echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Active Ingredient News > Drugs Articles > There is a way to choose: potential and cost focus of two types of improved new drugs under the new policy

    There is a way to choose: potential and cost focus of two types of improved new drugs under the new policy

    • Last Update: 2015-11-19
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    Source: from November 8, 2015 to November 19, 2015, CFDA drafted the pilot program of drug listing license holder system (Draft for comments) and the work program of chemical drug registration and classification reform (Draft for comments) (to be ended on November 20 for comments), November 11 Decree No 230 of the announcement on several policies of drug registration review and approval was issued on May 2 The intensive introduction of the policy points to a clear direction, that is, to encourage innovation, improve the quality of generic drugs, solve the backlog of registration applications, and crack down on fraud In a short period of time, many policies have been issued, which has caused heated discussions in the industry Expert advice, peer debate, media follow-up and so on have become the trend There are some psychological expectations for the transformation of class 1 new drugs from "China new" to "global new", but only those enterprises and institutions that have a special interest in the original class 3 new drugs However, the changes of the new 2.2 and 2.5 drugs, which belong to 5 and 6 kinds of chemicals, have caused many questions Since the application information requirements of class 2 modified new drugs are equivalent to class 1 new drugs, it means that the application of some simple modified dosage forms and increased specifications that are available now becomes extremely difficult What should we do? Among them, the reorientation of the registration and classification of chemicals can be said to bring subversive changes to enterprises How to adapt to new changes? Many enterprises said: resolutely do new drugs! Then, the next question is "what kind and how to do it" For class 1 drugs that have changed from "China new" to "global new", the requirements for application materials have not changed much, and enterprises that love it do not need to change their own track to reach their destination There is no small change in Category 2 improved new drugs Enterprises and institutions need to carefully identify It is important to select products suitable for their own development direction according to their own advantages Two kinds of improved new drugs are divided into five categories, the monitoring period is 3 years and 4 years, among which 2.1, 2.4 and 2.5 are 3 years, 2.2 and 2.3 are 4 years As the draft clearly stipulates that the improved new drug is a drug with obvious clinical advantages, which optimizes its structure, dosage form, route of administration, indications, usage and dosage, specifications, etc on the basis of known active ingredients Therefore, after this change, some categories have prominent opportunities, while some categories have steep costs Enterprises need to be patient in analyzing and identifying themselves Direction of 2.1 new improved drugs - "modified acid radical / base" and other definitions: APIs and their preparations containing the formation of ester, salt (including salt containing hydrogen bond or coordination bond) of known active ingredients, or other non covalent bond derivatives (such as complex, chelate or inclusion compound), or change of crystal water, crystal solvent, crystal form Classic case: nexin's oral medicine and injection medicine are both popular at home and abroad, with good opportunities For example, the active ingredients of the original drug Nexium of AstraZeneca include esomeprazole magnesium sustained-release capsule / suspension for oral administration and esomeprazole sodium for injection They have different bases and different dosage forms Nexium has made brilliant achievements and has been listed in the top 25 global sales medicine list for many times A few years ago, South Korea and the United States once applied for a new drug in the form of esomeprazole strontium, and tried to bypass the patent for approval, but it failed Compared with the original drug, there is no evidence to prove that it has obvious clinical advantages, so it is inevitable to refuse approval, which should be avoided 2.2 new improved drugs - definition of "modified dosage form / route of administration": new dosage form (including new administration system) and / or route of administration containing known active ingredients Classic cases: high-tech sustained-release agents, microsphere agents and other improved new drugs are included or partially included in the original registration 2, 3 and 5 categories, and this innovation is also very popular at home and abroad For example, nitroglycerin, which is used to treat and prevent coronary heart disease, is generally administered sublingually and absorbed rapidly and persistently through mucous membrane; while injection is intravenous drip after dilution, which is used to reduce blood pressure or treat heart failure The innovation of new dosage forms with known active ingredients will be polarized, and the categories with technical content will stand out, while the categories with simple modified dosage forms may withdraw from the market due to high cost First of all, the advantages of developing new drug delivery system are low cost, short cycle and quick effect, compared with the new chemical entity drug, which has more investment, high risk and great difficulty The major pharmaceutical giants have successful cases to look for, such as AstraZeneca's drug for schizophrenia, "srikan", which has been sold for more than one billion dollars for four consecutive years, uses slow-release technology; Johnson & Johnson's drug for depression, "Hengde", which has been sold for six consecutive years, uses microsphere preparation technology and so on It seems that the wonderful achievements are indeed encouraging, but it is not known that such cutting-edge preparations are closely related to the nature, excipients and technology of the drug itself, which can not be achieved by ordinary enterprises through several experiments