The urgency of China's innovative drugs

Author | Zhao Kun

National policy promotes China's biomedicine to enter a stage of rapid development

In recent years, we can truly feel that the country is sparing no effort to carry out the three medical reforms

It is precisely because of the continuous cooperation of various competent departments that high-quality technology platforms have emerged and products with high clinical value have continued to emerge

But behind the vigorous development, there are also some hidden worries, which are the pains that must be experienced on the road of reform

It is difficult to make medicines in China, but it is even harder to make innovative medicines

As a large country of traditional raw materials and generic drugs, innovative drugs are undoubtedly rising from the ground in China

1.

Most of the innovative drugs that are currently entering the harvest period in China were established at the beginning of the 20th century.

The research and development cost of generic drugs is low, and the original research is basically in the medical insurance catalog

In addition, some innovative drugs in China, because they can compete on the same stage with foreign products, are constantly exploring overseas markets and exploring new indications, which requires a steady stream of investment

2.

Judging from the current actual situation, the entry of innovative drugs into medical insurance does not mean that they can be admitted to the hospital immediately, and various selection procedures are required

A new drug that has just obtained marketing qualifications, in fact, still needs a very long process before being understood by doctors in detail

3.

Unlike generic drugs, China’s innovative drug talks do not actually guarantee sales: generic drugs are purchased in a centralized manner, and the price is exchanged for quantity.

The net profit of Betta Pharmaceuticals has shown a downward trend in the two years after the national talks.

In addition, in many places, the contract can be directly renewed for the collection of varieties, and the non-medical insurance varieties can be directly included in the medical insurance without reducing the price

The urgency of China's indigenous innovative drugs, the danger of "value"

China's indigenous innovative drugs, especially biological products, have a high cost in the early stage, and the price has been reduced significantly during the negotiation, making it difficult to recover the cost

On the one hand: Bio-innovative drug supervision is stricter, and under the premise of ensuring quality, the research and development cost of a single product is high, and the investment return period is long
.

Due to the complexity of the structure of biopharmaceuticals and the sensitivity to changes in the production and drug environment, regulatory agencies have implemented stricter regulations on the approval of biopharmaceuticals, including requirements for more comprehensive clinical data (such as immunogenicity and other chemical drugs that are not required Clinical data), complex registration procedures and continuous post-marketing supervision have made the research and development cycle longer, put forward higher requirements for many companies, and also meant that the corresponding cost was greatly increased
.

Take the domestic PD-1 as an example.
According to the current price, it is expected that the cost will be recovered only 6-7 years after the market is on the market, and the listing of a large number of PD-1 drugs also reduces the sales revenue of a single manufacturer
.
At the same time, due to the short time to market for PD-1, there is no mature sales channel and perfect commercialization team, it will take time to increase the market share, and the probability of a surge in sales in the short term is small
.

On the other hand: PD-1, as an important income indicator, also directly affects the capital market’s expectations of the company and the company’s R&D investment in subsequent new pipelines

More than 90% of emerging biopharmaceutical companies in China are at a loss, and for a long time they will still rely on financing to drive their operations
.
As an important income indicator, PD-1 also directly affects the capital market’s expectations of the company and the company’s R&D investment in subsequent new pipelines
.
In the future, if the profit of innovative drugs is too low, it will be difficult for the development of benign innovative drugs to form a virtuous circle
.

To sum up, innovative drugs naturally have the attributes of high investment, high risk, and high price.
If innovative drugs cannot be included in medical insurance simply because of price problems, the gains may not be worth the loss, and the annual price reduction negotiated is too low, resulting in damage to the enthusiasm of enterprises for research and development.
What hurts is the overall benefits of patients and society
.
Really establish a clinical value-oriented payment method, giving innovative drugs a reasonable profit margin
.
Establishing a multi-level health insurance system and improving the evaluation methods for the access of innovative drugs are the best medicine to promote the healthy development of the industry
.