Introduction

Traditional Chinese medicine (TCM) is a medical science that has been gradually formed and continuously enriched and developed by our people in thousands of years of production, living practice and struggling against diseases. General Secretary Xi Jinping ever pointed out, "TCM is the treasure of ancient Chinese sciences and also the key to the treasure house of Chinese civilization." TCM's thinking mode of giving treatment on the basis of syndrome differentiation contains profound philosophical thoughts of the Chinese nation. Despite a long history, TCM culture never loses its power, and till today, it is still the soul and the driving force for the development and innovation of TCM. Therefore, adhering to the original thinking of TCM is the motive power for promoting the innovation and development of TCM. Sichuan, known as "Hometown of Traditional Chinese Medicine and Repository of Traditional Chinese Herbs" all along, boasts a rich traditional Chinese medicine culture and a strong mass foundation in TCM. With generation upon generation of conditioning and accumulation, Sichuan was home to a galaxy of famous and accomplished doctors from different medical schools in every dynasty. Among other schools, Sichuan TCM is very distinctive. According to the existing literature, this school's medical practice can be traced back to the reign of Emperor Guangxu of the Qing Dynasty. Over the past centuries of inheritance and development of five generations of physicians such as Wen Zhuozhi and Ai Rudi, this school has formed a complete theoretical system and developed a rich number of external TCM preparations, carving out a reputation in TCM surgery and dermatology in China.

Chengdu Funan Pharmaceutical Co., Ltd. (hereinafter referred to as "Funan Pharm") is a modern enterprise specializing in the research, development and production of external TCM preparations for dermatology. As the fifth generation successor of Sichuan traditional Chinese medicine surgery, Funan Pharm's founder takes innovating traditional Chinese medicine as its responsibility to forge ahead; with the aim of "inheriting yet not sticking to old conventions, innovating yet not betraying the traditional quintessence", this enterprise combines TCM with international advanced biomaterial technologies to inject new blood into TCM. For today's interview, we have invited Dr. Ai Hua, co-founder of Funan Pharm. As a TCM practitioner with a research background in biomedical materials, he will talk about the current situation and the future development trends of TCM industry.

Expert Introduction

Dr. Ai Hua, co-founder of Chengdu Funan Pharmaceutical Co., Ltd., has many years of research and development experience in biomedical materials and modern preparations. Due to outstanding achievements in this field, he has been awarded many honorary titles such as AIMBE FELLOW, FBSE, and Expert with State Council Special Allowances. At present, he is a member of the Standing Committee of the All-China Youth Federation, deputy director of the Medicine and Health Industry Organization, secretary general of the Chinese Society for Biomaterials, deputy secretary general of the Advanced Materials Alliance of CAST Member Societies (formed by 11 first-class materials societies), one of the Chinese representatives of the International Union of Societies for Biomaterials Science and Engineering (IUSBSE), etc. Meanwhile, he also assumes some academic positions including professor and doctoral supervisor of Sichuan University, and member of the editorial boards of Biomaterials (a top-notch journal on biomedical materials), JBMR-A (the official journal of the Society For Biomaterials of the U.S.), and Journal of Pharmaceutical Sciences (a prestigious pharmacy journal). Dr. Ai Hua ever studied at Weatherhead School of Management in the U.S. and obtained a certificate in entrepreneurship. Currently, he is also in the board of directors of ACTA Materialia, a world-renowned publishing house in materials with authoritative journals in materials and biomaterials such as ACTA Materialia and ACTA Biometerialia under its name.

About the Modern Characteristics of TCM

Established in 2012, Funan Pharm specializes in the research and development of modern external TCM preparations. At present, Funan Pharm has developed a series of new external TCM formulations, and has successfully improved the stability and drug-loading efficiency of products by using advanced biomedical material technology, thus solving the related problems that the acid-base property and complex multi-component influence of TCM compound extract on the stability of external preparations.

