Top 5 Target	Count

HER2(Receptor tyrosine-protein kinase erbB-2)	3
IFNAR(Interferon alpha/beta receptor)	2
GHR(Growth hormone receptor)	2
4-1BB x HER2	1
FGFR2(Fibroblast growth factor receptor 2)	1

Drugs associated with Anhui Anke Biotechnology (Group) Co., Ltd.

Kangfu Tincture

Target-

Mechanism-

Active Org.

Anhui Anke Yuliangqing Pharmaceutical Co., Ltd.

Originator Org.

Anhui Anke Yuliangqing Pharmaceutical Co., Ltd.

Active Indication

Eczema [+1]

Inactive Indication-

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date25 May 2020

Recombinant human interferon alpha-1b(Beijing Tri-Prime Gene Pharmaceutical Co Ltd)

Target

IFNAR-1

Mechanism

IFNAR-1 stimulants

Active Org.

Beijing Tri-Prime Gene Pharmaceutical Co. Ltd.

Originator Org.

Beijing Tri-Prime Gene Pharmaceutical Co. Ltd.

Active Indication

Neoplasms [+3]

Inactive Indication

Pneumonia due to respiratory syncytial virus

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date01 Jan 1999

PEGylated recombinant somatropin(Anhui Anke Biotechnology (Group) Co., Ltd.)

Target

GHR

Mechanism

GHR agonists

Active Org.

Anhui Anke Biotechnology (Group) Co., Ltd.

Originator Org.

Anhui Anke Biotechnology (Group) Co., Ltd.

Active Indication

Growth hormone deficiency

Inactive Indication

Growth Disorders

Drug Highest PhasePhase 3

First Approval Ctry. / Loc.-

First Approval Date-

Clinical Trials associated with Anhui Anke Biotechnology (Group) Co., Ltd.

CTR20222798 / RecruitingPhase 2

评价人干扰素α2b 喷雾剂用于治疗儿童疱疹性咽峡炎患者的有效性和安全性的随机、双盲、安慰剂对照、多中心Ⅱ期临床试验

[Translation] A randomized, double-blind, placebo-controlled, multicenter phase II clinical trial to evaluate the efficacy and safety of human interferon α2b spray in the treatment of herpetic pharyngitis in children

初步评估人干扰素α2b喷雾剂用于治疗儿童疱疹性咽峡炎的有效性和安全性，为III期临床试验设计和给药剂量方案的确定提供依据。

[Translation]

To preliminarily evaluate the efficacy and safety of human interferon α2b spray in the treatment of herpetic pharyngitis in children, and provide a basis for the design of Phase III clinical trials and the determination of dosing regimen.

Start Date25 May 2024

Sponsor / Collaborator

Anhui Anke Biotechnology (Group) Co., Ltd.

CTR20234263 / RecruitingPhase 2

评价AK2017注射液治疗儿童矮小症（生长激素缺乏症、特发性身材矮小）有效性和安全性的随机、开放、阳性对照、多中心Ⅱ期临床试验

[Translation] A randomized, open, positive-controlled, multicenter phase II clinical trial to evaluate the efficacy and safety of AK2017 injection in the treatment of dwarfism (growth hormone deficiency, idiopathic short stature) in children

主要目的： 1、评价AK2017注射液用于治疗生长激素缺乏症、特发性身材矮小患儿的有效性和安全性。 2、探索AK2017注射液用于治疗生长激素缺乏症、特发性身材矮小患儿的药代动力学和药效学的剂量效应关系，为Ⅲ期给药剂量提供依据。次要目的：评价AK2017注射液用于治疗生长激素缺乏症、特发性身材矮小患儿的免疫原性。

[Translation]

Main objectives: 1. To evaluate the efficacy and safety of AK2017 injection in the treatment of children with growth hormone deficiency and idiopathic short stature. 2. To explore the pharmacokinetic and pharmacodynamic dose-effect relationship of AK2017 injection in the treatment of children with growth hormone deficiency and idiopathic short stature, and provide a basis for the Phase III dosing. Secondary objectives: To evaluate the immunogenicity of AK2017 injection in the treatment of children with growth hormone deficiency and idiopathic short stature.

Start Date13 May 2024

Sponsor / Collaborator

Anhui Anke Biotechnology (Group) Co., Ltd.

