NMPA-Approved Injectable Fillers in China's Market

by Grace Wang Nov 04, 2021

An approved injectable filler product could achieve success in China. For example, Ellansé, entered the Chinese mainland market in August this year, has brought advance payments of over 100 million yuan1 to Huadong Medicine Co., Ltd.

China's promising injectable filler market is expected to witness other new products' emergence. The market size is predicted to grow from US$ 603.8 million in 2019 to US$ 1,063.53 million by 20262.

China Tightens Regulatory Supervision on Injectable Fillers

China's current regulation on injectable fillers is stringent and tends to get stricter.

Earlier in 2014, the former China Food and Drug Administration (CFDA), started an inspection of hyaluronic acid injectable filler companies, punishing illegalities and ordering rectification.3 

In June 2021, National Health Committee (NHC) and other seven authorities jointly released the Special Work Plan on Cracking Down on Illegal Medical Aesthetic Services4. The plan forbids the use of unqualified medicines, medical devices and disinfectant devices.

This September, National Medical Products Administration (NMPA) announced that it would enhance the regulation on injectable fillers for cosmetic use.5

The tightening regulation shows that China won't be lenient with illegal aesthetic medical products or practices. Injectable fillers and relevant businesses won't be an exception.

Approved Injectable Fillers in China Market

On the basis of regulatory compliance, injectable filler manufacturers and suppliers still have chances to thrive in the Chinese market.

To better understand the market profile and dynamics, new injectable filler companies need to know their competitors who have obtained marketing authorization from NMPA.

The article will introduce NMPA-approved injectable fillers and their uses by categories, and give examples of specific products in each category.

1. Injectable Fillers Using Sodium Hyaluronate as Main Ingredient

China NMPA-Approved Sodium Hyaluronate Injectable Fillers

Category

Product

Approved Use

Manage-ment   Class

MAH

Cross-linked sodium hyaluronate as the main ingredient

 

Cross-linked Sodium   Hyaluronate Gel for Injection

Cross-linked Sodium Hyaluronate Gel for Injection

/Juvéderm ULTRA

Injected into the medium-to-deep layer of the facial dermis to correct moderate-to-severe   nasolabial folds.

Class III medical device

Allergan

Modified Sodium Hyaluronate Gel for Injection

Modified Sodium Hyaluronate Gel for Injection

/Princess Volume

Class III medical device

CROMA GmbH

Uncross-linked sodium hyaluronate as the main ingredient

Sodium Hyaluronate Compound Solution for Injection

Injected into the dermis to correct moderate-to-severe neck lines or wrinkles.

Class III medical device

IMEIK Technology Development Co., Ltd.

2. Injectable Fillers Using Collagen as Main Ingredient

China NMPA-Approved Collagen Injectable Fillers

Category

Product

Approved Use

Manage-

ment Class

MAH

Collagen Implant

Sunmax Collagen Implant I-Plus

Injected to medium-to-deep layer of the facial dermis for the correction of gravity-tugged nasolabial folds.

Class III medical device

Sunmax Biotechnology Co., Ltd.

Collagen Implant with Lidocaine

Sunmax FACIALGAIN Collagen Implant with Lidocaine

Injected to medium-to-deep layer of the facial dermis for the correction of gravitational nasolabial folds.

Class III medical device

Sunmax Biotechnology Co., Ltd.

Medical Collagen Implant

Medical Collagen Implant

/FILLDERM

Injected into the facial dermis to correct moderate-to-severe nasolabial folds.

Class III medical device

Changchun Botai Pharmaceutical Biotechnology Co., Ltd.

Type III Recombinant Freeze-dried Human Collagen Fiber

Type III Recombinant Freeze-dried Human Collagen Fiber

Indicated for filling facial dermis to correct dynamic wrinkles, including frown lines, forehead wrinkles, and crow's feet.

Class III medical device

Shanxi Jinbo Bio-Pharmaceutical Co., Ltd.

3. Injectable Fillers Combining Sodium Hyaluronate and Hydroxypropyl Methylcellulose

Grace Wang
ChemLinked Regulatory Analyst
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