When talking about modern TCM, Dr. Ai Hua emphasized the innovation of TCM dosage form as the key to accelerating the promotion of TCM and as also one of the main features of modern TCM. Modern TCM preparations originated from TCM dosage forms, but the former is the latter's improved version through innovation in extraction methods, preparation techniques, types of excipients, etc. TCM dosage forms mainly include soup, powder, pill, ointment, etc., while modern TCM, influenced by Western Medicine (WM), has developed a variety of forms such as tablet, capsule, intramuscular/intravenous injection, spray, etc. On the premise of maintaining or even improving the curative effect, these modern forms are easier to use. However, due to the complex and diverse components, it is more difficult for TCM, compared with small molecule drugs with a mono-chemical structure, to realize effective dispersion, stability, controlled release and other key parameters of different components in a preparation. Notably, adopting multi-parameter monitoring, optimizing formula selection and ensuring drug stability are the key research directions of Funan Pharm, and are also the focus of general concern among today's TCM industry.

TCM has its own complete theoretical system which is the crystallization of more than 5,000 years of clinical practice. Therefore, research and development and evaluation system of modern TCM should not rigidly copy WM and the excessive pursuit of simplification of TCM components is very likely to reduce the curative effect which is also the experience of the modernization research of TCM in the past few decades. Different from WM's R&D mode of "lab study - clinical application", TCM R&D adopts the "clinical application -lab study - clinical application" mode. Under the mode, systematic lab and clinical study is conducted to reaffirm the curative effect, and figure out the pharmacological basis therein. During the process, people have enhanced their understanding of TCM.

About the Current Situation of Domestic TCM Market

Skin disease is a globally recognized common and frequently-occurring disease. To cite some data, there are more than 800 million people suffering from skin diseases in the world, and the number of visits of dermatological department of various medical institutions in China exceeds 200 million each year. Notably, the number of patients with pathological skin diseases is still on increase year by year, and the age of patients is getting younger. At present, there are more than 600 kinds of eternal medicines curing skin diseases in the national drug retail market. Of them, chemical drugs are in the majority; some are mixed TCM and WM preparations; pure TCM medicines are in a very tiny minority. Judging from the sales amount, chemical drugs dominate with a market share of about 85%. According to relevant statistics, the sales of external drugs for skin diseases in China grew rapidly at an average annual growth rate of 9.5%.

At present, hormone drugs are one of the first-line external drugs in clinical dermatology. Because this kind of drug can obviously affect the structure and physiology of skin, long-term use will produce many adverse reactions, such as skin atrophy, pigment abnormalities, capillary dilatation, hirsutism, acne, infection, etc. which are very difficult to treat clinically. In the past ten years, there has been a drastic increase in the cases of skin damage caused by external hormone preparations, and clinical reports have also increased correspondingly day by day. A survey by Mayo Clinic, a world-renowned medical institution, found that the prevalence rate reached 2.9% and registered an upward trend year by year. It's noteworthy that in recent years, the cases of internal organ damage caused by external hormone preparations have increased sharply, and the extensive use of hormone in infantile eczema can lead to femoral head necrosis. In addition, the sudden stopping of hormone after long-term use will lead to "rebound" of skin symptoms, i.e. so-called topical corticosteroid dependent dermatitis, which has also become a difficulty for clinical dermatology. Therefore, the brand characteristics of dermatological products will shift from "immediately relieving itching" to "attaching equal importance to relieving itching and treating diseases", "repairing skin" and other strategies featured by treating skin diseases in a healthy and holistic manner.

As the advantages of external TCM for skin diseases are widely accepted, its market share will expand year by year. At present, the pure TCM drug varieties for skin diseases only have a tiny market share, so there is considerable scope for further development. As the new medical reform puts forward to support TCM industry, the existing competition landscape in the skin medicine market may be changed. In addition, Sichuan is rich in medicinal plant resources and many medicinal materials are to be further studied, so the scope for further exploration, research and development is quite great. Sichuan Province has a significant resource advantage in developing TCM industry, and exploring modern TCM preparations is conducive to enhancing the core competitiveness of the industry.

