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The domestic generic drug approval transfer market can be divided into two distinct stages
since the implementation of the MAH pilot law in 2016.
Before 2016, strictly speaking, there was no market for the transfer of drug production approvals in China, and at that time, domestic project transactions and cooperation were divided into several types: mergers and acquisitions, clinical approval transactions and approval agency holdings
.
M&A
.
Since the production approval cannot be transferred, then if the approval holding enterprise is acquired as a whole, won't the approval be taken? Indeed, this is the most efficient way
to buy a piece of work.
However, receiving an enterprise inevitably also needs to accept its production site and personnel, which is much more complicated than buying an approval document, especially when it comes to the acquisition of some old state-owned enterprises, personnel placement is a problem
that cannot be ignored.
Clinical approval transactions
.
Before the MAH system, transactions could only go to the clinical approval step
.
Clinical approvals can be applied for by any enterprise, but the declaration of production approvals must be bound to the manufacturing enterprise
.
Therefore, for R&D companies for the purpose of rapid cash out of R&D, it is a very reasonable business way
to declare and obtain clinical approval and then transfer.
However, due to the serious backlog of evaluation, the bad impact is to do-like research to report to the queue first, and the data will be slowly replenished
later.
It doesn't matter if you do well or not, it's most important
to line up first.
At that time, the registration fee was only 1500 yuan a piece, and it was not white
.
Early domestic innovative drugs are more interesting, clinical approvals can be divided into two and sold to two production enterprises to take two production approvals
.
In the past two years, I encountered an interesting example, the early clinical approval documents developed by a state-owned research institute C were sold to two enterprises A and B in the province, and after listing, enterprise A sold better, and enterprise B could not do each other's
sales.
So Company B simply bought Research Institute C, and then announced that I was the orthodox of this drug, but it didn't work, and I still couldn't sell it
.
However, because it is a domestic innovative drug, it is monopolized by two enterprises in China and others cannot enter, and the small life is still very comfortable
.
Approval is held
on behalf of the document.
Although the state did not allow the holding of approved pieces for commissioned production at that time, the wisdom of the masses was infinite
.
Since entrustment is not allowed, then I will negotiate with a production-oriented enterprise, I will pay, and they will declare the project, but the approved project belongs to the production enterprise in terms of regulations, but in essence belongs to me (it can be any type of enterprise), and the two parties agree
in the form of an internal agreement.
In the early days, there was no regulatory guarantee for commissioned production, and many of the dense generic drug production approvals held by many domestic production enterprises did not belong to them
.
After the introduction of the MAH pilot law in 2016, the above cooperation methods have become history
, except for corporate mergers and acquisitions.
The biggest feature of the MAH regulation is that a complete production approval holder (must be a production enterprise) is split into a holder (MA
holder) + Entrusted Producer (CMO) are two relatively independent entities, and the holder can trade and transfer at will (20 working days to complete).
The explanation of the national office is very clear, the focus of drug production quality management is on the production end, so if the production site is changed, a series of complex procedures
such as verification and declaration are required.
However, if the project owner changes many times, as long as the production site does not change, it does not really matter
.
Of course, the holder, as the ultimate responsible party for product quality, also needs to take corresponding responsibilities.
The implementation of MAH regulations has created conditions and space for the transfer of drug approvals, and the national centralized procurement opened in December 2018 directly affects the value anchoring of drug approvals, after all, the value of products needs to follow the market, and the impact of national centralized procurement on the generic drug market is huge
.
I divide the wave valley replacement of approval consideration into two phases
.
Phase I: 2018-2019
Phase I: 2018-20192018 and 2019 are the highlight periods
for the transfer of generic drug approvals.
The 4+7 expansion in 2018 and the 4+7 expansion in 2019 have one common feature: a single winning bid system
.
The single winning enterprise, under the seemingly huge price reduction, is actually not lacking in profits
.
Before the third centralized procurement in 2020, it was rumored that there would be no exclusive bid in the future, and more enterprises would have the opportunity
to enter the centralized procurement.
Therefore, in the approval trading market, the first imitation and the first three imitation products attract great attention
.
The cooperation price of a first imitation product starts at 100 million, and if it is a heavy indication product, the first three imitations may also exceed 100 million
.
The lower the listing ranking, the approval consideration will fall sharply, but projects above 30 million are still everywhere
.
