The reporter learned from authoritative sources that relevant authorities in China have recently brewed introduction of a policy of encouraging formulation innovation. The upcoming "12th Five-Year Plan" of the biomedical industry will also focus on the "upgrading" of the pharmaceutical industry, which mainly includes aspects such as drug innovation upgrades and formulation upgrades.

Mei Xingguo, director of the Department of Pharmaceutics of the Chinese Academy of Military Medical Sciences, said that at the moment when the global drug research and development enters the era of formulation innovation, China's formulation innovation business needs no policy support from research and development to product pricing, and there are many domestically homogeneous competitive APIs. Enterprises may also use this as an opportunity to set off the climax of the transition from raw material medicine to preparation, and the reshuffling of raw material medicine industry will accelerate.

"Light Raw Material Preparation" Needs to Change

In recent years, compared with the raw material drug business, China's pharmaceutical industry has been deficient in the development of the pharmaceutical industry for many years, causing the level of preparation technology to lag behind foreign countries and forming the trade status of China's "exported raw material medicines and imported preparations."

The technological content of a large number of bulk drug products produced in China is relatively low, and the gross profit margin has been repeatedly compressed due to homogenous competition. However, the preparations with higher gross profit margins need to be imported from abroad, which also leads to a significantly lower profit level in China's pharmaceutical industry than abroad. .

At present, the study of dosage forms in China has lagged behind that of Western developed countries. The U.S. Pharmacopoeia 90 edition contained 31 types of prescriptions, the British Pharmacopoeia contained 36 articles, and the Japanese Pharmacopoeia (12th edition) also contained 27 articles, while the Chinese Pharmacopoeia 90 edition contained only 12 articles. Usually, there are more than 10 types of pharmaceutical preparations in a foreign country, but in China, there are about 3 types, and most of them are imported varieties.

Mei Xingguo stated that the reason why China's innovative preparations have not been able to be industrialized has been delayed. In addition to the lack of medical policy support for formulation innovation, Chinese pharmaceutical companies have failed to fully understand the potential commercial value and long-term benefits of formulation development. Adequate industrial investment.

In fact, dosage form research is much more effective than raw material drugs in driving the development of the pharmaceutical industry. The data shows that the core of the pharmaceutical industry's industrial chain is pharmaceutical intermediates, raw material drugs and preparations. The proportion of these three links in the entire pharmaceutical industry is 5%, 10%, and 80%, respectively. Therefore, it is imperative for China to encourage innovative preparations.

It is understood that the biggest difference between China's domestic drugs and imported drugs lies in the pharmaceutical process and dosage forms, and the difference in actual raw materials is not significant. Luo Xiaolong, deputy general manager of Beijing Pharmaceutical Group, believes that, in fact, research and development of innovative agents are particularly suitable for Chinese pharmaceutical companies. For example, reforming the formulation of already-marketed drugs and developing them into controlled-release formulations with high convenience and high added value may be an effective supplementary means for the development of new drugs.

In addition, for drugs that will soon surpass the patent protection period, the drug can be regained market and sales volume by innovating the formulation of the drug. Nowadays, there are a large number of drugs with brilliant sales in the world facing the issue of expired patents. By intensifying the encouragement of preparation innovations at this time, it is likely to bring new vitality to China's pharmaceutical industry.

Preparation innovation is more feasible

No matter whether the State Council has recently disclosed the “Decision of the State Council on Accelerating the Cultivation and Development of Strategic Emerging Industries” or the “12th Five-Year Plan” of biomedicine, both will increase the innovation capability of the pharmaceutical industry and promote the development of innovative drugs to the forefront.

However, innovation drug development itself has encountered a staged dilemma. It is understood that in recent years, the research and development of innovative drugs in the global pharmaceutical industry are facing the embarrassment of “difficult birth”. In recent years, the cycle of developing a new drug abroad has been increasing, the risk of development is increasing, and more and more capital has been invested, and the chance of success has been getting smaller and smaller. In the short term, it is still difficult for Chinese pharmaceutical companies to compete with international pharmaceutical giants in this regard.

It is very difficult to pin its hope on the development of innovative drugs. This means that China must find a more feasible way to rapidly improve the competitiveness of China's pharmaceutical industry.

Mei Xingguo said that innovative preparations have the advantages of short development cycle, low investment, low risk, availability, safety, etc. As early as ten years ago, the development of the pharmaceutical industry in Western countries has clearly demonstrated the emphasis on the development strategy of pharmaceutical preparations. Nowadays, it can be said that the global pharmaceutical research and development has entered the era of formulation innovation.

According to statistics from U.S. pharmaceutical R&D institutions, the development of a brand-new chemical requires an average of US$ 5-10 billion, which lasted 10-12 years, while the development of an innovative formulation only costs US$ 50 million, which takes an average of 3-4 years.

Therefore, many large international pharmaceutical companies have begun to turn their attention to the development of new dosage forms for existing products. In addition to higher cost-effectiveness, many existing chemical and biological drugs have the disadvantages of low solubility, poor stability, and difficulty in delivery, making it difficult to achieve clinically optimal results. If traditional formulations of drugs are upgraded through formulation innovations, they can circumvent the above problems. Disadvantages greatly improve drug efficacy.

Pharmaceutical companies quietly move ahead

Mei Xingguo stated that during the “11th Five-Year Plan” period, the policy support for formulation innovation was obviously insufficient. For example, when setting up a major new drug research and development project and providing financial support for the research and development of new drugs, formulation innovation was not included in the price department. In the pricing of medical insurance catalogs and essential medicine lists, it is difficult for innovative preparations to enjoy the same independent pricing power of exclusive Chinese medicines.

On the one hand, it lacks support for R&D, and on the other hand, it lacks support for terminal pricing, which makes the enthusiasm of pharmaceutical companies in terms of preparation innovations hit. Pharmaceutical companies expect the status quo in these two aspects of the policy to be improved.

Analysts said that for Chinese pharmaceutical listed companies, despite the fact that each company has its own advantages, the lack of independent innovation makes the overall homogenization of pharmaceutical preparations more serious, and innovations in modern Chinese medicine preparations are also present. Just trying. Therefore, only the country can increase the enthusiasm for innovative preparations of pharmaceutical companies by increasing policy preferences, scientific research projects, and financial support.

At present, many pharmaceutical companies, including Hisun Pharmaceutical, have begun to consciously extend downstream, realize business transformation from "raw materials to preparations," and strive to export pharmaceutical products to high-end international markets. CICC analysts said that Hisun Pharmaceutical is currently in a critical period of transition, and the company’s pre-existing tacrolimus preparations for European exports have been certified, indicating that the company’s strategic implementation is effective.

Analysts' comments on Meiluo Pharmaceutical showed that the company's future growth mainly comes from the domestic formulation business and the export of pharmaceutical preparations, which is expected to be reflected in the next two years. In terms of domestic preparations, the company’s exclusive breed of traumatized bone grafts is expected to increase in volume after entering the basic drug list.

Shuanglu Pharmaceutical actively develops overseas markets based on the domestic market. Raw materials and preparations have been submitted for registration in more than a dozen countries, and more than ten varieties have obtained registration approvals from relevant national authorities.

Jingxin Pharmaceutical has achieved a gross profit margin of around 70% due to the integration of raw materials and preparations. In the future, the company will also have a variety of statins introduced to the market and will integrate raw material preparations. Analysts said that with the company's pre-sales of the new sales of the market, it is optimistic that the company's other statins market sales.