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Details:
KN035 is an investigational PD-L1 antibody, which is currently being evaluated for the treatment of undifferentiated pleomorphic sarcoma & myxofibrosarcoma.
Lead Product(s): Envafolimab,Ipilimumab
Therapeutic Area: Oncology Product Name: KN035
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 April 03, 2024
Details:
Glenmark will be responsible for further developing, registering, and commercializing KN035 (envafolimab), approved in China for the treatment of adult patients with previously treated MSI-H or dMMR advanced solid tumor, in multiple geographies around the World.
Lead Product(s): Envafolimab
Therapeutic Area: Oncology Product Name: KN035
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Glenmark Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement January 25, 2024
Details:
KN035 (envafolimab) is a single-domain antibody against PD-L1. It isbeing evaluated in phase 2 clinical trials for the treatment of undifferentiated pleomorphic sarcoma & myxofibrosarcoma.
Lead Product(s): Envafolimab
Therapeutic Area: Oncology Product Name: KN035
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 December 20, 2023
Details:
ASC22 (envafolimab) is the signal transmission to T cells and promotes T cell activation by blocking both PD-1/PD-L1 and PD-L1/cluster of differentiation 80 (CD80) signaling pathways, which is investigated for chronic hepatitis b.
Lead Product(s): Envafolimab
Therapeutic Area: Infections and Infectious Diseases Product Name: ASC22
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 September 28, 2023
Details:
KN035 (envafolimab) is a single-domain antibody against PD-L1 invented by Alphamab Oncology and licensed by TRACON, is the first approved subcutaneously injected PD-(L)1 inhibitor, which is investigated for MSI-H/dMMR advanced solid tumors.
Lead Product(s): Envafolimab,Ipilimumab
Therapeutic Area: Oncology Product Name: KN035
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 September 18, 2023
Details:
KN035 (envafolimab) is a single-domain antibody against PD-L1 invented by Alphamab Oncology and licensed by TRACON, is the first approved subcutaneously injected PD-(L)1 inhibitor, which is investigated for MSI-H/dMMR advanced solid tumors.
Lead Product(s): Envafolimab,Ipilimumab
Therapeutic Area: Oncology Product Name: KN035
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Alphamab Oncology
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 20, 2023
Details:
ASC22 (envafolimab) shows anti-tumor activity by blocking inhibitory signal transmission to T cells and promotes T cell activation by blocking both PD-1/PD-L1 and PD-L1/cluster of differentiation 80 (CD80) signaling pathways.
Lead Product(s): Envafolimab
Therapeutic Area: Infections and Infectious Diseases Product Name: ASC22
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 February 16, 2023
Details:
Envafolimab (KN035), a single-domain antibody against PD-L1 invented by Alphamab Oncology and licensed by TRACON, is the first approved subcutaneously injected PD-(L)1 inhibitor.
Lead Product(s): Envafolimab,Ipilimumab
Therapeutic Area: Oncology Product Name: KN035
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 December 14, 2022
Details:
YH001 is an IgG1 antibody against CTLA-4 that has shown enhanced antibody dependent cellular cytotoxicity and complement dependent cytotoxicity in vitro. YH001 demonstrated superior T cell activation and superior tumor growth inhibition activity compared to ipilimumab.
Lead Product(s): YH001,Envafolimab,Doxorubicin Hydrochloride
Therapeutic Area: Oncology Product Name: YH001
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 November 21, 2022
Details:
Envafolimab (KN035), a single-domain antibody against PD-L1 is the first approved subcutaneously injected PD-(L)1 inhibitor. Envafolimab is currently being studied in the ENVASARC Phase 2 and a Phase 3 pivotal trial in advanced biliary tract cancer patients.
Lead Product(s): Envafolimab,Ipilimumab
Therapeutic Area: Oncology Product Name: KN035
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 October 06, 2022
Details:
Envafolimab (KN035), a single-domain antibody against PD-L1 invented by Alphamab Oncology, is the first approved subcutaneously injected PD-(L)1 inhibitor.
Lead Product(s): Envafolimab,Ipilimumab
Therapeutic Area: Oncology Product Name: KN035
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Runway Growth Capital LLC
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Financing September 06, 2022
Details:
YH001 is an IgG1 antibody targeting CTLA-4,has shown enhanced antibody dependent cellular cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC) in vitro when compared with ipilimumab.
