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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.
It is expected that most of the original manufacturers are reluctant to become the reference preparati.
However, there is not enough clinical data support that meets the accreditation of registration regulations , which is likely to be an excuse for many original research compani.
It is expected that most of the original manufacturers are reluctant to become the reference preparati.
However, there is not enough clinical data support that meets the accreditation of registration regulations , which is likely to be an excuse for many original research compani.
For the establishment of imitation varieties, the centralized procurement policy is undoubtedly one of the biggest variables, and traditional Chinese medicine is no excepti.
Analysis of the purchase volume of thetwo alliances
Hubei: A purchase order selection rate of 35%
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 thatmeet the "declaration qualifications" , the shortlisted enterprises will be sorted from high to l.
Compared with the rest of the groups, the final price reduction was selected among the top 70% of the compani.
This means that the selection rate is about 3
Compared with the rest of the groups, the final price reduction was selected among the top 70% of the compani.
This means that the selection rate is about 3
The pharmaceutical institution fills in the purchase demand but is not in the selected range, has not been declared by the enterprise, and fills in the agreed purchase amount of products with a production capacity of "0", and the agreed purchase amount that is not allocated for the selected product as the amount to be allocated, 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.
Guangdong: The proposed alternative products are expected to increase
The Guangdong Regional Alliance has more complicated rul.
The non-exclusive product "unit comparable price" is sorted in order from low to high, and the companies ranked in the top 50% (rounded up and reserved for one digit) are included in the proposed selection; Or without the lowest price of the company: the decrease of P2 and P0) in order from high to low, and the top 70% (rounded up and reserved for one digit) companies are included in the proposed selection ran.
The proportion of the pre-purchased volume in the first year of the procurement period of the enterprise alliance region of the proposed enterprise shall be 100%, and it shall be used incremental.
The non-exclusive product "unit comparable price" is sorted in order from low to high, and the companies ranked in the top 50% (rounded up and reserved for one digit) are included in the proposed selection; Or without the lowest price of the company: the decrease of P2 and P0) in order from high to low, and the top 70% (rounded up and reserved for one digit) companies are included in the proposed selection ran.
The proportion of the pre-purchased volume in the first year of the procurement period of the enterprise alliance region of the proposed enterprise shall be 100%, and it shall be used incremental.
The proposed alternative products are also expected to be used incremental.
Non-exclusive products must be reduced by ≥15% compared to the company’s minimum daily average cost/minimum pri.
The proportion of pre-purchased volume in the first year is 70% and it is used incremental.
For every 1% reduction, the purchase volume will increase by 5%; exclusive products The purchase volume must be increased by 5% for each 1% decrease in the company's minimum daily average cost/minimum price, and the proportion of pre-purchase in the first year is 7
Non-exclusive products must be reduced by ≥15% compared to the company’s minimum daily average cost/minimum pri.
The proportion of pre-purchased volume in the first year is 70% and it is used incremental.
For every 1% reduction, the purchase volume will increase by 5%; exclusive products The purchase volume must be increased by 5% for each 1% decrease in the company's minimum daily average cost/minimum price, and the proportion of pre-purchase in the first year is 7
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.
In the alliance area, each province decides whether to purchase and use it according to the actual situation, and public medical institutions in Guangdong Province determine whether to choose to purchase and use .
If the non-exclusive proposed products are not selected by public medical institutions in Guangdong Province, the pre-purchased volume in the first year of the procurement period filled in by the corresponding public medical institutions shall be included in the volume to be allocat.
In the alliance area, each province decides whether to purchase and use it according to the actual situation, and public medical institutions in Guangdong Province determine whether to choose to purchase and use .
If the non-exclusive proposed products are not selected by public medical institutions in Guangdong Province, the pre-purchased volume in the first year of the procurement period filled in by the corresponding public medical institutions shall be included in the volume to be allocat.
New entrants cut prices for the market
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.
This means that new entrants have to switch markets by lowering pric.
This means that new entrants have to switch markets by lowering pric.
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.
Whether it is in Hubei or Guangdong, the selection rate of A purchase order is generally lower than 50%, which means that as long as the price of traditional Chinese medicine manufacturers has an advantage over the original manufacturers, they can obtain the market of original research drugs like chemical generic dru.
