Accelerate drug approval and sort high-quality drugs individually

Chen Baohua, the representative of the National People's Congress and Huahai Pharmaceutical, who participated in the two sessions for the second time, recently received an exclusive interview.

"We hope to expedite the speed of drug approval and establish separate channels for domestic companies to produce high-quality drugs and drugs that have reached the international advanced level, so that these drugs can enter the market as soon as possible, which will help ease the current high drug price phenomenon," said Chen Baohua.

Call for revision of the "Drug Administration Law"

Chen Baohua, who attended the two sessions for the second time, this time took five motions to attend the two sessions. They are the bill on amending the "Drug Administration Law," the bill on the amendment of the "Promotion Law on SMEs," the bill on the revision of the "Promotion Law on the Conversion of Scientific and Technological Achievements," and the "Amendment on the Law on the Quality and Safety of Agricultural Products (Bars)". The motion and the proposal to amend the Law on Prevention and Control of Atmospheric Pollution.

In this interview, Chen Baohua focused on his views on amending the "Drug Administration Law." "Since its implementation on July 1, 1985 and revised in 2001, the "Drug Administration Law" has not been moved for 13 years. However, China's economy has undergone great changes, and the entire pharmaceutical industry has undergone major changes. Including the import of foreign drugs, the scope of drug use, etc. This has led to a legal gap in the management law, and some have not adapted to the current development."

“For example, China's current drug production license and marketing license are bundled together as a 'bundled management' model, and drug marketing approval numbers are only issued to manufacturing companies that hold drug production licenses. This system is in line with the national conditions at the time, but With the development of economy and society, many new problems have emerged, and such a mode of examination and approval management has tended to lead to low-level and redundant construction of pharmaceutical production enterprises, the main body of drug commissioned production is limited, and the idle rate of production equipment is too high; The results of scientific research can only benefit from technology transfer, short-sighted behavior is universal, etc.” Chen Baohua preached.

In this regard, he suggested that the implementation of the eligibility to enter the type of drug market licensor system. “R&D institutions, manufacturing companies, distribution companies, etc. can all apply for drug marketing licenses, and drug consignment production is not subject to excessive restrictions, and drug marketing licensees can cooperate with manufacturers with production qualification to complete the production process of their products. People take full responsibility for drugs, and enterprises that accept entrusted production only have limited liability for the production of drugs.This type of management has specialized division of labor, which will help improve the quality of drug production, increase industrial concentration, and clarify the responsibility for drug safety. It is conducive to drug supervision," Chen Baohua wrote in the motion.

In addition, Chen Baohua believes that the current drug approval cycle is too long. "For example, a clinical application for a category 3.1 drug requires 7 years, a 6-type generic drug application needs 10 years, plus the time of its own development, a new drug will become an old drug after its release."

According to Chen Baohua, this is mainly caused by two reasons: First, there are many applications. It is understood that the number of drug backlogs currently applied for is more than 10,000; the second is the lack of manpower and material resources of the Drug Administration of the Food and Drug Administration. The center currently has 120 people. And the FDA in the United States has nearly 5,000 people.

In order to change this situation, Chen Baohua suggested: "I hope to increase the establishment of the assessment center; we can entrust third parties and purchase services to conduct assessments. That is to say, standards are established, and assessments are conducted by institutions in the society and paid by the drug review center. In addition, he also called for raising the fees for drug registration approval to raise the threshold for applications.

He also proposed to give priority to the approval of generic drugs at the international advanced level, "for medicines that meet the advanced national standards, clinical supply, public access and affordability, drugs for children, drugs for rare diseases, and drugs for special populations, As well as other drugs that have been identified as clinically urgently needed by the market value assessment, the application for registration of generic drugs can be subject to priority review.” Chen Baohua said that some pharmaceutical companies in China have fully complied with the cGMP standards for pharmaceutical production lines, and the products have passed the US FDA certification and high-end pharmaceuticals in Europe and the United States. The market has been sold on a large scale, and these medicines can be given priority approval, which can ease the pressure of high drug prices.

In addition to the current motion and suggestions for participating in the two sessions, Chen Baohua also talked to reporters about the development of the company.

Since its inception in 1989, Huahai Pharmaceutical has been engaged in the research, development, production and sales of APIs, which are mainly specialty APIs. More than 80% of the APIs produced by the company are sold abroad. Since then, the company began to engage in research and development, production and sales of pharmaceutical preparations in 2002, mainly including anti-hypertensive, nervous system and anti-AIDS products.

"Opening the company's annual report, you will find Huahai Pharmaceutical's strategy and vision is still very unique." An analyst in the pharmaceutical industry (trading stock trading point) told reporters that "the company's execution capability is also very strong." Huahai Pharmaceutical Co., Ltd. started from the raw material medicine and now realizes a rapid growth in the export of two-wheel drive products for APIs and preparations.

However, due to the impact of downstream demand, prices of raw material medicines continued to decline last year. Concerned about the outside world's concern about the decline in the price of APIs, Chen Baohua revealed that the overall sales volume of APIs increased by 9% last year, but the prices fell by 21%, which also caused sales to decline. Chen Baohua said, “The company is undergoing a second transformation, and the raw material drugs have to be transformed and upgraded. The most important task at present is to do a good job in environmental protection. As the country’s requirements for environmental protection become higher and higher, the company decided to use forward-looking From the perspective of sex, we will invest in environmental protection in advance, and we expect to invest 120 million yuan to upgrade the system."

In the future, on the basis of environmental protection, Huahai Pharmaceutical will realize the transformation and upgrading of APIs by expanding production capacity and reducing management costs. "In this piece, the profit rate may decline, but the overall profit growth." Chen Baohua introduced.

Huahai Pharmaceutical is the first pharmaceutical company in China to achieve large-scale sales of pharmaceutical preparations in Europe and the United States. In addition to the transformation and upgrading of APIs, Huahai Pharmaceutical's preparations are also seeking transformation.

“The future of our transformation in the United States is to make high-tech preparations, to be the first generic drug to challenge patents, and to expand the range of dosage forms.” Chen Baohua introduced. At present, the company’s sales of multiple products in the United States have exceeded 10 million US dollars.

In January 2013, Lamotrigine Controlled Release Tablets, jointly developed by Huahai Pharmaceutical and Par Pharmaceutical, was approved by the FDA of the United States. In the first quarter of the year, the profits contributed to the company were divided into 53.3 million yuan. According to Chen Baohua, "the profit of Lamotrigine is 120 million yuan."

"We had expected that 3 to 4 drugs approved by the US FDA last year may be delayed until the second quarter of this year," said Chen Baohua.

In addition, Chen Baohua hopes to lead the company to promote these products in South America, Africa and other places. “The domestic market is also an important market,” Chen Baohua said. He hopes that the company's drugs that have reached the international advanced level can pass domestic approval as soon as possible to replace imported drugs abroad. “What we Huahai Pharmaceuticals will do in the future is to provide more confidence in the efficacy of imported medicines and the price of domestically produced medicines, and continue to meet the needs of the people.”