May 29, 2026 – Beijing, China and San Diego, California
Anda Biology Medicine Development (Beijing) Co., Ltd. (“Anda”) today announced that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track designation to PCNAT-01, a Personalized Lyophilized Tumor Polypeptide Vaccine administered by subcutaneous injection, to prevent recurrence of pancreatic ductal adenocarcinoma following R0 resection and adjuvant chemotherapy. The designation was granted under IND 30952 following FDA’s review of the Fast Track designation request received on March 9, 2026.
Fast Track designation is intended to facilitate the development and expedite the review of drugs and biologics that are being developed to treat serious conditions and address unmet medical needs. In its grant letter dated May 7, 2026, FDA stated that PCNAT-01 meets the criteria for Fast Track designation for the specified pancreatic ductal adenocarcinoma treatment setting.
“We are very pleased that FDA has granted Fast Track designation to PCNAT-01,” said Dr. Liandian Hu, Founder and Chief Executive Officer of Anda. “Pancreatic ductal adenocarcinoma remains one of the most challenging malignancies, and patients who have completed surgery and adjuvant chemotherapy continue to face a substantial risk of disease recurrence. This designation represents an important regulatory milestone for Anda and supports our commitment to advancing personalized cancer immunotherapy for patients with significant unmet medical need.”
Dr. Hu added, “We look forward to continuing the clinical development of PCNAT-01 and to working closely with FDA, investigators, and our collaborators to further evaluate the potential of this personalized vaccination program in the post-resection, post-adjuvant chemotherapy setting for pancreatic ductal adenocarcinoma.”
CRC Oncology Corp serves as the U.S. regulatory agent for PCNAT-01 regulatory submissions to the U.S. FDA on behalf of Anda. “We are honored to support Anda in its U.S. regulatory strategy for PCNAT-01,” said Dr. Qinhua Cindy Ru, Founder and Managing Director of CRC Oncology. “The granting of Fast Track designation is an encouraging milestone that recognizes the seriousness of pancreatic ductal adenocarcinoma and the importance of advancing innovative therapeutic approaches in this high-risk post-resection setting. We look forward to continued collaboration with Anda and to supporting future regulatory interactions and development activities for the PCNAT-01 personalized vaccination program.”
About PCNAT-01
PCNAT-01 is a personalized lyophilized tumor polypeptide vaccine administered by subcutaneous injection. It is being developed for the treatment of pancreatic ductal adenocarcinoma following R0 resection and adjuvant chemotherapy. The PCNAT-01 program is intended to explore a personalized vaccination approach in a disease setting where recurrence risk remains high despite current standard therapies.
Following the receipt of FDA Fast Track designation grant letter, the Sponsor Anda has followed the requirement under section 561A(f)(2) of the Federal Food, Drug, and Cosmetic Act and made its expanded access policy for PCNAT-01 publicly available on ClinicalTrials.gov under NCT07612930 / Study ID PCNAT-01-2026-EAP, which was posted on May 19, 2026.
About Anda Biology Medicine Development (Beijing) Co., Ltd.
Anda Biology Medicine Development (Beijing) Co., Ltd. is a biotechnology company focused on the development of innovative therapeutic approaches for serious diseases with significant unmet medical need, including personalized cancer immunotherapy. Through its PCNAT-01 program, Anda is advancing a personalized vaccination strategy for patients with pancreatic ductal adenocarcinoma following surgical resection and adjuvant chemotherapy.
About CRC Oncology
CRC Oncology Corp is a U.S.-based regulatory and clinical development advisory firm supporting oncology-focused drug development programs. CRC Oncology serves as the U.S. regulatory agent for PCNAT-01 regulatory submissions to the U.S. FDA on behalf of Anda and provides strategic regulatory support for U.S. FDA interactions and IND/NDA/BLA-related drug development and regulatory submission activities.
Media Contact:
Emily Zhang
Corporate Communications
Anda Biology Medicine Development (Beijing) Co., Ltd.
media@andabiopharma.com
Rachel Bennett
Media Communications
CRC Oncology Corp
rbennett@crconc.org