Whether it is in Hubei or Guangdong, the selection rate of A purchase order is generally lower than 50%, which means that as long as the price of traditional Chinese medicine manufacturers has an advantage over the original manufacturers, they can obtain the market of original research drugs like chemical generic dru.
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.
For example, according to the policy of the Hubei Regional Alliance, if the number of shortlisted companies in the B purchase order is more than 4, the shortlisted companies will directly obtain the qualification to be selected; if the number of shortlisted companies is less than or equal to 4, the price reduction of the shortlisted companies will reach 17 product groups, and all the shortlisted companies in the A competition unit The minimum drop of the top 70% of the drop is expected to qualify for the proposed electi.
The Guangdong Regional Alliance still requires a 50% elimination ra.
Conservatively, the general trend of B purchase orders is to reduce prices to gain the mark.
For example, according to the policy of the Hubei Regional Alliance, if the number of shortlisted companies in the B purchase order is more than 4, the shortlisted companies will directly obtain the qualification to be selected; if the number of shortlisted companies is less than or equal to 4, the price reduction of the shortlisted companies will reach 17 product groups, and all the shortlisted companies in the A competition unit The minimum drop of the top 70% of the drop is expected to qualify for the proposed electi.
The Guangdong Regional Alliance still requires a 50% elimination ra.
Conservatively, the general trend of B purchase orders is to reduce prices to gain the mark.
New market entrants need to refer to the highest effective declared price of the original research produ.
If the price of the original research product is already very low, then the profit obtained by the imitation variety will not be very lar.
If the price of the original research product is already very low, then the profit obtained by the imitation variety will not be very lar.
Top Category Follow-Up Guide
Traditional Chinese medicine injection: the price competition is fierce, and quality control is very important
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 the Guangzhou regional alliance, the winning bid price of Qingkailing injection 10ml is as low as 74 yuan per injection; Xueshuantong injection is basically lower than 3 yuan per injection, and the lowest price is 78 yuan per injecti.
The selected products of more than 50 yuan per bottle are beneficial motherwort injection and Shenqi Fuzheng injecti.
In the Guangzhou regional alliance, the winning bid price of Qingkailing injection 10ml is as low as 74 yuan per injection; Xueshuantong injection is basically lower than 3 yuan per injection, and the lowest price is 78 yuan per injecti.
The selected products of more than 50 yuan per bottle are beneficial motherwort injection and Shenqi Fuzheng injecti.
In addition to price, highly competitive products will face the risk of losing bi.
Taking Xuesaitong/Xueshuantong as an example, Guangxi Wuzhou Pharmaceutical did not win the bid, and the lowest daily price of Kunpharm Group was 183 yuan / day, which means that Kunpharm Group will be expected to grab all the reported volume of Guangxi Wuzhou Pharmaceutical, as well as Harbin Zhenbao 30% of the orders totaled 267 million yuan, much higher than its 165 million yu.
However, it is worth noting that B purchase order can also grab the market of A purchase ord.
From the price point of view, the daily price of B purchase order is less than 5 yuan per day, which is more in line with the preference for varieties with low average daily cost/pri.
princip.
Taking Xuesaitong/Xueshuantong as an example, Guangxi Wuzhou Pharmaceutical did not win the bid, and the lowest daily price of Kunpharm Group was 183 yuan / day, which means that Kunpharm Group will be expected to grab all the reported volume of Guangxi Wuzhou Pharmaceutical, as well as Harbin Zhenbao 30% of the orders totaled 267 million yuan, much higher than its 165 million yu.
However, it is worth noting that B purchase order can also grab the market of A purchase ord.
From the price point of view, the daily price of B purchase order is less than 5 yuan per day, which is more in line with the preference for varieties with low average daily cost/pri.
princip.
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 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.
Special preparations of traditional Chinese medicine: pay attention to the grouping dynamics of the same indication
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 Pill.
In view of the selection rule based on price reduction, Compound Danshen Spray won the bid at 662 yuan per bott.
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
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.
Gynecological suppositories and gels are likely to be collected from a group of indications in the future, and the price will be more competiti.
Oral traditional Chinese medicine: the homogenization is serious, and the project needs to be carefully
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.
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.
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.
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.
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.
It is expected that most of the original manufacturers are reluctant to become the reference preparati.
