Generic pharmaceutical companies have a low success rate in transformation?

A few days ago, a survey of 600 people voted by the E-Pharmaceutical Managers Research Institute showed that under the normalization of centralized procurement, generic drug companies rely on their own accumulation to successfully transform the probability of innovative pharmaceutical companies, and 412 people voted for "less than 50%".
”, accounting for more than 68%
.
Source: E-Pharmaceutical Managers Research Institute Why is it so difficult? To sum up, there are five main reasons: Innovative drug research and development is a near-death, high failure rate is universal, and the failure rate of inexperienced generic drug companies will only be higher
.
The development cycle of new drugs is long and the cost is high
.
The general research and development time is about 8 years.
In the short term, it is impossible to save the generic drug companies that have been cornered by centralized procurement.
Moreover, during these 8 years, the company needs to invest continuously.
Usually, the research and development cost of a new drug needs at least 200 million yuan.
RMB, that is to say, the annual investment in research and development costs starts at 25 million yuan.
Most generic drug companies have a sharp drop in profits after centralized procurement, and may not be able to invest in innovative drugs for a long time
.
Deviations in understanding of innovative drug projects
.
The registration success rate of innovative drugs has led to the fact that generic drug companies are afraid to invest in innovative drugs easily, and the decision to transform innovative drugs has been delayed
.
In order to raise funds for the R&D stage of innovative drugs, external financing is often required, but most generic drug companies are risk-averse and are not necessarily willing to design financing plans
.
Innovative drugs require an experienced R&D team, and the culture of most generic drug companies in China differs greatly from that of innovative drug companies
.
In fact, many domestic generic drug companies have been exploring and transforming innovative drugs for many years, and they have also actively introduced returnee teams, but the teams are often disbanded again and again during the run-in period
.
The industry generally believes that it is difficult for a generic drug company with a strong result-oriented and local sales cultural background to successfully marry a team of returnee scientists
.
Even if the listing is successful, it does not mean that the product can quickly get market returns
.
Generic drug companies often use the thinking of generic drugs to make innovative drugs, and they like to follow the targets laid out by large domestic and foreign companies, but the research and development progress is not as good as that of large domestic and foreign companies, and the launch of products will face the involution of innovative drugs.
If the marketing layout of innovative drugs is not as good as that of large companies, it will be difficult to succeed in the final market return
.
The Teva model may not be feasible in China When it comes to the case of generic drugs transforming into innovative drugs, the international case that the industry likes to cite is Teva
.
Teva's future performance is believed to be driven by innovative medicines, including Austedo (for Huntington's disease and tardive dyskinesia), Ajovy (for migraine) and biosimilars
.
In 2022, Teva expects Austedo sales to reach about $1 billion
.
Ajoby is now the second largest migraine brand in Europe
.
But cases like Teva are difficult to succeed in China
.
Teva's Austedo (Chinese trade name: Antaitan) was approved for listing in China in May 2020, and will be included in medical insurance through medical insurance negotiation in 2021
.
According to the data of Minet.
com, the hospital market of deuterated tetrabenazine tablets in the first half of 2021 is 2.
14 million yuan, and the pharmacy market in 2021 is forecast to be 350,000 yuan for the whole year
.
Ajovy is the world's first and only subcutaneous injection of long-acting anticalcitonin gene-related peptide (CGRP), which has not yet been marketed in China
.
In 2021, 6 CGRP/CGRPR inhibitors have been approved worldwide, and the total sales in 2020 will reach 1.
21 billion US dollars
.
International analysts believe that the future competition for migraine drugs will be dominated by new CGRP antibody drugs
.
evaluate Pharma once predicted that the global CGRP antibody new migraine drug market size will be $5 billion in 2024
.
But the Chinese market is different
.
According to the data from Minet.
com, in the market of oral anti-migraine preparations in hospital terminals in 2021, gastrodia/ephedrine will account for more than 70% of the market, and even the global "overlord" triptans for the treatment of acute migraine will not account for 20%.
to
.
It can be seen that medicines that sell well abroad may not be able to sell well in China
.
Therefore, it can be seen that the transformation of Teva's innovative drugs is unlikely to be recognized in the domestic market
.
In fact, the international capital market is not buying it.
Under the situation that the transformation of innovative drugs is not recognized and blind expansion leads to high debt, Teva's overall market value in 2021 has dropped by 86% compared to the peak market value in 2015
.
Exploration of Hengrui, Chia Tai Tianqing and Simcere The data of the "Development and Operation of the Pharmaceutical Industry in 2021" released by the China Pharmaceutical Enterprise Management Association shows the list of domestic new drugs routinely approved in 2021
.
In 2021, a total of 44 domestic innovative drugs have been approved for marketing by domestic companies, a record high
.
Under the effect of continuous and high-intensity R&D investment, domestic innovative drugs have entered the stage of intensive marketing and batch commercialization
.
From the review process, 34 varieties are routinely approved new drugs, and 10 varieties are new crown prevention and treatment drugs for emergency use or conditional marketing
.
Judging from the approved companies, they are mainly new Biotech, and domestic leading pharmaceutical companies that have successfully transformed from generic drug companies to innovative drug companies
.
Routinely approved domestic new drugs in 2021 (excluding traditional Chinese medicine) Data source: "Development and Operation of the Pharmaceutical Industry in 2021" Judging from the number of approved innovative drugs in recent years, Hengrui deserves the first place, although many are Me-too /Me-better type of innovative drugs, but with its marketing capabilities, Hengrui's domestic innovative drugs may occupy the market even if they are launched later, and even win the marketing team of multinational pharmaceutical companies
.
