suvemcitug (APX003) / Simcere, Mabwell (Shanghai) Biosci, Pyxis Oncology - LARVOL DELTA

SIMCERE PHARMA's ENZESHU and ENDOSTAR Included in China's NRDL (iis.aastocks.com)

Platinum resistant • Reimbursement • Fallopian Tube Cancer • Non Small Cell Lung Cancer • Ovarian Cancer • Peritoneal Cancer

SCORES: A Phase III Study of BD0801 Combined With Chemotherapy in Recurrent, Platinum-resistant Epithelial Ovarian Cancer (clinicaltrials.gov) - P3 | N=421 | Completed | Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. | Active, not recruiting ➔ Completed

Platinum resistant • Trial completion • Epithelial Ovarian Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Refractory Ovarian Cancer • Solid Tumor

Pipeline Updates (GlobeNewswire) - "In July 2025, Pyxis Oncology received a $2.8 million ($3 million milestone payment, less $0.2 million of tax in China) milestone payment from Simcere Pharmaceutical Group Limited ('Simcere') for the approval of suvemcitug (BD0801) in China by the National Medical Products Administration."

Financing • Platinum resistant • Ovarian Cancer

China approves…new drugs, including a global first-in-class medicine (Fierce Pharma) - "In a third new cancer drug approval by NMPA, the agency greenlighted Simcere’s anti-VEGF antibody suvemcitug for use alongside chemotherapy for ovarian cancer patients who have tried no more than one line of therapy after developing resistance to platinum-based chemo....The drug proved its worth in a China phase 3 trial coded Scores carried out in patients with platinum-resistant ovarian cancer."

China approval • Platinum resistant • Ovarian Cancer

Final analysis of SCORES, a phase III randomized, double-blinded, placebo-controlled study of suvemcitug combined with chemotherapy for platinum-resistant ovarian cancer. (ASCO 2025) - P3 | "Eligible patients were randomly assigned (2:1) to either Suvemcitug (1.5 mg/kg q2w) or placebo combined with investigators chose CT (weekly paclitaxel, topotecan or pegylated liposomal doxorubicin) until progression or unacceptable toxicity. The addition of suvemcitug to chemotherapy significantly improved the outcomes of patients with PROC with manageable toxicities. To the best of our knowledge, this is the first phase III study demonstrated a significant OS benefit of anti-angiogenic agent in patients with PROC."

Clinical • P3 data • Platinum resistant • Fallopian Tube Cancer • Hypertension • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Anti-PD-L1 envafolimab combined with anti-VEGF suvemcitug in pretreated solid tumors and hepatocellular carcinoma: an open-label phase II study with safety run-in stage. (PubMed, Invest New Drugs) - P2 | "The combination of envafolimab and suvemcitug showed a tolerable safety profile and promising antitumor activity in HCC patients who failed later-line treatment."

Journal • P2 data • Hepatocellular Cancer • Hepatology • Oncology • Renal Disease • Solid Tumor

Envafolimab Plus Suvemcitug and FOLFIRI Shows Early Efficacy, Tolerability in Second-Line CRC (OncLive) - P2 | N=86 | NCT05148195 | Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. | "Preliminary findings from CRC cohort (n = 20) showed that patients who received the combination achieved an investigator-assessed objective response rate (ORR) of 25.0% (95% CI, 8.66%-49.10%). The disease control rate (DCR) was 90.0% (95% CI, 68.30%-98.77%). The median duration of response (DOR) and median progression-free survival (PFS) were 4.1 months (95% CI, 3.02-not evaluable) and 5.6 months (95% CI, 4.01-8.25), respectively. Topline safety data revealed that no dose-limiting toxicities occurred during the safety run-in. All patients experienced any-grade treatment-related adverse effects (TRAEs) and 90% of patients experienced grade 3 or higher TRAEs. Serious TRAEs were reported in 35% of patients. Dose interruption or reduction occurred in 80% and 70% of patients, respectively."

P2 data • Colorectal Cancer

The efficacy and safety of suvemcitug, envafolimab, and FOLFIRI in microsatellite-stable or mismatch repair-proficient colorectal cancer: preliminary results of a phase 2 study. (PubMed, Int J Colorectal Dis) - P2 | "The safety profile was manageable and the preliminary anti-tumor efficacy was observed in patients with MSS/pMMR CRC in this study, who had failed prior to one line of therapy."

