AN INTERVENTIONAL PHASE 3, OPEN LABEL, RANDOMIZED STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS PEMBROLIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN ADULT PARTICIPANTS WITH ADVANCED OR RECURRENT MISMATCH REPAIR PROFICIENT ENDOMETRIAL CANCER

This study is being conducted to assess whether the study medicine PF 08634404, given in combination with chemotherapy, improves outcomes compared with another medicine called pembrolizumab plus chemotherapy. Chemotherapy is a type of cancer treatment that uses medicines to destroy cancer cells or stop them from growing.
Our bodies have a built-in DNA "spell-checker," called the mismatch repair (MMR) system, that fixes genetic mistakes. In most endometrial cancers, this system works normally, and these cancers are called MMR-proficient (pMMR). However, pMMR tumors are harder for the immune system to recognize and attack. When endometrial cancer has spread beyond the uterus or comes back after previous treatment, it is called advanced or recurrent endometrial cancer. This study is for adults with mismatch repair-pMMR advanced or recurrent endometrial cancer.
Participants must meet key criteria, including:
* Women who are 18 years or older, and not pregnant at the time of joining the study
* pMMR endometrial cancer only
* Measurable Stage III disease, Stage IV disease (with or without measurable disease) per FIGO staging, a system doctors use to describe how far cancer has spread in the body, or recurrent (with or without measurable disease) endometrial cancer
* Has not received chemotherapy except for chemotherapy given after the main surgery and more than 6 months before relapse
* Be in good enough health to receive study treatment. Approximately 600 adult women will be enrolled. Each participant will be randomly assigned (like a flip of the coin) to one of two treatment groups, with about half in each group. The study is open, meaning both the doctors and participants know what treatment is being given. Participants will receive their assigned treatment through intravenous infusions (medicine is given directly into a vein). The treatment will be given in cycles.
Experimental Group will receive new study medicine called PF-08634404 plus chemotherapy. It will be followed by PF 08634404 alone for up to 2 years (35 cycles).
Control Group will receive an approved medicine called pembrolizumab plus chemotherapy. It will be followed by pembrolizumab alone for up to 2 years (20 cycles).
The study will include regular visits for:
* Participants will have regular visits to the study site for treatment, health checks, and tests.
* After stopping treatment, participants will come for a final visit within a month to check their health and review any reactions.
* Follow-up will continue every 12 weeks by phone or in person or by reviewing health records. This helps check health and any new treatments.
* Tests will be done every 9 weeks during the first 104 weeks to see how the cancer is responding. After that, tests will be done every 12 weeks.

Start Date09 Oct 2026

Sponsor / Collaborator

Pfizer Inc.

[+2]

NCT07476287

/ RecruitingPhase 2

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.

Start Date02 Jul 2026

Sponsor / Collaborator

Pfizer Inc.

NCT07489066

/ RecruitingPhase 2

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.

Start Date30 Jun 2026

Sponsor / Collaborator

Pfizer Inc.

100 Clinical Results associated with SSGJ-707

100 Translational Medicine associated with SSGJ-707

100 Patents (Medical) associated with SSGJ-707

News (Medical) associated with SSGJ-707

28 Sep 2026

·www.biospace.com

Pfizer Advances Today’s Cancer Care and Tomorrow’s Potential Breakthroughs at ESMO

