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Standing at the New Year's Eve node, it's time
to say goodbye to the past.
Pharmaceutical Slow Bull Starts Early (November 24 "Next Year's Pharmaceutical Bull Market? "), Class B tube means the end of the crowding of the payment side by epidemic prevention, and the hegemony of the news side exits, leaving only the last suspense of domestic 3CL new crown special drugs and domestic mRNA
vaccines.
Social values return to the theme of economic growth, the market returns to the main line of endogenous growth, and recognizable head companies will become the protagonists
.
In the past, the scene of dodging and looking for policy safe havens, scraps and third- and fourth-tier pharmaceutical companies flying against the wind is no longer the mainstream
.
The head company has high certainty, high growth, and a solid position in the industry, and there is no reason to lower its voice
when the valuation is large and reasonable.
We have seen that InnoCare ("Undervalued InnoCare", which was wrongly killed because of an ordinary incident, has quickly recovered, and the market has really turned the page, paying more attention to fundamentals and long-term innovation capabilities
.
As of Q3 2022, among all public funds, the holding ratio of pharmaceutical stocks was 8.
96% (-0.
59pp compared with Q2), which was the lowest allocation in history
.
Among them, CXO was the hardest hit area by the sell-off, with WuXi AppTec 31.
2 billion (down 24.
2 billion from Q2), Kanglong Chemical 7.
6 billion (down 8.
6 billion from Q2), and Tigermed 13.
7 billion (down 1 billion from Q2).
As of December 22, 2022, the PE-TTM of the pharmaceutical biology (Shenwan) index was only 23.
12 times, which was at the bottom
of dynamic PE history.
The pharmaceutical sector has a money-making effect, which will form a positive feedback, standing on the depression of history, the fund will give priority to the top companies
with high recognition when it increases its pharmaceutical position.
CXO, as the aggregator of the innovative pharmaceutical and device industry chain, transmits the temperature of the whole industry, and from this window, we can see the positive changes
in the pharmaceutical industry after its rebirth.
Major Biotechs established since 2020, financing in the second half of this year
Major Biotechs established since 2020, financing in the second half of this year01 Metamorphosis of small molecule CDMO
01 Metamorphosis of small molecule CDMOInvestment and financing data is a stone
to suppress biomedicine.
According to Arterial Network, in November 2022, a total of 28 financing events occurred in the domestic biomedical field, with a total financing of US$587 million, an increase of about 232%
from the previous month.
According to CaiLian Venture Capital Connect, in November 2022, a total of 140 private equity investment and financing events occurred in the statistics of the domestic medical and health field, an increase of 119% month-on-month, and the total disclosed financing was about 5.
199 billion yuan, an increase of 12% month-on-month.
The recovery of investment and financing in a single month may not yet have directional significance, but splitting specific cases will find that the quality of investment and financing is more important
than quantity.
We have an in-depth analysis of the 31 representative next-generation biotechs that will raise new funding rounds in the second half of 2022 (November 21, "Will the Next Generation of Innovative Pharmaceutical Companies Let Us Down?").
), to verify the great role of market regulation, innovative pharmaceutical companies established since 2020, pipelines and technical directions to avoid homogenization with predecessors as much as possible, have been to the greatest extent to the forefront and differentiation, involving synthetic lethality, CAR-NK and
TCR-T cell therapy, gene therapy, new generation of monoclonal and bispecific antibodies, next-generation protein-degrading drugs, new conjugate drugs
.
Next-generation Biotech, which was newly financed in December, continues to explore
new molecular species.
Westin Biologics, established in 2021, raised 150 million yuan in Series A financing, and 4 drug candidates entered the clinical trial stage, including mRNA vaccines with new coronavirus variants, mRNA drugs for the treatment of EBV-related tumors, mRNA drugs for the treatment of liver cancer, and WGa01
, a new adjuvant.
Sprout Gene, established in 2020, raised tens of millions of dollars in Series A financing to use base editing technology for gene therapy drug research and development
.
Founded in June 2022, Contingent Biologics raised US$15 million in seed rounds and has established a unique drug discovery platform
for targets related to protein translation regulation.
In response to new changes in the biotechnology industry, WuXi is prospectively executing its "follow and win the molecule" strategy
.
You should never doubt the determination of Chinese-American Li Ge to reduce his holdings and leave, or WuXi's ability to see into the future, the two can be completely separated, and the founder's behavior no longer affects the company's operations
.
In the first three quarters of this year, WuXi AppTec's capacity building for new molecular classes ran through all business segments
.
In the chemical business, revenue from the new molecule related business increased year-over-year
192.
5%, the number of D&M service customers for oligonucleotide and peptide drugs reached 97, a year-on-year increase of 98%, the number of molecules served reached 155, a year-on-year increase of 101%, and service revenue reached 1.
1 billion yuan, a year-on-year increase of 406%.
July 2022
In January, another new oligonucleotide and peptide production building at the Changzhou base was officially put into operation, further enhancing large-scale production capacity, and the aseptic lipid nanoparticle preparation platform in the Wuxi base was put into operation
.
In the biology business, involving targeted protein degradation, new nucleic acid molecules, conjugated new molecules, oncolytic viruses, vector platforms, and innovative drug delivery systems, the revenue related to new molecular types and biological drugs increased by 76% year-on-year, and the proportion of revenue in the biology business increased to 20.
5%.
CGT business, providing development and manufacturing services for 67 cell and gene therapy programs, including 8 III
Phase clinical trial projects (4 projects in the preparation stage of marketing application).
AAV produced by TESSA™ technology released this year
More than 10x based on plasmid methods are produced, and 38 related projects are currently being evaluated by customers
.
