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China's biomedical industry is developing rapidly, and in recent years, many enterprises have increased their efforts to build their own factories and expand production capacity
China's biomedical industry is developing rapidly, and in recent years, many enterprises have increased their efforts to build their own factories and expand production capacity
For now, "five years" may not be needed
The market winter has made it necessary for companies to choose
On September 19, WuXi Biologics announced that it has reached a number of strategic cooperation
In the brief information, WuXi Biotech and Kewang Pharma were unable to disclose more information
In the brief information, WuXi Biotech and Kewang Pharma were unable to disclose more information
However, superimposed on the depressed market situation and huge R & D investment, the era of overcapacity seems to have quietly arrived, and some enterprises that still have commercial market demand and production capacity have begun to explore part-time CDMO business
On the other hand, such as Kewang Pharmaceutical, this time chose to "entrust" production facilities to WuXi Biologics, and some enterprises have begun to put production capacity on the "shelf":
In March 2021, WuXi Biologics announced the acquisition of Pfizer China's advanced biologics production base in Hangzhou, and related employees will also be taken over
Industry view is that whether it is CDMO enterprises, BigPharma, or Biotech enterprises, self-built plants, independent production capacity of high input and long-term characteristics, as well as in order to achieve sustained and stable production needs to continue to run-in, debugging and optimization, these have brought great tests to the daily management and operation of enterprises, in the face of the cold winter of the capital market, I believe that more and more Biotech companies will more and more prudently consider the production capacity layout and "flexible configuration"
Industry view is that whether it is CDMO enterprises, BigPharma, or Biotech enterprises, self-built plants, independent production capacity of high input and long-term characteristics, as well as in order to achieve sustained and stable production needs to continue to run-in, debugging and optimization, these have brought great tests to the daily management and operation of enterprises, in the face of the cold winter of the capital market, I believe that more and more Biotech companies will more and more prudently consider the production capacity layout and "flexible configuration"
In the past, promoting clinical progress, increasing R&D investment, and expanding capacity construction were all important embodiments and choices of enterprise strength and capital financing; Nowadays, the tide has faded, and self-built factories and independent production capacity have become "not fragrant"? 011 R & D investment pressure R & D investment pressure to revitalize assets is a helpless choice? Is it a last resort to revitalize assets?
According to the agreement reached between WuXi Biologics and Kowang Pharma, WuXi Biologics will absorb the process development and pilot production facilities of Kovision Pharmaceutical Suzhou, and at the same time, the two parties will sign a strategic partnership service agreement, and WuXi Biologics will provide integrated R&D and production services as the exclusive CDMO partner to ensure the development and production needs
According to the agreement reached between WuXi Biologics and Kowang Pharma, WuXi Biologics will absorb the process development and pilot production facilities of Kovision Pharmaceutical Suzhou, and at the same time, the two parties will sign a strategic partnership service agreement, and WuXi Biologics will provide integrated R&D and production services as the exclusive CDMO partner to ensure the development and production needs
Regardless of whether this cooperation involves capital investment, Kewang Pharmaceutical's revitalization of fixed assets and strives to achieve the goal of global product research and development through higher efficiency seems to have the meaning
Founded in Suzhou Industrial Park in March 2018, Kewang (Suzhou) Biomedical Technology Co.
, Ltd.
is a biomedical innovation enterprise in the clinical stage, focusing on tumor immunotherapy and committed to leading the research and development
of a new generation of tumor immunological innovative drugs.
In fact, Suzhou process development and pilot production base was officially completed a year and a half ago, with a facility area of 5,500 square meters, with a 1,000-liter scale of cGMP production capacity, which can supply drugs for 20 batches of clinical phase 1 and phase 2 monoand double antibody drug trials every year
.
According to previous media reports, CobVienne Pharmaceutical has high hopes
for the base.
.
According to previous media reports, CobVienne Pharmaceutical has high hopes
for the base.
On March 18, 2021, at the inauguration ceremony, Ji Xiaohui, founder and CEO of Kewang Pharmaceutical, mentioned that Suzhou process development and pilot production base were completed The first step towards industrialization, and in 2025, Kewang is expected to usher in the first product, and the best way to foresee the future is to create it
.
.
As a biomedical innovation enterprise, Kewang Pharmaceutical's product pipeline covers a wide range, and there are innovative products for various targets under research, ES101, ES102, ES104 have been in the clinical trial stage, and 3 independently developed global innovative products are also about to be declared clinical
.
.