Data across 45 abstracts will highlight new evidence for established medicines, including PADCEV and TALZENNA, and promising late-stage pipeline candidates such as atirmociclib and tivunatamig (PF’4404) NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) will present data from 45 company-sponsored, investigator-sponsored, and collaborative research abstracts at the European Society for Medical Oncology (ESMO) Congress, taking place October 23-27, 2026 in Madrid, Spain. The presentations include 11 oral presentations spanning Pfizer’s established medicines and late-stage pipeline across its disease areas of focus, including breast cancer, genitourinary cancers, and lung cancer. “At Pfizer Oncology, we're focused on improving outcomes for people living with cancer. That means continuing to raise the standard of care today while pursuing the breakthroughs that will shape the future of oncology. The data we're presenting at ESMO reflect that focus, strengthening the evidence behind medicines such as PADCEV and TALZENNA, while advancing promising investigational candidates including atirmociclib and tivunatamig. By building on our leadership in breast, genitourinary, and lung cancers, we're working to bring meaningful progress to patients today and for years to come.” - Jeff Legos, Chief Oncology Officer, Pfizer Key Highlights of Pfizer’s Presence at ESMO 2026 Guiding the Next Wave of Oncology Innovation Phase 2 randomized results from the FOURLIGHT-1 study of atirmociclib, a highly selective cyclin-dependent kinase (CDK) 4 inhibitor, plus fulvestrant in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer (MBC) who had received prior CDK 4/6 inhibitor-based treatment. These results further support atirmociclib as a potential first-in-class cell cycle inhibitor backbone for HR+, HER2- MBC and Pfizer’s development strategy in earlier lines of therapy. A Phase 3 study in frontline MBC is ongoing and an additional Phase 3 study in early breast cancer is planned to evaluate atirmociclib in combination with giredestrant, an investigational oral selective oestrogen receptor degrader under development by Roche. (Presentation #1842O) Late-breaking overall survival (OS) and progression-free survival (PFS) results from the Phase 3 SigVie-002 study evaluating sigvotatug vedotin (SV), an investigational integrin β6 (IB6)-directed antibody-drug conjugate (ADC), as monotherapy in previously treated non-squamous non-small cell lung cancer (NSCLC). The findings will provide additional insight into previously announced topline results and inform the continued development of SV in earlier treatment settings, including an ongoing Phase 3 trial evaluating SV in combination with pembrolizumab in first-line advanced NSCLC and additional novel combinations under evaluation. (Presentation #LBA68) Updated Phase 2 data for tivunatamig (PF-08634404, PF’4404), a novel bispecific antibody targeting PD-1 and VEGF, in combination with chemotherapy in first-line PD-L1-expressing NSCLC. Tivunatamig is being developed as a potential best-in-class backbone therapy designed to combine two validated and complementary pathways in a single agent across tumor types, including ongoing pivotal studies in first-line NSCLC, first-line metastatic colorectal cancer, and advanced/recurrent endometrial cancer. Additional Phase 3 combination studies are planned, including with PADCEV ® (enfortumab vedotin-ejfv) in metastatic urothelial cancer. (Presentation #2660P) Expanding Evidence Across the Portfolio Updated exploratory analyses from the Phase 3 EV-302 trial evaluating outcomes with PADCEV plus pembrolizumab in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC), including among older patients, patients with comorbidities, and subgroups defined by disease-related characteristics. The findings further strengthen confidence in the regimen as a first-line foundation of care in la/mUC across clinically relevant populations. (Presentations #4760P and #4761P) Results from STARBOARD, a non-registrational Phase 3 trial evaluating an investigational triplet combination regimen of BRAFTOVI ® (encorafenib) and MEKTOVI ® (binimetinib) with pembrolizumab (KEYTRUDA ® ) in first-line BRAF V600-mutant advanced melanoma. These findings contribute important evidence to an evolving treatment landscape. (Presentation #2071O) Deepening Understanding of Treatment Outcomes and Patient Experience Patient-reported outcomes and a safety analysis from the Phase 3 TALAPRO-3 study further supporting TALZENNA ® (talazoparib) plus XTANDI ® (enzalutamide) as a potential treatment option for men with homologous recombination repair (HRR) gene-altered metastatic castration-sensitive prostate cancer (mCSPC; also known as metastatic APMN/S prostate cancer). A supplemental New Drug Application (sNDA) for TALZENNA plus XTANDI in mAPMN/S is currently under Priority Review by the U.S. Food and Drug Administration (FDA). (Presentations #2222RO and #2231P) An ad-hoc analysis from the Phase 3 EV-303 trial (also known as KEYNOTE-905) and circulating tumor DNA (ctDNA) and health-related quality of life analyses from the Phase 3 EV-304 (KEYNOTE-B15) trial. These analyses provide important biological and patient-centered context to previously reported survival data and further support perioperative PADCEV plus pembrolizumab as a new potential standard of care in muscle-invasive bladder cancer (MIBC). (Presentations #4733O, #4734O and #4738RO) ESMO Presence Reinforces Pfizer Oncology's Strategy to Advance Standards of Care and Deliver Next-Generation Breakthroughs As cancer remains the second-leading cause of death worldwide, Pfizer is focused on generating the evidence needed to bring treatment breakthroughs to as many patients as possible. Our data at ESMO reflect that strategy, concentrating innovation in disease areas with the greatest opportunity to impact patients globally. Highlights include emerging data from late-stage investigational programs advancing next-generation treatments, new analyses supporting established medicines as standards of care, and insights that deepen understanding of patient experience to better inform clinical decisions. Detailed Presentation Information Information on significant Pfizer and partner-sponsored abstracts, including date and time of presentation, follows in the chart below. A complete list of Pfizer and partner-sponsored abstracts and presentations is available here . LUNG CANCER Proffered Paper 1 LBA68 October 25, 2026 10:15–11:45 CET Phase 3 study of sigvotatug vedotin (SV) vs docetaxel in previously treated non-squamous non-small cell lung cancer (NSCLC) [ LBA ] Peters et al Poster Presentation 2660P October 26, 2026 12:00–12:45 CET Phase 2 trial of the PD-1/VEGF bispecific antibody, PF-08634404 (SSGJ-707), plus chemotherapy (chemo) in advanced NSCLC: Updated results [ 3SBio ] Wu et al BREAST CANCER Proffered Paper Session 1842O October 24, 2026 08:30–10:00 CET Efficacy and safety of atirmociclib (ATI) + fulvestrant (FUL) in patients (pts) with HR+/HER2– advanced/metastatic breast cancer (mBC) who progressed on prior CDK 4/6 inhibitor (CDK 4/6i) in a randomized phase 2 study (FOURLIGHT-1) Giordano et al Proffered Paper Session 1766RO October 24, 2026 10:15–11:45 CET Health-related quality of life from HER2CLIMB-05: A Phase 3 study of tucatinib versus placebo in combination with trastuzumab and pertuzumab as 1L maintenance therapy for HER2+ mBC Dieras et al GENITOURINARY CANCERS: BLADDER AND PROSTATE Rapid Oral Session 