Journal • Mismatch repair • P2 data • Cardiovascular • Colorectal Cancer • Hypertension • Oncology • Solid Tumor

A phase III randomized, double-blinded, placebo-controlled study of suvemcitug combined with chemotherapy for platinum-resistant ovarian cancer (SCORES). (ASCO 2024) - P3 | "After the investigators chose chemotherapy (CT) (weekly paclitaxel 80 mg/ m 2 d1, 8, 15 & 22 q4w, pegylated liposomal doxorubicin 40 mg/m 2 d1 q4w or topotecan 4 mg/m 2 d1, 8 & 15 q4w), patients were randomly assigned (2:1) to either Suvemcitug (1.5 mg/kg q2w) or placebo combine with CT until progression or unacceptable toxicity. To the best of our knowledge, this is the first double-blinded phase III study demonstrated promising antitumor activity of anti-angiogenic agent in patients with PROC. The improvement in PFS, ORR and DCR gained by adding Suvemcitug to single-agent CT was observed with no new safety concern."

Clinical • Late-breaking abstract • P3 data • Oncology • Ovarian Cancer • Solid Tumor

Suvemcitug plus chemotherapy for platinum-resistant epithelial ovarian, fallopian tube and primary peritoneal cancer: A phase 1b dose-escalation trial. (PubMed, Gynecol Oncol) - "Suvemcitug demonstrated an acceptable safety profile and promising antitumor activities in platinum-resistant ovarian cancer patients, supporting its further clinical development."

Journal • P1 data • Cardiovascular • Gastrointestinal Disorder • Hypertension • Oncology • Ovarian Cancer • Peritoneal Cancer • Renal Disease • Solid Tumor

A Phase II Study of Envofolimab and BD0801 With/Without Chemotherapy in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P2 | N=86 | Terminated | Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. | Trial completion date: Dec 2023 ➔ Jul 2023 | Recruiting ➔ Terminated; The study was terminated due to the sponsor's research and development strategy adjustment.

Combination therapy • Metastases • Trial completion date • Trial termination • Cholangiocarcinoma • Gastrointestinal Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • MSI • ROS1

A Phase III Study of BD0801 Combined With Chemotherapy in Recurrent, Platinum-resistant Epithelial Ovarian Cancer (clinicaltrials.gov) - P3 | N=421 | Active, not recruiting | Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2023 ➔ Dec 2024

Enrollment closed • Trial completion date • Oncology • Ovarian Cancer • Peritoneal Cancer • Refractory Ovarian Cancer • Solid Tumor

Combination therapy of envafolimab and suvemcitug with chemotherapy in patients with non-small cell lung cancer (NSCLC): Results from a phase II clinical trial (ESMO 2023) - P2 | "Envafolimab plus suvemcitug and docetaxel were administrated until disease progression or unacceptable toxicity...There was no grade 5 TRAE in either cohort. Conclusions This phase II clinical trial demonstrated antitumor activity and manageable safety profile of immunotherapy plus anti-angiogenic agent and chemotherapy in pts with NSCLC, who had failed at least one line of therapy."

Clinical • Combination therapy • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • ROS1

Combination therapy of envafolimab and suvemcitug in patients with hepatocellular carcinoma (HCC): Results from a phase II clinical trial (ESMO 2023) - P2 | "Research Sponsor: Shanghai Xianxiang Medical Technology Co., Ltd. and 3D Medicines Inc."

Clinical • Combination therapy • P2 data • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • FLT1

Combination therapy of envafolimab, suvemcitug, and FOLFIRI in patients with metastatic microsatellite stable (MSS) or mismatch-repair proficient (pMMR) colorectal cancer: Results from a phase II clinical trial (ESMO 2023) - P2 | "Eligible pts had received at least one prior line of treatment for MSS/pMMR mCRC and were treated with envafolimab plus suvemcitug and FOLFIRI (Irinotecan, Leucovorin, and 5-Fluorouracil)...Conclusions To the best of our knowledge, this is the first study demonstrated promising antitumor activity and a manageable safety profile of immunotherapy plus anti-angiogenic agent and chemotherapy in pts with MSS/ pMMR mCRC who had failed at least one line of therapy. The results support further evaluation of the therapy in a larger population."

