Pharmaceutical company innovation "tailor-made" and line

Photo Source: Baidu Pictures
This reporter Li Huixuan
Compared with the United States, China'sinnovationdrugs are few, and even caused the Chinese people to travel and not forget to hoard drugs situationHow difficult is it for China'spharmaceutical companies tothe path ofinnovation? Is there anything that Green leaf pharmaceuticals can learn from? For the domestic many imitationpharmaceutical enterprisesindustry, how to innovate?soon, the presence of Chinese innovative drugs is expected to appear in the U.Smarketrecently, Greenleaf Pharmaceuticals Announced that the U.SFood and Drug Administration (FDA) has confirmed that its development of the lipacoone microsphere injection does not require any further clinical trials, can be submitted in the United States for new drug marketing applications This means that China, which has been a big exporter of API, has for the first time got a pass to the U.S market for its own innovative drug compared with the United States, China's innovative drugs are few, and even caused the Chinese people to travel and do not forget to hoard drugs How difficult is it for Chinese pharmaceutical companies to follow the path of innovation? Is there anything that Green leaf pharmaceuticals can learn from? For the domestic large number of generic drug enterprises, how to innovate? improved new drugs or breakthrough
In August this year, the State Council issued the Opinions on Reforming the Review and Approval System for Medical Devices of Pharmaceutical Drugs (hereinafter referred to as "Opinions"), redefining the concept of new drugs and generic drugs, dividing new drugs into innovative and improved new drugs, and adjusting generic drugs from the current "drugs that mimic existnational standards" to "drugs that are comparable to the quality and efficacy of original drugs." from the redefinition of new drugs and the improvement of generic review standards, it is not difficult to see that the introduction of the Opinion is intended to encourage and support real innovative drugs or original innovation Compared with innovative drugs with the largest and most risky investment in capital and time, the development of improved new drugs may be more suitable for the actual situation of Chinese pharmaceutical companies improved new drugs refer to drugs that optimize structure, dosage type, route of administration, adaptation certificate or combination of drugs on the basis of substances with known structure and listed active ingredients, and have obvious clinical advantages Clearly, Green leaf pharmaceuticals chose this path Lipones is the most effective schizophrenic drug under Johnson and Johnson, and the main form on the market is its long-acting injection of lipeone, which does not reach blood concentration immediately after the first injection and must be taken orally for three weeks The microsphere injections of Green leaf pharmaceuticals only need to be injected every two weeks, no oral preparations are required for three weeks after the first injection, and the concentration of stable blood is achieved more quickly " microsphere injection is a concrete practice to select the innovative direction of dosage type in the research and development of green leaf pharmaceutical "Green leaf pharmaceutical group senior vice president Li Hexin recently said publicly, "New drug application system more mature drugs on the market, compared with new compound research and development, dosage type innovation, although the technical threshold is higher, but the clinical risk is lower, the approval time is shorter, more competitive." "
Wang Zeren, executive vice president of The Institute of Drug Technology of Nanda, Shenzhen, said that under the new policy situation in China, it is more practical for domestic pharmaceutical companies to make improved new drugs "improved new drug research and development cycle is relatively medium, about 5 years, research and development costs are also declining, generally less than 100 million U.S dollars, development risk is relatively small, the success rate is about 20%, but also have a good profit "At the recent BT Leaders Summit in Shenzhen, "to explore innovative ways for Chinese pharmaceutical companies in the new situation", Wang Zeren said in his view, improved new drugs will be the original pharmaceutical companies to extend the life cycle of their brand products, but also small and medium-sized biotechnology companies to improve the competitiveness of their products focus on clinical value
so how can we improve and make "better" drugs on the market? In this regard, Wang Ze people stressed that the improvement of new drugs in the clinical advantages " requirements for developing improved new drugs are of new clinical value, such as improving efficacy, safety, compliance with the patient's medication, or the convenience of patient use and reducing toxicity Wang Ze said to take microsphere injections as an example, compared to the long-acting ketone injection must be oral three-week drug weakness, this drug can better compensate patients with poor drug compliance defects, faster than market drugs to achieve steady-state blood drug concentration "
", "We consider the direction of research and development has four main elements: first, whether there is sufficient market potential, second, whether the corresponding clinical needs have not been met, third, whether competitors have significant product defects, and fourth, whether clinical and market risks are manageable." Li fuxin further explained Wang Zeren also believes that enterprises before innovation must first understand the current listed products have clinical defects Because clinical deficiencies are diverse, he recommends that companies communicate more with clinicians in the field of clinical treatment to know where improvements are needed For slow-release agents, the development also needs to consider whether the relationship between pharmacokinetics and pharmacokinetics is appropriate of course, in addition to understanding clinical deficiencies and market risks, the development of improved new drugs also requires a little creativity As seen from the many cases presented at the forum by Peter Farina, president of the Concogeneral Biopharmaceutical Innovation Alliance, companies can't limit themselves to small ideas and can improve in a very much different direction Farina said, for example, used to treat glaucoma protoscocin slow release nanoagent, the researchers made the drug into a small nanoparticle, put in the eye can maintain the efficacy of 6 to 9 months, for patients will be more convenient In addition, nanoparticles also have a variety of shapes, such as cones, long strips, rings, and so on, the size is also different, but if it is the shape of the propeller of the helicopter, it will be easier to go directly to the affected areas 　　Generic drugs should have their own characteristics
In short, improved new drugs more in line with China's national conditions and needs, to avoid the past low-level repeated imitation, at the same time can also make some advantages in clinical, which is the main way for many domestic generic drug enterprises to seek transformation however, it is not easy to do a good job of improving new drugs, without their own characteristics it is difficult to obtain patent protection In view of this, in the next 10 to 15 years, high-quality generic research and development will remain the focus of domestic pharmaceutical companies So, with the increasing threshold of generic drug approval, how can generic drug companies innovate to survive? " generic drug enterprises in addition to strict control of quality to fight for price advantage, but also to find their own market positioning, the formation of product characteristics "The president and chief scientist of Pharmula Laboratorie, " said Ms Tomlin, president and chief scientist it is clear that generics are not simply "doing what you do" Tang Liyuan pointed out to reporters that for China's generic drugs, the biggest weakness is too follow the trend, see good products on the rush In contrast, China's generic drugs should have their own characteristics, enterprises after market analysis, find the right market positioning, the formation of characteristics in Ms Tang's view, the core of generics is also to set up their own research and development team, to build their own technical expertise and technology platform The research and development team is familiar with marketing first and can provide very clear product requirements, including complete information on product color, shape, annual sales volume, etc In addition, the research and development team should be led by preparation experts, in the basic preparation stoking the beginning of the selection of varieties, it is necessary to research and development of the difficulty, cost of a certain estimate, this opinion of the entire preparation can be copied successfully is particularly critical not only, But also said that China's generic drugs to survive in the long term or have a market in the United States, the most important thing is to produce equal quality and bio-equivalent products "The characteristics of the research and development of generic drugs are mainly in bioequivalence, the laboratory in the formulation of research takes a long time, whether the smooth one-time through bioequivalence basically determines how much the development of generic drugs to spend." Ton added China Science Daily (2015-10-27, 7th edition of Biology) (Responsible Editor: HN666)