Tianshan Observation | Fifteen Years of Developing a Single "Medicine"
—The Inheritance and Innovation Behind Xinjiang's First Traditional Chinese Medicine and Ethnic Minority Medicine to be Included in the National Medical Insurance Catalog
Recently, a new name from Xinjiang—Compound Binaphedrine Granules—was added to the National Reimbursement Drug List. This Uyghur medicine for treating febrile colds may seem like just another new drug on the market, but it has caused quite a stir in the pharmaceutical industry.
It is labeled as "Xinjiang's first Class 1.1 new drug of traditional Chinese medicine and ethnic medicine with an A certificate." This special "identity card" is a milestone in the development history of traditional Chinese medicine and ethnic medicine in Xinjiang.
Logic Change
Why is the launch of a cold medicine called a "breakthrough"? To understand the significance of this "first," we need to trace the historical trajectory of Xinjiang's traditional Chinese medicine and ethnic medicine spreading throughout the country.
"In the 1990s, the State Drug Administration was established, centralizing drug approval authority. Local standards were elevated to national standards, and provincial-level governments no longer held drug registration approval authority. Localities compiled and reported mature drug varieties (including those derived from hospital preparations and empirical formulas) to form ministerial standards," said Yang Weijun, deputy director of the Xinjiang Institute of Pharmaceutical Research. Many well-known Xinjiang ethnic medicines, such as Zukamu granules and Hanchuan Zupa granules, are products of that period.
The core of the review logic at that time was "experience verification." Whether a drug could be approved mainly depended on whether it had a long history of clinical application and whether it was safe and effective. "The review was more based on the experts' recognition of traditional experience, and did not require the completion of systematic modern clinical trials as is required today," Yang Weijun explained.
This has led to a peculiar phenomenon: many effective traditional Chinese medicines and ethnic minority medicines are recognized solely on the logic of "because they have been used for many years, we believe they are effective." Since the ministerial standards were publicly available, any qualified company could apply for registration based on those standards, according to the registration regulations at the time. This explains why medicines like Zukamu granules are produced by multiple companies in Xinjiang alone, including Yinduolan, Xinqikang, and Xinjiang Uyghur Medicine.
The development of Compound Binaphedrine Granules marks the beginning of a completely new logic. It strictly follows the complete path of modern drug development, completing the entire chain of "ancient books - formulation - new drug - medical insurance" over a period of 15 years. This long journey of "inheritance and innovation" is a collision and integration of traditional Chinese medicine experience and modern science.
"This is the first Class 1.1 Uyghur medicine to be approved after completing all Phase II and III clinical trials in strict accordance with the current national 'Drug Registration Management Measures'," said Yang Weijun. Twenty clinical centers across the country participated in a rigorous randomized, double-blind, controlled trial and statistical analysis, providing a solid data foundation for the efficacy and safety of this drug in treating febrile colds.
Unlike the traditional model where production could be based solely on publicly issued standards, the core of this new drug lies in its complete independent intellectual property rights. The company holds an "A certificate" representing independent production, meaning that the entire chain from raw materials to finished products is independently controlled and managed by the company.
The approval logic has completely shifted to "proving its safety and efficacy through rigorous scientific testing and data verification." This fundamental change marks a shift in the research and development of ethnic medicines in Xinjiang from "experience inheritance" to "evidence-based innovation."
Differentiation of syndromes and treatment
For ordinary families, the most practical question is how to choose between Compound Binaphedrine Granules and Zukam Granules.
The answer is: they are not simply substitutes, but rather a precise embodiment and refinement of the Uyghur medical concept of "diagnosis and treatment based on syndrome differentiation" in people's medicine boxes.
Uyghur medicine has a unique understanding of the common cold, mainly classifying it into colds caused by cold or heat, with significantly different causes, mechanisms, and treatments. Therefore, the choice of medication must first determine whether it is a cold or heat-related cold.
For colds caused by cold, there are already well-established options on the market, such as Zupa granules for cold-induced asthma. Compound Binafusi granules, on the other hand, are specifically designed for colds caused by heat. As for the well-known Zukamu granules, their formula is more versatile and has a wider range of applications. In traditional use, they are often used for the early stages of a cold or for common colds where the cold or heat characteristics are not so typical.
"It's like a household toolbox," Yang Weijun explained. He likened the cold-asthma granules (Zupa granules) and compound Binafusi granules to specialized screwdrivers for specific types of conditions, addressing "cold" and "heat" symptoms respectively; while Zukamu granules are like a multi-purpose wrench, handling common situations. The emergence of these new drugs provides patients with more precise and targeted options.
In addition, safety is another prominent feature of the new drug. Its prescription consists of six medicinal materials, including Viola yedoensis, Crataegus pinnatifida root, and Ariolus spp., and does not contain any specially controlled medicinal materials.
Drive the entire chain
The 15 years it took for this new drug to go from ancient books to being covered by medical insurance reflects the difficult path of "modernization" for Xinjiang's biopharmaceutical industry.
This is a long-distance relay race involving government, industry, academia, and research: the government has made continuous investments; researchers have explored and verified data from ancient books and hospital preparations; enterprises have invested hundreds of millions of yuan to undertake lengthy and unpredictable clinical trials; and finally, they have passed the most stringent national review with solid data.
The launch of a new drug is significant far beyond the success of a single product. It demonstrates a clear path: by using modern scientific methods and internationally accepted review standards, ancient traditional medicine wisdom can be systematically transformed into safe, effective, and contemporary drugs that meet modern needs.
This breakthrough has instilled a strong sense of confidence in the entire Xinjiang traditional Chinese medicine and ethnic medicine industry, demonstrating its ability to achieve its goals. This confidence is rapidly translating into concrete actions: Yinduolan Pharmaceutical has committed 10% of its annual sales revenue to R&D; and to support the launch of new drugs, the company is simultaneously accelerating the construction of its intelligent production base and authentic medicinal herb planting base.
The pace of innovation continues to accelerate. Currently, another new drug developed by Yinduolan Pharmaceutical in collaboration with the team of Academician Aji Aikber Aisa of the Chinese Academy of Engineering—Naizilai Granules—has completed Phase III clinical trials and entered the preparation stage for market approval, indicating that a product pipeline and innovation relay are taking shape.
From a single pill to a road, from a single product to a cluster, this practice vividly illustrates Xinjiang's efforts to "deeply integrate technological innovation and industrial innovation." It proves that unique resource endowments can be fully transformed into industrial advantages and development momentum through technological innovation.
Inheritance and Innovation
The development process of Compound Binaphedrine Granules is essentially a dialogue across time and space—re-expressing the ancient wisdom of traditional Chinese medicine in the language of modern science.
Faced with the tide of globalization and modernization, traditional medicine often finds itself in a dilemma: either sticking to its original form and facing marginalization, or over-transforming and losing its authenticity.
Xinjiang's exploration has provided a different answer: while adhering to the essence of Uyghur medical theory, it has bravely accepted the most rigorous testing of modern science. This is a systematic "translation"—using clinical trials to verify efficacy, pharmacological analysis to elucidate mechanisms, and quality standards to ensure stability.
This path is destined to be difficult, requiring long-term investment and unwavering commitment. But it is precisely because of this that traditional wisdom can shed its static status as "heritage" and truly "live" in the healthy lives of contemporary people, gaining enduring vitality.
From ancient books at the foot of the Tianshan Mountains to the national medical insurance catalog, from laboratory data to medicine cabinets in every household, this is not just the journey of a single pill, but a vivid practice of a model of civilizational inheritance and innovation. (Tianshan Net - Xinjiang Daily reporter Xie Huibian)