The research and development cycle of innovative drugs is long, the cost is high, there are many pipelines under research of Kewang Medicine, and no products have been listed, in such a case, the funds of Kewang Pharmaceutical are undoubtedly a big test
.
.
Since 2017, Kewang Pharmaceutical has carried out 4 rounds of financing:
On August 30, 2017, Kewang Pharmaceutical announced the completion of a $20 million Series A financing
.
On December 3, 2018, Kewang Pharma announced the completion of a $35 million Series A+ financing
.
On December 28, 2019, Kewang Pharmaceutical announced the completion of a US$100 million Series B financing
.
On May 13, 2021, Kewang Pharmaceutical announced the completion of a US$105 million Series C financing
.
Burning money while financing is not a long-term solution
after all.
In this context, third-party outsourcing is undoubtedly a strategic choice
to reduce costs and increase efficiency.
after all.
In this context, third-party outsourcing is undoubtedly a strategic choice
to reduce costs and increase efficiency.
Industry insiders pointed out that through the professional division of labor system, not only can reduce the labor pressure of pharmaceutical companies, but also shorten the research and development cycle of innovative drugs and improve production efficiency
.
In the face of the capital winter, Kewang Pharmaceutical is not only more "asset-light" after the outsourcing of related production facilities, but also can focus more on research and development innovation
.
"'Small and Beautiful' may be the preferred strategy
for Biotech companies today rather than 'big and complete.
'"
.
In the face of the capital winter, Kewang Pharmaceutical is not only more "asset-light" after the outsourcing of related production facilities, but also can focus more on research and development innovation
.
"'Small and Beautiful' may be the preferred strategy
for Biotech companies today rather than 'big and complete.
'" 02 "self-built plant" risk test "self-built plant" risk test "self-built plant" risk test asset optimization quietly accelerated? Asset optimization quietly accelerating? Asset optimization quietly accelerating?
At present, most of the domestic Biotech has not been successfully listed or only one or two commercial products
have been approved for listing.
In order to accelerate the research and development process, or expand the product indications, the research and development cost is also increasing
year by year.
Nuo Cheng Jianhua's R&D cost in the first half of 2022 was 273 million yuan, compared with 185 million yuan in the same period of 2021, an increase of about 47.
96% year-on-year; BeiGene's R&D expenditure in the first half of 222 was approximately RMB5,387 million, an increase of 13.
49%
year-on-year.
have been approved for listing.
In order to accelerate the research and development process, or expand the product indications, the research and development cost is also increasing
year by year.
Nuo Cheng Jianhua's R&D cost in the first half of 2022 was 273 million yuan, compared with 185 million yuan in the same period of 2021, an increase of about 47.
96% year-on-year; BeiGene's R&D expenditure in the first half of 222 was approximately RMB5,387 million, an increase of 13.
49%
year-on-year.
In the face of capital winter, huge long-term research and development expenses, superimposed on the high investment of self-built production capacity, which is undoubtedly "worse"
for some Biotech companies.
Taking Maibo Pharmaceutical as an example, since 2021, the company has invested about 490 million yuan to expand the production capacity of production facilities; on the other side of the coin, this move has also pushed itself to the "life and death" edge of the capital chain, with only about
80 million yuan of book funds left.
for some Biotech companies.
Taking Maibo Pharmaceutical as an example, since 2021, the company has invested about 490 million yuan to expand the production capacity of production facilities; on the other side of the coin, this move has also pushed itself to the "life and death" edge of the capital chain, with only about
80 million yuan of book funds left.
In fact, since the drug marketing authorization holder system (MAH) allows the separation of drug marketing authorization and production license, more and more pharmaceutical companies have gradually concentrated their resources on the development of their own core research and development business, focusing on disease mechanism research and the discovery and research of new drug targets and the early stage of research, and entrusting the pharmaceutical compound screening and research and development, data collection and analysis, clinical and other production chain links involved in the late and development stages of follow-up research to third parties
.
.
Experts said that to avoid some production enterprises in order to pursue market effects, continue to expand the variety of pharmaceutical production or build new production lines, resulting in repeated construction of drug production and production equipment idle rate is too high false "prosperity", the landing of new policies will obviously help improve the problem of low allocation of
resources in the industry.
resources in the industry.
On the payment side, it is more important
to improve R&D efficiency and control production costs.
Whether it is the medical insurance negotiation of innovative drugs or the procurement of generic drugs, everything is cost-first, and capacity optimization has obviously become an important weight
for enterprises to revitalize assets and improve efficiency.
to improve R&D efficiency and control production costs.