2219RO October 23, 2026 13:30–15:00 CET Utility of ctDNA tumor fraction (TF) as a prognostic biomarker in TALAPRO-3: Phase 3 study of talazoparib (TALA) + enzalutamide (ENZA) vs placebo (PBO) + ENZA in patients (pts) with homologous recombination repair (HRR) gene–mutated metastatic castration-sensitive prostate cancer (mCSPC) Azad et al Rapid Oral Session 2222RO October 23, 2026 13:30–15:00 CET Patient-reported outcomes (PROs) in men with metastatic castration-sensitive prostate cancer (mCSPC) and homologous recombination repair (HRR) gene alterations receiving talazoparib (TALA) + enzalutamide (ENZA) vs placebo (PBO) + ENZA: Results from the Phase 3 TALAPRO-3 study Azad et al Proffered Paper Session 4733O October 23, 2026 13:30–15:00 CET Perioperative pembrolizumab (pembro) or enfortumab vedotin (EV) plus pembro in patients (pts) with muscle-invasive bladder cancer (MIBC) who are cisplatin-ineligible: Ad hoc analysis from KEYNOTE-905 [ MSD led ] Ullén et al Proffered Paper Session 4734O October 23, 2026 13:30–15:00 CET ctDNA analysis of the Phase 3 KEYNOTE-B15 trial: neoadjuvant and adjuvant (neoadj-adj) enfortumab vedotin (EV) + pembrolizumab (pembro) for participants (pts) with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin [ MSD led ] Chatzkel et al Poster Presentation 2296P October 23, 2026, 15:15-16:00 CET Safety and efficacy of mevrometostat monotherapy in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) J. Carles Galceran et al Poster Presentation 2231P October 23, 2026 15:15–16:00 CET Talazoparib (TALA) + enzalutamide (ENZA) in patients (pts) with metastatic castration-sensitive prostate cancer (mCSPC) with homologous recombination repair (HRR) gene alterations: Safety analyses from the Phase 3 TALAPRO-3 study Mateo et al Poster Presentation 4761P October 23, 2026 15:15–16:00 CET Enfortumab vedotin plus pembrolizumab (EV+P) for previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC): Updated exploratory analysis of EV-302 in older patients (pts) and those with comorbidities Sridhar et al Poster Presentation 4760P October 23, 2026 15:15–16:00 CET Enfortumab vedotin (EV) + pembrolizumab (P) in previously untreated locally advanced or metastatic urothelial cancer (la/mUC): Exploratory analyses based on disease-related characteristics from EV-302 Bedke et al Proffered Paper Session 4738RO October 24, 2026 10:15–11:45 CET Health-related quality of life (HRQoL) with neoadjuvant and adjuvant (neoadj-adj) enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants (pts) with muscle-invasive bladder cancer (MIBC) eligible for cisplatin in the phase 3 KEYNOTE-B15 study [ MSD led ] Gómez De Liaño et al MELANOMA Proffered Paper Session 2071O October 23, 2026 16:15–17:45 CET STARBOARD Phase 3: A randomized, double-blind study of first-line (1L) encorafenib (enco), binimetinib (bini), and pembrolizumab (pembro) vs placebo (PBO) and pembro for unresectable locally advanced or metastatic BRAF V600-mutant melanoma Schadendorf et al Pfizer is continuing its commitment to help non-scientists understand the latest findings with the development of abstract plain language summaries (aPLS) for company-sponsored research being presented at ESMO, which are written in non-technical language. Those interested in learning more can visit to access the summaries. Pfizer and Astellas have a clinical collaboration agreement with Merck to evaluate the combination of PADCEV ® and KEYTRUDA ® in patients with previously untreated metastatic urothelial cancer and MIBC regardless of cisplatin eligibility. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside of the United States and Canada). XTANDI ® is jointly developed and commercialized by Pfizer and Astellas in the United States. Prescribing Information for Pfizer Medicines Please see full Prescribing Information for BRAFTOVI ® (encorafenib) and full Prescribing Information for MEKTOVI ® (binimetinib). Please see full Prescribing Information for PADCEV ® (enfortumab vedotin-ejfv). Please see full Prescribing Information for TALZENNA ® (talazoparib). Please see full Prescribing Information for XTANDI ® (enzalutamide). About Pfizer Oncology At Pfizer Oncology, we are at the forefront of a new era in cancer care. Our industry-leading portfolio and extensive pipeline includes three core mechanisms of action to attack cancer from multiple angles, including small molecules, antibody-drug conjugates (ADCs), and multispecific antibodies, including immuno-oncology biologics. We are focused on delivering transformative therapies in some of the world’s most common cancers, including breast cancer, gastrointestinal cancer, genitourinary cancer, hematologic malignancies, and lung cancers. Driven by science, we are committed to accelerating breakthroughs to help people with cancer live better and longer lives. About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at . In addition, to learn more, please visit us on and follow us on X at @Pfizer and @Pfizer_News , LinkedIn , YouTube and like us on Facebook at . Disclosure notice The information contained in this release is as of September 28, 2026. The Company assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about Pfizer Oncology and Pfizer’s oncology portfolio of marketed and investigational therapies, including combinations, and including their potential benefits; expectations for our product pipeline, in-line products and product candidates, including anticipated regulatory submissions, data read-outs, study starts, approvals, launches, clinical trial results and other developing data; the development or commercial potential of our product pipeline, in-line products, product candidates and additional indications or combinations, including expected clinical trial protocols, the potential and timing for the initiation and progress of clinical trials and data read-outs from trials; the timing and potential for the submission of applications for and receipt of regulatory approvals; the timing and potential for product launches and commercialization; expected breakthrough, best- or first-in-class or blockbuster status or expected market entry of our medicines; potential patients reached; the regulatory landscape; the competitive landscape; and other statements about our business, operations and financial results that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risk and uncertainties include, among other things, uncertainties regarding the commercial success of Pfizer’s oncology portfolio; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with interim and preliminary data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any drug applications, biologics license applications and/or emergency use authorization applications may be filed in any jurisdictions for any potential indication for Pfizer’s product candidates; whether and when any such applications that may be pending or filed for any of Pfizer’s product candidates may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether any such product candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of Pfizer’s products or product candidates, including development of products or therapies by other companies; manufacturing capabilities or capacity; risks and uncertainties related to issued or future executive orders or other new, or changes in, laws or regulations; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at and . Contacts Pfizer Media Contact: PfizerMediaRelations@Pfizer.com Pfizer Investor Relations: IR@pfizer.com

