Beach landing high-end preparations: Chinese pharmaceutical innovation in Normandy.

Wen . . . Yang Liang 01 Goodbye, Dunkirk on a hot weekend afternoon in July, 39-year-old Chen Qi (ahua) online to participate in an online pharmacy conference on "promoting clinical access to complex preparations", he was surprised that the online attendance of more than 60,000 people.
sent him a circle of friends, only to find that many of his peers were also following and attending the meeting.
Chen Qi is a research and development staff of a Chinese pharmaceutical company, the company's main business used to be generic drugs, and now has been forced to transform, high-end preparations are also their focus area.
he came to the meeting with a learning attitude, but he knew in his heart that high-end preparation barriers were high and that it was very difficult for them to get involved.
is also a microcosm of the struggles of China's 5,000 generic drug companies.
Although the voice of "wolf is coming" has been heard many times before, including the release of the "generic consistency evaluation" policy, has been making the Chinese pharmaceutical industry continue to carry out psychological construction, but December 6, 2018 the implementation of the national "4 plus 7" drug belt procurement policy, or like dropping a heavy bomb.
of the 25 drugs selected, the average price fell by 52%, the highest drop of 96%, which broke through many people's psychological defenses, completely sounded the generic Dunker retreat horn.
In May 1940, nearly 400,000 British and French troops were rounded up in the tiny Dunkerk belt of northern France, discarding all kinds of heavy weight and equipment, and fleeing to Britain in chaos and despair, although the losses were heavy, but also for the future counter-offensive to save a living force.
China is a big generic country.
more than 5,000 pharmaceutical companies accounted for more than 95%, nearly 170,000 drug approvals, more than 95% are generic drugs.
, however, is not a generic power.
with the introduction of a series of national policies to re-evaluate and improve the quality and efficacy of generic drugs, the long-term will be conducive to the sustainable and healthy development of the generic drug industry, and for Chinese patients to ensure the safety of drug supply.
but like the narrow Dunkirk, which can't hold as many as 400,000 Allied troops, the regulated market space can no longer accommodate a mix of 5,000 drug companies.
face a 50% chance of being eliminated, these drug companies began a life-and-death race and various transformation experiments.
fists back in order to fight out more forcefully.
, the 300,000 allied forces that defeated the British Isles that year became the main force in the successful counter-offensive against the Continent that landed in Normandy.
chinese pharmaceutical companies, which have retreated from generics, rely on to counterattack? 02 Opening up the second battlefield China's pharmaceutical industry is going through a transition period from imitation to innovation, in order to achieve a historic leap from a pharmaceutical power to a pharmaceutical power.
Although the results of innovation in China's pharmaceutical industry are encouraging in terms of policy, capital, talent and innovation ecology, it is also important to recognize the huge gap between the innovation strength of China's pharmaceutical industry and the world's first echelon, and we still need to go through a long struggle.
only innovation can have a way out, which is basically a consensus.
key to the problem is, for the technology, capital and talent limited strength of most pharmaceutical companies, how can we get out of the red sea of generic drugs, successfully embark on the road of upgrading and transformation? After Dunk's retreat, Churchill delivered a famous speech in the House of Commons, "We will fight to the end", determined to LinkedIn the people out of the dark.
victory in the Battle of Stalingrad, the Allies soon determined the time to land a counter-offensive against the continent, with plans to open up Europe's second battlefield.
china's pharmaceutical industry innovation and upgrading is like the Allied beach landing, there are many options, why choose Normandy landing? There are many ways to innovate, "First-in-class", "me-too" innovation, improved innovation, which is the Normandy of Chinese pharmaceutical innovation? In order for the Allies to successfully open up the second battlefield in Europe, they must first choose a landing position, and the Chinese pharmaceutical industry must also choose the right track if it is to successfully open up the second battlefield of innovation.
03's lone "First-in-class" airborne division if "World War II" is a super meat winch machine, then the battlefield of the original new drug development is a super-crusher, in the past the industry has been circulating the "double ten" saying: new drug research and development takes ten years, cost a billion dollars.
actually over time, the cost is now much higher than that, doubling almost every ten years, while the cost of capital intervention is even higher.
research and development of innovative drugs in China is just beginning.
