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Envafolimab Obtained Its 2nd Orphan Drug Designation from the U.S. Food and Drug Administration

Release time:2021-06-30

On 29 June 2021, Simcere announced that the innovative subcutaneously injected PD-L1 single domain antibody Envafolimab has received the Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of patients with soft tissue sarcoma. This is the second ODD received by Envafolimab after its first ODD in advanced biliary tract cancer. Envafolimab is being developed in China as part of a strategic partnership of Simcere, 3D Medicines Inc. and Alphamab Oncology (9966.HK), and has the potential to become the first subcutaneous injectable anti-PD1/PD-L1 antibody to be approved globally.

The Orphan Drug Act passed in 1983 encourages the development of new drugs and treatments for rare diseases or conditions, which is defined as one that affects less than 200,000 patients 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.

Soft tissue sarcoma is a rare malignant tumor that originates from mesenchymal tissue. It has complex pathological types and obvious intra-tumor heterogeneity. Cytotoxic chemotherapeutics is the main treatment for soft tissue sarcoma. However, it often causes serious adverse reactions. There is a lack of immunotherapy.

Envafolimab is currently being studied in the ENVASARC Phase 2 pivotal trial in the U.S. on the treatment of patients with pleomorphic sarcoma (UPS)/ Myxofibrosarcoma (MFS) who have failed chemotherapy previously. The study design has been published as a poster at ASCO 2021.

About Envafolimab  

Envafolimab is a single domain Fc fusion PD-L1 antibody researched and developed by Alphamab Oncology. Its unique design that allows rapid subcutaneous injection provides the advantages of improved safety, convenience in drug administration, and treatment compliance. Patients do not need an intravenous infusion, hence lowers the cost of medical treatment.

On 30 March 2020, Alphamab Oncology has established strategic partnership with Simcere and 3D Medicines to advance the development and commercialization of Envafolimab for oncology indications in mainland China. As the original developer, Alphamab Oncology is responsible for the production and supply of KN035, 3D Medicines will oversee KN035’s clinical development, registration and commercialization, and Simcere will take charge of exclusive commercial distribution of KN035 in mainland China. 

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

Forward Looking Statements

Information set forth in this press release contains forward-looking statements, which involve a number of known and unknown risks, uncertainties and assumptions. The forward-looking statements contained herein reflect the current judgment and views of Simcere Pharmaceutical Group Limited as of the date of this press release. Such forward-looking statements are neither promises nor guarantees but are subject to a variety of risks and uncertainties, many of which are beyond our control, or may not materialize, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements, whether as a result of new information, future events or otherwise, to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based.