[Translation] A multicenter, randomized, open-label, active-drug parallel-controlled phase III clinical trial to evaluate the efficacy and safety of recombinant human parathyroid hormone (1-34) [56.5 μg] (SAL056) for injection in the treatment of osteoporosis in postmenopausal women at high risk of fracture

主要目的以阿仑膦酸钠为阳性对照药，评价 SAL056 治疗骨折高风险的绝经后妇女骨质疏松症患者的有效性。次要目的评价 SAL056 治疗骨折高风险的绝经后妇女骨质疏松症患者的安全性。

[Translation]

Primary objective Using alendronate as a positive control drug, evaluate the efficacy of SAL056 in the treatment of postmenopausal women with osteoporosis at high risk of fracture. Secondary objective Evaluate the safety of SAL056 in the treatment of postmenopausal women with osteoporosis at high risk of fracture.

Start Date24 Nov 2021

Sponsor / Collaborator

Genekey Biotech (Chengdu) Co. Ltd.

[+1]

CTR20210198 / CompletedNot Applicable

评价注射用重组人甲状旁腺素（1-34）[56.5 μg]（SAL056）与原研药Teribone在中国健康成年男性受试者中的随机、开放、自身交叉、单次给药的比较药代动力学临床研究

[Translation] A randomized, open-label, self-crossover, single-dose comparative pharmacokinetic clinical study to evaluate the efficacy of recombinant human parathyroid hormone (1-34) [56.5 μg] (SAL056) for injection and the original drug Teribone in healthy Chinese adult male subjects

对注射用重组人甲状旁腺素（1-34）[56.5 μg]和Teribone进行人体药代动力学对比研究，并评价两种制剂的生物等效性。

[Translation]

Objective To compare the pharmacokinetic characteristics of recombinant human parathyroid hormone (1-34) for injection [56.5 μg] and teribone in humans and evaluate the bioequivalence of the two preparations.

Start Date26 Mar 2021

Sponsor / Collaborator

Genekey Biotech (Chengdu) Co. Ltd.

[+1]

NCT04747392 / CompletedPhase 1

A Randomized, Open, Self-crossover, Single-dose Clinical Study to Compare Pharmacokinetic of Teriparatide Injection (SAL001) and the Original Drug FORSTEO in Healthy Chinese Adult Volunteers

This is a single-center, randomized, open label, single-dose, the original drug controlled, crossover design, two sequence, two periods, Phase Ⅰclinical study.
64 qualified subjects will be randomly assigned to two administration sequences (sequence A and sequence B) at the ratio of 1∶1, with 32 subjects in each sequence. Each period will be given subcutaneous injection once, and the washout period will be 72 hours, and each subject will be given subcutaneous injection twice. Sequence A: the test drug (SAL001) is injected in the first period, and the reference drug (FORSTEO) is injected in the second period. Sequence B: the reference drug (FORSTEO) is injected in the first period, and the test drug (SAL001) is injected in the second period.
If the geometric mean ratio (GMR) 90% confidence interval of the major pharmacokinetic indexes (AUC0-t, Cmax) for SAL001 and FORSTEO is between 80.00% and 125.00%, the two drugs are considered to be bioequivalent.

Start Date19 Aug 2020

Sponsor / Collaborator

Shenzhen Salubris Pharmaceuticals Co., Ltd.

100 Clinical Results associated with Recombinant human parathyroid hormone(Shenzhen Salubris Pharmaceuticals Co., Ltd.)

100 Translational Medicine associated with Recombinant human parathyroid hormone(Shenzhen Salubris Pharmaceuticals Co., Ltd.)

100 Patents (Medical) associated with Recombinant human parathyroid hormone(Shenzhen Salubris Pharmaceuticals Co., Ltd.)

Literatures (Medical) associated with Recombinant human parathyroid hormone(Shenzhen Salubris Pharmaceuticals Co., Ltd.)

