[Translation] A multicenter, randomized, single-blind, positive parallel controlled clinical study to evaluate the efficacy and safety of mitoxantrone hydrochloride injection for lymph node tracing in patients undergoing radical gastrectomy for gastric cancer

评估示踪用盐酸米托蒽醌注射液对比纳米炭混悬注射液对胃癌手术患者淋巴示踪的有效性和安全性。

[Translation]

To evaluate the effectiveness and safety of mitoxantrone hydrochloride injection versus carbon nanoparticle suspension injection in lymph node tracing in patients undergoing gastric cancer surgery.

Start Date05 Jul 2023

Sponsor / Collaborator

Shenyang Xintager Pharmaceutical Technology Development Co., Ltd.

[+2]

CTR20201906

/ CompletedPhase 1/2

一项评价淋巴示踪用盐酸米托蒽醌注射液用于胃癌患者淋巴示踪的单盲、单中心、安全性、耐受性、药代动力学特征及初步疗效的剂量递增和剂量扩展的I期/IIa 期临床试验研究

[Translation] A single-blind, single-center, dose-escalation and dose-expansion clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of mitoxantrone hydrochloride injection for lymphatic tracing in patients with gastric cancer.

本试验的目的是探索淋巴示踪用盐酸米托蒽醌注射液对胃癌患者淋巴示踪的有效性、安全性和耐受性并确定试验用药物最优使用剂量范围，同时探索淋巴示踪用盐酸米托蒽醌注射液对胃癌患者的药代动力学特征，为III 期临床试验的用药剂量及评价指标提供合理依据。

[Translation]

The purpose of this trial is to explore the effectiveness, safety and tolerability of mitoxantrone hydrochloride injection for lymphatic tracing in patients with gastric cancer and determine the optimal dosage range of the trial drug. At the same time, it is to explore the pharmacokinetic characteristics of mitoxantrone hydrochloride injection for lymphatic tracing in patients with gastric cancer, and to provide a reasonable basis for the dosage and evaluation indicators of the Phase III clinical trial.

Start Date01 Sep 2020

Sponsor / Collaborator

Shenyang Xintager Pharmaceutical Technology Development Co., Ltd.

[+2]

CTR20200992

/ CompletedPhase 1

盐酸小檗碱缓释胶囊在健康受试者中单次、多次给药及食物影响的安全性、耐受性及药代动力学的Ⅰ期临床研究

[Translation] Phase I clinical study on the safety, tolerability and pharmacokinetics of berberine hydrochloride sustained-release capsules in healthy subjects after single and repeated administration and food effects

评价盐酸小檗碱缓释胶囊在健康受试者中单次、多次给药的安全性、耐受性，确定最大耐受剂量，剂量限制性毒性，确定Ⅱ期临床推荐剂量。观察空腹和进食状态下健康受试者单次口服盐酸小檗碱缓释胶囊药代动力学的差异。评价盐酸小檗碱缓释胶囊在健康受试者中单次、多次给药的药代动力学特征及临床应用的安全性。

[Translation]

To evaluate the safety and tolerability of berberine hydrochloride sustained-release capsules in healthy subjects after single and multiple administrations, determine the maximum tolerated dose, dose-limiting toxicity, and determine the recommended dose for Phase II clinical trials. To observe the differences in the pharmacokinetics of berberine hydrochloride sustained-release capsules in healthy subjects after a single oral administration between fasting and feeding. To evaluate the pharmacokinetic characteristics of berberine hydrochloride sustained-release capsules in healthy subjects after single and multiple administrations and the safety of clinical application.

Start Date27 May 2020

Sponsor / Collaborator

Northeast Pharmaceutical Group Co., Ltd.

[+3]

100 Clinical Results associated with Shenyang Pharmaceutical University

0 Patents (Medical) associated with Shenyang Pharmaceutical University

8,399

Literatures (Medical) associated with Shenyang Pharmaceutical University

01 Mar 2027·Bioactive Materials

Janus-structured piezoelectric membrane couples barrier protection with pathological microenvironment-responsive bioactivity for periodontal bone regeneration

Article

Author: Wen, Xiaozhou ; Xiao, Meng ; Du, Xinhong ; Wang, Lin ; Qu, Zhipeng ; Ouyang, Han ; Wang, Engui ; Chen, Changxu ; Li, Jiaxuan ; Sun, Jianfeng ; Yao, Shuncheng ; Li, Zhou ; Fang, Kun ; Miao, Wei ; Cui, Xi

