Policy update
In recent years, the R & D and application of biological similar drugs have increased day by day. In order to standardize the R & D and evaluation of biological similar drugs and further guide the clinical pharmacology research of biological similar drugs, on February 13, 2022, the drug examination center organized and formulated the technical guiding principles for clinical pharmacology research of biological similar drugs.
On February 11, 2022, the Information Office of the State Council held a regular briefing on the policy of the State Council on deepening the reform of centralized procurement of drugs and high-value medical consumables. Chen Jinfu, deputy director of the state medical security administration, introduced the progress of deepening the reform of centralized procurement of drugs and high-value medical consumables.
Industry comments
China's biological analogues have witnessed great development in recent years, and many biological analogues imitating foreign mature drugs have emerged. However, due to the limited use of biological analogues in China and limited clinical data, there is a lack of relevant data on the safety and effectiveness of some unconfirmed indications. If the indications are directly extrapolated, there is a great unknown risk. The promulgation of the technical guiding principles for clinical pharmacology research of biological analogues emphasizes quality, safety and effectiveness, puts patients first, standardizes the research and development of biological analogues, and makes sufficient and timely preparations for the subsequent expansion of biological analogues in China.
Centralized procurement is normalized and institutionalized, and the overall trend is "price reduction, volume increase and high quality". The state has completed six batches of centralized drug procurement, and the seventh batch of centralized drug procurement will soon start reporting. A total of 234 varieties were involved in the first six batches of centralized mining. Before centralized mining, the total market scale of these varieties was about 150 billion yuan, and the average decline after centralized mining was about 50%. With the continuous optimization of centralized purchase rules, the quality supervision is more rigorous, and the supply guarantee is more stable. On the whole, there is a trend of "price reduction, volume increase and high quality".
Under the new normal of centralized mining, shape a new ecology and build a new pattern. The next step of the current centralized mining policy is to shape a new ecology and build a new pattern under the new normal. By constantly improving measures, especially incorporating supply, quality, credit and other relevant factors into the centralized procurement rules, we can purify the ecological environment of pharmaceutical circulation from the perspective of system and mechanism. We will improve the functions of the centralized pharmaceutical procurement platform, accelerate the standardization, standardization and specialization of the platform, improve the level of pharmaceutical price governance, and more effectively reduce the burden on the masses.
The bidding rules for centralized purchase will be further improved and the lowest price will not be pursued. Specific to the rule level, first, set bidding rules for specific varieties and competition pattern. For example, bidding rules, volume ratio and agreement period. For the varieties with sufficient competition, the agreed procurement volume can be liberalized and expanded accordingly. At the same time, we should appropriately compete according to the market supply. The earliest "4 + 7" pilot was to select only one and win the bid at the lowest price, resulting in fierce competition and lack of substitute supply, which limited the choice of clinical medication. In the future, centralized mining will gradually relax the competition pattern, balance the use and supply, appropriately maintain the competition rate, and make the price return reasonably.
Investment advice
It is suggested to focus on the supply chain direction of the upstream industrial chain, API, equipment and equipment, scientific instruments, upstream reagent consumables supporting scientific research, upstream consumables of the pharmaceutical industry and raw and auxiliary packaging materials, and be optimistic about the internationalization, industrialization and high-quality development of innovative instruments.
It is suggested to pay attention to pharmaceutical enterprises and integrated enterprises of API preparations. It is suggested to pay attention to: Stone Pharmaceutical Group, Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) , Apeloa Pharmaceutical Co.Ltd(000739) , China biopharmaceutical, etc.
Risk tips
The risk of expanding the scope of centralized purchase, the risk that the price reduction of centralized purchase exceeds the expectation, the risk that the product supply is less than the expectation after winning the bid, and other policy and market risks.