01 May 2023·Clinical Pharmacology in Drug Development

Biosimilarity Assessment of the Biosimilar Teriparatide Candidate and the Reference Drug in Healthy Subjects

Article

Author: Wang, Tenghua ; Li, Chen ; Xiao, Shuangshuang ; He, Jin ; Ban, Li ; Wang, Xuan ; Liu, Haiyan ; Wang, Xiaole ; Li, Xianbo ; Fang, Yi ; Liang, Xintong ; Hu, Zhiqin ; Li, Yongmei ; Ma, Hui ; Zhan, Yaoxuan

AbstractSAL001, a recombinant form of parathyroid hormone, is a biosimilar drug to teriparatide and is planned to be used in osteoporosis treatment. A single‐dose, randomized, open‐label, 2‐way crossover trial was conducted in healthy subjects to compare the pharmacokinetics (PK) and safety between SAL001 and the reference drug. Sixty‐four subjects were enrolled in the study, and 61 subjects completed the study. In each period, 20 μg of the test or reference formulation was administered subcutaneously. SAL001 was administered by autoinjector pen, whereas the reference drug was administered by a self‐matched injection pen. Serial blood samples were obtained for the analyses of PK and serum calcium concentration. Geometric mean ratios with 90%CIs for the maximum plasma concentration (Cmax) and area under the plasma concentration–time curve (AUC) were estimated. The safety of these 2 formulations was also evaluated. Overall, the 90%CIs for the geometric mean ratios of Cmax, AUC from time 0 to the last quantifiable time point, and AUC from time 0 extrapolated to infinity of the test or reference product were within 80.0%–125.0% of biosimilarity criteria. Other PK parameters, serum calcium concentration, and safety profiles had no significant differences between the 2 formulations. SAL001 demonstrated PK similarity to the reference drug, and the serum calcium concentration and safety profiles of SAL001 were also considered comparable to the reference drug.

01 Apr 2020·MicrobiologyOpenQ3 · BIOLOGY

Recombinant spider silk coatings functionalized with enzymes targeting bacteria and biofilms

Q3 · BIOLOGY

ArticleOA

Author: Seijsing, Fredrik ; Nilebäck, Linnea ; Pasupuleti, Rajeev ; Hedhammar, My ; Seijsing, Johan ; Ståhl, Camilla ; Öhman, Oskar

AbstractBacteria forming biofilms on surgical implants is a problem that might be alleviated by the use of antibacterial coatings. In this article, recombinant spider silk was functionalized with the peptidoglycan degrading endolysin SAL‐1 from the staphylococcal bacteriophage SAP‐1 and the biofilm‐matrix‐degrading enzyme Dispersin B from Aggregatibacter actinomycetemcomitans using direct genetic fusion and/or covalent protein–protein fusion catalyzed by Sortase A. Spider silk assembly and enzyme immobilization was monitored using quartz crystal microbalance analysis. Enzyme activity was investigated both with a biochemical assay using cleavage of fluorescent substrate analogues and bacterial assays for biofilm degradation and turbidity reduction. Spider silk coatings functionalized with SAL‐1 and Disperin B were found to exhibit bacteriolytic effect and inhibit biofilm formation, respectively. The strategy to immobilize antibacterial enzymes to spider silk presented herein show potential to be used as surface coatings of surgical implants and other medical equipment to avoid bacterial colonization.

01 Jun 2017·Antimicrobial Agents and ChemotherapyQ2 · MEDICINE

Pharmacokinetics and Tolerance of the Phage Endolysin-Based Candidate Drug SAL200 after a Single Intravenous Administration among Healthy Volunteers

Q2 · MEDICINE

Article

Author: Jung, Gi Mo ; Jang, Kyungho ; Jun, Soo Youn ; Yoon, Seonghae ; Jang, In Jin ; Seong, Moon-Woo ; Yu, Kyung-Sang ; Kang, Sang Hyeon ; Yoon, Seong Jun ; Cho, Joo Youn

ABSTRACT This study was a phase 1, single-center, randomized, double-blind, placebo-controlled, single-dosing, and dose-escalating study of intravenous SAL200. It is a new candidate drug for the treatment of antibiotic-resistant staphylococcal infections based on a recombinant form of the phage endolysin SAL-1. The study evaluated the pharmacokinetics, pharmacodynamics, and tolerance among healthy male volunteers after the intravenous infusion of single ascending doses of SAL200 (0.1, 0.3, 1, 3, and 10 mg/kg of body weight). SAL200 was well tolerated, and no serious adverse events (AEs) were observed in this clinical study. Most AEs were mild, self-limiting, and transient. The AEs reported in more than three participants were fatigue, rigors, headache, and myalgia. No clinically significant values with respect to the findings of clinical chemistry, hematology, and coagulation analyses, urinalysis, vital signs, and physical examinations were observed, and no notable trends in our electrocardiogram (ECG) results for any tested dose were noticed. A greater-than-dose-proportional increase with regard to systemic exposure and the maximum serum concentration was observed when the SAL200 dose was increased from 0.1 mg/kg to 10 mg/kg. This investigation constitutes the first-in-human phase 1 study of an intravenously administered, phage endolysin-based drug. (This study has been registered at ClinicalTrials.gov under identifier NCT01855048 and at the Clinical Research Information Service [ https://cris.nih.go.kr/cris/ ] under identifier KCT0000968.).

