About 6 people in China are diagnosed with cancer every minute. There are 105 new cases of cancer every day in Beijing, and 150 cases of new cases every day in Shanghai... Nowadays, cancer has become the "number one killer" of Chinese people's health.
Because of this, among the top 10 drugs in global sales in 2012, antibody drugs with anti-tumor drugs as the core accounted for half of the total, and the market growth momentum continued unabated. However, what is worrying is that in the antibody drug industry, China's core competitiveness is still insufficient. How should Chinese pharmaceutical companies develop the gold mine of the antibody drug market and benefit more people? The reporter interviewed the experts of the Patent Analysis Report of the Antibody Drug Industry to bring readers some thoughts.
Status: still in the "ivory tower"
Although the earliest antibody drugs date back to 1891, because of the little knowledge of antibodies at the time, their true mass use was nearly 30 years.
"As a biopharmaceutical, antibody drug technology has undergone several major technological breakthroughs, coupled with the express train on the Human Genome Project, which is now mature and used to treat malignant tumors, infections, blood or extracellular fluid diseases, etc. Major illnesses have gradually attracted the attention of all countries in the world." Ma Qiujuan, director of the Beijing Branch of the Patent Examination and Cooperation Center of the Patent Office of the State Intellectual Property Office, said.
According to the "Report", since 1980, the number of patent applications for antibody drugs has been rising all the way. As of July 5, 2013, the number of patent applications involving antibody drug technology in the world totaled 626.95 million, of which the number of patent applications in the United States was 39.536 million. More than half of the total number of patent applications in the world, far ahead of other countries; followed by Japan and Europe, respectively, 8663 and 4043; China ranked fourth, 3846. In the Chinese patent application in the field of antibody medicine, foreign applications in China account for about 60%, and domestic applications account for only 40%.
"Overall, China has made great progress in the field of antibody medicine, with certain technical reserves and industrial scale, but there is still a certain gap compared with the United States, Japan and Europe. In the antibody drug market, it can be described as 'survival in the cracks.'" Ma Qiujuan pointed out.
Not only that, but the lack of development of the market body of Chinese antibody drugs also made Ma Qiujuan very worried. The "Report" also shows that among the top 20 applicants in the world, foreign companies account for about 2/3, and the rest are foreign R&D institutions. In China, the top 10 applicants from China are all enterprises. Only one of the top 10 domestic applicants ranked eighth, and the rest were universities and research institutes.
Zhu Jingyu, an examiner of the Patent Office of the Patent Office of the State Intellectual Property Office, said that this indicates that the market subject of antibody drugs in China lacks strong technical support, and there is a lack of convergence in production, education and research. The development of antibody drug technology is still in the ivory. Tower" stage.
Hot spot: anti-tumor indications
According to the "Report", there are a total of 304.21 million patent applications involving specific indications (application areas) of global antibody drug-related patents, including 14,573 patent applications involving anti-tumor and 9558 patent applications for treatment of immune/allergic diseases. There were 8110 patent applications for infectious diseases, and the above three accounted for 38% of the total number of patent applications.
Unlike other countries, China's application in the field of anti-infective drugs is greater than the number of applications for immune-type antibody drugs. Ma Qiujuan believes that this reflects from a side that China has more research in the field of anti-infection. She specifically reminded that "the use of antibody drugs for immune diseases should be a big application trend."
In her view, the current cost of chemical drugs in the field of anti-infection is relatively low, so the field is still dominated by chemical drugs. Anti-infective antibody drugs are usually used to treat serious diseases, such as inflammation in the presence of cancer complications. Narrower. "Immunotype antibody drugs have good prospects for development, and anti-tumor antibody drugs have been active in the past decade. Applicants in China can appropriately improve the research and development of anti-tumor antibody drugs against tumors and immune diseases," Ma Qiujuan said.
