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Simcere, Alphamab Oncology and 3D Medicines Announce Partnership to Develop and Commercialize Subcutaneous Injectable anti-PD-L1 Antibody for Oncology Indications in Mainland China

Release time:2020-03-30


Nanjing, March 30, 2020 – Simcere announced today that it has established strategic partnership with Jiangsu Alphamab Biopharmaceuticals Co., Ltd. (“Jiangsu Alphamab”), a wholly-owned subsidiary of Alphamab Oncology (stock code: 9966HK) and 3D Medicines (Beijing) Co., Ltd. ("3DMed") to advance the development and commercialization of KN035 (also known as envafolimab), a checkpoint inhibitor for programmed cell death ligand-1 (PD-L1), for oncology indications in mainland China.

Under the terms of the agreement, Alphamab Oncology is the exclusive manufacturer of KN035 and responsible for the production and supply of KN035. 3DMed will oversee KN035’s clinical development, registration and commercialization. Simcere will exclusively market KN035 in mainland China upon the product’s registration, and charge a marketing fee to 3DMed.

Invented by Alphamab Oncology, KN035 is a recombinant anti-PD-L1 single domain antibody fused with human Fc. In 2016, Alphamab Oncology and 3DMed reached an agreement to co-develop KN035 which is on track to be the first subcutaneous injectable anti-PD1/PD-L1 antibody to be approved globally. Compared to other marketed PD1/PD-L1 antibodies, KN035 has demonstrated distinctive advantages in safety, convenience and patient compliance, which may further improve patients’ quality of life. 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 investigating the treatment of advanced solid tumors with microsatellite instability-high (MSI-H)/mismatch repair deficiency (dMMR). 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).

Mr. Jinsheng REN, Founder and Chairman of Simcere, added: "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 first PD-L1 inhibitor with subcutaneous administration to be approved globally. Compared to PD-1/PD-L1 drugs on the market currently, it has strong differentiation and advantages including stability, compliance, convenience and cost. KN035 is one of our many globally competitive innovative candidates as a result of our relentless R&D effort by focusing 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. And this 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. ”

Dr. Zhaolong GONG, Chairman and CEO of 3DMed added, “We are pleased to reach a major partnership with Simcere, a company with a well-established marketing network and in-depth experience in the China market, to drive the development and commercialization of KN035 in oncology. In addition to the indications being investigated, we will fully leverage KN035’s distinctive differentiation advantages in convenience and safety features, by pursuing clinical development of KN035 in the first line treatment of advanced stage cancer, in maintenance therapy, in adjuvant and neo-adjuvant treatment, with the aim of providing better treatment options for cancer patients worldwide.”


About Simcere

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.

About 3D Medicines

3DMed is a clinical stage biopharmaceutical company that adheres to the ‘patient-centered’ principle. In anticipation of a future when cancer is being treated as a chronic disease, the company focuses on the development of differentiated next-generation immune-oncology therapies to help cancer patients worldwide live longer and better. The company’s pipeline includes differentiated biologics and small molecule anti-cancer treatments. 3DMed has a seasoned team with global talents that is capable of conducting global clinical development and registration of oncology products.

Visit www.3d-medicines.com for more information.