A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Safety and Efficacy of Human Interferon α1b Inhaled Solution in the Treatment of Respiratory Syncytial Virus Lower Respiratory Tract Infection in Children.

To evaluate the efficacy and safety of interferon α1b (GB05) in the treatment of children under 2 years of age with respiratory syncytial virus infection.

Start Date27 Mar 2024

Sponsor / Collaborator

Kexing Biopharm Co., Ltd.

NCT06256627

/ RecruitingNot ApplicableIIT

A Multicenter, Single Arm Clinical Study on the Efficacy and Safety of the "ITIVA" Protocol in Patients With Complete Remission of AML at Initial Diagnosis

We apply for this clinical study to evaluate the efficacy of "combined recombinant human interference'- α- 1b, interleukin-2, and thalidomide" regimen in obtaining MRD positive AML patients in CR,as well as the efficacy of the "Venentoclax and azacitidine" regimen and the "combined recombinant human interference'- α- 1b, interleukin-2, and thalidomide" regimen in alternately maintaining the treatment of MRD negative AML patients. The study included two cohorts. The first cohort consisted of AML patients who obtained CR or CRi but MRD positive after induction chemotherapy and consolidation chemotherapy. They were randomly given two cycles of "recombinant human interference'- α- 1b, interleukin-2, and thalidomide" or "VA" regimen treatment, and the MRD conversion rates of the two groups were analyzed. In the second cohort , after induction chemotherapy and consolidation chemotherapy, AML patients with CR or CRi and negative MRD were obtained, and were given "recombinant human interference'- α- 1b, interleukin-2, and thalidomide", Venentoclax and Azacitidine triple alternative maintenance treatment, to analyze the impact of maintenance treatment scheme on long-term survival of aml patients.

Start Date11 Jul 2023

Sponsor / Collaborator

Henan Cancer Hospital

CTR20231702

/ CompletedPhase 1

一项随机、开放、单中心I期临床研究，评估人干扰素α1b吸入溶液在中国健康成年受试者中单次雾化吸入给药的药代动力学特征

[Translation] A randomized, open-label, single-center phase I clinical study to evaluate the pharmacokinetic characteristics of human interferon α1b inhalation solution after a single nebulized inhalation in healthy Chinese adult subjects

主要目的：评估在健康成年受试者中人干扰素α1b吸入溶液的局部药代动力学特征；次要目的： 1、评估在健康成年受试者中人干扰素α1b吸入溶液血清中药代动力学特征； 2、评估在健康成年受试者中人干扰素α1b吸入溶液的安全性和耐受性； 3、评估在健康成年受试者中人干扰素α1b吸入溶液的免疫原性。

[Translation]

Primary purpose: To evaluate the local pharmacokinetic characteristics of human interferon α1b inhalation solution in healthy adult subjects; Secondary purposes: 1. To evaluate the pharmacokinetic characteristics of human interferon α1b inhalation solution in serum in healthy adult subjects; 2. To evaluate the safety and tolerability of human interferon α1b inhalation solution in healthy adult subjects; 3. To evaluate the immunogenicity of human interferon α1b inhalation solution in healthy adult subjects.

Start Date21 Jun 2023

Sponsor / Collaborator

Shenzhen Kexing Pharmaceutical Co., Ltd.

100 Clinical Results associated with Recombinant human interferon alpha-1b (Shenzhen Kexing)

100 Translational Medicine associated with Recombinant human interferon alpha-1b (Shenzhen Kexing)

100 Patents (Medical) associated with Recombinant human interferon alpha-1b (Shenzhen Kexing)

Literatures (Medical) associated with Recombinant human interferon alpha-1b (Shenzhen Kexing)

01 Mar 2025·INTERNATIONAL JOURNAL OF PHARMACEUTICS

GB05, a safe and effective IFNα1b inhalation solution for treating respiratory syncytial virus infection

Article

Author: Qin, Suofu ; Li, Huiming ; Yang, Lijun ; Yu, Yi ; You, Qiongying ; Yang, Jingan ; Hao, Meiqi ; Sun, Kaiqing ; Zhang, Wenjun ; Peng, Hengxin ; Zhou, Xinrong ; Wang, Bo