However, there is not enough clinical data support that meets the accreditation of registration regulations , which is likely to be an excuse for many original research compani.
It is expected that most of the original manufacturers are reluctant to become the reference preparati.
However, there is not enough clinical data support that meets the accreditation of registration regulations , which is likely to be an excuse for many original research compani.
For the establishment of imitation varieties, the centralized procurement policy is undoubtedly one of the biggest variables, and traditional Chinese medicine is no excepti.
Analysis of the purchase volume of the two alliances
Hubei: A purchase order selection rate of 35%
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.
Compared with the rest of the groups, the final price reduction was selected among the top 70% of the compani.
This means that the selection rate is about 3
Compared with the rest of the groups, the final price reduction was selected among the top 70% of the compani.
This means that the selection rate is about 3
The pharmaceutical institution fills in the purchase demand but is not in the selected range, has not been declared by the enterprise, and fills in the agreed purchase amount of products with a production capacity of "0", and the agreed purchase amount that is not allocated for the selected product as the amount to be allocated, 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.
Guangdong: The proposed alternative products are expected to increase
The Guangdong Regional Alliance has more complicated rul.
The non-exclusive product "unit comparable price" is sorted in order from low to high, and the companies ranked in the top 50% (rounded up and reserved for one digit) are included in the proposed selection; Or without the lowest price of the company: the decrease of P2 and P0) in order from high to low, and the top 70% (rounded up and reserved for one digit) companies are included in the proposed selection ran.
The proportion of the pre-purchased volume in the first year of the procurement period of the enterprise alliance region of the proposed enterprise shall be 100%, and it shall be used incremental.
The non-exclusive product "unit comparable price" is sorted in order from low to high, and the companies ranked in the top 50% (rounded up and reserved for one digit) are included in the proposed selection; Or without the lowest price of the company: the decrease of P2 and P0) in order from high to low, and the top 70% (rounded up and reserved for one digit) companies are included in the proposed selection ran.
The proportion of the pre-purchased volume in the first year of the procurement period of the enterprise alliance region of the proposed enterprise shall be 100%, and it shall be used incremental.
The proposed alternative products are also expected to be used incremental.
Non-exclusive products must be reduced by ≥15% compared to the company’s minimum daily average cost/minimum pri.
The proportion of pre-purchased volume in the first year is 70% and it is used incremental.
For every 1% reduction, the purchase volume will increase by 5%; exclusive products The purchase volume must be increased by 5% for each 1% decrease in the company's minimum daily average cost/minimum price, and the proportion of pre-purchase in the first year is 7
Non-exclusive products must be reduced by ≥15% compared to the company’s minimum daily average cost/minimum pri.
The proportion of pre-purchased volume in the first year is 70% and it is used incremental.
For every 1% reduction, the purchase volume will increase by 5%; exclusive products The purchase volume must be increased by 5% for each 1% decrease in the company's minimum daily average cost/minimum price, and the proportion of pre-purchase in the first year is 7
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.
In the alliance area, each province decides whether to purchase and use it according to the actual situation, and public medical institutions in Guangdong Province determine whether to choose to purchase and use .
If the non-exclusive proposed products are not selected by public medical institutions in Guangdong Province, the pre-purchased volume in the first year of the procurement period filled in by the corresponding public medical institutions shall be included in the volume to be allocat.
In the alliance area, each province decides whether to purchase and use it according to the actual situation, and public medical institutions in Guangdong Province determine whether to choose to purchase and use .
If the non-exclusive proposed products are not selected by public medical institutions in Guangdong Province, the pre-purchased volume in the first year of the procurement period filled in by the corresponding public medical institutions shall be included in the volume to be allocat.
New entrants cut prices for the market
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.
This means that new entrants have to switch markets by lowering pric.
This means that new entrants have to switch markets by lowering pric.
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.
Whether it is in Hubei or Guangdong, the selection rate of A purchase order is generally lower than 50%, which means that as long as the price of traditional Chinese medicine manufacturers has an advantage over the original manufacturers, they can obtain the market of original research drugs like chemical generic dru.
Whether it is in Hubei or Guangdong, the selection rate of A purchase order is generally lower than 50%, which means that as long as the price of traditional Chinese medicine manufacturers has an advantage over the original manufacturers, they can obtain the market of original research drugs like chemical generic dru.
