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For a long time, the domestic vaccine industry has been an innovation desert, and there is a big gap between it and overseas
For a long time, the domestic vaccine industry has been an innovation desert, and there is a big gap between it and overseas
However, in the past few years, due to the resonance of a series of industry catalysts such as the new crown epidemic, policies, population, cost dividends, etc.
Today, it is an indisputable fact that the domestic vaccine industry will play an increasingly important role in the global public health system
Even though the pharmaceutical sector is in the cold winter, we can still see that many outstanding companies continue to grow and accelerate their transformation
Even though the pharmaceutical sector is in the cold winter, we can still see that many outstanding companies continue to grow and accelerate their transformation
Coinciding with the disclosure of the semi-annual report, Ruike Bio, a Hong Kong stock 18A company that disclosed the "transcript" recently (August 25), provides us with an effective observation window
Coinciding with the disclosure of the semi-annual report, Ruike Bio, a Hong Kong stock 18A company that disclosed the "transcript" recently (August 25), provides us with an effective observation window
It is worth noting that, thanks to their excellent performance, the market is also regaining confidence
During the disclosure of this semi-annual report, many biotech companies have given positive feedback from the secondary market after releasing their excellent "transcripts"
Perhaps, the pharmaceutical industry has entered the "darkness before dawn"
/ 01 /
/ 01 // 01 // 01 /A number of pipelines under development have been steadily "accelerated" in the late stage,
A number of pipelines under development are "accelerated" in the late stage of clinical stability, a number of pipelines under development are "accelerated" in the late stage of clinical stability, and a number of pipelines under development are "accelerated" in the later stage of clinical stability,Value upgrade under efficient execution
Value enhancement under efficient execution Value enhancement under efficient execution Value enhancement under efficient executionFor biotech companies, different industry stages lead to different investment logics
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In the early days of the rise of the domestic biotechnology industry, the "facade" of biotech was only the pipeline
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Ruike Bio, an innovative vaccine company with a variety of vaccine varieties and core technology platforms, has attracted much attention
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Ruike Bio, an innovative vaccine company with a variety of vaccine varieties and core technology platforms, has attracted much attention
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According to the semi-annual report, Ruike Bio has 12 innovative vaccine products, covering HPV vaccine combination, new crown vaccine combination, shingles vaccine, influenza vaccine, adult tuberculosis vaccine and other heavy categories
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But now, the biotech industry has entered a new phase
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As the pipelines of leading biotech companies begin to enter the late-clinical or commercialization stage, investors gradually find that "execution" is another core factor that affects the value of biotech in addition to pipelines
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As the pipelines of leading biotech companies begin to enter the late-clinical or commercialization stage, investors gradually find that "execution" is another core factor that affects the value of biotech in addition to pipelines
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Because the biotechnology industry pays attention to "I have what I have without others, and I am fast with others"
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Due to the gap in execution between different companies, the product value will be different
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Due to the gap in execution between different companies, the product value will be different
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For example, under the epidemic, many companies' clinical trials were hindered and stagnant, and even failed due to high dropout rates; while a few companies accelerated against the trend, such as Ruike Bio
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It can be seen that in the first half of the year, the clinical progress of various HPV vaccines of Ruike Bio has been accelerated
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Among them, the main efficacy trial of the core product nine-valent HPV vaccine REC603 is in the follow-up phase; the small age group bridging and head-to-head immunogenicity comparison trial with Gardasil 9 have still completed the enrollment and vaccination of all subjects under the impact of the epidemic
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We may not be unfamiliar with the nine-valent HPV vaccine
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As a product that can protect 90% of cervical cancers and 90% of anal and genital warts, the nine-valent HPV vaccine is the most recommended HPV vaccine and has always been sought after by female consumers (HPV also infects men, and in the long run Looking at the male market is expected to further open)
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As a product that can protect 90% of cervical cancers and 90% of anal and genital warts, the nine-valent HPV vaccine is the most recommended HPV vaccine and has always been sought after by female consumers (HPV also infects men, and in the long run Looking at the male market is expected to further open)
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The HPV vaccine has also been one of the main engines of Merck's growth over the past few years
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It can be seen that in the first half of this year, the revenue of Merck's four/nine-valent HPV vaccine has reached 3.
133 billion US dollars, with a year-on-year growth rate of 46%
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The domestic market has contributed greatly: Merck said that the release of market demand in China is an important factor for its HPV vaccine volume
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It can be seen that in the first half of this year, the revenue of Merck's four/nine-valent HPV vaccine has reached 3.
133 billion US dollars, with a year-on-year growth rate of 46%
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The domestic market has contributed greatly: Merck said that the release of market demand in China is an important factor for its HPV vaccine volume
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But even so, the domestic market demand is far from being met
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At present, only Merck Gardasil9, a nine-valent vaccine, has been approved for marketing globally
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Due to the factor of production capacity, it is difficult to find a needle in China, and the lottery is generally used in various places to sell
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At present, only Merck Gardasil9, a nine-valent vaccine, has been approved for marketing globally
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Due to the factor of production capacity, it is difficult to find a needle in China, and the lottery is generally used in various places to sell
.
