Subcutaneously Injected PD-L1 Antibody Envafolimab (KN035) Obtained Its Second Orphan Drug Designation From The U.S. FDA

Alphamab Oncology announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to envafolimab (KN035), a recombinant humanized PD-L1 single-domain antibody independently invented by Alphamab Oncology, for the treatment of patients with soft tissue sarcoma. This is the second Orphan Drug Designation for Envafolimab after its first ODD in advanced biliary tract cancer and fourth ODD that Alphamab Oncology has obtained from the U.S. FDA.

The Orphan Drug Act was passed in 1983 and Orphan Drug Designation is granted by the U.S. FDA to drugs or biologics intended to treat a rare disease or condition, defined as one that affects fewer than 200,000 people in the United States. Programs with Orphan Drug status receive partial tax credit for clinical trial expenditures, waived user fees and eligibility for seven years of marketing exclusivity. Obtaining the Orphan Drug Designation is of great significance for accelerating the development and marketing of new drugs. In 2020, 58% of the 53 new drugs approved by the U.S. FDA have obtained the Orphan Drug Designation.

Envafolimab is currently being studied in the ENVASARC Phase 2 pivotal trial in the U.S. sponsored by Alphamab's partner TRACON Pharmaceuticals (" TRACON", NASDAQ: TCON), for the treatment of patients with pleomorphic sarcoma (UPS)/ Myxofibrosarcoma (MFS) who have progressed on prior chemotherapy, and the study design has been published as a poster at ASCO 2021 by TRACON.

Dr. Ting Xu, Chairman and CEO of Alphamab Oncology, commented, "After being granted ODD in advanced biliary tract cancer last year, this is the second Orphan Drug Designation for Envafolimab granted by the U.S. FDA，which is a recognition of our first BLA product's differentiated advantages and innovation. The BLA for Envafolimab (KN035) has been accepted and granted Priority Review by the National Medical Products Administration (NMPA), and it is expected to be launched in the second half of this year. With this second ODD, we look forward to accelerating the development of Envafolimab in the United States, to benefit cancer patients in need around the world as soon as possible."

"The receipt of Orphan Drug Designation is the first of multiple milestones we expect this year for Envafolimab, including interim efficacy data from the pivotal ENVASARC trial in the second half of 2021," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON." "The 40% response rate demonstrated by Envafolimab in the ASPS patients is similar to the 42% response rate reported by the National Cancer Institute in ASPS patients treated with the PD-L1 antibody Tecentriq, which is consistent with data in MSI-H colorectal cancer."

About Envafolimab  （ KN035 ）

Envafolimab (KN035) is a single domain Fc fusion PD-L1 antibody independently invented by Alphamab Oncology. Based on its unique design that allows rapid subcutaneous injection, it has advantages of improved safety, convenience in drug administration, and treatment compliance. Patients do not require an intravenous infusion which lowers medical costs. On December 20, 2019, Alphamab Oncology, 3D Medicines, and TRACON Pharmaceuticals reached a strategic cooperation, whereby Alphamab Oncology is responsible for production and quality control, and TRACON is responsible for the clinical development and commercialization of KN035 for the treatment of soft tissue sarcomas in North America.

At present, Envafolimab (KN035) has been studied in clinical trials for multiple tumor indications in China, the United States and Japan, including registration/phase III clinical trials in multiple indications. Envafolimab (KN035) obtained orphan drug designation from the US FDA for advanced biliary tract cancer and the National Medical Products Administration (NMPA) accepted the biologic license application (BLA) for Envafolimab (KN035) in MSI-H/dMMR cancer and granted priority review.

About Alphamab Oncology

Alphamab Oncology is focusing on innovation, production and commercialization of anti-tumor drugs. On December 12, 2019, the Company was listed in the mainboard of Hong Kong, S.A.R., China Stock Exchange with stock code 9966.

Alphamab has fully integrated proprietary biologics platforms in bi-specifics and protein engineering. Its highly differentiated in-house pipeline includes fifteen tumor monoclonal antibodies and bispecific antibodies and a Covid-19 multifunctional antibody. Four products have advanced into phase I-III clinical trials or pre-marketing stage in China, the United States, Japan and Australia. The BLA for Envafolimab (KN035) has been accepted and granted Priority Review by the National Medical Products Administration (NMPA).

The Company also has state-of-the-art manufacturing capabilities designed and built to meet NMPA and EU/FDA's cGMP standards and a complete quality system which has passed the on-site inspection of an European Union qualified person. Alphamab Oncology is committed to building a global leading, multi-dimensional drug development and commercialization platform, focusing on multifunctional biological innovative drugs, and to benefit patients in China and around the world.