Trade Star Pharmaceutical Holding Group collaborates with Nobelpharma

to expedite the commercialization of the rare disease drug Sirolimus Gel in China 

Strategic Collaboration:

On 31^st Aug. Trade Star Pharmaceutical Holding Group and Nobelpharma signed a strategic collaboration agreement in Tokyo, Japan, reaching a consensus on the commercialization in China of the topical medication Sirolimus Gel (trade name of "Xianluoli") for tuberous sclerosis-associated angiofibromas. 

Li Chao

 President of Trade Star Pharmaceutical Holding Group

President of Trade Star Pharmaceutical Holding Group, Li Chao, stated that: "This strategic collaboration marks a new chapter for Trade Star Pharmaceutical Holding Group. The innovation capabilities of Nobelpharma in rare disease drugs and their product layout in the field of rare diseases possess a strong industry barrier and competitive advantage. Today's collaboration regarding the Sirolimus Gel “Xianluoli” is just the beginning. In the future, in areas such as gynecology and pediatrics, both sides will fully expand a broader and deeper commercial cooperation in China. By introducing and commercially operating specialized products, Trade Star Pharmaceutical Holding Group will continuously accumulate and refine its commercial framework and professional promotion capabilities in the field of rare diseases. At the same time, we will gather talent and management experience in the rare disease sector, laying the groundwork in advance for professional capabilities in the field of rare diseases in China. This aims to serve the Chinese rare disease patients and benefit for the patient group." 

Jin SHIOMURA

Managing Director&CEO of Nobelpharma

CEO of Nobelpharma, Jin SHIOMURA, stated that: "China and Japan are friendly neighbors to each other. Both sides hope for amicable exchanges between enterprises of the two countries, aiming to bring happiness and fulfillment to the lives of the people in both nations. An essential component of Nobelpharma internationalization strategy is to find appropriate commercial partner in China to enhance the treatment accessibility for rare disease patients. Trade Star Pharmaceutical Holding Group holds a leading advantage in China's pharmaceutical sector, from R&D and producting to commercial capabilities. This strategic partnership between Nobelpharma and Trade Star Pharmaceutical Holding Group will help enhance the former's understanding of the Chinese pharmaceutical market further. Leveraging the marketing capabilities of Trade Star Pharmaceutical Holding Group, we will continuously strive to improve the health and well-being of rare disease patients in China." 

Members of Trade Star Group and Nobelpharma

Background Information:

About Tuberous Sclerosis Complex:

Tuberous sclerosis complex is a multi-system neurocutaneous syndrome and is a rare autosomal dominant hereditary disease. The overall prevalence is 1/20,000, with an incidence rate ranging from 1/10,000 to 1/6,000. The pathogenic mechanism is often associated with the activation of the mammalian target of rapamycin (mTOR) signaling pathway. Overactivation of mTOR leads to increased protein synthesis, cell growth, and angiogenesis, resulting in the formation of hamartomas in multiple organ systems, including the skin, brain, heart, kidneys, eyes, and lungs. Symptoms and severity vary among patients. Approximately 80% of patients have one or more characteristic skin lesions, including hypomelanotic macules, facial angiofibromas, shagreen patches, and subungual fibromas. Notably, the development of facial angiofibromas during childhood and adolescence can bring about a series of personal psychological, familial and societal challenges during a patient's growth and development.

About Facial Angiofibromas:

Facial angiofibromas is one of the most common skin conditions in tuberous sclerosis complex. They appear as pink or reddish nodules, typically located on the cheeks, nose, and chin. While they can emerge on other parts of the skin, facial angiofibromas often manifest in a butterfly-pattern across the nose and cheeks. Composed of blood vessels and fibrous tissue, they can coalesce to form larger patches. Although benign, these angiofibromas can bleed, obstruct nasal passages, and cause disfigurement. These tumors can appear during infancy and tend to enlarge with age. Initially, facial angiofibromas may cause a pale red or rosy appearance on the cheeks. Over time, they can become rougher and thicker. The primary treatment methods for angiofibromas currently are laser or surgical removal, but these treatments come with numerous challenges, such as high recurrence rates, pigment changes, risks of scarring, and infection.

About Sirolimus Gel (Trade name of "Xianluoli"):

The National Medical Products Administration approved, through a priority review process, the marketing of the chemical drug Sirolimus Gel (Trade name: Xianluoli) submitted by Nobelpharma Co., Ltd. on June 9, 2023. The approval is for the treatment of facial angiofibromas associated with tuberous sclerosis complex in children aged 6 and above and adults. This drug is the first to have its efficacy validated for treating angiofibromas and head plaques related to tuberous sclerosis complex. As the only mTOR inhibitor that can be administered topically, the product is easy to use and non-invasive, with a low rate of systemic adverse reactions.

About Nobelpharma Co., Ltd. of Japan:

Founded in 2003, Nobelpharma Co., Ltd. of Japan contributes to society by providing medicines and medical devices that are needed but have been overlooked. "Patient's benefit first" is the starting point of the company's code of conduct. To date, Nobelpharma have released a total of 18 types of "needed but overlooked medicines and medical devices", of which 10 have been designated for rare diseases (orphan drugs) and the like. Additionally, Nobelpharma's Sirolimus Gel has been designated as the number one drug for priority review. To meet the needs of patients, Nobelpharma is intensifying its global expansion efforts. As long as there are patients waiting, Nobelpharma will do its utmost to meet their needs, thereby making a contribution to human society.

About Trade Star Pharmaceutical Holding Group:

Trade Star Pharmaceutical Holding Group was founded in 2000. After years of development, it has transformed into a commercial stage company with integrated functions across drug research and development, manufacturing, medical promotion, marketing, sales and distribution. Guided by the corporate mission of "Cherish hope for humanity, Devote to life and health" and adhering to the company values of "Integrity, Diligence, Insight, and Expansion," Trade Star focuses on the innovation of pharmaceutical industry, dedicates to drug development with clinical advantage and meets unmet medical need through groups excellence marketing and sales capablity.