Whether it is the medical insurance negotiation of innovative drugs or the procurement of generic drugs, everything is cost-first, and capacity optimization has obviously become an important weight
for enterprises to revitalize assets and improve efficiency.
Earlier last year, WuXi Biologics announced the acquisition of Suqiao Biologics and reached a strategic partnership
with Kangqiao Capital.
Suqiao Biologics is a contract custom R&D and manufacturing enterprise (CDMO) headquartered in Suzhou, China, providing cell line development, process development and clinical GMP production services, and WuXi Biologics has directly added biological stock line (MFG21) and liquid and lyophilized production line (DP11)
after completing the merger.
with Kangqiao Capital.
Suqiao Biologics is a contract custom R&D and manufacturing enterprise (CDMO) headquartered in Suzhou, China, providing cell line development, process development and clinical GMP production services, and WuXi Biologics has directly added biological stock line (MFG21) and liquid and lyophilized production line (DP11)
after completing the merger.
Since its establishment in 2017, with its excellent CDMO capabilities, Suqiao Bio has successfully helped multiple partners to rapidly promote the process of new drug research and development, and has also completed several batches of clinical sample production for a number of domestic biopharmaceutical head enterprises; In particular, as an important CDMO platform for Suzhou Industrial Park (BioBay), it has been supported
by local development.
by local development.
If WuXi Biologics' acquisition of Suqiao Biologics focuses more on the extension of CDMO production capacity and the improvement of project management efficiency after the integration of production capacity; Then, Pfizer's choice to "optimize" the Hangzhou production base will undoubtedly make the industry sigh, and also make the "universe big pharmaceutical company" shout out the "help achieve the goal of Made in China 2025" shouted by the self-built production base of "Cosmic Big Pharmaceutical Company" has become a slogan
.
.
It is reported that Pfizer China Biopharmaceutical Production Base, which was acquired by WuXi Biologics in March last year, is located in Hangzhou, which was officially completed and used in 2018, with two 2,000-liter production lines and an investment of $350 million
.
.
In fact, the construction plan of Hangzhou Biomedical Base was launched in 2015
.
On September 11, 2015, Pfizer signed a contract with Hangzhou Economic and Technological Development Zone and soon started construction of the factory
.
.
On September 11, 2015, Pfizer signed a contract with Hangzhou Economic and Technological Development Zone and soon started construction of the factory
.
At that time, the domestic biomedical industry was in the ascendant, most of the macromolecular innovative drug products under research and development of many domestic Biotech companies were still in the research and development stage, and the macromolecular biological drugs listed overseas were almost monopolized, and the market prospects were "gratifying"
.
.
However, with the continuous acceleration of the approval process of the listing of macromolecule drugs by domestic pharmaceutical companies, the competition in the macromolecular drug market has rapidly entered a period of "involution"; The policy of "three medical linkages" has deepened, and the high prices of biosimilar drugs and bioinnovative drugs in the market payment environment have begun to encounter a "ceiling", which has intensified the production capacity and cost test
of the macromolecular drug market.
of the macromolecular drug market.
In June 2016, Pfizer Hangzhou site officially started
.
"Pfizer's largest overseas investment project since 2008", "Pfizer's third biotechnology center in the world and the first in Asia", "The first monoclonal antibody research and development and production base established by Fortune 500 companies in China".
.
.
One "halo" after another, but after just a few years, it has become a "label"
on the shelf goods.
.
"Pfizer's largest overseas investment project since 2008", "Pfizer's third biotechnology center in the world and the first in Asia", "The first monoclonal antibody research and development and production base established by Fortune 500 companies in China".
.
.
One "halo" after another, but after just a few years, it has become a "label"
on the shelf goods.
Founder Securities pointed out in the research report that the scale of the global biopharmaceutical market, the number of products under research continue to increase, and the investment in research and development and production continues to grow; Due to the increase in the proportion of R&D investment and pipelines in small innovative pharmaceutical companies, as well as the need for pharmaceutical companies to improve R&D returns, the outsourcing rate is also rising
.
.
The market view is that self-built factories and independent production capacity are of course the embodiment of enterprise strength, and how to balance costs and risks in the choice of outsourcing and self-construction, and then seize the opportunity in research and development and market competition is the "winning and losing hand"; Factors such as low plant utilization, slow progress in research and development, and lack of liquidity seem to make it difficult for self-built plants to become the "standard"
of all pharmaceutical companies.
of all pharmaceutical companies.