Heavyweight New Rules Live Improvement Drugs: What's Worth Doing? Which ones step on the thunder?

Medicine Network July 29th, the much-anticipated technical guide to improved medicines has come! At the end of June, CDE issued the Technical Guidelines for Clinical Trials of Chemical LycintS New Drugs (Draft for Comments) (hereinafter referred to as "Technical Guidelines")Previously, China has no clear technical guidelines to explain the clinical advantages of new drugs to improve chemical drugs, and how to prove their clinical advantages through clinical trials"Technical guidelines" will be a number of stuck on the "technical off" on the improvement of drug projects, improved new drugs finally come to spring! The three major clinical advantages PK in the project direction according to the Chemical Registration Classification and Reporting Data Requirements (Draft for Comments), the new modified drugs that are not listed at home and abroad belong to the new 2 categories (further subdivided into 2.1, 2.2, 2.3, 2.4 categories), and the improved drugs listed abroad belong to the 5.1 categoryWhether the new class 2 or 5.1, improved drugs are required to have obvious clinical advantages, is a key conditionAccording to the "technical guidelines", whether there are clinical advantages, to "conduct clinical research, usually in clinical trials of clinical advantages of the concept of verification, and ultimately confirm." The "Technical Guidelines" divide clinical advantages into effectiveness advantages, safety advantages and compliance advantagesSo, which will become the hot spots of the project? Optical isomers, esters, salts, acid roots, bases or metal elements, or non-covalent bond derivatives (such as complexes, chelates, or claddings) are classified as class 2.1 modified drugsFor such modified drugs, it is expected that the increase in safety is more hot, hand drug research and development may re-emergeFor such modified drugs, it is important to consider whether new unacceptable adverse reactions are added, whether efficacy is reduced on the replacement endpoint, etcThe new dosage form (including the new dosing system), the new prescription process, the new drug route improvement drug is 2.2 categories, it is expected to improve compliance (especially for the elderly, children and other special patients to take) research and development heat is higherIn addition, the heat is higher by replacing or removing items with clear lysis on adverse reactionsThe new compound improved drug 2.3 category, it is expected that the guide in the different mechanisms of the first-line drug compound preparation project heat is higher, good import improvement drugs2.4 new indications modified drugs, involving the effectiveness of the target, is expected to be higher in pediatric indicationsThe modified new drug with effectiveness as its main goal cannot accept the equivalence or non-poor design and results, need to do the non-clinical pharmacodynamic model and other early exploratory tests, as well as randomized, with the domestic listed drug positive control, excellent efficacy design of the III phase confirmed test, the overall project cost is higherWhile no matter which registration classification can be based on effectiveness, clinical studies targeting drug registration and listing are not expected to be preferred given the high risk of failureBoth safety benefits and compliance can accept validity as a non-bad research designFrom a cost perspective, non-poor compliance-modified new drugs that can accept effectiveness and safety are expected to be more willing to invest"Sales account" price elasticity space how much an improved new drug project is worth investing in, after clearing the direction of the project, but also to calculate a "sales account" - the price pressure of the new modified drug in the end how much? Is it worth the high cost of clinical research? The price of the difference ratio space can refer to the price of the listed generic product and consider the difference ratio of the drug Ten years ago, the "Drug Difference Price Rule" (The Price of The Reform (2011) No 2452), the granule is 1.2 times the tablet, the dry suspension agent is 1.1 times the granule, the price of the elasticity is greatly reduced However, what is not covered in the document has a relatively large price elasticity For example, change the difference between the conversion of the drug route, as well as the difference between ordinary tablets and slow release agents, there is a greater price space Paediatric medicine is expected to have a large space For children to use, it is expected that a single column of the network representative products to calculate the difference, but there is still the possibility to escape into the belt procurement of this pass If innovation in improved medicines deserves to be encouraged, then pricing should be supported by new regulations Since the classification distinguishes three different purpose-oriented improvement paths, will there be a bias in pricing policy for products that aim to be effective? Otherwise, a large number of modified projects will choose the easiest to market, improve compliance direction for design The pressure of health insurance negotiations is the same as that of the improved listed drug target indications, as well as the optimization of API structure-improved new drugs with clear adverse reactions, and the pressure to be faced in the future is mainly due to health insurance negotiations The price pressure of the health insurance negotiations does not stem from the products of the modified drugs that have been marketed, but from the same mechanism and the same target (different structures) If the same mechanism and target (different structures) of the product target indications, larger sales, and low prices, then the improved drug has no pharmacoeconomic data to support higher pricing Such projects are highly invested and risky Such projects mainly involve the associated volume of the same mechanism of action/ target of the same type of drug priceist already very low, such as hypertension, diabetes, lipid-lowering drugs If the modified drugs don't have a breakthrough advantage, health-care buyers should opt for a lower-priced option In fact, the price of the compound formulations of the two listed ingredients is observed to be clear that the fixed-dose compound formulations are priced at less than the sum of the two unilateral formulations This means simplicity of compliance, as well as economic simplicity: less accessories, lower prices, lower health insurance payments, and incentiveford health-care payers to buy Therefore, before the reform of the drug project may wish to change the thinking, as a health insurance buyer, what kind of improved medicine is the health insurance payer is willing to choose to buy If the health insurance payer feels that the clinical benefits of the modified drug to the original listed drug are not enough to raise the price, the health insurance payer may choose to replace the same drug with efficacy, compliance and best price