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.
For example, according to the policy of the Hubei Regional Alliance, if the number of shortlisted companies in the B purchase order is more than 4, the shortlisted companies will directly obtain the qualification to be selected; if the number of shortlisted companies is less than or equal to 4, the price reduction of the shortlisted companies will reach 17 product groups, and all the shortlisted companies in the A competition unit The minimum drop of the top 70% of the drop is expected to qualify for the proposed electi.
The Guangdong Regional Alliance still requires a 50% elimination ra.
Conservatively, the general trend of B purchase orders is to reduce prices to gain the mark.
For example, according to the policy of the Hubei Regional Alliance, if the number of shortlisted companies in the B purchase order is more than 4, the shortlisted companies will directly obtain the qualification to be selected; if the number of shortlisted companies is less than or equal to 4, the price reduction of the shortlisted companies will reach 17 product groups, and all the shortlisted companies in the A competition unit The minimum drop of the top 70% of the drop is expected to qualify for the proposed electi.
The Guangdong Regional Alliance still requires a 50% elimination ra.
Conservatively, the general trend of B purchase orders is to reduce prices to gain the mark.
New market entrants need to refer to the highest effective declared price of the original research produ.
If the price of the original research product is already very low, then the profit obtained by the imitation variety will not be very lar.
If the price of the original research product is already very low, then the profit obtained by the imitation variety will not be very lar.
Top Category Follow-Up Guide
Traditional Chinese medicine injection: the price competition is fierce, and quality control is very important
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 the Guangzhou regional alliance, the winning bid price of Qingkailing injection 10ml is as low as 74 yuan per injection; Xueshuantong injection is basically lower than 3 yuan per injection, and the lowest price is 78 yuan per injecti.
The selected products of more than 50 yuan per bottle are beneficial motherwort injection and Shenqi Fuzheng injecti.
In the Guangzhou regional alliance, the winning bid price of Qingkailing injection 10ml is as low as 74 yuan per injection; Xueshuantong injection is basically lower than 3 yuan per injection, and the lowest price is 78 yuan per injecti.
The selected products of more than 50 yuan per bottle are beneficial motherwort injection and Shenqi Fuzheng injecti.
In addition to price, highly competitive products will face the risk of losing bi.
Taking Xuesaitong/Xueshuantong as an example, Guangxi Wuzhou Pharmaceutical did not win the bid, and the lowest daily price of Kunpharm Group was 183 yuan / day, which means that Kunpharm Group will be expected to grab all the reported volume of Guangxi Wuzhou Pharmaceutical, as well as Harbin Zhenbao 30% of the orders totaled 267 million yuan, much higher than its 165 million yu.
However, it is worth noting that B purchase order can also grab the market of A purchase ord.
From the price point of view, the daily price of B purchase order is less than 5 yuan per day, which is more in line with the preference for varieties with low average daily cost/pri.
princip.
Taking Xuesaitong/Xueshuantong as an example, Guangxi Wuzhou Pharmaceutical did not win the bid, and the lowest daily price of Kunpharm Group was 183 yuan / day, which means that Kunpharm Group will be expected to grab all the reported volume of Guangxi Wuzhou Pharmaceutical, as well as Harbin Zhenbao 30% of the orders totaled 267 million yuan, much higher than its 165 million yu.
However, it is worth noting that B purchase order can also grab the market of A purchase ord.
From the price point of view, the daily price of B purchase order is less than 5 yuan per day, which is more in line with the preference for varieties with low average daily cost/pri.
princip.
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 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.
Special preparations of traditional Chinese medicine: pay attention to the grouping dynamics of the same indication
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 Pill.
In view of the selection rule based on price reduction, Compound Danshen Spray won the bid at 662 yuan per bott.
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
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.
Gynecological suppositories and gels are likely to be collected from a group of indications in the future, and the price will be more competiti.
Oral traditional Chinese medicine: the homogenization is serious, and the project needs to be carefully
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.
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.
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.
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.
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.
It is expected that most of the original manufacturers are reluctant to become the reference preparati.
However, there is not enough clinical data support that meets the accreditation of registration regulations , which is likely to be an excuse for many original research compani.
Regulations and RegulationsIt is expected that most of the original manufacturers are reluctant to become the reference preparati.