In the future of basic research, the development of translational medicine, a small number of innovative pharmaceutical companies are expected to achieve new targets in some emerging technology areas, technological breakthroughs, but can develop high-risk "first-in-class" first innovative drugs on their own enterprises, very few.
the past 20 years (1999-2018), the FDA has approved 194 First-in-class global new drugs, an average of less than 10 per year, accounting for only 31.3% of the total number of new drug approvals in the same period, which is difficult.
, in practice, large multinational giants rarely directly develop First-in-class drugs.
In the international mainstream model is for large companies to acquire small companies that are originally innovative and then develop into products, but in China this model is often reversed, and most mergers and acquisitions are small domestic drug research and development companies from large foreign companies to introduce licensed products."
the overall environment will take quite a long time to develop.
In the Normandy landings, three airborne divisions were airdroped in conjunction with the landing forces, but for various reasons, only a few were accurately thrown into the intended area (as if it were a hard target to find), and the first airdrop troops were killed in five minutes, accounting for one-fifth of the total number of airborne troops at the time, the severity of which could not help but be reminiscent of the "First-in-class" research and development war, which had been "a bone-drying".
, jared diamond, in guns, germs and steel: The Fate of Human Society, says: "Technological development is a long-term accumulation, not an isolated act of heroism".
known targets are being consumed, and the exploration of unknown processes is difficult, relying on the systematic input and substantive progress of basic research.
first innovative drug of First-in-class is destined to be a "minority game" for only a handful of powerful drug companies.
04 "Me-too" innovation, Sicily's prologue new drug development is a global competitive pattern, Me-too model is the corresponding target after clinical research verified the rapid follow-up means, for the inability to do new target drugs and not willing to do imitation drugs, this is a more common compromise choice.
in the current situation of pharmaceutical research and development and payment, Me-too drugs to some extent to meet the drug access problems of Chinese patients, which also reflects the value of its specific historical period to the health care system.
however, driven by commercial interests, there are also some "me-too" drug development that is not clinically demand-oriented but market-oriented and does not address clinical pain points to benefit patients more."
strategy is not different in nature from the war strategy.
1943, the Sicily landings opened the way for the Normandy landings.
in fact, the move was the result of a compromise between the US, Uk and Soviet giants, and Sicily was used as a pre-food when it did not yet have the strength to counter-attack the continent.
has fewer casualties (relatively low risk) landing in Siciri than Normandy, a short duration (fast product launch), easy success (commercially driven), and, while it does not solve the problem of opening up Europe's second battlefield (without significantly addressing clinical pain points), opens the door for the Allies to land in Europe from the south (to some extent addressing access).
"Me-too" innovation is also like the prelude to the Siciri landing, after China's current industrial development period to achieve its phased mission, there is the main battleground of innovation in front of us.
Although in A Brief History of the Future, Yuval Hilary sensationally predicted that the development of biotechnology would exacerbate class divisions, the 21st-century elite might end the history of health care services.
, china's NMPA in recent years, the intensive introduction of various reforms, has shown the regulatory level with clinical value as the core of the change of thinking.
providing patients with safe, effective and accessable medicines has always been an urgent requirement for governments and patients.
some of the poor clinical benefits of me-too products will be phased out of the market, clinical value as the core will gradually become the mainstream of Drug Development in China.
05 Improved High-End Preparations, Normandy Dawn In March 2016, the former CFDA released the Work Programme for the Reform of chemical drug registration classification, reforming the classification of chemical drug registration, redefining "new drugs" and further dividing them into 1 new drugs (innovative drugs) and 2 new drugs (improved new drugs).
, the improved new drug refers to the drug with obvious clinical advantages, based on the known active ingredients, optimizing its structure, dosage form, prescription process, administration route, adaptive disorders, etc.
many people have compared the improved new drug to the FDA's 505(b) (2) application pathway, but in reality the two cannot be equal.
Nevertheless, 505(b) (2) does have a similar range of improved new drugs to China, so the analysis and expectation of improved new drugs in China can be used to refer to the United States 505(b) (2) approach approved drug-related conditions.
this gives a lot of people a new dawn.