Human respiratory syncytial virus (HRSV) infection is linked to significant morbidity and mortality in infants and young children worldwide, yet no effective treatment is available. Interferon α (IFNα), a major subtype among the IFN family, has demonstrated antiviral effects by activating the human immune system. Aerosol inhalation is a way of IFN administration that can enhance efficacy while decreasing serum IFNα concentrations and systemic exposure, thereby minimizing the risk of systemic toxicity. However, at present, human interferon α1b (IFNα1b) injection solution is used off-label for inhalation, raising safety concerns for infants. Additionally, natural IFNα1b contains a free sulfhydryl group from cysteine residue, increasing the risk of structural instability. Human serum albumin (HSA), an excipient in IFNα1b formulations, may pose safety risks to infants. To address these concerns, we developed GB05-human IFNα1b inhalation solution with optimized molecular design, expression system and formulation. First, GB05 protein was expressed in the periplasmic space to achieve easier purification. GB05 was engineered with a C86S mutation to prevent the formation of intermolecular disulfide bonds. Furthermore, GB05 was formulated according to regulations for inhalation solution, with a minimal HSA of 0.1 %, to ensure safety while preserving biological activity and stability. Plasma concentrations of GB05 following nebulization in cynomolgus macaques were significantly lower than those in the lungs, suggesting a reduced risk of systemic adverse events. Finally, GB05 showed good efficacy against HRSV infection in vitro and in vivo. In summary, GB05 is the first reported IFN inhalation solution manufactured in compliance with regulatory standards, to our knowledge, exhibiting safety and efficacy due to effectively local delivery. GB05 will fill the gap in the treatment of HRSV infection.

01 Sep 2024·Infectious Diseases and Therapy

Safety, Tolerability, and Pharmacokinetics of Nebulized GB05-Human IFNα1b Inhalation Solution: A Randomized, Placebo-Controlled, Dose-Escalation Phase I Study in Healthy Chinese Adult Volunteers

Article

Author: Peng, Hengxin ; Qin, Suofu ; Li, Huiming ; Lin, Yanqing ; Zhang, Wenjun

INTRODUCTION:

Human respiratory syncytial virus (RSV) is the leading cause of lower respiratory tract infection, especially in children and older people. However, no effective treatment is currently available. Type I interferons (IFNs) are a group of cytokines that help regulate the activity of the immune system. GB05, human IFNα1b inhalation solution, was developed under US Food and Drug Administration (FDA) standard guidelines to combat RSV infection. This randomized, double-blind, placebo-controlled, dose-escalation phase I trial evaluated the safety, tolerability, and pharmacokinetics of nebulized GB05.

METHODS:

A total of 35 eligible healthy Chinese adult volunteers were enrolled in this study. In the single ascending dose (SAD) study, volunteers were randomized into 0.2, 0.6, 1.2, and 1.8 million IU of GB05 or placebo. In the multiple ascending dose (MAD) study, volunteers received 1.2 or 1.8 million IU of GB05 or placebo for four consecutive days. Safety, tolerability, immunogenicity, and plasma pharmacokinetics were assessed for all groups.

RESULTS:

All adverse events were mild or moderate and resolved spontaneously. The most common adverse event was decreased white blood cell count (8.6% in SAD and 10% in MAD). No serious adverse events, deaths, or adverse events that reached the termination criteria occurred during the study. In SAD, the maximum concentration and area under the curve increased across the dose range of 1.2-1.8 million IU in a non-linear relationship. The maximum plasma concentration after GB05 nebulization (1.06 IU/ml in the 1.8 million IU group) reflected a low concentration in the blood, suggesting a better lung uptake of GB05 and reduced incidence or risks of adverse events. In MAD, a steady state was reached after continuous administrations of twice daily for 3 days.

CONCLUSIONS:

Overall, nebulized GB05 exhibited satisfactory safety, tolerability, and favorable pharmacokinetic (PK) profiles in healthy adult volunteers, supporting further clinical investigation in patients infected with respiratory syncytial virus.

CLINICAL TRIAL REGISTRATION:

ClinicalTrials.gov Identifier NCT06277167.