However, there is not enough clinical data support that meets the accreditation of registration regulations , which is likely to be an excuse for many original research compani.
For the establishment of imitation varieties, the centralized procurement policy is undoubtedly one of the biggest variables, and traditional Chinese medicine is no excepti.
Analysis of the purchase volume of the two alliances
Procurement and procurement volume analysis of the two major alliances Hubei: A purchase order selection rate of 35%
Hubei: A purchase order selection rate of 35% 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.
medicine medicine medicineWithin 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.
Compared with the rest of the groups, the final price reduction was selected among the top 70% of the compani.
This means that the selection rate is about 3
enterprise enterprise enterpriseCompared with the rest of the groups, the final price reduction was selected among the top 70% of the compani.
This means that the selection rate is about 3
The pharmaceutical institution fills in the purchase demand but is not in the selected range, has not been declared by the enterprise, and fills in the agreed purchase amount of products with a production capacity of "0", and the agreed purchase amount that is not allocated for the selected product as the amount to be allocated, 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.
Guangdong: The proposed alternative products are expected to increase
Guangdong: The proposed alternative products are expected to increase The Guangdong Regional Alliance has more complicated rul.
The non-exclusive product "unit comparable price" is sorted in order from low to high, and the companies ranked in the top 50% (rounded up and reserved for one digit) are included in the proposed selection; Or without the lowest price of the company: the decrease of P2 and P0) in order from high to low, and the top 70% (rounded up and reserved for one digit) companies are included in the proposed selection ran.
The proportion of the pre-purchased volume in the first year of the procurement period of the enterprise alliance region of the proposed enterprise shall be 100%, and it shall be used incremental.
The non-exclusive product "unit comparable price" is sorted in order from low to high, and the companies ranked in the top 50% (rounded up and reserved for one digit) are included in the proposed selection; Or without the lowest price of the company: the decrease of P2 and P0) in order from high to low, and the top 70% (rounded up and reserved for one digit) companies are included in the proposed selection ran.
The proportion of the pre-purchased volume in the first year of the procurement period of the enterprise alliance region of the proposed enterprise shall be 100%, and it shall be used incremental.
The proposed alternative products are also expected to be used incremental.
Non-exclusive products must be reduced by ≥15% compared to the company’s minimum daily average cost/minimum pri.
The proportion of pre-purchased volume in the first year is 70% and it is used incremental.
For every 1% reduction, the purchase volume will increase by 5%; exclusive products The purchase volume must be increased by 5% for each 1% decrease in the company's minimum daily average cost/minimum price, and the proportion of pre-purchase in the first year is 7
Non-exclusive products must be reduced by ≥15% compared to the company’s minimum daily average cost/minimum pri.
The proportion of pre-purchased volume in the first year is 70% and it is used incremental.
For every 1% reduction, the purchase volume will increase by 5%; exclusive products The purchase volume must be increased by 5% for each 1% decrease in the company's minimum daily average cost/minimum price, and the proportion of pre-purchase in the first year is 7
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.
In the alliance area, each province decides whether to purchase and use it according to the actual situation, and public medical institutions in Guangdong Province determine whether to choose to purchase and use .
If the non-exclusive proposed products are not selected by public medical institutions in Guangdong Province, the pre-purchased volume in the first year of the procurement period filled in by the corresponding public medical institutions shall be included in the volume to be allocat.
In the alliance area, each province decides whether to purchase and use it according to the actual situation, and public medical institutions in Guangdong Province determine whether to choose to purchase and use .
If the non-exclusive proposed products are not selected by public medical institutions in Guangdong Province, the pre-purchased volume in the first year of the procurement period filled in by the corresponding public medical institutions shall be included in the volume to be allocat.
New entrants cut prices for the market
New entrants cut prices for the market 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.
This means that new entrants have to switch markets by lowering pric.
This means that new entrants have to switch markets by lowering pric.
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.
Whether it is in Hubei or Guangdong, the selection rate of A purchase order is generally lower than 50%, which means that as long as the price of traditional Chinese medicine manufacturers has an advantage over the original manufacturers, they can obtain the market of original research drugs like chemical generic dru.
