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

Shandong Kexing Bioproducts Co., Ltd.

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.

NCT06277167

/ CompletedPhase 1

A Randomized, Double-Blind, Placebo-Controlled Phase-I Clinical Study to Evaluate the Tolerability, Safety and PK Profiles of Human Interferon Alfa 1b Inhalation Solution in Healthy Adult Subjects After Administration of Single Ascending Doses and Multiple Ascending Doses

A Randomized, Double-Blind, Placebo-Controlled Phase-I Clinical Study to Evaluate the Tolerability, Safety and PK Profiles of Human interferon alfa 1b inhalation solution in Healthy Adult Subjects after Administration of Single Ascending Doses and Multiple Ascending Doses

Start Date07 Jan 2023

Sponsor / Collaborator

Shandong Kexing Bioproducts Co., Ltd.

[+2]

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

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

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

Literatures (Medical) associated with Recombinant human interferon alpha-1b(Shenzhen Kexing Biotech Co. Ltd.)

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 ; Hao, Meiqi ; Yang, Jingan ; Sun, Kaiqing ; Peng, Hengxin ; Zhang, Wenjun ; 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.

01 Oct 2023·Archives of dermatological research

Combined therapy of local recombinant human interferon α1b injection and acupuncture on verruca vulgaris: a retrospective study.

Article

Author: Gao, XingHua ; Wang, JingYu ; An, Qian ; Sun, Yan ; Xiao, BiHuan ; Qiao, Shuai ; Chen, LiangHong ; Wu, Yan

Verruca vulgaris is always stubborn to treat. We applied a new combined therapy of local recombinant human interferon alpha 1b (rhIFNα1b) injection plus acupuncture on verruca vulgaris recently to evaluate the efficacy and safety of the combined therapy. The retrospective study was conducted in The First Hospital of China Medical University from 2018 to 2020. Patients with verruca vulgaris were included. Combined therapy with local rhIFNα1b injection plus acupuncture was set as treatment group, rhIFNα1b injection and carbon dioxide (CO₂) laser were set as control groups. A total of 2415 patients were included in the study. The cure rates were 81.85%, 85.93%, and 100% in combined group, rhIFNα1b group, and CO₂ laser group, separately. All lesions cured in combined group were located on hands or feet, while majority of lesions cured in other groups were located on other sites. For patients with medium/big single lesion or 6-9 lesions, less treatment times were needed in combined group than rhIFNα1b group. For patients with small single, two to five or more than ten lesions, the treatment times of combined group and rhIFNα1b group were comparable. All patients complained of pain in varying degrees when local injection or laser irradiation. Compared with CO₂ laser group, more fever, less swelling or scar was reported in combined group. In conclusion, combined therapy of local rhIFNα1b plus acupuncture was beneficial for verruca vulgaris with limited adverse effects. The therapy was more acceptable by younger female patients with verruca vulgaris.

News (Medical) associated with Recombinant human interferon alpha-1b(Shenzhen Kexing Biotech Co. Ltd.)

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 Biotech Co. Ltd.)

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Indication	Country/Location	Organization	Date
Neoplasms	China	Shenzhen Kexing Pharmaceutical Co., Ltd.	01 Jan 1996
Virus Diseases	China	Shenzhen Kexing Pharmaceutical Co., Ltd.	01 Jan 1996

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

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