Dialogue Fosun Pharma Back to Emin: The latest developments in the mRNA new crown vaccine BNT162b2

November 24th is a crucial day for the development of mRNA's new coronary nucleic acid vaccine in China.
the mRNA new coronary nucleic acid vaccine BNT162b2, developed by Fosun Pharma and BioNTech SE in Germany, started Phase II clinical trials in Taizhou, Jiangsu Province, China, and Sushui, China.
And just today, BioNTech, Fosun's global collaborating company for the new crown vaccine, announced that it had received emergency approval from the UK Medicines and Health Products Regulatory Agency (MHRA) for the emergency use of its new crown vaccine, BNT162b2, the world's first new crown vaccine.
means that the world's new crown vaccine is expected to be approved within a short period of time.
Recently, before the COVID-19 Vaccine/Antibody Research and Development and Industrialization Forum held at Crowne Plaza Hotel in Kunming Center on December 11-12, the Organizing Committee had the honor of interviewing Dr. Hui Aimin, President and Chief Medical Officer of Fosun Pharma Global Research and Development, in advance to talk about the latest development of the mRNA new coronary nucleic acid vaccine BNT162b2, which has attracted much attention in the industry.
President of Global Research and Development, Chief Medical Officer Fosun Pharma Global Research and Development President, Chief Medical Officer, Director of the Scientific Committee, Co-President of Fosun Pharmaceuticals.
director of the Shanghai Stem Cell Therapy Key Laboratory and deputy director of the Oncology Professional Committee of the China Drug Promotion Association.
was Sanofi's Global Vice President responsible for global oncology clinical research and development.
30 years of experience in cancer diagnosis and development at the world's leading medical centers and well-known pharmaceutical companies, he has directly led the global development and registration of anti-cancer drugs for small molecules and biologics such as Ixazomib, Isatuximab (anti-CD38).
recently led the signing and landing of Fosun Pharma's joint development agreement with BioNTech's new crown pneumonia mRNA vaccine.
published more than 80 papers (including the New England Journal of Medicine, The Lancet, Cell Cancer and other top journals), and served as Deputy Director of the Academic Committee of the 5th China Oncology Conference.
the 1990s at the National Cancer Center of Japan, University Hospital of Tokyo and other units engaged in oncology clinical and molecular biology research, in the field of molecular biology of liver cancer was at the time in the international leading position.
2000 in the United States National Cancer Institute, GE Medical Group, Takeda, Sanofi and Fosun Pharma and other research and development of cancer drugs.
has led ixazomib's global clinical research and development and international registration at Takeda, from drug entry to FDA approval in just six years, from filing a listing application to FDA approval in just four months.
in China, the first model to apply a globally registered clinical China extension trial in 2013 led to the approval of ixazomib to market, greatly speeding up the time to market in China, the drug has become a strong driving force for Takeda's revenue.
Sanofi, which dominates the global clinical, registration strategy and clinical trial design of the anti-CD38 antibody Isatuximab, has been approved by the FDA.
has led the development and listing of several innovative drugs in China, including Isazzomi, Bendamustin, Avaquperpa and others.
COVID-19 Forum Organizing Committee: Fosun Global Cooperation mRNA New Crown Vaccine BNT162b2 Overseas Phase III Clinical Final Effectiveness reached 95%, compared to the influenza vaccine about 70% effectiveness rate, can be described as a revolutionary improvement in the field of vaccines.
fosun initially chose this vaccine for the purpose of joint development, can you talk about the advantages of this vaccine? Dr. Hui: We've been looking at mRNA for almost three years, and I'm personally very bullish on mRNA because of its wide application.
protein is a biological unit of function, a variety of human functions, are carried out by protein.
and protein production is trinated by DNA into RNA, RNA is translated into proteins, so whether DNA is good, RNA is good, or protein is good, at what level abnormal, will lead to abnormal proteins and cause disease.
then mRNA technology uses human cells as a factory in the body to produce normal proteins by entering a RNA, which allows him to use human cells as a factory in the body, thus achieving a cure.
so it's very widely used in theory, which is why we've always been very bullish on mRNA.
so we've been looking at this area for the last three years.
when the new crown outbreak broke out, we realized early on that we might end the outbreak and eventually need a vaccine.
we have also studied several technical paths, including inactivated vaccines, detox vaccines, vector vaccines, recombinal protein vaccines, DNA vaccines, and mRNA vaccines.
