Lei Jufang: Some of our aspirations have already been realized, but there are still challenges ahead on our journey.

　　Lei Jufang, Chairwoman of Qizheng Tibetan Medicine, is a deputy to the Tenth National People's Congress and a member of the 11th and 12th National Committees of the Chinese People's Political Consultative Conference. For many years, she has consistently called for national medicine to receive policy support and become stronger during the Two Sessions—and this year is no exception.

　　Qizheng Tibetan Medicine is the largest enterprise in the Tibetan medicine sector. In 2016, the overall market size for Tibetan medicine exceeded 3 billion yuan, and Qizheng Tibetan Medicine accounted for one-third of that figure. Lei Jufang believes she has a responsibility to promote the essence of Tibetan medicine and drive the industry’s development. This year, she proposed initiatives such as “Prioritizing the formulation and approval of a catalog of classic prescriptions for ethnic medicines” and “Encouraging appropriate dosage-form improvements for Tibetan medicines.” Over the years, her calls for including ethnic medicines in the national medical insurance system have gradually been adopted. In the “National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug List (2017 Edition)” (hereinafter referred to as the 2017 Medical Insurance Drug List), more than 40 ethnic medicines were included.

　　New process

　　Lei Jufang, whom those within the company and her close acquaintances all call “Engineer Lei,” is part of a unique cultural practice at Qizheng Tibetan Medicine: among technical leaders at middle and senior levels and above, titles are given without reference to formal rank—for example, Chairman Lei is referred to as “Engineer Lei,” and Vice President Xiao as “Engineer Xiao.”

　　This story dates back to before Lei Jufang founded Qizheng Tibetan Medicine. She was a senior engineer at the Institute of Modern Physics in Lanzhou, Chinese Academy of Sciences, and her colleagues respectfully called her “Engineer Lei.” In the 1990s, responding to the national call for scientific and technological talents to move to the forefront of the economy, Lei Jufang left the institute to start Qizheng Tibetan Medicine. The name “Engineer Lei” and her down-to-earth, research-oriented style became deeply embedded in the company’s culture. Later on, perhaps out of respect for technical talent, mid- and high-level managers at Qizheng Tibetan Medicine came to be simply referred to as “Xiao Gong,” “Bao Gong,” and so forth.

　　For more than a decade, Lei Jufang has been drafting proposals centered on ethnic medicines and Tibetan medicine. She says she knows exactly where the treasures of ethnic and Tibetan medicines are hidden—and so do experts in ethnic medicine. However, the outside world and the general public may not be aware of this. That’s precisely why she feels it’s her responsibility to raise awareness about these treasures.

　　Lei Jufang insists on inheritance, innovation, and steadfastness. Inheritance encompasses values and vision. Innovation means responding to impermanence and embracing constant change. Faced with change, there may be ups and downs, and at times, the situation may not seem particularly promising. Yet, if we fail to remain steadfast after making a broad, long-term judgment, it’s simply impossible to achieve success in the short term. That’s precisely why the power of steadfastness is so crucial.

　　China’s classic ancient prescriptions have become a valuable medical resource for foreign countries. Several years ago, after visiting Japan to study the development process of Kampo medicine, Lei Jufang was deeply moved and felt that China’s ancient prescriptions had enriched others’ coffers. Japan has been using Zhang Zhongjing’s ancient prescriptions unchanged, without any modifications.

　　This has prompted Lei Jufang to reflect: As the origin of traditional Chinese medicine, we still face numerous obstacles in registering classic prescriptions from ethnic medicines. If this delay continues, our own valuable treasures will quietly slip into others’ hands—what then will become of our ethnic medicines, our classic prescriptions, and our national industries?

　　In her proposal, Lei Jufang called for relaxing the regulatory requirements regarding clinical registration approval for classic traditional Chinese medicine formulas. Last year’s proposal also advocated encouraging the secondary development and formulation innovation of these time-honored traditional formulas, thereby enhancing patient compliance with the products and supporting China’s ethnic pharmaceutical industry to make its offerings more diverse and appealing.

　　In 2016, the "Law of Traditional Chinese Medicine" was promulgated. The Law explicitly states that ethnic medicines reflect the Chinese nation's understanding of life, health, and disease within the medical system, and they boast a long-standing historical tradition as well as unique theoretical and technical approaches. The Law also supports the development of classic traditional Chinese medicine formulas.