It is estimated that by 2025, there will still be 234 million women of school age who have not received the HPV vaccine, corresponding to a gap of about 700 million doses
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If the potential demand of men is further considered, the nine-valent HPV vaccine is imported by Merck, and the supply is obviously seriously insufficient
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If the potential demand of men is further considered, the nine-valent HPV vaccine is imported by Merck, and the supply is obviously seriously insufficient
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However, with the efforts of domestic vaccine companies such as Ruike Bio, this situation is expected to be alleviated
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Based on outstanding execution, superimposed on the leading phase III clinical progress and excellent clinical design, REC603 is expected to become the first domestic nine-valent HPV vaccine approved for marketing, realizing the import substitution of HPV vaccine and alleviating the situation of "hard to find a needle"
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Based on outstanding execution, superimposed on the leading phase III clinical progress and excellent clinical design, REC603 is expected to become the first domestic nine-valent HPV vaccine approved for marketing, realizing the import substitution of HPV vaccine and alleviating the situation of "hard to find a needle"
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In addition, the company's bivalent HPV vaccine has completed Phase I clinical trials, and the new adjuvant quadrivalent HPV vaccine REC604a has completed preclinical studies and will submit an IND application in the second half of this year
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The clinical advancement of Ruike Bio's new crown vaccine is progressing even more rapidly
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On August 19, Ruike Bio announced that its comparative study of ReCOV and mRNA vaccine has completed the enrollment and research vaccination of all subjects
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At this time, it is only two weeks before the approval is obtained, which fully reflects the efficient execution of the team
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On August 19, Ruike Bio announced that its comparative study of ReCOV and mRNA vaccine has completed the enrollment and research vaccination of all subjects
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At this time, it is only two weeks before the approval is obtained, which fully reflects the efficient execution of the team
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At present, ReCOV is also promoting the Phase II/III clinical research of ReCOV in the Philippines and the United Arab Emirates, as well as domestic clinical research
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According to the clinical data disclosed by the company, ReCOV can induce high-titer broad-spectrum neutralizing antibodies and Th1-biased T-cell immune responses, as well as have good cross-neutralizing effects on variant viruses such as Omicron variant virus and delta variant virus.
and immune persistence
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and immune persistence
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This means that ReCOV may soon become a new choice for global epidemic prevention; and for RecoBio, it has seized the need for "strengthening needles" that are about to break out
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In addition, the world's first freeze-dried mRNA vaccine developed by a subsidiary of Ruike Bio has obtained approvals from the Philippines and New Zealand, and is rapidly advancing clinical work
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According to the above information of Ruike Bio, it is not difficult to find that although the market is still cold, a few biotech companies with rich pipeline layouts are quickly on the road to fulfill expectations and even realize value enhancement with their outstanding execution capabilities
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/ 02 /
/ 02 // 02 // 02 /"Building a Nest and attracting Phoenix" promotes the introduction of talents,
"Building a Nest and attracting Phoenix" promotes talent introduction, "Building a Nest and attracting Phoenix" promotes talent introduction, "Building a Nest and attracting Phoenix" promotes talent introduction,Strengthen the company's leading position and build long-term value
Strengthen the company's leadership and build long-term value Strengthen the company's leadership and build long-term value Strengthen the company's leadership and build long-term valueUnder the cold winter, we need a sense of urgency, but we don't need to be overly anxious
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Although in the trough of this cycle, most innovative pharmaceutical companies will face survival choices due to the closure of the financing window
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However, many companies still have abundant cash flow and can carry out R&D work calmly
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However, many companies still have abundant cash flow and can carry out R&D work calmly
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For example, Ruike Bio's efficient business promotion, in the case of many clinical trials entering the later stage, as of the end of June 2022, it still holds nearly 1.
5 billion yuan of fund reserves on the account, with a very high safety pad
.
5 billion yuan of fund reserves on the account, with a very high safety pad
.
What is certain is that the cold winter will eventually pass, market financing channels will be reopened, and outstanding companies will accelerate their rise
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Of course, with reference to the overseas biotech industry, innovation cannot continue to accelerate, and stop-and-go is the norm
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This also means that only long-distance runners with super endurance can continue to break through
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This also means that only long-distance runners with super endurance can continue to break through
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For biotech companies, the core of achieving super endurance is a capable management team
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The rapid development of the domestic innovative drug industry in the past few years has largely benefited from the return of many returnees to start businesses
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In particular, the vaccine development cycle is too long, and only a reliable team can sit on the "cold bench"
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In particular, the vaccine development cycle is too long, and only a reliable team can sit on the "cold bench"
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In fact, Ruike Bio was able to buck the trend thanks to its experienced management team
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The founder of the company, Liu Yong, has more than 20 years of experience in vaccine research and development and commercialization.
