Artemisinin market is mostly occupied by foreign companies, how to crack?
Since Professor Tu Youyou won the 2015 Nobel Prize in Physiology and Medicine on October 5, people from all walks of life have lamented and regretted that most of the market share of artemisinin antimalarial drugs has been occupied by foreign pharmaceutical companies.
According to the "Daily Business News" report, China has contributed more than 70% of artemisinin raw materials to the world, but the competitiveness of Chinese companies in this industry is very limited, and the profitable downstream part is basically controlled by international giants. Bio-Valley learned that in addition to the Swiss Novartis and French Sanofi, the market for anti-malaria drugs, some generic drug companies in India also have a place.
WHO is the gatekeeper for antimalarial drugs
Why do foreign pharmaceutical companies occupy such a large share of the antimalarial industry chain represented by artemisinin drugs, and even Indian generic drug companies? In order to answer these two questions, it is important to mention that the World Health Organization launched the drug pre-certification program (WHO-PQ) in 2001.
As we all know, there are not many malaria patients in China, so the domestic market for artemisinin drugs is very limited. The real market is in less developed parts of the world, led by Africa, where the incidence of malaria is high.
In order to ensure that patients in these areas have access to reliable and affordable medicines, WHO has decided to join some international charitable organizations to purchase specific medicines and give them to patients in these countries at reduced prices or free of charge. And anti-malaria "Chinese god medicine" artemisinin drugs, on this list.
Since it is necessary to achieve "reliable quality", there must be a set of audit standards, which is the drug pre certification program (WHO-PQ). PQ is short for Pre-qualification. Only by passing this standard will WHO purchase your products and companies can open the door to the anti-malaria drug market.
At the beginning of its establishment, the WHO-PQ was based on the drug quality standards of the European Union and the United States. Compared with China's GMP and GCP, the requirements are higher. Therefore, many domestic antimalarial manufacturers encountered problems in the application process and were eventually blocked by WHO.
It is worth mentioning that in this process, several Indian generic drug companies have passed the WHO-PQ certification with excellent quality. This is why, in addition to Novartis and Sanofi, Indian pharmaceutical companies have been able to gain a foothold in the antimalarial market.
At present, only Guilin Nanyao, a subsidiary of Fosun Pharma, is the only antimalarial drug manufacturer in China that has passed the certification. A total of 13 antimalarial preparations of Guilin Southern Medicine have been pre-certified by the World Health Organization. Among them, artesunate injection is completely independently developed by China, and it is also the most effective and best antimalarial drug in the world. It is a typical representative of China's innovation.
Quality and intellectual property are the key to the market
The success of artesunate is inseparable from the protection of quality and intellectual property rights.
In the face of the above-mentioned WHO-PQ certification, Fosun Pharmaceutical President (currently Fosun Group President) Wang Qunbin once said that "Chinese brand drugs want to go to the world, innovation and quality are important criteria for drug evaluation, and Fosun Pharmaceutical must reach the highest level if it wants to be internationalized." After years of trial, optimization and improvement, the dissolution rate of artesunate produced by Guilin Nanyao, a subsidiary of Fosun Pharmaceutical, is 85% within the validity period, and the newly manufactured artesunate can reach 95%, while the international standard only requires 75%. The quality of excellence makes WHO list artesunate as the preferred drug for the treatment of severe malaria.
In addition, artesunate has also taken many detours in the protection of intellectual property rights. We must know that in the era when artemisinin was discovered, my country's intellectual property rights and other related legal systems were not perfect, and Chinese people did not pay enough attention to the importance of patents and intellectual property rights.
According to the Legal Daily, powerful R & D institutions and pharmaceutical companies such as the United States and Switzerland have conducted extensive research on the artificial total synthesis of artemisinin, artemisinin complexes, purification and preparation processes based on the technologies disclosed in Chinese papers, and have applied for a large number of patents for improvements and peripheral technologies. This has also led to many domestic follow-up studies on artemisinin because they are not creative enough to obtain patents.
Artesunate solves the two major pain points of artemisinin, the first is insoluble in water, and the second is large dose. In 1987, artesunate completed a new round of pharmacological tests and became China's No. 1 synthetic drug that met international standards, and obtained the No. 001 certificate of New China's first-class new drug. In 1988, won the national patent, breaking the patent barriers of foreign pharmaceutical companies.
In June 2005, the World Health Organization officially confirmed that the original creator of artesunate was Guilin Pharmaceutical (now Guinan Pharmaceutical), an innovative drug developed entirely by China, and its intellectual property rights were recognized by international organizations.
The pharmaceutical industry is a long industrial chain from R & D to achievement transformation. Upstream intellectual property protection, quality assurance during production transformation, etc., any step that is not in place may lead to market loss. Artemisinin is actually a microcosm of these problems.
Fortunately, the country has just recently revised the law on promoting the transformation of scientific and technological achievements, which has been implemented since October 1. It is hoped that the new transformation method can improve a series of problems and deficiencies in the process of my country's innovative drugs from research and development to production; it is also hoped that in the future, my country's independent research and development of innovative drugs can have more representative products such as "artesunate". Let the world change its view of Chinese pharmaceuticals.