I. About Us: “HIST Blue” represents the beating lifeblood
HIST was established in 2005 in Guangzhou, China. We mainly engage in the R&D, production and sales of medicines, nutritional supplements and biological products. Guided by the traditional Chinese medicine theories of " integration of nature and man", "holistic concept", "dialectical treatment" and "prevention of untreated diseases", our target is to construct a large-scale health industrial chain led by the R&D of new small molecule botanical drug and its related series of new products/new formulations/new systems, aiming at meeting the unfinished demands of patients with related immune diseases (including but not limited to psoriasis and allergic diseases) as well as striving to achieve win-win social and economic benefits.
II. TC White Paper
TC APIs and preparations are the world's first new natural plant-based small molecule drugs with completely Chinese independent IP rights for psoriasis treatment in the past 30 years.
Through multi-target, multi-level and multi-system synergistic adjustments or effects on the human bodies, these drugs have overturned the direction of drug R&D in Western Medicine that concentrates on individual immune cells or cytokines.
The clinical applications of TC in various nations (China, USA) as well as in different racial groups (yellow, white, black) have shown that our drug is safe & effective, with comparable efficacy to similar Western first-line products including hormones, immunosuppressants and so on, as well as low side effects, low relapse rate and long-term application.
HIST will keep treating psoriasis patients of different ages, races, parts, and clinical subtypes with high precision and customized treatment plans, building new drugs, strategies and systems for psoriasis treatment led by TC APIs and preparations. We focus the safety of the medicines in women ( pregnancy/lactation) and children with psoriasis. Our ultimate goal is to provide first-line, systemic and guideline drugs for psoriasis patients globally to better limit the disease, shorten its course and reduce costs for the benefit of humanity.
Psoriasis is a major immune-related global disease identified by the World Health Organization (WHO). In 2014, psoriasis was designated as "a serious non-infectious chronic disease" and called the "undead cancer". Nevertheless, there is a lack of safe and effective medicines for long-term use both at domestic and abroad.
Though the causes and pathogenesis of psoriasis are not fully defined, the number of associated susceptibility genes is more than 80 currently. The incidence of psoriasis is increasing annually (global: >125 million; domestic: >8 million), with growing clinical evidences suggest that it is a disease with links to the human neurological and cardiovascular systems.
The currently used topical, oral, injectable chemical and biological drugs are all symptomatic treatments. In recent years, new drugs developed for psoriasis treatment targeting TNF-α, IL and its receptors, PDE-4, T cells, etc. are expensive and have the risk of causing secondary infectionto patients. To achieve short-term clinical effects, the above-mentioned drugs have problems such as difficult to suppress relapses and high toxic side effects. In addition, the side effects caused by the use of chemical and biological drugs such as hormones and immunosuppressants for treatment may put patients with mild disease at risk of becoming moderate or severe, even life-threatening...numerous problems have been unresolved.
In March 2016, the U.S. FDA, in its leading drug R&D program for patients with psoriasis, called on the pharmaceutical profession to develop safe, effective, long-term, and affordable drug therapy.
The treatment guidelines for psoriasis emphasize the principle of "gentle therapy and combination of standardized and individualized treatment", ensuring firstly on patients' medication safety and life quality. Through strengthening health training for patients, including basic disease knowledge education, regular life guidance, dietary control, physical exercise, appropriate health care products and mental counseling, we can ultimately achieve the goals of controlling the disease, reducing recurrence and improving quality of life.
The original new drug "TC" APIs and preparations are the world's first new natural plant-based small molecule drugs for psoriasis treatment, whose R&D ideas are derived from the long-term clinical application practices of the developers, which are extracting the effective part of a single traditional Chinese medicine, and using modern technology standards for R&D. TC ingredients are clear, quality controlled, safe and effective, which can be used for long-term. Pre-clinical studies have shown its anti-inflammatory, anti-allergic, anti-itching and regulating epidermal keratin-forming cell keratinization effects.
