US FDA granted PD-L1 antibody KN035 with Orphan Drug Designa

January 18, 2020 – 3D Medicines(”3D Med”) and Alphamab Oncology (Stock code : 9966.HK) (“Alphamab” or “the Company”) announced that the US Food and Drug Administration (“US FDA”) have granted Orphan Drug Designation(“ODD”) to PD-L1 antibody KN035 for the treatment of biliary tract cancer (“BTC”).


The Orphan Drug Designation from US FDA originates from the Orphan Drug Act which is provide incentives for the development of potentially promising orphan drugs  to treat rare diseases with target patient population less than 200,000 in the US. Drug candidates with Orphan Drug Designation qualify for seven-year FDA-administered market Orphan Drug Exclusivity (ODE). In addition, US FDA also rewards ODD drugs with comprehensive incentives including tax credit for clinical trial cost, waiver of BLA user fee, subsidies for R&D costs, protocol assistance and expedited regulatory approval pathway. In 2018, 34 out of the 59 new drugs approved by US FDA are Orphan Drugs; and 8 out of the top 10 best-selling cancer drugs in US, have received Orphan Drug Designation for part of their indications.
Dr. John Z. Gong, Chairman and CEO of 3D Medicines, commented, "FDA's granted of Orphan Drug Designation for KN035(Envafolimab) is a good news for the BTC patients who had lack of effective treatment options. KN035, as the first drug candidate treating first-line BTC patients, is currently in Phase III pivotal randomized trial. The clinical development of KN035 has always been focusing on global market. Our first patient was from the US, followed by continuous scientific communications with FDA, then the End-of-Phase II meeting in 2019, all of these efforts have prepared us to develop KN035 even further valuable indications."
Dr. Ting Xu, Founder, Chairman and CEO of Alphamab Oncology, commented, “KN035 was invented by Alphamab with the goal to be the first subcutaneously injectable PD-L1 inhibitor globally, offering distinctively differentiated advantage over other marketed or clinical stage PD-(L)1 antibody. Alphamab and 3D Medicines have co-developed the product to late clinical stage. The Orphan Drug Designation for KN035 is an important progress for KN035’s global development strategy. we are confident that it will become a valuable option for BTC patients worldwide.”

About KN035
Invented by Alphamab, Co-development with 3D Medicines, KN035 is a fusion protein of PD-L1 domain antibody with the Fc domain of a regular antibody. Based on its unique design, KN035 has advantages in safety, convenience, and compliance over conventional PD-(L)1 antibodies. It can be used for patients who are not suitable for intravenous infusion, and has lower medical costs. Currently, KN035 is undergoing clinical trials in China, the United States, and Japan for multiple cancer indications, and it has entered pivotal trials for some cancer indications.
About 3D Medicines
3D Medicines is a clinical-stage biopharmaceutical company focused on the development of differentiated next-generation immuno-oncology drugs for cancer patients. The company's current pipeline includes two clinical stage drug candidates: KN035, the world's first subcutaneous PD-L1 antibody (approved by the FDA/NMPA/PMDA for clinical study in 2017); 3D-185, a highly selective FGFR-1/2/3 inhibitor (3D Medicines has the global development rights in oncology and pulmonary fibrosis.) A total of six global clinical trials for KN035 are undergoing simultaneously in the United States, China, and Japan. Two key registration trials are being conducted in China., and it is expected to file BLA for the first indication in 2020. With a professional team in China and the United States, 3D Medicines is capable of conducting global clinical development and registration.
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About Alphamab Oncology (Stock code: 9966.HK)
Alphamab Oncology is a biopharmaceutical company focusing on the research and development, manufacturing and commercialization of biologics for oncology. In December 12, 2019, the Company was listed in the mainboard of Hong Kong Stock Exchange with stock code 9966.Alphamab has fully integrated proprietary biologics platform in bi-specifics and protein engineering. Its highly differentiated in-house pipeline consists of eight anti-cancer drug candidates, four of which have advanced into Phases I – III clinical development phase in China, US and Japan. The Company also has proprietary CRIB and CRAM platforms for bi-specifics and antibody mixtures, and state-of-the-art manufacturing capability designed and built to meet NMPA and EU/FDA’s cGMP standards.With multiple in-house proprietary platforms for innovative biopharmaceuticals, Alphamab Oncology has built a robust pipeline in oncology/immunology to benefit cancer patients around the world.
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