WuXi AppTec's DDSU (Domestic New Drug R&D) business is an important window to observe the trend of domestic innovative drugs, and revenue in the first three quarters of this year fell by 27.
9% year-on-year, reflecting the pain
of homogenization capacity clearance.
Positive change is what the company is carrying out for its customers
15 new molecule classes preclinical programs, including peptides/peptide drug conjugates (PDCs),
Protein degraders and oligonucleotides, several of which will submit IND applications
in late 2022 or early 2023.
Small molecule CDMOs are evolving, no longer static concepts
as you understand them.
Kailaiying and Porton are also expanding new molecular types of business and looking for new impetus in incremental space, which can also be regarded as an effort
by CDMO to avoid overcapacity.
In the first three quarters of this year, the revenue of emerging business was 671 million yuan, a year-on-year increase of 154%, and the orders in hand were about
1.
5 billion yuan.
At the end of this year, a 12,000-square-meter R&D center exclusive to chemical macromolecules was built
9500 square meters GMP workshop
.
The synthetic biotechnology R&D center and production workshop will also be completed by the end of this year
Enabled
.
The production capacity of biological macromolecules is about to enter the release period, and 2022H1 has completed the construction of 2x2000L disposable bioreactor antibody stock solution production capacity; 100L ADC
The coupling stock pilot plant has been put into use, and the 2x500L ADC commercial coupling stock production capacity was put into use at the end of September; Suzhou plasmid, mRNA business pilot capacity
It has been put into production and has the service capabilities
of IND and clinical sample preparation.
On December 21, the CDMO industrialization base of Boton Biotech was officially launched, with a total area of more than 20,000 square meters of gene and cell therapy process development and production workshops, 10 GMP virus vector production lines, 12 GMP cell therapy production lines (including 2 positive production workshops) and hundreds of clean workshops, CGT therapy will gradually achieve large-scale commercial production
.
02 The pace of the head company
02 The pace of the head companyInvestment and financing, overcapacity, and geopolitical risks are the three dark clouds
that suppress CXO.
The inflection point of investment and financing volume has yet to be confirmed, but the qualitative inflection point has already occurred, and CXOs actively adapt to the trend of biotechnology primitiveness and differentiated innovation, which will also delay the arrival of their own overcapacity
.
Striving for a more accommodative environment for internal economic recovery, although geopolitical risks cannot be completely eliminated, will show a trend of easing, and the suppression of CXOs will be reduced
.
Previous industry experience shows that when there is a trend of overcapacity in any industry, the development direction is not a hundred flowers, but the share is concentrated in the head company, showing a structural growth
.
Coupled with the latest IPO of Hongbo Pharmaceutical, there are about 40 companies involved in CXO business in A-shares and Hong Kong stocks, and there is a crowded state, since the industry has entered the stage of survival of the fittest, the uncertainty of small companies has become greater, while the performance stability of the head companies is better, the layout of frontier fields is earlier, and the impact of overcapacity is less
.
Like WuXi Biologics, Zhaoyan New Drug actually belongs to the biologic camp
of CXO.
According to Frost & Sullivan, the scale of China's biopharmaceutical market will reach US$125.
2 billion in 2026, continuing to be in a high prosperity, and the corresponding safety assessment business orders will grow
rapidly.
The targets targeted by macromolecular biologics and vaccines are relatively conservative between species, rodent test results are poorly matched with humans, and non-human primates with the highest degree of homology with human genes have become the first choice
for preclinical trials.
More than 70-80% of new drugs in biologic drugs need to be used in monkeys for preclinical trials, and 20-30% of small molecule chemicals will use experimental monkeys
in preclinical studies.
Zhaoyan New Drug holds the most powerful experimental monkey resources in China, accounting for about 70% of biological macromolecule orders, and establishes the ability
to evaluate new molecular species (CGT, nucleic acid drugs, cellular exosomes, and innovative delivery system drugs).
Another incremental space comes from overseas
.
Unlike CDMO, the security assessment business is still mainly based on onshore outsourcing, with revenue mainly coming from domestic customers, and the international business is still in the early stage
of development.
In 2019, Zhaoyan New Drug acquired the United States
Biomere Inc.
, which conducts preclinical trials in primates
CRO
。 In the first half of this year, Biomere signed nearly 200 million yuan in new orders, a year-on-year increase of nearly 30%, and Zhaoyan domestic companies' new overseas orders increased by more than 100% year-on-year, a record high
.
In the case of WuXi division in two, Kanglong Chemical is the only CXO industry chain integration platform, although the clinical business, cell and gene therapy services are not profitable, and the macromolecule business progress is slow, but it is the favorite of the institution, enjoying the top valuation
of CXO.
It is relatively restrained in financing and expansion, and has a good reputation
like Kailaiying.
Tigermed was the least affected by overcapacity and decoupling, with non-net profit of 421 million yuan in Q3, a year-on-year increase of 29% and a month-on-month increase of 7.
1%, and its main business achieved sequential growth
for 10 consecutive quarters.
WuXi AppTec's clinical CRO and SMO revenue in the first three quarters was 1.
135 billion yuan, a year-on-year increase of 4.
6%, and the growth rate slowed
down significantly.
The gross profit margin of Kanglong Chemical's clinical research services is only 10.
2%, which is flat or slightly loss, and it will be profitable
next year.
Shenwan Hongyuan expects Tigermed to have more than 10 billion
yuan of orders on hand.
From January to October 2022, CDE accepted a total of 1,187 domestic new drug INDs, a year-on-year increase of 3.
31%, and the popularity of new drug research and development remained unabated
.
CXO is the thermometer of the pharmaceutical industry, and despite valuation setbacks, the pace of growth has never slowed
.
Looking forward to 2023, there are more positive factors, and the recovery of biotechnology should be more optimistic
.