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更新于：2026-05-20
Haisco Pharmaceutical Group Co., Ltd.
更新于：2026-05-20
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肿瘤
免疫系统疾病
其他疾病
小分子化药
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NCT07581951
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of HSK31679 in Patients With Metabolic Dysfunction Associated Steatohepatitis (MASH)
NCT07583849
A Phase III Clinical Study to Evaluate the Efficacy and Safety of HSK39004 Inhalation Powder in the Treatment of Chronic Obstructive Pulmonary Disease (COPD): a Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Design
NCT07580794
A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HSK56630 in Healthy Participants
100 项与 海思科医药集团股份有限公司 相关的临床结果
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2026-04-01Clinical Gastroenterology and Hepatology
Efficacy and Safety of HSK31679 in Asian Patients With MASLD: A Randomized Controlled Trial
Article
作者: Du, Laijing ; Zhang, Jianming ; Chen, Qincong ; Ma, Wei ; Zhu, Chuanwu ; Lv, Lingchun ; Li, Guangming ; Hao, Kunyan ; Wu, Tingting ; Wang, Le ; Ma, Genshan ; Gao, Yanhang ; Ji, Xianyou ; Xia, Bihua ; Huo, Yong ; Li, Fangqiong ; Wei, Lai ; Liu, Yang ; Chen, Hao ; Liu, Fei ; Chen, Liang ; Zhong, Bihui ; Yao, Lvfeng ; Cai, Qingxian ; Xue, Feng ; Chen, Ying ; Sheng, Jianlong ; Bu, Peili ; Pei, Zhaohui ; Yue, Wei ; Gao, Jixian ; Chen, Jinjun
BACKGROUND & AIMS:
This study evaluated the efficacy and safety of the thyroid hormone receptor β agonist HSK31679 in Asian patients with metabolic dysfunction-associated steatotic liver disease (MASLD).
METHODS:
This was a phase 2a, multicenter, randomized, double-blind, placebo-controlled study at 26 centers in China. Subjects with a liver fat content (LFC) of ≥8% at screening, when assessed by magnetic resonance imaging-proton density fat fraction, were eligible. Subjects were randomly assigned in a 1:1:1:1:1 ratio using a centralized randomization system to receive daily oral HSK31679 40 mg, HSK31679 80 mg, HSK31679 160 mg, ezetimibe 10 mg, or placebo. The primary endpoint was a relative change from baseline in LFC after 12 weeks of treatment.
RESULTS:
A total of 210 participants were randomly assigned to placebo (n = 42), HSK31679 40 mg (n = 42), HSK31679 80 mg (n = 42), HSK31679 160 mg (n = 42), or ezetimibe (n = 42). At week 12, the mean relative change from baseline in LFC was -4.1% in the placebo group, -14.0% in the 40 mg group (mean difference vs placebo -9.9% [95% confidence interval (CI), -21.5% to 1.6%]; P = .092), -22.7% in the 80 mg group (-18.6% [95% CI, -30.2% to -7.0%]; P = .002), and -29.2% in the 160 mg group (-25.2% [95% CI, -36.8% to -13.5%]; P < .001). The most common treatment-emergent adverse event was diarrhea (11 [26.2%] of patients in the 40 mg group, 13 [31.0%] in the 80 mg group, 16 [38.1%] in the 160 mg group, and 2 [4.8%] in the placebo group). No drug-related serious adverse events or grade ≥3 adverse events were reported.
CONCLUSIONS:
In Asian MASLD patients, HSK31679 was well tolerated, with significant reductions in LFC after 12 weeks of treatment with 80 mg and 160 mg.
CLINICALTRIALS:
gov, Number: NCT05795517.
