In-depth analysis of the procurement volume of the two major alliances, centralized procurement forces the rational admission of traditional Chinese medicine imitation

The centralized procurement of traditional Chinese medicines in Hubei and Guangdong is still beneficial to the original research products of traditional Chinese medicines with market sca.

From a policy perspective, the first step in the imitation of traditional Chinese medicine is to determine the reference preparati.

For the establishment of imitation varieties, the centralized procurement policy is undoubtedly one of the biggest variables, and traditional Chinese medicine is no excepti.

In the procurement volume allocation rules for the centralized procurement of proprietary Chinese medicines in the regional alliance initiated by Hubei (Ejijin Inner Mongolia, Liaoning, Fujian, Jiangxi, Hunan, Qiongyu, Sichuan, Guizhou, Shaanxi, Gansu, Ningxia, and Xinjiang Corps), if the products for which the pharmaceutical institution fills in the procurement requirements are in the selected range, The selected products with the highest decline in the same competitive unit (calculated by the decline in shortlisted quotations) will be allocated to the corresponding pharmaceutical institutions according to the agreed purchase volume; other selected products will be allocated to the corresponding pharmaceutical institutions according to 90% of the agreed purchase volu.

Within the A purchase order and the competition unit, according to the comprehensive score of the actual declaration enterprises that meet the "declaration qualifications", the shortlisted enterprises will be sorted from high to l.

The pharmaceutical institution fills in the purchase demand but is not in the selected range, has not declared the enterprise, fills in the agreed purchase volume of products with a production capacity of "0", and the agreed purchase volume of the selected product that is not allocated as the to-be-allocated quantity, which shall be allocated by the pharmaceutical institution in the following order: ① Allocate 30% of the to-be-allocated volume to the selected companies with the highest drop in the same product group; ② The remaining 70% of the to-be-allocated volume will be independently selected by the pharmaceutical institutions from all the products of the selected compani.

The Guangdong Regional Alliance has more complicated rul.

The proposed alternative products are also expected to be used incremental.

Public medical institutions fill in the products that are within the scope of this procurement, and do not meet the application conditions, have not registered, have not quoted, have not quoted, have been discontinued, have not been selected, and have not selected alternative products, and their pre-purchased volume in the first year of the procurement period Include the amount to be allocat.

It can be seen from the centralized procurement rules of the Hubei Regional Alliance and the Guangdong Regional Alliance for the centralized procurement of Chinese patent medicines that if the generic varieties of traditional Chinese medicines want to compete for the market, it is difficult to obtain the procurement volume of medical institutions at the beginni.

If the imitation is an exclusive product, the Chinese medicine imitation enterprise is likely to be included in the A purchase order at the same ti.

However, if there are more than 3 similar products on the market, it is possible for companies with generic Chinese medicines to enter the B purchase ord.

New market entrants need to refer to the highest effective declared price of the original research produ.

Traditional Chinese medicine injection is currently the largest dosage form in the domestic Chinese patent medicine mark.

The price reduction rate of Hubei Regional Alliance this time is 44%, but the unit price of traditional Chinese medicine injections has generally dropped to below 30 yuan per bottle, and the price of Shengmai injection has been reduced to below 7 yuan per bott.

In addition to price, highly competitive products will face the risk of losing bi.

It can be seen that the traditional Chinese medicine injections with better maintenance price and the products are not easy to form a group with other generic names have the market value of imitati.

However, there is a high probability that the imitation of traditional Chinese medicine injections requires the initiation of confirmatory clinical research, and the quality requirements of imitation will be very high, especially in the research on impurity and component contr.

The proportion of active ingredients has increased from 60% to more than 90%, and the clinical efficacy is comparable, and it is expected that the possibility of approval will be high.

All need to wait for the release of specific regulatio.

The Hubei regional alliance did not include external medicines, while the Guangdong regional alliance included some more special preparations, such as compound Danshen spray, Huoxuezhitong ointment, Baofukang suppository, Baofukang gel and Shenkang supposito.

Compound Danshen Spray was tendered in groups together with Compound Danshen Pil.

In view of the selection rule based on price reduction, Compound Danshen Spray won the bid at 662 yuan per bott.

Gynecological external suppositories and gels were tendered in the same group, but products with the same efficacy were not included in the same group for centralized procureme.

Only Baofukang Suppository won the bid for Baofukang Suppository and Baofukang Gel, with a price reduction of 1

The difficulty of imitating special preparations still lies in how the efficacy, quality and clinical practice are consistent with the original resear.

Gynecological suppositories and gels are likely to be collected from a group of indications in the future, and the price will be more competiti.

The homogeneity of oral traditional Chinese medicine is serious, and it is very difficult to find differentiated produc.

Although the Hubei Regional Alliance and the Guangdong Regional Alliance have creatively bid similar products as the same group, they have not bid the same type of traditional Chinese medicine products with the same indications as the same gro.

It is not expected that similar products with the same indications will be included in the large group bidding in the short te.

Even if the bidding is not included in the same group, after the bidding, products with the same indications will inevitably substitute each other, which means that the market size of the original research products is also changing dynamical.

In view of the high probability of conducting BE research on oral Chinese medicine, if the competitive environment of the target product is in a state that can be replaced at any time, the product with exclusive generic name is not actually "exclusiv.

Be very caref.

For a traditional Chinese medicine oral medicine with market value, in addition to considering the market potential, it also needs to consider the differentiation of product positioni.

Patent status is also something to consider for generic Chinese medicine varieti.

For traditional Chinese medicine products, where is the threshold for patent challenges? How to challenge a series of patents such as fingerprints? Success stories have rarely been reported in the pa.