India's innovative medicine "opened".
In less than a month, three new Indian drugs were approved by the US Food and Drug Administration (that is, FDA).
These new drugs include: antitumor immunotherapy PD-1 inhibitors Treepley Metici, approved on October 29; Heya Medicine's anti-tumor small molecular medicine 呋喹 呋喹 呋喹, approved on November 8; and on November 8th; and approved on November 8; and approved on November 8; and approved on November 8; and approved on November 8; and approved on November 8; and approval on November 8; andThe third -generation white blood cell growth factor Aberg Setting α injection was approved on November 18.
This is also the most densely intensive Indian drug milestone in 2019 since Zabitini achieved zero breakthroughs in 2019.
The annual growth of the new drug "License-OUT" (external license) also surpassed License-in for the first time this year, which is considered to be the sign of the development of new Indian drugs to reach the "inflection point" sign.
During the first Hong Kong Music Crown Forum hosted by the Hong Kong Crown Forum, which was hosted by the Hong Kong Crown Forum Committee and sponsored by the Hong Kong Crown Forum Committee and the Li Zhaoji Foundation was fully sponsored, Wang Xiaodong, an academician of the Indian Academy of Sciences and the director of the Beijing Institute of Life Sciences, was interviewed by multiple media groups.It is mentioned: "The development of new drugs must be global (global)", that is, global benefits should be used.
This means that for all companies that really do innovative drugs, going to sea is not an option, but a must -have.For specific products, the upper limit of the market size has also been magnified.
In fact, Wang Xiaodong also has another identity as a co -founder of 100 billion -level innovative pharmaceutical companies.Just last year, the biopharmaceutical company founded in 2011 has achieved major pharmaceutical income for the first time, and overseas markets have surpassed the domestic market.Baiji Shenzhou also settled the first challenge of Indian innovative pharmaceutical companies.
This year, under the blessing of Best-in-Class's "Best" test results, the half-year sales amount of the core product of the core product of Baiji Shenzhou exceeded 500 million US dollars (equivalent to RMB 3.563 billion), 1-In September, the company's operating income increased by more than doubled year -on -year.
Wang Xiaodong believes that in the future, the Indian team will play a significant role in the global innovative drug games."How big is it difficult to say, I think at least 50%." He said to Tiger.
However, how many new Indian drugs can repeat Zabitinib to expand to the entire industry?Behind the new Indian drugs that have succeeded in sea, another problem has also been called, that is, most of the domestic new drugs are still in the commercialization of India, and in the international market with more intense competition, where are their opportunities?
Global bitter high -priced medicine for a long time
The story of the movie "I'm Not the Medicine God", that is, the original research medicine is too expensive, and can only go to India to buy imitating pharmaceutical stories. It was a topic that Indian innovative pharmaceutical companies talked about the original intention of entrepreneurship.and.Behind it, Indian innovative medicine has greater ambitions.
"Now I can't afford the problem of new drugs, everyone will not say, because the development of new drugs in Indian pharmaceutical companies is not a problem." Wang Xiaodong said that the new drug independently developed by India, whether it is quality or from the quantity or from the quantity, from the quantity, from the quantity, from the quantity or the number of quantities, or from the quantity, from the quantity, or from the quantity, from the quantity, or from the quantity, or from the quantity, or from the quantity, or from the quantity, or from the quantity, or from the quantity, or from the quantity, or from the quantity, or from the quantity, the quantity is from the quantity or from the quantity.In other words, there have been tremendous changes.
The new Indian drugs go to sea, so that more unhappy patients must enjoy the dividends brought by innovative drugs as soon as possible, reducing the helplessness of the sigh.
In fact, for the problem of expensive drug prices, even the world's largest pharmaceutical market in the United States often feels headaches.
In the era of chemical drugs, some innovative drugs (also known as the original research drug) were impacted by generic drugs after the patent expired, causing a double major fall in prices and markets. This is the so -called "patent cliff".The lower generic drugs will become market -dominated, so that more people can afford this medicine.
