On April 22, 2023, the opening ceremony of the Class B Radioisotope Laboratory of Suzhou Smart Nuclide Biopharmaceutical Co., Ltd. (hereinafter referred to as Smart Nuclide) was held in the Innovation and Entrepreneurship Center of Liandong U Valley in Suzhou Industrial Park. Dr. Jun Liu, CEO of TOT BIOPHARM, attended the ceremony and signed a strategic cooperation agreement with Smart Nuclide in the presence of Mr. Jianfeng Sun, General Manager of Suzhou Liandong U Valley Group and Mr. Hui Wang, Vice Chairman of Chinese Medical Association nuclear medicine branch. In the future, both parties will further consolidate and deepen their cooperation to rapidly advance the development of innovative radiopharmaceuticals based on bioconjugation technology.

As one of the few companies that have commercial production lines integrating antibody intermediate, ADC DS and ADC DP, and also one of the leading CDMO service companies in the world that have complete ADC industry line, TOT BIOPHARM has built an integrated ADC platform with high standard quality management system and commercialization capability that meets GMP standards. It also has rich experience in coupling process development and scale-up, covers cytotoxic and non-cytotoxic coupling drugs, and provides one-stop CDMO solutions. The commercial production base of TOT BIOPHARM is equipped with several complete upstream and downstream production lines, with antibody production capacity exceeding 20,000L; the ADC DS workshop is equipped with several 100L - 500L reaction kettles, with a conjugation reaction scale of 5kg/batch; in addition, with the world-leading pilot and commercial formulation production workshop capable of producing 50,000 needles per batch, which can provide flexible lyophilization services.

This strategic cooperation will further deepen the cooperation between TOT BIOPHARM and Smart Nuclide in the field of radiopharmaceuticals. TOT BIOPHARM will provide a complete antibody coupling development solution, while Smart Nuclide will provide a complete radioisotope labeling development solution with its Class B radioisotope laboratory. The two companies will work together to promote the development of innovative radiopharmaceuticals based on coupling technology and jointly accelerate the transformation of innovative results for the benefit of more patients.

Dr. Jun Liu, CEO of TOT BIOPHARM, said:

"We are very pleased to enter into a strategic partnership with Smart Nuclide to jointly empower the overall development of nuclide drugs. Smart Nuclide has created a single-domain antibody radiopharmaceuticals discovery, development and manufacturing technology platform with independent intellectual property rights, and their current R&D pipeline covers more than 10 innovative nuclide diagnostic and therapeutic products. TOT BIOPHARM has rich experience in ADC core coupling process and scale-up production, and also has technical advantages and independent analysis capability of ADC key quality attributes. Therefore, we can provide one-stop CDMO solution from antibody intermediate to ADC DS/DP in one site. We believe that this strategic collaboration will accelerate the development and growth of Smart Nuclide as well as other radiopharmaceuticals companies, to benefit patients worldwide as early as possible.”

Dr. Tao Xu, Founder of Smart Nuclide , said:

“TOT BIOPHARM has rich experience in the field of ADC development, covering the whole process from development to production of coupling drugs. We are honored to join hands with TOT BIOPHARM; combined with TOT BIOPHARM' strengths in antibody coupling, the Class B Radioisotope Laboratory of Smart Nuclide will further accelerate its development in the field of radiopharmaceuticals, which can also help nuclide drug companies at home and abroad, contributing to the development of innovative nuclide drugs, empowering industry partners and accelerating the innovation and development of radiopharmaceuticals around the world. ”