[Transfer] Chinese Pharmaceutical Enterprise, three major dilemmas

Source: Sai Bailan/Dong Zecheng

Traditional Chinese medicine is the treasure of the Chinese nation. For thousands of years, it has made outstanding contributions to the health of the people. The development of Chinese medicine is my country's national strategy and part of the nation's self -confidence and cultural self -confidence. Among them, Chinese medicine, as the main weapon of prevention and treatment of Chinese people for thousands of years, has a visible role and is unquestionable.

The development prospects of the exclusive Chinese varieties, the sales dilemma of proprietary Chinese medicines, and the collection of Chinese medicines are all issues that are urgently paid attention to by Sino -paddish medicine enterprises. Below, the author talks about his views and thoughts in conjunction with what he has seen and heard.

01

The collection rules of Chinese patent medicines can continue to be optimized

Recently, Beijing and other places have launched Chinese patent medicine collection. The collection of Chinese patent medicines, chemical drugs, and biopharmaceuticals are different, logical, and different rules. Overall, the patent patent patent is smaller than that of the album.

(1) The purpose of the collection of patent medicines is different from chemical generic drugs.

From the perspective of industrial perspectives, there are three main purpose:

1. Improve the quality and efficacy of imitation drugs, which is mainly realized through consistency evaluation;

2. Return the price of generic drugs to a reasonable level;

3. Promote the improvement of concentration of generic pharmaceutical companies.

In comparison, the collection of proprietary medicines is mainly two purposes:

1. Promote the improvement of the concentration of Chinese patent medicine enterprises, and then gradually improve the quality level of Chinese patent medicines;

2. Make the prices of proprietary Chinese medicines fall.

Because the purpose and logic of the Chinese patent medicine are different from the imitation drugs, the formulation of its collection rules is very different from the generic drug.

(2) Two dilemma of Chinese patent medicine collection.

The first is the contradiction of price reduction and ensuring quality. The imitation drugs passed the consistency evaluation, and the subsequent high -frequency quality sampling detection solved the problem. However, Chinese patent medicines cannot do consistency evaluation, and the quality standards of each product of each family in the actual production process cannot be unified; whether the Chinese medicine materials are affected by the real estate area, the price and quality are still very different; in addition Compared with industrialized production, Chinese medicine materials are greatly affected by the natural environment, and the prices are changing every month ... The above -mentioned types make the price reduction of Chinese patent patents softer than chemicals. main purpose.

Followed by the difficulties of collecting rules. The national mining of generic drugs is to eliminate prices to reduce prices through differential eliminations. For example, because of 6 to 4, companies must reduce prices. However, many of the Chinese medicines are exclusive products. Among them, more than 2,000 Chineseopathy exclusive varieties are dormant. It is difficult to generate enough price reduction driving force.

The collection of Chinese medicine alliances in Guangdong, Hubei and other places, separated the exclusive varieties separately, or the similar varieties are included in a group to formulate special rules. After the actual implementation, the price reduction is limited.

Due to the above reasons, the author expects that Chinese medicines are unlikely to carry out national optics nationwide, and will mainly focus on the expansion of alliance collection.

(3) It is recommended that Chinese patent medicine optimize local centralized band procurement models to increase market access negotiations.

The current collection of Chinese medicine collection is facing practical problems such as difficulty reduction, difficulty quality assurance, and complicated rules. The previous batches of Chinese patent medicine collection, the formulation of rules has been considered racking, and almost even the functions have been used. This has brought great difficulty to the manufacturer's standard.

In fact, the local patent patent collection of patent medicines is essentially a traditional bidding model, just adding a band.

The author recommends that the Chinese medicine collection is gradually optimized into two models: collection+market access negotiations, and the medical insurance talks from drugs. That is, a certain product, especially the exclusive product of traditional Chinese medicine, is to obtain market access opportunities and negotiate with relevant departments face -to -face, mainly including price reduction and sales and quality commitments. Simply and clearly, the province, money, and effort, does not involve whether it is a debate on the market economy. Some competitive Chinese medicines still adopt the volume procurement model.

02

Careful look at the exclusive approval of Chinese medicine

Let's talk about the approval of Chinese patent medicines -look at the family of Chinese patent medicine.

According to the Database of the State Drug Administration, there are more than 160,000 approved articles in my country. After merging the different specifications of the same product, the number of products exceeds 130,000, attributable to 5305 manufacturers. Among them, about 100,000 chemical drugs (Chinese medicine quasi -word H), 1,857 biological preparations (Chinese medicine quasi -character S), and a total of 59,000 Chinese medicine.