However, most domestic generic drug companies do not have Hengrui's innovative drug R&D team, nor do Hengrui's marketing team
.
Hengrui's successful model is difficult for most generic drug companies to replicate
.
There is also Chia Tai Tianqing in the case of domestic top generic drugs transforming into innovative drugs.
With the help of Anlotinib hydrochloride, it achieved a revenue of 221 million yuan in 2018
.
When it went public that year, it entered the medical insurance catalog.
After entering the medical insurance catalog, the market size immediately reached 2.
032 billion yuan, exceeded 3 billion yuan in 2020, and 5 billion yuan in 2021
.
However, Chia Tai Tianqing is backed by the big tree of China Biopharmaceuticals, and its resources and energy at all levels are not within the reach of ordinary generic drug companies
.
If there are innovative drug products on the market in the original strong sales area, this is the most ideal way for generic drug companies to transform
.
In 2003, Simcere became the second best-selling edaravone drug brand in the world and the first domestically listed Bicun (Edaravone)
.
Bizun's sales in 2018 were as high as 1.
2 billion yuan, but because it was included in the "first batch of national key monitoring rational drug catalogues (chemical drugs and biological products)" in 2019, the sales of the drug dropped sharply to 940 million yuan in 2019 In the first six months of 2020, sales fell by 68.
92% year-on-year to only 178 million yuan
.
However, with the new listing of Xianbi in 2020, Simcere Pharma's revenue from the central nervous system segment in 2020 has soared against the wind, reaching 740 million yuan
.
Symbiote is scientifically compatible with two active ingredients, edaravone and dexbornol.
The application of the two ingredients to scavenge free radicals, anti-inflammatory and protect the blood-brain barrier can significantly reduce the risk of acute ischemic stroke.
Cranial nerve damage, it is the first medicine of two components
.
In 2020, Xianbixin will enter the medical insurance catalogue through medical insurance negotiation
.
The case of Xianbixin is something that domestic generic drug companies want to learn, but it is worth noting that Xiansheng is the first batch of domestic companies to develop Class 1 new drugs and biological products
.
Moreover, the initiation of Xianbixin's project was in 2007, and the clinical application was not made until 2010
.
How many domestic generic drug companies are willing to continue to invest 13 years to wait for a new drug to be launched? Generic drug R&D and innovative drug R&D are often two different R&D thinking, often requiring two different teams to operate
.
Normally, pharmaceutical companies should accumulate generic drugs first, and then move towards improved drugs and innovative drugs
.
However, domestic generic drug companies often hope to overtake in corners and directly transform generic drugs into innovative drug companies
.
The successful research and development of innovative drugs often occurs in teams of scientists who have accumulated experience in the research and development of innovative drugs in the past
.
Generic drug companies want to transform innovative drugs to be successful.
After preparing the money and time, they should start by learning to cooperate with these scientists with successful experience
.
There is no innovative drug team, so we can only consider buying and buying
.
However, buying a project is quite challenging for generic drug companies compared to companies with experience in innovative drug R&D and operation
.
The direction of project cooperation can be roughly divided into two categories: buy the results of scientific research institutions in China, or buy research projects abroad, which is usually referred to as obtaining projects through BD
.
The difficulty in this is that if the BD of a generic drug company has no experience in innovative drug research and development, it is difficult to identify the "pit" of the project, including but not limited to animal experiments that do not support the drug entering the clinical stage at all, or the introduction of foreign products into the domestic market.
To do a large clinical and so on
.
In order to avoid the "pit", generic drug companies prefer to buy products in the mature stage, but usually the products in the mature stage are very expensive, which is twice or even more expensive than the R&D expenses invested in the early accounting
.
Another way to broaden the project is to outsource the R&D project after the company has established the project
.
Outsourcing of new drug R&D projects includes sub-project full-package and project-stage outsourcing
.
This requires the internal team of the generic drug company to do management output.
If the team has no experience in new drugs, the generic drug company will still have to pay tuition fees
.
The WuXi Department has always been the main force for project outsourcing, and it already has a formed and streamlined model
.
Under normal circumstances, WuXi often has a prototype before selling it to the industry, while most of the other CROs are customized according to what customers want.

.
No matter whether it is CRO, imported projects from abroad, or cooperation with domestic scientific research institutions, most of the project's entire milestone transaction costs will cost 100 million yuan, in addition to more than 100 million personnel and clinical supporting investment
.
For innovative drugs to succeed, both money and people are indispensable
.
The current successful cases all give credit to the BD transaction.
In fact, negotiating the BD transaction is just the beginning of the long march.
After the purchase, the project management, registration, and commercialization are many hardships
.
Generic drug research and development and innovative drug research and development are often two different research and development thinking, and often require two different teams to operate
.
Normally, pharmaceutical companies should accumulate generic drugs first, and then move towards improved drugs and innovative drugs
.
However, domestic generic drug companies often hope to overtake in corners and directly transform generic drugs into innovative drug companies
.
The successful research and development of innovative drugs often occurs in teams of scientists who have accumulated experience in the research and development of innovative drugs in the past
.
Generic drug companies want to transform innovative drugs to success.
After preparing the money and time, they should start by learning to work with these successful teams of scientists
.
There are rumors in the market that individual 18A companies listed in HK are facing financing difficulties.
Some industry insiders suggest that perhaps the fastest way for generic drug companies to transform into innovative drug companies is to buy an 18A company
.