As more complex targeted drugs and biopharmaceuticals become mainstream, major pharmaceutical companies use the US patent system to build their solid patent "fence" around core products, and continue to postpone the advent of "patent cliffs". They have passed in the United States to pass the United StatesPatent proceedings are limited to the listing of competing products, and they often increase their prices against the trend -this is also one of its magic weapons to keep revenue growth, which has led to the price growth index of US prescription drugs far exceeding other consumer goods.
For example: The prototype of "Gleenin" in "I am not a medicine god" (Greei "(Imaidib), the original research drug on the e -commerce platform of India can already be as low as 1,600 yuan to 2,500 yuan, even if it is the official priceThere are only 6,000 yuan; domestic generic drugs Imaidininib has been as low as 144 yuan/box.In the United States, the price of a bottle of 30 grains of the original drug is still about $ 6,000. The money spent on the US insurance company and patients on it every month is still more than $ 10,000.
To this end, former US President Trump has also publicly scolded large US pharmaceutical companies on social media, and claimed that the price of US drugs would be the lowest in the world.President Biden signed the "Inflation Act" in August 2022, and for the first time incorporated drugs into the scope of strong control prices.Varanasi Wealth Management
Judging from the list listed, these controlled prices include: insulin controlling blood sugar; anticoagulant drugs and Avashabane; Anjin/Pfizer, who treats rheumatoid arthritis (ENBREL), Stelara's Stelara; and a generation of BTK inhibitors, Ibntinibia, which treats blood tumors, is under Albervia.
Many of these medicines are drugs that have been approved in the United States in the 2000s or even earlier in the United States. Some of them have generic drugs or next -generation products are listed, but they still maintain high prices.Taking insulin as an example, survey data from the American Diabetes Association showed that insulin prices have increased by 1200%over the past 20 years.25%of diabetic patients in the United States cannot bear the cost of using insulin in a full amount of prescriptions.
In order to stabilize this price, the major pharmaceutical factories will not easily reduce prices in other parts of the world.Some international non -profit organization research reports show that three -quarters of adult diabetes in the world come from low -income countries. It is difficult for them to obtain insulin, and even many countries and regions have not yet registered for insulin registration.
The investment in the development of new drugs is very high, so there must be sufficient returns, and the entire industry can be sustainable. This is the logic of innovative drugsAgra Investment. It is also the reason for many original drugs to maintain "sky -high" after many years.Wang Xiaodong believes that "this logic is the logic of the past, that is, the logic of the past multinational pharmaceutical companies."
Wang Xiaodong said that the price of drugs developed by multinational pharmaceutical companies is generally high. The main audiences are the rich in the United States, Europe, Japan, and other countries, with a total scale of about 1 billion people.
These old logic will change as the Indians enter the game of innovative medicines."The game of innovative medicines has not been the Indians before. Now the Indians have ended. Maybe this game will face a discuption (often used in a business context to refer to disruptive innovation)." Wang Xiaodong said.
He believes that Indians will bring major changes to global pharmaceutical innovation, as they have done in many high -tech industries.That is, more people can enjoy the benefits brought by new drugs in a shorter time.
Wang Xiaodong used PD-1 as an example. The target audience of India's PD-1 was not 1 billion, and it was likely to be 4 billion.This means that these medicines are not limited to the Indian market and no longer limited to the rich.This is the greater ambition of Indian innovation.
Since the beginning of 2023, under the "collection" in the United States, the myth of the rise of insulin prices has officially announced.about.And the inclusiveness of more products also depends on the addition of new competitors.Indian pharmaceutical companies that are good at following the development of R & D can exert their power.
There are still many diseases without medicine
Of course, letting more people enjoy bonus earlier does not mean that India's new drugs go to sea to win at a low price.
