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Details:
Cejemly (sugemalimab) is a fully human, full-length IgG4 monoclonal anti-PD-L1 antibody, being investigated against locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma.
Lead Product(s): Sugemalimab
Therapeutic Area: Oncology Product Name: Cejemly
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 28, 2023
Details:
Cejemly (sugemalimab) is a fully human, full-length IgG4 monoclonal anti-PD-L1 antibody, being investigated against metastatic squamous and non-squamous non-small cell lung cancer.
Lead Product(s): Sugemalimab
Therapeutic Area: Oncology Product Name: Cejemly
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 23, 2023
Details:
Cejemly (sugemalimab) is a fully human, full-length IgG4 monoclonal anti-PD-L1 antibody, being investigated against relapsed or refractory extranodal natural killer (NK)/T-cell lymphoma (R/R ENKTL) in adult patients and T-cell lymphoma.
Lead Product(s): Sugemalimab,Fluorouracil,Cisplatin
Therapeutic Area: Oncology Product Name: Cejemly
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 03, 2023
Details:
In the final progression-free survival analysis, CS1001 (sugemalimab) showed sustained clinical benefits in patients with unresectable stage III nSCLC whose disease had not progressed following concurrent or sequential chemoradiotherapy compared with placebo.
Lead Product(s): Sugemalimab
Therapeutic Area: Oncology Product Name: Cejemly
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 08, 2022
Details:
The National Medical Products Administration approved Cejemly (sugemalimab) for treatment of patients with unresectable stage III non-small cell lung cancer whose disease has not progressed following concurrent or sequential platinum-based chemoradiotherapy.
Lead Product(s): Sugemalimab
Therapeutic Area: Oncology Product Name: Cejemly
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Pfizer Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 06, 2022
Details:
Approval from China’s NMPA for sugemalimab (Cejemly®), an OmniAb-derived anti-PD-L1 monoclonal antibody, for the first-line treatment of metastatic NSCLC in combination with chemotherapy is based on the Phase 3 study.
Lead Product(s): Sugemalimab
Therapeutic Area: Oncology Product Name: Cejemly
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 22, 2021
Details:
Sugemalimab is the world’s first anti-PD-1/PD-L1 monoclonal antibody to significantly improve progression-free survival (PFS) in patients with stage III non-small cell lung cancer (NSCLC) without disease progression after concurrent or sequential chemoradiotherapy.
Lead Product(s): Sugemalimab
Therapeutic Area: Oncology Product Name: CS1001
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 02, 2021
Details:
GEMSTONE-301 study investigating sugemalimab as consolidation therapy in patients with locally advanced, unresectable Stage III NSCLC without disease progression after either concurrent or sequential chemoradiotherapy.
Lead Product(s): Sugemalimab
Therapeutic Area: Oncology Product Name: CS1001
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: CStone Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 28, 2021
Details:
Funding accelerates development of late-stage cancer therapies which includes sugemalimab, almonertinib, EQRx’s PD-1 antibody (formerly known as CS1003) and lerociclib, a CDK4/6 inhibitor.
Lead Product(s): Sugemalimab
Therapeutic Area: Oncology Product Name: CS1001
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: $500.0 million Upfront Cash: Undisclosed
Deal Type: Series B Financing January 11, 2021
Details:
Two large multinational pharmaceutical companies with a license to OmniAb have reached clinical-development milestones with their programs.
Lead Product(s): Sugemalimab
Therapeutic Area: Oncology Product Name: CS1001
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: CStone Pharmaceuticals
Deal Size: $4.5 million Upfront Cash: Undisclosed
Deal Type: Collaboration November 23, 2020
Details:
The results showed sugemalimab plus chemotherapy as first-line treatment for advanced non-small cell lung cancer showed clinically meaningful benefit in PFS with a well-tolerated safety profile compared to chemotherapy across PD-L1 expression levels and histologies.
Lead Product(s): Sugemalimab,Pemetrexed,Carboplatin
Therapeutic Area: Oncology Product Name: CS1001
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 21, 2020
Details:
Agreement provides a pathway to bring CStone's sugemalimab and CS1003 to global patient communities by partnering with a company with an innovative business model and unique ability to commercialize these two assets competitively against established treatments.
Lead Product(s): Sugemalimab
Therapeutic Area: Oncology Product Name: CS1001
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: EQRx
Deal Size: $1,300.0 million Upfront Cash: $150.0 million
Deal Type: Partnership October 27, 2020
Details:
This collaboration provides financing to support CStone’s development of sugemalimab, a potential best-in-class PD-L1 antibody that is being developed for high-incidence cancer indications in China, including lung, gastric and esophageal cancers, among others.
Lead Product(s): Sugemalimab
Therapeutic Area: Oncology Product Name: CS1001
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Pfizer Inc
Deal Size: $480.0 million Upfront Cash: Undisclosed
Deal Type: Collaboration September 30, 2020
Details:
CS1001-201 study demonstrated an objective response rate of 44.7% , a complete response rate of 31.6%, mOS of 19.7 months and an one-year overall survival rate of 55.5% in patients with relapsed or refractory extranodal natural killer /T cell lymphoma treated with sugemalimab.
Lead Product(s): Sugemalimab,Oxaliplatin,Capecitabine
Therapeutic Area: Oncology Product Name: CS1001
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 24, 2020
Details:
FDA has completed their review of the Investigational New Drug application for anti-PD-L1 monoclonal antibody sugemalimab (CS1001) monotherapy in the relapsed or refractory extranodal natural killer (NK)/T-cell lymphoma (R/R ENKTL) with study may proceed (SMP) letter received.
Lead Product(s): Sugemalimab
Therapeutic Area: Oncology Product Name: CS1001
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 31, 2020
Details:
CS1001-302 is the first randomized double-blind phase III clinical trial of anti-PD-L1 monoclonal antibody combined with chemotherapy as a first-line treatment in patients with stage IV squamous and non-squamous non-small cell lung cancer (NSCLC) histological subtypes.
Lead Product(s): Sugemalimab,Carboplatin,Paclitaxel
Therapeutic Area: Oncology Product Name: CS1001
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 06, 2020
Details:
This is the first global study carried out as a collaboration between CStone and Bayer assessing the safety, tolerability, pharmacokinetics, and antitumor activity of the CS1001 plus regorafenib combination in cancer.
Lead Product(s): Sugemalimab,Regorafenib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 24, 2020
Details:
The GEMSTONE-304 trial is a multicenter clinical study designed to evaluate the efficacy and safety of CS1001 in combination with 5-fluorouracil plus cisplatin (FP) doublet chemotherapy.
Lead Product(s): Sugemalimab,Fluorouracil,Cisplatin
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 08, 2020
Details:
This trial will assess the potential for two complementary treatment approaches – precision therapy and immuno-oncology therapy – to enhance anti-tumor activity in locally advanced or metastatic HCC.
Lead Product(s): Fisogatinib,Sugemalimab
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 06, 2020
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