Periodontal bone regeneration remains challenging due to the persistent infection-inflammation-bone resorption cycle and the rapid invasion of epithelial and gingival connective tissues into defect sites. Here, we developed a biodegradable Janus membrane (J-PLLA-ZnO) based on poly(L-lactic acid) (PLLA) that spatially integrates barrier protection and pH-responsive bioactivity within a single construct. A dense PLLA layer facing soft tissues prevents premature tissue infiltration and maintains regenerative space, while a porous defect-facing interface functionalized with ZnO nanowires provides bioactive regulation. The ZnO nanowires enhance the overall piezoelectric response of the membrane and enable pH-responsive Zn²⁺ release under the acidic periodontal microenvironment, thereby delivering antibacterial, immunomodulatory, and osteogenic cues. In a rat periodontitis model, J-PLLA-ZnO rapidly suppressed infection-associated inflammation. One week after implantation, peripheral neutrophil percentage decreased to approximately 21% of those in the J-PLLA group, accompanied by reduced tumor necrosis factor-α expression and increased cluster of differentiation 206 expression, consistent with a shift toward a reparative macrophage phenotype. At week 6, J-PLLA-ZnO increased the osteocalcin-positive bone-forming area by approximately 1.5-fold compared with non-Janus PLLA-ZnO, indicating improved periodontal bone regeneration. Moreover, the cementoenamel junction-alveolar bone crest distance was reduced by approximately 40% relative to untreated controls. Meanwhile, the membrane underwent gradual biodegradation throughout the healing process. These findings demonstrate that integrating spatial barrier function with pH-responsive bioactivity represents a promising strategy for guided tissue regeneration in inflammatory periodontal defects.

01 Feb 2027·BIOMATERIALS

Oligomerized flavonoid nanointerfaces regulate gastrointestinal nutrient flux and metabolic inflammation

Article

Author: Wang, Yongjun ; Zhang, Rui ; Zhao, Yan ; Li, Li ; Li, Huiting ; Zhou, Tengfei ; Liu, Hongzhuo ; Yu, Jiang

Oral strategies for obesity and its associated metabolic dysfunction rarely coordinate nutrient digestion, microbial ecology, barrier integrity and low-grade inflammation within the gastrointestinal lumen. Here we report an interface-engineering strategy that converts flavonoid monomers into oligomerized flavonoid-derived polyphenolic nanointerfaces for local gastrointestinal regulation. Five representative flavonoids were oligomerized through an acetaldehyde-mediated reaction and assembled into carrier-free nanoparticles with clustered surface phenolic motifs. Among them, oligomeric EGCG nanoparticles (O-EGCG NPs) showed the strongest interfacial activity, outperforming monomeric EGCG and non-assembled oligomers. Mechanistic analyses showed that O-EGCG NPs non-competitively modulated α-glucosidase, α-amylase, pancreatic lipase and pancreatic cholesterol esterase through enzyme binding and conformational remodeling. After oral administration, the nanoparticles maintained gastrointestinal colloidal stability, prolonged intestinal retention and reduced postprandial carbohydrate and lipid flux in substrate and mixed-meal tolerance tests. Repeated administration in high-fat diet-fed mice attenuated body-weight gain, hepatic lipid accumulation, dyslipidaemia and insulin resistance, accompanied by changes in intestinal barrier status, inflammatory cytokines and gut microbiota composition. These findings establish oligomerized flavonoid nanoparticles as locally acting luminal nanomaterials for regulating nutrient processing and microbiota-associated metabolic inflammation.

01 Feb 2027·EXPERIMENTAL NEUROLOGY

MR-409 promotes neurogenesis and improves neurological function after cerebral ischemia through attenuation of microglial activation

Article

Author: Cao, Xin ; Zhou, Ming-Sheng ; Li, Yayi ; Liu, Wen ; Fu, Xinyi ; Fu, Rong ; Zhang, Yuliang ; Ding, Ding ; Che, Xiaohang ; Wang, Tingting ; Liu, Yueyang

Neurological recovery during the chronic phase of ischemic stroke (IS) remains a major clinical challenge. Our previous studies showed that the growth hormone-releasing hormone analogue (GHRH-A) MR-409 promotes neurogenesis and improves neurological outcomes. However, the underlying mechanisms remain unclear. Here, a transient middle cerebral artery occlusion (tMCAO) mouse model was used to investigate whether early modulation of microglial activation mediates these effects. MR-409 (2.5, 5, or 10 μg, s.c.) was administered immediately after tMCAO and daily for 3, 7, 14, or 28 days depending on the experimental design. The GHRH receptor antagonist MIA-602 and the microglial inhibitor minocycline (MINO) were used to assess mechanism involvement. We found that MR-409 (10 μg, s.c.) significantly reduced infarct volume and brain edema and improved function and cerebral blood flow at 3 days. It suppressed hippocampal microglial activation and promoted M2 polarization at 3-7 days, decreasing TNF-α, IL-1β, and IL-6 while increasing CD206, Arg-1, and YM1/2, which were reversed by MIA-602. MR-409 enhanced hippocampal neurogenesis, increasing Nestin⁺, Tbr2⁺, and DCX⁺ cells at 7-14 days and newborn neuron survival at 28 days. These effects were enhanced by MINO but abolished by MIA-602. Functionally, MR-409 or MINO improved motor performance at 7 days, whereas only MR-409 improved both motor and cognitive function at 28 days. These findings indicate that MR-409 promotes long-term neurological recovery by attenuating acute microglial activation, improving the post-ischemic microenvironment, and enhancing hippocampal neurogenesis, highlighting its therapeutic potential for IS.

