Beimei Pharma announced that TWYNEO^® (Tretinoin, Benzoyl Peroxide) received clinical trial approval from the NMPA on September 25, 2025. The approval permits “a Phase III clinical study evaluating efficacy and safety in patients aged 9 years and older with common acne, conducted as a multicenter, randomized, double-blind, placebo-controlled trial.”

This clinical trial is planned to be led by Shanghai Huashan Hospital with participation from multiple other hospitals. The company is actively preparing to initiate the related clinical trial activities.

TWYNEO^® received U.S. FDA approval in July 2021 for the treatment of acne vulgaris in patients aged 9 years and older. The FDA approval was based on positive results from two prior U.S. Phase III clinical trials (SGT-65-04 and SGT-65-05). In these trials, TWYNEO^® significantly reduced inflammatory and non-inflammatory acne lesions in over 60% of patients. After one course of treatment (12 weeks), over 33% of patients achieved complete or almost complete clearance of acne lesions. The trials also confirmed that TWYNEO^® is safe and effective, TWYNEO^® is safe and effective, which greatly improves patient compliance and reduced skin irritation and other side effects.

TWYNEO^® (Tretinoin, Benzoyl Peroxide) was approved for marketing in July 2021 in the United States. Beimei Pharma aquired the asset of TWYNEO^® in China (including Hong Kong, Macau, and Taiwan) and Israel on May 15th, 2024, including but not limited to patents, trademarks and domain names for product development, commercialization, and manufacture. 

TWYNEO^® is the first and only FDA-approved fixed-dose combination of tretinoin and benzoyl peroxide cream for the treatment of acne vulgaris in adults and pediatric patients nine years of age and older. Benzoyl peroxide and tretinoin are both first-line treatment therapies for acne vulgaris. However, the two ingredients are prone to a chemical reaction when mixed, limiting the combined use, so the two ingredients require to be applied at different times of a day. In addition, using benzoyl peroxide or tretinoin alone may cause skin irritation, which also impacts the patient compliance. TWYNEO^® is the first breakthrough in using patented microencapsulation technology to solve the difficulty in combining benzoyl peroxide and tretinoin, and has in the history, for the first time accomplished the combination of the two active ingredients. The microencapsulation technology also relieves the skin irritation of topical benzoyl peroxide or tretinoin.

The American Academy of Dermatology's (AAD) 2024 updated and published Guidelines for the Management of Acne vulgaris, the classification, diagnosis, assessment, and treatment options for acne have been comprehensively updated. TWYNEO^® (the only topical cream that consists of a fixed-dose combination of tretinoin 0.1% and benzoyl peroxide 3%) is highly recommended for the treatment of acne patients 9 years of age and older.

Acne vulgaris is a chronic inflammatory disease of the sebaceous glands caused by Corynebacterium Acnes under the influence of a circulation level of dehydroepiandrosterone during puberty. There are a huge number of acne patients in China. According to a cross-sectional statistical analysis in the Chinese population, the incidence of acne is 8.1%, and more than 95% of such patients suffer from varying degrees of acne. The peak incidence of acne is in adolescence, with a prevalence rate of at least 80% among teenagers aged 11-25 years old, and 15% among younger adults aged 25-35 years old. It is reported that in the past 20 years, the incidence of acne in China has increased significantly, with a growth rate of about 36%, and the trend far exceeds the global average. In addition, among patients under the age of 20, the acne recurrence rate is as high as 37.3%. 

Existing treatments for acne vulgaris include topical drugs such as tretinoin, benzoyl peroxide, antibiotics etc. or oral antibiotics, isotretinoin etc. Chinese and international guidelines have proposed that combination therapy can significantly increase treatment efficacy, reduce adverse reactions, and improve patient compliance. Currently, the Chinese market is still dominated by single-ingredient drugs and very few fixed-dose combination drugs are available. Existing treatment options may be associated with safety issues and will likely reduce patient compliance, leaving a huge clinical demand unmet, and a large potential market remains to be fulfilled.

As analyzed by Global Market Insights, the global acne treatment drug market will grow from US$9.9 billion in 2022 to US$17.5 billion in 2032, with a CAGR of 5.86%. The global drug market for anti-acne will expand steadily due to the increase in the penetration of new drugs. The scale of the drug market in China for anti-acne treatment will increase from 4.2 billion RMB in 2024 to 8.1 billion RMB in 2027. (As referred to Pacific Securities' "Special Report on New Acne Drugs" in April 2024)