The early winter has arrived in Suzhou in December, but this ancient city in the south of the Yangtze River has brought spring-like warmth to the vast number of thyroid cancer patients. The phase III clinical trial for Recombinant Human Thyroid-stimulating hormone injection (SNA001) developed by Suzhou SmartNuclide Biopharma was officially launched in Suzhou Industrial Park on December 6, 2019.

Grand event in nuclear medicine field

The opening ceremony was presided over by the project’s main investigator, Prof. Hongcheng Shi, Deputy Chairman of the Nuclear Medicine Branch of the Chinese Medical Association and Director of the Department of Nuclear Medicine of Zhongshan Hospital affiliated to Fudan University. Professor Tie Wang, chairman of nuclear medicine branch of Chinese Medical Association, Professor Yaming Li, former chairman of nuclear medicine branch of Chinese Medical Association, Ms. Zhihui Jiang, deputy director of science and technology investment center of Suzhou Industrial Park, and Dr. Tao Xu, CEO of Suzhou SmartNuclide, delivered warm speeches successively, placing high praise and deep hope on the kick-off meeting. The other attending representatives included Professor Anren Kuang, the seventh chairman of nuclear medicine branch of Chinese Medical Association, Professor Wensheng Huang, the former president of Taiwan Nuclear Medicine Association, Professor Tan Jian, the chairman of nuclear medicine branch of China Medical Imaging Technology Research Association, Professor Fan Wei, the chairman of cancer nuclear medicine professional committee of China Anti-Cancer Association, and Professor Xuemei Wang, the chairman designate of nuclear medicine branch of China Medical Imaging Technology Research Association Professor Quanyong Luo, director of nuclear medicine discipline of Shanghai Sixth People’s Hospital, Professor Yifan Zhang, deputy director of nuclear medicine discipline of Ruijin Hospital Affiliated to Shanghai Jiaotong University, representatives of nuclear medicine discipline and GCP center of all participating units, representatives of the Management Committee of the Dushu Lake Science and Education department, representatives of the Industrial Park Biological Industry Company, representatives of the Sponsor SmartNuclide, and CRO partners. Hundreds of people gathered together to share this “grand feast” in the field of nuclear medicine in China!

SNA001 phase III launching ceremony was held after the opening speech. Professor Tie Wang, Professor Yaming Li, Professor Anren Kuang, Professor Wensheng Huang, Professor Jian Tan, Professor Wei Fan, Professor Xuemei Wang, Professor Hongcheng Shi, Dr. Tao Xu and Dr. Xiaoxia Zhang pressed the fingerprint on the screen at the same time, implying to work together in the same boat. After the countdown of 5 seconds, the name of the city where each research center is located rises slowly, and finally converges in Suzhou, the place where SmartNuclide is located, representing the official launch of SNA001 phase III clinical trial.

Q&A and Progress of Disciplines

Project PI Professor Hongcheng Shi then introduced the project background, inclusion and exclusion criteria, end point indicators, research process, combined medication regulations, adverse event records, etc. of SNA001 phase III clinical trial scheme. Participating experts, scholars, and guests strongly agreed with the experimental scheme, and also shared insights and raised questions about some details. Prof. Jian Tan, Prof. Hongcheng Shi and Dr. Xiaoxia Zhang, Director of clinical department of SmartNuclide, provided professional, detailed and convincing answers to questions.

After a short tea break, Professor Anren Kuang from the West China Hospital of Sichuan University gave a keynote speech on “The Latest Progress of Radioactive Iodine Therapy for Thyroid Cancer”, using solid theory and detailed data to describe the broad development of radioactive iodine therapy for thyroid cancer, making the guests have full confidence in the future of radioiodine therapy for thyroid cancer. Professor Wensheng Huang from Taiwan Rongmin general hospital gave a wonderful speech on the application of recombinant human thyrotropin in Asian people, which broadened the thinking and vision of the delegates. At the end of the meeting, under the chairmanship of Professor Yaming Li, Professor Anren Kuang, Professor Wensheng Huang, Professor Jian Tan, Professor Yifan Zhang and Professor Quanyong Luo summarized and prospected the present and future of radioiodine therapy for thyroid cancer.

Expert opinion

Participating experts all looked forward to the development of SNA001. They believe that under the background of the increasing number of thyroid cancer patients in China, the emergence of SNA001 that has safe and effective effect fills the gap in the treatment of thyroid cancer iodine-131 in China, provides a new choice for clinical diagnosis and treatment, changes the situation of impotence and inability in clinical, benefits patients from the perspective of humanistic concerns, greatly reduces the pain of some patients who can not tolerate hypothyroidism, and fully reflects the value of drugs. Clinicians are also full of expectations for SNA001 research and development, and hope that the drug will be launched as soon as possible to benefit patients.

About phase III clinical trial of SNA001

The IND of SNA001 was approved by NMPA on October 05, 2018. Phase I / II clinical trials were completed in Zhongshan Hospital Affiliated to Fudan University. Based on its positive results, SmartNuclide conducted a phase III clinical trial to evaluate the safety and effectiveness of SNA001 in postoperative RAI remnant ablation in patients with differentiated thyroid cancer. The purpose of the trial is to evaluate the efficacy of SNA001 in the treatment of RAI remnant ablation, which is not inferior to the currently used through withdrawal of thyroid hormone therapy (THW). The experimental leader unit is Zhongshan Hospital Affiliated to Fudan University, and the main researcher is Professor Hongcheng Shi. The ethical approval of SNA001 was approved by the leader unit on 26^th November 2019.
About SNA001

SNA001 is a recombinant human thyroid stimulating hormone (rhTSH) drug. The brand-name drug Thyrogen, developed by Genzyme, can safely and quickly raise serum thyroid stimulating hormone levels in human body. It has important clinical value in the treatment of iodine 131 and follow-up inspection in differentiated thyroid cancer. The CMC part of SNA001 was developed by Alphamab Biopharma with advanced technology, and its results of preclinical and early clinical trials are all highly similar with those of brand-name drug. There are more than 200000 new cases of thyroid cancer in China every year, but there is no rhTSH drug on the market in the mainland, the market is completely blank, and there is no drug available for doctors and patients. SNA001 is expected to become the first rhTSH drug in China mainland.
About SmartNuclide

Based in Suzhou Industrial Park, SmartNuclide is a clinical-stage biopharmaceutical company focused on discovering and developing innovative biologics for nuclear medicine, with its world-leading research and development technology platform for domain antibody-radiopharmaceuticals. The company has built a broad yet unique pipeline composed of radiopharmaceuticals for both imaging and therapy and recombinant proteins for nuclear medicine.