Phase 3Phase 2Clinical ResultASCOPriority Review

26 Aug 2026

·www.prnewswire.com

3S Bio Announces 2026 Interim Results: Innovation-Driven, Win-Win Collaboration, and Sustainable Growth

SHANGHAI, Aug. 21, 2026 /PRNewswire/ -- 3S Bio (01530.HK) today announced its interim results for the first half of 2026. During the period, the Company recorded revenue of RMB 4.53 billion, representing a year-over-year growth of 3.9%. Net profit attributable to equity holders of the Company reached RMB 1.15 billion, and adjusted operating net profit attributable to shareholders of the parent stood at RMB 1.44 billion, up 26.5% year-over-year. R&D expenses amounted to RMB 680 million, an increase of 24.9% year-over-year. The Company's financial resources totaled RMB 19.4 billion, providing a solid foundation for R&D investments and strategic initiatives. During the first half of the year, marketing approvals for core products were obtained in 23 countries globally, and overseas product sales surged by 43% year-over-year, primarily driven by the increasing market penetration of products such as rhEPO, Yisaipu, and rhTPO in multiple emerging economies. Since the beginning of 2026, three Class 1 innovative drugs have been approved for marketing, and five products have advanced to the New Drug Application stage. The Company has successfully constructed a multi-therapeutic pipeline matrix, further consolidating its global competitiveness and advantages in core therapeutic areas. 3SBio has made significant progress in global partnerships, innovative R&D, and product commercialization, marching steadily toward high-quality development. I. Global Multi-Center Clinical Trials of PF-08634404 (SSGJ-707) Progressing Concurrently PF-08634404 (SSGJ-707) is an anti-PD-1/VEGF bispecific antibody independently developed by 3SBio, widely recognized as a highly promising next-generation immuno-oncology therapeutic. In 2025, 3SBio granted Pfizer the global development and commercialization rights to SSGJ-707, with a total potential deal value exceeding US$6 billion. The Company is also entitled to receive tiered, double-digit royalties based on cumulative global net sales. Notably, the US$1.4 billion upfront payment and US$100 million equity investment set a new record for the upfront payment of a single out-licensing transaction for a Chinese innovative drug. During the reporting period, the Company recognized RMB 850 million in Business Development revenue. In 2026, Pfizer is fully accelerating the global multi-center clinical development of SSGJ-707. Nine global multi-center clinical trials have been initiated, covering multiple high-incidence cancers, including squamous/non-squamous non-small cell lung cancer, metastatic colorectal cancer, extensive-stage small cell lung cancer, gastroesophageal cancer, hepatocellular carcinoma, metastatic urothelial carcinoma, and renal cell carcinoma. Among these, two trials have advanced to Phase III, three are in Phase II, and four are in Phase I. As of August 19, 11 clinical trials for SSGJ-707 have been registered, activating over 1,361 clinical sites and expecting to enroll 5,016 patients across 23 countries and regions. Notably, 75 clinical sites in China are participating in nine clinical protocols, ranking second globally, behind only the United States. The Phase III trials cover a target patient population of 225,000 in the U.S., underpinning its subsequent commercial potential. Moving forward, the indication expansions and combination therapy regimens for SSGJ-707 will be continuously explored to fully unlock its global clinical value and commercial growth potential. II. Intensive Realization of Innovation Value, Building New Growth Engines In the first half of 2026, 3SBio saw a wave of concentrated milestones across its innovative pipeline. Three Class 1 innovative drugs were successively approved for marketing, and five products progressed to the NDA stage, rapidly translating innovative momentum into performance drivers. Three internally developed Class 1 innovative biologics were approved for marketing: Yisaituo® (amdokitug injection) was approved in February, indicated for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. With core advantages including robust and rapid clearance of skin lesions, low immunogenicity, favorable safety and tolerability profile, and convenient administration, Yisaituo® is poised to reshape psoriasis treatment expectations. The product is expected to further broaden its clinical applications in autoimmune diseases as new indications are continuously developed. NuPIAO® (loncipetin alfa injection) was approved for marketing in March 2026 as the first long-acting recombinant EPO biweekly formulation in China, indicated for the treatment of anemia in hemodialysis patients with chronic kidney disease. The product features an ultra-long half-life of 120 hours and low immunogenicity. The intravenous administration route is highly suitable for hemodialysis patients, and the "once every two weeks" dosing regimen significantly improves patient compliance and convenience. Yisaina® (anflekitug injection) was approved in August, as the first self-developed IgG1/κ humanized anti-IL-1β monoclonal antibody in China, indicated for the treatment of acute gouty arthritis in adults. The product offers differentiated clinical value with rapid pain relief, long-lasting prevention of recurrence, and a favorable safety profile, serving as a preferred alternative to traditional corticosteroid therapy and a novel precision anti-inflammatory option for gout. Five products in the NDA stage are poised for launch: 3SBio has established a robust pipeline of five products currently under NDA review, covering therapeutic areas such as atopic dermatitis, ophthalmology, breast cancer, and weight management. Among them, NDAs have been accepted for 611 (anti-IL-4Rα mAb) for moderate-to-severe atopic dermatitis in adults, and 601A (anti-VEGF mAb) for macular edema following branch retinal vein occlusion. In-licensed products, including Liporaxel® Paclitaxel Oral Solution for HER2-negative breast cancer, DB-1303 (HER2 ADC) for HER2-positive breast cancer, and WS2403 (GLP-1 receptor agonist) for chronic weight management in overweight or obese adults, have also advanced to the NDA stage. These products are expected to be approved sequentially, providing substantial product reserves for the Company's sustainable growth. III. Constructing a Multi-Therapeutic Pipeline Matrix to Solidify Long-Term Core Competitive Advantages 3SBio's R&D pipeline continues to expand, featuring 25 key investigational drug candidates across core therapeutic areas including hemoncology, autoimmune diseases, nephrology, dermatology, and weight management. Hemato-oncology: Strategic layout of bispecific antibodies/fusion proteins to establish differentiated advantages. TPIAO® (recombinant human thrombopoietin injection) has been cleared by the U.S. FDA to initiate a global multi-center bridging clinical trial for the treatment of thrombocytopenia associated with chronic liver disease. 