2026-04-01JOURNAL OF PHARMACEUTICAL SCIENCES
A novel bicyclic peptide-drug conjugate of 3-fluoro-10-hydroxy-evodiamine for targeted colorectal cancer therapy
Article
作者: Fan, Wei ; Li, Cuiping ; Shi, Kourong ; Zhao, Siyuan ; Zhai, Qiaoli ; Wu, Xin ; Sun, Huan ; Liu, Juan ; Chu, Chang
This study aimed to develop a novel peptide-drug conjugate (PDC) by conjugating 3-fluoro-10-hydroxy-evodiamine (FOE) with a bicyclic peptide (BiP) targeting the EphA2 receptor. The goal was to enhance the solubility, tumor selectivity, and therapeutic efficacy of FOE against colorectal cancer (CRC). FOE and BiP were chemically synthesized and coupled through a valine-citrulline cleavable linker to generate BiP-FOE. The compound was structurally characterized, and its solubility, plasma stability, and in vitro cytotoxicity were evaluated in CRC cells. Its effects on cell migration, invasion, apoptosis, and the cell cycle were also assessed. The in vivo targeting ability, antitumor efficacy, and safety were evaluated in an HCT116 xenograft mouse model. BiP-FOE exhibited a greater than 200-fold improvement in aqueous solubility and good metabolic stability. In vitro, BiP-FOE showed selective and potent cytotoxicity toward EphA2-positive HCT116 cells, significantly inhibiting migration and invasion while inducing S-phase arrest and apoptosis. In vivo, BiP-FOE achieved significant accumulation at the tumor site and effectively suppressed tumor growth, with efficacy comparable to or exceeding that of 5-FU. It demonstrated a favorable safety profile, showing minimal body weight loss, negligible hemolysis, and no detectable organ toxicity. BiP-FOE successfully combines the cytotoxic potential of FOE with the tumor-targeting capacity of a bicyclic peptide, resulting in improved solubility, selectivity, efficacy, and safety. These findings highlight BiP-FOE as a promising candidate for targeted CRC therapy and warrant further preclinical development.
2026-01-01Journal of Diabetes Research
Long‐Term Safety and Efficacy of Crisugabalin for Diabetic Peripheral Neuropathic Pain: A 52‐Week, Multicenter, Single‐Arm Trial
Article
作者: Li, Fangqiong ; Zhang, Fang ; Zhang, Yawei ; Wang, Yihua ; Li, Yufeng ; Wu, Xiaohong ; Guo, Xiaohui ; Tang, Xulei ; Sun, Xin ; Hu, Honglin ; Wang, Lijun ; Li, Ya ; Ning, Tao ; Pang, Shuguang ; Liu, Jie ; Pan, Tianrong ; Sun, Jia ; Li, Yukun ; Bian, Fang ; Li, Yaming ; Liu, Weijuan ; Jiang, Chengxia ; Wang, Kailiang ; Ma, Jianhua ; Zhang, Tingting ; Huang, Qin ; Li, Ping ; Mao, Hong
Introduction:
The HSK16149‐201/301 trial demonstrated short‐term efficacy of the GABA analog crisugabalin for diabetic neuropathic pain.
Methods:
In the current study, patients in both the crisugabalin and placebo control groups of the HSK16149‐201/301 trial were invited to receive 80 mg/day crisugabalin for an additional 52 weeks. The primary end point was safety. The secondary end point was pain control as measured using the Short‐Form McGill Pain Questionnaire (SF‐MPQ). A total of 301 patients (mean age 59.7 years and males 58.1%) were enrolled.
Results:
The rate of treatment‐related adverse events (TRAEs) was 38.9% (117/301). The most frequent TRAEs were dizziness (27.2%), somnolence (8.3%), and peripheral edema (3.0%). The rate of Grade 3 or higher TRAEs was 1.7%. TRAEs led to dose reduction in 41 patients (13.6%), treatment interruption and discontinuation each in three patients (1.0%). At week 52, the mean difference in SF‐MPQ pain rating index (PRI) and visual analog scale pain score from baseline was −2.5 (95% CI −2.9 to −2.0; paired
t
‐test
p
< 0.0001) and −23.4 (95% CI −25.6 to −21.2; paired
t
‐test
p
< 0.0001), respectively. The proportion of patients with SF‐MPQ PPI score ≤ 1 increased by 19.0% over baseline (
p
< 0.0001).
Conclusions:
In summary, crisugabalin at 80 mg/day was well tolerated and demonstrated sustained analgesic activities.
Trial Registration:
ClinicalTrials.gov identifier: NCT05890053
2026-05-19
100 项与 海思科医药集团股份有限公司 相关的药物交易
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100 项与 海思科医药集团股份有限公司 相关的转化医学
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