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.

[+1]

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

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

29 Jul 2026

·www.fiercebiotech.com

Merck posts—then pulls—trial plan for PD-1xVEGF and TROP2 ADC combination

After keeping tight-lipped for nearly two years, Merck & Co. briefly dropped the first concrete hint as to where it intends to take its PD-1xVEGF bispecific antibody—before quietly scrubbing the evidence. A brief, now-deleted clinical trial listing on Merck’s website revealed that the New Jersey pharma plans to test the bispecific, coded MK-2010, alongside its TROP2-directed antibody-drug conjugate, sac-TMT. The phase 2 trial, coded MK-2010-003, was marked as “Study in start-up” on Merck’s website, with St. Gallen and Bellinzona in Switzerland listed as study centers. The open-label study would test the combo in patients with advanced solid tumors. Following a request for comment from Fierce Biotech on Wednesday morning, Merck has apparently removed the entry and deleted other listings for MK-2010, including a separate phase 2 monotherapy trial. The company didn’t reply to Fierce’s inquiry by publication time. China-based life sciences data aggregator PharmCube was among the first to report on the trial entry. The secrecy underscores a highly competitive race within the PD-(L)1xVEGF bispecific class, which also includes Summit Therapeutics and Akeso’s frontrunner ivonescimab , Bristol Myers Squibb and BioNTech’s pumitamig, and Pfizer and 3SBio’s PF-08634404 (SSGJ-707). Merck has kept its PD-1xVEGF strategy close to its chest since acquiring the asset from China’s LaNova Medicines (now part of Sino Biopharmaceutical) in 2024, citing a fiercely competitive environment . As bispecifics threaten to unseat Keytruda as the new immuno-oncology backbone, industry watchers and rivals alike have been closely tracking every move by the Keytruda maker while trying to decipher every comment the company makes. During an investor event on the sidelines of the 2026 American Society of Clinical Oncology annual meeting in June, Merck’s head of oncology global clinical development, Marjorie Green, M.D., pointed to the company’s experience combining Keytruda with VEGF inhibitors. She touted a “portfolio of novel agents that offer combination opportunities oriented towards combinations of the future rather than adding on to today’s current standard, including ADCs like sac-TMT.” Hints of Merck’s development plan for MK-2010 dropped as questions also began to swirl around potential competition—rather than synergy—between PD-1xVEGF drugs and TROP2 ADCs in the lucrative non-small cell lung cancer indication. As Akeso has reported ivonescimab head-to-head wins against PD-1 inhibitors in first-line NSCLC, Merck’s partner, Kelun-Biotech, has also delivered strong phase 3 results for sac-TMT in the same setting. Standing only on the verge of phase 2, Merck’s measured approach to MK-2010 reflects a cautious stance that contrasts sharply with the expansive phase 3 programs underway at BioNTech/BMS and Pfizer, as well as Merck’s own 17-trial roster for sac-TMT. For pumitamig , BioNTech and BMS have laid out the first wave of nine global pivotal trials across multiple tumor types, with lung cancer and breast cancer leading the way. In potential combinations of PD-1xVEGF and TROP2 ADC, specifically, Merck also appears to be behind. China’s Minghui Pharmaceutical is already about a year into phase 2 development , pairing its PD-1xVEGF candidate MHB039A with a TROP2 ADC coded MHB036C for advanced breast cancer and other solid tumors. Despite what appears to be a conservative approach so far, Leerink Partners analyst Daina Graybosch, Ph.D., has argued that Merck could rapidly pivot to more aggressive development of MK-2010 if it so chooses. “We believe Merck’s ‘wait-and-then-move’ strategy for MK-2010 will prove successful, as they have a strong portfolio to leapfrog the competition via ADC combinations,” Graybosch and colleagues wrote in an April note after Merck unveiled the first clinical data for MK-2010 in NSCLC at the American Association for Cancer Research annual meeting. “Should Merck proceed with MK-2010 more aggressively, we believe they are likely to leverage their vast ADC program (including […] sac-TMT) to combine with MK-2010,” the team said at the time. Meanwhile, the oncology field is eagerly waiting for phase 3 readouts from AstraZeneca and Daiichi Sankyo’s Avanzar trial for a cocktail of their TROP2 ADC, Datroway, with AZ’s PD-L1 inhibitor Imfinzi and chemotherapy in first-line NSCLC.

