The quality of drug preparations is directly related to the life, health and treatment effects of hundreds of millions of patients. At present, China is the world's second largest pharmaceutical market. It is reported that the total output value of China's pharmaceutical industry will reach about 3.8 trillion yuan in 2022, and generic drugs will dominate the

Chinese pharmaceutical market, accounting for more than 60%. However, in the field of high-end generic drugs, especially in sustained-release preparations and complex injections, there are high technical barriers, and the market accessibility of domestic high-end generic preparations is relatively low. The root cause is the weakness of the core production process, especially the precise control of the drug release mechanism, the application of complex excipient systems, and the precision quality control technology in large-scale production, which has become a key bottleneck restricting domestic high-end preparations from achieving equivalence with original research drugs and entering the international high-end market.

Faced with the growing demand of Chinese patients for high-quality and accessible drugs, and the strategic requirements of the country to promote the high-quality development of the pharmaceutical industry, breaking through the technical barriers of high-end preparations and achieving a leap from "imitation" to "combination of imitation and innovation" has become a core issue that needs to be urgently solved by the entire pharmaceutical industry in China . In this context, a number of leading local pharmaceutical companies such as Hengrui Medicine, Shijiazhuang Pharmaceutical Group, and Qilu Pharmaceutical are increasing their investment in the research and development of complex preparations. In addition, there are also "small and beautiful" leading companies such as Lianya Pharmaceutical that continue to deepen their roots in the field of complex drug preparations and have opened up a unique path. They have taken the lead in achieving a "two-way breakthrough" from technical breakthroughs to market access in the field of high-end sustained-release preparations, providing a sample for reference for the industry.

Leading the overseas market, Lianya Pharmaceuticals has passed FDA cGMP inspections for seven consecutive times

According to public information, Nantong Lianya Pharmaceutical is a company focusing on the field of complex pharmaceutical preparations. Its product line mainly covers two categories of high-end generic drugs: different types of sustained-release preparations and very low-dose preparations. They are widely used in major diseases such as hypertension, coronary heart disease, diabetes, schizophrenia, and women's health.

At present, Lianya Pharmaceutical's high-end pharmaceutical preparations have achieved outstanding results in overseas markets. In 2023, Lianya Pharmaceutical's nifedipine sustained-release tablets (AB1), nifedipine controlled-release tablets (AB2), and diltiazem hydrochloride sustained-release capsules (AB3) ranked first in the US market with 82.5%, 56.5%, and 28.9% of the market share, respectively, and sales volume led overseas.

Not only that, Lianya Pharmaceutical has passed the FDA cGMP inspection for seven consecutive times, reflecting the long-term stability of its quality management system. According to the company's previous public information disclosure, four products and five specifications, including nifedipine sustained-release tablets (AB1) 60mg and 90mg, norethindrone ethinyl estradiol tablets 0.035mg/0.5mg, have replaced the original drugs and have been designated by the FDA as international standard preparations in the Orange Book. At the same time, the dissolution methods and dissolution standards of 9 high-end preparations are included in the United States Pharmacopoeia (USP).

The company's outstanding performance in overseas markets stems from a solid research and development foundation. At present, Lianya Pharmaceuticals has built six core technology platform groups, including "multi-unit sustained-release preparation technology platform", "pulse preparation technology platform based on chronopharmacology", "composite multi-polymer technology platform", "ultra-low dose preparation technology platform", "preparation stability prediction technology platform" and "drug analysis research platform", which have laid a solid foundation for overcoming complex preparation technology problems and ensuring high product quality.

Chinese and foreign technology co-production, high-end preparations benefit Chinese people's livelihood

Lianya Pharmaceuticals did not stop at overseas success, but seamlessly introduced advanced processes and production systems verified by the highest international standards of the FDA into China , achieving consistent prescriptions, production lines, processes, controls, and quality for Chinese foreign preparations. This enables Chinese patients to obtain high-quality drugs equivalent to original research drugs at affordable prices.

Relying on the mature six major technology platforms and process experience of more than 40 FDA-approved products, Lianya Pharmaceuticals ensures a high degree of uniformity in technical standards and quality control of production lines outside China . At the same time, the company has reached a strategic cooperation with Sinopharm Holdings, the leader of China's pharmaceutical distribution, to implement exclusive distribution in Beijing, Guangdong, Jiangsu, Jilin and other provinces selected in the centralized procurement, and build an efficient and high-quality drug supply network.

This "international quality, China sharing" model has released huge benefits for people's livelihood in the national centralized volume procurement of drugs. Taking metoprolol succinate sustained-release tablets as an example, it is understood that this product was selected as the first in the seventh batch of national centralized procurement in 2022, covering six provinces and cities, and the price was only 0.4313 yuan/tablet (47.5 mg), compared with the sales price of about 2.1 yuan/tablet of the same variety before centralized procurement, the decline was as high as 80%.

The dual advantages of high quality and low price have enabled this product to quickly win the trust of doctors and patients. According to the sales data of Didu.com , in 2024, the sales volume of metoprolol succinate sustained-release tablets produced by Lianya Pharmaceutical accounted for 26.26% of the sales volume of public hospitals in China , ranking at the forefront of the market. Therefore, it is estimated that for this product alone, the implementation of the seventh batch of centralized procurement has saved more than 3.4 billion yuan in drug expenses for medical insurance funds and patients. This not only greatly reduces the medication burden and medical insurance expenditure of Chinese patients, but also proves the feasibility of domestic high-end preparations to achieve "high quality and high price" for patients.

Breakthrough and universal benefits: the future of high-end preparations in China

The practice of Lianya Pharmaceuticals provides a path to break the quality bottleneck of domestic high-end preparations: through the tempering of the international high-end market, the process technology is forced to upgrade, and then the proven advanced productivity is fed back to the needs of Chinese people's livelihood.

At present, Lianya Pharmaceuticals is relying on the consistent high-standard production system at home and abroad and the continuous innovation of six major technology platforms to deepen the layout of the Chinese market with a clear strategy. The company actively participates in the national centralized procurement, and more high-difficulty and high-quality generic drugs that have passed international certification are included in the Chinese medical insurance system at a reasonable price, making "high quality and low price" the synonym of domestic high-end preparations.

This has gone beyond the business trajectory of a single enterprise, and it also indicates the important direction of the upgrading of China's pharmaceutical industry - overcoming the core process barriers, connecting the quality standards outside China , and ultimately achieving universal access to high-end drugs. When more and more Chinese pharmaceutical companies can cross the technological gap and internalize international quality into local advantages, the beneficiaries will be the health and well-being of hundreds of millions of people, and it will also lay an indispensable foundation for drug security for the "Healthy China" strategy.

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