　　Lei Jufang’s aforementioned proposal has received support, much to the delight of Lei Jufang and several experts in ethnic pharmacology. Lei Jufang said that they had been looking forward to this for a long time. The Traditional Chinese Medicine Law has played a key role in lowering the barriers for the development and registration of time-honored prescriptions. For ethnic medicines, the implementation of supplementary provisions under the TCM Law represents significant support.

　　The proposal to develop classic traditional prescriptions has, for the first time, been elevated to a high level through legal means, demonstrating the nation’s strong emphasis on this area. This will also bring about an excellent development opportunity for ethnic medicines.

　　It is understood that ethnic medicines represented by Tibetan, Mongolian, and Uyghur medicine possess highly sophisticated theoretical systems and classical texts. For example, the Tibetan canon, as documented in the "Four Medical Tantras" from the 8th century, includes 443 commonly used classic prescriptions.

　　In the 2017 edition of the National Reimbursement Drug List, 43 ethnic medicines were included. In the 2009 edition, there were 45 ethnic medicines listed.

　　Initially, the evaluations of the national medical insurance catalog were mainly conducted by experts in traditional Chinese medicine who lacked sufficient understanding of ethnic medicines. Later, numerous figures from the ethnic medicine community—including Lei Jufang—have consistently called for involving experts in ethnic medicine to evaluate ethnic drugs.

　　There are still obstacles.

　　Currently, ethnic medicines hold a very small market share within the entire traditional Chinese medicine system. In 2016, the overall size of Tibetan medicine just exceeded 3 billion yuan. In the eyes of most experts in ethnic medicines and ethnic medical practices, the 1,050 classic prescriptions of ethnic medicines embody the very soul of the Chinese medicine system and hold the potential to unlock a future market worth tens of billions of yuan.

　　Lei Jufang said that every enterprise will encounter disruptions and uncertainties during its development stage. So-called entrepreneurial spirit is the ability to identify and eliminate pressures—whether related to performance or other aspects—and to lead and stay committed to the right direction. Whether to sacrifice certain principles for immediate, short-term gains, or even veer off course altogether, ultimately depends on the philosophy held by the enterprise’s top leaders.

　　Currently, ethnic medicines have received significant attention and support from the state—just as the overall development of ethnic minority groups is being promoted. However, the overall development of ethnic minority groups has been hampered by their relatively weak foundational conditions. Throughout history—from the period before liberation to the present day—our country’s policies have prioritized the development of coastal cities, leaving rural areas inhabited by ethnic minorities and remote, border-adjacent regions in a state of poverty. Now, finally, a ray of hope from policy is shining on ethnic medicines.

　　In 2016, the market size of Qizheng Tibetan Medicine was nearly 1 billion yuan. In Lei Jufang’s view, over the next five years or so, Tibetan medicine will grow at a rate tenfold faster. Tibetan medicine is steadily gaining acceptance and is gradually becoming increasingly popular. Meanwhile, Tibetan medicine entrepreneurs are eager to embrace innovation, leveraging advancements in science and technology to make Tibetan medicine more accessible to urban residents beyond the Tibetan regions.

　　However, the problem persists. In recent years, pharmaceutical companies have been grappling with headaches whenever it comes to developing new drugs in the field of traditional ethnic medicines. Take Tibetan medicine, for example: today, clinical requirements—including the time and effort needed—have deterred many entrepreneurs from pursuing this path. Yet they still eagerly await “detailed guidelines for developing renowned prescriptions” and hope for special treatment tailored specifically to clinical trials involving ethnic medicines. For instance, if a renowned prescription undergoes a change in dosage form, all its indicated conditions must be re-validated. This restriction stems from the past when there were too many generic drugs, leading to a “one-size-fits-all” approach. In classical renowned prescriptions, the conditions treated often correspond to what modern medicine calls targeted therapies. The clinical validation requirement stipulates that when an original product—say, a traditional Chinese medicine pill—is reformulated into a tablet, every single indication involved must be re-evaluated individually. Suppose a particular renowned prescription covers more than ten different indications, one of which is effective against leprosy; then the entire prescription would need to be re-validated. But today, leprosy has been virtually eradicated, and the number of new cases is extremely low, making validation exceedingly difficult. If the validation process were carried out as required, completing clinical trials for just one drug would consume nearly as much time and effort as developing an entirely new drug from scratch. As a result, entrepreneurs are likely to give up on such projects altogether.