CTR20240094 / RecruitingPhase 1

评价AK1012吸入用溶液在中国健康成年志愿者中单次给药及多次给药的安全耐受性、药代动力学特征和免疫原性的I期临床研究

[Translation] A phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and immunogenicity of AK1012 solution for inhalation in healthy Chinese adult volunteers after single and multiple administrations

主要目的：评价AK1012吸入用溶液在中国健康成年志愿者中单次给药及多次给药的安全耐受性。次要目的： 1. 评价AK1012吸入用溶液在中国健康成年志愿者中单次给药及多次给药的药代动力学特征； 2. 评价AK1012吸入用溶液在中国健康成年志愿者中单次给药及多次给药的免疫原性。探索目的：探索AK1012吸入用溶液在中国健康成年志愿者中单次给药的局部药代动力学特征。

[Translation]

Primary objective: To evaluate the safety and tolerability of AK1012 solution for inhalation after single and multiple administration in healthy Chinese adult volunteers. Secondary objectives: 1. To evaluate the pharmacokinetic characteristics of AK1012 solution for inhalation after single and multiple administration in healthy Chinese adult volunteers; 2. To evaluate the immunogenicity of AK1012 solution for inhalation after single and multiple administration in healthy Chinese adult volunteers. Exploratory objective: To explore the local pharmacokinetic characteristics of AK1012 solution for inhalation after single administration in healthy Chinese adult volunteers.

Start Date22 Jan 2024

Sponsor / Collaborator

Anhui Anke Biotechnology (Group) Co., Ltd.

100 Clinical Results associated with Anhui Anke Biotechnology (Group) Co., Ltd.

0 Patents (Medical) associated with Anhui Anke Biotechnology (Group) Co., Ltd.

Literatures (Medical) associated with Anhui Anke Biotechnology (Group) Co., Ltd.

24 Jul 2023·Antibody Therapeutics

A NOVEL MSLN×4-1BB BISPECIFIC ANTIBODY FOR SOLID TUMOR

Author: Zhou, Weiming ; Zeng, Xiaoli ; Cheng, Liansheng ; Zhao, Qun ; Shen, Guodong ; Liu, Wenting ; Zhang, Dayan

AbstractBackgroundMesothelin (MSLN) is a 70 KD glycosylphosphatidylinositol (GPI)-anchored cell surface glycoprotein that is rarely expressed in normal tissues but overexpressed in a variety of cancers, including mesothelioma, ovarian cancer, pancreatic cancer and breast cancer et.al. 4-1BB is a member of the tumor necrosis factor receptor superfamily that functions as a co-stimulatory molecule. Agonistic antibodies bind to 4-1BB, triggering a signaling cascade leading to T-cell activation and expansion of cytotoxic CD8+ T lymphocytes. Here, we developed two bispecific antibodies (bsAbs) targeting both MSLN and 4-1BB with an intact Fc fragment from human IgG1 or IgG4, named HK013-G1 and HK013-G4 respectively. We suspected that HK013-G1 can simultaneously exert the cytotoxic effect of CD8+T cells and NK cells on tumor cells expressing MSLN to achieve better antitumor efficacy.MethodsBoth HK013-G1 and HK013-G4 were constructed by fused a single-chain variable fragment (scFv) targeting hu4-1BB to the C terminus of an anti-MSLA nanobody. And their affinity was optimized to making it highly effective in tumor localization. Next, we tested the killing ability of bsAbs-mediated PBMC or NK92 against tumor cells with different expression levels of MSLN in vitro. And the IFN-γ secretion was detected when CD8+T cells co-cultured with MSLN+ or MSLN- cells in the presence of antibodies. Also, the 4-1BB agonist activity of bsAbs was measured in a luciferase report gene assay. To confirm the safety of HK013-G1, non-specific activation of 4-1BB signal mediated by Fc receptor and CRS was evaluated in vitro. Finally, we compared the antitumor activity of two bispecific antibodies in both MC38/hMSLN and CT26/hMSLN tumor model and hepatotoxicity as well as cardiotoxicity was evaluated.ResultsAffinity-optimized HK013-G1 has an order of magnitude greater affinity for MSLN(KD≈10−9M) than 4-1BB (KD≈10−8M). HK013-G1 induced stronger PBMC against tumor cells than MOARb009 while HK013-G4 does not. Also, HK013-G1 could only mediate the killing of NK92 on MSLN-positive tumor cells. In co-cultured assay, HK013-G1 had superior ability to stimulate CD8+T cell secretion of IFN-γ than urelumab in the presence of MSLN. In luciferase reporter assay, the bsAbs-induced 4-1BB activation is dependent on expression level of MSLN. In addition, HK013-G1 was shown no stronger ability to inducing non-specific activation of 4-1BB signal mediated by Fc receptor and CRS in vitro. Compared with HK013-G4, HK013-G1 showed a more significant anti-tumor effect in both MC38/hMSLN and CT26/hMSLN tumor model. And, HK013-G4 showed significant hepatotoxicity in mice while HK013-G1 not. Moreover, HK013-G1 can protect mice against tumor re-challenge.ConclusionsHK013-G1, an MSLN×4-1BB bsAb with human IgG1 Fc fragment, prevents tumor development by killing tumor cells directly via effector functions mediated by NK and cytotoxic T cells. More importantly, HK013-G1 showed no stronger toxic side effects both in vitro and in vivo. These results show that HK013-G1 has the potential to develop into a new clinical therapy for cancer types with MSLN expression.