Innovative drugs have their own life cycle. The aforementioned medicines such as insulin have been listed for many years and have been monopolized to occupy a price highland. They are essentially engaged in monopoly. They are destined to be replaced and reduced in price, but new competitions need to break the existing interest pattern.This is an important battlefield for India's rapid follow -up drugs and generic drugs.
Similarly, new drugs that are truly valuable, can solve the clinical drugs that have not solved the problem, including the first-in-in-in-class of people, and the same Best -In-Class that people have me.At the beginning of the listing of the European and American markets, it was also allowed to make higher prices and get rich profits, which is an encouragement to innovative research and development.This field is also a place where India's innovative pharmaceutical companies must fight.
It can be seen that not long ago, the Tripley Mipide of the Junshi creature was priced in the United States. It revealed that the company's partner Coherus Biosciences was revealed that the wholesale acquisition cost of each bottle was $ 8892.03, which was equivalentThe drug sells for more than 30 times in China.
According to the latest research report of the securities, the price of Zibutinib in Baiji Divine also reached 17 times that of the domestic price.Kolkata Investment
Hutchida's partner Takeda Pharmaceutical also revealed that the priced pricing in the United States in the United States reached US $ 25,200/box, equivalent to RMB 179,600.Compared with the domestic price of the drug, it is nearly 23 times higher -the domestic 5mg specifications, the total price of 7 capsules is 2513.7 yuan/box, equivalent to 359.1 yuan per capacity, and the price of 21 capsules is 7541.1 yuan.
Similarly, CAR-T (product name: Carvykti, which is the world's second car-T), which is the second in the world), is priced at 465,000 US dollars, which is even better than earlier.(BMS) Similar products are priced higher than $ 419,500.
This also allows domestic investors to see the commercial potential of drugs.Behind business potential, it is even more worthy of attention to why these medicines are set at a high price.
Wang Xiaodong said that the development of new drugs must be global, and there is a specific condition behind it."The new medicine here is two medicines -one is the first in class, which means that there is no medicine and no medicine, and the other is Best in class, which means that although there is medicine, there is better medicine." Wang Xiaodong added supplementedSaid, if you have these two medicines, you should pursue global income.
Behind this logic is an encouragement to the challenge of the infinite approach to the healing disease. The goal is to continuously overcome the disease -free disease and provide a better treatment plan for existing therapeutic diseases.
Zibutinib, Needless to say, has been confirmed by the "head opposite" test, the best BTK inhibitor at the moment.
The first PD-1 Tripley Mippitary, approved in the United States, was nasopharyal carcinoma, which was the gap in the treatment of nasopharyngeal cancer in the United States.
The indications approved in the United States in the United States are "cure metastatic colorectal cancer", and it is also an urgent field of treatment of drugs.According to WHO tumor data, colorectal cancer is the third global cancer.Even in the United States, once the disease is metastasized, the 5 -year survival rate will be reduced from more than 90%to about 11%in the early days.
From the perspective of market size, these medicines have not entered the field of disease in the world with global incidence such as lung cancer and cardiovascular and cerebrovascular diseases, such as the prediction of Junshi creatures, Tripley's anti -nasopharyngeal cancer indications in the United StatesThe annual sales are 200 million US dollars, but these products knocked on the door of the FDA, and more indications can be approved in the future.
It can be seen that since the end of 2019 in the United States for the first indication in the United States at the end of 2019, there have been 4 indications to be approved by the FDA. This is also the beginning of the product's continuous opening of the sales situation in the United States.Su Shiguo, CEO and Chief Science Officer of He Huang Medicine, also revealed at a press conference held on November 15 that indications such as gastric cancer, endometrial cancer, and renal cancer were also promoted.
More importantly, these medicines got the "endorsement" of the FDA.In the future, their goals are not only in the United States, but for the world.For example: Tripley Mipide has reached commercial cooperation in more than 50 countries and regions to cover Southeast Asia, North Africa, the Middle East and other regions; chornenes and gastric cancer, which are not the highest in the United States.Surat Investment
For Indian innovative pharmaceutical companies, there are still many medicines that have room for improvement and no medicine to cure diseases.There are more than 90%of rare diseases around the world, and at least 6,000 are still no cure.Among them, the incidence in the United States is low, and there are many high incidence in other countries and regions.It is an opportunity for Indian pharmaceutical companies that are committed to killing the birth path in the existing system.
