The era of meager profit for Chinese pharmaceutical enterprises has come with more opportunities than challenges for market reform

At the end of September 2019, the latest round of "4 + 7" volume procurement ended, setting off another wave of industry turbulence From the result of winning the bid, the "4 + 7" pilot volume procurement was clearly promoted to 25 alliances across the country This alliance procurement generated 45 enterprises to be selected and 60 products to be selected Compared with the lowest purchase price in 2018 in the alliance region, the average price to be selected will be reduced by 59%; compared with the price level of "4 + 7" pilot, the average price will be reduced by 25% In the early pilot, some drugs have been reduced by more than 90%, while the new bid price has dropped by more than 50% Faced with such a situation, there is no doubt that the profits of pharmaceutical enterprises have been greatly reduced, and the era of low profits of Chinese generic drugs has come In the face of some major challenges brought by volume procurement, such as the decline of profit margin, the sharp drop in sales volume, and the strict quality control forcing transformation, etc., it is no doubt that accelerating the consistency evaluation will be the first choice for the survival of major pharmaceutical enterprises in the era of meager profit At the end of May 2019, the Pharmacopoeia Committee first published the draft of the dissolution test of the current cell method, that is, the dissolution test of the current cell method will be officially recorded in the Chinese Pharmacopoeia 2020 edition, which is undoubtedly the official affirmation and recognition of this dissolution technology The dissolution methods included in the 2015 edition of Chinese Pharmacopoeia include the first method basket method, the second method paddle method, the third method small cup method, the fourth method paddle plate method and the fifth method rotating cylinder method, which do not involve the flow pool method which has been included in the US pharmacopoeia, Japanese Pharmacopoeia and European Pharmacopoeia However, with forward-looking strategic thinking, Liyang enterprise took the lead in introducing the international advanced sotax CE 7smart into the Chinese market, witnessing and actively promoting the development of this technology in China In recent two years, Liyang company's laboratory has completed more than 70 breakthroughs in the dissolution test project of flow cell method, helping customers to solve the difficult problems in the dissolution test The dosage forms involved in the project include: API, tablet, capsule, sustained and controlled release tablet, enteric coated preparation, pellets, microspheres, liposomes, suppositories, suspension for injection and other dosage forms In the process of consistency evaluation of generic drugs, it also plays a unique role in the flow pool method, that is, the selection of prescription preparations related to the body has been recognized by the industry Ms Zhao Yu, director of business development of Liyang enterprise, once said: "with the implementation of the 4 + 7 volume purchase policy, numerous pharmaceutical enterprises have been rejected because they failed to pass the generic drug consistency evaluation, and even faced the dilemma of being eliminated by the market Most enterprises fail because of the failure of bioequivalence (be) test, and the enterprises can not bear the high cost of repeated test The advantage of flow cell method lies in its flexible test method, which can design the corresponding scheme on the instrument according to the characteristics of different preparations, or even design according to the requirements of different quality components, so as to realize the ability of detecting various dosage forms It is also one of the important reasons that pharmaceutical companies favor flow pool method to pass consistency evaluation quickly and efficiently In the face of the pressure of consistency evaluation, Chinese pharmaceutical enterprises mainly focus on generic drugs seek innovation for survival, and with the continuous expansion of volume procurement in the country, there is no doubt that the era of low profit for ordinary generic drugs, but for generic drugs with high technical barriers, that is, generic drugs developed by high-end preparation technology still have great profit space and development advantages High end preparation technology is the core of generic drugs The generic drugs developed by high-end preparation technology can be gradually absorbed by human body, play a slow-release role, and improve the efficacy, reduce adverse reactions, and increase new indications The high-end preparation technology makes generic drugs more mature, safer and more reassuring for consumers.