Not to mention that the most closely related excipients are mostly monopolized by several large pharmaceutical groups in Europe and the United States It is an indisputable fact that domestic excipients enterprises are small and scattered Therefore, it is impossible for China to compete with Europe and America in this field However, it will be a good direction for the enterprises with real strength to engage in this research and development In addition, cost, because the modified dosage form originally belongs to 5 categories, it is no longer news that enterprises simply change tablets into capsules for the convenience of bidding, etc., which leads to a backlog of CDE evaluation and serious homogenization of the market The promotion of this class of new drugs to class 2 means that the application materials will be made in accordance with class 1 new drugs, and the application cost will increase several times or dozens of times, which is daunting It is clear at a glance what the enterprise will choose 2.3 new improved drugs - "new compound preparation" definition: new compound preparation with known active ingredients Classic case: harvoni (including sovaldi's compound) is a model for the development of such improved new drugs Gilead is the absolute leader in the field of HIV / AIDS Its products, such as Atripla, stribild, complera, genvoya, are all compound preparations composed of known components of nucleoside and / or non nucleoside reverse transcriptase inhibitors The sales of the products are promising all the way Now, Gilead has applied this advantage to the research and development of hepatitis C drugs After the great success of sovaldi, the compound product harvoni of ledipasvir / sovaldi, a cocktail therapy for hepatitis C, has also been approved Of course, other pharmaceutical giants such as Bristol Myers Squibb and Johnson & Johnson are not idle The R & D and market competition of such preparations are also fierce Compared with the development of new molecular entities, the risk of the development of new drugs is significantly smaller For some enterprises that are deeply involved in a certain field, they can show their strength 2.4 new improved drugs - definition of "new indications": preparations with new indications containing known active ingredients Classic case: in my opinion, the development of new aspirin and thalidomide is no less than that of class 1 new drug If it is only the extension of some indications, the difficulty is relatively small; if it is an alternative indication, it is quite difficult For example, the most well-known aspirin, which is a kind of antipyretic and analgesic drug, was found to have antithrombotic effect in a small dose in long-term clinical practice, so the indication was approved; subsequently, it was found that the drug also has anti-tumor effect, becoming the hottest research model of "old drug new use" There's also thalidomide, a drug that's worth reading about Thalidomide, developed in the 1950s, was originally used for sedation and hypnosis After it was found that thalidomide significantly inhibited pregnant women's pregnancy reaction (such as antiemetic reaction), it was widely used in pregnant women's pregnancy reaction, resulting in the most famous "seal fetus" event in the medical field However, scientists did not give up thalidomide After the drug was banned for more than 40 years, it was found that thalidomide has rapid anti-inflammatory effect and anti-tumor effect on leprosy patients with erythema nodosum In 1998, FDA approved thalidomide in the treatment of myeloma; in 2006, FDA reviewed and passed the application of thalidomide in the treatment of multiple myeloma or myeloma Because of the in-depth study of thalidomide, lenalidomide is a derivative of thalidomide Compared with thalidomide, lenalidomide has better efficacy, lower toxicity and lower teratogenicity risk The author believes that the development of such new drugs is suitable for enterprises that have done solid basic research or cooperate with institutions with deep basic research skills to develop products with half the effort 2.5 new improved drugs - definition of "new usage and new dosage": new usage and dosage with known active ingredients and new specifications of preparations Classic case: domestic enterprises of children's drugs and antidepressants are very skilled in the application of new specifications in such applications, which is also one of the important reasons for the backlog of drug registration applications Because of the low cost of application and test, some enterprises report the specifications they can think of one time, so that doctors are at a loss when they use them This time, the application of this kind of preparation is increased to class 2 new drugs, which means that all tests are conducted with reference to class 1 new drugs Like the application of the simple modified dosage form mentioned above, the cost increases sharply, and there is no doubt whether the enterprise is willing to apply However, for those drug research and development institutions dedicated to children and other special groups, there will be good development opportunities Under the guidance of this policy, the situation that 90% of drugs in China do not have children's version will be alleviated It seems that the development of products with new usage and dosage of known active ingredients is not very operational, but it actually contains huge business opportunities Taking fluoxetine (trade name: Prozac), a star antidepressant product of Lilly, as an example, it was first introduced to the market by Lilly with the usage and dosage of 20mg / tablet and two tablets at a time After the expiration of the patent, India's redI company seized the opportunity to develop 40mg / tablet and one tablet at a time by understanding the doctor's habits In that year, it was a miracle that it achieved a blowout growth The story of fluoxetine doesn't stop there Once a week, 90 mg fluoxetine long-acting capsules developed by Lilly immediately after the expiration of the patent add luster to the enterprise Because of the treatment needs of depression duration and maintenance period, long-term preparation has become the only choice for patients.
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.