News (Medical) associated with Recombinant human parathyroid hormone(Shenzhen Salubris Pharmaceuticals Co., Ltd.)

31 Oct 2023

·www.prnewswire.com

iNtRON, Executes Evaluation License and Option Agreement for SAL200

iNtRON Grants Basilea exclusive right for preclinical evaluation with an undisclosed payment Basilea has the option to enter into exclusive License Agreement following the evaluation BOSTON and SEOUL, South Korea, Oct. 30, 2023 /PRNewswire/ -- iNtRON Biotechnology ("iNtRON", ) has announced today that they have signed an "EVALUATION LICENSE AND OPTION AGREEMENT" with Basilea Pharmaceutica Ltd, Allschwil ("Basilea"), granting Basilea the option to enter into an exclusive license agreement for the antibacterial bio-drug SAL200 (Tonabacase). Basilea, headquartered in Switzerland, is a commercial-stage biopharmaceutical company specializing in the development of anti-infective drugs. Basilea has successfully developed and commercialized "Cresemba®," a treatment for invasive fungal infections, and "Zevtera®," a treatment for bacterial infections. They possess significant expertise in late-stage clinical development and commercialization. Basilea has assessed the clinical success potential by reviewing certain preclinical and clinical data and entered into this agreement with iNtRON to conduct evaluation studies to determine the optimal future clinical development program for SAL200. iNtRON will receive an initial upfront payment upon the execution of this agreement and will receive an additional payment upon Basilea exercising the option to negotiate an exclusive license agreement after the completion of the evaluation test, which can last up to one year. Certain essential terms of the exclusive license agreement have been pre-agreed upon along with the current agreement. The total contract amounts shall be undisclosed under the confidential obligations between the two companies. iNtRON has been actively discussing the exclusive license agreement with Basilea, who showed keen interest in SAL200. It was determined that Basilea is a suitable partner for the further development and commercialization of SAL200 in the field of infectious disease, and iNtRON has signed the agreement to ensure the development progress of SAL200. YOON, Kyung Won, the CEO of iNtRON, stated, "Basilea is a suitable partner, since they have a strong track record of successfully developing and commercializing anti-infective drugs, and in particular, they are a stable company with ample clinical development experience, including a recent NDA submission to the US FDA." He added "We are confident that the planned evaluation tests will significantly increase the probability of successful completion of a Phase 2 study. With a partner who already possesses commercialization capabilities, we believe in the success of SAL200." About SAL200 (Tonabacase) SAL200 is a novel endolysin-based anti-staphylococcal drug formulated for injection. Its active pharmaceutical ingredient is the recombinant phage endolysin SAL-1, derived from the staphylococcus-specific bacteriophage SAP-1. SAL200 is proven to be effective in treating staphylococci-associated infections including MSSA, MRSA, and other so-called superbugs through the previous in vitro, in vivo and clinical studies. The phase 1a, 1b MAD and 2a study for SAL200 was completed in Korea and the further development is expected to be conducted in global. The IND application for the US Phase 2 study has been approved by FDA. About iNtRON Biotechnology, Inc. iNtRON () is a bio-new drug developing venture company and a leader in bacteriophage-based technology for human with aim to develop and investigate into the 'Immune & Immunotherapeutics' market. While pursuing global research and business development (R&BD) investments since the foundation and accelerated development after entering its IPO in KOSDAQ, the company honed in on innovating BIO New Drugs by developing various 'First-in-Class" and "First-in-Concept' bio-drugs and conducting clinical studies in phases. The Company is committed to development of innovative innovation in the infectious diseases and 'Immune & Immunotherapeutics' area. Contact Us YOON, Kyung Won (Kevin) / CEO, Vice President / [email protected] SHIN, Tae Kyu (TK) / BD Team Leader / [email protected] BD Team / [email protected] it is iNtRON. SOURCE iNtRON Biotechnology, Inc.

