Centralized procurement of proprietary Chinese medicines is overwhelming!

On August 2, the National Health and Medical Commission held a press conference to introduce the improvement of the traditional Chinese medicine policy system and the improvement of service capabilities since the 18th National Congress of the Communist Party of Chi.

Yu Haiyang, director of the Department of Policy, Regulation and Supervision of the State Administration of Traditional Chinese Medicine, introduced that since the "18th National Congress of the Communist Party of China", under the promotion of the inter-ministerial joint meeting mechanism for traditional Chinese medicine work under the State Council, relevant departments of the State Council have introduced service system construction and personnel traini.

Focusing on the unmet clinical needs, the high-quality development of traditional Chinese medicine is the general tre.

On July 29, the official website of the Beijing Municipal Medical Insurance Bureau posted the "Notice on Carrying out the Procurement of Chinese Proprietary Medicines in Beijing in 2022", unveiling the prelude to the centralized procurement of Chinese patent medicines in Beiji.

In fact, since 2022, the centralized procurement of proprietary Chinese medicines has entered the fast la.

Industry insiders pointed out that centralized procurement is mainly aimed at mainstream Chinese patent medicine varieties with large clinical use and high purchase amount, so "large varieties" bear the bru.

Perfect evidence-based basis

Get more bargaining space

One of the functions of the national centralized drug procurement is to squeeze out the "water" of drug prices and reduce the burden of drug u.

In the centralized procurement of proprietary Chinese medicines, quality evaluation has become the focus of attenti.

However, different from the consistency evaluation of chemical drugs, the quality control indicators are clear and clear, which ensures the efficacy and safety of generic drugs; the composition of Chinese patent medicines is complex, and the quality is affected by many factors, so it is difficult to formulate consistency evaluation standar.

At this press conference, Zhang Boli, an academician of the Chinese Academy of Engineering and a master of traditional Chinese medicine, also pointed out that evidence-based medicine is an evaluation meth.

According to Zhang Boli, after the establishment of the China Center for Evidence-Based Medicine of Traditional Chinese Medicine in 2019, research in this area has been more organiz.

Is there always a contradiction between the rational use of traditional Chinese medicine and the creation of core varieties by enterprises? "Exchange price for quantity" is still the core guiding principle of the centralized procurement of Chinese patent medicin.

Although the centralized procurement of Chinese patent medicines carried out by Hubei Alliance and Guangdong Alliance is not a nationwide centralized procurement, the varieties involved are clinically representative, and most of them are products with the highest sales value in each provin.

In fact, in the procurement of Hubei Alliance, Shanxi Zhendong Taisheng Pharmaceutical's Shuxuening Injection won the bid with the only hard gas price cut by 0

The analysis of business logic is inseparable from its investment in R&D innovati.

It is reported that the volume-based procurement of proprietary Chinese medicines initiated by the Beijing Municipal Medical Insurance Bureau includes 64 drugs with sufficient market competition into the scope of volume-linked drugs, including Ginkgo biloba, Shuanghuanglian, Xuefuzhuyu, e.

According to the requirements of the notice, for the centralized procurement of Chinese patent medicines in Beijing, the upper limit of quotation for drugs with volume linkage is set, and the quotation of enterprises shall not be higher than the lowest selected price of the product with volume procurement and the current lowest price in each province (there is no provincial or inter-provincial alliance with volume procuremen.

For the products with the selected price, refer to the products in the same group); the transaction reference price for drugs negotiated with volume shall not be higher than the provincial or inter-provincial alliance procurement price of the brand enterprise drug with volume and the current lowest price in each provin.

(See the attached picture at the end of the article for the specific purchase varieties)

Facing the requirements of the era of "high-quality development", under the baton of therapeutic value and "cost-effectiveness", the price reduction of Chinese patent medicine centralized procurement is relatively mild compared to the common "ankle slash" in chemical drug centralized procureme.

But in the final analysis, only by perfecting the evidence-based medicine evidence of the product can we cope with the squeeze on the price by centralized procurement, gain more market share, and maintain the clinical dominant positi.

Discover new treatment scenarios

New indications reduce market impact

To accelerate the high-quality development of the traditional Chinese medicine industry, the research on the mechanism and mechanism of traditional Chinese medicine is receiving more and more attenti.

Industry experts generally believe that the establishment of a scientific evaluation system and quality assurance measures and the demonstration of evidence-based medicine have become the top priorities in the development of traditional Chinese medici.

To dispel the public's concerns about the use of traditional Chinese medicine, post-marketing evaluation of Chinese patent medicines is the k.

"Traditional Chinese Medicine Development Strategic Planning Outline (2016-2030)" proposes: "Re-evaluate Chinese patent medicines after listing, increase the secondary development of Chinese patent medicines, carry out large-scale and standardized clinical trials, and cultivate a group of internationally competitive Chinese medicin.

Famous medici.

"

Nowadays, more and more traditional Chinese medicine companies have taken the initiative to start the re-evaluation of Chinese patent medicines, and have done a lot of research on the efficacy and safety evaluation of dru.