27 Apr 2022·Evidence-based complementary and alternative medicine : eCAMQ4 · MEDICINE

Safety and Effectiveness of Inhaling Different Dosage Recombinant Human Interferon α1B for Bronchiolitis in Children: a Systematic Review and Meta-Analysis

Q4 · MEDICINE

ArticleOA

Author: Huang, Liang ; Zeng, Linan ; Jia, Zhi-Jun ; Luo, Jiefeng ; Pan, Xiangcheng ; Zhang, Lingli ; Chen, Ting ; Diao, Sha ; Yang, Mengting ; Liu, Dan ; Cheng, Guo ; Yu, Qin

Purpose. To systematically evaluate the safety and effectiveness of different dosages of recombinant human interferon α1b (IFNα1b) inhaled for bronchiolitis in children. Methods. 7 databases, including PubMed, EMBASE, Cochrane Library, Web of Science, CNKI, Wanfang Database, and VIP, were searched. The search time was from their inception dates to March 28, 2022. A randomized controlled trial (RCT) of 2 μg/kg IFNα1b (low dosage group) monotherapy or in combination with other drugs vs. 4 μg/kg IFNα1b (high dosage group) monotherapy or in combination with the other drugs was included. The risk of bias 2.0 evaluated the RCT’s quality, and the grading of recommendations assessment, development and evaluation (GRADE) tool was used for evaluating the overall quality of the evidence. Then, a meta-analysis was performed by RevMan 5.4. Results. A total of 13 RCTs with 1719 children were included. The meta-analysis results showed that the high dosage group was significantly shorter than the low dosage group of the duration of hospital stays (MD = −0.40, 95%CI (−0.73, −0.07),

P

= 0.02) (low quality), three depressions sign disappearing time (MD = −0.60, 95%CI (−1.05, −0.14),

P

= 0.010) (low quality), and wheeze disappearing time (MD = −0.62, 95%CI (−1.17, −0.06), = 0.03) (low quality). There was no significant difference between the two groups in coughing disappearing time, pulmonary rales disappearing time, wheezing sound disappearing time, or adverse event rates. Conclusions. Compared with low dosage IFNα1b, high dosage IFNα1b reduces the duration of hospital stays, the disappearance time of the three depression signs, and the disappearance time of wheeze in the treatment of bronchiolitis in children. Limited by the low quality of the evidence, the conclusions still need to be supported by high-quality studies.

News (Medical) associated with Recombinant human interferon alpha-1b (Shenzhen Kexing)

14 Feb 2025

·pipelinereview.com

Kexing Biopharm Obtained IND Approval for Its Self-developed GB05 from U.S. FDA

SHENZHEN, China I February 14, 2025 I Kexing Biopharm Co., Ltd. (Stock Code: 688136.SH) recently announced that the Investigational New Drug Application (IND) of GB05, Human Interferon α1b Inhalation Solution, a self-developed product by the Company’s wholly-owned subsidiary, Shenzhen Kexing Pharmaceutical Co., Ltd., has been approved by the United States Food and Drug Administration (FDA), and this approval allows Shenzhen Kexing to initiate its proposed clinical trials in the US. The proposed indications are pediatric lower respiratory tract infections caused by respiratory syncytial virus (RSV), such as pneumonia and bronchiolitis. This significant breakthrough in antiviral drug development brings new hope to the treatment of RSV infections in children globally. RSV is one of the most causative viruses for acute respiratory infections in infants. Children under the age of five are particularly vulnerable, and the situation is even worse for infants and children with underlying health conditions, who are likely to suffer severe pneumonia when infected. There is yet no effective anti-viral drugs targeting RSV approved globally. GB05, Human Interferon α1b Inhalation Solution, is specifically formulated for pediatric use: it incorporates a mutation to increase stability, is formulated with low human albumin content for increased safety and lower cost, and in inhaled regimen, the active ingredient can be delivered directly to the infection site for better efficacy and reduced side effects. In addition, inhalation delivery enhances pediatric patients’ compliance compared to subcutaneous injection. In summary, the safety, efficacy and compliance of GB05 have been significantly improved. Currently, phase III clinical trials for GB05 are on going in China. Kexing Biopharm has been deeply engaged in antiviral, oncology, and immunology areas, keeping refining and balancing its product pipeline. The approval of GB05 for clinical trials in both China and the US is not only a reflection of Kexing Biopharm’s prowess in innovative R&D, but also an important achievement after years of efforts in antiviral area. Besides GB05, Kexing Biopharm is also gaining progress in the development of other innovative medicines. For instance, Kexing is actively working on a new biological entity, GB08, a long-acting growth hormone in the form of an Fc-fusion protein. Meanwhile, the IND applications of GB18 indicated for cancer cachexia (a nanobody targeting GDF-15) are about to be submitted in both China and the US within this year. In recent years, Kexing Biopharm’s R&D pipeline becomes more focused, and the R&D investment is more precise and targeted. Its innovation capability has attracted attention from peers and venture capitals at home and abroad. In the future, Kexing will adhere to the platform-based development strategy driven by innovation and internationalization, bringing more breakthroughs on the road of innovation. SOURCE Kexing Biopharm