From a scientific point of view, we think the mRNA vaccine has an advantage, why we choose the mRNA vaccine, specifically from the mRNA vaccine five aspects of the advantages: First, the mRNA vaccine development cycle is short, can quickly according to the gene sequence of the virus to develop a new candidate vaccine.
, the mRNA vaccine is a dual mechanism of body fluid immunity and T-cell immunity.
in the past, traditional vaccines had only one body fluid immunity, and the mRNA vaccine, in addition to body fluid immunity, which produces meso-antibodies to the virus, also has a cellular immunity that stimulates T-cells to prevent the invasion and proliferation of the virus.
, the mRNA vaccine is immunogenic and does not require adage.
traditional vaccine, a advent is needed to aid the vaccine, and our mRNA vaccine does not need advent.
by the way, the adulent itself may also cause side effects.
, the mRNA vaccine does not contain viral components, is not at risk of infection, and is safe.
last point, the technical barriers to mRNA vaccines are high, but their production process is simple, easy to mass produce and supports global supply targets, so it is particularly suitable for this major outbreak.
Fosun Pharma chose the vaccine in the first place, but also took into account some of the risks.
is that the mRNA vaccine has no previous successful experience.
is not only an mRNA vaccine, any mRNA-type products, there is no research and development market experience, no one can guarantee that it will be able to develop successfully.
at the time, we decided to make an mRNA vaccine based on a scientific inference that there were advantages and that mRNA technology had potential prospects for dealing with major diseases such as tumors.
In fact, there are many manufacturers in the international world to do mRNA vaccine, our partner BioNTech is one of the world's top three strongest mRNA companies, we chose this company, but also for a variety of reasons, the most important point is that the company has a diversified mRNA technology platform.
COVID-19 Forum Organizing Committee: According to Fosun Pharma previously revealed that the BNT162b2 vaccine into the Chinese market, only need to carry out bridding experiments, equivalent to covering phase I., II. clinical trials, rather than the need for long phase III clinical trials.
can you share further on the current clinical progress of the vaccine and its prospects and challenges in entering the Chinese market? Dr. Hui: The BNT162b2 vaccine is currently the world's leading mRNA nucleic acid vaccine.
overseas, jointly developed by BioNTech and Pfizer, has achieved a 95% efficiency of all major therapeutic endpoints in phase III clinical studies worldwide (excluding Chinese mainland, Hong Kong, Macao and Taiwan) and on November 20 announced its application to the U.S. Food and Drug Administration (FDA) for emergency use authorization (EUA) approval for the BNT162b2 vaccine. On December 1st it was announced that a conditional application for a new crown vaccine for BNT162b2 had been submitted to the European Medicines Agency (EMA).
addition to the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA) and the U.K. Drug and Health Products Administration (U.K.). In addition to the MHRA's conditional listing permits, BioNTech has rolled out rolling applications around the world, including Australia, Canada and Japan, and plans to file applications with other regulators around the world.
, we will conduct Phase II clinical trials of the BNT162b2 new crown vaccine in Taizhou and Sushui, Jiangsu Province, China.
the vaccine has been done in foreign clinical trials, in the country do not need to do another phase III clinical, and now the domestic outbreak control is better, do not have the conditions to carry out phase III clinical trials at home.
so-called phase III clinical, mainly to see the protective effect.
to compare in a certain group of people do not fight the vaccine, how many people get pneumonia, after the vaccine how many people get pneumonia, is to see how much the incidence reduced.
Whether it is domestic enterprises, or foreign enterprises, including joint research and development is also good, in fact, are doing phase III clinical trials abroad, and then use foreign clinical trial data, plus some domestic data to support the application for the new crown vaccine on the market.
our vaccine has now been approved for clinical trials by the National Drug Administration, and on November 24th we had a clinical launch.
at the same time, we are also in active communication with the national drug regulatory agencies, in accordance with the law as soon as possible to apply for listing, can benefit our citizens at an early time.
