December 20, 2019 – 3D Medicines, Inc. (“3D Medicines”) announced that it has signed a collaboration agreement with Jiangsu Alphamab Biopharmaceuticals Co., Ltd. (“Alphamab”), a wholly owned subsidiary of Alphamab Oncology (Stock code: 9966.HK) and TRACON Pharmaceuticals (“TRACON”) for the clinical development and commercialization of KN035, a PD-L1 single-domain antibody, in soft tissue sarcoma in North America.

KN035, which is expected to be the PD-L1 immuno-oncology drug that can be administered by subcutaneous injection, has been jointly developed by 3D Medicines and Alphamab, and it is now in the late clinical stage in the United States, Japan and China. TRACON will be responsible for the clinical development and commercialization of KN035 for the treatment of soft tissue sarcoma in the North American market, mainly in the United States. TRACON will pay sales-based royalties to Alphamab and 3D Medicines, and Alphamab will supply KN035 to TRACON at the negotiated price.

John Gong, M.D., Ph.D., Chairman and Chief Executive Officer of 3D Medicines, commented, "In previous clinical trials, KN035 has demonstrated safety and efficacy comparable to other PD-1/PD-L1 antibodies on the market, and its registration clinical trial is currently ongoing. We believe that KN035 will give cancer patients a better option with subcutaneous injection for cancer patients worldwide."

Dr. Ting Xu, Founder, Chairman and President of Alphamab Oncology, commented, "KN035 is currently the only PD-L1 inhibitor available for subcutaneous injection and has obvious differentiation advantages over PD-(L)1 antibodies already on the market and in development. This collaboration is an important part of KN035‘s global development strategy, and we believe it will bring valuable treatment options to cancer patients."

TRACONCharles Theuer：“Given the activity of other PD-1 and PD-L1 inhibitors in sarcoma, we believe a registration enabling study of KN035 in the sarcoma subtype of UPS will be meaningful to patients and providers, and is strategically aligned with TRACON’s mission to rapidly develop and commercialize drugs targeting unmet need indications in the U.S.，we expect to discuss our plan of initiating a pivotal trial of KN035 in UPS with the U.S. FDA in early 2020. Our ultimate goal is to enable a biomarker directed approach for treatment with KN035 in patients with multiple types of soft tissue sarcoma.”

Charles Theuer, M.D., Ph.D., President and Chief Executive Officer of TRACON, added, “Given the activity of other PD-1 and PD-L1 inhibitors in sarcoma, we believe a registration enabling study of KN035 in the sarcoma subtype of UPS will be meaningful to patients and providers, and is strategically aligned with TRACON’s mission to rapidly develop and commercialize drugs targeting unmet medical need indications in the U.S. We expect to discuss our plan of initiating a pivotal trial of KN035 in UPS with the U.S. FDA in early 2020. Our ultimate goal is to enable a biomarker directed approach for treatment with KN035 in patients with multiple types of soft tissue sarcoma.”

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 leading clinical-stage biopharmaceutical company in China with 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 clinical development phase. 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 Alphamab’s website at http://www.alphamabonc.com for more information.

About TRACON

TRACON develops targeted therapies for cancer and ophthalmic diseases. The Company’s clinical-stage pipeline includes: DE-122, the ophthalmic formulation of carotuximab, an endoglin antibody that is being developed for patients with wet AMD through a license to Santen Pharmaceutical Company Ltd.; TRC102, a small molecule drug being developed for the treatment of lung cancer; TRC253, a small molecule drug being developed for the treatment of prostate cancer; and TJ004309, a CD73 antibody being developed for the treatment of advanced solid tumors. TRACON is actively seeking additional corporate partnerships whereby it leads regulatory and clinical development and shares in the cost and risk of clinical development and leads U.S. commercialization. In these partnerships TRACON believes it can serve as a solution for companies without clinical and commercial capabilities in the U.S. To learn more about TRACON and its product candidates.

Visit TRACON's website at www.traconpharma.com for more information.