To give a few examples, in September 2019, CSPC Pharmaceutical Group acquired the first generic drug of Shanghai Chuangnuo, erlotinib hydrochloride tablets, for a consideration of 120 million yuan
.
In December of the same year, Shenzhen Salubris transferred erlotinib hydrochloride tablets to Qingdao Blue Valley that are expected to be listed in the fifth place, and the consideration also reached 30 million
.
Another more exaggerated product is rivaroxaban tablets, as the star variety of anticoagulant drugs that year, with sales of 5 billion US dollars in the international market, the declaration of rivaroxaban has attracted the pursuit of many domestic companies
.
In 2018, a top five imitation of rivaroxaban tablets (actually listed in 2020) was valued at more than 100 million, while in 2019, the transaction price of a top ten ranked rivaroxaban tablets (actually the market date is 2021) also reached 54 million yuan
.
In addition, in 2019, Suzhou Erye introduced Hainan Shuangcheng's bivalirudin for injection, and the consideration was as high as 50 million yuan
.
Compared with the crazy price of generic drug approvals, the technology transfer of ANDA approved products, which was once lively after the MAH system, is far
from it.
In 2019, Haisco received Aprepitant capsules from GlenMark in India for a consideration of only $400,000
.
At that time, the intended technology transfer of some generic drug companies in Europe generally cost about 2-3 million yuan
.
Phase 2: 2020-present
Phase 2: 2020-presentSince 2020, the situation has changed dramatically, and generic drug approvals are becoming less and less valuable
.
There may be many reasons, but I think the more important point is that the third national centralized procurement price in 2020 is too hurtful, the market scale has shrunk seriously, and only a few hundred million of billions of varieties have been left after entering the centralized procurement, which seems to be quite profitable varieties, and the profits have fallen sharply after entering the centralized procurement, making everyone doubt
the market size and prospects of generic drugs.
In today's generic drug approval trading market, it is impossible to have hundreds of millions of projects, and the first imitation is not possible
.
If the transaction consideration of a product can be 50 million yuan, it is already an excellent variety
.
For most chemical projects, the price given by the market fluctuates
around 10 million.
The quotation is based on the approximate total R&D investment
.
At this time
, the first three generic varieties have faded.
In 2021, Salubris third generic variety imatinib tablets were transferred to Sinopharm Yixin for 27 million, and in the same year, Chifeng Yuansheng's second generic variety Alanyl Glutamine Injection was transferred to Hainan Lingkang
for 20 million yuan.
These two are the most popular projects in China, and now 30 million yuan has become the ceiling
.
There is also a project that is somewhat representative
.
In 2020, Hangzhou Minsheng Pharmaceutical's Class 3 drug ibuprofen injection was the third in the country to pass the evaluation, and then transferred to Shaanxi Licai Pharmaceutical for a transaction consideration of 40 million yuan
.
Surprisingly, both companies said they suffered losses
.
Hangzhou Minsheng Pharmaceutical said that ibuprofen, which covers various dosage forms in China, is a large variety of more than three billion, and the injection project is declared by category 3, and we have spent money to do large clinics
.
40 million yuan will also recover the investment in research and development, this price is sold low, which is a pity
.
Shaanxi Licai Pharmaceutical said that it spent 40 million yuan to buy ibuprofen injection approval parts, and it has not been sold on the market for a few days, and the good days have not yet been enjoyed into centralized procurement, and then faced a sharp price reduction, the profit decline is serious, and I feel that this transaction is a bit of a loss
.
Including the popular product rivaroxaban tablets mentioned above, in 2021, a pharmaceutical company in the south also bought a top ten approval documents (just on the market, and the first five marketing approvals mentioned above were approved only a few months), and the price has dropped to 16 million yuan
.
Generally, such as US Binding Tablets, Amlodipine Tablets, etc.
, the value of more than a dozen domestic approved projects has fallen to 6-7 million yuan
.
The highlight of generic drug approvals is behind and won't be coming back
.
Now perhaps only the internal transactions of affiliated enterprises can see exciting prices, such as in 2020, Huadong Pharmaceutical's self-affiliated enterprise Penglai Nokang purchased the approval of adenosine injection, and the transaction consideration was 50 million yuan
.
However, the decline in the price of chemical drug approvals does not affect the domestic drug approval trading market is still lively, in today's trading market, the mainstream trading varieties are traditional Chinese medicine rather than chemical drug approvals, traditional Chinese medicine is characterized by cheap prices, 50-2 million a project, can not buy much to be deceived
.
