A Prospective, Multicenter, Randomized, Double-blind, Parallel Controlled, and Superiority Clinical Trial to Evaluate the Effectiveness and Safety of Ingested, Space Occupying Hydrogel Capsules for Simple Obesity Treatment

To evaluate the effectiveness and safety of Ingested, Space Occupying hydrogel capsules for simple obesity treatment

Start Date31 Jul 2024

Sponsor / Collaborator

Imeik Technology Development Co., Ltd.

CTR20230095

/ CompletedPhase 3

利多卡因丁卡因乳膏用于成人浅层皮肤手术前对完整皮肤的局部麻醉有效性及安全性随机、阳性药自身对照、双盲、多中心、等效性临床研究

[Translation] A randomized, positive self-controlled, double-blind, multicenter, equivalence clinical study on the efficacy and safety of lidocaine tetracaine cream for local anesthesia of intact skin before superficial skin surgery in adults

以原研药 PLIAGLIS ®为阳性对照，通过随机、双盲、自身对照的临床试验，验证试验药物利多卡因丁卡因乳膏用于成人浅层皮肤手术前对完整皮肤局部麻醉的有效性。通过实验室检查、临床症状、体征、不良事件等，验证利多卡因丁卡因乳膏的安全性。

[Translation]

Using the original drug PLIAGLIS ® as a positive control, a randomized, double-blind, self-controlled clinical trial was conducted to verify the effectiveness of the experimental drug lidocaine tetracaine cream for local anesthesia of intact skin before superficial skin surgery in adults. The safety of lidocaine tetracaine cream was verified through laboratory tests, clinical symptoms, signs, adverse events, etc.

Start Date29 Mar 2023

Sponsor / Collaborator

Shandong Liangfu Pharmaceutical Co., Ltd

[+1]

CTR20211394

/ CompletedPhase 3

多中心、双盲、随机、平行、阳性对照的Ⅲ期试验，评价注射用A型肉毒毒素HUTOX相较于BOTOX®在中度至重度眉间纹受试者中的有效性和安全性

[Translation] A multicenter, double-blind, randomized, parallel, active-controlled Phase III trial to evaluate the efficacy and safety of HUTOX for injection compared with BOTOX® in subjects with moderate to severe glabellar lines

主要目的：评价在中国的中至重度眉间纹成年受试者中，使用试验药品 Huons BioPharma Co., Ltd.生产的注射用A型肉毒毒素（HUTOX）在注射后4周的最大皱眉时眉间纹改善率是否非劣于对照药品BOTOX ®

[Translation]

Primary objective: To evaluate whether the investigational product, botulinum toxin type A for injection (HUTOX), manufactured by Huons BioPharma Co., Ltd., is non-inferior to the control product BOTOX® in terms of improvement in glabellar lines at maximal frown 4 weeks after injection in Chinese adult subjects with moderate to severe glabellar lines.

Start Date03 Dec 2021

Sponsor / Collaborator

Imeik Technology Development Co., Ltd.

[+1]

100 Clinical Results associated with Imeik Technology Development Co., Ltd.

0 Patents (Medical) associated with Imeik Technology Development Co., Ltd.

Literatures (Medical) associated with Imeik Technology Development Co., Ltd.

01 Nov 2024·Aesthetic Plastic Surgery

Cross-linked Sodium Hyaluronate Gel with PLLA-b-PEG Microsphere for Facial Contouring in Chinese: A Retrospective Study

Article

Author: Diao, Yu-Jia ; Zhang, Shu-Xian ; Qiu, Yin-Xian ; Huang, Jian-Mei ; Lou, Xia ; Luo, Sheng-Kang ; Song, Ping ; Liu, Xiang ; Du, Pei ; Pan, Bao-Hua ; Zhu, Meng-Jie ; Zeng, Dong ; Liao, Zhi-Feng ; Zhu, Lin ; Yang, Wei ; She, Yu-Hong ; Ou, Jian-Tao ; Han, Chu ; Ya, Zu-Meng ; Hu, Wen-Hao ; Chen, Ke

BACKGROUNDIn Asia, the demand for cosmetic facial treatments has surged due to technological advancements, increased social acceptability, and affordability. Poly-L-lactic acid (PLLA) fillers, known for their biocompatibility and biodegradability, have emerged as a popular choice for facial contouring, yet studies specifically addressing their use in Asian populations are scarce.METHODSThis retrospective study examined 30 Chinese patients who underwent facial contouring with PLLA fillers, focusing on product composition, injection techniques, and safety measures. A comprehensive clinical evaluation was performed, including the Global Aesthetic Improvement Scale (GAIS) and Global Impression of Change Scale (GICS) for effectiveness and patient satisfaction, respectively.RESULTSNo significant difference in GAIS scores was observed between injectors and blinded evaluators over a 12-month period, indicating consistent effectiveness. Patient satisfaction remained high, with GICS scores reflecting positive outcomes. The safety profile was favorable, with no serious adverse events reported. The study highlighted the importance of anatomical knowledge to avoid complications, particularly in areas prone to blindness.CONCLUSIONSPLLA fillers offer a safe, effective option for facial contour correction in the Asian population, achieving high patient satisfaction and maintaining results over time. The study underscores the need for tailored approaches in cosmetic procedures for Asians, considering their unique facial structures and aesthetic goals. Further research with larger, multicenter cohorts is recommended to validate these findings and explore long-term effects.LEVEL OF EVIDENCE IIIThis journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

01 Oct 2024·Aesthetic Plastic Surgery

Objective Noninvasive Measurement of the Volumizing Effect of a Dermal Filler: An In Vivo Study

Article

Author: Chen, Bin ; Shi, Mengrou ; Wang, Shiwei ; Li, Xin ; Ren, Jizhen ; Liu, Xiaowen ; Niu, Huanyun

AbstractBackgroundInformation about the volumizing effects of dermal fillers is critical for physicians’ understanding of product features and prudent decision-making in clinical practice. It is important for material engineers to develop and optimize new dermal fillers, especially when comparing the physiochemical properties of a new product with those of existing fillers that are used worldwide.ObjectiveThis study aimed to establish a reliable, noninvasive method for in vivo quantitative evaluation of the filling effect in order to predict possible effectiveness after filler injection and to evaluate the degradation trend over time.MethodsA rabbit model of ear injection with dermal fillers was established. Hyaluronic acid (HA) filler was injected into the subcutaneous layer of rabbit ears, resulting in a stable skin bulge. Ultrasonography was used to noninvasively measure the skin bulge for volume calculation; the volume change was analyzed periodically until 38 weeks. Pathological examination, the gold standard, was performed to confirm degradation.ResultsThe immediate volumizing effect of HA filler injection was macroscopically observed as a local skin bulge. Ultrasound was able to precisely detect the shape of the filler and calculate the length, width, and height of the skin bulge at each time point. The degree of uplift and amount of residual samples in the pathological evaluation were consistent with the results of morphological observation using ultrasound.ConclusionEvaluation of the volume impact of dermal filler through the rabbit ear injection model evaluation enables material science evaluation in the early stage of material development, and has certain clinical reference value.Level of Evidence IThis journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

01 Apr 2024·Aesthetic Plastic Surgery

Infraorbital Rejuvenation Combined with Thread-Lifting and Non-cross-linked Hyaluronic Acid Injection: A Retrospective, Case-Series Study

Article

Author: Yang, Wei ; Liao, Zhi-Feng ; Liu, Fang-Cen ; Wang, Shi-Wei ; Luo, Sheng-Kang ; Li, Xin

AbstractBackgroundInfraorbital aging develops during the natural aging process. Various treatment options offer unique benefits, accompanied by diverse side effect profiles, and can be synergistically combined to optimize results. This study aimed to evaluate the efficacy of a comprehensive approach involving non-cross-linked hyaluronic acid injection and smooth absorbable PPDO (poly p-dioxanone) thread insertion for infraorbital rejuvenation.MethodsThis retrospective case series study enrolled ten female patients with infraorbital aging from March 2022 to April 2023. Clinical outcomes, patient satisfaction, and adverse events were assessed at 1, 3, and 6 months posttreatment.ResultsThe median Global Aesthetic Improvement Scale scores evaluated by the operator and blinded evaluator were 1.70 ± 0.42 and 1.80 ± 0.35, respectively, at six months posttreatment. The median Allergan Infraorbital Hollows Scale determined by the operator was 1.15 ± 0.34 at six months posttreatment, whereas the scores evaluated by the blinded evaluator were 1.15 ± 0.53. At six months after treatment, 50% of patients were satisfied, and an additional 40% reported strong satisfaction with the clinical improvement following treatment. No serious adverse events, such as infections, lumps, irregularities, Tyndall effect, hematoma, or skin necrosis, occurred during the treatment period.ConclusionsThe combination of PPDO thread insertion and non-cross-linked hyaluronic acid injection yielded satisfactory and effective clinical outcomes with no occurrence of serious adverse events for infraorbital rejuvenation. We anticipate that this study will contribute to the advancement of novel treatment options for infraorbital aging.Level of Evidence IV This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

News (Medical) associated with Imeik Technology Development Co., Ltd.

23 Jun 2021

·koreajoongangdaily.joins.com

Imeik invests ￦155 billion for 25% stake in Huons BioPharma

Top executives of Huons Global and Imeik Technology sign an agreement, Thursday. [HUONS GROUP] Bio pharmaceutical company Huons Group received in investment 155.4 billion won ($137.2 million) from China’s Imeik Technology in exchange for a 25.4 percent stake in Huons BioPharma. According to the Korean company on Thursday, the investment will go to subsidiary Huons BioPharma, which is in charge of selling its botulinum toxin product, Hutox, overseas. Also known as “botox,” the substance is widely used by beauty surgeons to reduce wrinkles. Imeik Technology signed up as Huons BioPharma’s exclusive partner for Hutox in China in 2018. It is one of China’s largest players in the aesthetic industry and was listed on the Shenzhen stock exchange last year with a market cap currently standing at 26 trillion won. As part of Thursday’s deal, Imeik Technology will become the second largest shareholder of Huons BioPharma with 25.4 percent. Huons Global, the group’s holding company unit, will remain the major stakeholder with 74.6 percent. The stock purchase will need approval from Imeik Technology’s board of directors. According to Huons Group, the deal is intended to strengthen the partnership between the two companies and expand Hutox’s market share in China, where the botulinum toxin market has an estimated size of 600 billion won. Hutox is currently under preparation to launch Phase 3 clinical trials in China and has not yet launched sales.

Phase 3Acquisition

100 Deals associated with Imeik Technology Development Co., Ltd.

100 Translational Medicine associated with Imeik Technology Development Co., Ltd.

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Pipeline Snapshot as of 02 Feb 2025

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Phase 3 Clinical

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Botulinum toxin type A(Aquavit Pharmaceuticals/Huons) ( SNAP25 )	Glabellar frown lines More	NDA/BLA
Lidocaine/Tetracaine ( SCNA )	Anesthesia More	Phase 3
Recombinant Human Hyaluronidase (Beijing Novotel) ( Hyaluronic acid )	Drug adjuvant More	IND Approval
Semaglutide biosimilar(QL Biopharma) ( GLP-1R )	Obesity More	IND Approval
Liraglutide biosimilar(Nobot Biotechnology) ( GLP-1R )	Obesity More	Pending

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