【MPP】
Q: What is the progress of the approval and commercialization of the new crown small molecule drug MPP in different regions?
A: MPP is the patent pool organization, when Merck and Pfizer opened patents to low-income countries, the company's team participated in the first time, according to their access requirements for products, submitted information. The company's ability to internationalize is recognized, with licenses from Merck and Pfizer, which is 105 countries and Pfizer is 95 low-income countries.
At present, the drug is still in the process of research and development, to do the process research and development of raw materials and preparations and process verification, to ensure that it meets the requirements of the WHO PQ, and some strict regulations of the country, and can be supplied globally after passing the review. Judging from the current progress, by the end of the year, the study can be completed and declared.
The company has its own sales layout in Africa and some low-income countries, and can supply after completing the review. At present, the approval application has not been completed, and the order has not been undertaken. Capacity reserves and supply chain arrangements are sufficient, and the progress of research and development is normal. In addition, the company also has sufficient cost competitiveness. Because for low-income countries, it is mainly necessary to reflect the characteristics of "high quality and affordability", and to ensure adequate supply, so as to alleviate the problem of the epidemic.
Q: In the layout of domestic anti-epidemic products, does the company have any plans to introduce small molecules of new crown drugs into China?
A: In the entire anti-epidemic toolbox, from the perspective of prevention, there are vaccines and long-acting neutralizing antibodies, and from the perspective of treatment, there are small molecule drugs, neutralizing antibodies, and special drugs such as double antibodies. A necessary combination of the two is a must, and of course, there needs to be an effective detection to support.
Fosun Pharma is fully committed to the development of testing, preventive drugs and therapeutic drugs. In terms of drugs, Fosun was first licensed to develop the pharmaceutical industry's pkrutamine, and the pioneer will publish the results of clinical trials in the United States at the end of March and early April; in addition, the company also participated in the MPP of Pfizer and Merck;
Third, the company is also developing therapeutic antibodies, including Henlius and other subsidiaries are developing, at present, the company's therapeutic antibodies are quite broad-spectrum, low-cost, and a single drug can achieve the effect, the next step may be to the special population can not be vaccinated preventive immunity and treatment after severe illness will play an important role. The company has also developed an inhalable dual antibody, highly broad-spectrum, that is a site that hardly changes against the virus.
Recently, everyone has paid more attention to Shiono's products, and the company has also noticed that the company's pipeline also develops other COVID-19 therapeutic drugs; and the company has always been open to discussing potential cooperation opportunities around the world, and strives for a comprehensive layout in this regard. This is very critical.
Q: After MPP gets the authorization, how long does it take to complete the development and then go public?
A: The company needs to carry out process development and verification of raw material preparations, which takes about 9-10 months, and is expected to declare to the WHO at the end of this year and supply to low-income countries after approval.
3) Therapeutic drugs: the introduction of MPP drugs, Merck for 105 low-income countries, Pfizer for 95 low-income countries, is currently in the process of process development, the overall progress is still very fast, is expected to apply at the end of the year, after approval can be launched. We have also developed therapeutic diphtavigs, which can be administered by inhalation route.
Q: What is expected to be the performance of Côte d'Ivoire, the distribution centre for the African market, during the MPP process?
A: MPP is mainly aimed at low-income countries, Côte d'Ivoire will certainly play a major role, covering dozens of low-income countries in Africa, has developed steadily in the past few years, and has played a great role in supporting the public and private markets of Guilin Southern Medicine Innovative Drugs, english and French. Some of the first batch of Gland Pharma in Africa have already been registered and put on sale. Côte d'Ivoire's performance has maintained normal growth in recent years, and its growth rate is still faster than the company's bottleneck growth rate.
Q: MPP's entire order situation?
A: MPP is a process, after we get the license, we need to carry out process development,
Then the validation of the production process, the process required by this regulation must be completed. This is followed by PQ certification and the submission of applications. After the application is approved, we can only pick up the order. The entire order volume can only be determined according to the trend of the global epidemic. At present, from our own point of view, when declaring MPP, we have increased the production capacity at the same time. The important requirements of MPP audit are not only the quality system compliance, the ability to develop and research, the supply chain to be able to pass the guarantee, and the production capacity to meet the requirements, so in this regard, the most important thing is to look at the entire future demand. We have made great efforts in internationalization in recent years, especially in low-income countries, such as Africa we have our own team layout, after approval, I believe that we still have some unique advantages, can occupy a certain reasonable MPP market share, and our costs also have advantages, especially for low- and middle-income countries Accessibility is the most important.