News (Medical) associated with Shenyang Pharmaceutical University

08 Jul 2011

·huyabio.com

HUYA Bioscience International Engages In Partnership With Liaoning (Benxi) Bio-Pharmaceutical Industry Base

San Diego, CA, USA – July 8, 2011 — HUYA Bioscience International, a leader in globalizing China’s biopharmaceutical innovations, today announced a strategic partnership with the Liaoning (Benxi) Bio-Pharmaceutical Industry Base. The collaboration agreement will combine both parties’ strength in aiding the advancement of China’s drug innovation platform. HUYA is one of the first companies to have recognized China’s potential to help meet the global need for new preclinical and clinical stage compounds. The company is committed to facilitating and promoting the global development and commercialization of novel pharmaceutical products originating in China. HUYA has established a series of collaborations with leading universities and research institutions throughout China and has pioneered in-licensing clinical stage compounds from the country, utilizing its expertise to advance these compounds for global markets. Liaoning (Benxi) Bio-pharmaceutical Industry Base is the third national biomedical industry base approved by the National Ministry of Science and Technology. Located between Benxi and Shenyang, Liaoning (Benxi) Bio-pharmaceutical Industry Base is now the northeast pharmaceutical center and has attracted both domestic and foreign pharmaceutical companies and research institutions to assemble at this base, including Shenyang Pharmaceutical University, Liaoning Analytical Science Research Institute, and Liaoning TCM Research Institute. Under the agreement, Liaoning (Benxi) Bio-pharmaceutical Industry Base and HUYA will collaborate to promote new drug development. HUYA will have the first opportunity to provide assistance in evaluating research and development projects conducted by pharmaceutical enterprises residing in Liaoning (Benxi) Bio-pharmaceutical Industry Base. HUYA will also be able to globalize select programs from Liaoning (Benxi) Bio-pharmaceutical Industry Base through HUYA’s innovative co-development model and worldwide pharmaceutical partners. “It’s a great honor to form partnership with Liaoning (Benxi) Bio-pharmaceutical Industry Base,” said Clement Gingras, HUYA’s CTO and COO, China. “Together, we will help promote the acceleration and development of China’s emerging bio-pharmaceutical industry.” Xiaofan Zhang, Vice Director of Liaoning (Benxi) Bio-pharmaceutical Industry Base, commented, “Liaoning (Benxi) Bio-pharmaceutical Industry is committed to becoming the ‘pharmaceutical valley’ in northern China; with HUYA’s knowledge and capacity in international drug development, Liaoning (Benxi) Bio-pharmaceutical Industry Base hopes to solidify its position as a leading medical and pharmaceutical base in China.” About HUYA Bioscience International HUYA is the leader in global pharmaceutical co-development with Chinese partners. With seven offices strategically located in China, the most comprehensive Chinese compound portfolio, and a rapidly growing number of exclusive agreements with premier Chinese research and development organizations, HUYA is uniquely positioned to identify and license novel Chinese compounds. HUYA offers Western pharmaceutical companies efficient access to innovative therapeutic opportunities and helps to reduce deal-making complexity in China. The company has become a champion of guiding China’s biomedical innovations to the worldwide marketplace. HUYA has joint headquarter offices in San Diego, CA, USA and Shanghai, China. Additional information about the company is available at www.huyabio.com. About Liaoning (Benxi) Bio-Pharmaceutical Industry Base Liaoning (Benxi) Bio-pharmaceutical Industry Base is situated in between Benxi and the Liaoning provincial capital, Shenyang. It spans an area of 205 square km. Up to date, 264 enterprises have invested a total of 73.9 billion RMB ($11.4 billion) in the pharmaceutical base, with accumulated production capacity of 98 billion RMB ($15.1 billion). In 2010, with the approval from Ministry of Science and Technology, Liaoning (Benxi) Bio-pharmaceutical Industry Base formally became a national-level high-tech industry base. For more information, please visit www.benxi.gov.cn. Contact USA: Yung-Chih Wang, Ph.D., MBA Vice President, Corporate Development China HUYA Bioscience International +1.858.798.8800 ywang@huyabio.com China: Qing (Vicky) Xia, MS, MBA Senior Business Development Manager HUYA Bioscience International +86.21.51323312 vxia@huyabio.com

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100 Deals associated with Shenyang Pharmaceutical University

100 Translational Medicine associated with Shenyang Pharmaceutical University

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Pipeline

Pipeline Snapshot as of 06 Nov 2026

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Discovery

227

Preclinical

Phase 1

Phase 2

Phase 3

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Tongshuan Jiuxin Tablets	Angina, Stable More	Phase 3
Imidol Hydrochloride	Hepatitis B, Chronic More	Phase 2
Mitoxantrone Hydrochloride ( DNA x Top II )	Adenocarcinoma of large intestine More	Phase 1
Demethylcantharidin	Liver Cancer More	Phase 1
Larotaxel Dihydrate ( Tubulin )	Advanced Malignant Solid Neoplasm More	Phase 1

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