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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36695
Submission : 2022-02-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36695
Submission : 2022-02-16
Status : Active
Type : II
Details:
The primary objective of Phase 3 program is to demonstrate non-inferiority of BC Lispro on HbA1c reduction from baseline vs. Humalog. BioChaperone® Lispro (BC Lispro) is ultra-rapid prandial insulin containing insulin lispro and Adocia’s proprietary technology BioChaperone®.
Lead Product(s): Insulin Lispro
Therapeutic Area: Endocrinology Brand Name: BioChaperone Lispro
Study Phase: Phase IProduct Type: Peptide
Sponsor: Adocia
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 14, 2021
Lead Product(s) : Insulin Lispro
Therapeutic Area : Endocrinology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Adocia
Deal Size : Not Applicable
Deal Type : Not Applicable
Adocia’s partner Tonghua Dongbao Receives Clearance to Start Ultra-Rapid Insulin BioChaperone® ...
Details : The primary objective of Phase 3 program is to demonstrate non-inferiority of BC Lispro on HbA1c reduction from baseline vs. Humalog. BioChaperone® Lispro (BC Lispro) is ultra-rapid prandial insulin containing insulin lispro and Adocia’s proprietary t...
Brand Name : BioChaperone Lispro
Molecule Type : Peptide
Upfront Cash : Not Applicable
October 14, 2021
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Tonghua Dongbao Pharma is a supplier offers 1 products (APIs, Excipients or Intermediates).
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