Recently, an "innovative drug research and development summit forum" was held in Guangzhou. Grasp the favorable policies of biomedical industry in many ways, promote the landing and comprehensive promotion of ICH guiding principles in China, and realize the international integration of innovative drug research and development in China, especially in Guangdong. The forum was hosted by Guangdong Biomedical Innovation Technology Association and CRO Branch of China Medical Quality Management Association, and jointly undertaken by Guangzhou Ji Bo Pharmaceutical Biotechnology Co., Ltd. and Guangzhou Ji Bo Biomedical Science and Technology Park Co., Ltd.
policy
The introduction of favorable policies reshapes the ecology of pharmaceutical industry
In recent years, China has successively introduced a series of favorable medical policies and regulations, such as zero tariff on anticancer drugs, speeding up the examination and approval of innovative drugs, and adjusting the national medical insurance drug list, which has promoted the research and development enthusiasm of domestic pharmaceutical companies, improved the accessibility of patients to innovative drugs, and enabled patients to obtain better treatment services.
"In fact, these favorable policies are reshaping the ecology of the entire pharmaceutical industry." Wu Yilong, director of Guangdong Institute of Lung Cancer and former chairman of Chinese Society of Clinical Oncology, said that in the past, many patients bought drugs privately because some policies were not in place and the accessibility of drugs was low, which led to complications and side effects. "These are the situations we are facing now."
On April 17 this year, the National Medical Insurance Bureau issued a work plan for adjusting the national medical insurance drug list for 20 19, and determined that the drug list should be transferred in and out before the end of July. The drugs newly transferred to the national medical insurance drug list continue to adopt the national negotiation mechanism, and negotiators negotiate with enterprises according to the evaluation opinions to determine the unified national medical insurance payment standards and management policies.
"This will ensure the accessibility of our medicines, that is,' affordable medicines'. At this point, I think it has been done quite well. " Wu Yilong explained that all pharmaceutical factories must apply for drugs from hospitals according to the availability of drugs and the national medical insurance drug list. At the same time, according to the guidelines for rational drug use issued by the National Health Commission, all doctors in hospitals must strictly observe the indications. "This forces pharmaceutical companies to operate step by step according to the indications when developing drugs." In his view, this is reshaping the ecology of the pharmaceutical industry. "From medicine to doctors, patients benefit the most after ecological reshaping."
challenge
Introducing intangible cultural heritage rules into China is both an opportunity and a challenge.
On June 4, 20 17, the State Administration of Medical Supplies officially became a member of ICH (International Technical Coordination Committee for the Registration of Medicines for Human Use), and became the eighth member of the global regulatory body. One year later, it was elected as a member of the management committee. This means that China drug regulatory authorities, pharmaceutical industry and R&D institutions will gradually transform and implement the highest international technical standards and guidelines, and actively participate in the formulation of international rules.
According to previous media reports, the State Administration of Pharmaceutical Products' joining the CMC this time will not only help to promote the reform of China's drug review and approval system, but also help to expand the international influence of ICH rules, accelerate the realization of drug accessibility, and promote exchanges between Chinese and foreign pharmaceutical industries. Zhu Shaoxuan, executive director of Guangdong Biomedical Innovation Technology Association, agreed. She further explained, "This can promote international innovative drugs to enter the China market as soon as possible, meet the demand for clinical drugs, and enhance the innovation ability and international competitiveness of domestic pharmaceutical companies."
"ICH guiding principles are introduced into China, and the integration level or standard from clinical trials to new drug research and development is close to internationalization, which is both an opportunity and a challenge." Dr. Wang Jianhua, former deputy director of R&D of Novartis R&D Center (CNIBR), said that the ICH guidelines put forward higher requirements for R&D and production capacity of domestic pharmaceutical companies because of the late start and low level of domestic innovative drug research and development. "Foreign-approved products enter the China market faster and the competition is more intense, so domestic enterprises need to rebuild their systems to meet international standards, and the biggest challenge is to develop some internationally recognized innovative drugs".
remind
With the implementation of consistency evaluation of generic drugs and centralized bidding for drugs, pharmaceutical companies will face "reshuffle"
Although the policy is favorable and there are opportunities in the world, it is not so easy to reshape the ecology of the pharmaceutical industry. As we all know, China is a big country of generic drugs. According to the data of China Pharmaceutical Industry Information Center, the market size of generic drugs in China was about 9 167 billion yuan in 2065 and 438,438+01600 million yuan in 2020. The generic drug market accounts for more than 60% of the whole drug market, and more than 95% of the chemicals are generic drugs. Therefore, many domestic manufacturers that rely on generic drugs have achieved long-term and stable development.
However, "the era of conquering the world by relying on generic drugs may be gone forever." Dr. Wang Tingchun, the current president of CRO Branch of China Medical Quality Management Association, said at the forum that with the implementation of the consistency evaluation of generic drugs and the centralized bidding system for drugs, domestic pharmaceutical companies will face "reshuffle" and develop towards polarization.
Wang Tingchun introduced that large pharmaceutical companies with financial strength and superior R&D capabilities will gradually set foot in the field of innovation due to increased cost control, price reduction and competitive pressure, thus entering the era of rapid development of innovative drugs. However, most small and medium-sized pharmaceutical companies are still trapped in the consistency evaluation of generic drugs. "Consistency evaluation requires huge time cost and financial cost, which is no small pressure for small and medium-sized enterprises trapped in insufficient funds. The business volume of some enterprises has dropped sharply and they are facing the risk of being eliminated. "
For the rapid development of China, the demand for high-quality drugs is definitely growing, and generic drugs that pass the consistency evaluation have the opportunity to re-divide the market share. However, under the increasingly fierce competition in the domestic generic drug market, is it "safe" for pharmaceutical companies to pass the consistency evaluation? "This just proves that generic drugs have the same quality and efficacy as the original drugs." Wang Tingchun believes that the consistency evaluation of pharmaceutical companies is only the beginning, which is not enough to cope with the fierce competition in the market.
direction
The improved new drug conforms to the reality.
But innovative drug research and development is the future.
At present, there are two types of enterprises committed to the research and development of innovative drugs in China: one is the established large-scale enterprises that have developed from generic drugs to innovative drugs, such as Hengrui Pharma; The other is overseas innovative drug companies, which have a lot of financing and are listed overseas, such as Baekje Shenzhou. The warm wind of policy has stimulated more and more pharmaceutical companies to embark on the road of "innovation".
"Now the national policy has been guiding enterprises to develop from generic drugs to innovative drugs." For example, Wang Tingchun said that the well-known antihypertensive drug amlodipine besylate costs six or seven yuan a box in China, while the original drug Luohuoxi costs more than 40 yuan a box. 2065438+June 2008, 1 1, the document of "purchasing with quantity" called "the first medical insurance purchase order" was completed in Shanghai Medical Office. Amlodipine was pre-qualified at the price of 0. 14 yuan, and the profit was greatly reduced. "Companies that used to make generic drugs made profits by quantity, but now some drugs with poor sales may give up consistency evaluation or stop production, which forces everyone to make innovative drugs," said Wang Tingchun.
Despite this, the profits of innovative drugs are considerable, but R&D investment is large and the cycle is long, and not all enterprises can afford it. Wang Tingchun believes that "improving new drugs is a realistic choice". According to reports, the improved new drug refers to a drug that has obvious clinical advantages by optimizing its structure, dosage form, route of administration and combination of indications on the basis of substances with known structures and listed active ingredients.
2065438+In March 2006, the State Administration of Pharmaceutical Products issued a new registration classification of chemicals. Among them, the improved new drug was listed separately for the first time, and it appeared in a brand-new look of two new drugs. Improved new drugs have attracted the attention of many pharmaceutical companies because of their development advantages such as high success rate, long life cycle and low competitive pressure. Wang Tingchun introduced that there are many ways to improve this new drug, such as reducing daily dosage and reducing side effects. "The investment is only half or even one-fifth of that of innovative drugs, and domestic pharmaceutical companies can afford it and have patents, which is more in line with the status quo of many domestic pharmaceutical companies." But he admits that the research and development of innovative drugs is still the future of China's biomedical industry.