Domestic and abroad clinical studies have proved its advantages of high cure rate, low side effects, low recurrence rate as well as its overall regulating effect on human immunity, which fully reflects natural botanical‘s therapeutic features compound with multi-target, multi-level and multi-system. These characteristics make them potentially become the irreplaceable or first-line guideline drugs in biology and chemistry compared to me-too copycat drugs.
On the ground of evidence-based, translational and real-world data, TC has gradually formed a psoriasis medicine R&D system program of prevention and intervention, and it is expected to become the future global pioneer in new drugs, strategies and systems for psoriasis treatment.
The FDA phase IIb clinical trial of our new drug "TC Cream" has been completed successfullyin terms of efficacy and safety endpoints. It is entering Phase III clinical trial in the U.S which tobecome the first new small molecule botanical drug to enter the world mainstreampharmaceutical market, which will become a sparkling moment in the global new small moleculebotanical drug R&D process.
• World's 3rd small-molecule drug using natural botanical ingredients
• First small molecule botanical drug to be approved specifically for the treatment of psoriasis
• Indigenous IP granted in 35 countries• PCT: “Novelty & Creativity, industrialization ”
With the application of modern science and technology, "TC" has systematically completed theintegrated industry chain R&D of plant cultivation (GAP), pre-clinical experiment (GLP), clinical trial (GCP: Phase I/II/III) and process production quality (GMP), and has become thefirst new small molecule botanical drug approved by the National Medical ProductsAdministration (NMPA). It also obtained the China National Drug Production License, the codenumber approved by SFDA and the pilot variety for marketing license holders. Our workshopsand lines have also passed the GMP audit.
IV.The Subversive Process of Reverse Exploration of Innovative Drug R&D
Based on the theories of traditional Chinese medicine and pharmacy, through clinical practice, experience empirical evidence, translational science, evidence-based healthcare and dataresearch, HIST focuses on the R&D of the first new small molecule botanical drug and aims tobuild a new system for the treatment of major immune diseases with China's independent IPrights and TCM core technology. The patient-centric and clinical-centric reverse evidence-based medicine development process of HIST:
It shortens the development cycle, reduces the total cost of research and development, andimproves the direct rate of new drug launch while improving the safety and efficacy of newdrugs.
(1) New system products for psoriasis treatment: 2-5
(2) Grand health new products series: 2-5
(1) No.1 pipeline
(2) No.2 pipeline
(3) No.3 pipeline
I. Psoriasis Research Institute of Guangzhou (PRIG): R&D institution of the technologycompany under HIST.
With full responsibility for filing and organizing the accountability of new drug clinical trialstudies in the US
Contact Info: Tel (china) +8620-32215437(O)
II.U.S. Medical Partners: Responsible for U.S. clinical trial studies of new drugs
(1) New York Psoriasis Medical Cooperative Center
(2) Chicago Psoriasis Medical Cooperative Center
(3) Seattle Psoriasis Medical Cooperative Center
I. Founder's Profile
Prof. L.P. Yang, M.D.
• Engaged in decades-long basic and clinical research on immune mediated diseases, innovative drug / wellness product’s development and industrialization
• Embed modern medical science into HiST’s unique exploration of disease treatment
- preventive medicine
- genetic immunology
- medical statistics
• Perform clinical best practice in new drug discovery
- translational medicine
- RWD research
• Holder of two international patents granted in 35 developed countries including the US, Japan and EU
II. R&D Teams
The team has experts with experience, management and operation in all areas of GoodAgricultural Practice (GAP), Good Laboratory Practice (GLP),Good Clinic Practice (GCP) , Good Manufacturing Practice (GMP) and Good Supply Practice (GSP). The international team includes PhDs, senior experts, professors, consultants and other experts inpharmaceutical sciences who have worked in large-scale U.S. pharmaceutical enterprises or theFDA for a long time. They have years of experience in new medicine R&D, clinical trials, newdrug reporting and actual work as well as management.
III. Robust TC Supply Chain and Quality Assurance
• cGMP compliant multi-province plantation sites
• Collaboration with cGLP certified domestic and international institutes to completepipeline product development
• A cGMP-compliant production facility established in Guangzhou Science City, Guangdong;
• Using genetic engineering and bioreactor technologies to enhance TC yield and todiversify future global supply chain