He has both an international perspective and is familiar with the domestic vaccine market.
The chief scientist Hong Kunxue, chief medical officer Zhang Jianhui and other core personnel have rich experience in R&D and clinical practice
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He has both an international perspective and is familiar with the domestic vaccine market.
The chief scientist Hong Kunxue, chief medical officer Zhang Jianhui and other core personnel have rich experience in R&D and clinical practice
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Obviously, for biotechnology companies, only by constantly enriching their teams can they meet more challenges and achieve the leap from laboratory innovation to global innovative pharmaceutical companies
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For this reason, even if it has a leading position in the industry, Ruike Bio is still promoting the introduction of talents
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In the first half of the year, in terms of talent construction and team building, the company's team continued to recruit high-quality talents in an orderly manner, which has rapidly expanded to 478 people
.
The newly joined Chief Quality Officer Ms.
Wang Jing and Chief Commercial Officer Ms.
Feng Yanfei have extensive experience in quality management and global business cooperation
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The newly joined Chief Quality Officer Ms.
Wang Jing and Chief Commercial Officer Ms.
Feng Yanfei have extensive experience in quality management and global business cooperation
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With the addition of these industry experts, it will undoubtedly further lay a solid personnel foundation for Ruike Bio to efficiently promote the market access and commercialization of candidate vaccines including 9-valent HPV vaccine and new crown vaccine, and fully prepare the company to go global
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/ 03 /
/ 03 // 03 // 03 /Based on the domestic to the global,
Based on the domestic to the global, based on the domestic to the global, based on the domestic to the global,Potential vaccine "nova" breaks through the development ceiling
Potential vaccine "Nova" breaks through the development ceiling Potential vaccine "Nova" breaks through the development ceiling Potential vaccine "Nova" breaks through the development ceilingGoing overseas has always been the poetry and distance of biotechnology companies, but overseas is not a safe haven for innovative drugs, but a testing ground
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Because there is no shortcut to go overseas, the clinical location, layout and destination must be aligned with overseas
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This is a challenge, and it places more demands on a company's management team
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This is a challenge, and it places more demands on a company's management team
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But going overseas is also an opportunity
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After all, overseas has a larger audience and higher payment ability
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For this reason, even though it is difficult to enter overseas markets, many pharmaceutical companies still set their sights overseas
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After all, overseas has a larger audience and higher payment ability
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For this reason, even though it is difficult to enter overseas markets, many pharmaceutical companies still set their sights overseas
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In April this year, ReCOV Bio-Industrialization Base successfully passed the EU QP (Quality Authorized Person Audit) audit, marking the company's Taizhou production base and quality management system in line with EU GMP standards, laying a solid foundation for ReCOV's high-quality development and future international commercialization foundation
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In fact, the wave of domestic biotechnology companies going overseas is just the beginning, because many powerful players already have the ability to stand on the global stage
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For example, Ruike Bio has been deeply involved in the field of recombinant protein vaccine + mRNA vaccine since its establishment, and is one of the few hard-core players in the domestic vaccine field who has broken through the "stuck neck" technology
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In the field of recombinant protein vaccines, the most difficult technology to overcome is adjuvant
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So far, only 6 new vaccine adjuvants have appeared in marketed vaccines
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So far, only 6 new vaccine adjuvants have appeared in marketed vaccines
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And Ruike Bio has made breakthroughs in this field
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The company's new adjuvant platform can develop new adjuvants that are comparable to FDA-approved adjuvants, and can also discover new adjuvants that have not been researched by companies so far
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The company's new adjuvant platform can develop new adjuvants that are comparable to FDA-approved adjuvants, and can also discover new adjuvants that have not been researched by companies so far
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In addition to the new adjuvant platform, Ruike Bio also has a protein engineering platform and an immune evaluation platform
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The three complement each other, allowing for the development of more competitive vaccine products
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The three complement each other, allowing for the development of more competitive vaccine products
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In the field of cutting-edge mRNA technology, the company has also accumulated a large number of underlying core patents and has made technological breakthroughs
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The freeze-dried mRNA vaccine mentioned above is the representative of the company's technology towards industrialization
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The freeze-dried mRNA vaccine mentioned above is the representative of the company's technology towards industrialization
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For biotech companies such as Ruike Bio, having the underlying core technology is the key to building the existing core pipeline, and it also brings more possibilities for them to stand on the global stage
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The biggest charm of biotech companies lies in "three days apart, you should be impressed": they follow a leap-forward development, that is, from 0 to 1, then from 1 to 10, from 10 to 50.
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The growth flywheel is turning faster and faster
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The growth flywheel is turning faster and faster
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Soon, outstanding players, including Rico Bio, may bring them new and different feelings
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