Clinical • Combination therapy • IO biomarker • Metastases • Mismatch repair • P2 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • KRAS • SMAD4 • TP53

Suvemcitug as second-line treatment of advanced or metastatic solid tumors and with FOLFIRI for pretreated metastatic colorectal cancer: phase Ia/Ib open label, dose-escalation trials. (PubMed, ESMO Open) - "Suvemcitug has an acceptable toxicity profile and exhibits antitumor activities in pretreated patients with advanced solid tumors or metastatic colorectal cancer."

Journal • Metastases • P1 data • Cardiovascular • Colorectal Cancer • Gastrointestinal Cancer • Hematological Disorders • Hepatology • Hypertension • Neutropenia • Oncology • Renal Disease • Solid Tumor

A Phase II Study of Envofolimab and BD0801 With/Without Chemotherapy in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P2 | N=110 | Recruiting | Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Cholangiocarcinoma • Gastrointestinal Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • MSI • ROS1

A Phase II Study of Envofolimab and BD0801 With/Without Chemotherapy in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P2; N=110; Not yet recruiting; Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

Clinical • Combination therapy • New P2 trial • Cholangiocarcinoma • Gastrointestinal Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • MSI • ROS1

A Phase III Study of BD0801 Combined With Chemotherapy in Recurrent, Platinum-resistant Epithelial Ovarian Cancer (clinicaltrials.gov) - P3; N=357; Recruiting; Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Oncology • Ovarian Cancer • Peritoneal Cancer • Refractory Ovarian Cancer • Solid Tumor

Antiangiogenic antibody BD0801 combined with immune checkpoint inhibitors achieves synergistic antitumor activity and affects the tumor microenvironment. (PubMed, BMC Cancer) - "These data provide a solid rationale for combining antiangiogenic agents with immunotherapy for cancer treatment and support further clinical development of BD0801 in combination with ICIs."

Biomarker • Checkpoint inhibition • Journal • Tumor microenvironment • Colorectal Cancer • Gastrointestinal Cancer • Immune Modulation • Inflammation • Oncology • Solid Tumor • CD4 • CD8

Apexigen Announces First Patient Dosed in Phase 3 Pivotal Trial for BD0801, an Anti-VEGF Monoclonal Antibody, in Combination Therapy for Ovarian Cancer (GlobeNewswire) - "Apexigen, Inc...announced that Simcere Pharmaceutical Co. Ltd. has initiated a Phase 3 pivotal trial evaluating BD0801 in combination with chemotherapy for patients with recurrent, platinum-resistant ovarian cancer...'We look forward to seeing BD0801 progress towards commercialization in China and potentially address unmet medical needs in cancer patients with limited effective treatment options.'"

Commercial • Trial status • Gynecologic Cancers • Oncology • Ovarian Cancer

[VIRTUAL] The anti-angiogenic antibody BD0801 demonstrates better anti-tumor activity than bevacizumab and synergize with chemotherapies in multiple tumor models (AACR-NCI-EORTC 2021) - No abstract available

Preclinical • Oncology

Preliminary results from a study of sevacizumab in Chinese patients with metastatic colorectal cancer resistant to oxaliplatin-based first-line chemotherapy. (ASCO 2018) - P1; "Preliminary results from this study showed good efficacy of sevacizumab in mCRC patients and the study also provide good insights of dose selection in future clinical development of sevacizumab."

Clinical • Colorectal Cancer

Simcere/3D/Alphamab's PD-L1 / VEGF combo mAb regimen set for Phase II in China (GBI Health) - "China-based Simcere Pharmaceutical Group (2096.HK) announced that its envafolimab (KN035), a programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb) under co-development with 3D Medicines and Alphamab Oncology (HKEX.09966), has received the go-ahead from the National Medical Products Administration (NMPA) for a Phase II clinical study in advanced solid tumors in combination with sevacizumab (BD0801)."

New P2 trial • Oncology • Solid Tumor

A Phase III Study of BD0801 Combined With Chemotherapy in Recurrent, Platinum-resistant Epithelial Ovarian Cancer (clinicaltrials.gov) - P3; N=357; Not yet recruiting; Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

Clinical • New P3 trial • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor