Weekly Aesthetic Medicine Roundup: Cracking Down on 'Beauty Shills', CAPA Warns Against Korean Low-Price Medical Tourism, and Multiple New Devices Approved

Mar 09, 2025 18:01 CST Updated 18:01

Medlander

Developer of Intelligent Pelvic Floor Rehabilitation Diagnosis and Treatment System Products

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丨First RF Microneedling Device in China Receives FDA Certification

Recently, the official website of the U.S. Food and Drug Administration (FDA) announced that the golden microneedle product developed and manufactured by Shenzhen Peninsula Medical Group Co., Ltd. (hereinafter referred to as "Peninsula Medical") has obtained FDA 510(k) registration certification. It is reported that this device is the first domestically produced radiofrequency microneedle instrument in China to receive such registration certification, advancing the "going overseas" progress of domestic photoelectric medical aesthetic equipment brands.

Industry research institute - LeadLeo Research Institute, in a 2023 report, pointed out that the market size calculated by project revenue has grown from 4.502 million yuan to 7.277 million yuan for China's radiofrequency microneedling industry from 2018 to 2022. It is projected that from 2023 to 2027, the scale of China's radiofrequency microneedling industry will increase from 8.410 million yuan to 14.732 million yuan.(Source of information:(Shenzhen Business Daily)

丨The 3rd in China,Medlander "Facial Anti-Aging" Medical Aesthetic Indication "Ultrasonic Treatment Device" Approved

February 28, 2025Medlander Medical Technology Inc.,自主研发的二类“超声波治疗仪”正式获得江苏省药监局批准，注册证号：苏械注准20252090332。据悉，超声波治疗仪产品由主机、脚踏开关、手柄和治疗头组成，主要利用超声波能量，在不发生组织变性的情况下，有助于面部皮肤的紧致提升、祛除皱纹。

As of now, two Class II ultrasound therapy devices for "skin tightening, lifting, and wrinkle removal" have been approved in China: the MFU pro "Mirame Ultrasonic Device" (Approval No. Yuxie Zhunzi 20242090073), exclusively represented by Jingyan Biotech, and Bolida Polida® "Platinum Ultrasound Device" (Approval No. Qianxie Zhunzi 20242090048) from Guizhou Polida Medical. The "Ultrasonic Therapy Device" recently approved for Medlander is the third compliant medical aesthetic ultrasound therapy device to be approved in China.(Source of information:Medactive ）

丨Medlander's "Golden Microneedle" Approved for Medical Device Class III

According to the information on "Delivery of Medical Device Approval Documents" published by the National Medical Products Administration on March 6, 2025, "High-Frequency Surgical Equipment" under the brand Simis received approval. Registration Number: NMPA Approval 20253010499; Intended Use: The product is used in medical institutions and works with high-frequency surgical accessories for cutting and coagulating skin tissue.

It is the first gold microneedle approved by the China NMPA for Class III medical devices. High-frequency surgical equipment implies its wide application, including in surgical procedures such as plastic surgery, cosmetic treatments, dermatology, and other fields.

Revenue of 32 Billion! Medical Beauty Giant Galderma Releases Latest Financial Report

On March 6, Galderma (SIX:GALD) released its 2024 annual financial report. The report showed that Galderma's net sales in 2024 reached US$4.41 billion, approximately RMB 32 billion, representing a year-on-year increase of 9.3% at constant exchange rates.

Business growth was mainly driven by the following three major segments: 1) Injectable Aesthetics: Net sales of $2.299 billion, a year-on-year increase of 9.6%. Among them, Dysport and Sculptra achieved double-digit growth. 2) Skincare: Net sales of $1.331 billion, a year-on-year increase of 10.7%. Strong performance from Cetaphil and Alastin brands, especially in international markets. 3) Therapeutic Dermatology: Net sales of $780 million, a year-on-year increase of 6.1%, mainly due to the first sales of Nemluvio® (nemolizumab) in the United States.

