On March 17, 2025, the kick-off meeting of two Phase II clinical trial projects of Beijing Scitech-MQ Pharmaceuticals Limited (Scitech Pharma) was held at Nanjing Tianyinshan Hospital affiliated with China Pharmaceutical University. The meeting was hosted by Director Chen Yingxia of the Clinical Trial Organization Office of the hospital, Professor Qin Shukui, President of the hospital, relevant medical and nursing staff of the clinical study, and the research and development team of Scitech Pharma attended the meeting.
Two clinical trials were initiated at Tianyinshan Hospital, namely, “A Phase Ib/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Initial Antitumor Activity of ST-1898 Tablets in Patients with Inoperable Resectable or Metastatic Melanoma” and “A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II/III Clinical Trial to Evaluate the Effectiveness and Safety of ST-1898 tablets as a multicenter, randomized, double-blind, placebo-controlled Phase II/III clinical trial to evaluate the efficacy and safety of ST-1898 tablets in the treatment of locally advanced or metastatic radioiodine-refractory differentiated thyroid cancer that has failed at least one line of TKI-based systemic therapy”.
Among them, the clinical trial for the melanoma indication, led by Professor Guo Jun of Beijing Cancer Hospital, has been initiated as the first center in October 2023, and three sub-centers are currently involved in the study. With preliminary data suggesting that it has demonstrated excellent anti-tumor activity and safety for patients with national acromegaly melanoma subtypes. The clinical trial for the thyroid cancer indication is led by Professor Lin Yansong of Peking Union Medical College Hospital and has been initiated in November 2023 as the first center, and five sub-centers are currently involved in the study. In patients with radioiodine-refractory differentiated thyroid cancer who have failed first-line and above treatments, enrolled subjects have shown shrinkage of the target lesion from baseline and a favorable safety profile.
At the kick-off meeting, Dr. Qiang Zhang, President and Chief Scientific Officer of Scitech Pharma, briefly introduced the history of ST-1898 tablets which was developed by the company through its large-scale drug design and drug screening AI platform, reviewed and summarized the results of the preliminary clinical research, and expressed full confidence in the prospects of the subsequent clinical research.
Professor Qin Shukui said, ST-1898 is the first multi-target small molecule drug designed by Scitech Pharma using AI platform, and he affirmed the data of preclinical study and early clinical trial of this drug; for the follow-up clinical trial work, he emphasized that it would be implemented carefully in strict accordance with the research plan and protocol, and pay attention to the observation and recording of the effectiveness and adverse reactions; he also commented on the relevant issues of the clinical protocol and gave professional guidance. At the meeting, Director Zhang Yu, the PI of this trial sub-center, expressed her support and determination on behalf of the clinical research team of Tianyinshan Hospital.
About ST-1898
ST-1898 Tablet is a small molecule multi-target tyrosine kinase inhibitor independently developed by Scitech Pharma through SigmaHit® platform with global intellectual property rights and interests, capable of inhibiting c-MET, VEGFR-2, PDGFRa, RET, c-KIT, TRK-A, TRK-B, AXL and other targets, and was approved by the National Drug Administration (NMPA) in July 2020 to conduct clinical trials. The trial drug highly inhibits targets related to tumorigenesis, development and metastasis through targeted design against multiple targets, inhibits multiple signaling pathways, directly and indirectly inhibits tumor cell growth and migration, promotes apoptosis, and inhibits tumor growth and metastasis through combined action and synergistic mechanisms.
Currently, a total of three indications of ST-1898 have entered into clinical trial phase II, namely thyroid cancer, renal cancer and melanoma. The expansion of Tianyinshan Hospital as a research sub-center is expected to accelerate the progress of clinical trials and accumulate sufficient safety and efficacy data for the subsequent conduct of pivotal clinical trials.
Scitech Pharma