings;
the risk and impact of tax related litigation and investigations;
governmental laws, regulations and policies affecting our operations, including, without limitation, the IRA, as well as changes in such laws, regulations or policies or their interpretation, including, among others, new or changes in tariffs, tax laws and regulations internationally and in the U.S., including the One Big Beautiful Bill Act, which was enacted on July 4, 2025, and is still subject to further guidance; the adoption of global minimum taxation requirements outside the U.S. generally effective in most jurisdictions since January 1, 2024, government cost-cutting measures and related impacts on, among other matters, government staffing, resources and ability to timely review and process regulatory or other submissions; restrictions related to certain data transfers and transactions involving certain countries; and potential changes to existing tax laws, tariffs, or changes to other laws, regulations or policies in the U.S., including by the U.S. Presidential administration and Congress, as well as in other countries;
Risks Related to Intellectual Property, Technology and Cybersecurity:
the risk that our currently pending or future patent applications may not be granted on a timely basis or at all, or any patent-term extensions that we seek may not be granted on a timely basis, if at all;
risks to our products, patents and other intellectual property, such as: (i) claims of invalidity that could result in loss of patent coverage; (ii) claims of patent infringement, including asserted and/or unasserted intellectual property claims; (iii) claims we may assert against intellectual property rights held by third parties; (iv) challenges faced by our collaboration or licensing partners to the validity of their patent rights; or (v) any pressure from, or legal or regulatory action by, various stakeholders or governments that could potentially result in us not seeking intellectual property protection or agreeing not to enforce or being restricted from enforcing intellectual property rights related to our products;
any significant breakdown or interruption of our information technology systems and infrastructure (including cloud services);
any business disruption, theft of confidential or proprietary information, security threats on facilities or infrastructure, extortion or integrity compromise resulting from a cyber-attack, which may include those using adversarial artificial intelligence techniques, or other malfeasance by, but not limited to, nation states, employees, business partners or others; and
risks and challenges related to the use of software and services that include artificial intelligence-based functionality and other emerging technologies.
Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in our subsequent reports on Form 10-Q, in each case including in the sections thereof captioned “Forward-Looking Information and Factors That May Affect Future Results” and “Item 1A. Risk Factors,” and in our subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.
Financial StatementVaccineAcquisition
100 Deals associated with SSGJ-707
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R&D Status
10 top R&D records. to view more data
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Non-small cell lung cancer stage IIIB | Phase 3 | United States | 27 Apr 2026 | |
| Non-small cell lung cancer stage IIIB | Phase 3 | China | 27 Apr 2026 | |
| Non-small cell lung cancer stage IIIB | Phase 3 | Japan | 27 Apr 2026 | |
| Non-small cell lung cancer stage IIIB | Phase 3 | Argentina | 27 Apr 2026 | |
| Non-small cell lung cancer stage IIIB | Phase 3 | Australia | 27 Apr 2026 | |
| Non-small cell lung cancer stage IIIB | Phase 3 | Brazil | 27 Apr 2026 | |
| Non-small cell lung cancer stage IIIB | Phase 3 | Canada | 27 Apr 2026 | |
| Non-small cell lung cancer stage IIIB | Phase 3 | Czechia | 27 Apr 2026 | |
| Non-small cell lung cancer stage IIIB | Phase 3 | France | 27 Apr 2026 | |
| Non-small cell lung cancer stage IIIB | Phase 3 | Greece | 27 Apr 2026 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
View All Results
| Study | Phase | Population | Analyzed Enrollment | Group | Results | Evaluation | Publication Date |
|---|
Phase 2 | Metastatic Colorectal Carcinoma First line Proficient DNA Mismatch Repair (pMMR) | Microsatellite Stable (MSS) | 68 | SSGJ-707 + Chemotherapy (10mg/kg Q3W + XELOX) | mbwvpzpikt(mowglphbvm) = nudifwvwpc zndrdfozwr (cmduhiyqdn ) View more | Positive | 13 Oct 2025 | |
SSGJ-707 + Chemotherapy (10mg/kg Q2W + mFOLFOX6) | mbwvpzpikt(mowglphbvm) = xfppjmqyeu zndrdfozwr (cmduhiyqdn ) View more | ||||||
Phase 2 | 83 | rvdrbnfzth(zpvrmpnkbb) = 6% of pts experienced TRAE leading to discontinuation nllyrkcnwy (ldpdphjpxq ) View more | Positive | 30 May 2025 | |||
Phase 2 | 108 | SSGJ-707 + chemotherapy (NSQ) | gmpedeviqq(unnarqshzn) = etceqoddek ooxelryzht (ymqmaeqmzo ) View more | Positive | 16 Jan 2025 | ||
SSGJ-707 + chemotherapy (SQ) | gmpedeviqq(unnarqshzn) = zqutwboquc ooxelryzht (ymqmaeqmzo ) View more | ||||||
Phase 2 | Colorectal Cancer First line | Last line | Third line | 68 | lnbdesauvh(dmawzyvycb) = oznmrbuitx pxbowkugkq (qldulosdlr ) View more | Positive | 16 Jan 2025 | ||
SSGJ-707 + chemo | lnbdesauvh(dmawzyvycb) = sabwymrywf pxbowkugkq (qldulosdlr ) View more | ||||||
Phase 1/2 | 85 | kogrsozcbz(lnienzuqzn) = wqwyyijbfr qofcidacpx (cuoguetooo ) View more | Positive | 16 Jan 2025 | |||
Phase 2 | PD-L1 positive Non-Small Cell Lung Cancer PD-L1 High Expression (TPS >= 1%) | 83 | SSGJ-707 10 mg/kg Q3W | qumxoeyahy(wtljivkqoz) = aacesriklv vnndkymatg (nxvsmrhorr ) View more | Positive | 16 Jan 2025 |
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