[Translation] Phase I clinical trial comparing the pharmacokinetics, safety and immunogenicity of SJ04 injection and Aize® in healthy Chinese female subjects

主要目的评价SJ04注射液与艾泽®在中国健康女性受试者中单次皮下注射给药后药代动力学（PK）的相似性。次要目的评价SJ04注射液与艾泽®在中国健康女性受试者中单次皮下注射给药后的安全性和免疫原性。

[Translation]

Primary objective To evaluate the pharmacokinetic (PK) similarity between SJ04 injection and Aize® in healthy Chinese female subjects after a single subcutaneous injection. Secondary objective To evaluate the safety and immunogenicity of SJ04 injection and Aize® in healthy Chinese female subjects after a single subcutaneous injection.

Start Date12 Aug 2024

Sponsor / Collaborator

Suzhou Shengji Pharmaceutical Co Ltd

100 Clinical Results associated with Choriogonadotropin alfa biosimilar( Suzhou Shengji)

100 Translational Medicine associated with Choriogonadotropin alfa biosimilar( Suzhou Shengji)

100 Patents (Medical) associated with Choriogonadotropin alfa biosimilar( Suzhou Shengji)

Literatures (Medical) associated with Choriogonadotropin alfa biosimilar( Suzhou Shengji)

01 Feb 2015·Journal of Chemical EcologyQ2 · ENVIRONMENTAL SCIENCE & ECOLOGY

Anatomical, Morphological, and Phytochemical Effects of Inoculation with Plant Growth- Promoting Rhizobacteria on Peppermint (Mentha piperita)

Q2 · ENVIRONMENTAL SCIENCE & ECOLOGY

Article

Author: Walter Giordano ; Lorena del Rosario Cappellari ; Claudia Travaglia ; Erika Banchio ; Maricel Valeria Santoro ; Herminda Reinoso

Plant growth-promoting rhizobacteria (PGPR) generally exert their effects through enhancement of plant nutrient status and/or phytohormone production. The effects of PGPR on aromatic plant species are poorly known. We measured plant growth parameters, chlorophyll content, trichome density, stomatal density, and levels of secondary metabolites in peppermint (Mentha piperita) seedlings inoculated with PGPR strains Bacillus subtilis GB03, Pseudomonas fluorescens WCS417r, P. putida SJ04, or a combination of WCS417r + SJ04. The treated plants, in comparison with controls, showed increases in shoot biomass, root biomass, leaf area, node number, trichome density, and stomatal density, and marked qualitative and quantitative changes in monoterpene content. Improved knowledge of the factors that control or affect biosynthesis of secondary metabolites and monoterpene accumulation will lead to strategies for improved cultivation and productivity of aromatic plants and other agricultural crops without the use of chemical fertilizers or pesticides.

Plants

Antifungal Activity and Alleviation of Salt Stress by Volatile Organic Compounds of Native Pseudomonas Obtained from Mentha piperita

Article

Author: Gil, Samanta Soledad ; Giordano, Walter ; Cappellari, Lorena del Rosario ; Banchio, Erika

