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US FDA rewarded PD-L1 antibody KN035 with Orphan Drug Designation

Janurary 19, 2020 16:00 Eastern Daylight Time

January 18, 2020 – Alphamab Oncology (Stock code : 9966.HK) (“Alphamab” or “the Company”) and 3D Medicines (“3D Med”) announced that the US Food and Drug Administration (“US FDA”) have rewarded 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 was enacted to encourage the development of innovative drugs to treat orphan 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 certain 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, 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 milestone for KN035’s global development strategy. we are confident that it will become a valuable option for BTC patients worldwide.”


Dr. John Z. Gong, Chairman and CEO of 3D Medicines, commented, “Orphan Drug Designation for KN035 (Envafolimab) is good news for the BTC patients who lack effective treatment options. KN035, as the first drug candidate for first line BTC patients, is currently in pivotal Phase III randomized trial. The clinical development of KN035 has always been focusing on global market. Our first patient dosed was in US, followed by continuous scientific communication with US FDA, then the End-of-Phase II meeting in 2019, all of these efforts have prepared us to develop KN035 even further for other valuable indications.”


About KN035

Invented by Alphamab, KN035 is a Fc fusion protein with PD-L1 domain antibody with. Based on its unique feature for subcutaneous administration, KN035 has advantages in safety, convenience, compliance and, lower medical costs over conventional PD-(L)1 antibody. It can also be used for patients who are not suitable for intravenous infusion. Currently, KN035 is undergoing clinical trials in China, the United States, and Japan for multiple cancer indications, and it has entered phase III clinical trials for some cancer indications.


About Alphamab Oncology

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 Phase I – III clinical development phases 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.

Visit http://www.alphamabonc.com for more information.


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.

Visit http://3d-medicines.com for more information.