Whether it is in Hubei or Guangdong, the selection rate of A purchase order is generally lower than 50%, which means that as long as the price of traditional Chinese medicine manufacturers has an advantage over the original manufacturers, they can obtain the market of original research drugs like chemical generic dru.
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.
For example, according to the policy of the Hubei Regional Alliance, if the number of shortlisted companies in the B purchase order is more than 4, the shortlisted companies will directly obtain the qualification to be selected; if the number of shortlisted companies is less than or equal to 4, the price reduction of the shortlisted companies will reach 17 product groups, and all the shortlisted companies in the A competition unit The minimum drop of the top 70% of the drop is expected to qualify for the proposed electi.
The Guangdong Regional Alliance still requires a 50% elimination ra.
Conservatively, the general trend of B purchase orders is to reduce prices to gain the mark.
For example, according to the policy of the Hubei Regional Alliance, if the number of shortlisted companies in the B purchase order is more than 4, the shortlisted companies will directly obtain the qualification to be selected; if the number of shortlisted companies is less than or equal to 4, the price reduction of the shortlisted companies will reach 17 product groups, and all the shortlisted companies in the A competition unit The minimum drop of the top 70% of the drop is expected to qualify for the proposed electi.
The Guangdong Regional Alliance still requires a 50% elimination ra.
Conservatively, the general trend of B purchase orders is to reduce prices to gain the mark.
New market entrants need to refer to the highest effective declared price of the original research produ.
If the price of the original research product is already very low, then the profit obtained by the imitation variety will not be very lar.
If the price of the original research product is already very low, then the profit obtained by the imitation variety will not be very lar.
Top Category Follow-Up Guide
Top Category Follow-Up Guide Traditional Chinese medicine injection: the price competition is fierce, and quality control is very important
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 the Guangzhou regional alliance, the winning bid price of Qingkailing injection 10ml is as low as 74 yuan per injection; Xueshuantong injection is basically lower than 3 yuan per injection, and the lowest price is 78 yuan per injecti.
The selected products of more than 50 yuan per bottle are beneficial motherwort injection and Shenqi Fuzheng injecti.
In the Guangzhou regional alliance, the winning bid price of Qingkailing injection 10ml is as low as 74 yuan per injection; Xueshuantong injection is basically lower than 3 yuan per injection, and the lowest price is 78 yuan per injecti.
The selected products of more than 50 yuan per bottle are beneficial motherwort injection and Shenqi Fuzheng injecti.
In addition to price, highly competitive products will face the risk of losing bi.
Taking Xuesaitong/Xueshuantong as an example, Guangxi Wuzhou Pharmaceutical did not win the bid, and the lowest daily price of Kunpharm Group was 183 yuan / day, which means that Kunpharm Group will be expected to grab all the reported volume of Guangxi Wuzhou Pharmaceutical, as well as Harbin Zhenbao 30% of the orders totaled 267 million yuan, much higher than its 165 million yu.
However, it is worth noting that B purchase order can also grab the market of A purchase ord.
From the price point of view, the daily price of B purchase order is less than 5 yuan per day, which is more in line with the preference for varieties with low average daily cost/pri.
princip.
Taking Xuesaitong/Xueshuantong as an example, Guangxi Wuzhou Pharmaceutical did not win the bid, and the lowest daily price of Kunpharm Group was 183 yuan / day, which means that Kunpharm Group will be expected to grab all the reported volume of Guangxi Wuzhou Pharmaceutical, as well as Harbin Zhenbao 30% of the orders totaled 267 million yuan, much higher than its 165 million yu.
However, it is worth noting that B purchase order can also grab the market of A purchase ord.
From the price point of view, the daily price of B purchase order is less than 5 yuan per day, which is more in line with the preference for varieties with low average daily cost/pri.
princip.
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 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.
Special preparations of traditional Chinese medicine: pay attention to the grouping dynamics of the same indication
Special preparations of traditional Chinese medicine: pay attention to the grouping dynamics of the same indication 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 Pill.
In view of the selection rule based on price reduction, Compound Danshen Spray won the bid at 662 yuan per bott.
Tender Tender TenderIn 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
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.
Gynecological suppositories and gels are likely to be collected from a group of indications in the future, and the price will be more competiti.
Oral traditional Chinese medicine: the homogenization is serious, and the project needs to be carefully
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.
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.
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.
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.