Lead Product(s): YH001,Envafolimab,Doxorubicin Hydrochloride
Therapeutic Area: Oncology Product Name: YH001
Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: TRACON Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 29, 2022
Details:
Envafolimab (KN035), a single-domain antibody against PD-L1 invented by Alphamab Oncology, is the first approved subcutaneously injected PD-(L)1 inhibitor.
Lead Product(s): Envafolimab,Ipilimumab
Therapeutic Area: Oncology Product Name: KN035
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 10, 2022
Details:
YH001, an IgG1 antibody against CTLA-4 invented by Biocytogen, the parent company of Eucure Biopharma, and licensed by TRACON, has shown enhanced antibody dependent cellular cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC) in vitro.
Lead Product(s): YH001,Envafolimab,Doxorubicin Hydrochloride
Therapeutic Area: Oncology Product Name: YH001
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 August 08, 2022
Details:
ASC22 (Envafolimab) is a subcutaneously administered single domain antibody against PD-L1 and has the potential to restore virus-specific immune responses in patients with chronic viral infection.
Lead Product(s): Envafolimab,Antiretroviral Therapy
Therapeutic Area: Infections and Infectious Diseases Product Name: ASC22
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 June 28, 2022
Details:
ASC22 (Envafolimab) is a subcutaneously administered single domain antibody against PD-L1 and has the potential to restore virus-specific immune responses in patients with chronic viral infection.
Lead Product(s): Envafolimab
Therapeutic Area: Infections and Infectious Diseases Product Name: ASC22
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 June 15, 2022
Details:
Result demonstrated highly tolerable safety profile and significantly higher objective response rate observed in lower weight patients in ENVASARC, to increase dose of envafolimab to 600 mg every three weeks, which is double the original envafolimab dose of 300 mg Q3W.
Lead Product(s): Envafolimab,Ipilimumab
Therapeutic Area: Oncology Product Name: KN035
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Alphamab Oncology
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 19, 2022
Details:
ASC22 (envafolimab) is a subcutaneously administered single-domain antibody against PD-L1 and has the potential to restore virus-specific immune responses in patients with chronic viral infection such as hepatitis B virus (HBV) and HIV.
Lead Product(s): Envafolimab,Chidamide
Therapeutic Area: Infections and Infectious Diseases Product Name: ASC22
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Ascletis Pharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 14, 2022
Details:
Company announced that envafolimab (KN035), the world's first single-domain PD-L1 antibody formulated for subcutaneously Administered Checkpoint Inhibitor injection received marketing authorization from the Chinese NMPA.
Lead Product(s): Envafolimab,Ipilimumab
Therapeutic Area: Oncology Product Name: KN035
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 November 29, 2021
Details:
The Phase IIa and IIb studies are focused on chronic hepatitis B (CHB) functional cure using a subcutaneously administered PD-L1 antibody ASC22 (Envafolimab).
Lead Product(s): Envafolimab,Nucleotide Analogs
Therapeutic Area: Infections and Infectious Diseases Product Name: ASC22
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 November 16, 2021
Details:
Under the terms of this agreement, Ascletis obtained an exclusive and worldwide license outside Greater China from Suzhou Alphamab to develop and commercialize ASC22 for all viral diseases including Hepatitis B.
Lead Product(s): Envafolimab
Therapeutic Area: Infections and Infectious Diseases Product Name: ASC22
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Ascletis Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement November 08, 2021
Details:
The ASC22 Phase IIb study is a randomized, single-blind, placebo-controlled, multi-center clinical trial in China which evaluates the safety and efficacy of treating patients with CHB for 24-week treatment of 1 mg/kg or 2.5 mg/kg ASC22 or matching placebo.
Lead Product(s): Envafolimab,Nucleotide Analogs
Therapeutic Area: Infections and Infectious Diseases Product Name: ASC22
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 July 27, 2021
Details:
The Company intends to use the net proceeds from this offering to support the continued clinical development of envafolimab:a PD-L1 single-domain antibody given by rapid subcutaneous injection that is being studied in the pivotal ENVASARC trial for sarcoma.