705 (anti-PD-1/HER2 bispecific antibody) has entered Phase II clinical trials for HER2-positive solid tumors, standing as the only drug with this target actively advancing in clinical stages in China, demonstrating significant differentiation. 706 (anti-PD-1/PD-L1 bispecific antibody) has entered Phase II trials for advanced non-small cell lung cancer and advanced gastrointestinal tumors. 708 (anti-PD-1/TGFβ bispecific antibody), 709 (anti-PD-1/LAG-3 bispecific antibody), and SPGL008 (anti-B7-H3 antibody/IL-15 fusion protein) are all in Phase I clinical trials for solid tumors. SSS57 (long-acting ActRIIB-Ig Trap fusion protein) obtained IND clearance from the U.S. FDA for hematological disorders, marking the first innovative biased bispecific antibody entering clinical trials in China. The hemato-oncology pipeline is being continuously optimized, building a robust reserve of high-quality assets for long-term growth. Nephrology: Focusing on core unmet needs with a first-in-China novel-target portfolio. SSS55 (C3b bifunctional fusion protein) has entered Phase I trials for paroxysmal nocturnal hemoglobinuria, complement-mediated kidney diseases, and periodontitis, demonstrating Best-In-Class potential. SSS68 (long-acting anti-APRIL/BAFF bispecific antibody) has obtained IND approvals in both China and the U.S. for IgA nephropathy, making it the only long-acting bispecific antibody for this indication to enter clinical trials in China. Dermatology and Weight Management: Exploring new frontiers and expanding pipelines. WS204 (clascoterone cream) is in Phase III clinical trials for moderate-to-severe acne vulgaris. SSS67 (anti-ActRIIA/ActRIIB bispecific antibody) has entered Phase I trials for overweight/obesity. Autoimmune Diseases: Multiple candidates entering pivotal trials, leading R&D in China. Yisaituo® (amdokitug injection): Patient enrollment completed for the Phase III trial in ankylosing spondylitis; first patient enrolled in the Phase III trial for non-radiographic axial spondyloarthritis. Yisaina® (anflekitug injection): Dose-exploration Phase II study for intermittent gouty arthritis has been initiated. 610 (anti-IL-5 mAb): Patient enrollment completed for the Phase III trial in severe eosinophilic asthma in adults; Phase III enrollment for severe eosinophilic asthma in adolescents is ongoing. 611 (anti-IL-4Rα mAb): NDA submitted and accepted for moderate-to-severe atopic dermatitis in adults. 626 (anti-BDCA2 mAb): Phase II trials for systemic lupus erythematosus and cutaneous lupus erythematosus are being initiated. 627 (anti-TL1A mAb): Phase II enrollment initiated for ulcerative colitis. 716 (OX40L/IL-31RA bispecific antibody): Obtained IND clearances in both China and the U.S. for atopic dermatitis, with Phase I enrollment initiated. In the early-stage pipeline, 717 (CD3/BCMA/CD19 humanized trispecific antibody) for systemic lupus erythematosus/lupus nephritis/rheumatoid arthritis, 718 (anti-TL1A/IL-23 bispecific antibody injection) for inflammatory bowel disease, 719 (anti-TSLP/IL-4R bispecific antibody inhaler) for asthma/chronic obstructive pulmonary disease, and 629 (oral IL-23R peptide) for psoriasis/inflammatory bowel disease have all entered the IND or pre-clinical stages, showcasing the Company's forward-looking, end-to-end strategic layout in the autoimmune field. IV. ESG Practices Receive Authoritative Recognition, Demonstrating Sustainable Development Capabilities 3SBio has consistently integrated Environmental, Social, and Governance principles into its entire operational and management processes. By continuously refining governance structures, fulfilling social responsibilities, and promoting green operations, the Company has achieved solid results in sustainable development, earning accolades from multiple authoritative platforms. In July 2026, 3SBio's Wind ESG rating was upgraded to "AA", placing it in the top 3.2% of the biotechnology industry, which fully validates its comprehensive strength in risk management, compliance operations, and corporate social responsibility practices. Concurrently, the Company's implemented public welfare initiatives were once again recognized as an "Excellent Case of Social Responsibility among Chinese Pharmaceutical Industrial Enterprises", reflecting the industry's acknowledgment of its dedication to philanthropy and corporate social responsibility. Dr. Jing LOU, Chairman and Chief Executive Officer of 3SBio, commented: "In early 2026, the biopharmaceutical sector was designated as a emerging strategic pillar industry in China. Amid the industry's ongoing shift toward high-quality growth, innovative R&D capabilities have emerged as the core engine driving sustained corporate expansion. Leveraging over 30 years of industry legacy, 3SBio stays true to its fundamental principles while actively pursuing innovation. The Company will continuously increase its R&D investment, deepen its focus on oncology, autoimmune diseases, and nephrology, optimize its R&D pipeline, and strengthen its talent pool. In the first half of this year, multiple approvals of key innovative drugs significantly expanded the Company's long-term growth prospects. Moving forward, we will continue to accelerate the regulatory approval process for our late-stage pipeline, bringing more innovative drugs with substantial clinical value to serve a broader patient population." SOURCE 3SBio Inc. 21% more press release views with Request a Demo