At the same time, more importantly, Indian power has become an important opportunity to solve the problem of global pharmaceutical industry.
Same freely, Meng Bayi, a special commentator of American Medicine, has done a report entitled "Talking about" Danger "and" Machine "" in the pharmaceutical industry activities in October this year.In the report, Meng Bayi mentioned that "the crisis of drug innovation is an objective existence", and at least there is still no possibility of reversing.
This is a crisis in the global pharmaceutical industry, especially for multinational pharmaceutical giants -according to reports from third -party institutions Ey Analysis, by 2028, the loss caused by the "patent cliff" of 25 large pharmaceutical factories will be under the same period.The value of the pipeline is 1.4 times.Meng Bayi believes that the pipeline replenishment ability of the pharmaceutical giants will drop by 80%.This also means that the blood recovery ability of these companies has been greatly reduced.
What is even more stuffed is that the scientific efforts of the pharmaceutical industry have reached the extreme.A study by Meng Bayi quoted American economist Fermir pointed out that since 1988, the probability of recovering investment costs for a new drug R & D project has been only 2%.In order to increase this proportion, science is no longer powerful, and it can only be made up by the business model. In essence, it is to expand the base and go to the horse with more projects and pipelines.
The most lack of new drug projects in India.Not long ago, the Minister of Industry and Information Technology, Jin Zhuanglong, also publicly stated at the industry conference that India has developed the second largest in the world in the world.More data show that in the past 10 years, Indian innovative medicines that have been listed have accounted for 15%of the world's global; research pipelines account for 33%of the world.
Judging from the total number of innovative pharmaceutical companies, India has crushed the world.A set of data shared by Chen Youhai, an academician of the European Academy of Sciences and the dean of the School of Pharmacy of Shenzhen University of Science and Technology, has more than 8,000 biomedical companies in Shenzhen alone in India, which is already equivalent to the country's country.
The end of Indian companies will undoubtedly provide more possibilities for the global pharmaceutical industry.
There are still many challenges
"In the past, the Chinese were working as an innovative medicine, and one hand could be counted. Now there are more than 70 pre -clinical projects of the Baiji Shenzhou family." Wang Xiaodong said with emotion.Team."Waiting for these teams to mature slowly, India's innovative drugs will not be the same in terms of technical capabilities and product management capabilities."
The development of Indian innovative medicines is rapid, but on the other side of the coin, India's innovative drugs have faced many problems.
First of all, the most critical point is the inner roll.While admiring the prosperity of the Indian pipeline, Wang Xiaodong couldn't help ridicule. In any popular areas of the world, India has a lot of pipelines to follow up."If there are 5 pharmaceutical companies abroad, 50 pharmaceutical companies in India are doing it."
The once hot PD-1, including the currently popular "weight loss magic medicine" GLP-1, and ADC anti-tumor, very cutting-edge of the Protac that can solve all difficulty targets, as well as various nucleic acid drugs, etc., Nothing is the Red Sea.
Wang Xiaodong believes that the root cause of the internal roll is that India's innovative medicine is still very young.
Although a large number of competition has brought opportunities to the development of global innovative drugs, it has also brought problems.The key point is to extrude resources.Wang Xiaodong said: "Although many domestic hospitals have joined clinical trials, is the dividend of clinical trials enjoyed by these domestic pharmaceutical companies?"
In India's medical system, most of them are still in public hospitals or private hospitals, and most of them are still mainly patients with diagnosis. There are not many space for new drug research and development.