Less than 60,000 batches belong to more than 9,000 Chinese medicine varieties.

In July 2020, 9,336 Chinese medicine varieties that have been approved by the "New Pharmaceutical Pharmaceuticals-3rd Edition" have been published.

It is not difficult to see that the number of Chinese medicines is about 60%of the chemical drugs. Because of this, the market size of proprietary Chinese medicine is much smaller than the medicine.

Many of these more than nine thousand batch are exclusive approval.

However, in the author's opinion, the exclusive batch of Chinese medicine and exclusive approval of chemical drugs cannot be the same. Many exclusive approval not have too much market value.

The "New Edition of Chinese Pharmaceuticals-the 3rd Edition" mentioned earlier. In the foreword, the author pointed out: "According to recent years, more than 9,000 Chinese medicine varieties, about 60,000 online big data surveys, about about 60,000 texts. 70 % of the Chinese patent medicine approval number is not in use, including about 2,000 exclusive varieties or dosage forms. For various reasons, some varieties have been abandoned and registered. situation."

The reason why so many exclusive approval appears is related to the pharmaceutical registration policy of previous years.

Look at a set of data from new Chinese medicine new drugs. "2021 National Traditional Chinese Medicine Supervision Blue Book" data shows that in 2021, my country approved 12 new Chinese medicines for Chinese medicine, and the number of new Chinese medicines for the first time exceeded the double digits -in the previous ten years, the number of new Chinese medicines in my country was very small. 2016 2016 -In 2019, there is no new drug listing (see the figure below). Last year, the number of new Chinese medicines' new drugs increased, which was mainly related to the implementation of the new version of the new version of Chinese medicine registration in 2020.

In the author's opinion, there are few new Chinese medicines for listing, and the value of no development is a main reason. Anyone who has a certain scale of Chinese medicine companies, which are not as exclusive to Chinese medicine? Some are even dozens or more. The problem is that the existing exclusive products are small, even zero.

Figure 1: The number of new Chinese medicines through 2012-2020 approved the number of approval

The main reasons for the exclusive products of Sino -patent medicines are not fully confirmed in clinical value, which has caused Chinese patent medicine to become a must -have for doctors like chemical medicines.

Many people in charge of traditional Chinese medicine companies feel that it is a matter of sales that cannot be sold exclusively. In fact, this statement is used on Chinese medicine, which is unreasonable.

The exclusive proprietary Chinese medicine is now severely differentiated. Many sales volume is zero or very small, and a small part of the sales volume is very large -mainly because of the early listing time, and it was made by the company more than ten years ago.

It is difficult to build a large variety of Chinese medicine now.

In the future, some of the exclusive patent medicines may be like the fate of digestion of policy digestion, just like the chemical drug approval that cannot carry out consistency evaluation.

03

Sales of Chinese patent medicines are constrained

Compared with other medicines, what are the particularity of Chinese medicine? What are its clinical development?

First of all, its curative effect is the result of the comprehensive role of various traditional Chinese medicines, rather than some exact ingredients of chemical drugs. This characteristic has led to the status of unable to occupy the need to take medicine during clinical use.

Before the epidemic, due to the influence of national regulatory policies, many Chinese medicines were limited in the hospital, and even Chinese medicine was banned from prescribing Western medicine. Some traditional Chinese medicine injections have been strongly monitored -some opinions point out that this is actually paying for the past behavior of certain pharmaceutical companies.

Since the epidemic, the situation has improved in this regard. At present, the common prescriptions of clinical clinicals are that for outpatient patients, generally one or several exact effects of western medicine+a Chinese medicine with clear indications indications.

The reason why Chinese medicines cannot be used to be clinically necessary for first -line medication are mainly related to the lack of evidence -based medical evidence.

Secondly, the fans of Chinese patent medicine are gradually getting old. People born before 1970, including some generations of post -80s, are mainly traditional Chinese medicines, especially post -60s and 50s. They are loyal fans of Chinese medicine. But these people are growing old, and their children are basically taking western medicine to treat diseases.

Although the sales of Chinese medicine have been regulated during the landing stage, national policy has spared no effort to support the development of Chinese medicine in recent years.

However, related enterprises should spend great efforts to carry out the modernization of traditional Chinese medicine, study Japanese Chinese research technology, so that the composition of Chinese medicines is clear, controllable, the mechanism of function is clear, and the clinical effect is clear.

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