Phase 2Phase 1Drug ApprovalPhase 3Clinical Result

21 Aug 2026

·www.prnewswire.com

Sunshine Guojian Releases 2026 Interim Report:

Innovation-driven, Steady Advancement SHANGHAI, Aug. 20, 2026 /PRNewswire/ -- Today, Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. (hereinafter referred to as "Sunshine Guojian", stock code: 688336.SH), a pioneer in China's antibody therapeutics, released its 2026 interim report. In the first half of 2026, Sunshine Guojian pursued its dual-engine strategy of "In-house R&D plus External Collaboration", drove growth through innovation, delivered solid performance, advanced its R&D pipeline efficiently, and secured successive approvals for multiple products, demonstrating a positive development trajectory. Solid Growth in Performance and Continued Progress in External Collaboration In the first half of 2026, Sunshine Guojian delivered solid performance growth, with total operating revenue reaching RMB 866 million, representing a year-on-year increase of 34.84%; net profit attributable to equity holders of the Company amounted to RMB 371 million, up 95.10% year-on-year; net profit attributable to equity holders of the Company excluding non-recurring gains and losses stood at RMB 260 million, up 65.15% year-on-year; basic earnings per share reached RMB 0.41, up 95.24% year-on-year. Sunshine Guojian continued to increase its innovative R&D investment, with R&D expenses rising 32.41% year-on-year to RMB 245 million. Based on its strong confidence in stable operations and future growth, Sunshine Guojian proposed an interim profit distribution plan for 2026: a cash dividend of RMB 0.42 (tax inclusive) per 10 shares for the first half of 2026, with no conversion of capital reserve into share capital and no bonus share issue. This reflects Sunshine Guojian's robust cash flow and sustainable profitability foundation, while sharing its growth with shareholders. The PF-08634404 (SSGJ-707) program, in collaboration with Pfizer, has initiated 9 global multicenter clinical trials covering multiple solid tumor indications, including non-small cell lung cancer and colorectal cancer, with the clinical development significantly accelerated. As several clinical milestones are successively achieved and overseas commercialization is subsequently realized, various clinical and regulatory milestone payments, as well as global sales revenue sharing, will continue generating returns, which is expected to bring sustained and solid cash flow to Sunshine Guojian, and further reinforce its overall financial position. Continued Breakthroughs Across the R&D Pipeline, Poised for Milestone Realization In the first half of 2026, Sunshine Guojian accelerated the advancement of clinical studies for its R&D programs, and achieved multiple milestone events, continuously building a new growth driver. As of the report date, Yisaituo® (Amdokitug Injection) and Yisaina® (Anflekitug Injection), both independently developed by Sunshine Guojian, had been approved for marketing. The approval timeline for NDA of one key new autoimmune product is clearly visible, and multiple autoimmune programs have entered the NDA submission or mid-to-late-stage clinical phases. Yisaituo® (Amdokitug Injection, R&D code: 608) was approved for marketing by the National Medical Products Administration (NMPA) in February 2026 for adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. With core advantages including robust and rapid clearance of skin lesions, low immunogenicity, favorable safety and tolerability profile, and convenient administration, Yisaituo® is poised to reshape psoriasis treatment expectations. Currently, two additional indications for this product, both ankylosing spondylitis and non-radiographic axial spondyloarthritis, have entered Phase III clinical studies. The product is expected to further broaden its clinical applications in autoimmune diseases as new indications are continuously developed. Yisaina® (Anflekitug Injection, R&D code: 613) was approved for marketing by the NMPA in August 2026 for acute flares of gouty arthritis in adult patients who are contraindicated for, intolerant of, or inadequately responsive to non-steroidal anti-inflammatory drugs (NSAIDs) and/or colchicine, and those are unsuitable for repeated use of corticosteroids. As the first in-house IgG1 kappa humanized anti-IL-1β monoclonal antibody marketed in China, Yisaina® holds broad market potential. The product demonstrates significant effects in pain relief and recurrence prevention, while maintaining a favorable safety and tolerability profile. It addresses an unmet clinical need among patients with limited response to conventional therapies, intolerance to corticosteroids or colchicine, and recurrent gout attacks. One product's NDA has been accepted for review. The marketing application for anti-IL-4Rα mAb injection (R&D code: 611) for moderate-to-severe atopic dermatitis in adults was submitted and accepted for review in February 2026. Sunshine Guojian continues to advance Phase III clinical trials for multiple products. Amdokitug Injection (R&D code: 608): Enrollment of all subjects in the Phase III clinical trial for ankylosing spondylitis has been completed. The first subject has been enrolled in the Phase III clinical trial for non-radiographic axial spondyloarthritis. Humanized anti-IL-5 monoclonal antibody injection (R&D code: 610): Enrollment of all subjects in the Phase III clinical trial for severe eosinophilic asthma in adults has been