Top 5 Target	Count

TNF-α(Tumor necrosis factor α)	2
HER2(Receptor tyrosine-protein kinase erbB-2)	2
LTα x TNF-α	1
Trop-2(Tumor-associated calcium signal transducer 2)	1
PDL1 x TGF-β2	1

Drugs associated with Hisun Bio Pharmaceutical Co., Ltd.

BR-102

Target

PDL1 x TGF-β2

Mechanism

PDL1 inhibitors [+1]

Active Org.

Zhejiang University [+1]

Originator Org.

Hisun Bio Pharmaceutical Co., Ltd. [+1]

Active Indication

Neoplasms

Inactive Indication

Advanced cancer [+1]

Drug Highest PhaseDiscovery

First Approval Ctry. / Loc.-

First Approval Date-

CN115057934

Patent Mining

Target

Trop-2

Mechanism-

Active Org.

BioRay Biopharmaceutical Co., Ltd. [+1]

Originator Org.

Hisun Bio Pharmaceutical Co., Ltd. [+1]

Active Indication

Neoplasms

Inactive Indication-

Drug Highest PhaseDiscovery

First Approval Ctry. / Loc.-

First Approval Date-

Tocilizumab biosimilar (Zhejiang Hisun)

Target

IL-6RA

Mechanism

IL-6RA antagonists

Active Org.

Hisun Bio Pharmaceutical Co., Ltd.

Originator Org.

Zhejiang Hisun Pharmaceutical Co., Ltd.

Active Indication

Cytokine Release Syndrome [+2]

Inactive Indication-

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date25 Jun 2024

Clinical Trials associated with Hisun Bio Pharmaceutical Co., Ltd.

CTR20230791 / TerminatedPhase 1

BR108注射液在血液系统恶性肿瘤的安全性、耐受性、药代动力学、免疫原性和有效性的I期单臂、开放临床研究

[Translation] A Phase I single-arm, open-label clinical study of the safety, tolerability, pharmacokinetics, immunogenicity and efficacy of BR108 injection in hematological malignancies

Ia期：评价BR108注射液治疗CD70阳性复发/难治的血液系统恶性肿瘤患者的安全性和耐受性，并确定最大耐受剂量（MTD）和II期推荐剂量（RP2D）。 Ib期：评价推荐剂量的BR108在CD70阳性的不同肿瘤的有效性。次要目的： 1.评价BR108注射液在CD70阳性血液系统恶性肿瘤受试者中的抗肿瘤活性。 2.评估BR108注射液在CD70阳性血液系统恶性肿瘤受试者中的安全性（不适用Ia期）。 3.评估BR108注射液在CD70阳性血液系统恶性肿瘤受试者中的药代动力学（PK）特征。 4.评估BR108注射液在CD70阳性血液系统恶性肿瘤受试者中的免疫原性。探索性目的： 1. 评价患者血清中sCD27的水平与临床疗效的相关性。 2. 评价CD70状态与临床疗效的相关性。 3. 评价T、B、NK和Treg细胞水平变化情况。（仅在Ib期开展） 4. 如数据允许，评价BR108注射液在CD70阳性血液系统恶性肿瘤患者中暴露量与疗效和不良事件的关系。 5. 如数据允许，基于群体药代动力学（PopPK）分析方法，探索BR108注射液在CD70阳性血液系统恶性肿瘤受试者中的PK特征

[Translation]

Phase Ia: To evaluate the safety and tolerability of BR108 injection in patients with CD70-positive relapsed/refractory hematological malignancies, and to determine the maximum tolerated dose (MTD) and Phase II recommended dose (RP2D). Phase Ib: To evaluate the effectiveness of the recommended dose of BR108 in different CD70-positive tumors. Secondary objectives: 1. To evaluate the anti-tumor activity of BR108 injection in subjects with CD70-positive hematological malignancies. 2. To evaluate the safety of BR108 injection in subjects with CD70-positive hematological malignancies (not applicable to Phase Ia). 3. To evaluate the pharmacokinetic (PK) characteristics of BR108 injection in subjects with CD70-positive hematological malignancies. 4. To evaluate the immunogenicity of BR108 injection in subjects with CD70-positive hematological malignancies. Exploratory objectives: 1. To evaluate the correlation between the level of sCD27 in patient serum and clinical efficacy. 2. To evaluate the correlation between CD70 status and clinical efficacy. 3. To evaluate the changes in the levels of T, B, NK and Treg cells. (Only in Phase Ib) 4. If data permit, evaluate the relationship between exposure, efficacy and adverse events of BR108 injection in patients with CD70-positive hematological malignancies. 5. If data permit, explore the PK characteristics of BR108 injection in subjects with CD70-positive hematological malignancies based on population pharmacokinetic (PopPK) analysis.

Start Date14 Jun 2023

Sponsor / Collaborator

Hisun Bio Pharmaceutical Co., Ltd.

