Analysis on the Development Characteristics of China's Medicine and Health Industry in 2015

Introduction: In 2015, the pharmaceutical industry in China's pharmaceutical industry showed high investment characteristics and remained unchanged, looking for unmet areas of demand, the arrival of the “patent cliff”, the boom in the development of biosimilar drugs, and the global cross-border cooperation in drug discovery and development.

High input characteristics of the pharmaceutical industry remain unchanged

The strength of domestic pharmaceutical R&D has been continuously enhanced. Among the top 10 pharmaceutical companies in China, the R&D intensity of Hisun Pharmaceutical is 12.3%, which is close to the top 10 global investment level. From the FDA's review of new drug approval data over the years, it can be found that the approval time for most drugs does not exceed 10 months, which is the fuze of the global drug development speed. The most significant is to encourage the creation of breakthrough new drugs. From January to September of 2015, among the 27 new drugs approved by the FDA, there are 13 breakthrough drugs, accounting for nearly half, of which 31% of the 13 breakthrough drugs are anti-tumor drugs and are mainly used for the treatment of rare diseases.

Finding Unmet Needs

In the field of drug treatment approved by the FDA in 2014, there were 9 anti-tumor drugs and anti-infective drugs each. At present, new oncology drugs are mainly concentrated in the research and development of rare drug use, and there is an urgent need for accurate and effective anti-tumor drugs. At the same time, in 2015, it became a major year for the development of antibacterial drugs. After the super bacteria raged, the U.S. incorporated the GAIN provisions into the law as part of the FDA's Safety and Innovation Act, and those drugs that received QIDP certification were in the patent period. In addition, it enjoys an additional five years of market exclusive rights. China is a big country in the use of antibacterial drugs. The long-term irrational use of drugs leads to serious drug resistance, and companies need to attach importance to the development of antibiotic-resistant new drugs.

"Patent Cliff" arrives

In 2015, the medical field is facing the second wave of the most severe “patent cliff”, and will have expired patents with a brand value of up to US$44 billion. An inventory of the top ten patent expired drugs in 2015 reveals that the total global sales of these 10 branded drugs exceed US$32 billion.

Biosimilar development boom

The global Biosimilar market will be approximately US$20 billion in 2015 and will exceed US$55 billion by 2020. In particular, the market for anti-tumor biosimilar drugs accounts for about 2%-4% of the global market for biological products. After the FDA approved the first biosimilar drug on March 6, 2015, there were successive biological analogs pending FDA approval.

Global Cross-border Cooperation Drug Development

At present, the R&D model of multinational pharmaceutical companies has shifted from spending huge amounts of money to setting up R&D centers in the country to streamlining the R&D sector, cutting R&D expenditures, establishing small and flexible drug R&D execution units, increasing R&D outsourcing, and introducing drug candidates. Transnational pharmaceutical companies have begun to pay attention to minor diseases and orphan diseases, and transferred research and development centers to cities with talents, innovative capabilities and relatively low-cost medical resources, such as Shanghai, China and Beijing. The current trend is the "VC (risk investment) + IP (IP) + CRO" drug innovation model, this three-dimensional integrated innovation model has spawned a series of new R & D incubators in the country.

Global Vision + Local Innovation

The Chinese-style drug innovation entrepreneurship incubator is a new practice with both global perspective and local characteristics. It has attracted more attention from the pioneering pharmaceutical industry, focusing on the creation of innovative drugs “hundreds of foreign exchanges” model. It has been selected from nearly 400 projects worldwide. The new drug has attracted more than 40 local pharmaceutical innovation and startup companies. Another more active form is the establishment of a new drug fund. There are also several domestic companies that have transferred their own proprietary intellectual property rights to foreign companies, which provides a realistic path for participating in the international R&D chain for domestic emerging small and micro-medicine innovation R&D companies.

In the “13th Five-Year Plan” major task plan for the creation of China's major new drugs, five-year research and development targets have been proposed in five areas: innovative drug research and development, clinically urgently needed pharmaceutical preparations, internationally registered drug research and development, major core technology research, and forward-looking new technology research. , and proposed to focus on the development of malignant tumors, cardiovascular and cerebrovascular diseases and other top ten categories, to strengthen the source of innovation and transformation research, create a major new drug.

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