completed. Enrollment is ongoing in the Phase III clinical trial for severe eosinophilic asthma in adolescents. Anti-IL-4Rα mAb injection (R&D code: 611): Enrollment is ongoing in the Phase III clinical trial for chronic obstructive pulmonary disease. Enrollment of all subjects in the Phase III clinical trial for moderate-to-severe atopic dermatitis in adolescents aged 12 to 17 has been completed. The primary endpoint in the Phase III clinical trial for chronic rhinosinusitis with nasal polyps has been achieved, with significant efficacy demonstrated. The Phase III clinical trial for moderate-to-severe atopic dermatitis in children is being initiated. The interim analysis met the primary endpoint in the Phase III clinical trial evaluating combination treatment with topical corticosteroids for moderate-to-severe atopic dermatitis in adults. Anflekitug Injection (R&D code: 613): A Phase II multiple-dose dose-exploration study has been initiated for the intercritical gouty arthritis. Early-stage clinical programs are progressing rapidly. The enrollment of all subjects in Phase Ib clinical study of recombinant humanized anti-BDCA2 monoclonal antibody injection (R&D code: 626) for systemic lupus erythematosus has been completed. Phase II clinical studies for systemic lupus erythematosus and cutaneous lupus erythematosus are being initiated. The Phase I clinical study of recombinant humanized anti-TL1A monoclonal antibody injection (R&D code: 627) for ulcerative colitis in healthy Chinese subjects via subcutaneous administration across all dose cohorts has been completed, and positive results were obtained. Enrollment in Part 1 of the Phase II clinical study for ulcerative colitis has been initiated. The IND application for OX40L/IL-31RA bispecific antibody injection (R&D code: 716) for atopic dermatitis has been approved by the NMPA and U.S. Food and Drug Administration (FDA). Enrollment of healthy Chinese subjects in a Phase I clinical study has been initiated. Accelerated Translation of Cutting-Edge Targets, Deepening Commitment to Autoimmune Diseases By deeply exploring the key immune pathways and regulatory nodes in disease onset and progression, and leveraging its structural biology, AI-assisted drug design, and high-throughput screening platforms, Sunshine Guojian continues to build a portfolio of next-generation high-value targets and innovative molecular formats, forming a diversified and differentiated product matrix encompassing bispecific antibodies, trispecific antibodies, oral peptides, and inhaled antibodies. Multiple innovative programs have now entered the IND or pivotal preclinical study stages, including CD3/BCMA/CD19 humanized trispecific antibody injection (R&D code: 717), recombinant anti-TL1A/IL-23 bispecific antibody injection (R&D code: 718), TSLP/IL-4R bispecific antibody inhalation (R&D code: 719), IL-23R oral peptide (R&D code: 629), among others. Leveraging its world-class core technology platforms and innovation systems, Sunshine Guojian is moving beyond the traditional monoclonal antibody format and initiating multi-dimensional iteration of technological pathways. From discovery to development and from data to value, Sunshine Guojian is accelerating new drug R&D and enhancing clinical value. Sunshine Guojian is driving leapfrog progress in the autoimmune disease field through coordinated development of multiple products, establishing a full-cycle pipeline portfolio characterized by products that can be commercialized in the short term, provide meaningful support in the medium term, and deliver industry leadership over the long term. Dr. Jing Lou, Chairman of the Board and Chief Executive Officer of 3S Bio Inc., and Chairman of Sunshine Guojian, stated: With Sunshine Guojian's pipeline gradually entering a harvest phase, it has established a tiered innovation portfolio consisting of mature products that fortify the operational foundation, innovative products that foster growth momentum, and cutting-edge pipelines that underpin long-term development. Supported by a commercialization platform covering nearly 4,800 medical institutions, Sunshine Guojian has established an integrated sales network encompassing hospitals, dual-channel pharmacies, specialty DTP pharmacies, and Internet hospitals. Looking ahead, Sunshine Guojian will continue to increase investment in early-stage innovative R&D, take a forward-looking approach to building an end-to-end innovation system, identify targets with clinical advantages, steadily advance the development and launch of new products, and deliver high-quality innovative biologics to more patients faster. SOURCE 3SBio Inc. 21% more press release views with Request a Demo

Phase 2Drug ApprovalPhase 1Phase 3

100 Deals associated with SSGJ-707

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
MSS/pMMR/MSI-L Endometrial Carcinoma	Phase 3	United States	Pfizer Inc.	09 Oct 2026
MSS/pMMR/MSI-L Endometrial Carcinoma	Phase 3	Japan	Pfizer Inc.	09 Oct 2026
Adenocarcinoma of Esophagus	Phase 3	United States	Pfizer Inc.	14 May 2026
Adenocarcinoma of Esophagus	Phase 3	China	Pfizer Inc.	14 May 2026
Adenocarcinoma of Esophagus	Phase 3	Japan	Pfizer Inc.	14 May 2026
Adenocarcinoma of Esophagus	Phase 3	Canada	Pfizer Inc.	14 May 2026
Adenocarcinoma of Esophagus	Phase 3	France	Pfizer Inc.	14 May 2026
Adenocarcinoma of Esophagus	Phase 3	Israel	Pfizer Inc.	14 May 2026
Adenocarcinoma of Esophagus	Phase 3	Italy	Pfizer Inc.	14 May 2026
Adenocarcinoma of Esophagus	Phase 3	Spain	Pfizer Inc.	14 May 2026

