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Approval deals behind pharmaceutical companies and mergers and acquisitions are "flowing"
Approval deals behind pharmaceutical companies and mergers and acquisitions are "flowing" Behind the capital flow-led pharmaceutical companies and mergers and acquisitions, approval transactions are flowing "privately", and some pharmaceutical companies have begun to "bet" on Chinese medicine approvals
.
A few days ago, TusPharma acquired 100% of the shares of Guangdong Xiantong Pharmaceutical for a consideration of 220 million yuan, and according to the announcement, Guangdong Xiantong holds 16 Chinese medicine approvals
.
Some experts told Cyberblue, "The acquisition of enterprises may be mainly for approval, or it may be intended for the production plant and local market
of the acquired enterprise.
" As for why you chose a 100% acquisition in the end, it may be a package acquisition, or it may be a value combination
.
”
of the acquired company.
Logging on to a number of pharmaceutical property rights change trading platforms, Cyberblue observed that the most inquired about are exclusive Chinese medicine products, followed by chemical drugs that have passed the consistency evaluation, and less
biological drug transactions.
"Enterprises need to transform, replace approvals, transfer mostly approvals that have not been produced for a long time, and approvals with small profits," a staff member of a pharmaceutical M&A platform told Cyberblue
.
"Many pharmaceutical companies feel that it is more shameful to sell document numbers, does it mean that the business is not good? In fact, they are all selling in private," a pharmaceutical company person who is preparing to approve the sale told Cyberblue
.
Since last year, the consistency evaluation approval of chemical drugs has begun to be cleaned; In the future, more than 60,000 proprietary Chinese medicine approvals will also face a major reshuffle
.
According to the Annual Report on Drug Supervision and Administration Statistics (2020) released by the State Medical Products Administration, by the end of 2020, there were 156355 domestic drug approval numbers and 4,269 imported drug registration certificates nationwide, while as of April 2022, there were 151704 domestic drug approval numbers nationwide, a decrease of about 5,000 from the end of 2020
.
Guided by clinical value, chemical drug products that have not passed the consistency evaluation will not be re-registered; Although there is no consistency evaluation of proprietary Chinese medicines, "some varieties of approvals are not sold and it is also troublesome, a variety needs more than 18,000 funds to register in 5 years, and some provinces, there are approvals but no production address, factory, the next step may not be re-registered, the future may clean up a large number of 'zombie' approvals," the above pharmaceutical company said
.
In the first half of 2022, a pharmaceutical asset change trading platform published a number of proprietary Chinese medicine approval transfer information
.
Behind the continuous cleaning of approvals with no clinical value and "zombie" approvals, big pharmaceutical companies have also begun to fall into anxiety, can small pharmaceutical companies overtake in a bend under the encouragement of policies and the continuous optimization of Chinese medicine review and approval standards?
Source: Screenshot of a health industry investment and financing platform
Big Pharma's anxiety
Big Pharma's anxiety The phenomenon of exceptionally active transfer of individual approvals mainly occurred after the
official implementation of the drug marketing authorization holder (hereinafter referred to as "MAH") system.
According to the latest version of the "Drug Administration Law of the People's Republic of China", "the state implements the drug marketing authorization holder system for drug management", in 2019, the MAH system was officially implemented, compared with the previous "bundling" of drug marketing authorization and production license, after the implementation of the MAH system, the approval holder can entrust production, and small pharmaceutical companies do not have to worry about getting the approval, but there are problems of
dilapidated factory equipment and insufficient preparation.
Therefore, a large number of approval "trading" have been bred, and "after the MAH system came out, everyone felt that this was a business opportunity, and wholesale and sales companies also participated in it," a pharmaceutical company source told
Cyberblue.
Affected by the "no restricted area for collective procurement", the era of profiteering of generic drugs has ended, and the profits of collective procurement drugs have been continuously diluted, looking for "new generic drugs" and buying a part of the approval of traditional Chinese medicine, which has become the choice of
many enterprises.
However, it is also the implementation of the MAH system that "pulls" the anxiety
of big pharma.
"If it weren't for the MAH system, many of the approvals we don't want to reproduce ourselves would not be freely transferable
.
" The above-mentioned pharmaceutical company sources said
.
Panasonic Pharmaceutical made two acquisitions in 2013 and 2015, acquiring the pill workshop and 39 drug production approval numbers of Guangdong Baike Pharmaceutical Co.
, Ltd.
Guangzhou Dongkang Pharmaceutical Co.
, Ltd.
has 81 drug production approval numbers, including eye drops, tablets and other dosage forms
.
Interestingly, after three or four years, companies start to change hands on approvals
.
The company person told Cyberblue that the reason why a large number of approvals were bought at that time and now they want to be sold is because "at that time, the document number could not be directly bought and sold, unless you were a new drug, which could be carried out in accordance with the requirements of technology transfer, but according to technology transfer, the required workload was very large
.