[+1]

CTR20212300 / TerminatedPhase 1

评价BR102注射液在晚期恶性肿瘤受试者中的安全性、耐受性、抗肿瘤活性的开放、剂量递增及队列扩展的I 期临床试验

[Translation] Phase I clinical trial to evaluate the safety, tolerability, and anti-tumor activity of BR102 injection in subjects with advanced malignant tumors

主要目的： Ia期：评价BR102单药治疗（单次/多次给药）在晚期恶性肿瘤受试者中的安全性和耐受性探索最大耐受剂量 Ib期：初步探索BR102单药治疗在晚期HPV阳性肿瘤、晚期胆管癌受试者中的抗肿瘤活性探索推荐II期临床研究的使用剂量次要目的： Ia期：评价BR102单药治疗（单次/多次给药）在晚期恶性肿瘤受试者中的药代动力学特征及免疫原性初步评估BR102抗肿瘤活性 Ib期：进一步评估BR102在晚期HPV阳性肿瘤、晚期胆管癌受试者中的有效性进一步评价BR102安全性进一步评价BR102的药代动力学特征、免疫原性探索性目的：检测BR102给药后血清TGFβ1、β2、β3浓度，如条件允许，初步探索PD-L1表达、血清TGF-β抑制与BR102疗效之间的关系，BR102的暴露量与疗效及不良事件（AE）的关系

[Translation]

Primary objectives: Phase Ia: Evaluate the safety and tolerability of BR102 monotherapy (single/multiple administration) in subjects with advanced malignant tumors Explore the maximum tolerated dose Phase Ib: Preliminary exploration of the anti-tumor activity of BR102 monotherapy in subjects with advanced HPV-positive tumors and advanced cholangiocarcinoma Explore the recommended dose for Phase II clinical studies Secondary objectives: Phase Ia: Evaluate the pharmacokinetic characteristics and immunogenicity of BR102 monotherapy (single/multiple administration) in subjects with advanced malignant tumors Preliminary evaluation of BR102 anti-tumor activity Phase Ib: Further evaluate the effectiveness of BR102 in subjects with advanced HPV-positive tumors and advanced cholangiocarcinoma Further evaluate the safety of BR102 Further evaluate the pharmacokinetic characteristics and immunogenicity of BR102 Exploratory objectives: Detect serum TGFβ1, β2, and β3 concentrations after BR102 administration. If conditions permit, preliminarily explore the relationship between PD-L1 expression, serum TGF-β inhibition and BR102 efficacy, and the relationship between BR102 exposure and efficacy and adverse events (AEs)

Start Date06 Jan 2022

Sponsor / Collaborator

Hisun Bio Pharmaceutical Co., Ltd.

[+1]

CTR20211828 / CompletedPhase 1

评估BR101注射液在晚期实体瘤患者中单药治疗的安全性、耐受性、药代动力学、免疫原性、抗肿瘤活性的开放、剂量递增和剂量扩展I期临床研究

[Translation] An open-label, dose-escalation, and dose-expansion Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of BR101 injection as a monotherapy in patients with advanced solid tumors

Ⅰa期部分：评价BR101注射液单药（单次给药和多次给药）在晚期实体瘤受试者中的安全性和耐受性，确定最大耐受剂量（MTD）。 Ⅰb期部分：初步探索BR101单药治疗在晚期三阴性乳腺癌及晚期胰腺癌患者中的有效性，确定II期临床试验推荐剂量（RP2D）。

[Translation]

Phase Ia: Evaluate the safety and tolerability of BR101 injection (single and multiple administrations) in subjects with advanced solid tumors and determine the maximum tolerated dose (MTD). Phase Ib: Preliminary exploration of the effectiveness of BR101 monotherapy in patients with advanced triple-negative breast cancer and advanced pancreatic cancer, and determine the recommended dose (RP2D) for Phase II clinical trials.

Start Date10 Sep 2021

Sponsor / Collaborator

Hisun Bio Pharmaceutical Co., Ltd.

[+1]

100 Clinical Results associated with Hisun Bio Pharmaceutical Co., Ltd.

0 Patents (Medical) associated with Hisun Bio Pharmaceutical Co., Ltd.

Literatures (Medical) associated with Hisun Bio Pharmaceutical Co., Ltd.

01 Feb 2024·Biotechnology Journal

Exploring metabolic responses and pathway changes in CHO‐K1 cells under varied aeration conditions and copper supplementations using ¹H NMR‐based metabolomics

Article

Author: Xie, Xinyuan ; Pan, Jianyang ; Yang, Jiayu ; Wan, Yuxiang ; Shi, Yingting ; Wang, Haibin ; Lu, Yuting ; Qu, Haibin ; Sun, Yan

