The new drug enters the market to sit for 5 years

Ding Liming, chairman of the National People's Congress and chairman of Beida Pharmaceutical Co., Ltd., told reporters during an exclusive interview. At the same time, he also said, "In foreign countries, the newly-listed drugs may be available in the hospital within a few hours, but in the country, after the completion of the province's bidding, hospital approval and other processes, may have passed for several years."

"In October last year, a thousand entrepreneurs in Suzhou plan to find me (complaint), he returned to business in 2006, which lasted 8 years, 80 million yuan investment, research and development of a product for the treatment of liver cancer, and sales in 2014 only More than 1.7 million yuan is not enough for the interest in these years (input money). This is not a case. I did a survey. The innovative drug sales that were listed in these years were also the best at more than 60 million yuan. I remember research and development in our company. When a new anti-cancer drug was launched on the market, a colleague poured cold water on me and said that you should not be too happy to be too early, you should not expect this product to make money within 5 years, and in foreign countries, some new drugs will reach billions or even billions of dollars in the year of listing. What is the reason why the gap is so great? The main factor is that there are too many bottlenecks in China to enter the market and the approval process is too long."

Ding Liming, chairman of the National People's Congress and chairman of Beida Pharmaceutical Co., Ltd., told reporters during an exclusive interview. At the same time, he also said, "In foreign countries, the newly-listed drugs may be available in the hospital within a few hours, but in the country, after the completion of the province's bidding, hospital approval and other processes, may have passed for several years."

Based on these pain points in the industry, in this year's "two sessions," Ding Liming once again proposed a bill to put forward his own suggestions on the problems existing in the bottleneck of the industrialization of new drugs.

Into the market cycle is too long

Devouring innovation enthusiasm

Ding Liming analyzed in the proposal that China has implemented a government-led centralized bidding for drugs for nearly 15 years. This system was originally designed to compete by market competition and purchase quality and cheap drugs, but in the actual implementation process, it has produced many deviation. In the near term, the policy of “only low prices are adopted” has led to a serious shortage of successful bidding prices for many drugs, affecting supply and quality, and has caused hundreds of drug companies to jointly sign up in various localities, which has led to heated discussions among public opinion. . Among them, the interests of patients are neglected, and the pharmaceutical industry's R&D and production enthusiasm are suppressed. Such tendering cannot achieve the purpose of medical reform that “guarantees the health of the people and reduces the growth of medical expenses”. It is even more obvious that the anti-doping of China’s pharmaceutical innovations has been made.

“There is no uniform requirement in the bidding cycle, which affects the timeliness of new drugs. At the same time, the current tendering system has unreasonable requirements for drug prices. This is the two prominent manifestations of the negative effect of the current tendering system on pharmaceutical innovation,” said Ding Liming.

At present, many provinces have no tenders for more than three years. There are no shortages of economically developed provinces and cities such as Beijing, Tianjin, Jiangsu, and Zhejiang. The longest ones have been tendered for nearly five years. Uncertainty in the bidding cycle has led to almost one-third of new drugs in China still unable to enter the provinces for sales after two years of listing. In the first year, more than half of the drug types could not enter the hospital for sale. This means that innovative medicines cannot be used in time for clinical use, and new medicines change old medicines, which not only affects the further improvement of medical quality, but also seriously undermines the enthusiasm for innovation of Chinese pharmaceutical companies that have just been in the initial stage of new drug R&D. Comparing the performance of innovative drugs at home and abroad after listing, it can be found that domestic new drugs are often sold for several million tens of millions of pounds within a few years after being listed. In Europe and the United States, new drugs are often available for hundreds of millions of dollars in the first year of listing. Billions of sales, or even billions of dollars in sales, are not unrelated to the constraints of the current tendering system. Such results are extremely unfavorable both to Chinese patients who are eager to receive the latest treatments, and to Chinese pharmaceutical companies that are committed to innovation.

In fact, the country has licensed its own category 1.1 innovative drugs. There is no comparable price for this type of drug in the market, and the tender itself does not make sense. In many provinces, there is often no clear scientific basis for the bargaining price. According to the price quoted by each bidder, the bid solicitor shall determine the final price by uniformly reducing the price according to the drug classification. However, innovative drugs are unique and not comparable. In practice, the pricing of tenders is not objective and cannot truly reflect the value of innovative drugs. At the same time, in the process of bargaining by the hospital, experts are mostly from doctors or pharmacy staff working in different departments. They often do not know much about the non-professional innovative drug specific drugs, and the price limit (base price) or bargaining price given is often the same across the board. The way it was approved was arbitrary and led to unacceptable corporate conditions. Administrative price cuts instead of tender procurement have become the means of performance, contrary to the laws of the market and the basic principles of the state encouraging new drug innovation. In order to cope with the preparation of the documentary procedures for the tendering process and the personnel energies involved, the degree of complexity is no less than the approval of another price submission, which is a few words for innovative drug price protection.

Since the “One Thousand Talents Program” has been implemented, one quarter of the talents returning to China are active in the fields of biomedicine and life sciences. These people have accumulated years of overseas experience and are the backbone of their respective fields. After returning home, many people chose to innovate and start their own businesses. The bottleneck that they report the most prominent constraint (industry development) is the long process of approval. In desperation, they only have to apply for clinical research overseas to save the country. This is obviously not conducive to the development of the industry, and it also detracts from the original intention of thousands of people planning to introduce talent. Ding Liming introduced the "Securities Daily" reporter.

approval procedure

Should be broken down

How long is the time for innovative drug listing? Ding Liming said: “Every year in China, 7,000 new drug projects are waiting for approval, and newly approved projects have to wait 8 months for someone to open materials for review. Overall, not all categories of drugs are approved. All of them are innovative drugs in the fundamental sense, and many are imitation products.The reasons for this situation are many, including the shortage of approval personnel and the low approval fees, which has led many companies to hold him in control. The blind declaration of the mentality takes up a lot of time for approval and manpower costs, so we propose that the standard for approval fees should be raised, and the priorities of the applications must be prioritized, and the cattle carts, carriages and cars cannot be squeezed into one lane and should form a positive one. Guide and divert."

Looking at past data, we can see that in the “two sessions,” Ding Liming has already proposed relevant proposals for the new drug approval process. What are the reasons for the long delay in these issues today? Ding Liming explained that “this appeal is still useful, and we can see that through the suggestions of everyone, there are some improvements at present, but this is a long process and requires constant efforts.”

In this year's "two sessions" proposal, Ding Liming proposed three suggestions on how to open up the bottleneck of new drug industrialization, including improving the pricing mechanism for new drugs, standardizing the bidding cycle, and innovating the tendering system.

“For a new class of drugs that have independent intellectual property rights in their true sense, the pricing mechanism should be based on their degree of innovation to give patents with varying degrees of protection and support, to ensure that innovative drugs can recover their research and development costs through the market and obtain reasonable profits; The application of various new technologies is accelerating and new drugs are emerging in an endless stream, and the birth of a new drug may mean the birth of a new treatment means, which should allow Chinese patients to enjoy the benefits of scientific and technological progress in time. The tender-free period for new drugs will enter the market directly, and if tendering is required, it shall be clarified once a year, and medicines listed during this period may be filed for procurement at any time, so as to guarantee the demand for clinical drugs, benefit the majority of patients as quickly as possible, and stimulate the motivation for continuous innovation of the company. Ding Liming said in the proposal.

Early R&D company

How to leverage the capital market

In addition to addressing the factors of the approval process, Ding Liming believes that the current small and scattered problems in the industry and the lack of innovation are the ceilings that restrict the development of the industry.

“The enthusiasm of corporate innovation has improved greatly over the years. A welcome phenomenon is that a large number of overseas talents have joined the ranks of domestic innovation and entrepreneurship. However, innovation is still an inexplicable pain in the industry because of the large investment in innovative drugs and high risks. It used to be said that innovation is to find death.” Ding Liming has some helplessness. “To ensure the enthusiasm of the introduction of talent, we must improve the back-end supporting measures of the industry. If innovation results are not applied in a timely manner, innovation will be meaningless.”

In addition to the back-end supporting policies, Ding Liming proposed that in the capital market, whether it can also introduce some policies to support research and development companies? “In foreign countries, the proportion of revenues from pharmaceutical companies R&D investment can reach 30%, but in China, it can be 7% or 8% even if it is good, resulting in a lot of factors in this situation, long input and output, R&D. In the process of approval, this cannot be realized, because the pharmaceutical companies in our country are small and scattered, failing to achieve economies of scale, and it is difficult to invest heavily in research and development of new products, which in turn restricts the development of enterprises. If the listing fails to meet profit requirements, venture capital is also difficult to intervene. Whether it can take advantage of the reform of the capital market will have some positive support for companies in the R&D stage so that early-stage potential R&D companies can rely on the strength of capital to become stronger.”