January 18, 2020 – 3D Medicines, Inc. (“3D Medicines”）and Alphamab Oncology (stock code: 9966.HK) (“Alphamab”) announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to PD-L1 antibody KN035 for the treatment of biliary tract cancer (BTC). The FDA's Orphan Drug Designation, derived from the Orphan Drug Act (ODA), was the FDA's initiative to encourage the development of potentially promising orphan drugs for diseases that affect fewer than 200,000 people in the United States. Drug candidates with Orphan Drug Designation qualify for seven-year market Orphan Drug Exclusivity (ODE). In addition, FDA also grants ODD drugs comprehensive incentives including tax credit, waiver of prescription drug user fee, subsidies for R&D costs, protocol assistance and fast-track approval. In 2018, 34 out of the 59 new drugs approved by FDA were Orphan Drugs, and 8 out of the top 10 best-selling cancer drugs in the U.S., have received Orphan Drug Designation for part of their indications. The best-selling drug, lenalidomide, for the treatment of multiple myeloma, was granted ODD for all three indications.

John Gong, M.D., Ph.D., Chairman and Chief Executive Officer of 3D Medicines., commented, “The Orphan Drug Designation for Envafolimab (KN035) granted by FDA is good news for the BTC patients with limited effective treatment options. KN035, as the world’s first product to enter Phase III randomized trial for first-line treatment of BTC patients, targets unmet clinical needs and is innovative both at home and abroad. The trial, led by Professor Shukui Qin of the Cancer Center, PLA Eastern Theater Command General Hospital, is currently progressing well. KN035, the  subcutaneous PD-L1/PD-(L)1 antibody new drug, has a differentiation advantage in improving the quality of life of cancer patients. From the beginning, our development efforts have been directed toward a global market and the Human (FIH) clinical trial was conducted in the United States. We have had a lot of scientific communication with FDA and held the End-of-Phase II meeting in 2019, in ways to prepare ourselves to further develop KN035 for more valuable indications. We have entered the sprint phase in the domestic market, and as the Chinese company to receive clinical approval for PD-(L)1, we hope that KN035 would be available to domestic cancer patients sooner, and we also hope to provide better drug options for cancer patients worldwide."

Dr. Ting Xu, Founder, Chairman and Chief Executive Officer of Alphamab Oncology, commented, “KN035 is the subcutaneous PD-(L)1 antibody independently developed by Alphamab, with obvious differentiation advantages over PD-(L)1 antibodies currently on the market and in development. We collaborated with Medicines for joint development which has entered 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.”

About KN035

KN035 is a Fc fusion protein of PD-L1 single-domain antibody and conventional antibody. Based on its unique feature, KN035 has advantages in safety, convenience, compliance and 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 3D Medicines

3D Medicines is a clinical-stage biopharmaceutical company focused on the development of differentiated immuno-oncology drugs for cancer patients. The company's current pipeline includes two clinical stage drug candidates: KN035, the 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 initiated 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.

About Alphamab Oncology

Alphamab Oncology is a biopharmaceutical company focusing on the research and development, manufacturing and commercialization of biologics for oncology. On 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.