Lead Product(s): Envafolimab
Therapeutic Area: Oncology Product Name: KN035
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: H.C. Wainwright & Co.
Deal Size: $15.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering July 21, 2021
Details:
The phase IIa data indicated that there is a trend of dose dependent HBsAg reduction after single dose administration of 0.3, 1.0 or 2.5 mg/kg ASC22. Eight out of nine patients treated with ASC22 exhibited some decline in HBsAg at the end of 12-week follow-up.
Lead Product(s): Envafolimab
Therapeutic Area: Infections and Infectious Diseases Product Name: ASC22
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 May 05, 2021
Details:
3D Medicines will obtain rights to develop, manufacture, and commercialize YBL-013, a T cell bi-specific engager based on ALiCE platform technology, in the Territory of Greater China (mainland China, Hong Kong, Macau and Taiwan) and will co-developed it across the globe.
Lead Product(s): YBL-013,Envafolimab
Therapeutic Area: Oncology Product Name: YBL-013
Highest Development Status: PreclinicalProduct Type: Large molecule
Partner/Sponsor/Collaborator: 3D Medicines
Deal Size: $87.0 million Upfront Cash: $2.0 million
Deal Type: Licensing Agreement January 05, 2021
Details:
In partnership with the Reed Research Group out of the University of Wisconsin-Madison, the Company is developing its tannin-chitosan composite of orally dissolvable thin films which offers a unique delivery platform for therapeutic doses of psilocybin into the oral cavity.
Lead Product(s): Envafolimab
Therapeutic Area: Oncology Product Name: KN035
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 September 21, 2020
Details:
TRACON intends to use the net proceeds from the private placement to conduct the ENVASARC pivotal study of envafolimab in sarcoma and for working capital and general corporate purposes.
Lead Product(s): Envafolimab,Ipilimumab
Therapeutic Area: Oncology Product Name: KN035
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: $5.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement August 27, 2020
Details:
The application cross referenced the open envafolimab IND maintained by TRACON’s corporate partners 3D Medicines and Alphamab Oncology. TRACON expects to initiate enrollment in the ENVASARC trial at 25 sites in the U.S. in the fourth quarter of 2020.
Lead Product(s): Envafolimab,Ipilimumab
Therapeutic Area: Oncology Product Name: KN035
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 17, 2020
Details:
ASC22(Envafolimab) Phase IIa clinical trial is a single dose escalation study with three subcutaneously administered doses (0.3, 1.0 and 2.5 mg/kg) to explore the safety and efficacy of ASC22(Envafolimab) in chronic hepatitis B patients.
Lead Product(s): Envafolimab
Therapeutic Area: Infections and Infectious Diseases Product Name: ASC22
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 17, 2020
Details:
The application cross references the open envafolimab IND maintained by TRACON’s corporate partners 3D Medicines and Alphamab Oncology.
Lead Product(s): Envafolimab,Ipilimumab
Therapeutic Area: Oncology Product Name: KN035
Highest Development Status: IND EnablingProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 16, 2020
Details:
Undifferentiated Pleomorphic Sarcoma is the major sarcoma subtype to be enrolled in TRACON’s Pivotal ENVASARC trial of Envafolimab as a single agent and in combination with Yervoy.
Lead Product(s): Envafolimab
Therapeutic Area: Oncology Product Name: Undisclosed
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 May 29, 2020
Details:
Envafolimab demonstrated a 30% confirmed Objective Response Rate (ORR) by RECIST by Independent Central Review in patients with advanced refractory MSI-H/dMMR colorectal and gastric cancer.
Lead Product(s): Envafolimab
Therapeutic Area: Oncology Product Name: Undisclosed
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 May 14, 2020
Details:
FDA agreed with TRACON’s proposals on key elements of the pivotal ENVASARC trial for envafolimab in the soft tissue sarcoma subtypes of undifferentiated pleomorphic sarcoma and myxofibrosarcoma.
Lead Product(s): Envafolimab,Ipilimumab
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 11, 2020
Details:
TRACON plans to propose a pivotal trial with two cohorts of approximately 80 patients each to assess the objective response rate in sarcoma subtypes known to be responsive to checkpoint inhibition.
Lead Product(s): Envafolimab,Ipilimumab
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 16, 2020
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