AbstractThe optimization of bioprocess for CHO cell culture involves careful consideration of factors such as nutrient consumption, metabolic byproduct accumulation, cell growth, and monoclonal antibody (mAb) production. Valuable insights can be obtained by understanding cellular physiology to ensure robust and efficient bioprocess. This study aims to improve our understanding of the CHO‐K1 cell metabolism using 1H NMR‐based metabolomics. Initially, the variations in culture performance and metabolic profiles under varied aeration conditions and copper supplementations were thoroughly examined. Furthermore, a comprehensive metabolic pathway analysis was performed to assess the impact of these conditions on the implicated pathways. The results revealed substantial alterations in the pyruvate metabolism, histidine metabolism, as well as phenylalanine, tyrosine and tryptophan biosynthesis, which were especially evident in cultures subjected to copper deficiency conditions. Conclusively, significant metabolites governing cell growth and mAb titer were identified through orthogonal partial least square‐discriminant analysis (OPLS‐DA). Metabolites, including glycerol, alanine, formate, glutamate, phenylalanine, and valine, exhibited strong associations with distinct cell growth phases. Additionally, glycerol, acetate, lactate, formate, glycine, histidine, and aspartate emerged as metabolites influencing cell productivity. This study demonstrates the potential of employing 1H NMR‐based metabolomics technology in bioprocess research. It provides valuable guidance for feed medium development, feeding strategy design, bioprocess parameter adjustments, and ultimately the enhancement of cell proliferation and mAb yield.

01 Jul 2023·Biotechnology journal

¹ H NMR-based process understanding and biochemical marker identification methodology for monitoring CHO cell culture process during commercial-scale manufacturing.

Article

Author: Pan, Jianyang ; Shi, Yingting ; Wan, Yuxiang ; Chen, Zhenhua ; Sun, Yan ; Jiao, Jingyu ; Qu, Haibin ; Zhao, Fang ; Gao, Dong ; Nie, Lei ; Wang, Haibin ; Yang, Jiayu

Controlling the process of CHO cell fed-batch culture is critical for biologics quality control. However, the biological complexity of cells has hampered the reliable process understanding for industrial manufacturing. In this study, a workflow was developed for the consistency monitoring and biochemical marker identification of the commercial-scale CHO cell culture process through ¹ H NMR assisted with multivariate data analysis (MVDA). Firstly, a total of 63 metabolites were identified in this study object in ¹ H NMR spectra of the CHO cell-free supernatants. Secondly, multivariate statistical process control (MSPC) charts were used to evaluate process consistency. According to MSPC charts, the batch-to-batch quality consistency was high, indicating the CHO cell culture process at the commercial scale was well-controlled and stable. Then, the biochemical marker identification was provided through orthogonal partial least square discriminant analysis (OPLS-DA) based S-line plots during the cell logarithmic expansion, stable growth, and decline phases. Identified biochemical markers of the three cell growth phases were as follows: L-glutamine, pyroglutamic acid, 4-hydroxyproline, choline, glucose, lactate, alanine, and proline were of the logarithmic growth phase; isoleucine, leucine, valine, acetate, and alanine were of the stable growth phase; acetate, glycine, glycerin, and gluconic acid were of the cell decline phase. Additional potential metabolic pathways that might influence the cell culture phase transitions were demonstrated. The workflow proposed in this study demonstrates that the combination of MVDA tools and ¹ H NMR technology is highly appealing to the research of the biomanufacturing process, and applies well to provide guidance in future work on consistency evaluation and biochemical marker monitoring of the production of other biologics.

01 Apr 2022·Journal of Pharmaceutical SciencesQ3 · MEDICINE

Physicochemical and Functional Characterization of HS016, a Biosimilar of Adalimumab (Humira)

Q3 · MEDICINE

Article

Author: Wu, Zhenhua ; Wang, Haibin ; Hu, Feng ; Lin, Qunhai ; Nie, Lei ; Yuan, Junjie ; Gao, Dong

The characterization of a biosimilar drug HS016, the reference product adalimumab (Humira), and their biosimilarities were determined using physical chemistry and functional similarity tests. The primary and higher order structures, size and charge variants, glycosylation profiles, and in vitro potency of both antibodies were characterized both for unstressed and stability samples. Slight differences were observed in the relative levels of methionine oxidation, low molecular weight components, terminal lysine variant, high mannoses and galactosylated glycans between HS016 and Humira. However, no differences in antigen binding activity, Fc receptor affinity, antibody-dependent cell-mediated cytotoxicity or complemented-dependent cytotoxicity were found. The primary and higher order structures, physicochemical properties, and biological activity of HS016 and adalimumab were similar.

100 Deals associated with Hisun Bio Pharmaceutical Co., Ltd.

100 Translational Medicine associated with Hisun Bio Pharmaceutical Co., Ltd.

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Pipeline

Pipeline Snapshot as of 24 Dec 2024

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

NDA/BLA

Approved

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Adalimumab biosimilar(Hisun Pharmaceutical) ( TNF-α )	Rheumatoid Arthritis More	Approved
Etanercept biosimilar (Hisun Bio Pharmaceutical Co., Ltd.) ( LTα x TNF-α )	Ankylosing Spondylitis More	Approved
Infliximab Biosimilar(Hisun Bio Pharmaceutical Co., Ltd.) ( TNF-α )	Pediatric Crohn's Disease More	Approved
Trastuzumab biosimilar (Hisun Pharma) ( HER2 )	HER2 Positive Breast Cancer More	Approved
Tocilizumab biosimilar (Zhejiang Hisun) ( IL-6RA )	Cytokine Release Syndrome More	Approved

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