The current situation and prospects of biomedicine industry

Continuing the successful experience of the world's largest bio-industry event-BIO International Bio-Industry Conference, the third annual BIO China Bio-Industry Conference was held at the National Convention Center (Beijing) from November 11-13, 2013. The BIO China Biotechnology Industry Conference brings together business executives and core decision makers from the global biotechnology, pharmaceutical and investment fields in Beijing to jointly explore the development and business opportunities of China's biopharmaceutical industry. Beijing is always at the forefront of the high-end biotechnology and pharmaceutical industry, and it has a significant influence on the status of the majority of users and peers. Holding the BIO China Bioindustry Conference is very important for promoting the competition and development of the Chinese biopharmaceutical industry in the international market Historical significance.

Development status of biomedicine industry in the world and China

In recent years, the development focus of the global pharmaceutical market is gradually shifting from small-molecule chemical drugs to large-molecule biological drugs, the latter ’s proportion in the global pharmaceutical market has climbed from 13% in 2006 to 17% in 2010. However, in China, the proportion of biopharmaceuticals has remained at around 5% in the past five years, and development needs to be accelerated. The National Twelfth Five-Year Plan also vigorously cultivates and develops strategic emerging industries, including vigorously developing the biological industry. The State Council released the "Bio-Industry Development Plan" in December 2012, which shows that in the next three years, the bio-industry will grow at a rate of 20% every year. By 2020, the biological industry will become a pillar industry of our economy. The bio-industry is one of the seven strategic emerging industries identified by the Chinese government, and the bio-pharmaceutical industry ranks first in the bio-industry. The development of the biopharmaceutical industry helps China achieve breakthrough innovations in the treatment of various diseases and make up for a large number of unmet medical needs, especially in the fields of diabetes, cancer, hemophilia, and immune system defects.

Challenges facing China's biopharmaceutical industry

It is the biggest challenge for patients to obtain safe and effective innovative biological drugs in time. Under the influence of current regulatory policies, the speed of innovative biopharmaceuticals entering the Chinese market is very slow, which poses obstacles for patients to obtain safe and effective innovative biopharmaceuticals in a timely manner. In addition, the existing regulatory approval process and requirements fail to effectively distinguish biosimilars from innovative biopharmaceuticals. The consistency of regulatory policies is not yet clear, and the post-market monitoring mechanism is relatively weak, which cannot effectively regulate the quality of biopharmaceuticals. Ensure patient safety. The current medical insurance policy has very limited reimbursement for biopharmaceuticals, which restricts patients ’timely access to biopharmaceuticals. For example, monoclonal antibody biopharmaceuticals commonly used in cancer and Other diseases are currently reimbursed for medical insurance.

Lessons from China's biopharmaceutical industry

Due to the complexity of biopharmaceuticals and the inconsistency of molecular structure, if there is no large amount of clinical scientific data to confirm, it is very likely to cause adverse immune reactions and produce drug safety problems. . Similar problems were encountered in the early development of the biopharmaceutical field in China. Due to excessive competition due to low quality standards, the quality of some domestically produced erythropoietin (EPO, a biologic drug that treats anemia by stimulating erythropoiesis) is worrying. As a result, the patient may suffer from pure red blood cell aplasia (PRCA), which requires very long-term blood transfusions to supplement red blood cells.

Suggestions for promoting the development of China's biomedicine industry

First of all, it is necessary to let the public understand the high complexity of biopharmaceuticals, which is different from small molecule chemical drugs: biopharmaceuticals cannot be completely copied. Generic drugs only exist in small molecule chemicals, and their structure is easy to define and copy. The biological drugs are highly complex and the molecular structure is not uniform, there are no imitation products, only biosimilars (biosimilar).

Second, in order to allow more patients to benefit from the help of biopharmaceuticals in a more timely manner, it is recommended to establish scientifically based regulatory requirements to optimize and accelerate the approval of innovative biopharmaceuticals, such as accelerating the optimization of new drug clinical trial applications (CTA) The approval process ensures that Chinese patients can obtain innovative biopharmaceuticals that have been recognized in other regions of the world as soon as possible.

Third, in order to maintain the quality of biopharmaceuticals and patient safety, clear and transparent quality standards and regulatory approval mechanisms that are in line with international standards need to be established. On the basis of referring to the global standards of the European Union and WHO, a regulatory approval system and testing system suitable for China's national conditions and in line with international standards are established to ensure the high quality and safety of biological drugs. At the same time, define the definition of innovative biopharmaceuticals and biosimilars, and establish clear and transparent quality certification standards and regulatory approval systems (including patent application, registration, naming to later market access and supervision) to ensure consistent supervision Sex, thereby checking the quality assurance and patient safety of the two types of drugs.

Fourth, establish a mechanism that allows more Chinese patients to benefit from innovative biopharmaceuticals, such as accelerating the creation of medical insurance payment terms for biopharmaceuticals, or promoting the adoption of co-payment mechanisms undertaken by governments / enterprises / patients and other parties, so that more patients can Conditionally benefit from innovative biopharmaceuticals.

China has the strength and the conditions to build a first-class biopharmaceutical industry. In order to help more Chinese patients improve the quality of life and enjoy the beauty of life, China urgently needs to learn from the successful development practices of biopharmaceutical industries around the world and absorb the chemical pharmaceutical industry and early biomedical industry. Lessons from the development of China ’s bio-pharmaceutical quality system with Chinese characteristics, so as to help attract more domestic and foreign innovative pharmaceutical companies, and ultimately benefit Chinese patients, so that they can safely use safe and high-quality biological agents .

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