Beijing, China, March 30, 2020 – 3D Medicines announced that 3D Medicines (Beijing) Co., Ltd., a wholly-owned subsidiary of 3D Medicines, Inc., has established strategic partnership with Simcere Pharmaceuticals and Jiangsu Alphamab Biopharmaceuticals Co., Ltd. （“Jiangsu Alphamab”）to advance the development and commercialization of Envafolimab (KN035), a checkpoint inhibitor for programmed cell death ligand-1 (PD-L1), for the treatment of cancer indications in mainland China.

According to the partnership agreement, Alphamab will be the exclusive manufacturer of KN035 and responsible for the production and supply of KN035. 3D Medicines will oversee the clinical development, registration and commercialization of KN035. Simcere will obtain the exclusive right to promote KN035 in mainland China upon its registration, and charge 3D Medicines for promotion.

Envafolimab (KN035) is a recombinant humanized PD-L1 single-domain antibody Fc fusion protein independently invented by Alphamab. In 2016, 3D Medicines reached an agreement with Alphamab to co-develop Envafolimab, which is expected to be the world’s first subcutaneous PD-L1 antibody approved. Compared to other PD1/PD-L1 antibodies on the market, it has obvious differentiation advantages in stability, compliance, convenience and cost, providing a better quality of life for patients. KN035 is undergoing clinical trials in China, the United States, and Japan for multiple cancer indications, with more than 900 patients enrolled, including a pivotal Phase II clinical trial evaluating the treatment of advanced microsatellite instability-high (MSI-H)/mismatch repair deficiency (dMMR) solid cancers. Additionally, KN035 is undergoing pivotal Phase III clinical trials for advanced biliary tract cancer (BTC) in China. On January 18, 2020, KN035 was granted FDA Orphan Drug Designation (ODD) for the treatment of advanced biliary tract cancer (BTC).

John Gong, M.D., Ph.D., Chairman and CEO of 3D Medicines, commented:” We are pleased to reach a major partnership with Simcere to drive the development and commercialization of KN035 in cancer indications, with the help of Simcere’s well-established marketing network and in-depth experience in the China market. In addition to the indications being evaluated, we will fully utilize KN035’s distinctive differentiation advantages in convenience and safety, and push forward the clinical development of KN035 for the first-line treatment, maintenance therapy, adjuvant and neo-adjuvant treatment of advanced cancers, providing better treatment options for cancer patients worldwide.”

Mr. Jinsheng Ren, Founder and Chairman of Simcere, commented, "KN035 is a first-in-class single domain PD-L1 antibody. With distinctive characteristics and advantages such as subcutaneous injection and stability at room temperature, KN035 can improve compliance and the quality of life of cancer patients, and simultaneously may reduce medical costs and improve drug accessibility. It is a medication with greater clinical significance and can truly benefit patients and our society. This strategic partnership will enable synergy in early stage development, clinical development, and commercialization. Together, we hope to fulfill our mission of making better medicines available to patients sooner. "

Dr. Ting Xu, Founder, Chairman and CEO of Alphamab Oncology, commented, “KN035 is likely the world’s first PD-L1 antibody with subcutaneous administration to be approved. Compared to PD-1/PD-L1 drugs currently on the market, it has obvious differentiation advantages in stability, compliance, convenience and cost. KN035 is one of our globally competitive innovative candidates as a result of our relentless R&D efforts focused on globally innovative biologics for over a decade. To certain extent, this also represents the trend that Chinese pharmaceutical companies are becoming more competitive in global innovation. The collaboration amongst three companies not only has demonstrated how top tier innovative R&D, clinical and commercial teams in China join forces, but also could set the example of an outstanding collaboration of innovative drug R&D and commercialization in China aiming to benefit more cancer patients in the near future. ”

About 3D Medicines

3D Medicines, Inc. is a clinical-stage biopharmaceutical company with a mission to help people with cancer live longer and better. Envisioning a future when cancer is managed as a chronic disease, 3D Medicines focuses on the development of differentiated next-generation immuno-oncology drugs, helping cancer patients live with prolonged survival time and a better quality of life. 3D Medicines has established a pipeline with innovative biological and small-molecule anti-cancer drugs, as well as a professional team capable of global development, registration and commercialization operation.

About Simcere Pharmaceuticals

Simcere is a research and development-driven Chinese pharmaceutical company with a State Key Lab for Translational Medicine and Innovative Drug Development. It is committed to delivering highly effective treatments to patients. Simcere achieves this by focusing its efforts on the therapeutic areas of oncology, neurology, inflammation/immunology diseases and more. By leveraging its commercial capability, all of the company’s best products have achieved leading market shares in China. Simcere continues to promote the advancement of international scientific and medical breakthroughs through a collaborative R&D strategy and extensive strategic partnership with several multinational companies.

For more information, please visit: www.simcere.com

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 www.alphamabonc.com for more information.