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Shijiazhuang Sihua Pharmaceutical Group Continues to Advance Innovative Drug R&D; Clinical Trial Progress of SYN045 Tablets Meets Expectations
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发布时间：2025-07-09
【概要描述】
Clinical trials of SYN045 tablets, a Class 1 new chemical entity independently developed by Shijiazhuang Sihua Pharmaceutical Group—specifically the single-dose studies at 50 mg and 100 mg, as well as the multiple-dose study at 25 mg—have recently been completed with smooth progress. This milestone indicates that the clinical trial for this innovative drug targeting pulmonary arterial hypertension is on track and meeting expectations.
Clinical trials of SYN045 tablets, a Class 1 innovative chemical drug independently developed by Shijiazhuang Sihua Pharmaceutical Group—specifically the single-dose studies at 50 mg and 100 mg, as well as the multiple-dose study at 25 mg—have recently been completed smoothly. This milestone indicates that the clinical development of this novel therapy for pulmonary arterial hypertension is on track and meeting expectations.
Pulmonary arterial hypertension is a malignant pulmonary vascular disease that can lead to severe complications, including right ventricular failure. In May 2018, the National Health Commission and four other departments jointly issued the “First Batch of Rare Disease Catalog,” which included the most typical form of pulmonary arterial hypertension—idiopathic pulmonary arterial hypertension. On January 26, 2024, SYN045 received the Clinical Trial Approval Notice from the National Medical Products Administration.
Clinical trial studies have demonstrated that SYN045 tablets exhibit favorable pharmacokinetic profiles in humans and demonstrate significantly improved safety and tolerability compared with other drugs targeting the same biological pathway, thereby facilitating long-term oral administration. To date, a total of 18 patent applications have been filed for the SYN045 program, including 5 international patents (for which PCT applications have been submitted) and 13 domestic patents, of which 5 related to the compound, crystal forms, and formulations have already been granted.
According to reports, based on the final results of the Phase 1 clinical trial of SYN045, the Group is planning to initiate a Phase 2 clinical trial to establish the dose–response relationship in humans and to evaluate the efficacy and safety in patients.
Meanwhile, the Group is actively integrating high-quality innovation resources to advance the research and development of innovative drugs, with a focus on unmet major disease areas such as oncology, neurological disorders, autoimmune diseases, and metabolic diseases, thereby accelerating the strategic positioning and development of its product pipeline. The Group’s independently developed Class 1 innovative anti-epileptic drug program targets the potassium ion channel KCNQ2/3; compound screening is currently underway, with toxicity evaluation slated for subsequent execution. Another Class 1 innovative anti-diabetic drug program targeting peripheral neuropathic pain focuses on adaptor-associated kinase 1 (AAK1); compound screening is also in progress at this stage.
In addition, the Group is currently conducting research on three improved formulations of new drugs, two of which have already completed pharmacokinetic-based formulation studies, while the third is scheduled to submit an Investigational New Drug (IND) application within this year.
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Non-Commercial (Filing) – 2025-0091