For pharmaceutical companies, through re-evaluation after listing, more room for bargaining can be obtained in centralized procureme.

On January 28, 2021, the General Office of the State Council issued the "Opinions on Promoting the Normalization and Institutionalization of the Procurement of Drugs with Centralized Volume", which clearly stated that "exploring the merger of different generic drugs with similar indications or functions and main functions to carry out centralized volume delive.

Purchasing”, which clarified the direction of work for the centralized procurement of proprietary Chinese medicines and provided policy suppo.

Grouping based on similar indications or functions rather than common names will undoubtedly increase the number of competing products and intensify competition in the Chinese patent medicine mark.

Therefore, adding new indications to listed drugs means adding new drug use scenarios, and can also occupy more advantages in centralized procureme.

Yiling Pharmaceutical Lianhua Qingwen Granules and Tasly Compound Danshen Dropping Pills are two prominent exampl.

On April 8, the Guangdong Provincial Drug Trading Center announced the results of the proposed selection/alternative for the centralized procurement of Chinese patent medicines by the Guangdong Allian.

A total of 30 exclusive varieties of proprietary Chinese medicines are to be selected, including Yiling Pharmaceutical Lianhua Qingwen Granules, Tasly Compound Danshen Dropping Pills, Tongjitang Xianling Gubao Capsules, and Hehuang Pharmaceutical Shexiang Baoxin Pil.

Among them, the proposed alternative price of Lianhua Qingwen Granules is 3295 yuan/bag, which is 388% lower than the highest effective declared price of 75 yuan/bag, and about 1% lower than the listed price; The price of the exclusive product, Compound Danshen Dripping Pills, has been reduced by only 15% in the field of "Compound Danshe.

On April 12, 2020, the State Food and Drug Administration approved Lianhua Qingwen capsules/granules to add a new indication of "new type of coronavirus pneumonia mild and common" on the basis of the original approved indicatio.

Up to now, Lianhua Qingwen has been included in the diagnosis and treatment plans or guidelines for infectious public health events such as influenza A, B, and new coronary pneumonia issued by the National Health Commission and the State Administration of Traditional Chinese Medicine more than 30 tim.

According to the data of Min.

com, from the perspective of the share of medical terminal products, Lianhua Qingwen products ranked first in the public medical market in the first half of 2020 and the first half of 2021 in terms of sales of Chinese patent medicines and cold medicines, and their market share increased from 39% to 4

In October 2021, Compound Danshen Dripping Pills obtained the "Approval Notice for Supplementary Drug Application" approved and issued by the State Food and Drug Administrati.

Moderate) non-proliferative diabetic retinopathy due to qi stagnation and blood stasis syndrome, blurred vision, dull complexion, patchy hemorrhage in the fundus, dark purple tongue or petechiae, astringent or fine pulse", the drug The treatment of indications for diabetic retinopathy has been included in the "China Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 Edition.

Looking at the 2019-2021 annual report of Tasly, the sales volume of its exclusive product Compound Danshen Dripping Pills has successfully drawn a "smile curv.

At present, there are more than 60,000 Chinese patent medicine approvals, but not every variety can be made into a large varie.

With the further advancement of centralized procurement of proprietary Chinese medicines, centralized procurement will be bad for small traditional Chinese medicine companies, and for large and medium-sized enterprises with dominant brands and leading products, it means an opportunity to create large varieti.

According to industry insiders, whether a drug can become a large variety depends on whether it has clinical efficacy and whether it has advantages in safe.

"Many proprietary Chinese medicines have broad indications, which is actually a manifestation of ambiguous clinical positioni.

The problem of indication focus and patient population segmentation should be solved through resear.

" New theories can be launched on the basis of market research, or products can be used to treat diseas.

One of the outstanding advantages of the company will be taken as a breakthrough poi.

Based on the principle of understanding one indication and opening a new indication, we will continue to explore new clinical applications of product formulations and main components, gradually expand the application population, and expand our produc.

sca.

In addition to pre-clinical pharmaceutical research, pharmacological mechanism research, and toxicology research, clinical evaluation of products after they are launched, accumulation of a large amount of evidence-based evidence, and recognition of expert consensus or diagnosis and treatment guidelines will help increase the market size of produc.

Experts said that the normalization of the centralized procurement of proprietary Chinese medicines is unstoppable, and large varieties with large clinical use and a high proportion of the amount will inevitably be impacted, and Chinese medicine companies must adjust and adapt more quick.

"On the one hand, we can improve the brand value by improving the evidence-based medical evidence of our own products, and have a stronger voice in centralized procurement; on the other hand, we should actively take advantage of the wave of traditional Chinese medicine development and strive for a larger market in an innovative w.

spa.

"

At present, Chinese patent medicine enterprises are relatively small and scattered, and the overall volume is still very lar.

In the long run, the centralized procurement of Chinese patent medicines will benefit leading Chinese patent medicine enterprises with high-quality resourc.

The quality assurance system supports the innovative development of Chinese patent medicines and promotes Chinese patent medicines to the wor.