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新药是制药业的灵魂,也是制药企业的主要利润来源,技术和产品竞争是所有竞争的基础,它贯穿于企业的生存和发展的全过程。“中国是制药大国,不是制药强国”是目前我国制药行业的写照。所谓大国,是指化学原料药,目前我国能生产24类近1400多种原料药,生产能力仅次于美国,居世界第二位。但是,我国的创新药物开发远远落后于发达国家。迄今为止,我国开发的获得国际承认的创新药物只有两个:青蒿素和二巯基丁二酸钠,超过97%的化学药是仿制药物。我国可能是唯一给中成药以药品身份的国家,但在国际药品市场并非主流药品,出口欧美的中成药是以“食品添加剂”的身份登陆的,同时还面临农药残留、重金属超标的问题。随着我国动物药业的发展,重视新药的研发已经成为企业的共识。出于对兽药行业前景看好,近来业外资本纷纷涉足兽药制造业,投资力度显著加大,加速了兽用药物的研究和开发。因此,为了适应GMP后的下一轮竞争,重视新兽药研发和再造至关重要。
The new medicine is the soul of the pharmaceutical industry and the main source of profits for pharmaceutical companies. Technology and product competition are the basis of all competition. It runs through the whole process of the survival and development of enterprises. “China is a big pharmaceutical power, not a pharmaceutical power” is the portrayal of China’s pharmaceutical industry. The so-called big country, refers to the chemical raw material medicine, at present our country can produce 24 kinds of nearly 1400 kinds of APIs, the production capacity is second only to the United States, ranking second in the world. However, the development of innovative drugs in our country lags far behind developed countries. So far, there are only two internationally recognized innovations developed in our country: artemisinin and sodium dimercaptosuccinate, and over 97% of chemical drugs are generic drugs. China may be the only country that treats proprietary Chinese medicines as pharmaceutical products. However, it is not a mainstream pharmaceutical product in the international pharmaceutical market. Proprietary Chinese medicines that are exported to Europe and the United States land as “food additives”, while pesticide residues and excessive heavy metals are still being confronted. With the development of animal medicine industry in our country, it has become the consensus of enterprises to attach importance to the research and development of new drugs. Out of optimistic prospects for the veterinary industry, recently, the capital outside the industry have set foot in the veterinary drug manufacturing industry, a significant increase in investment, accelerated veterinary drug research and development. Therefore, in order to adapt to the next round of GMP competition, emphasis on new veterinary drug R & D and recycling is crucial.