04 Apr 2023·Cancer Research

Abstract 1880: A novel CD137 agonist exhibits potent antitumor efficacy with a good safety profile

Author: Liu, Wenting ; Zhang, Dayan ; Shen, Guodong ; Zhou, Pengfei ; Fang, Qing ; Li, Liangwei ; Zhou, Weiming ; Cheng, Liansheng ; Wang, Fengrong ; Huang, Yang

AbstractBackground: CD137 (TNFRSF9, 4-1BB) is a member of the tumor necrosis factor receptor superfamily that functions as a costimulatory molecule of immunocytes and is mainly expressed on the surface of immune cells including activated T and natural killer (NK) cells. Agonists against CD137 have shown promising therapeutic activity in mouse tumor models but have suffered setback in the clinic due to notably hepatotoxicity, or suboptimal agonistic potency. Here, we developed a fully human agonistic anti-CD137 monoclonal IgG4 antibody, ZG033, with an exclusive epitope, to achieve a better efficacy and safety profile for immunotherapy.Methods: The antigen binding specificity and affinity of ZG033 were determined by ELISA, surface plasmon resonance (SPR). X-ray crystallography was conducted to resolve the binding epitopes of the respective binding arms. The activities were determined using cell-based and reporter gene assays. In vivo antitumor activities were evaluated in human 4-1BB transgenic mice bearing with syngeneic tumors, and possible toxicity was evaluated in humanized mice and cynomolgus monkeys. Cytokine release assay was conducted by incubating ZG033 with PBMCs from healthy donors. The pharmacokinetic (PK) behavior of ZG033 were characterized in cynomolgus monkeys. A phase 1 study was initiated to evaluate the safety and preliminary clinical activities of ZG033, as well as the immunogenicity and pharmacokinetics.Results: ZG033 showed high specificity for human CD137 without cross-species reactivity across mouse, rat and exhibited potent CD137 agonist activity dependent on FcγR crosslinking. The binding affinity of ZG033 determined by surface plasmon resonance (SPR) was moderate (KD=10 nM). X-ray crystallography revealed that the Fab of ZG033 binds CD137 at an epitope overlap with the ligand binding interface. ZG033 increased CD137-driven NFκB reporter gene activation and the production of IFN-γ by human T cells in a FcγR-dependent manner. In human CD137 transgenic mice, ZG033 showed robust antitumor activity and induced durable antigen-specific immunological memory that prevented the tumor formation in the rechallenged mice. There were no signs of toxicity in human cytokine release assay which confirmed that ZG033 did not induce pro-inflammatory cytokines in the absence of TCR stimulation. Toxicology data in mice showed that ZG033 was well-tolerated with normal ALT and AST levels. ZG033 was further confirmed to well tolerated up to 180 mg/kg (MTD≥180mg/kg) dose without systemic toxicity in cynomolgus monkeys. Patients with advanced tumors, who are refractory after exhausting available therapies, were enrolled for ZG033 treatment. We will report the results from early dose escalation part of the study.Conclusion: These data demonstrate that ZG033 is an FcγR crosslinking-dependent CD137 agonist that displays a favorable safety profile and has potential in either mono- or combinational immunotherapies.Citation Format: Yang Huang, Liangwei Li, Wenting Liu, Dayan Zhang, Pengfei Zhou, Qing Fang, Weiming Zhou, Fengrong Wang, Guodong Shen, Liansheng Cheng. A novel CD137 agonist exhibits potent antitumor efficacy with a good safety profile [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 1880.

01 Aug 2022·Fish Physiology and Biochemistry

Correction to: Transcriptome analysis of skin color variation during and after overwintering of Malaysian red tilapia

Author: Dong, Zaijie ; Zhu, Wenbin ; Luo, Mingkun ; Fu, Jianjun ; Jiang, Bingjie ; Wang, Lanmei ; Liu, Wei

100 Deals associated with Anhui Anke Biotechnology (Group) Co., Ltd.

100 Translational Medicine associated with Anhui Anke Biotechnology (Group) Co., Ltd.

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Pipeline

Pipeline Snapshot as of 05 Nov 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

Preclinical

IND Approval

Phase 1 Clinical

Phase 2 Clinical

Phase 3 Clinical

Approved

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Human Growth Hormone (Anhui Anke) ( GHR )	Growth hormone deficiency More	Approved
Trastuzumab biosimilar (Anhui Anke) ( HER2 )	HER2-positive gastric cancer More	Approved
Interferon alfa-2b(Anhui Anke Biotechnology (Group) Co., Ltd.) ( IFNAR )	Hepatitis C More	Approved
Kangfu Tincture	Neurodermatitis More	Approved
PEGylated recombinant somatropin(Anhui Anke Biotechnology (Group) Co., Ltd.) ( GHR )	Growth hormone deficiency More	Phase 3

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