Specialist
Former Director at Stemirna Therapeutics Co Ltd
Agenda
- LNP (lipid nanoparticle), LPP (lipopolyplex) and LPX (lipoplex) delivery systems – technology routes and advantages and disadvantages
- Domestic vs foreign players in technology platform, pipeline planning and R&D progress
- China’s mRNA vaccine development progress and clinical research challenges
- Talent shortage in China and domestic players’ team competency comparison
Questions
1.
In our interview today, we will discuss the technical barriers in mRNA technology development. The creation of mRNA requires the process of in vitro transcription. How is the DNA template determined? How could we evaluate the impact of DNA template on the selectivity and output of transcription reactions?
2.
Could you compare the several mainstream nucleotide modification strategies? Different technologies would be applied to control the content of adenine, uracil, guanine and cytosine and to modify m5C (5- methylcytosine) and pseudouracil. How have the technologies matured?
3.
Could you talk about the technology routes of common delivery systems, including LNP (lipid nanoparticle), LPP (lipopolyplex) and LPX (lipoplex) delivery systems? What are their advantages and disadvantages?
4.
What kinds of test data could we refer to in order to evaluate delivery systems’ maturity? What do you think are the technical challenges or barriers that are worth our attention?
5.
What are the barriers in the synthesis of delivery systems? Could you introduce the technical barriers in terms of, for example, the process development and equipment required? Do domestic players mostly develop the processes on their own or by outsourcing the sector to third-party companies? Are different companies’ processes notably different?
6.
mRNA vaccines are not stable enough. What could be the challenges during process scale-up at a later stage? What are the matters that we need to pay attention to during mRNA vaccine process scale-up?
7.
How to implement quality control in the later stage of mRNA vaccine development? What are the main analytical testing methods for the vaccines?
8.
You mentioned the limitations of equipment on relevant suppliers in the upstream industry chain. What is the current maturity of the upstream supply chain in the mRNA industry? What are the mainstream domestic and foreign suppliers of DNA templates, polymerases, nucleotides, reagents for capping and transcription and other raw materials? What are the difficulties to be solved at present?
9.
The coronavirus pandemic is the first time for mRNA to be used in practical applications. Could you evaluate the technology platform maturity, pipelines other than COVID-19 vaccines, as well as the relevant R&D progress of domestic and foreign players that you are familiar with? Among the current domestic players, which companies are you more optimistic about?
10.
It takes a short period of time to develop a sample of COVID-19 mRNA vaccines. In the early stage, many domestic companies quickly produced sample vaccines, but they lag far behind foreign players in terms of clinical progress in recent years. Could you introduce the problems in clinical research?
11.
In view of the current international studies, what are the noteworthy cancer types and mechanism directions for the development of mRNA vaccines related to tumour immunotherapy in the US?
12.
Several domestic companies are conducting multi-regional clinical trials on COVID-19 vaccines internationally, but the progress is slow. Based on your understanding, what are the weaknesses of domestic players compared with global leading players such as Moderna in terms of clinical progress?
13.
Have you had any contact with clinical centres or some PIs (principal investigators), especially experts in China? What about their opinions on, or concerns about the clinical research on mRNA vaccines?
14.
At present, mRNA vaccines have not been approved in China. Fosun Pharma has introduced products of Pfizer and BioNTech, but those products have not been approved yet. Relevant products have already been approved in the US. Based on your understanding of the working styles of approval agencies in China and the US, could you compare the current risks that the agencies are still paying attention to? As the US is getting increasingly experienced in the approval of relevant products, when will the CDE (Center for Drug Evaluation) in China follow suit in the future? Is it possible for domestic mRNA vaccines or the first domestically manufactured mRNA vaccine to get approved in the coming two years?
15.
What talent is in shortage in China at present? Could you compare the team competency of domestic players such as Abogen and Stemirna Therapeutics?
16.
Could you comment on the long-term development potential of mRNA vaccine technology? The mRNA vaccine technology is highly expected to be used for producing COVID-19 vaccines. Which segments, including infectious diseases and tumours, will the mRNA vaccine technology be highly expected to be used in from the perspective of long-term technological development?
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