NMPA-Approved Injectable Fillers in China's Market

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

China NMPA-Approved Injectable Fillers Combining Sodium Hyaluronate and Hydroxypropyl Methylcellulose
Category and Main Components	Product	Approved Use	Manage-ment Class	MAH
Medical Hydroxypropyl Methylcellulose-Sodium Hyaluronate Solution: gel-like aseptic solution made by hydroxypropyl methylcellulose, sodium hyaluronate, and balanced salt solution.	Medical Hydroxypropyl Methyl-cellulose-Sodium Hyaluronate Solution/EME	Injected into the area between the deep dermis and superficial subcutaneous tissues to correct forehead wrinkles or moderate-to-severe nasolabial folds.	Class III medical device	IMEIK Technology Development Co., Ltd.
Medical Sodium Hyaluronate-Hydroxypropyl Methylcellulose Gel: mainly made of cross-linked sodium hyaluronate particles, hydroxypropyl methylcellulose, sodium chloride-phosphate buffer, and water for injection.	Medical Sodium Hyaluronate-Hydroxypropyl Methyl-cellulose Gel	Injected into superficial to the deep layer of subcutaneous tissues to correct moderate-to-severe forehead wrinkles or moderate-to-severe nasolabial folds.	Class III medical device	IMEIK Technology Development Co., Ltd.

4. Injectable Fillers Made of Biodegradable Polyester Microspheres and Excipients

China NMPA-Approved Injectable Fillers Made of Biodegradable Polyester Microspheres and Excipients
Category and Main Components	Product	Approved Use	Manage-ment Class	MAH
Polylactic Acid (PLA) Facial Filler: freeze-dried powder made of PLA particles, mannitol, and carboxymethyl cellulose (CMC). It should be dissolved with 0.9% sodium chloride solution for injection into suspension before use.	PLA Facial Filler	Injected into subcutaneous tissues to correct moderate-to-severe nasolabial folds.	Class III medical device	Changchun Shengboma Biological Materials Co., Ltd.
Polycaprolactone Microspheres Facial Filler for Injection: pre-filled syringe, stainless steel syringe needle, and gel particle suspension packaged in the syringe. The gel is made of artificially synthesized polycaprolactone (PCL) microspheres, glycerol, CMC, and phosphate-buffered saline. The PCL microspheres account for 33.1% in weight.	Polycaprolactone Gel for Injection	Injected to subcutaneous tissues to correct moderate-to-severe nasolabial folds.	Class III medical device	AQTIS Medical B.V.
Polylactic-co-glycolic Acid (PLGA) Microspheres and Cross-linked Sodium Hyaluronate Gel for Injection: made of cross-linked sodium hyaluronate, PLGA microspheres, lignocaine hydrochloride, and phosphate buffer.	PLGA Microspheres and Cross-linked Sodium Hyaluronate Gel for Injection	Injected to the deep dermis or superficial subcutaneous tissues to correct moderate-to-severe nasolabial folds.	Class III medical device	IMEIK Technology Development Co., Ltd.

5. Injectable Fillers Using Non-Biodegradable Ingredients

China NMPA-Approved Injectable Fillers Using Non-Biodegradable Ingredients
Category and Main Components	Product	Approved Use	Manage-ment Class	MAH
Plastic-Surgery-Use Collagen and Polymethylmethacrylate (PMMA) Dermal Filler System: gel suspension of PMMA microspheres, collagen from cowhide, and a small amount of lidocaine. PMMA is non-biodegradable.	Plastic-Surgery-Use Collagen and Polymethylmethacrylate (PMMA) Dermal Filler System /ArteColl	Injected into deep dermis to correct nasolabial folds, or into the outer periosteum for augmentation rhinoplasty at the nasal bone area.	Class III medical device	Hafod Bioscience GmbH
Medical Polyvinyl Alcohol (PVA) Gel Microsphere and Sodium Hyaluronate- Hydroxypropyl Methylcellulose Gel: mainly made of sodium hyaluronate, hydroxypropyl methylcellulose, PVA microspheres, and balanced salt solution. Polyvinyl alcohol is non-biodegradable.	Medical Polyvinyl Alcohol Gel Microsphere and Sodium Hyaluronate-Hydroxypropyl Methylcellulose Gel	Injected into the area between the deep dermis and the superficial subcutaneous tissues to correct moderate-to-severe forehead wrinkles or moderate-to-severe nasolabial folds.	Class III medical device	IMEIK Technology Development Co., Ltd.

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