[Translation] A multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the safety and efficacy of human interferon α1b inhalation solution in the treatment of respiratory syncytial virus lower respiratory tract infection in children

主要目的：评估人干扰素α1b吸入溶液治疗小儿呼吸道合胞病毒性下呼吸道感染（肺炎、毛细支气管炎）的有效性和安全性。次要目的：评估在小儿呼吸道合胞病毒性下呼吸道感染患儿中人干扰素α1b吸入溶液血清中药代动力学特征。

[Translation]

Primary objective: To evaluate the efficacy and safety of human interferon α1b inhalation solution in the treatment of respiratory syncytial virus lower respiratory tract infections (pneumonia, bronchiolitis) in children. Secondary objective: To evaluate the pharmacokinetic characteristics of human interferon α1b inhalation solution in serum in children with respiratory syncytial virus lower respiratory tract infections.

Start Date27 Mar 2024

Sponsor / Collaborator

Shenzhen Kexing Pharmaceutical Co., Ltd.

NCT06363370 / RecruitingPhase 3

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.

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 Nov 2024·Molecular Genetics and Metabolism

Pompe disease: Unmet needs and emerging therapies

Review

Author: George, Kelly A ; Berger, Kenneth I ; Anding, Allyson L ; George, Kelly A. ; Zhang, Tracy Y. ; Tomassy, Giulio S ; Sardi, S. Pablo ; Berger, Kenneth I. ; Sardi, S Pablo ; Zhang, Tracy Y ; van der Flier, Arjan ; Anding, Allyson L. ; Tomassy, Giulio S.

Pompe disease is a debilitating and life-threatening disease caused by aberrant accumulation of glycogen resulting from reduced acid alpha-glucosidase activity. The first treatment for Pompe disease, the enzyme replacement therapy, Myozyme® (recombinant human acid alpha-glucosidase, alglucosidase alfa), is a lifesaving treatment for the most severe form of the disease and provided clinically meaningful benefits to patients with milder phenotypes. Nonetheless, many patients display suboptimal responses or clinical decline following years of alglucosidase alfa treatment. The approval of avalglucosidase alfa (Nexviazyme®) and cipaglucosidase alfa (Pombiliti®) with miglustat (Opfolda®) represents a new generation of enzyme replacement therapies seeking to further improve patient outcomes beyond alglucosidase alfa. However, the emergence of a complicated new phenotype with central nervous system involvement following long-term treatment, coupled with known and anticipated unmet needs of patients receiving enzyme replacement therapy, has prompted development of innovative new treatments. This review provides an overview of the challenges of existing treatments and a summary of emerging therapies currently in preclinical or clinical development for Pompe disease and related lysosomal storage disorders. Key treatments include tissue-targeted enzyme replacement therapy, which seeks to enhance enzyme concentration in target tissues such as the central nervous system; substrate reduction therapy, which reduces intracellular glycogen concentrations via novel mechanisms; and gene therapy, which may restore endogenous production of deficient acid alpha-glucosidase. Each of these proposed treatments shows promise as a future therapeutic option to improve quality of life in Pompe disease by more efficiently treating the underlying cause of disease progression: glycogen accumulation.

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: Sun, Yan ; Chen, LiangHong ; Qiao, Shuai ; Gao, XingHua ; Wang, JingYu ; An, Qian ; Xiao, BiHuan ; 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, sep.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 irradiationCompared 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.

27 Apr 2022·Evidence-Based Complementary and Alternative MedicineQ4 · 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: Chen, Ting ; Pan, Xiangcheng ; Zhang, Lingli ; Huang, Liang ; Jia, Zhi-Jun ; Yang, Mengting ; Yu, Qin ; Luo, Jiefeng ; Liu, Dan ; Diao, Sha ; Zeng, Linan ; Cheng, Guo

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.

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

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R&D Status

Approved

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

Developing

10 top R&D records.

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

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