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	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	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
Adenocarcinoma of Esophagus	Phase 3	Taiwan Province	Pfizer Inc.	14 May 2026
Gastrooesophageal junction cancer	Phase 3	United States	Pfizer Inc.	14 May 2026
Gastrooesophageal junction cancer	Phase 3	China	Pfizer Inc.	14 May 2026

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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	bxtnhktwmy(ykskdgqggj) = pmqbrbjfeh stthzolbxw (tiudffazqe )	Positive	12 Sep 2026
NCT07222800 (Symbiotic-GI-03, ASCO2026)	Phase 3	Metastatic Colorectal Carcinoma First line	800	PF-08634404 + mFOLFOX6	ntejvhvdna(ippkafevwq) = tgvimazwpu xvtbcymkrp (ocpvtrfdna ) View more	Positive	29 May 2026
				Bevacizumab + mFOLFOX6	ntejvhvdna(ippkafevwq) = ombopjgavb xvtbcymkrp (ocpvtrfdna )
NCT06522828 (SSGJ-707-ST-II-02, ASCO2026)	Phase 2	Endometrial Carcinoma First line	32	SSGJ-707 5 mg/kg Q3W + chemo	xtjjqgfryl(psvfnxkdvh) = ujaxfwrtyj vvqcbpzjua (bwojmnetar ) View more	Positive	29 May 2026
				SSGJ-707 10 mg/kg Q3W + chemo	xtjjqgfryl(psvfnxkdvh) = kcockgolop vvqcbpzjua (bwojmnetar ) View more
NCT06361927 (ASCO2026)	Phase 2	Advanced Lung Non-Small Cell Carcinoma First line	83	SSGJ-707 10 mg/kg	pkdtguzcyq(nazbkfarjt) = gwwhgcupqg iryzjbhjpv (kyhiqchlyl, 49.5 - 82.6) View more	Positive	29 May 2026
				SSGJ-707 10 mg/kg (Squamous)	pkdtguzcyq(nazbkfarjt) = acdyiaftca iryzjbhjpv (kyhiqchlyl, 42.8 - 94.5) 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	genpdklxpq(hjeuagjkfz) = sppnccbcya vwgexlyctg (xdtsxkpxsq, 36.2 - NR)	Positive	25 Mar 2026
				PF-08634404 plus carboplatin and pemetrexed	genpdklxpq(hjeuagjkfz) = fwbjlgqrha vwgexlyctg (xdtsxkpxsq, 36.3 - NR)
NCT07227298 (Symbiotic-Lung-20, ESMO_ELCC2026)	Phase 1/2	Advanced Malignant Solid Neoplasm First line	42	PF-08634404 + sigvotatug vedotin	mzenrsnuvz(aczbcwcrzn) = lipssofxhn gcbbldxnmj (dfykzrplni ) View more	Positive	25 Mar 2026
				PF-08634404 + PDL1V	xjevcudbxn(zbgqzmgxor) = krmcfuibnw eeowdwbbgh (wsyjfnmlkh ) View more
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	guhhpkrgdt(jvtkavfqju) = etlngbqvtl tkmoniatfl (nwmqqdxbwv )	Positive	25 Mar 2026
				anti-PD-L1 plus carboplatin and etoposide followed by anti-PD-L1 monotherapy	guhhpkrgdt(jvtkavfqju) = zvbcpfuixh tkmoniatfl (nwmqqdxbwv )
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)	ozbygugpte(queanzmbpz) = rojpcuoypd idfvymhflw (pqacyiaydw ) View more	Positive	13 Oct 2025
				SSGJ-707 + Chemotherapy (10mg/kg Q2W + mFOLFOX6)	ozbygugpte(queanzmbpz) = apsdqclknu idfvymhflw (pqacyiaydw ) View more
NCT06361927 (SSGJ-707-NSCLC-II-01, ASCO2025)	Phase 2	Non-Small Cell Lung Cancer	83	SSGJ-707 5mg/kg Q3W	jqlrtsyicu(ohlxfqqvnv) = 6% of pts experienced TRAE leading to discontinuation vdlombpcne (zttyjyritu ) View more	Positive	30 May 2025
				SSGJ-707 10mg/kg Q3W
NCT06493760 (Corporate Publications) Manual	Phase 2	Colorectal Cancer First line \| Last line \| Third line	68	SSGJ-707	uejxxrvnrc(ioatqmkjnh) = osmppsicws pkxrgrdnyo (wuncigfota ) View more	Positive	16 Jan 2025
				SSGJ-707 + chemo	uejxxrvnrc(ioatqmkjnh) = dtrpqpoykb pkxrgrdnyo (wuncigfota ) View more

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