【Fu bi tai】
Q: As of the end of February, Fubitai has received more than 20 million doses in Hong Kong, Macao and Taiwan, contributing to the revenue?
A: At the end of 21, the revenue was recognized as 22 million doses, and the 20 million doses disclosed in the financial report were the number of vaccinations by the end of February. The company's agreement with BNT has sales milestones, paying a total of $70 million when it reaches its first $200 million, $500 million sales milestone, which was already reached last year.
Q: What is the difference between the pricing of Fupitech and the pricing of BNT?
A: BNT pricing in different markets is different, but the difference will not be very large. Our pricing in Hong Kong, Macao and Taiwan is slightly different, but it will not be much worse.
Q: How much is The approval progress of Fubitai in China? If approved in the Mainland, the distribution system?
A: Fubitai has played a very good protective role in the epidemic in Hong Kong, Chinese mainland approval situation, the company and the Food and Drug Administration in the normal communication process.
Fosun Pharma has a layout in the cold chain, and the selection of partners includes the head of the business such as Shangyao, and the cooperation with them can ensure that once approved, all vaccination points can be reached. As soon as it is needed, the entire system can be operated immediately and can fully meet the requirements of cold chain transportation. BNT also audited the company's entire cold chain operations.
Q: If Fubitai is approved, how long will the capacity of the Jinshan plant climb? What is the maximum capacity?
A: The ramping capacity of the Kingsoft plant is not the main time consumption factor, depending on the equipment installed by the company. The company is designed with a capacity of 1 billion.
Mainly the IQ, OQ, PQ time after the technology transfer, and the time of the FDA GMP inspection, which takes about 6-9 months.
If it passes the review, it can quickly reach an annual production of 1 billion doses.
In addition, BNT and Pfizer provided a total of 3 billion doses to the world last year, and the production capacity has increased a lot, and if it is approved domestically, it needs to be imported, and it can have a good amount.
Q: Where has the company and BNT's technology transfer been achieved, and how long will it take?
A: According to the contract between the two parties, the company's technology transfer needs to be approved, and the preparation work has been done, so it has not yet started.
Q: How are hong Kong, Macao and Taiwan's demand for vaccines this year?
A: The demand is normal, the recent vaccination volume in Hong Kong is still quite large, the main vaccination points are full, and the demand is comparable to last year. The needs of Taiwan and Macao are still in friendly negotiations. Overall, there is still normal demand in these markets.
Q: What is the revenue and profit contribution of the 2021 Fupitech COVID-19 vaccine?
A: The sales volume of Fubitai in Hong Kong, Macao and Taiwan last year was 2200w (disclosed), and the sales amount was not disclosed, but it has reached the sales milestone of 500 million US dollars.
Fupitech has a positive contribution to our profits but not much, for the following reasons: 1) We have R&D milestones and sales milestones, which total $15 million. We have already reached the payment conditions of the milestone last year, so it is necessary to pay for these two parts of the milestone, which is an investment; 2) Last year's investment in clinical research and development, early investment in production lines, layout of cold chain, market medical team, marketing team investment.
Q: How is the progress of Fubitai's domestic declaration, and has there been any communication with the NMPA in the near future?
A: The mainland is currently in normal progress in the process of approval.
Our comprehensive plan for anti-epidemic products: 1) there is mRNA in vaccines; we have developed long-acting prophylactic antibodies for people who are not suitable for vaccination, and there have been clinical advances in the United States, and there are ongoing second-generation effective antibodies, which may be disclosed within this year, more effective and lower cost. 2) Testing: the first time to launch nucleic acid detection, antigen detection believes that we will also catch up with the needs of the market.
Q: Last year,the domestic declaration was done for a long time, and I don't know if there is a plan for capacity transfer, and will the cost of building the domestic sales team in the early stage be reflected a little more last year?
A: The cost of the team does exist. Including the cost of the R&D and sales milestones just mentioned, but this can be considered a one-time expenditure, we have met the conditions in the first year, we have paid.
Q: The capacity transfer was mentioned earlier, but because the domestic approval is also relatively slow, I don't know if there is any change in the company's thinking now? Is it that after getting the approval, will you talk to BioNTech about capacity transfer?
A: Our technical team is always ready and changing, and once approved, we initiate a technology transfer as soon as it is approved. Our related work is ready, including the workshop auxiliary facilities, the basic design, process technicians, sales team are ready. We and BioNTech have regular meetings at different levels every week to communicate about related matters, and we have been in a normal state and there has been no change.
