TRACON Pharmaceuticals, a US based clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, has announced that it has signed a collaborative partnership agreement with 3D Medicines (Beijing) Co., Ltd., a China-based biopharmaceutical company focused on cancer precision medical treatment, and Jiangsu Alphamab Biopharmaceuticals Co., Ltd., a wholly-owned subsidiary of Alphamab Oncology and a China-based clinical stage biopharmaceutical company primarily engaging in research and development, manufacturing and commercialization of biologics of oncology,  for the development of envafolimab, also known as KN035, a PD-L1 single-domain antibody administered by subcutaneous injection, for development in soft tissue sarcoma in North America.

TRACON and 3D Medicines and Jiangsu Alphamab entered into a product development collaboration whereby TRACON will be responsible for the clinical development and commercialization of envafolimab in soft tissue sarcoma in North America, with the majority of the development activities expected to occur in the U.S. TRACON will bear the costs of clinical trials and 3D Medicines and Jiangsu Alphamab will supply envafolimab at pre-negotiated prices.

TRACON will be responsible for commercializing envafolimab for sarcoma in North America, except in certain circumstances involving the approval of envafolimab for other indications in North America, in which case TRACON has the option to co-market envafolimab for sarcoma in North America.

If TRACON has responsibility for commercialization under the Collaboration Agreement, it will owe 3D Medicines and Jiangsu Alphamab escalating double digit royalties on net sales of envafolimab for sarcoma in North America ranging from the teens to mid-double digits, which amounts shall be split between 3D Medicines and Jiangsu Alphamab as negotiated. 

If 3D Medicines and Jiangsu Alphamab have responsibility for commercialization under the Collaboration Agreement, TRACON will be entitled to (a) escalating double digit royalties on net sales of envafolimab for sarcoma in North America ranging from the teens to mid-double digits if TRACON has chosen to not co-market envafolimab in sarcoma or (b) a 50% royalty on net sales of envafolimab for sarcoma in North America if TRACON has chosen to co-market envafolimab in sarcoma