　　This year, Lei Jufang has rewritten a proposal, hoping that “regulations should not only ensure the safety of medication for the public but also allow for some flexibility in verifying expanded indications.” Lei Jufang pointed out that, for instance, the traditional Chinese medicine Xiaoqinglong Tang San—when properly prepared—can be applied to nearly every infectious disease. If we were to require that all the original indications listed in this classic formula be re-verified today, it would create countless obstacles and make it virtually impossible to promote the product. Therefore, it would be appropriate to slightly modify or narrow the scope of previously approved indications for such products.

　　In traditional ethnic medicines, Mongolian medicine still commonly uses over 300 classic prescriptions, while Uyghur medicine continues to rely on more than 200 classic prescriptions. A rough estimate suggests that the classic prescriptions used by Tibetan, Mongolian, and Uyghur medicine—along with those from the Korean, Zhuang, and Kazakh ethnic groups—average around 150 per ethnicity, totaling 1,050 classic prescriptions in all.

　　A large number of classic prescriptions from ethnic groups such as the Miao, Hui, Yi, Yao, Tujia, and Dong-Shui are still widely used in clinical practice today. Unfortunately, only a few dozen of these prescriptions have been developed into officially approved Chinese medicinal products with national drug registration numbers. Yet despite having undergone thousands of years of clinical practice, these classic prescriptions continue to be extensively employed in Tibetan, Mongolian, Uyghur, Dai, Korean, and Zhuang medical hospitals—and some of these products are even used abroad. Lei Jufang pointed out that this clearly demonstrates the remarkable efficacy and enduring vitality of these time-tested formulas, making them highly promising for further development.

　　The Traditional Chinese Medicine Law, promulgated in 2016, clearly defines the development pathway for classic prescriptions and stipulates that compound TCM preparations derived from ancient, time-tested formulas can be developed. The implementing rules also state that specific management measures will be formulated jointly by the drug regulatory authority under the State Council and the competent authority for TCM.

　　However, the systematic compilation and cataloging of classic prescriptions from ethnic medicines such as Tibetan, Mongolian, and Uyghur medicine have yet to be initiated. If we wait until the future for their development, it could delay progress by several years. Lei Jufang stated that this year she has called on the competent authorities for traditional Chinese medicine and the National Medical Products Administration to ensure that, in accordance with the spirit of the Traditional Chinese Medicine Law, ancient ethnic classic prescriptions—still widely used today, with proven efficacy, and possessing distinct characteristics and advantages—are given priority in terms of compilation, cataloging, registration, and focused development and utilization.

　　Lei Jufang’s specific proposal is as follows: First, under the unified guidance of the State Administration of Traditional Chinese Medicine, entrust autonomous regions inhabited by ethnic minorities or influential ethnic medicine industry associations to organize experts to develop principles for selecting and compiling a catalog of classic prescriptions from various ethnic groups. Such catalogs shall be jointly reviewed and approved by the State Administration of Traditional Chinese Medicine and the National Medical Products Administration, with priority given to their registration and publication. Second, to enable the ethnic medicine industry to quickly reap the policy benefits brought about by the Traditional Chinese Medicine Law and enhance its sense of gain, a phased approach can be adopted: compile and mature a batch of selected prescriptions, then register and publish them in turn, thus establishing a rapidly operational system. Third, when formulating technical details for the registration of classic ethnic prescriptions, the National Medical Products Administration and the State Administration of Traditional Chinese Medicine should fully take into account the distinctive features of commonly used dosage forms among ethnic groups, allowing for the preservation and development of these unique characteristics and avoiding a one-size-fits-all approach. For example, Tibetan medicines are often administered in solid dosage forms such as pills and powders; due to their small dosages and adherence to traditional manufacturing processes, they are well-suited for formulation into pills, tablets, capsules, and other dosage forms. Fourth, ethnic medicine enterprises should be encouraged to conduct new drug research and development or to explore alternative dosage forms based on registered classic prescriptions.

　　Reporting media: Economic Observer

　　Report link: http://www.eeo.com.cn/2017/0311/300000.shtml