AbClon's AC101 (HLX22) Received FDA Orphan Drug Designation for HER2-Positive Locally Advanced and Metastatic Gastric Cancer, Signaling a Green Light for Global Commercialization.

 

AbClon announced on the 25th that its AC101 (Henlius’s code name HLX22), an antibody therapy licensed to Henlius in 2016, has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of HER2-positive locally advanced and metastatic gastric cancer.

 

FDA ODD status provides various research and development support benefits, including up to 25% tax credits for R&D expenses, grant on clinical trial, exemption from FDA application fees, and eligibility for priority review and accelerated approval (Fast Track).

 

Furthermore, seven years of market exclusivity shall be granted on FDA orphan drug approval, enhancing commercial competitiveness. ODD is considered a significant certification that indicates innovative potential and global R&D competitiveness of a drug candidate, beyond mere regulatory advantages.

 

HER2-positive gastric cancer affects approximately one million new patients worldwide annually and has a poor prognosis with a 5-year survival rate of only 6% due to difficulties in early diagnosis. While the combination therapy of trastuzumab (Herceptin) and XELOX (capecitabine + oxaliplatin) is currently the standard treatments, the need for new treatment options persists due to its limited efficacy in some patients.

 

Recent clinical studies have demonstrated that the combination therapy of HLX22 + trastuzumab + XELOX significantly improved survival rates compared to the group treated with trastuzumab + XELOX. The 24-month progression-free survival (PFS) rate was 61.5% in the HLX22 group and 25% in the standard treatment group. The overall survival rate was not reached in the HLX22 group and was reported to be 22 months in the standard treatment group, indicating the superiority of HLX22 combination therapy over the existing standard treatment.

 

Currently, the Investigational New Drug (IND) application for the HLX22-GC-301 Phase 3 clinical trial, which combines HLX22 with trastuzumab and chemotherapy, has been approved in several countries including China, the United States, Japan, and Australia. The study has commenced in multiple countries and carried out the first patient dosing. In addition to gastric cancer, research on HLX22 is being expanded to breast cancer treatment, potentially offering new treatment options to more patients.

 

An AbClon representative stated, "This orphan drug designation has further increased the potential for HLX22's entry into the global market and officially is recognized as an innovative therapeutic drug candidate. We will continue to focus on research and development to strengthen our competitiveness in the global market and provide effective treatment options for cancer patients."

 

They emphasized, "We will continue to develop innovative anticancer therapies through ongoing research and collaboration, and accomplish a significant role in the global healthcare market."

 

AbClon's AC101 (HLX22) Received FDA Orphan Drug Designation for HER2-Positive Locally Advanced and Metastatic Gastric Cancer, Signaling a Green Light for Global Commercialization.

 

AbClon announced on the 25th that its AC101 (Henlius’s code name HLX22), an antibody therapy licensed to Henlius in 2016, has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of HER2-positive locally advanced and metastatic gastric cancer.

 

FDA ODD status provides various research and development support benefits, including up to 25% tax credits for R&D expenses, grant on clinical trial, exemption from FDA application fees, and eligibility for priority review and accelerated approval (Fast Track).

 

Furthermore, seven years of market exclusivity shall be granted on FDA orphan drug approval, enhancing commercial competitiveness. ODD is considered a significant certification that indicates innovative potential and global R&D competitiveness of a drug candidate, beyond mere regulatory advantages.

 

HER2-positive gastric cancer affects approximately one million new patients worldwide annually and has a poor prognosis with a 5-year survival rate of only 6% due to difficulties in early diagnosis. While the combination therapy of trastuzumab (Herceptin) and XELOX (capecitabine + oxaliplatin) is currently the standard treatments, the need for new treatment options persists due to its limited efficacy in some patients.

 

Recent clinical studies have demonstrated that the combination therapy of HLX22 + trastuzumab + XELOX significantly improved survival rates compared to the group treated with trastuzumab + XELOX. The 24-month progression-free survival (PFS) rate was 61.5% in the HLX22 group and 25% in the standard treatment group. The overall survival rate was not reached in the HLX22 group and was reported to be 22 months in the standard treatment group, indicating the superiority of HLX22 combination therapy over the existing standard treatment.

 

Currently, the Investigational New Drug (IND) application for the HLX22-GC-301 Phase 3 clinical trial, which combines HLX22 with trastuzumab and chemotherapy, has been approved in several countries including China, the United States, Japan, and Australia. The study has commenced in multiple countries and carried out the first patient dosing. In addition to gastric cancer, research on HLX22 is being expanded to breast cancer treatment, potentially offering new treatment options to more patients.

 

An AbClon representative stated, "This orphan drug designation has further increased the potential for HLX22's entry into the global market and officially is recognized as an innovative therapeutic drug candidate. We will continue to focus on research and development to strengthen our competitiveness in the global market and provide effective treatment options for cancer patients."

 

They emphasized, "We will continue to develop innovative anticancer therapies through ongoing research and collaboration, and accomplish a significant role in the global healthcare market."