About the Cultivation of Talent in Pharmaceutical Industry

In Dr. Ai Hua's view, it is more difficult to train TCM talent than WM talent. Like WM students, TCM undergraduates also take five years, but the specialized course load of TCM school students is very heavy. Apart from studying a lot of TCM courses, they also have to study many basic and clinical courses in WM, including physiology, anatomy, pathology, WM diagnosis, WM internal medicine and WM surgery, so it is quite difficult for them to spare time for reading TCM classics. In contrast, TCM major focuses more on using modern analytical methods to understand TCM information such as components. One direction of new drug development is to find a single, effective chemical structure for drug research and development. Moreover, TCM adopts a R&D mode of "clinical application -lab study - clinical application", while WM follows a different R&D mode of "lab study -clinical application". Without this guiding principle, it is always very difficult to develop products with prominent clinical effects. Therefore, cultivating TCM R&D talent requires not only solid modern analysis methods, but also the idea of respecting clinical effects and following TCM formulas.

However, Dr. Ai Hua said with pity that today's many TCM graduates divert to other professions. Our country has spent a lot of resources in training such professionals, and diverting to other professions may make them less competitive. Therefore, more attention should be paid to this situation. Under the preparatory training mode, students can acquire knowledge of general courses such as biology and chemistry. If they are still interested in medicine after graduation, they can study further for a medical doctor. If not, they can still have a wide choice of employment opportunities.

About the Expectations of New Supporting Policies of Government/Tianfu Life Science Park

With regards to policies, Dr. Ai Hua said that in recent years, the state and local governments have promulgated a series of policies to support the development of TCM, and fostered a batch of enterprises with bright market prospects. As a TCM industrial player, he sees hope from them for the future development of domestic TCM. As one of the founders of Funan Pharm, Dr. Ai Hua spoke highly of the help of a series of preferential policies provided by the Park. Following that, he pointed out that pharmaceutical industrial players are long-term enterprises. They need long-term and stable capital investment, because the whole process from developing a new product and obtaining approval to rolling out takes quite a long time. With weak risk-resisting ability, small pharmaceutical enterprises hope the government can issue relevant policies to help those small players with original intellectual property rights, transformation prospects and technological competitive advantages to control operating costs and innovation risks so as to grow further and become healthier.

About Funan Pharm's Flagship Products and Future Plan

As to TCM dosage forms, the development of external TCM drugs is relatively insufficient. But external TCM drugs have shown extremely advantageous curative effects in treating skin diseases and other diseases alike. Seeing this, Dr. Ai Hua decided to combine modern TCM with his years of research experience in biomedical materials, and lead Funan Pharm to research and develop a new-type external TCM preparation for dermatology. This new-type external TCM preparation highlights the effectiveness and safety of TCM formula and improves drug performance through the optimal design of materials. It is mainly used for treating common skin diseases, such as eczema, psoriasis, neurodermatitis, etc., and has provided a safer and more effective solution, thus developing a unique advantage in children's dermatology.

Moreover, Dr. Ai Hua in his capacity as secretary general of the Chinese Society for Biomaterials is also very concerned about the development of biomedicinal materials industry in the domestic market. At the Second Definition Consensus Conference of the International Biomaterial Community held in Chengdu in June this year, he together with more than 50 experts from around the world reviewed and determined through voting a new biomaterials definition consensus list, which will provide guidance for scientific research, industrialization, supervision and other fields.

As a modern TCM research and development enterprise, Funan Pharm also dabbles in the field of biomedical materials. In the study of TCM dosage forms, polymer films, coatings, liposomes, etc. can be used as carriers to realize new routes of administration to organically combine TCM preparations with biomedical materials. In this aspect, Funan Pharm has formulated a strategic plan. Committed to providing the best treatment for patients, Funan Pharm works to give full play to the advantages of TCM whilst combining modern materials and technological innovation, thus striving to grow into a leader of modern TCM preparations in dermatology.