21世紀(jì)是生物科學(xué)的世紀(jì)，是生物技術(shù)、生物信息學(xué)和納米技術(shù)的時(shí)代。生物技術(shù)、生物信息學(xué)和納米技術(shù)為生物醫(yī)藥的發(fā)展提供了前所未有的機(jī)遇，帶來迎接創(chuàng)新挑戰(zhàn)的科學(xué)基礎(chǔ)和力量，理應(yīng)對傳統(tǒng)創(chuàng)新藥物研發(fā)模式帶來革命性變化。回顧半個(gè)多世紀(jì)的傳統(tǒng)創(chuàng)新藥物研發(fā)模式，不難發(fā)現(xiàn)世界高成本、高風(fēng)險(xiǎn)、低效率的研發(fā)傳統(tǒng)模式，存在不利于創(chuàng)新發(fā)展的問題。根據(jù)近20年的進(jìn)展和研發(fā)水平，估計(jì)未來10年小分子化學(xué)藥物的創(chuàng)新仍然主導(dǎo)世界新藥發(fā)展，小公司的前景和多渠道整合研發(fā)是世界新藥不可抗拒的力量。面對挑戰(zhàn)，采用先進(jìn)監(jiān)管科學(xué)技術(shù)和新方法，加強(qiáng)生物技術(shù)新藥的研究開發(fā)和藥物有效性和安全性風(fēng)險(xiǎn)評(píng)估研究十分迫切。其次，創(chuàng)新藥物的高成本、高風(fēng)險(xiǎn)、低效率瓶頸需要提升合作效率來突破。第三，根據(jù)我國國情，注意發(fā)展分子靶向藥物的研發(fā)戰(zhàn)略和策略，重視給藥系統(tǒng)的研究、明確創(chuàng)仿結(jié)合發(fā)展新藥的目標(biāo)，更需要合理整合研發(fā)發(fā)展模式，需要優(yōu)化資源配置來提高研發(fā)效益。第四，中國特色的自主創(chuàng)新需要國家政策引導(dǎo)，政府在規(guī)劃、政策、開放和實(shí)力建設(shè)的四大舉措的實(shí)現(xiàn)，需要企業(yè)實(shí)力支持和官–產(chǎn)–學(xué)–研–企的多元協(xié)同創(chuàng)新體制的變革。

The 21st century is the century of biological sciences, biotechnology, bioinformatics, and nanotechnology era. Biotechnology, bioinformatics, and nanotechnology provided unprecedented opportunities and challenges, brought innovation to meet the scientific basis and strength for the development of biomedicines, and should be innovative to traditional drug development model which brought revolutionary change. Recalling the research and development (R&D) mode of tradition innovative drug could find that the traditional R&D mode with high-cost, high-risk, and low efficiency did not have the conducive to innovation and development in the past half-century. According to the progress and development of the new drugs in the past 20 years, the innovative small molecular drugs would still dominate the worldwide drug development, and the development prospects of small R&D companies and multi-channel integration were the irresistible power for the worldwide new drugs. To face the challenges, the use of advancing science, technology, and supervision methods is very urgent to strengthen the biotechnology in drug efficacy and safety risk assessment study for R&D of new drugs. The bottleneck of “high-cost, high-risk, low-efficiency” needs to be broken by increasing the efficiency of cooperation in innovative drugs. According to the national conditions in China, the development strategies and tactics on molecular targeting drugs and the drug delivery system should be focused, and the R&D combination of innovative drugs and generic drugs to develop new drugs needs to reasonably integrate the development mode and to optimize the allocation of R&D resources to improve the R&D efficiency. The independent innovation with Chinese characteristics needs the guidance by national policy, and in the planning, policy, openness, and efficiency construction by policy, the government-industry-academy-research diverse collaborative innovation system should be needed.