2024-05-16
Shenzhen Beimei Pharmaceutical Co., Ltd. ("Beimei Pharma") announced that on May 15th, 2024, an asset purchase agreement (the "Agreement") was signed with Sol-Gel Technologies, Ltd. ("Sol-Gel", Nasdaq stock Code: SLGL) to acquire all relevant assets of dermatology product TWYNEO® in the mainland of China, Hong Kong, Macau, Taiwan and Israel (the "Territory") from Sol-Gel. Under the terms of the agreement, Beimei Pharma purchases and licensed rights to exclusively commercialize TWYNEO® in the Territory, including but not limited to patents, trademarks and domain names for product development, commercialization, and manufacture.
"The clinical need in the acne market remains unmet for a long time in China, especially for adolescents. TWYNEO® as an innovative combination formulation approved by the U.S. FDA, and its efficacy in treating acne has been proven by clinical trials. Beimei Pharma will perform the registration and commercialization process of TWYNEO® in the Territory, to bring a new treatment to the vast population of acne patients. I believe this deal encourages Beimei Pharma to deeper cultivate our pediatric pipeline layout in the field of dermatology, leading Beimei Pharma into a new stage.” said Ms. Wu Guangmei, founder and CEO of Beimei Pharma.
“This agreement demonstrates the potential of TWYNEO® outside of the U.S., and we expect to announce other agreements regarding the commercialization of both our FDA-approved assets, TWYNEO® in other territories.” said Alon Seri-Levy, Ph.D., Chief Executive Officer of Sol-Gel.
About TWYNEO®
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, and the combination of the two ingredients is a classic regimen recommended by Chinese and international guidelines. 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. TWYNEO® has been proven in clinical trials to significantly reduce inflammatory and non-inflammatory acne lesions in patients by more than 60%, and patients have improved with a clinical indicator, IGA (investigator's global assessment), by at least 2 grades and reaching clear or almost clear after receiving a course of treatment. TWYNEO® is safe and effective, which greatly improves patient compliance and reduced skin irritation and other side effects.
TWYNEO® is exclusively licensed to Galderma for commercialization in the US, and has been approved for marketing by the FDA since July 2021; and it is exclusively licensed to Searchlight in Canada.
About Acne Vulgaris
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%. (Source: Prevalence of Acne Vulgaris in Chinese Adolescents and Adults: A Community-based Study of 17,345 Subjects in Six Cities)
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)
About Sol-Gel Technologies
Sol-Gel Technologies, Ltd. is a dermatology company focused on identifying, developing, and commercializing or partnering drug products to treat skin diseases. Sol-Gel developed TWYNEO®, which is approved by the FDA for the treatment of acne vulgaris in adults and pediatric patients nine years of age and older, and EPSOLAY®, which is approved by the FDA for the treatment of inflammatory lesions of rosacea in adults. Both drugs are exclusively licensed to and commercialized by Galderma in the US; and are exclusively licensed to Searchlight in Canada. TWYNEO® was purchased and licensed by Beimei Pharma to be exclusively commercialized by them in the mainland of China, Hong Kong, Macau, Taiwan and Israel.
Sol-Gel’s pipeline also includes a Phase 3 clinical trial of Orphan and Breakthrough Drug candidate SGT-610, which is a new topical hedgehog inhibitor being developed to prevent the new basal cell carcinoma lesions in patients with Gorlin syndrome that is expected to have an improved safety profile compared to oral hedgehog inhibitors as well as topical drug candidate SGT-210 under investigation for the treatment of rare hyper-keratinization disorders.
For additional information, please visit Sol-Gel’s website: www.sol-gel.com
About Beimei Pharma
Shenzhen Beimei Pharmaceutical Co., Ltd. ("Beimei Pharma") focuses on the field of pediatric prescription medicines, integrating full-spectrum capabilities of R&D, manufacture, commercialization and global cooperation, driven by the core strategy of self-development and global collaboration via in-licensing, asset purchase acquisition etc. Synergizing with the manufacture base in Liangyungang to fulfil sufficient production and global supply of diversified special formulations for children's medications, Beimei is aiming to provide pediatric patients with high-quality and full range of drugs.
Beimei Pharma has more than 40 pediatric drug products in portfolio and pipeline, including 4 approved drugs launched in the market, and several innovative drugs with global rights and independent intellectual property rights. The current pipeline covers the therapeutic fields of dermatology, respiratory, gastroenterology, anti-infection, neurology, neonatal, endocrinology, etc.
Beimei Pharma has established long-term partnerships with multiple large international pharmaceutical companies, such as Hetero, Cipla, Deva, Dr. Reddy’s, LTS, MedPharma, Synthon, EMP, NTC, Syrimed, etc.
Beimei Pharma has completed the Angel Round, Round A, Round B/B+ and Round C financing with hundreds of millions of RMB. Beimei Pharma gained recognition from many well-known investment institutions, including Efung Capital and the industrial parties.
For additional information, please visit the website: http://www.beimeiyaoye.com/
