PF-08634404 / 3SBio, Pfizer - LARVOL DELTA

A Study to Learn About Study Medicine Called PF-08634404 as a Single Treatment and Combination Treatment in Adult Participants With a Liver Cancer Called Hepatocellular Carcinoma, That is Too Advanced to be Removed by Surgery and May Have Spread to Other Parts of the Body. (clinicaltrials.gov) - P1/2 | N=138 | Not yet recruiting | Sponsor: Pfizer

Monotherapy • New P1/2 trial • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Extensive-Stage Small Cell Lung Cancer (clinicaltrials.gov) - P2/3 | N=550 | Not yet recruiting | Sponsor: Pfizer

New P2/3 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=1500 | Not yet recruiting | Sponsor: Pfizer

New P3 trial • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

SSGJ-707, a PD-1/VEGF bispecific antibody, combined with platinum-based chemotherapy in first-line treatment of advanced non-small cell lung cancer (NSCLC): results from a phase 2 study (SITC 2025) - P2 | "In Part 1, patients with nonsquamous NSCLC received SSGJ-707 at 5/10/20 mg/kg or tislelizumab with carboplatin+pemetrexed...Based on the selected dose from cohort A, Part 2 cohort B evaluated SSGJ-707 10 mg/kg or tislelizumab with carboplatin + paclitaxel or SSGJ-707 10 mg/kg + carboplatin + nab-paclitaxel in squamous NSCLC.Results At the data cutoff of July 4, 2025, 119 patients with nonsquamous NSCLC and 125 with squamous NSCLC were enrolled in Parts 1 and 2, respectively...ORRs with SSGJ-707 exceeded that of tislelizumab + chemotherapy. These results support further evaluation of SSGJ-707 10 mg/kg Q3W combined with chemotherapy in a phase 3 study in first-line NSCLC regardless of PD-L1 expression.Abstract 1328 Table 1View inline•Open as popupEfficacy and safetyAbstract 1328 Figure 1Request permissionsWaterfall plots for SSGJ-707 + chemotherapy in Part 1, Part 2 cohort A, and Part 2 cohort B"

Clinical • IO biomarker • Late-breaking abstract • Metastases • P2 data • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-1 • PD-L1

SSGJ-707, a PD-1/VEGF bispecific antibody, combined with platinum-based chemotherapy in first-line treatment of advanced non-small cell lung cancer (NSCLC): results from a phase 2 study (SITC 2025) - P2 | "In Part 1, patients with nonsquamous NSCLC received SSGJ-707 at 5/10/20 mg/kg or tislelizumab with carboplatin+pemetrexed...Based on the selected dose from cohort A, Part 2 cohort B evaluated SSGJ-707 10 mg/kg or tislelizumab with carboplatin + paclitaxel or SSGJ-707 10 mg/kg + carboplatin + nab-paclitaxel in squamous NSCLC.Results At the data cutoff of July 4, 2025, 119 patients with nonsquamous NSCLC and 125 with squamous NSCLC were enrolled in Parts 1 and 2, respectively...ORRs with SSGJ-707 exceeded that of tislelizumab + chemotherapy. These results support further evaluation of SSGJ-707 10 mg/kg Q3W combined with chemotherapy in a phase 3 study in first-line NSCLC regardless of PD-L1 expression.Abstract 1328 Table 1View inline•Open as popupEfficacy and safetyAbstract 1328 Figure 1Request permissionsWaterfall plots for SSGJ-707 + chemotherapy in Part 1, Part 2 cohort A, and Part 2 cohort B"

Clinical • IO biomarker • Late-breaking abstract • Metastases • P2 data • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-1 • PD-L1

A phase II trial to evaluate the safety and efficacy of SSGJ-707: A bispecific antibody targeting PD-1 and VEGF, in combination with chemotherapy in patients with metastatic CRC (ESMO 2025) - P2 | "Conclusions SSGJ-707 in combination with XELOX/mFOLFOX6 demonstrated promising efficacy results in 1L mCRC with manageable safety profile. The study of SSGJ-707 monotherapy in ≥3L mCRC and in combination with chemotherapy for the whole pMMR/MSS 1L mCRC pts is ongoing."

Clinical • Combination therapy • IO biomarker • Metastases • P2 data • Colorectal Cancer • Oncology • Solid Tumor • PD-1 • PD-L1

A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Different Anticancer Agents in Advanced Cancers (clinicaltrials.gov) - P1/2 | N=162 | Not yet recruiting | Sponsor: Pfizer

New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Pfizer built its confidence in its phase 3 approach for PF-08634404 based on results from a phase 2 trial conducted by 3SBio in China. (FierceBiotech) - "In the study, treatment with the bispecific at 10 mg/kg and chemo yielded an overall response rate (ORR) of 58.6% in patients with nonsquamous NSCLC. Further, the ORR was 69.2% among those with squamous disease who were treated with the bispecific when the chemo partner was nab-paclitaxel and 37.5% when paclitaxel was the combo partner...The ORR for the squamous population was calculated after a 'considerably shorter' follow-up period, Legos noted. The results were presented at the Society for Immunotherapy of Cancer 2025 annual meeting during this past weekend."