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT07476287 (Symbiotic-Lung-14, WCLC2026)	Phase 2	Small Cell Lung Cancer First line EGFR-mutated	40	PF-08634404 + Chemotherapy	dzmbqljxot(haamrbjrqa) = axntpfabnf simrpwuevf (smbnrztovm )	Positive	12 Sep 2026
NCT07227012 (Symbiotic-GI-13, ESMO_GI2026)	Phase 1/2	Unresectable Hepatocellular Carcinoma	83	PF-08634404 + ipilimumab	ftfxsjhsua(sxgcoiuobl) = nbukwxufik tmeehdwyar (gteyglexzv )	Positive	02 Jul 2026
NCT06522828 (SSGJ-707-ST-II-02, ASCO2026)	Phase 2	Endometrial Carcinoma First line	32	SSGJ-707 5 mg/kg Q3W + chemo	vbgbtbzowp(wourcmqqje) = nlkglcjmzw rijnrsfhmi (hgsfdfbnal ) View more	Positive	29 May 2026
				SSGJ-707 10 mg/kg Q3W + chemo	vbgbtbzowp(wourcmqqje) = ovjwephmti rijnrsfhmi (hgsfdfbnal ) View more
NCT07222800 (Symbiotic-GI-03, ASCO2026)	Phase 3	Metastatic Colorectal Carcinoma First line	800	PF-08634404 + mFOLFOX6	qppppgvrqv(crgzukgbku) = vqggbjymne nuzsveekww (wenibzaryv ) View more	Positive	29 May 2026
				Bevacizumab + mFOLFOX6	qppppgvrqv(crgzukgbku) = drwpwkluil nuzsveekww (wenibzaryv )
NCT06361927 (ASCO2026)	Phase 2	Advanced Lung Non-Small Cell Carcinoma First line	83	SSGJ-707 10 mg/kg	wokxtteykh(jftytsmglb) = wumgbkqnzc ujzldqnrxa (hhpuxtuphi, 49.5 - 82.6) View more	Positive	29 May 2026
				SSGJ-707 10 mg/kg (Squamous)	wokxtteykh(jftytsmglb) = okmofwpqwq ujzldqnrxa (hhpuxtuphi, 42.8 - 94.5) View more
NCT07227298 (Symbiotic-Lung-20, ESMO_ELCC2026)	Phase 1/2	Advanced Malignant Solid Neoplasm First line	42	PF-08634404 + sigvotatug vedotin	xdnmhgycjb(lpdipvmxyp) = xgoydnpnmf jphvfjlnwm (xnpdcdwpqv ) View more	Positive	25 Mar 2026
				PF-08634404 + PDL1V	lvdhseqour(ofmlnfvkbk) = crntzrjkpc znivjtmrjh (pavzseswgb ) View more
NCT07222566 (Symbiotic-Lung-01, ESMO_ELCC2026)	Phase 3	Locally Advanced Lung Non-Small Cell Carcinoma First line	1,410	PF-08634404 plus carboplatin and investigator’s choice of paclitaxel or nab-paclitaxel	iyccfanser(slukicemtc) = nhgptrphla ayghlukrhy (gwtdokzhqs, 36.2 - NR)	Positive	25 Mar 2026
				PF-08634404 plus carboplatin and pemetrexed	iyccfanser(slukicemtc) = gebijsbkif ayghlukrhy (gwtdokzhqs, 36.3 - NR)
NCT07226999 (Symbiotic-Lung-04, ESMO_ELCC2026)	Phase 2/3	Extensive stage Small Cell Lung Cancer First line	540	PF-08634404 plus carboplatin and etoposide followed by PF-08634404 monotherapy	qjjtcnoqgs(kabcxlbnel) = fjjlnyuzrd awadxtgzzx (azqxjwynfp )	Positive	25 Mar 2026
				anti-PD-L1 plus carboplatin and etoposide followed by anti-PD-L1 monotherapy	qjjtcnoqgs(kabcxlbnel) = abvznnigrt awadxtgzzx (azqxjwynfp )
NCT06493760 (ESMO 12025 \| ESMO 22025) Manual	Phase 2	Metastatic Colorectal Carcinoma First line Proficient DNA Mismatch Repair (pMMR) \| Microsatellite Stable (MSS)	68	SSGJ-707 + Chemotherapy (10mg/kg Q3W + XELOX)	jlofxemhyg(saduhkpxls) = zugckbyriu aqmlbedvoi (sauqqclxfv ) View more	Positive	13 Oct 2025
				SSGJ-707 + Chemotherapy (10mg/kg Q2W + mFOLFOX6)	jlofxemhyg(saduhkpxls) = xgzyquhogf aqmlbedvoi (sauqqclxfv ) View more
NCT06361927 (SSGJ-707-NSCLC-II-01, ASCO2025)	Phase 2	Non-Small Cell Lung Cancer	83	SSGJ-707 5mg/kg Q3W	qzlvgzlbyo(izvlqnpnio) = 6% of pts experienced TRAE leading to discontinuation fwsjcvasri (imoezuamgl ) View more	Positive	30 May 2025
				SSGJ-707 10mg/kg Q3W

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