丨HuiXin Biotech Completes Nearly RMB100 Million Series A Financing, Dedicated to Solving Exosome Application Bottlenecks

Recently, Shenzhen Huixin Biomedical Technology Co., Ltd. successfully completed its Series A financing, raising nearly 100 million RMB. This round of financing attracted investments from well-known investors and received strong support from the Haoyue China Healthcare Industry Fund. The proceeds will accelerate Huixin Biomedical's global business expansion, promote the full automation of upstream separation and purification in the exosome and cell industry, and achieve cost reduction and efficiency improvement, enhancing the overall efficiency of the industrial chain.

EXODUS: A Breakthrough in Exosome Separation TechnologyHuiXin Biotech, established in 2017 and located in Shenzhen, has quickly gained recognition with its groundbreaking membrane vibration separation technology. The company’s self-developed EXODUS, the world's first fully automatic exosome separation and purification device, utilizes negative pressure oscillation and ultrasonic oscillation to construct an entirely new membrane vibration separation system. Evaluated by multiple authoritative institutions worldwide, EXODUS demonstrates significantly superior separation and purification performance compared to traditional methods, successfully overcoming technical bottlenecks in the industry and greatly advancing the rapid development of the exosome field.(Source of information:Investment Community ）

丨Medlander Medical Technology Inc.'s Optical RF Treatment Device V30 China Registration Application Accepted by NMPA

On March 5, 2025, Viora Ltd. (hereinafter referred to as "Viora"), a wholly-owned subsidiary of Huadong Medicine Co., Ltd. (hereinafter referred to as "the Company"), received the Acceptance Notice issued by the National Medical Products Administration (NMPA). The registration application for the Class III medical device, optical radiofrequency therapy device V30, submitted by Viora has been accepted.(Source of information:Tonghuashun Finance ）

丨PDRN Compound Solution Completes Clinical Subject Enrollment, Jiangsu WuZhong Poised to Fill Domestic Market Gap

Jiangsu Wuzhong (600200.SH)’s injectable sodium hyaluronate-polydeoxyribonucleotide (hereinafter referred to as "PDRN") composite solution product has completed the enrollment of all clinical trial participants and is expected to be approved for marketing within 2026.

PDRN, due to its extremely high safety, has been approved for marketing in multiple countries including Italy and South Korea. In contrast, the medical aesthetics market in China has a strong demand for compliant and efficient products. Although the hyaluronic acid injection market is large, PDRN solution as a Class III medical device remains absent. Jiangsu WuZhong, through its collaboration with Lirui Technology, is expected to be the first to fill this gap. PDRN compound solution is a rare "regenerative hydrating product" and is expected to become the next big hit like "HiBody," becoming Jiangsu WuZhong's new blockbuster product.(Source of information:Eyewear Finance )

丨Medlander "Lipolysis Injection RZL-012" Initiates Phase III Clinical Trial in China

It was recently reported that Tianjin Xingmei Biotechnology Co., Ltd. ("Xingmei Bio" or "Juvestar," a Fosun Pharma affiliate) has announced the introduction of an injectable fat-reduction drug (RZL-012) under development by Israeli company Raziel Therapeutics to initiate Phase III registration trials in China, with the target indication being submental fat reduction (double chin).

It is reported that Xingmei Biologics has the exclusive rights for clinical development and commercialization of this product in Greater China (Mainland and Hong Kong, Macao, Taiwan), with an expected launch in China in 2027.(Source of information:Medactive ）

丨Hyaluronic Acid Accounts for 51% of China's Medical Aesthetics Injectable Market Share

From the perspective of细分 product categories, the most widely used products in China's medical aesthetics injectables market currently include hyaluronic acid, botulinum toxin, and collagen. According to statistics, in the domestic medical aesthetics injectables market, hyaluronic acid is the primary filler substance, accounting for a market share as high as 51%; followed by botulinum toxin, which holds a 33% market share, and together with hyaluronic acid, they occupy over 80% of the medical aesthetics injection market; although collagen has gained significant market attention in recent years, its market share is only 9% due to factors such as high technical barriers, few approved products, and insufficient market awareness.(Source of information:(Zhiyan Consulting)

丨Warning from the Chinese Association of Plastic and Reconstructive Surgery on the Phenomenon of Low-Cost Medical Tourism in South Korea

March 7,The WeChat Official Account of the Membership Department of the Chinese Association of Plastic Surgery released an article titled "Consumer Alert | Warning from the Chinese Association of Plastic Surgery on the Phenomenon of Low-Cost Medical Tourism in South Korea"

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Source of Information:Member Department of the Chinese Association of Plastic and Reconstructive Surgery

丨People's Hot Review: The Preoperative System Should Be Improved to Eliminate Metoprolol

Following the "meal pushers" and "drink pushers," a marketing scheme known as "beauty pushers" has quietly emerged in the medical aesthetics industry.

The so-called "Meituo" refers to salespeople pre-arranged by medical aesthetic institutions in beauty salons, who collaborate with beauty salon staff and medical aesthetic consultants. Following a pre-written "script," they use "sales tactics" to precisely "target" potential customers.
This "scripted encirclement" jointly woven by medical aesthetics institutions, beauty salons, and sales personnel instills erroneous concepts such as "one treatment solves all problems" into consumers, gradually trapping them in a chain of "lead generation - conversion - harvesting." As a result, consumers overlook their true needs and are induced into excessive spending. Some even sink deeply into the quagmire of "beauty loans," unable to extricate themselves!

These "beauty cons" that induce consumers to purchase goods or services are suspected of false advertising and fraud. In May 2023, the Guiding Opinions on Further Strengthening the Supervision of the Medical Aesthetics Industry, jointly issued by 11 departments including the State Administration for Market Regulation, pointed out that it is strictly forbidden to make promises or statements that do not comply with laws, regulations, and medical standards during diagnosis consultations and medical guidance activities. The guidelines also emphasized increasing legal efforts to handle "medical cons" and "pharmaceutical cons," investigating commercial bribery, and severely cracking down on illegal diagnosis consultations and medical guidance activities.

However, the actions of "Meituo" and "Yituo" are extremely covert, and consumers often encounter difficulties such as challenges in providing evidence, high standards for proof, and exorbitant costs when defending their rights. Therefore, it is necessary to promptly establish and improve relevant systems while strengthening supervision, clarifying the identification standards and legal responsibilities of "Meituo" and "Yituo," and taking strong measures to crack down on and rigorously rectify unethical marketing practices.

At the same time, to supervise whether some medical aesthetic institutions engage in fraudulent behavior, the system of audio and video recording of preoperative conversations is worth promoting widely within the medical aesthetics industry. This system can standardize doctor-patient communication and serve as crucial evidence for dispute resolution. Some larger medical aesthetic institutions can take the lead in adopting this system to create a benchmark effect, achieving the result of "driving out bad practices with good ones" and promoting the healthy development of the industry.

Medical aesthetics is a special field in the healthcare industry that is very close to consumers. While rapidly developing, it should strengthen its social responsibility. Consumers who pursue beauty should also do their homework and consume rationally, avoid traps set by exploiting appearance anxiety, and protect their health and rights, so as to fully enjoy beauty.(Source of information:People's Daily Online ）

丨Mudanjiang Market Supervision Bureau in Heilongjiang Province Conducts Special Inspection on Medical Device Safety for Cosmetic Medicine

Recently, the Mudanjiang Market Supervision Administration conducted inspections on the safe use of medical devices in medical beauty institutions to safeguard the public's safety in using medical equipment.

The inspection team focused on high-risk products such as injectable sodium hyaluronate gel, microneedles, radiofrequency (skin) therapy devices, and plastic implant materials, with an emphasis on examining purchase channels, supplier qualifications, and standardized acceptance procedures. For routine varieties, the focus was on inspecting product registration certificates and the storage of cold chain products. Regarding complex issues in quality safety control during enterprises' daily operations, the team guided companies in establishing quality management systems and quality records, providing precise services.

Next, the Mudanjiang Market Supervision Bureau will continue to deepen the "regulation + service" model, promoting enterprises to shift from passive rectification to active standardization, and fully creating a safe and reassuring medical aesthetics consumption environment.(Source of information:Heilongjiang Provincial Drug Administration）