As salt stress has a negative impact on plant growth and crop yield, it is very important to identify and develop any available biotechnology which can improve the salt tolerance of plants. Inoculation with plant-growth-promoting rhizobacteria (PGPR) is a proven environmentally friendly biotechnological resource for increasing the salt stress tolerance of plants and has a potential in-field application. In addition, bacterial volatile organic compounds (mVOCs) are signal molecules that may have beneficial roles in the soil–plant–microbiome ecosystem. We investigated the effects of mVOCs emitted by Pseudomona putida SJ46 and SJ04 on Mentha piperita grown under different levels of NaCl stress by evaluating their growth-promoting potential and capacity to increase salt tolerance effects. Furthermore, we evaluated under control and salt stress conditions the biocontrol ability of VOCs emitted by both these strains to inhibit the growth of Alternaria alternata and Sclerotium rolfsii. The VOCs emitted by both strains under control conditions did not lead to an significant improvement in peppermint growth. However, under salt stress conditions (75 or 100 mM NaCl), an amelioration of its physiological status was observed, with this effect being greater at 100 mM NaCl. This led to an enhancement of the number of leaves and nodes and, increased the shoot fresh and root dry weight by approximately twice in relation to control stressed plants. Moreover, the VOCs released by the two bacteria grown in control or saline media showed a significant reduction in the mycelial growth of A. alternata. In contrast, S. rolfsii growth was reduced 40% by the mVOCs released only under control conditions, with no effects being observed under salt stress. We also explored the composition of the bacterial volatile profiles by means of a solid-phase microextraction/gas chromatography–mass spectrometry (SPME/GC–MS) analysis. From the headspace of SJ46, three VOCs were identified: n-octanol, decane and tetradecane. The emission of SJ04 had the same chromatographic profile, with the addition of two more compounds: 1-(N-phenyl carbamyl)-2-morpholino cyclohexene and tridecane. Only compounds that were not present in the headspace of the control groups were recorded. The salt stress conditions where the bacteria were grown did not qualitatively modify the mVOC emissions. Taken together, our results suggest that plant-associated rhizobacterial VOCs play a potentially important role in modulating plant salt tolerance and reducing fungal growth. Thus, biological resources represent novel tools for counteracting the deleterious effects of salt stress and have the potential to be exploited in sustainable agriculture. Nevertheless, future studies are necessary to investigate technological improvements for bacterial VOC application under greenhouse and open field conditions.

Plants

Exploring the Differential Impact of Salt Stress on Root Colonization Adaptation Mechanisms in Plant Growth-Promoting Rhizobacteria

Article

Author: Bogino, Pablo Cesar ; Giordano, Walter ; Banchio, Erika ; Cappellari, Lorena Del Rosario ; Nievas, Fiorela

Salinity inhibits plant growth by affecting physiological processes, but soil microorganisms like plant growth-promoting rhizobacteria (PGPR) can alleviate abiotic stress and enhance crop productivity. However, it should be noted that rhizobacteria employ different approaches to deal with salt stress conditions and successfully colonize roots. The objective of this study was to investigate the effect of salt stress on bacterial survival mechanisms such as mobility, biofilm formation, and the autoaggregation capacity of three plant growth-promoting strains: Pseudomonas putida SJ04, Pseudomonas simiae WCS417r, and Bacillus amyloliquefaciens GB03. These strains were grown in diluted LB medium supplemented with 0, 100, 200, or 300 mM NaCl. Swimming and swarming mobility were evaluated in media supplemented with 0.3 and 0.5% agar, respectively. Biofilm formation capacity was quantified using the crystal violet method, and the autoaggregation capacity was measured spectrophotometrically. In addition, we evaluated in vitro the capacity of the strains to ameliorate the effects of saline stress in Mentha piperita. The study found that the GB03 strain exhibited enhanced swarming mobility when the salt concentration in the medium increased, resulting in a two-fold increase in the halo diameter at 300 mM. However, high concentrations of NaCl did not affect the swimming mobility. In contrast, swimming motility was reduced in WCS417r and SJ04 under salt stress. On the other hand, exposure to 300 mM NaCl resulted in a 180% increase in biofilm formation and a 30% rise in the percentage of autoaggregation in WCS417r. Conversely, the autoaggregation percentage of the strains SJ04 and GB03 remained unaffected by saline stress. However, for GB03, biofilm formation decreased by 80% at 300 mM. Simultaneously, inoculation with the three evaluated strains alleviated the detrimental effects of salinity on plant growth. Under 150 mM salt stress, all strains showed increased fresh weight, with GB03 and WCS417r improving by 40% and SJ04 exhibiting the most remarkable effect with a 70% rise compared to non-inoculated plants. Despite their different strategies for mitigating salt stress, the application of these strains presents a promising strategy for effectively mitigating the negative consequences of salt stress on plant cultivation.

100 Deals associated with Choriogonadotropin alfa biosimilar( Suzhou Shengji)

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Indication	Highest Phase	Country/Location	Organization	Date
Infertility, Female	Phase 1	CN	Suzhou Shengji Pharmaceutical Co Ltd	01 Oct 2024
Anovulation	Phase 1	CN	Suzhou Shengji Pharmaceutical Co Ltd	12 Aug 2024
Infertility	Preclinical	CN	Shanghai Bao Pharmaceuticals Co., Ltd.	06 Jul 2022

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