" At that time, we bought the document number, that is, the merger of the whole factory, or the entire workshop, so we bought all the approvals of the pill workshop of Baike Pharmaceutical at that time
.
”
"In fact, we mainly engage in Chinese medicine and eye drops, so we only built an eye drop workshop and a Chinese medicine workshop, and bought so many just to buy those varieties
.
" ”
At that time, pharmaceutical companies through equity transfer, approval circulation is not few, and at that time regulations allowed the transfer of dosage forms, there was a more interesting phenomenon, a manufacturer of different dosage forms fell in different manufacturers, for example, at that time Guangdong Luo Custom Pharmaceutical Co.
, Ltd.
, pills and decoctions transferred to Guangdong Fengchun Pharmaceutical Co.
, Ltd.
, other dosage forms belong to Guangdong Yililuo Custom Pharmaceutical Co.
, Ltd.
According to Xianda Data V3.
1, from 2002 to 2015, the frequency of factory name changes of drug approval numbers due to technology transfer is expected to exceed 50,000.
"At that time, some pharmaceutical companies acquired a lot, and after the policy came out, many Chinese medicine research and development slowed down, mainly because everyone felt that the speed of buying document numbers was relatively fast
.
The approval of the new document number takes three or four years, and after a few years, the environment may change, and the acquisition of the document number is the most practical, buy it immediately, and it can be put on the market immediately, and it will take half a year at most
.
As a result, many companies choose to buy document numbers, the company person added
.
Big Pharma has a lot of approvals in hand, "everyone is trading privately, and some are still buying while selling"
.
"Some varieties of approvals are not sold and it is also troublesome, a variety needs more than 18,000 to register in 5 years, and some provinces, there are approvals but no production address, factory, the next step may not be re-registered, the future may clean up a large number of 'zombie' approvals," the above-mentioned pharmaceutical company said
.
It is imperative to clean the "zombie" approval, maintenance also requires costs, and big pharma is actually anxious
.
Can small pharmaceutical companies overtake in curves?
Can small pharmaceutical companies overtake in curves? Whether it is chemical drugs or proprietary Chinese medicines, they need to be guided by clinical value, and the relevant documents also clearly "increase the re-evaluation of proprietary Chinese medicines after marketing"
.
.
The "Opinions of the Central Committee of the Communist Party of China and the State Council on Promoting the Innovation and Development of Traditional Chinese Medicine" issued in October 2019 clearly promotes the quality of
Chinese medicine pieces and proprietary Chinese medicines.
"Explore the establishment of a clinical value-oriented evaluation path, comprehensively use evidence-based medicine and other methods, increase the intensity of post-market evaluation of proprietary Chinese medicines, and establish linkage mechanisms with public hospitals such as drug procurement, essential drug selection, and medical insurance catalogue adjustment, so as to promote industrial upgrading and structural adjustment
.
"
In the examination and approval of the registration of traditional Chinese medicines, it is also proposed to "accelerate the construction of an evidence system for the registration and review of traditional Chinese medicines that combines the theory, human experience and clinical trials of traditional Chinese medicine (hereinafter referred to as "three combinations"
).
It is worth noting that the research and development of "three-party" new drugs is advancing
.
In 2020, in the fight against the new crown pneumonia epidemic, the emerging drugs represented by the "three parties" of lung cleansing and detoxification soup, detoxification and detoxification formula, that is to say, in the registration and approval of traditional Chinese medicines, "three combinations" can be used to shorten phase III clinical trials
.
In addition, on July 23, 2020, the State Administration of Traditional Chinese Medicine and the State Food and Drug Administration jointly organized and held a symposium on the transformation of "tripartite" achievements, promoting full attention to the theory and human experience of traditional Chinese medicine in the review and approval of new Chinese medicines, and improving the method and path
of the transformation of "tripartite" achievements.
On September 27 of the same year, the State Food and Drug Administration issued the "Requirements for Registration Classification and Application Materials of Traditional Chinese Medicines", which clarified the "tripartite" transformation path
.
Under favorable policies, can small pharmaceutical companies overtake in a bend?
Previously, due to the inability to achieve the separation of approval and production, small pharmaceutical enterprises had insufficient plant equipment and technical process workshops, which limited their development, but now through the purchase of approvals, post-market re-evaluation, the next few years may usher in a period
of opportunity.
"Among the more than 60,000 proprietary Chinese medicine approvals, there are still many exclusive Chinese medicines, but most of the document numbers are originally upgraded to the national standard, and some proprietary Chinese medicines do not even have very strict clinical data
.
" The above-mentioned pharmaceutical company sources said
.
In the next few years, Chinese medicines will be evaluated or put on the agenda after they are marketed, and the "zombie" approval cleaning and some approval transfers will continue
.