It should be noted that antibody drug conjugates (ADCs) are becoming a new hotspot and trend in the development of anti-tumor antibody drugs. Among them, the candidoid ADC is one of the types of ADC drugs that have developed rapidly in recent years.
Although maytansin itself has no benefit in the treatment of tumors, in recent years, this compound and its derivatives have become the focus of many researchers as a "warhead" drug in ADC. The data shows that as of March 2014, there were approximately 385 core patent applications involving metoprol-conjugated antibody drugs in the WPI database, the vast majority of which were from the United States.
"Mentanol mainly includes two kinds of derivatives in specific applications, DM1 and DM4. Although their carbon chain structure is different in length, they can be linked with a coupling agent through a disulfide bond." Ma Qiujuan told reporters that Roche's resistance Kadcyla, a new drug for breast cancer, uses DM1, which consists of a trityl monoclonal antibody, a cross-linking succinimide ester (SMCC) and DM1.
What is worrying is that in the patent application of China's candidoid ADC, the number of foreign applicants is the majority, and Ignano and Roche have also carried out a large number of patent distributions of the candidoid ADC in China. Only a few companies or research institutes have filed patent applications for the Maytan ADC. "Compared with the situation of foreign applicants, there is a big gap between the number of domestic applicants and the number of applications." Ma Qiujuan said.
Strategy: Combination of production, study and research
At the moment, antibody drugs are infinite. According to statistics, from 1997 to 2012, the antibody drug market increased from 310 million US dollars to 65.3 billion US dollars, an increase of nearly 211 times in 16 years.
Some antibody drugs "predators" took the opportunity to make a lot of money. According to the data, the 2012 drug drug sales champion is Abbott’s Xiu Mei Le, with annual sales of 9.534 billion US dollars; Roche (including Genentech) three star antibody drugs Ma Luohua, Herceptin and Avistin sales in 2012 The sum reached $19.554 billion.
The market outlook is self-evident. In the face of the "anti-strong and weak" situation in the field of antibody drugs, how can Chinese antibody drug companies find a place in the four "smokes"?
"At present, domestic applications are mostly based on modified drugs. The proportion of innovative drugs at the source is relatively low. The number of applications is relatively small and scattered, and there is a lack of pharmaceutical companies that can compete with foreign countries." Ma Qiujuan believes that domestic inventors in the field of antibody drugs are mainly concentrated in Colleges and universities, mostly scholar-type talents, lack of market-oriented guidance for their technological achievements. In this context, if we can consciously promote the combination of industry, university and research to make them partners, or build industry alliances, give full play to their respective advantages, and strive to master some core technologies, we can achieve "win-win".
While promoting the combination of production, education and research, the patent application strategy should also pay attention to it. “Because of the high risk, high investment and high profitability of the biomedical industry, the more reasonable scope of protection in the field of antibody drugs is the patent application of “wide and not pan”.” Ma Qiujuan said that the scope of protection has been “pan” The application may make the patent acquisition period too long. During this period, the company's competitors may use the updated technology to apply for the relevant topics, so that the first application is in a passive situation.
In view of this, Ma Qiujuan suggested that applicants can use the "product" technical solution to apply for patents, seize the favorable position in the competition, and then patent the application of the "preferred effect" to achieve the patent for extending the preferred drug regimen. The purpose of the term of protection.
“It is estimated that by 2015, there will be a bio-patented drug with a market value of US$64 billion, and the proportion of single-antibody drugs will be as high as 48%. This is an opportunity for Chinese pharmaceutical companies, and relevant enterprises should be fully prepared,” said Zhu Jingyu. However, she also reminded that after the expiration of the patent, there will usually be a situation of vicious competition in which many companies compete for imitation. Since the companies that master the core technology also have peripheral patents to further expand and maintain their enclosure, in this case, if they want to form antibody drugs. In the scale industry, domestic related companies must improve their innovation capabilities and continuously improve their antibody drugs. For example, efforts are being made to find new targets, humanization, and improve antibody affinity and effector functions.
