Business News Agency April 20th The FDA's Drug MasterFile (DMF file) is a necessary qualification document for pharmaceutical raw materials such as chemical raw material medicines, intermediates, excipients, excipients, and pharmaceutical packaging materials to enter the United States.

More than 300 DMF file numbers in 25 years Since the FDA began in 1940 and ended in December 2004, there have been 17,894 DMS file registrations issued, of which 7,160 are currently valid. Among them, China began to obtain this registration number from the end of 1980. Up to now, 317 raw materials, medicines, and intermediates have been registered with DMF files. Currently, there are 200 document numbers that are valid. According to a follow-up survey conducted by the Health Network, in 2004, a total of 38 products in our country received the DMF file number.

The earliest DMF file number for China's raw material medicine products was that of Seoul Taiyuan Pharmaceutical Factory on December 31, 1980 (which has now expired). The number of documents that received the largest number of records in history was in 1998. There were a total of 47 document registration numbers in the year, 31 of which are still valid. In particular, since 2002, the number of Chinese products passed has gradually increased, and 96 valid document numbers have been obtained in the past three years. It can be seen that Chinese companies are beginning to realize the importance and necessity of quality and management in the journey to the international market, and they are practicing in line with the international standardized market.

Most of the companies that have obtained the DMF file number are dominant enterprises, and the most advantageous products are Chinese enterprises that have obtained the DMF file number, which are the most advantageous enterprises in the country. For example, Zhejiang Hisun Pharmaceutical has the largest number of DMF files (24 items), and its products are lovastatin, simvastatin, mevastatin, pravastatin, and antitumor antibiotics, among others; Shandong Xinhua Pharmaceutical is our country. The main manufacturers of antipyretic analgesics, their ibuprofen, caffeine, aspirin, trimethoprim also received the DMF file number; domestic key antibiotic production company Hebei Zhongrun Pharmaceutical, its products 7-ACA, 6-APA Penicillin G Potassium and Amoxicillin also received DMF file numbers in the last two years.

Among the 200 document numbers obtained in China, antibiotics, antineoplastic agents and antipyretic analgesics accounted for the largest proportions, which were 27%, 15%, and 8%, respectively. These three types of products represent the dominant categories of raw material drug production in China. At the same time, we also see that the advantages of raw material medicine in China are more in the field of basic type, bulk quantity, and low added value.

There are 134 generic products with DMF file numbers in China. These products have the most anti-infective drugs, including 10 clindamycin hydrochlorides, followed by 8 antipyretic analgesics, and an anti-tumor drug paclitaxel. There are 6 items. Therefore, we also recommend that companies avoid excessively concentrated products and reduce competition risks.

The benefits of quality, credit, and profit increase. The benefits of obtaining the US DMF registration number and on-site inspections through the FDA are obvious. Not only do drug substance intermediates gain access to the US market, but also because of the FDA's Authoritativeness is recognized by all countries in the world, and its approval also plays an important role in entering the entire international market. China has become a major producer of bulk pharmaceuticals in the world, while the United States is the largest importer of bulk drugs.

Therefore, the U.S. market should become the most attractive market for many Chinese pharmaceutical companies. In U.S. pharmaceutical preparations with annual sales of nearly 10 billion U.S. dollars, 70% of the raw materials used in its production are imported from foreign countries, of which India and China are the major source countries. However, we have seen that the number of DMF file numbers obtained by India and Japan far exceeds that of China, being 622 and 425, respectively. Our gap is still very clear.

In fact, this is a question that VC investors often have to ask themselves and their partners. More and more venture capital funds and institutional investors are pondering whether it is worthwhile to continue to soak in the ocean of biopharmaceuticals. This is also the most discussed topic in the recent global M&A summit. The investment eyes of executives and venturers have clearly shifted from biotechnology to a more socialized world of hype concepts. FACEBOOK has a market value of up to US$50 billion when it is not on the market. This is something that ordinary biopharmaceutical companies have dreamed of but could never achieve.

“Imagine a biopharmaceutical company in the early stage of R&D that took the IPO road and needed 5 to 9 years of investment to have income and profitability. This is hardly acceptable to most investors today.” Pete ·Salomon company analyst Frederick Frank said. For biopharmaceutical companies, the current IPO market has not yet completely closed, but it is also dying.

Barclays Capital’s Drew Birch also has the same pessimistic view: “Look at other attractive options for venture capital funds, if you invest in social networks, you may be listed in the next 12 months; biotech-like ideas and ideas, It will take 8 years to become an FDA-approved product, and then the most important thing is to spend further on clinical trials. These clinical trials are often high-risk and no one can guarantee success." Today's new drug development environment, to do It may be okay to have effective safety, but it takes courage and courage to do better than the old medicines and patents that have expired.

In recent months, biopharmaceuticals have paid a lot for the success of the market. If there is enough money, they may not want to be listed at a low price. From the perspective of companies that have already listed, these biopharmaceutical companies have to cut their stock offering prices and increase the number of shares to be issued in order to raise the required funds, because the IPO is their last hope, otherwise they will be big pharmaceutical companies. Eat cheaply.

Another direct benefit of obtaining a DMF file number is to increase the "worth of value" of the product. Since the DMF file number represents high quality and excellent management, its products and manufacturers are likely to gain a very wide reputation in the industry and are often worth more in the international market.

In the past, many domestic pharmaceutical manufacturing companies failed to pass the FDA cGMP certification, resulting in the company's products can not be directly imported into the United States. Although some domestic drugs have infiltrated into the United States through re-exports of agents or indirectly, most products have lost the opportunity to enter the mainstream market in the United States.

Nowadays, more and more companies have realized the importance and necessity of products entering the international market, and set out to prepare for the entry of products into European and American markets. China is a big exporter of raw material medicines, and it is crucial for APIs to be exported to the United States.