INDPhase 3

14 Feb 2025

·www.prnewswire.com

Kexing Biopharm Obtained IND Approval for Its Self-developed GB05 from U.S. FDA

SHENZHEN, China, Feb. 14, 2025 /PRNewswire/ -- Kexing Biopharm Co., Ltd. (Stock Code: 688136.SH) recently announced that the Investigational New Drug Application (IND) of GB05, Human Interferon α1b Inhalation Solution, a self-developed product by the Company's wholly-owned subsidiary, Shenzhen Kexing Pharmaceutical Co., Ltd., has been approved by the United States Food and Drug Administration (FDA), and this approval allows Shenzhen Kexing to initiate its proposed clinical trials in the US. The proposed indications are pediatric lower respiratory tract infections caused by respiratory syncytial virus (RSV), such as pneumonia and bronchiolitis. This significant breakthrough in antiviral drug development brings new hope to the treatment of RSV infections in children globally. RSV is one of the most causative viruses for acute respiratory infections in infants. Children under the age of five are particularly vulnerable, and the situation is even worse for infants and children with underlying health conditions, who are likely to suffer severe pneumonia when infected. There is yet no effective anti-viral drugs targeting RSV approved globally. GB05, Human Interferon α1b Inhalation Solution, is specifically formulated for pediatric use: it incorporates a mutation to increase stability, is formulated with low human albumin content for increased safety and lower cost, and in inhaled regimen, the active ingredient can be delivered directly to the infection site for better efficacy and reduced side effects. In addition, inhalation delivery enhances pediatric patients' compliance compared to subcutaneous injection. In summary, the safety, efficacy and compliance of GB05 have been significantly improved. Currently, phase III clinical trials for GB05 are on going in China. Kexing Biopharm has been deeply engaged in antiviral, oncology, and immunology areas, keeping refining and balancing its product pipeline. The approval of GB05 for clinical trials in both China and the US is not only a reflection of Kexing Biopharm's prowess in innovative R&D, but also an important achievement after years of efforts in antiviral area. Besides GB05, Kexing Biopharm is also gaining progress in the development of other innovative medicines. For instance, Kexing is actively working on a new biological entity, GB08, a long-acting growth hormone in the form of an Fc-fusion protein. Meanwhile, the IND applications of GB18 indicated for cancer cachexia (a nanobody targeting GDF-15) are about to be submitted in both China and the US within this year. In recent years, Kexing Biopharm's R&D pipeline becomes more focused, and the R&D investment is more precise and targeted. Its innovation capability has attracted attention from peers and venture capitals at home and abroad. In the future, Kexing will adhere to the platform-based development strategy driven by innovation and internationalization, bringing more breakthroughs on the road of innovation. SOURCE Kexing Biopharm WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

INDPhase 3Drug Approval

100 Deals associated with Recombinant human interferon alpha-1b (Shenzhen Kexing)

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Approved

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Indication	Country/Location	Organization	Date
Hairy Cell Leukemia	China	Shenzhen Kexing Pharmaceutical Co., Ltd.	01 Jan 1996
Hepatitis B, Chronic	China	Shenzhen Kexing Pharmaceutical Co., Ltd.	01 Jan 1996
Hepatitis C, Chronic	China	Shenzhen Kexing Pharmaceutical Co., Ltd.	01 Jan 1996

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Indication	Highest Phase	Country/Location	Organization	Date
Bronchiolitis	Phase 3	China	Shenzhen Kexing Pharmaceutical Co., Ltd.	27 Mar 2024
Lower Respiratory Tract Infections	Phase 3	China	Kexing Biopharm Co., Ltd.	27 Mar 2024
Pneumonia	Phase 3	China	Shenzhen Kexing Pharmaceutical Co., Ltd.	27 Mar 2024
Respiratory Syncytial Virus Infections	Phase 3	China	Kexing Biopharm Co., Ltd.	27 Mar 2024
Pneumonia due to respiratory syncytial virus	Phase 1	China	Shenzhen Kexing Pharmaceutical Co., Ltd.	07 Jan 2023

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