P2 data • Lung Non-Squamous Non-Small Cell Cancer

A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Metastatic Colorectal Cancer (clinicaltrials.gov) - P3 | N=800 | Not yet recruiting | Sponsor: Pfizer

New P3 trial • Colorectal Cancer • Gastroenterology • Gastrointestinal Cancer • Gastrointestinal Disorder • Oncology • Solid Tumor

A Study to Learn About the Medicine Called PF-08634404 Dosed Alone and in Combination With Other Anticancer Therapies in Adults With Locally Advanced or Metastatic Renal Cell Cancer (clinicaltrials.gov) - P1/2 | N=224 | Not yet recruiting | Sponsor: Pfizer

Monotherapy • New P1/2 trial • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Pfizer Completes Licensing Agreement with 3SBio (Pfizer Press Release) - "Pfizer Inc...announced today the completion of a global, ex-China, licensing agreement with 3SBio, Inc. (01530.HK) granting Pfizer exclusive rights for the development, manufacturing and commercialization of 3SBio’s SSGJ-707, a bispecific antibody targeting PD-1 and VEGF developed using 3SBio’s proprietary CLF2 platform. This agreement solidifies Pfizer at the forefront of innovative cancer research and further enhances the company’s robust oncology pipeline...Pfizer plans to manufacture drug substance for SSGJ-707 in Sanford, North Carolina, and drug product in McPherson, Kansas. The clinical development plan for SSGJ-707 moving forward will include trial sites across the U.S. and rest of world with priority to the Phase 3 global development plan for NSCLC and other solid tumors. The first Phase 3 global studies will initiate enrollment in the U.S."

Licensing / partnership • New P3 trial • Colorectal Cancer • Endometrial Cancer • Non Small Cell Lung Cancer • Ovarian Cancer

SSGJ-707 in Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=420 | Recruiting | Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD. | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

A phase II trial to evaluate the safety and efficacy of SSGJ-707, a bispecific antibody targeting PD-1 and VEGF, as a monotherapy in patients with advanced NSCLC. (ASCO 2025) - P2 | "The increase of SSGJ-707 affinity for PD-1 was 10-fold more than that of Ivonescimab in the presence of VEGF. SSGJ-707 monotherapy demonstrated promising efficacy results in treatment naive advanced NSCLC with manageable safety profile. Monotherapy and combination trials with chemotherapy for NSCLC are still ongoing. Research Sponsor: 3S BIO.COM."

Clinical • IO biomarker • Metastases • Monotherapy • P2 data • Dyslipidemia • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • PD-1

Pfizer Enters into Exclusive Licensing Agreement with 3SBio (Pfizer Press Release) - "Pfizer...announced it has entered into an exclusive global, ex-China, licensing agreement with 3SBio...for the development, manufacturing and commercialization of SSGJ-707, a bispecific antibody targeting PD-1 and VEGF, currently undergoing several clinical trials in China for non-small cell lung cancer, metastatic colorectal cancer, and gynecological tumors....3SBio plans to initiate the first Phase 3 study in China in 2025. Under the terms of the agreement, 3SBio and its subsidiaries Shenyang Sunshine Pharmaceutical Co., Ltd. and 3S Guojian Pharmaceutical (Shanghai) Co., Ltd. will grant Pfizer an exclusive global license to develop, manufacture and commercialize SSGJ-707 worldwide, excluding China....3SBio will receive an upfront payment of $1.25 billion and is eligible to receive milestone payments associated with certain development, regulatory and commercial milestones up to $4.8 billion..."

Licensing / partnership • New P3 trial • Colorectal Cancer • Gynecologic Cancers • Non Small Cell Lung Cancer

SSGJ-707 in Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=420 | Not yet recruiting | Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD.

IO biomarker • New P3 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

707 Injection (Anti-VEGF/PD-1 Bispecific Antibody) Granted Breakthrough Therapy Designation by NMPA (HKEXnews) - "On 17 April, 2025, the anti-VEGF/PD-1 bispecific antibody (R&D code: 707 Injection), independently developed by 3SBio, was granted a Breakthrough Therapy Designation ('BTD') by China’s National Medical Products Administration ('NMPA'). The designated indication is the first-line treatment of PD-L1 positive locally advanced or metastatic non-small cell lung cancer ('NSCLC'). 707 Injection is a bispecific antibody targeting VEGF/PD-1, independently developed by 3SBio based on its proprietary CLF2 platform."

Breakthrough therapy • Non Small Cell Lung Cancer

A Study to Evaluate SSGJ-707 in Advanced Gynecologic Cancer Patients (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Endometrial Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

A Phase 2 Study of SSGJ-707 in Metastatic Colorectal Cancer Patients (clinicaltrials.gov) - P2 | N=130 | Recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

A Phase II Study of SSGJ-707 Combination Therapy in Advanced NSCLC Patients (clinicaltrials.gov) - P2 | N=235 | Recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Phase 2 Study to Evaluate SSGJ-707 in Advanced Gynecologic Cancer Patients (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Metastases • New P2 trial • Endometrial Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

A Phase 2 Study of SSGJ-707 in Metastatic Colorectal Cancer Patients (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Metastases • New P2 trial • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

A Phase II Study of SSGJ-707 Combination Therapy in Advanced NSCLC Patients (clinicaltrials.gov) - P2 | N=235 | Not yet recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Combination therapy • Metastases • New P2 trial • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Phase II Study of SSGJ-707 Monotherapy in First-line PD-L1 Positive Advanced NSCLC Patients (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Metastases • Monotherapy • New P2 trial • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor