Reading summary: "I can't earn 10,000 yuan a month, so I can't cure it." The expensive sky-high medicine cannot be used by the people, and the blind fate cannot be changed. Ten years ago, many patients like Yang Ning (pseudonym) chose to give up treatment. Today, 10 years later, Yang Ning’s self-paid treatment for macular degeneration can cost up to 400 yuan per month. "Being able to afford to see a doctor" is Yang Ning's biggest feeling now.
(Health Times reporter Wang Zhenya) PD-1 drug was introduced into China four years ago, with an annual treatment fee of more than 300,000 yuan, which makes many ordinary people far beyond their reach. Nowadays, the annual treatment fee after reimbursement of domestic PD-1 drugs is less than 20,000 yuan, and more cancer patients can afford PD-1 drugs.
has gone from no medicine to drug possession, from being unable to afford it to being able to use it, from speeding up review and approval to lowering medical insurance negotiations, the achievements of China's innovative drugs have been obvious to all in the past ten years. More and more new and good drugs are on the market, benefiting the Chinese people.
has reduced the burden of medical treatment, thanks to the team of BeiGene R&D Center for the launch of new domestic drugs. BeiGene Picture
"There is a kind of disease that is poor. When people get old, just be blind and don't waste money." This is the helpless choice of many elderly patients with macular degeneration.
In February 2018, Yang Ning (pseudonym), who had just celebrated his 60th birthday, found that he had distorted and deformed things when he saw things, and he also became one of the patients with macular degeneration. This disease is recognized as a "blind killer". It was once recognized by the international ophthalmology community as one of the most difficult ophthalmic diseases to treat. It was beyond cure before 2006.
After the ranizumab developed by Novartis in 2006 was released, it has given the disease a cure. In 2012, ranibizumab entered China and monopolized the Chinese market at a price of 9,800 yuan per unit. It was injected once a month, and the annual treatment cost was nearly 120,000 yuan.
In my country, the prevalence rate of this disease in people over 60 years old is 13.5%, and the prevalence rate of this disease over 80 years old is as high as 23.5%. If treatment is not done in time, 80% of patients may be blind within 2 to 3 years.
"I can't earn 10,000 yuan a month, so I can't cure it." The expensive sky-high medicines cannot be used by the people, and the fate of blindness cannot be changed. Ten years ago, many patients like Yang Ning chose to give up treatment. Today, 110 years later, Yang Ning’s self-paid treatment of macular degeneration can be up to 400 yuan per month. "Being able to afford to see a doctor" is Yang Ning's biggest feeling now.
So how did the medical expenses be reduced? The reduction in medical treatment burden is first due to the launch of the new domestic drug, , .
Conbocept is an innovative drug of "me-better". Its efficacy is not inferior to ranibizumab, and it only needs to be given once every three months. In 2013, the listing price of Conborcept was 6,800 yuan, fighting a beautiful "Made in China" counterattack. Three years later, ranibizumab, which still has 10 years of patent protection, actively reduced the price by 2,600 yuan per unit. Although the three-month cost is still higher than that of Conborcept, the innovative drug Conborcept forced the price of imported drugs to be reduced, breaking the history of the original drug not being reduced during the foreign patent period.
From then on, domestic products dominated the market prices and benefited from the Chinese people more and more stories. Whether it is PD-1 drugs or TKI targeted drugs, more and more domestic innovative drugs have been approved for the launch of the market. "Being a new drug that Chinese people can afford", the ideals of Chinese pharmaceutical people are gradually being realized.
Conborcept price is still declining every year, and then it is the role of medical insurance. In the first medical insurance negotiation in 2017, the price was reduced by 17% to 5,550 yuan/subs; in the second medical insurance negotiation two years later, the price was reduced by 25% to 4,160 yuan/subs; in the third medical insurance negotiation in 2021, the price was reduced by 17% to 3,450 yuan/subs.
is calculated based on the proportion of 50% to 70% reimbursement in various places, and is calculated based on the minimum reimbursement of 50%. If a combaship is used, the patient will pay 1,150 yuan at his own expense and inject it once every 3 months. The average monthly treatment fee is less than 400 yuan. The approval of new drugs for
has accelerated, and the entry into medical insurance has accelerated. It took 12 years to develop furquitinib, developed by Professor Li Jin, became the first Chinese original innovative drug to appear in JAMA magazine. Health Times Network Picture
2021 review passed 47 innovative drugs, setting a new record high. 47 seem to be not many, but it is extremely difficult. The "2021 Annual Drug Review Report" gives this conclusion-my country's pharmaceutical industry innovation capabilities and high-quality development have been further enhanced.
In 2021, the Drug Review Center of the State Food and Drug Administration accepted 11,658 drug registration applications, including 1,886 innovative drug registration applications, an increase of 76.1% over the previous year. Compared with four years ago, there were 506 innovative drug registration applications in 2017, less than one-third of that in 2021.
These changes stem from the reform of drug review in recent years. Drug review policies have been introduced one by one, and drug review capabilities have been continuously improved. From the original number of backlogs of drug applications for up to 20,000 of them over the years to more than 10,000 of them approved in one year. The industry evaluated that "the original loose drug supervision system has been gradually implemented as the strictest supervision." The reform of the
drug review system is undoubtedly an event in the ten-year development milestone of innovative drugs.
In 2013, National Food and Drug Administration was changed to National Food and Drug Administration . In January 2015, 60-year-old Bi Jingquan became the director and secretary of the Party Group of the State Food and Drug Administration.
In August 2015, the State Council issued the "Opinions on Reforming the Review and Approval System of Drugs and Medical Devices"; in February 2016, the General Office of the State Council issued the "Opinions on Carrying out the Consistency Evaluation of Generic Drugs Quality and Efficacy"; in February 2017, the State Council issued the "
3th Five-Year Plan" National Drug Safety Plan; in October 2017, the General Office of the State Council issued the " Opinions on Deepening the Reform of the Review and Approval System to Encourage Innovation in Drugs and Medical Devices". The effectiveness of
is quickly revealed, drug review has been accelerated, and local Chinese medicines have also benefited from the priority review channel. In 2017, the locally developed Ebola vaccine was approved for the application for a new drug in just ten days, but the approval condition was to ensure that the third phase of the trial was completed later.
According to the "2019 Annual Drug Review Report" released on July 30, 2020, the backlog of drug approvals dropped from nearly 22,000 to 4,423 from 2015 to 2016. In 2016, the Drug Review Center completed 12,068 review and registration applications; 9,680 review and approval applications were completed in 2017; 9,796 review and approval applications were completed in 2018.
The launch of domestic innovative drugs and medical insurance negotiations are often a "combination punch" that makes the people affordable.
Liu Guoen, professor of economics at the National Institute of Development of Peking University, proposed that the speed at which new drugs in my country are included in medical insurance is unprecedented. Among the 83 new drugs approved last year, 19 drugs have been approved and received medical insurance in the same year, including 13 new domestic drugs and 6 imported drugs, including multiple sclerosis drugs, HIV infection drugs, liver cancer drugs, etc. From being approved for marketing to being included in medical insurance, the average cycle of a new drug has been shortened to one year and two months.
Take PD-1 drugs as an example. In the 2019 national medical insurance negotiations, Junshi Bio's teriplizumab, Innobi sindilizumab and two imported drugs were shortlisted for this round of medical insurance negotiations. Among them, Innovent Biologics' Xindilizumab actively reduced its price to 2,843 yuan (10 ml: 100 mg/bottle), a decrease of 63.73% compared with 7,838 yuan when it was launched. After multiple rounds of price cuts, the world's cheapest PD-1 inhibitor is in China.
From "innovation is seeking death" to "only innovation can have a future"
Zhangjiang China Pharmaceutical Valley Biomedical Innovation Exchange Center. China News Network Zheng Yingying Photo by
With the rise of more and more innovative pharmaceutical companies such as Innovent Biologics, Beida , BeiGene, and China's innovative pharmaceutical environment is getting better and better. The industry says this is the "golden age of innovative drugs."
's eyes are focused on the south of Beijing. Yizhuang, now known as the "Medicine Valley", was still a famous "training lot" in the southern suburbs of Beijing 20 years ago. Beida Pharmaceutical innovator Wang Yinxiang "Second Entrepreneurship", Jiakosi, founded in Yizhuang Economic and Technological Development Zone.
Wang Yinxiang, who became famous for Beida Pharmaceutical's lung cancer targeted drug " eketinib ", never thought that when he started his business again, he ushered in the beginning of the rise of China's innovative drugs.
The most important thing for innovative drug companies is capital. Whether for Beida or BeiGene, the first generation of innovative drug companies have troubled this. BeiGene founder Wang Xiaodong once said that when he first returned to China, "making innovative drugs was seeking death."
However, in the past ten years, Biomedical has become a new trend in capital after the Internet.
"In the past decade, my country's medical and health system and pharmaceutical industry have undergone earth-shaking changes." Dr. Wu Xiaobin, President, Chief Operating Officer and General Manager of China, told the People's Daily Health Client reporter that one of the important nodes is the national pharmaceutical government reform since 2015. It has brought spring to the local innovative pharmaceutical industry and driven the prosperity and development of my country's pharmaceutical industry. Encouraged by policies, a large number of outstanding scientists, international talents and capital have poured into the local innovative drug industry, which has created an unstoppable torrent in China's innovative drug industry.
In 2015, with the release of the "Opinions on Reforming the Review and Approval System of Drugs and Medical Devices", domestic innovative drug companies have gained new opportunities and the industry ushered in a tide of capital. Within one year, more than 300 investment cases appeared in the domestic drug field, involving an amount of 29.208 billion yuan. BeiGene has also benefited a lot, and since then it no longer has to worry about money.
Only with money can there be motivation for innovation. In April 2018, BeiGene was listed on the Hong Kong Stock Exchange, and the amount of funds raised by IPO reached US$902 million; in November 2019, its independently developed new anti-cancer drug zebutinib was accelerated by the US FDA to treat serbtinib patients who have received at least one therapy in the past. Zebutinib has therefore become the first new anti-cancer drug independently developed by Chinese companies and approved by the FDA for the FDA, achieving a "zero breakthrough" in China's original anti-cancer drug overseas and was praised by foreign media as "the business card of China's biotechnology industry."
In June 2020, Zebutinib was approved for marketing by China NMPA.
BeiGene’s success has also allowed more people to see the future of innovative pharmaceutical companies. Wu Xiaobin told reporters that more than ten years ago, none of the innovative drugs that Chinese patients could use had independent intellectual property rights, and almost all the original innovative drugs came from imported ones. By 2021, my country's innovative drugs have accounted for 14% of the global innovative drug pipeline, accounting for the second largest proportion in the world, even surpassing Japan, the United Kingdom, and Germany. To achieve such a huge change, "It only took us about ten years. This is China's speed and the power of China's innovation."
Not only that, Hong Kong's 18A and the new listing policies for the Science and Technology Innovation Edition have brought about changes in innovative drug capital. Innovent Biologics CEO 7 Yu Dechao is also a scientist who developed Conborcept. He said that giving unprofitable companies the opportunity to enter the capital market, pharmaceutical companies have formed a closed loop in the capital market, and the access to new drugs and the introduction of talents has created the best era of new drug innovation.