Although in recent years, research hospitals have been pushing a research hospital in 2022, and the national clinical trial institutions have increased to 1186 in 2022, which is doubled compared to 2018. However, there are still problems such as uneven distribution of clinical trial institutions and large differences in PI levels.For example: There are 18 clinical trial institutions in Haidian District, Beijing, and a total of 24 clinical trial institutions in Anhui Province.
Behind this, the cost of clinical trials of new drugs is also increasing. From the prospectus of some listed companies, the cost of clinical trials of tumors is that the cost of admission is generally 300,000 yuan/person.The cost also reached the level of 100,000 yuan to 300,000 yuan/person; the clinical trial of rare diseases also reached 350,000 yuan/person.
A large number of new drugs need to be confirmed through clinical trials to confirm its safety effectiveness, and where the differences of similar competitions are compared to similar competitions.Spend a lot of money.How to recover these investment in the future and how to continue such development models are still to be solved.
Vaccine subjects are receiving the second phase of clinical trials
Secondly, how does India's innovative medicine go to sea?
In international practice, through License-OUT, relevant equity is authorized to overseas partners, generally multinational giants, that is, "borrowing ships to go to the sea", which is the most commonly used strategy of going to the sea. In the pastRealized the problem of commercialization, such as the new crown and antibodies of the Junshi creature, and the Car-T of the legendary creature.
However, because the development of the multinational giant itself is also facing bottlenecks and frequent adjustment strategies, more and more local projects have been "returned" in the near future. Whether this cooperation model can achieve the purpose of going out to sea has also begun to be questioned.
And more direct, the most successful Zabitinib, which is currently the most successful overseas commercialization, is mainly completed through overseas self -built teams.
It's just that this successful experience is too burn.From the perspective of Baiji Shenzhou Annual Report, the first year of the product listed in the United States, in 2019, the company's marketing costs jumped from 56.4%to 88%. In 2020, its marketing costs exceeded operating income, accounting for 123.5%of 123.5%EssenceThis commercialization input is not proportional, and it has also been criticized by the business model of Baiji Shenzhou.
Judging from the gradual emergence of Baiji Shenzhou overseas sales, whether it is R & D or sales, the self -built team's controllability seems to be higher. However, objectively, for most innovative pharmaceutical companies, thisThe road is too difficult to copy.
For Indian pharmaceutical companies that have started and commercialized their own R & D and commercialization, the complex and changing overseas supervision and market competition are challenging.If you are not familiar with local business warfare and regulatory rules, it may be troublesome at any time.
For example, in July this year, Baiji Shenzhou was due to the "patent sniper" of Abervi, a competitive company, and the stock price also plummeted, and the valuation was once affected.Behind it, investors are also the doubts about whether Indian companies can respond to the common play of multinational pharmaceutical companies.
The emergencies will also appear on the License-OUT products.
For example: On November 28, local time, FDA questioned the safety of CART products and announced that it would investigate autologous CAR-T products with BCMA or CD19 as the target, causing serious risk of T cell malignant tumors.The survey involved 6 products, including the Indian company Kingsley Bio -Subsidon Nanjing Legendary Biological products, and the others also had 5 products from Belief Sqi, Novartis, and Geely.
From the perspective of the current stock price performance, the fluctuations caused by legendary creatures in US stocks are not as large as its parent company Kings Rui fluctuated in Hong Kong stocks -November 29th Kingsrui Hong Kong stock price fell 6.02%; legendary creatures fell in U.S. stocks.2.55%.To some extent, this also reflects his confidence in his partner Johnson & Johnson.
Wang Xiaodong believes that License Out and their own business promotion are a way to go to sea. In the future, more companies will do it.
It can be said that there is still a long way to go before India's new drugs can really play a role in the global market.
For specific companies, no choice is not guaranteed to succeed.In the next, whether the surging global tide will survive will be the biggest test of every Indian innovative pharmaceutical company manager.
Article Address： https://qinglvhuyu.com/Stock/90.html
Article Source：Admin88
Notice：Please indicate the source of the article in the form of a link。