COVID-19 Forum Organizing Committee: Since the new crown occurred, you, as president and chief medical officer of Fosun Pharma's Global Research and Development Center, can you describe what Fosun Pharma has done in the anti-epidemic layout? Dr. Hui: In the face of this outbreak, Fosun Pharma has made many efforts and contributions, including the development of nucleic acid diagnostic reagents, therapeutic drugs and vaccines, in combination with its own innovative research and development and global layout.
should say that Fosun Pharma's partnership with BioNTech to develop the vaccine is Fosun Pharma's first battle since its global research and development center was officially established earlier this year.
two sides from the beginning to the formal signing, only six weeks, the official meeting is no more than 2 times, fully demonstrated the high degree of mutual trust and recognition between the two sides.
From the first conference call between the two sides on January 29, to the signing of a non-disclosure agreement, to the first meeting, and then on March 13 signed a cooperation agreement, Fosun Pharma, BioNtech, CDE tri-party meeting, Fosun Pharma in China and the United States research and development team to take advantage of jet lag, 24-hour relay work, all links are in rapid operation, reflecting the efficiency of both sides, but also reflects the high hopes of the two sides.
In addition to this mRNA vaccine, our biopharmaceutical platform, Fuhong Hanxuan, is also developing antibody drugs for the treatment of new coronary pneumonia, and both HLX70 and HLX71 candidates for new coronary therapy have been approved in FDA clinical trials, which is some of the work we are doing in treatment.
in terms of diagnosis, our diagnostic research and development of nucleic acid kits, both at home and abroad have been marketed and sold, in response to the outbreak has also played an important role.
year has passed since the outbreak of neo-crown pneumonia began to rage, and researchers around the world are scrambling for the final vaccine development sprint.
In mid-to-late November, the positive results of the new crown vaccine continue to emerge, several candidate vaccine clinical performance, in the face of fierce global competition, Fosun Pharma next to take what action, what strategic layout in the future? Dr. Hui: Our top priority should be to advance clinical trials of the new mRNA coronary nucleic acid vaccine in China, to actively work with our international partners, and then to actively communicate with the Drug Administration to bring the vaccine to market in China as soon as possible, to build our strong sales team, hoping that our vaccine will be widely used in China as soon as possible, and to actively promote some antibody therapy drugs.
: "We did learn a lot in this outbreak.
The birth of a vaccine in the past took ten years, and from the current state of development, this time we have a chance to develop this vaccine in a year's time, and I think this is very promising.
So why can we shorten the ten-year time to a year, there are many reasons, I personally mainly in three ways: First, the new coronary pneumonia virus itself has less variation, and the mutation is more occurred in the un important part.
is a convenient condition for us to develop vaccines.
second, the progress of science.
next-generation gene sequencing, ultra-low temperature electron microscopes, these new technologies provide us with the gene sequence of the virus, provide the virus structure, and provide us with a good basis for the development of vaccines.
, we have a diversified vaccine technology path.
we have both traditional, mature inactivated vaccines, detox vaccines, viral vector vaccines, recombinated protein vaccines, and brand-new DNA and mRNA vaccines, which increase the chances of success.
experienced this outbreak, the mRNA vaccine stands out.
later outbreaks, the mRNA vaccine may be a good weapon against future outbreaks.
fourth, international cooperation.
why humans have been able to develop this new crown vaccine so quickly this time, and one of the most important is international cooperation.
International cooperation is really important, for example, in mid-January, when Chinese scientists isolated the new coronavirus, sequenced the virus, and put it on a public website that scientists around the world can use as a tool for research and development to study the new coronavirus, which is the largest international cooperation.
the outbreak from China to foreign countries, in China can not do this phase three clinical, can only do three phases of clinical abroad, in fact, this is also an international cooperation.
our partnership with Fosun Pharma and BioNTech is a classic success story.
BioNTech has the leading mRNA technology, Fosun Pharma has extensive clinical research and development, registration and commercialization experience, especially in China, which