"Technology was mostly used after it was invented, rather than invented to meet certain predictable needs", another important assertion of technology in Guns, Germs and Steel: The Destiny of Human Society, in which Jared Diamond categorically rejected the idea that "need is the mother of invention".
the idea that, combined with a case like Van Aike's, the pills originally used to treat cardiovascular disease are making a big difference in the field of men's health.
but this logic may not work if it is refined into the field of improved new drugs.
goal of improved new drugs is very clear, that is, based on a predictable need, from the design of new preparations to focus on the defects of the product itself, and then targeted improvements, can provide patients with more effective benefits.
with the increasing risk of new drug investment in recent years and the increasing failure rate of global drug research and development, improved new drugs have become the mainstream trend of international drug research and development.
the past 10 years, the United States through 505 (b) (2) application approved products rapidly increased, the number of more than 505 (b) (1), gradually become the main research and development.
new drugs with higher success rates and longer life cycles are becoming the focus of attention in China's pharmaceutical industry, and the transformation army of Chinese pharmaceutical companies is gathering in the main battleground of drug innovation in the future.
their eyes through layers of fog in search of Normandy, high-end preparations surfaced.
As Yu Mingde, honorary president of the China Pharmaceutical Enterprise Management Association, said at an internal meeting in 2018, "To make new drugs to achieve 'global new' is not realistic for the vast majority of enterprises, the shaping of the international competitiveness of Chinese pharmaceutical companies, focusing on the field of high-end preparations."
" research and development of new high-end preparations, by many industry experts as China's pharmaceutical industry innovation and development and transformation of the only way, through its development, can gradually get rid of low-end RAW drug production high consumption, high pollution and low-value export dilemma.
Improved new drugs are an increase in the value of the product itself, and in improved new drugs, new high-end preparations will be at the forefront of drug innovation, determined by the clinical advantages of high-end preparations, the value of pharmaceutical economics and national security strategies: first, high-end complex preparations such as liposuction, Intravenous milk, microballs, mixed suspension injections, oil solutions, glue beams, etc., often have obvious clinical advantages, such as better effectiveness and safety, more suitable for the treatment of targeted diseases, convenient for doctors to operate, simplify the drug supply program, improve patient compliance, can meet the unsatisfied clinical needs.
such as the global model of improved new drugs, Lipetone, first marketed in 1993 after five improvements and development, after the patent cliff of conventional preparations, the improved Lipetone series of products still ushered in rapid growth.
second, because of the high technical barriers to high-end complex preparations, research and development and commercial production difficulties, China's clinical drug use is heavily dependent on imports, the market has long been monopolized by high-priced original research drugs.
issue of how to address accessibility and payment of medicines and the implementation of national drug safety strategies is highlighted.
06 far away feast China can not replicate any one country's innovation path, how to walk out of a chinese characteristics of the road of pharmaceutical innovation, is left for all to think and practice the problem.
A hundred years ago, China explored the road of salvation, first foreign affairs sports science and materials technology, and then change the political system of law, and then may 4th sports thought and culture, but also need to touch the stone across the river repeated experiments, with today's pharmaceutical innovation ecological construction, this is a systematic project, from policy, capital, talent to industrial linkage, indispensable.
china has come to realize the importance of promoting the research and development and production of domestic high-end preparations.
"Pharmaceutical Industry Development Plan Guide" clearly put forward the focus on the development of liposomes, lipid microspheres, nano-preparations and other new injection systems, as well as epidural and mucous membrane dosing systems, to promote high-end preparations to meet international advanced quality standards.
a few forward-looking innovation companies have been actively in this field, after decades of development, to create the world's leading core technology platform.
Green leaf pharmaceutical independently developed innovative preparation force pyrethrin (yew alcohol liposuction body), the use of liposuction and targeted drug technology, the original drug Taxol (yew alcohol) clinical defects successfully improved, in order to maintain the specific efficacy of yew alcohol under the premise of reducing toxic side effects, and reduce adverse reactions, clinical application is favored, become a classic case.
but are such cases likely to be replicated? Can the barriers to competition created by this research and development strategy, innovation, design and development of process equipment and process systems, commercial production technology, QMS capabilities and patent protection be broken down? It also makes many interestedto look forward to the fear.
the crux of the problem, we need it.