License out/inPhase 2

12 Jan 2023

·www.prnewswire.com

iNtRON is finalizing the SAL200 Tech Transfer

Including the contract transfers of the external studies planned for the successful out-licensing and commercialization of SAL200 BOSTON and SEOUL, South Korea, Jan. 11, 2023 /PRNewswire/ -- iNtRON Biotechnology ("iNtRON", ) has announced today that the Tech Transfer process of SAL200, endolysin-based new biologic, is in the final stage. According to the Company official, the Tech Transfer process took a little longer than expected due to the massive volume of data transferred from the previous Partner. Along with the data that have been transferred during the last three months, it was required to take over the studies of external institutions that the previous partner had been conducting. Through the renewal of the contracts with the external institutions, the Company has taken various measures to continue the clinical study of SAL200. The Tech Transfer process has been carried out well as most materials including the US FDA approved SAL200 IND related documents have been secured except few from the CRO, and the follow-up studies are also in progress as planned. The follow-up studies are being conducted through a number of external institutions according to the transferred rights, which are necessary for the clinical trial of SAL200 to be conducted as planned by the US clinical experts. The Company official explained, since the data generated by the follow-up studies will be important for the out-licensing of SAL200, the Company has focused on transfer of the documents and studies by the external institutions in a while, and the Company will be able to focus more on the out-licensing of SAL200 when the Tech Transfer process is fully completed soon. Dr. KANG, Sang Hyeon, CTO of iNtRON said, "We believe that our strategy and the clinical trial plan for SAL200 has been very well prepared through the consultation with clinical experts. We will make much of efforts to take over the rights of external studies that support our well established plan and to ensure that those progresses lead to good results in out-licensing of SAL200." About SAL200, TONABACASE SAL200 is a novel endolysin-based anti-staphylococcal drug formulated for injection. Its active pharmaceutical ingredient is the recombinant phage endolysin SAL-1, derived from the staphylococcus-specific bacteriophage SAP-1. SAL200 is proven to be effective in treating staphylococci-associated infections including MSSA, MRSA, and other so-called superbugs through the previous in vitro, in vivo and clinical studies. The phase 1a, 1b MAD and 2a study for SAL200 was completed successfully in Korea and the further development is going to be conducted in global. The IND application for the US Phase 2 study has been approved by FDA in January, 2022. About iNtRON Biotechnology, Inc. iNtRON () is a bio-new drug developing venture company and a leader in bacteriophage-based technology for human with aim to develop and investigate into the 'Immune & Immunotherapeutics' market. While pursuing global research and business development (R&BD) investments since the foundation and accelerated development after entering its IPO in KOSDAQ, the company honed in on innovating BIO New Drugs by developing various 'First-in-Class" and "First-in-Concept' bio-drugs and conducting clinical studies in phases. The Company is committed to development of innovative innovation in the infectious diseases and 'Immune & Immunotherapeutics' area. About iNtODEWORLD, Inc. iNtRON has established its wholly owned US subsidiary, iNtODEWORLD, Inc. in 2017. iNtODEWORLD was initially registered in Delaware and the headquarter office is currently located in Boston. iNtODEWORLD provides news, updates and platform development progresses of iNtRON to its potential global partners and collaborators along with its own R&BD works in the US. Contact Us YOON, Kyung Won (Kevin) / CEO, Vice President / [email protected] SHIN, Tae Kyu (TK) / BD Team Leader / [email protected] BD Team / [email protected] iNtRON Biotechnology, Inc. #708, 148, Sagimakgol-ro, Jungwon-gu, Seongnam-si, Gyeonggi-do, Republic of Korea iNtODEWORLD, Inc. 1500 District Avenue, Suite 2097, Burlington, MA 01803, USA it is iNtRON. SOURCE iNtRON Biotechnology, Inc.

INDLicense out/inIPOPhase 2

100 Deals associated with Recombinant human parathyroid hormone(Shenzhen Salubris Pharmaceuticals Co., Ltd.)

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Osteoporosis, Postmenopausal	CN	Salubris (Suzhou) Pharmaceuticals Co., Ltd.	29 Sep 2019

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Fractures, Bone	Phase 3	CN	Salubris (Suzhou) Pharmaceuticals Co., Ltd.	24 Nov 2021
Fractures, Bone	Phase 3	CN	Genekey Biotech (Chengdu) Co. Ltd.	24 Nov 2021
Primary osteoporosis	Discovery	CN	Salubris (Suzhou) Pharmaceuticals Co., Ltd.	28 Dec 2018
Primary osteoporosis	Discovery	CN	Genekey Biotech (Chengdu) Co. Ltd.	28 Dec 2018

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